Lilly to give biotech startups access to AI tools
Eli Lilly will give small biotechnology companies a chance to use artificial intelligence models trained on years of the pharmaceutical company’s research, launching Tuesday a new platform its says could help young startups a leg up in discovering new drug…
Novartis to gain heart drug in $1.4B deal for Tourmaline Bio
Dive Brief: Novartis on Tuesday said it will pay $1.4 billion to acquire the New York-based biotechnology company Tourmaline Bio and its experimental cardiovascular disease drug. Per deal terms, the Swiss pharmaceutical company will pay $48 per Tourmaline share, a…
BioNTech says dual-acting lung cancer drug helped shrink tumors
Dive Brief: BioNTech’s experimental bispecific cancer drug pumitamig helped shrink tumors in three-quarters of people with small cell lung cancer who were enrolled in a Phase 2 trial, and stabilized disease in all of them, the company said Monday. Company…
Pfizer, BioNTech showcase new data supporting COVID booster
Dive Brief: Pfizer and partner BioNTech said Monday their updated COVID-19 booster spurred strong immune responses against currently circulating coronavirus strains in late-stage testing, adding a key piece of evidence in support of the recently approved shot. According to Pfizer…
Wave shares sink on new study results for RNA editing drug
Dive Brief: An experimental RNA editing medicine from Wave Life Sciences helped study participants with a rare liver and lung disease produce a protein their bodies can’t make, but wasn’t as effective in testing as investors had anticipated. Last year,…
A drug discovery startup banks $150M for immune and obesity drugs
Dive Brief: Enveda Biosciences said Thursday it raised $150 million in Series D financing, doubling the cash it’s pulled in from venture capitalists this year to further its drug discovery. Its latest round was led by Premji Invest, the family…
Sanofi’s touted eczema drug hits study goal, but data fall short of expectations
Dive Brief: Sanofi shares dropped after the French drugmaker reported results from a highly anticipated study of a new kind of medicine for eczema that disappointed analysts and investors. The experimental drug, amlitelimab, technically succeeded in the trial, meeting all…
Atlas Venture reels in $400M to grow its biotech startups
Prolific biotechnology investment firm Atlas Venture said Thursday it raised $400 million to pump into its existing portfolio of drug startups, a move meant to support the companies that might struggle to secure further funding in the current climate. The…
Bravehart, a stealthy startup, looks to China to challenge Bristol Myers heart drug
A newly launched startup is the latest young company to build itself around a drug discovered in Chinese laboratories. Hengrui Pharma on Friday said it licensed an experimental heart medicine to a secretive startup called Braveheart Bio. Per deal terms,…
FDA to publish CRLs in real time; PEPFAR to distribute Gilead’s Yeztugo
Today, a brief rundown of news involving the Food and Drug Administration and Gilead Sciences, as well as updates from AC Immune, Agios Pharmaceuticals, Merck KGaA that you may have missed. Moving forward, the Food and Drug Administration plans to…
At Senate hearing, lawmakers express dissatisfaction with RFK Jr.’s vaccine moves
U.S. lawmakers clashed with Health and Human Services Secretary Robert F. Kennedy Jr. over his changes to the country’s vaccine policy and oversight of the Centers for Disease Control and Prevention, including the recent ouster of director Susan Monarez. Several…
FDA outlines new review pathway for drugs treating ultra-rare diseases
Dive Brief: The Food and Drug Administration plans to work more closely and flexibly with developers of drugs for certain ultra-rare conditions, outlining Wednesday a new process to coordinate its assessment of such medicines across the agency’s two principal review…
Biohaven’s rare disease drug is ‘ready to ship on Day 1’ following FDA approval
Biohaven’s top executive said his team is well-prepared to sell a therapy that could be not only the first approved medicine for a group of rare brain diseases, but also the company’s first commercial product since it sold off its…
Secretive startup Treeline unveils first clinical candidates, $200M in new funding
For the past four years or so, veteran drug hunters Josh Bilenker and Jeff Engelman have kept tightly under wraps the details of their latest project, a biotechnology startup called Treeline Biosciences. On Monday, they pulled back the curtain a…
Novartis thinks Arrowhead brain drug can succeed where others couldn’t
Novartis is once again taking aim at Parkinson’s disease, through a deal with Arrowhead Pharmaceuticals that could be worth billions of dollars. The deal, announced Monday, revolves around a preclinical drug that Arrowhead designed to silence the genetic instructions for…
Amgen to invest $600M in new US center; Sanofi drug for ITP approved
Today, we’re catching up after a long weekend on news involving Amgen and Replimune, as well as updates from Sanofi, Roche, Eisai and Biogen that you may have missed. Amgen on Tuesday said it will invest more than $600 million…
Why an FDA decision on Stealth’s Barth drug could ripple through the rare disease field
The case of Stealth BioTherapeutics and its rare disease drug could become a regulatory bellwether for other biotechnology companies seeking to understand how flexibly new leaders at the Food and Drug Administration will evaluate medicines for uncommon conditions. At the…
Startup Wugen raises $115M for ‘off-the-shelf’ CAR-T
Dive Brief: Wugen said Wednesday that it brought in $115 million in a new financing round that will help the company advance an “off-the-shelf” CAR-T therapy. Fidelity Management & Research led the financing, which involved more than a half dozen…
Amylyx drug comes up short; Sanofi names new CMO
Today, a brief rundown of news involving Amylyx Pharmaceuticals and Sanofi, as well as updates from Novartis, Roche and Eisai that you may have missed. A mid-stage clinical trial testing the best-known drug from Amylyx Pharmaceuticals has failed, leading the…
Novo strikes RNA drug deal with startup Replicate
Dive Brief: Novo Nordisk is again looking for help outside its own laboratories as it works to build on the success of Ozempic and its sister medicine Wegovy. In the latest deal, Novo will provide research funding for Replicate Bioscience…
CDC panel to discuss COVID, hepatitis B shots in meeting next month
A federal vaccine panel recently remade by Health and Human Services Secretary Robert F. Kennedy Jr. will meet in September to discuss and potentially vote on recommendations for vaccines against COVID-19, hepatitis B and measles. According to a federal notice posted…
FDA approves updated COVID boosters, but narrows use
The Food and Drug Administration on Wednesday approved updated COVID-19 vaccines that target a commonly circulating coronavirus strain, but narrowed who in the U.S. can receive them. In a post on the social media site X, Health and Human Services…
Lilly says breast cancer drug extended survival in study
Dive Brief: People with early breast cancer who were treated in a late-stage study with Eli Lilly’s drug Verzenio and standard hormone therapy lived longer than those given hormone therapy alone, the company reported Wednesday. The summary results come from…
RNA drug from Regeneron, Alnylam succeeds in rare autoimmune disease trial
Dive Brief: An RNA medicine developed by Regeneron Pharmaceuticals and Alnylam Pharmaceuticals helped control symptoms of the chronic autoimmune disease generalized myasthenia gravis in adults enrolled in a late-stage study, Regeneron said Tuesday. Regeneron also tested the RNA medicine, called…
Lilly to submit obesity pill after hitting goal in third late-stage trial
Dive Brief: Eli Lilly on Tuesday said it is ready to ask the Food and Drug Administration for approval of its GLP-1 pill orforglipron after the drug met the main weight loss goal in a Phase 3 trial in people…
FDA suspends license for Valneva’s chikungunya shot
The Food and Drug Administration has suspended the license of Valneva’s chikungunya vaccine following new reports of serious adverse reactions, sending shares in the French drugmaker sharply lower on Monday. In a statement Friday, the agency said its decision was…
Royalty Pharma buys BeOne stake in Amgen lung cancer drug sales
Dive Brief: Royalty Pharma has grabbed rights to a share in revenue from lung cancer drug Imdelltra, announcing Monday it will pay $885 million upfront for BeOne Medicine’s royalties paid by partner Amgen for sales outside China. BeOne, formerly known…
MAHA may take aim at pharma DTC ads
A much-anticipated report from the Make America Healthy Again Commission was postponed earlier this month. But nestled within leaked documents is a strategy that reveals more about health leaders’ goals, including potential new oversight of pharma’s direct-to-consumer advertising practices. DTC…
Rocket can resume gene therapy trial after FDA lifts hold
Dive Brief: Rocket Pharmaceuticals plans to restart a Phase 2 gene therapy trial for a rare heart disease after working with the Food and Drug Administration to resolve questions around a study participant’s death earlier this year. The FDA ordered…
US, EU agree to terms of framework trade pact
The United States and the European Union formalized the terms of the framework trade agreement the two trading partners announced at the end of July, per a joint statement published by the White House Thursday. The statement provides additional clarity…
Sarepta pushes off debt payments in bid to regain financial footing
Dive Brief: Sarepta on Thursday said it’s reached agreements that remove about $700 million from a pile of debt due in 2027. The private agreements with debt holders will allow Sarepta to exchange the 1.25% convertible senior notes due in…
FDA cancels adcomm on Biohaven drug; Catalent lays off staff
Today, a brief rundown of news involving Biohaven and Catalent, as well as updates from Stealth Biotherapeutics, Jazz Pharmaceuticals and Celldex Therapeutics that you may have missed. The Food and Drug Administration no longer plans to hold a meeting with…
Gilead dives into ‘in vivo’ cell therapy with $350M buyout of Interius
Dive Brief: Gilead Sciences is deepening its investment in cancer cell therapy, announcing Thursday a deal to pay $350 million to buy privately held Interius BioTherapeutics for a technology designed to reprogram immune cells in patients’ bodies. If successful, Interius’…
FDA approves Ionis’ hereditary angioedema drug
The Food and Drug Administration on Thursday approved a drug Ionis Pharmaceuticals developed for the rare genetic disease hereditary angioedema, making the therapy, known as donidalorsen, the third new medicine to reach market this year for the rare genetic condition….
Xoma, a drug royalty specialist, buys another ‘zombie’ biotech
Xoma Royalty Corp. is acquiring another struggling biotechnology company in further sign of interest among certain firms in buying floundering drugmakers and shutting them down. Xoma on Wednesday agreed to buy Mural Oncology, a cancer biotech once spun out of…
Lilly searching for new neuro chief as White set to retire
Eli Lilly is searching for a new neuroscience chief after announcing Wednesday that the division’s current head, Anne White, will retire in December after a 30-year career at the Indianapolis pharmaceutical company. White, who serves on Lilly’s executive committee, took…
Viking shares sink as obesity pill misses expectations in key study
Dive Brief: An experimental weight loss pill from Viking Therapeutics helped people with obesity lose up to 12% of their body weight over 13 weeks in a Phase 2 trial, beating a placebo by 11 percentage points, the company said…
PTC drug for Friedrich’s ataxia rejected; Lilly sells nearly $7B in bonds
Today, a brief rundown of news involving PTC Therapeutics and Eli Lilly, as well as updates from Regenxbio, Skyhawk Therapeutics and Adaptive Biotechnologies that you may have missed. An experimental drug developed by PTC Therapeutics for the neuromuscular disorder Friedrich’s…
Stealth resubmits rare disease drug to FDA
Dive Brief: Stealth BioTherapeutics is once again seeking U.S. approval of a drug for the rare condition Barth syndrome, claiming in an announcement Monday that it has addressed concerns that led the Food and Drug Administration to reject the therapy…
Kennedy’s mRNA cuts could set US science back, experts warn
To many scientists and doctors, messenger RNA vaccines are an incredible feat of modern medicine. But to top health leaders in the Trump administration, shots made with the technology pose more risks than they do benefits. Earlier this month, Secretary…
With FDA PreCheck, drugmakers may get a manufacturing boost
The Trump administration recently added to an ongoing push to boost pharmaceutical manufacturing in the U.S., launching a new program dubbed PreCheck that aims to ease the process of bringing domestic facilities online. Using a two-phase approach, the program offers…
Vedanta, PureTech’s microbiome startup, to cut staff after study setback
Vedanta Biosciences, a startup working on microbiome drug research for more than a decade, will lay off nearly a fifth of its staff after one of its top prospects failed a clinical trial. The privately held company said Wednesday that…
Merck KGaA ventures into new territory in the US
Merck KGaA has been making moves to propel itself into becoming what CEO Belén Garijo described as a “globally diversified science and technology powerhouse.” Most recently, the company closed a $3.4 billion acquisition of Pfizer spinout SpringWorks Therapeutics, which will…
Precigen wins immunotherapy approval; Pfizer sickle cell drug fails trial
Today, a brief rundown of news involving Precigen and Pfizer, as well as updates from the Institute for Clinical and Economic Review, Superluminal Medicines and Generation Bio that you may have missed. The Food and Drug Administration granted full approval…
HHS revives defunct task force on childhood vaccine safety
The Department of Health and Human Services announced Thursday it will reinstate a disbanded task force on childhood immunizations, claiming that it will work to improve the “safety, quality, and oversight of vaccines administered to American children.” The Task Force…
Lilly says it will raise drug prices in Europe, responding to Trump threats
Eli Lilly on Thursday responded to a Trump administration plan to lower U.S. drug costs by issuing a statement claiming it will raise prices in European countries to “align” them with the costs paid “across developed countries.” The statement, which…
Sarepta sells Arrowhead shares as partnership, debt payments loom
Dive Brief: Sarepta on Wednesday announced the divestment of its entire equity stake in partner Arrowhead Pharmaceuticals as the company faces the need to make milestone payments of as much as $300 million in coming months. Arrowhead agreed to take…
Vor says drug licensed from RemeGen succeeded in Sjögren’s study
Dive Brief: Vor Biopharma on Wednesday said a late-stage study run in China by its partner RemeGen succeeded, showing that treatment with an experimental drug called telitacicept helped reduce disease activity in people with the autoimmune condition Sjögren’s syndrome. Vor…
AbbVie to build API plant in Illinois as it steps up US production
AbbVie plans to spend $195 million to build a new facility to produce active pharmaceutical ingredients in its hometown of North Chicago, Illinois. Construction will begin in the fall, and the site should be fully operational in 2027, AbbVie said…
Insmed gains US approval of lung disease drug forecast to be blockbuster
Dive Brief: Insmed has gained approval for its second lung disease medicine, announcing Tuesday Food and Drug Administration clearance of Brinsupri to treat a chronic condition that results in dilated airways in the lungs, chronic cough and frequent respiratory infections….
Bayer buys into KRAS cancer drug; Novartis immune therapy goes 3 for 3
Today, a brief rundown of news involving Bayer and Novartis, as well as updates from Biohaven, Biogen and the Food and Drug Administration that you may have missed. Bayer is licensing an experimental cancer therapy from Kumquat Biosciences in a…
IO Biotech sees path forward for skin cancer vaccine despite study setback
An experimental cancer vaccine fell short of its main objective in a Phase 3 trial in melanoma, causing shares of the shot’s developer, IO Biotech, to fall by double digits on Monday. IO Biotech, however, still believes the vaccine performed…
As gene therapy sales sputter, one biotech aims to defy the odds
Market challenges continue to plague the gene therapy space. Despite their curative potential, many treatments struggle to gain traction once they’re available to patients. Sarepta Therapeutics’ recent roller-coaster ride with Elevidys is a prime example. After a controversial approval in 2023,…
Lilly shares fall as obesity pill misses expectations in key trial
Dive Brief: Eli Lilly’s experimental pill for obesity helped people lose more weight than placebo in a Phase 3 study, but was less effective than Wall Street investors had anticipated, leading to a selloff in shares that erased about $100…
FDA to start new ‘precheck’ program to boost US drug production
The Food and Drug Administration has unveiled a new initiative meant to boost U.S. drug manufacturing, responding to a recent Trump administration order to find ways to speed the construction of new pharmaceutical factories. The agency on Thursday announced what…
FDA to start new ‘precheck’ program to boost US drug production
The Food and Drug Administration has unveiled a new initiative meant to boost U.S. drug manufacturing, responding to a recent Trump administration order to find ways to speed the construction of new pharmaceutical factories. The agency on Thursday announced what…
Vinay Prasad, in surprise reversal, to rejoin FDA after abrupt departure
Vinay Prasad will return to lead the Food and Drug Administration office that oversees vaccines and gene therapy in a stunning reversal that comes less than two weeks after he abruptly left the job. Andrew Nixon, a spokesperson for the…
Inside AstraZeneca’s long-term strategy in lung cancer
For AstraZeneca, a single mutation has launched an entire blockbuster lung cancer franchise. In 2003, the pharma giant began a complicated journey that was almost doomed from the outset. The lung cancer treatment Iressa, which targeted the mutation of the…
BioNTech ends patent fight with mRNA rival CureVac ahead of buyout deal
Dive Brief: BioNTech on Friday said it will pay as much as $870 million, plus a royalty stream, to CureVac and partner GSK to settle claims that it infringed on CureVac patents in developing the first approved COVID-19 vaccine, Comirnaty. Under…
Elevidys sales weaken; Neumora gets into obesity
Today, a brief rundown of news involving Sarepta Therapeutics and Neumora Therapeutics, as well as updates from Prothena, Jazz Pharmaceuticals and Chai Discovery that you may have missed. Sales of Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy Elevidys totaled $282…
Strand raises another $153M to make ‘programmable’ mRNA drugs
Strand Therapeutics has raised a $153 million Series B round fresh off unveiling early, but promising results for a cancer therapy it’s making with messenger RNA technology. The biotechnology startup plans to use the funding to advance that therapy, STX-001,…
Arvinas, Pfizer reworking partnership on ‘Protac’ cancer drug
Dive Brief: Arvinas may soon be looking for a new partner for a breast cancer medicine awaiting Food and Drug Administration approval after years of working with Pfizer, as company executives revealed Wednesday that the partners are reworking their existing…
HHS abandons mRNA vaccine research
The Department of Health and Human Services is canceling nearly $500 million in contracts for the development of messenger RNA vaccines in a controversial pivot away from a technology that delivered safe and effective COVID-19 shots in record time during…
Nxera debuts an obesity pipeline; BridgeBio battles Alynam for market share
Today, a brief rundown of news involving Nxera Pharma and Seres Therapeutics, as well as updates from BridgeBio Pharma, Madrigal Pharmaceuticals and BioMarin Pharmaceutical that you may have missed. Scientists at Nxera Pharma have worked for the past year to…
US biotech needs government support to match China’s gains, Pfizer CEO says
Lawmakers in Washington share U.S. drugmakers’ angst about being surpassed by China’s fast-progressing biotechnology sector, but aren’t raising alarms over the recent surge in licensing deals for medicines discovered there, according to Pfizer CEO Albert Bourla. On an earnings conference…
David Altshuler, geneticist who helped transform Vertex, to retire next year
Dive Brief: David Altshuler, the renowned geneticist who’s helped shape Vertex Pharmaceuticals’ research strategy over the last decade, will step down next year, the company said Monday. Alongside its quarterly earnings report, Vertex said Altshuler, the company’s chief scientific officer,…
Gates Foundation pledges $2.5B toward women’s health research
The Gates Foundation on Monday said it is committing to invest $2.5 billion over the next five years to accelerate research and development in neglected areas of women’s health. The funding will be channeled toward five priority areas of research…
The race to scale to 1,000 liters and beyond in gene therapy manufacturing
Viral-based gene therapies (GTs) represent a new frontier in medicine, offering hope to patients who previously had few, if any, treatment options. As therapeutic developers increasingly target polygenic indications with larger patient populations, including Parkinson’s disease, they have the potential…
Venture firm Frazier closes $1.3B fund for early-stage biotech investing
Frazier Life Sciences on Thursday said it has closed a new venture capital fund for startup creation and investing in early-stage biotechnology companies, raising $1.3 billion. Frazier is the third life sciences investor to announce fresh funding in the last…
Alnylam reaches new highs on strong sales of closely watched rare disease drug
Dive Brief: Sales of an Alnylam Pharmaceuticals rare disease medicine substantially outpaced Wall Street expectations in the drug’s first full quarter since U.S. regulators expanded its use, lifting the biotechnology company’s market value to new highs on Thursday. According to…
In rumored AbbVie deal, Wall Street sees momentum for psychedelics M&A
Biotechnology companies specializing in psychedelics research saw their share prices rise after rumors of a billion-dollar acquisition hinted that big pharma is now more open to betting on this area of drug development. Bloomberg News reported early Thursday that AbbVie…
Experts ousted from CDC panel warn of damage to US vaccine policy
The 17 vaccine advisers fired by Robert F. Kennedy Jr. last month called Wednesday for an alternative to the panel from which they were ousted, arguing that the federal government has “upended the U.S. vaccine policymaking process.” The former members…
US to install country-specific tariffs Aug. 7
The U.S. plans to lift its pause on country-specific tariffs while implementing a range of new rates for specific trading partners on Aug. 7, per an executive order President Donald Trump signed Thursday. The order lists rates for over 60…
Regeneron cancer bispecific rejected again; Allogene discloses trial death
Today, a brief rundown of news involving Regeneron Pharmaceuticals and Allogene Therapeutics, as well as updates from Bristol Myers Squibb, Biogen, and Argenx that you may have missed. Regeneron said two more of its new drugs hit regulatory setbacks because of Food…
Trump redoubles threats in attempt to strongarm drugmakers on prices
President Donald Trump on Thursday threatened 17 large drugmakers with “every tool in [the federal government’s] arsenal” if they don’t take steps to lower the prices of their products in line with those charged in other industrialized nations. Letters sent…
Moderna to lay of 10% of workforce in ‘difficult but necessary step’
Moderna said Thursday it plans to lay off 10% of its workforce, or more than 800 employees, as part of an ongoing effort to cut expenses amid slowing vaccine sales. Moderna first announced last September a plan to lower $1.5…
Madrigal buys into GLP-1 from CSPC; Apellis wins expanded drug approval
Today, a brief rundown of news involving Madrigal Pharmaceuticals and Viridian Therapeutics, as well as updates from Apellis Pharmaceuticals, PTC Therapeutics and Arrowhead Pharmaceuticals that you may have missed. Seeking to expand treatment of the liver disease MASH, Madrigal Pharmaceuticals…
Merck plans spending shift to boost business beyond Keytruda
Dive Brief: Merck & Co. is launching a new cost-cutting program, announcing Tuesday a plan to redirect by the end of 2027 $3 billion away from older, slow-growth businesses to newly launched drugs and experimental medicines it hopes can drive…
Vinay Prasad, controversial FDA official, abruptly departs agency
Vinay Prasad, the controversial head of the Food and Drug Administration office that oversees vaccines and gene therapy, has abruptly left the agency after less than three months on the job. Andrew Nixon, a spokesperson for the Department of Health…
Bavarian Nordic agrees to $3B take-private deal
Vaccine maker Bavarian Nordic on Monday said it has agreed in principle to a roughly $3 billion take-private offer from private equity firms Nordic Capital and Permira. The company’s board of directors plans to unanimously recommend the deal to Bavarian…
FDA allows Sarepta to resume some Elevidys shipments
The Food and Drug Administration has given Sarepta Therapeutics a green light to resume shipping its gene therapy Elevidys to some patients with Duchenne muscular dystrophy, a little over one week after demanding the company halt sales over safety concerns….
Atai backs away from schizophrenia drug after trial failure
The small, brain-focused biotechnology company Atai Life Sciences plans to direct resources away from an experimental drug it bought into several years ago, now that the therapy has come up short in a mid-stage clinical trial. Atai got access to…
AstraZeneca drug acquired in Alexion deal succeeds in autoimmune disease trial
An experimental drug from AstraZeneca succeeded in a late-stage trial in an autoimmune condition called generalized myasthenia gravis, positioning the company to grow a business it inherited when acquiring Alexion Pharmaceuticals five years ago. The drug, known as gefurulimab, met…
Galapagos, having backtracked on split, weighs sale of cell therapy business
Dive Brief: Galapagos on Wednesday said it’s considering selling its cell therapy business, which previously had been the centerpiece of a restructuring plan. In January, the Belgian drugmaker said it would split into two pieces, one that would keep the…
Sarepta woes mount as Duchenne gene therapy knocked back in Europe
European drug regulators on Friday recommended rejecting Sarepta Therapeutics’ Elevidys in the latest setback for the struggling biotechnology company and its embattled gene therapy for Duchenne muscular dystrophy. The European Medicines Agency issued a negative opinion on an application submitted…
Bristol Myers shuffles its executive ranks with new CMO
AstraZeneca executive Cristian Massacesi will join Bristol Myers Squibb as its chief medical officer, replacing outgoing executive Samit Hirawat, the company said Friday. Massacesi, who served as chief medical officer at AstraZeneca the past four years, will start Aug. 1….
FDA delays approval decision for Bayer menopause therapy
The Food and Drug Administration has delayed its review of a Bayer therapy for hot flashes related to menopause, telling the drugmaker it needs additional to review the company’s application. In a Friday statement, Bayer said the FDA did not…
In reversal, European regulators take positive view on Lilly Alzheimer’s drug
A key committee that helps decide what new medicines enter the European market has changed its mind about a closely watched drug for Alzheimer’s disease, and is now putting its support behind the therapy. The reversal is a win for…
A TCG offshoot pulls in $400M for biotech startup creation
TCG Labs Soleil, a venture firm building narrowly focused biotechnology startups and readying them for partnerships, said Thursday it raised $400 million to continue launching new companies. The firm originally launched last year in collaboration with The Column Group, raising…
Rocket lays off staff; Abivax capitalizes on immune drug data
Today, a brief rundown of news involving Rocket Pharmaceuticals and Atara Biotherapeutics, as well as updates from Abivax, Gate Bioscience and Matchpoint Therapeutics that you may have missed. Rocket Pharmaceuticals is laying off approximately 30% of its workforce and focusing…
RFK Jr. adopts CDC panel recommendation to remove thimerosal from flu shots
Health and Human Services Secretary Robert F. Kennedy Jr. on Wednesday endorsed a federal advisory committee’s recommendation to remove a contested preservative from the few influenza vaccines that currently contain it. Advisers to the Centers for Disease Control and Prevention…
Dispatch emerges with $216M and plans for a ‘universal’ solid tumor therapy
Dive Brief: A new biotechnology company debuted Wednesday with a hefty bankroll and an immunotherapy approach it claims has the potential to treat an array of tough-to-reach solid tumors. Called Dispatch Bio, the startup was formed in 2022 through a…
Sanofi to acquire vaccine biotech in billion-dollar deal
Dive Brief: French pharmaceutical giant Sanofi said Tuesday it will pay $1.15 billion to acquire the privately held London-based private biotechnology company Vicebio and its portfolio of experimental vaccines. Through the deal, Sanofi will gain a combination shot now in…
Sarepta stops Elevidys shipments after standoff with FDA
Sarepta Therapeutics said Monday evening it will temporarily pause all shipments of its Elevidys gene therapy for Duchenne muscular dystrophy so it can address questions from the Food and Drug Administration, which three days ago asked the company to halt…
AstraZeneca grows US presence with $50B in spending plans
WASHINGTON — AstraZeneca, the U.K.’s third biggest company by market value, is making itself a bit more American. On Monday, AstraZeneca CEO Pascal Soriot joined Virginia Governor Glenn Youngkin in Washington D.C. to sign an agreement on the company’s plans…
Alkermes narcolepsy drug headed for late-stage testing
A potential multibillion-dollar drug is advancing to late-stage testing now that its developer, Alkermes, has in hand positive results from a smaller study focused on a certain kind of narcolepsy. According to Alkermes, the study found all three doses of…
Bristol Myers, Pfizer to offer Eliquis at a discount for some patients
Bristol Myers Squibb and Pfizer will begin offering their top-selling heart medicine Eliquis through a new online service at a discounted price — the latest example of pharmaceutical companies establishing direct-to-consumer options to bypass traditional drug distribution channels. The two companies,…
Novartis CEO says resolution on Trump plan to cut US drug prices will take time
Novartis is exploring options to meet the Trump administration’s goal of bringing U.S. drug prices down to match what European and other high-income countries pay, but doesn’t expect any policy resolution soon, CEO Vas Narasimhan said on an earnings call…
Bristol Myers’ Reblozyl falls short in Phase 3; Blenrep voted down by FDA panel
Today, a brief rundown of news involving Bristol Myers Squibb and the Food and Drug Administration, as well as updates from DiaMedica Therapeutics, GSK and PureTech Health that you may have missed. An anemia treatment from Bristol Myers Squibb failed…
Panel urges FDA to remove warnings on hormonal menopause therapy
A panel of medical experts called for the removal of warning labels on hormone therapy for menopausal women during a meeting convened Thursday by the Food and Drug Administration. Led by FDA Commissioner Martin Makary, the meeting focused on the…
FDA to ask Sarepta to stop shipping Duchenne gene therapy
The Food and Drug Administration will ask Sarepta Therapeutics to halt all shipments of its marketed gene therapy for Duchenne muscular dystrophy, a source familiar with the matter confirmed to BioPharma Dive. Sarepta last month paused shipments for certain older…
Patient reportedly dies in Sarepta study of limb-girdle gene therapy
Another person treated with a Sarepta Therapeutics gene therapy has died, according to reports from BioCentury and multiple other publications. According to the publications, a 51-year-old man with limb-girdle muscular dystrophy died after treatment with the company’s experimental SRP-9004 therapy in…
Biotech startup funding dried up in second quarter, HSBC finds
Dive Brief: New data from HSBC Innovation Banking add further evidence venture capital funding for private biotechnology companies has slid lower as the year has progressed, erasing what was a fast start to 2025. According to a report HSBC published…
AstraZeneca rare disease drug fails key trial tests
An experimental rare disease drug from AstraZeneca failed in two late-stage trials, though the company said Wednesday there were signs of a survival benefit in a prespecified subgroup of patients. AstraZeneca has been developing the drug, anselamimab, for people with…
Sarepta to lay off about 500 employees after Duchenne gene therapy setbacks
Sarepta Therapeutics is laying off roughly 500 employees in an extensive workforce reduction that follows a series of setbacks and the collapse of the company’s share price this year. In a statement Monday, Sarepta said it plans to cut approximately…
33 states pick up CMS program to pay for sickle cell gene therapies
Nearly three dozen states have signed onto a U.S. government initiative designed to help improve access to gene therapies that can eliminate serious symptoms of sickle cell disease, but remain little-used because of their high price tags. The Centers for…
Cancer drugmaker LaNova to sell to China’s Sino Biopharm
Dive Brief: LaNova Medicines, a cancer drugmaker that previously licensed medicines to Merck & Co. and AstraZeneca, has agreed to be acquired by Sino BioPharmaceutical in a deal worth up to $950.9 million. In an agreement disclosed Tuesday, Sino BioPharm…
Vertex secures Alyftrek coverage in England; Merck starts Phase 3 trials of HIV drug
Today, a brief rundown of news involving Vertex Pharmaceuticals, the Food and Drug Administration and Merck & Co., as well as updates from Essa Pharma and Atara Biotherapeutics that you may have missed. The National Health Service in England will…
AstraZeneca blood pressure drug succeeds in late-stage trial
Dive Brief: An experimental drug being developed by AstraZeneca significantly reduced blood pressure versus placebo in a Phase 3 study of people with either uncontrolled or treatment-resistant hypertension, the pharmaceutical firm said Monday. The reduction in mean seated systolic blood…
Takeda to seek approval of new kind of narcolepsy drug after study data
A new kind of sleeplessness medicine developed by Takeda met its goals in late-stage testing, positioning the company to capitalize on what Wall Street analysts believe could be a multibillion-dollar market opportunity. The drug, formerly known as TAK-861 but now…
AbbVie to pay $700M for trispecific drug from Ichnos Glenmark
Dive Brief: AbbVie agreed to pay Ichnos Glenmark $700 million upfront for rights to an early-stage experimental trispecific antibody that has shown promise in multiple myeloma. Under the terms of the deal announced Thursday, AbbVie will gain rights to ISB…
FDA, in policy shift, publishes some drug rejection letters
The Food and Drug Administration on Thursday published more than 200 drug rejection letters in a notable policy shift it said will pull back the curtain on feedback the agency gives to biotechnology and pharmaceutical companies. The FDA has not…
Moderna COVID vaccine gets full approval for children
Dive Brief: The Food and Drug Administration on Thursday granted full approval for Moderna’s COVID-19 vaccine Spikevax in children aged 6 months through 11 years who are at an increased risk for COVID disease. The shot was previously available for…
With Verona deal, Merck wagers on strength of lung drug’s patents
Merck & Co.’s $10 billion acquisition of Verona Pharma Wednesday is a dramatic outcome for a company that’s spent 20 years developing a respiratory drug it now sells as Ohtuvayre. The treatment has been in testing so long its principal…
Jazz names new CEO; Ultragenyx, Mereo shares slide on trial update
Today, a brief rundown of news involving Valneva and Jazz Pharmaceuticals, as well as updates from Ultragenyx Pharmaceutical, Nuclidium and Pharvaris that you may have missed. The European Medicines Agency on Friday lifted its order to pause use of Valneva’s…
FDA turns back Capricor’s Duchenne cell therapy
The Food and Drug Administration has rejected what was set to be the first treatment for heart-related complications of Duchenne muscular dystrophy, indicating that its developer, Capricor Therapeutics, didn’t prove the treatment’s effectiveness in clinical testing. Capricor on Friday said…
Soleno sales of new Prader-Willi drug rise faster than expected
The first marketed treatment for the insatiable hunger associated with Prader-Willi disease is selling more quickly than Wall Street analysts expected, an early, but encouraging sign of demand. According to Soleno Therapeutics, net revenue from sales of the medicine, known…
Renasant Bio, chasing drugs for ADPKD, raises $55M in seed funding
The drug industry’s efforts to develop a treatment for a rare kidney condition known in shorthand as ADPKD have come in fits and starts. People with ADPKD, or autosomal dominant polycystic kidney disease, can use an Otsuka drug, Jynarque, that…
Lilly gets FDA OK of modified dosing for Alzheimer’s drug
Dive Brief: The Food and Drug Administration has approved a modified dosing schedule for Eli Lilly’s Alzheimer’s disease drug Kisunla, permitting a smaller first dose and a more gradual increase that in clinical trials, reduced dangerous episodes of brain swelling,…
Actithera draws new investors to radiopharma drug pitch
Dive Brief: Actithera, a radiopharmaceutical drugmaker based in Oslo, Norway and Cambridge, Massachusetts, has raised just under $76 million in Series A venture financing to build out its cancer drug pipeline. In a Wednesday statement, the biotechnology company said it…
Trump says pharmaceutical, copper tariffs coming ‘very soon’
President Donald Trump is planning to introduce tariffs of 50% on copper imports and levies “at a very, very high rate, like 200%” on pharmaceutical products, he said at a cabinet meeting Tuesday. Trump indicated official announcements of the tariffs…
Protein degraders: chasing undruggable targets
For decades now, scientists have been experimenting with a new way to target and destroy proteins linked to disease. Unlike most approved drugs, which work by turning cell signaling up or down like a dimmer switch, this approach aims to…
Medical groups, pregnant doctor sue RFK Jr. over vaccine changes
Six medical groups and a pregnant physician have sued Health and Human Services Secretary Robert F. Kennedy Jr. and his principal deputies over changes made to federal COVID-19 vaccine recommendations. Fiiled Monday, the lawsuit argues that Kennedy’s directive, which removed…
AbbVie to buy CAR-T developer Capstan in deal worth up to $2.1B
Dive Brief: Abbvie has agreed to acquire cell therapy developer Capstan Therapeutics in a deal worth up to $2.1 billion, the companies announced Monday. The acquisition will hand AbbVie access to technology developed by Capstan that uses small fatty spheres…
Acadia CEO sets sights on ‘much more assertive’ deals to invigorate pipeline
Acadia Pharmaceuticals, the brain-focused drug developer, surprised some on Wall Street last week with a pair of predictions. The first: the company’s two products, which brought in close to $1 billion in 2024, should eventually generate between $1.5 billion and…
Organon drug for endometriosis falls short in mid-stage study
Dive Brief: Organon’s experimental treatment for endometriosis failed to improve pelvic pain for women in a Phase 2 study, leading the company to give up on the drug. The trial tested three oral doses of OG-6219 in women between the…
Regeneron bispecific approved for myeloma; Concentra to buy IGM
Today, a brief rundown of news involving Regeneron Pharmaceuticals, IGM Biosciences and Catalio Capital, as well as updates from Roche, Hikma Pharmaceuticals and several others that you may have missed. The Food and Drug Administration on Wednesday approved Regeneron Pharmaceuticals…
Moderna flu shot outperforms marketed vaccines in large late-stage trial
Dive Brief: Moderna’s seasonal influenza vaccine met its main goal in a large Phase 3 trial, reducing the risk of influenza-like illness in people 50 years and older by 27% compared with those given a marketed shot targeting three or four…
Atai and Beckley, set to merge, reveal study success for psychedelic drug
Dive Brief: Atai Life Sciences and Beckley Psytech are making plans to push the psychedelic drug mebufotenin into Phase 3 testing after it safely and significantly reduced symptoms of treatment-resistant depression in a Phase 2b study. Shares of Atai jumped…
Sodium channel blockers for pain: New opportunities after Vertex’s ‘watershed’ moment
In the notoriously expensive business of drug development, SiteOne Therapeutics made do with little. The biotechnology startup formed in 2010, aiming to create new, non-addictive pain relievers at a time when overdoses involving opioids were killing more than 20,000 people…
Sage to lay off most staff amid Supernus buyout
Dive Brief: Sage Therapeutics will lay off 338 employees, the vast majority of its workforce, while in the process of being acquired by Supernus Pharmaceuticals, according to a Massachusetts regulatory filing. The move comes less than two weeks after Supernus…
Incyte replaces CEO Hoppenot with dealmaker Meury
Dive Brief: Incyte has named veteran pharmaceutical executive Bill Meury as its new CEO, replacing longtime head Hervé Hoppenot, who led the cancer and blood disease drugmaker for the past 11 years. Meury, whose appointment is effective immediately, previously ran…
Acadia’s ‘very bullish’ sales forecast restores some confidence on Wall Street
Acadia Pharmaceuticals has proposed that its pipeline of experimental medicines could, if eventually brought to market, peak at $12 billion in annual sales. The brain drug developer disclosed this estimate Wednesday, during its first major research and development event. The…
Congress should reconsider breaking up PBMs, experts say
Bipartisan policies in Congress meant to lower drug costs by targeting middlemen in the pharmaceutical supply chain are likely to run up against a fundamental issue: the three major pharmacy benefit managers’ chokehold on the U.S. drug market, experts said…
Supreme Court upholds ACA preventive services mandate
The Supreme Court on Friday upheld a popular provision of the Affordable Care Act that requires private insurers cover a range of preventive healthcare services without cost sharing. The 6-3 ruling is a victory for public health advocates and providers, who…
Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules
Today, a brief rundown of news involving Biocryst and Peter Marks, as well as updates from UCB and Altimmune that you may have missed. Biocryst said Friday it is selling the European business of its hereditary angioedema drug Orladeyo to Italy’s…
FDA takes major step to ease access to CAR-T therapy
Dive Brief: The Food and Drug Administration is easing limitations it imposed around the complex cancer drugs known as CAR-T therapies, removing several onerous requirements as well as loosening restrictions on which facilities can provide treatment. The FDA’s action applies to…
Vor, with new CEO, changes course to target autoimmune disease
Dive Brief: Vor Biopharma is licensing rights to an immune disease drug from Chinese biotechnology company RemeGen, it said Wednesday, a little over one month after announcing plans to review strategic alternatives. As part of its shift in focus, Vor…
RFK Jr.-appointed panel recommends flu shots be free of contested preservative
Dive Brief: Advisers to the Centers for Disease Control and Prevention recommended Thursday that influenza vaccines used in the coming flu season be free of the preservative thimerosal, addressing unproven fears the mercury-containing substance can lead to developmental disabilities. If…
Kymera adds Gilead as research partner, while advancing new candidate with Sanofi
Dive Brief: Kymera Therapeutics and Gilead Sciences will develop oral molecular glue degraders under a deal announced Wednesday, which could hand the former as much as $85 million in upfront and option exercise fees. The biotech also said Wednesday that…
CDC panel, newly remade by RFK Jr., questions vaccine evidence
Robert F. Kennedy Jr.’s newly hand-picked panel of federal vaccine advisers met for the first time Wednesday since the Health and Human Services secretary abruptly fired their predecessors earlier this month. While the advisers didn’t vote on any new recommendations,…
Lexeo to help launch spinout around RNA drugs for the heart
Dive Brief: Perceptive Xontogeny Venture Funds and venBio Partners are contributing up to $40 million to a spinout of genetic medicine maker Lexeo Therapeutics to that will aim to advance drugs for heart conditions. The new biotech will focus on…
FDA investigating Elevidys safety; Nektar shares spike on eczema data
Today, a brief rundown of news involving Sarepta Therapeutics, Capricor Therapeutics and Nektar Therapeutics, as well as updates from AstraZeneca, Revolution Medicines and Carisma Therapeutics that you may have missed. The Food and Drug Administration is investigating two deaths among…
Top drug official at FDA reportedly set to exit next month
Dive Brief: A top Food and Drug Administration official responsible for overseeing drug reviews is reportedly retiring from the agency, adding to an exodus of senior staff who have either left or been forced out by Trump administration leadership. Jaqueline…
Relentless innovation: Bold exploration in advancing therapeutic options for every patient, every discovery
On the heels of the BIO International Convention and as I reflect on the passion for innovation that drives this industry, one truth I keep coming back to is this: there is the potential for failure in drug development, but…
The rise of GLP-1 drugs: Transforming weight loss treatment
In the last episode of the podcast Balancing the Future, hosted by Chai Nussbaumer and Micah Schweizer from Mettler Toledo, Ben Locwin, Vice President of Reliant Life Sciences and an expert in clinical services, joined as a guest to unpack…
FDA clears CSL’s swelling disease drug; Regeneron loses 23andMe auction
Today, a brief rundown of news involving CSL and Intellia Therapeutics, as well as updates from Eli Lilly and 23andme that you may have missed. The Food and Drug Administration on Tuesday approved CSL’s Andembry, an antibody drug known scientifically as…
Gene therapy faces fresh uncertainty as two more top FDA officials depart
Dive Brief: Two senior officials at the Food and Drug Administration office that regulates gene therapies have reportedly been placed on administrative leave, resurfacing questions about the way the complex medicines will be regulated under new agency leadership. Nicole Verdun,…
A longer ‘winter’: Public funding slowdown heightens pressure on biotech startups
Biotechnology industry watchers were hopeful at the start of 2025. Venture funding appeared to be rebounding after a lengthy slump, and a smattering of new stock offerings and company acquisitions brewed optimism that the public markets might be similarly warming…
Prothena to lay off majority of staff; Zealand shares obesity drug data
Today, a brief rundown of news involving Prothena and Zealand Pharma, as well as updates from Biogen and Sanofi that you may have missed. Prothena is laying off 63% of its workforce to focus resources on its remaining wholly owned…
A startup banks $66M to pursue ‘inclusive precision medicine’
Dive Brief: Actio Biosciences, a San Diego-based biotechnology startup, announced Wednesday it raised a $66 million Series B financing to support drug research it’s initially aiming at rare genetic diseases, but sees having broader potential, too. Actio’s most advanced program…
Draig, a brain drug startup, debuts with $140M to treat depression
Psychiatric medicine remains one of the more challenging and risky areas of drug research. Many prospects show initial promise only to fail later on. Still, recent breakthroughs are spurring more investments and acquisitions in biotechnology companies working on new brain…
Scholar Rock drug preserves muscle in obesity trial
Dive Brief: A medicine developed to treat a genetic muscle-wasting disease can improve results for patients taking GLP-1 weight-loss medicines, according to a new Phase 2 study. Scholar Rock has already applied for Food and Drug Administration approval of the…
FDA approves twice-yearly shot of Gilead drug for HIV prevention
The Food and Drug Administration has approved a new way to prevent HIV, clearing a Gilead Sciences drug that requires only two injections a year to protect against infections. The treatment, known scientifically as lenacapavir and to be sold as…
FDA to speed reviews for drugs supporting ‘national interests’
Food and Drug Administration Commissioner Martin Makary has proposed a dramatic expansion of the agency’s powers to speed up drug reviews, announcing on Tuesday a plan to evaluate new medicines that address U.S. “national interests,” like a health crisis, in…
Lilly to acquire Verve in $1B bet on gene editing for heart disease
Dive Brief: Eli Lilly agreed to buy Verve Therapeutics for $1 billion, betting on the promise of one-and-done gene therapies to treat cardiovascular disease. The deal announced Tuesday offers Verve stockholders $10.50 a share, plus a contingent value right worth…
Roche, waving off study failures, commits to Phase 3 trials for Parkinson’s drug
Dive Brief: Roche will advance an experimental Parkinson’s disease drug with a mixed track record into late-stage development, announcing Monday that it is “encouraged by the efficacy signals” the medicine displayed in earlier testing despite missing its main objectives in…
Could the FDA take an indirect approach to regulate lab developed tests?
When the deadline to appeal the court decision that blocked the Food and Drug Administration’s final rule regulating laboratory developed tests as medical devices slipped by in May without a word from the agency, industry groups were relieved that the…
FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche
Dive Brief: The Food and Drug Administration has approved a new oral medication for an uncommon kind of tumor, clearing Nuvation Bio’s Ibtrozi on Wednesday for certain people whose metastatic non-small cell lung cancer has a type of alteration in…
Insmed surges on lung drug data; Recursion cuts staff
Today, a brief rundown of news involving Insmed and Recursion Pharmaceuticals, as well as updates from Odyssey Therapeutics, Gilead Sciences and Novo Nordisk that you may have missed. Insmed said Tuesday its experimental drug for pulmonary arterial hypertension succeeded in…
Pharma’s wins and losses in the budget bill
The budget bill currently under consideration in Congress is big — and it’s complicated. The 1,000-plus page document is full of tax and spending cuts, including some significant changes that will impact pharma and the larger healthcare industry. The legislation,…
AstraZeneca forms an AI deal in China; Third Harmonic advances liquidation plans
Listen to the article 4 min This audio is auto-generated. Please let us know if you have feedback. Today, a brief rundown of news involving AstraZeneca and Third Harmonic Bio, as well as updates from UCB, UroGen Pharma and Insmed…
Moderna wins FDA OK to widen use of RSV vaccine
The Food and Drug Administration has approved wider use of Moderna’s respiratory syncytial virus vaccine in a boost for a company that’s been negatively impacted by the recent leadership changes atop U.S. public health agencies. The shot, dubbed mResvia, was…
Novo, searching for a spark, plans late-stage trials for amylin drug
Dive Brief: Novo Nordisk is planning Phase 3 clinical trials for a obesity drug combination called amycretin, adding another emerging weight-loss medicine to the list of prospects it has in advanced testing. The Danish drugmaker said Thursday the trials could…
RFK Jr. reveals picks for influential vaccine panel
Health and Human Services Secretary Robert F. Kennedy Jr. on Wednesday continued his efforts to alter the government structure supporting immunizations, naming vaccine skeptics and doctors with different focus areas to a critical advisory board days after purging the old…
BioNTech buys mRNA, courtroom rival CureVac in all-stock deal
Dive Brief: COVID vaccine maker BioNTech is buying rival CureVac, announcing Thursday an all-stock deal weeks before the two companies were due to face off in a German court over potentially billions of dollars worth of royalties related to intellectual property…
Bristol Myers bolsters radiopharma portfolio with PhiloChem deal
Dive Brief: Bristol Myers agreed to pay $350 million up front to Philochem for worldwide rights to an experimental radiopharmaceutical to diagnose and treat prostate cancer. The agent, OncoACP3, has shown promise in a Phase 1 trial for diagnostic imaging…
SpliceBio lands $135M for a new kind of eye gene therapy
SpliceBio, a Spanish biotechnology company working on next-generation gene therapies, said Wednesday it raised $135 million in a Series B round to advance its lead program in Stargardt disease into further clinical testing. The startup is built around a technology…
Vaccine makers face fresh uncertainty after firing of CDC panel
Dive Brief: Health and Human Services secretary Robert F. Kennedy Jr., has abruptly fired all members of the committee guiding the Centers for Disease Control and Prevention’s vaccine recommendations, creating fresh uncertainty about the way the public health agency might…
Scorpion, fresh off Lilly deal, spins out startup Antares
Fresh off a multibillion-dollar deal with Eli Lilly, cancer drug startup Scorpion Therapeutics is trying for an encore, debuting a successor company on Tuesday that’s carrying forward much of its previous work. Called Antares Therapeutics, the startup is launching with…
Concentra to acquire Elevation in bid to eliminate another biotech ‘zombie’
Elevation Oncology has agreed to be acquired by an investment firm focused on buying struggling biotechs and shutting them down. The cancer drug developer on Monday accepted a bid from Concentra Biosciences, a vehicle controlled by hedge fund Tang Capital…
Merck antibody drug for RSV approved by FDA
The Food and Drug Administration has cleared a new treatment designed to protect infants from respiratory syncytial virus. Called Enflonsia and developed by Merck & Co., the drug is an antibody intended to prevent illness from RSV, which can be…
[Podcast] Trial Trailblazers: Behind clinical breakthroughs
In this three-part podcast series, “Trial Trailblazers: Behind clinical breakthroughs,” gain rare insight into the human stories driving innovative clinical research. From pioneering treatments for rare pediatric diseases to exploring natural killer cells for Alzheimer’s and developing FDA-approved digital therapeutics…
Lilly partners with Camurus in search of a long-lasting obesity drug
Dive Brief: Looking to defend its giant cardiometabolic health franchise, Eli Lilly is licensing a technology from Swedish biotechnology firm Camurus that promises to produce longer-acting medications. Camurus’ FluidCrystal technology is designed to methodically release a therapeutic drug substance into…
Biotech funding plummets as Trump policies unnerve investors: Jefferies
The amount of funding going into biotechnology companies has fallen off over the last couple months, a trend the investment bank Jefferies pins on Trump administration policies aimed at gutting the agencies responsible for conducting and regulating drug research. Looking…
FDA’s AI tool ‘Elsa’ is here, and the industry has questions
The Food and Drug Administration aims to roll out its new AI tool, called Elsa, “ahead of schedule and under budget,” according to Commissioner Marty Makary, who offered up the most information to date about the agency’s new tool and…
Otsuka tops Vera with kidney drug data; Regenxbio sinks on Duchenne update
Today, a brief rundown of news involving Otsuka Pharmaceutical and Arvinas, as well as updates from Regenxbio, Vigil Neuroscience and Sagimet Biosciences that you may have missed. Vera Therapeutics lost nearly a third of its market value Friday after Otsuka…
FDA meeting gives window into gene therapy field’s angst
Anyone looking for evidence of genetic medicine’s enormous promise need only read of KJ Muldoon. The 10-month-old infant headed home from a Philadelphia hospital this week, dressed in a celebratory cap and gown, after his life-threatening disease was successfully treated…
Bispecific cancer drugs, data caveats and funding alarms: 3 takeaways from ASCO
New drugs, however heralded, take time to embed into clinical care. Enhertu, the powerful antibody-drug conjugate from Daiichi Sankyo and AstraZeneca, was first approved in the U.S. in 2019, before the world had even heard of a novel coronavirus. This…
Cullinan doubles down on bispecifics for autoimmune disease with Genrix deal
Dive Brief: After changing its name and focus, Cullinan Therapeutics is beefing up its autoimmune disease pipeline by licensing an experimental drug from China. The company will pay Genrix Bio $20 million up front for the rights to a bispecific…
Daiichi Sankyo struck gold with ‘ADC’ cancer drugs. Its new CEO has to figure out what’s next.
CHICAGO — Hiroyuki Okuzawa holds an enviable position. The veteran Daiichi Sankyo executive took over as the Japanese drugmaker’s new CEO two months ago and inherited a company whose cancer medicines have, over the past half-decade, won it three of…
FDA to use new review tool on Sarepta’s gene therapy work
Dive Brief: The Food and Drug Administration has awarded Sarepta Therapeutics a new kind of fast pass that could help speed the reviews of certain gene therapy applications it brings to the regulator in the future. The so-called platform technology…
J&J data support earlier use of combo pill in prostate cancer
CHICAGO — A Johnson & Johnson drug currently used for advanced prostate cancer can help keep the disease from progressing in men who are at earlier stages and have certain genetic mutations, according to newly unveiled data from a Phase 3…
Bayer drug could ease side effects of common breast cancer treatment, detailed data show
An experimental, non-hormonal drug from Bayer can reduce the hot flashes and other menopausal side effects many women taking a common breast cancer therapy experience, according to results from a late-stage clinical trial run by the pharmaceutical company. The study,…
Bispecific competition, debating oral SERDs and a bold GLP-1 prediction
CHICAGO — The American Society of Clinical Oncology’s annual meeting is a forum for data. On Monday, it was also the backdrop to oncology’s latest deal, when Bristol Myers Squibb and BioNTech announced a multibillion-dollar alliance around a newly in-vogue…
Kymera, with new data, takes early step toward a Dupixent-like pill
Dive Brief: An experimental protein-degrading drug from Kymera Therapeutics appeared safe and able to affect its intended target in an early-stage clinical trial, leading shares in the biotechnology company to climb by nearly 50%. Data from a Phase 1 study…
Enhertu potential broadens as new data point to frontline breast cancer role
CHICAGO — Enhertu, the antibody-drug conjugate developed by AstraZeneca and Daiichi Sankyo, year by year proves more indispensable in the treatment of metastatic breast cancer. Already enmeshed in clinical practice as a go-to choice for tumors that have come back…
A funding flashpoint, Pfizer’s $1B poster and AstraZeneca advertising
CHICAGO — Funding cancer research isn’t usually a political flashpoint. But as the Trump administration signals its desire to drastically cut the budget of the National Cancer Institute, the American Society of Clinical Oncology is finding itself forced to defend…
AstraZeneca drug could help keep a common breast cancer at bay
Too often, cancer has a way of evading treatment. Tumors that were held in check begin to spread anew, forcing doctors to try different drugs in a desperate race to keep malignant cells from multiplying. For a common type of…
FDA clears Moderna’s new COVID vaccine, but with limits
The Food and Drug Administration has granted an approval to Moderna’s next-generation COVID-19 vaccine, but with limits that will restrict use to older adults and people with preexisting health conditions. The OK is the first since agency leadership rolled out…
At ASCO, Enhertu cements growing role in stomach cancer care
AstraZeneca and Daiichi Sankyo’s targeted cancer medicine Enhertu helped participants in a late-stage clinical trial with a type of advanced gastric cancer live longer than those who received a commonly prescribed, two-drug regimen involving chemotherapy. The finding, detailed Saturday at…
New Summit data could slow US approval plans for PD-1/VEGF drug
Dive Brief: A dual-acting drug developed by Summit Therapeutics and Akeso delayed tumor progression in a Phase 3 lung cancer trial but didn’t extend survival, complicating its potential path to approval in the U.S. When administered alongside chemotherapy, the drug,…
Intellia filing spurs safety concerns over CRISPR drug
Dive Brief: Intellia Therapeutics shares dropped 25% early Thursday after the gene-editing company disclosed that one patient in an ongoing Phase 3 trial had signs of liver stress. Lab tests showed the patient had grade 4 liver transaminase elevations that…
HHS terminates Moderna contract to develop bird flu vaccine
The U.S. The Department of Health and Human Services has canceled a contract with Moderna to develop messenger RNA vaccines against influenza strains seen as potential pandemic risks, leaving the future of the underlying research uncertain. Moderna revealed in a…
Muscle-sparing obesity drug safe for Phase 3 trial, Veru says
Dive Brief: Veru’s muscle-preserving obesity drug enobosarm, when combined with Novo Nordisk’s Wegovy, may have less gastrointestinal side effects at the dose planned for pivotal testing than Wegovy alone, according to safety results from a Phase 2 clinical trial the company…
Cancer drugmaker iTeos to shut down
Dive Brief: Cancer drugmaker iTeos Therapeutics said Wednesday it plans to wind down operations and seek to sell the company’s assets and intellectual property rights. ITeos has for years struggled to develop a cancer treatment that sufficiently impressed investors and…
Lilly to buy pain drug developer SiteOne, challenging Vertex
Eli Lilly is wagering up to $1 billion on a private biotechnology company developing new, non-opioid pain drugs that have already caught the attention of other large pharmaceutical firms. Per an announcement Tuesday, Lilly plans to acquire SiteOne Therapeutics in…
FDA sets COVID vaccine formula as RFK Jr. narrows guidance for shots
Dive Brief: The Food and Drug Administration on Thursday recommended COVID-19 vaccine manufacturers tailor their shots for the upcoming fall and winter season to target the “JN.1” strain, ideally a subvariant known as LP.8.1. The decision followed a vote by FDA…
Navigating the evolving landscape of fill/finish: Challenges and what’s ahead
As the pharmaceutical and biotech industries continue to innovate at a rapid pace, the demand for fill/finish capabilities has never been greater. From the pandemic-driven surge in vaccine production to the current boom in GLP-1 therapeutics, CDMOs are playing an…
Moderna pulls application for combo COVID, flu shot
Dive Brief: After discussions with the Food and Drug Administration, Moderna on Wednesday said it has voluntarily withdrawn its application for a combination COVID-19 and influenza shot in adults aged 50 years and older. The biotechnology company said it plans…