Sanofi moves ahead with CD&R deal for stake in consumer business
Dive Brief: French pharmaceutical company Sanofi is proceeding with plans to sell U.S.-based private equity firm Clayton Dubilier & Rice a controlling stake in its consumer health busines Opella, which would be valued at around 16 billion euros, or about…
Harnessing the power of upstream platform integration to accelerate biopharma innovation
The biopharmaceutical industry has been a hotbed of innovation in recent years, with an increasing number of novel recombinant protein therapeutics receiving the U.S. Food and Drug Administration’s (FDA) green light. However, these therapies are often very expensive, highlighting the…
After rejections, AbbVie secures approval for Parkinson’s drug
People with advanced Parkinson’s disease have a new treatment option, as the Food and Drug Administration on Thursday approved a combination therapy from AbbVie that’s designed to provide longer-lasting movement control. Parkinson’s is hallmarked by unintentional muscle movements like shaking…
CVS replaces CEO Karen Lynch with Caremark head
Dive Brief: CVS Health on Thursday replaced CEO Karen Lynch as the healthcare and pharmacy giant’s financial challenges mount. CVS’ new chief executive is David Joyner, a company veteran who most recently headed up CVS’ pharmacy benefit manager Caremark. Lynch, who held…
PTC rebuffed again by EMA; Novartis licenses China-based biotech’s cancer drug
Today, a brief rundown of news from PTC Therapeutics and Novartis, as well as updates from Amylyx Pharmaceuticals and Intercept Pharmaceuticals that you may have missed. Europe’s drug regulator is standing firm in its decision not to renew the marketing…
Gilead withdraws Trodelvy in bladder cancer
Dive Brief: Gilead will no longer sell its combination drug Trodelvy to treat bladder cancer, announcing Friday it had agreed with the Food and Drug Administration to withdraw it following negative trial results. The FDA granted Trodelvy accelerated approval for…
Merck antibody reduces RSV-related disease, hospitalizations in trial
Dive Brief: An experimental antibody drug developed by Merck & Co. significantly reduced the incidence of disease due to respiratory syncytial virus infections as well as related hospitalizations in infants, the company said Thursday. Called clesrovimab, the antibody met all…
Sage to cut one-third of workforce, streamline drug pipeline
Sage Therapeutics is restructuring yet again, announcing Thursday a company shakeup that will involve layoffs for about one-third of its workforce and a reprioritization of its early-stage drug pipeline. Alongside the cuts, five senior executives will depart, including Sage’s top…
What leverage options are available on a CFD trading platform?
CFD trading platform Using leverage can amplify your profits but it also increases your risk. It’s important to understand this and utilise proper risk management strategies when trading CFDs. A good CFD trading platform offers a full range of markets…
Wave sees RNA editing validation in early trial results
Clinical trial results released by Wave Life Sciences Wednesday appear to provide early validation for the company’s newest drugmaking technology as well as a burgeoning field of genetic medicine, RNA editing. The data are from just two patients, the first…
Novocure wins FDA approval for electric field device in lung cancer
Dive Brief: The Food and Drug Administration on Tuesday approved a new device to treat non-small cell lung cancer, Novocure’s Optune Lua, which creates electric fields that its manufacturer says disrupts malignant cell division. The FDA cleared the device for…
Tremfya, Carvykti sales grow as J&J prepares for Stelara patent loss
Dive Brief: Sales of Johnson & Johnson’s cancer therapy Carvykti and immune disease drug Tremfya grew strongly during the third quarter, the pharmaceutical company reported Tuesday, as new approvals helped broaden the two medicines’ market reach. The growth from Carvykti…
Forbion follows string of startup exits with $2.2B fundraise
Dive Brief: European life sciences venture firm Forbion on Tuesday said it has raised 2 billion euros, or more than $2.2 billion, for two of its newest investment funds. Forbion Growth Opportunities III pulled in 1.2 billion euros, while Forbion…
Lundbeck to buy brain drug developer Longboard for $2.6B
Danish drugmaker Lundbeck has agreed to spend $2.6 billion acquiring a young biotechnology company with an experimental brain medicine that could become a blockbuster product. The acquisition, announced Monday, has Lundbeck paying $60 in cash for each outstanding share of…
FDA, facing pressure, to review position on Zepbound, Mounjaro shortage
The Food and Drug Administration has temporarily deflected a lawsuit alleging it violated federal law by removing Eli Lilly’s obesity and diabetes drugs Zepbound and Mounjaro from an agency shortage list. But in the process, the regulator agreed to evaluate…
The number of AI medical devices has spiked in the past decade
The number of medical devices with artificial intelligence technology has risen sharply in the past decade. The Food and Drug Administration has authorized 950 AI or machine learning-enabled devices as of Aug. 7, 2024, according to the agency’s database. While…
Ex-Pfizer execs ‘threatened’ for supporting plans to shake up company, Starboard says
Two former Pfizer executives announced late Wednesday night that they won’t support efforts by activist investor Starboard Value to shake up the giant drugmaker. “We have decided not to be involved,” former Pfizer CEO Ian Read and former CFO Frank…
UnitedHealth, CVS push to remove FTC Chair Lina Khan from PBM case
Dive Brief: UnitedHealth Group and CVS Health want Federal Trade Commission Chair Lina Khan and two other commissioners to recuse themselves from the agency’s lawsuit against the nation’s largest pharmacy benefit managers. In separate documents filed Tuesday, UnitedHealth-owned Optum Rx…
Upstream prices $255M IPO in bid to challenge Amgen, AstraZeneca asthma drug
Dive Brief: Upstream Bio announced Thursday it priced its initial public offering, raising $255 million to fund development of an antibody drug it’s testing against several respiratory diseases. The Waltham, Massachusetts-based biotechnology company sold 15 million shares at $17 apiece, exceeding the projections it set…
FDA clears Roche breast cancer drug; Turnstone lays off 60% of staff
Today, a brief rundown of news from Roche and Turnstone Biologics, as well as updates from Sanofi, Pfizer and Flagship Pioneering that you may have missed. Turnstone Biologics will lay off about 60% of its workforce and trim its pipeline…
Sanofi may have found a buyer for its consumer health business
For the past year, French pharmaceutical giant Sanofi has been searching for a buyer to take control of its consumer health business. That search may now be over. On Friday, Sanofi said it’s in negotiations with the private equity firm…
Upstream prices $255M IPO in bid to challenge Amgen, AstraZeneca asthma drug
Dive Brief: Upstream Bio announced Thursday it priced its initial public offering, raising $255 million to fund development of an antibody drug it’s testing against several respiratory diseases. The Waltham, Massachusetts-based biotechnology company sold 15 million shares at $17 apiece, exceeding the projections it set…
Lilly partners with AI specialist Insitro to develop metabolic medicines
Dive Brief: Eli Lilly and Insitro said they have entered into three drug development deals that offer a “new paradigm” for collaborations between major pharmaceutical companies and smaller biotechs. Insitro, which specializes in applying machine learning to drug discovery, will…
Purespring raises $105M to advance gene therapy for kidney disease
Biotechnology company Purespring Therapeutics has raised about $105 million to fund its development of gene therapies for diseases of the kidney. The Series B funding announced Wednesday was led by Sofinnova Partners and will support Purespring’s initiation of a Phase…
GSK says RSV vaccine protects against disease over three seasons
Dive Brief: Vaccine maker GSK unveiled new data Tuesday showing its respiratory syncytial virus vaccine Arexvy protected older adults over three seasons against disease caused by infection. Across the entire time period, one dose of Arexvy was 63% effective against…
Sage continues downslide as Alzheimer’s study fails
Alzheimer’s disease remains one of the world’s most indomitable illnesses, and on Tuesday it defeated yet another potential treatment in an experimental drug from Sage Therapeutics. A mid-stage clinical trial has been evaluating the drug, known as dalzanemdor or SAGE-718,…
Scholar Rock scores with ‘surprise’ success in SMA drug study
Dive Brief: An experimental, muscle-preserving therapy from Scholar Rock succeeded in a Phase 3 trial in spinal muscular atrophy, positioning the biotechnology company to seek approvals in the U.S. and Europe early next year. A regimen of Scholar Rock’s drug,…
GSK’s ViiV to expand supply of HIV drug in Africa
Dive Brief: GSK-backed ViiV Healthcare on Monday said it plans to triple the amount of its HIV prevention therapy it will make available at a not-for-profit price in low- and middle-income countries next year and in 2026. The company, which…
With $115M more, Triveni accelerates immune drug work
Dive Brief: Triveni Bio has raised $115 million in Series B funding, the company said Wednesday, adding to an upward trend in investment this year in startups developing drugs for immune conditions. The Watertown, Massachusetts-based biotech will use the funds…
Blue Shield of California sidesteps PBMs with new Humira biosimilar deal
Dive Brief: A major California health plan has struck a novel deal with a drug manufacturer for a cheaper version of Humira, entirely cutting out pharmacy benefit managers — controversial middlemen in the drug supply chain that typically control access…
An Alzheimer’s drugmaker is accused of data manipulation. Should its trials be stopped?
Cassava Sciences has faced intense regulatory scrutiny over alleged clinical impropriety in studies of its experimental Alzheimer’s disease drug. Most recently, Cassava agreed to pay millions of dollars to resolve corporate misconduct allegations from the Securities and Exchange Commission. Now,…
Opdivo gets ‘perioperative’ approval; pharmas cut jobs in New Jersey, Ireland
Today, a brief rundown of news from Bristol Myers Squibb and Johnson & Johnson, as well as updates from Bayer, the World Health Organization and Frazier Life Sciences that you may have missed. Bristol Myers Squibb said Thursday its cancer…
Sanofi’s rare disease drug finds yet another home
Over the past decade, the medicine Enjaymo has been passed around no less than five times by developers large and small. Now it’s trading hands again, through a deal announced Friday. Sanofi is selling global rights to Enjaymo to the…
Editas trades Vertex fees for upfront cash in DRI deal
Dive Brief: Gene editing company Editas Medicines has sold off license fees and future payments it’s owed under an agreement with Vertex Pharmaceuticals to DRI Healthcare Trust for $57 million upfront. Last year, Vertex paid Editas $50 million for rights…
FDA makes end of Zepbound, Mounjaro shortage official
Dive Brief: Shortages affecting the availability of Eli Lilly’s top-selling diabetes and weight-loss drugs have now been resolved, the Food and Drug Administration said Wednesday. Lilly has assured regulators that product availability and manufacturing capacity is enough to meet both…
Medicare tweaks rules for second round of drug price talks
The U.S. government is fine-tuning the rules for how it will negotiate drug prices within Medicare when the second round of talks with drugmakers begins early next year. Specifically, officials at the Centers for Medicare and Medicaid Services plan to…
Lilly plans $4.5B ‘foundry’ for advanced drug manufacturing
Dive Brief: Eli Lilly on Wednesday announced plans to spend $4.5 billion on a new facility that will use advancements in technology for research and manufacturing. Dubbed the Lilly Medicine Foundry, the new site will be located in the “LEAP…
Gilead agrees to license new HIV drug in low-income countries
Dive Brief: Gilead on Wednesday said it signed royalty-free licensing agreements with six generic drugmakers to produce and sell its HIV drug lenacapavir in countries with high incidence of the disease but limited resources. Announcement of the licensing deals comes…
The top biopharma conferences in 2025
With rare exceptions, biotechnology and pharmaceutical companies validate their business plans through clinical trials, results from which are often presented and dissected at medical conferences throughout the year. These are the forums where executives get to showcase the “proof of…
Merck claims late-stage study success for RSV antibody
Dive Brief: An experimental Merck & Co. drug designed to protect infants from illness caused by respiratory syncytial virus succeeded in a late-stage trial, the company said Tuesday. In a statement, Merck said the therapy, an antibody called clesrovimab, met…
Ionis plots next steps for Angelman drug Biogen passed on
Ionis Pharmaceuticals plans to push one of its rare disease drugs into late-stage testing now that a smaller trial has delivered positive results. The trial focused on Angelman syndrome, an uncommon genetic disorder that causes severe functional and learning disabilities….
US government declines to clear Bluebird fertility support for Zynteglo patients
The U.S. government will not give Bluebird bio a green light to offer fertility support to federally insured people undergoing treatment with the biotechnology company’s gene therapy Zynteglo. In a “negative opinion” issued Monday, the Department of Health and Human…
Breakthroughs in immunotherapy: glycoproteins as predictive biomarkers for therapeutic response
Recent advancements in immune checkpoint inhibitors (ICIs) targeting PD-1 or CTLA4 have shown significant success in treating various advanced cancers and tumor types. However, a substantial number of patients fail to respond to treatment, and currently there are no consensus…
Gilead’s CMO to depart next year
Dive Brief: Gilead chief medical officer Merdad Parsey will step down from his role and leave the biotechnology company early next year, Gilead said in a statement Wednesday. The planned departure of Parsey, who has served as Gilead’s top doctor…
Caribou lays off staff; Roche walks away from Relay
Today, a brief rundown of news from Caribou Sciences and Relay Therapeutics as well as updates from Corden Pharma, Celldex Therapeutics, and Beam Therapeutics that you may have missed. Caribou Biosciences is laying off staff one month after a clinical…
Obesity pill from Roche shows promising weight loss in small study
Dive Brief: A closely watched obesity pill being developed by Roche helped people in a small Phase 1 trial lose 7.3% of their body weight over four weeks when taken once daily — 6.1 percentage points more than those given…
Lilly alone in bidding for Morphic; Novartis won’t yet file MorphoSys drug
Today, a brief rundown of news from Morphic Holding as well as updates from Novartis, the Parker Institute and Agenus that you may have missed. No company other than Eli Lilly made a bid for Morphic Holding during several months…
Global tech outage hits US hospitals
Cybersecurity firm CrowdStrike triggered a massive IT outage on Friday, disrupting businesses, including healthcare, after issuing what was supposed to be a routine software update. The firm attempted to update its Falcon Sensor product, which protects data encrypted on the cloud from…
Artiva prices $167M IPO, riding optimism for autoimmune cell therapy
Dive Brief: Artiva Biotherapeutics on Thursday raised $167 million in an initial public offering centered around the promise of donor-derived cell therapies for autoimmune diseases. Artiva sold 13.92 million shares at $12 apiece, securing more money than it expected but at…
Boehringer cuts price of Humira biosimilar in bid to build use
Boehringer Ingelheim will sell an unbranded version of its Humira biosimilar at a 92% discount to the list price of AbbVie drug for people who pay cash at pharmacies through the GoodRx price comparison platform, the companies said Thursday, putting further…
In strengthening Spravato sales, a positive sign for psychedelic drugs
Dive Brief: Sales of Johnson & Johnson’s depression drug Spravato accelerated in the second quarter, putting the medicine on pace to eclipse $1 billion in annual revenue this year. Globally, Spravato sales totaled $271 billion between April and June, a…
Medical device firms have cut more than 14,000 jobs in the past 18 months
Medical device companies have been steadily cutting jobs for the past 18 months, eliminating thousands of positions as firms look to lower costs, close facilities or restructure businesses. More than 14,000 employees in the device industry have been laid off…
NGM, now private, raises $122M for redrawn research plans
Dive Brief: NGM Biopharmaceuticals, which was taken private earlier this year, has raised $122 million from venture investors to advance its recently revamped drug development plans. The Series A round, which NGM disclosed Wednesday, will fund a registrational trial for…
Cardurion raises another $260M to fuel heart drug pipeline
Dive Brief: Biotechnology startup Cardurion Pharmaceuticals on Tuesday raised a $260 million Series B round that will help it build its portfolio of heart disease drugs. Cardurion will use the funds to advance a pair of medicines into mid- and…
Asceneuron raises another $100M for Alzheimer’s drug development
Asceneuron, a Switzerland-based biotechnology company, has raised another $100 million to support its work developing drugs that target a protein linked to Alzheimer’s disease and other nerve-destroying disorders. Disclosed Tuesday, the Series C fundraising round received more interest than Asceneuron…
Revolution Medicines firms up Phase 3 trial plans with latest cancer drug data
Dive Brief: An experimental cancer drug developed by Revolution Medicines shrank pancreatic tumors in about one-quarter of participants who had been followed for at least five months after treatment in an early-stage study. The update, which Revolution Medicines shared with…
Amylyx, with GLP-1 buy, doubles down on blood sugar drugs
Amylyx Pharmaceuticals achieved what all upstart drugmakers hope to accomplish. In less than 10 years, the Massachusetts-based biotechnology company identified a potential medicine, gathered enough evidence to get it approved and started turning a profit. But success was short-lived. A…
As GLP-1 drugs boom, other healthcare companies are cashing in
The popularity of new GLP-1 drugs for weight loss is giving rise to a secondary market with large revenue potential, and companies are vying for a piece of the action. Obesity treatments from Novo Nordisk and Eli Lilly are poised…
Flagship raises $3.6B for biotech investing
Dive Brief: Flagship Pioneering said Wednesday that it’s added another $3.6 billion to its capital base, bringing the total raised since 2021 to $6.4 billion. The Cambridge, Massachusetts-based company said $2.6 billion will be allocated into its eighth venture fund,…
FDA’s lab-developed test rule could be first test of agency’s power post-Chevron
The recent U.S. Supreme Court decision to overturn the Chevron doctrine could open the door to more challenges of Food and Drug Administration regulations, including the agency’s controversial rule on lab-developed tests. In late June, the Supreme Court voted 6-3…
Bristol Myers’ leukemia blockbuster set to face generic rivals
Pharmaceutical companies face a looming patent cliff over the next several years, as generic rivals could erode sales of some of the industry’s best-selling medicines. For some drugmakers, copycat competitors are already on the doorstep. Bristol Myers Squibb, for one,…
Leqembi sales inch higher; Spark’s pivot leads to layoffs
Today, a brief rundown of news from Eisai, Spark Therapeutics and Ipsen as well as updates from Element Biosciences and Novartis that you may have missed. New data from Symphony Health indicate sales of Eisai and Biogen’s Alzheimer’s drug Leqembi…
Novo’s once-weekly insulin rejected by FDA
Dive Brief: The Food and Drug Administration rejected Novo Nordisk’s application to sell a once-weekly insulin treatment called icodec, sending the Danish drugmaker a series of requests related to manufacturing and its potential use in Type 1 diabetes. Regulators have…
Pfizer thinks it found its obesity pill
With tens of billions of dollars at stake, some of the world’s largest drug companies are racing to develop pills with the same power as the weight loss shots that have quickly become among the industry’s best-selling medicines. Pfizer is…
AbbVie names new R&D head; Arcutis eczema cream approved
Today, a brief rundown of news from AbbVie and Skyhawk Therapeutics, as well as updates from Arcutis Biotherapeutics and Zevra Therapeutics that you may have missed. AbbVie on Wednesday named Roopal Thakkar as its chief scientific officer and head of…
FTC to sue three largest PBMs over drug price practices: WSJ
Dive Brief: The Federal Trade Commission is preparing to sue the three largest pharmacy benefit managers in the U.S. — CVS’ Caremark, Cigna’s Express Scripts and UnitedHealth’s Optum Rx — over how they negotiate prices for drugs with pharmaceutical manufacturers,…
SciRhom pulls in $70M for a new type of immune disease drug
SciRhom, a German biotechnology startup focused on autoimmune diseases, has raised a $70 million Series A funding round that will help the company bring its first drug prospect into human testing. The fundraise announced Tuesday will support development of antibody…
FTC criticizes PBM power over prescription drug market
The Federal Trade Commission on Tuesday released a long-awaited report criticizing the pharmacy benefit manager industry for manipulating the drug supply chain to profit at the expense of patients and independent pharmacists. The report, which focuses on PBMs’ pharmacy practices,…
HilleVax’s norovirus vaccine ineffective in large trial of infants
Dive Brief: Biotechnology company HilleVax on Monday said it will halt development of an experimental norovirus vaccine in infants after the shot proved ineffective in a large trial, sending shares sliding. HilleVax’s candidate, dubbed HIL-214, failed to meet its primary…
Lilly to buy Morphic in $3B bet on inflammation drug
Eli Lilly plans to spend $3.2 billion acquiring a Massachusetts-based biotechnology company and its experimental pill for inflammatory bowel disease. Announced Monday, the all-cash deal has Lilly buying all the outstanding shares of Morphic Therapeutics for $57 apiece — a…
With revised IPO pitch, Artiva touts ‘natural killer’ cell therapy for autoimmune disease
Dive Brief: Two years after canceling an initial public offering, Artiva Biotherapeutics has filed a new proposal centered around plans to develop a donor-derived cell therapy for autoimmune disease. The company originally registered for an IPO in April 2021 to…
UniQure, with sale of plant, outsources Hemgenix manufacturing
Dive Brief: UniQure will sell a gene therapy production plant in Lexington, Massachusetts, to contract manufacturer Genezen in a deal designed to reduce the biotechnology company’s operating expenses. Genezen will pay UniQure $25 million in stock and debt for the…
Cartesian data add to progress, questions for CAR-T in autoimmune disease
Dive Brief: Cartesian Therapeutics on Tuesday said an experimental cell therapy it’s developing succeeded in a mid-stage clinical trial of people with the rare autoimmune condition myasthenia gravis, but shares in the biotechnology company fell by double digits nonetheless. According…
5 FDA decisions to watch in the third quarter
Two of last year’s largest biotechnology company acquisitions centered on a new type of treatment for schizophrenia. By the end of September, the first of those therapies could win Food and Drug Administration approval, a decision that would highlight the…
Beacon raises $170M for eye gene therapy; J&J confirms Carvykti survival benefit
Today, a brief rundown of news from Beacon Therapeutics and Regeneron Pharmaceuticals, as well as updates from Vertex Pharmaceuticals, Johnson & Johnson and Codexis that you may have missed. Gene therapy developer Beacon Therapeutics has reloaded with a $170 million…
CureVac cuts jobs, licenses out vaccines to GSK
Dive Brief: CureVac, a specialist in messenger RNA-based therapies, disclosed Wednesday plans to lay off 30% of its workforce as part of a “significant strategic restructuring” that will direct the company’s resources toward “high-value” projects. The announcement comes less than…
Moderna gets US funding for bird flu vaccine development
The U.S. government has awarded $176 million to vaccine maker Moderna for development of an mRNA-based influenza shot. The funding was awarded through the Biomedical Advanced Research and Development Authority, or BARDA, and will support late-stage testing of a vaccine…
Lilly drug for Alzheimer’s approved by FDA
The Food and Drug Administration on Tuesday approved a new Alzheimer’s disease drug from Eli Lilly, several weeks after a panel of independent experts unanimously recommended its clearance. The drug, which Lilly will sell as Kisunla, is designed to slow…
Eisai and Bristol Myers cancel cancer ADC deal
Dive Brief: Eisai and Bristol Myers Squibb will cancel a collaboration on a dual-acting drug being developed to treat lung and ovarian cancer, Eisai said Monday. The termination is the result of the U.S. drugmaker’s “portfolio prioritization efforts,” Eisai said,…
Eli Lilly inks another radiopharma deal, gaining option to buy startup
Dive Brief: Eli Lilly is expanding further into radiopharmaceuticals, inking a deal with Radionetics Oncology that gives it an option to later acquire the San Diego biotechnology company for $1 billion. Lilly will pay Radionetics $140 million upfront for the…
The right viral safety program can guard against costly bioburden incidents in biopharma development
Viral contamination is a threat to biopharmaceutical product development.1 Contaminants can be present in the cells and source materials or introduced during manufacturing, necessitating viral clearance studies for all biological drugs, including vaccines, blood products and cell and gene therapeutics.2…
Alumis cuts IPO size, but nets $250M for immune drug work
Immune drug developer Alumis has raised $210 million in one of the biotechnology sector’s largest initial public offerings this year. Still, the IPO announced Thursday comes in below projections Alumis set earlier this week. The company expected to sell 17.7…
Supreme Court overturns Chevron doctrine, limiting reach of federal agencies
Dive Brief: The U.S. Supreme Court overturned the Chevron doctrine on Friday in a decision that could dramatically limit federal agencies’ regulatory power. In a 6-3 vote, the high court overruled a 1984 decision in Chevron v. Natural Resources Defense…
PTC faces another Duchenne drug rejection; Coherus sells Humira biosimilar
Today, a brief rundown of news from PTC Therapeutics, Esperion Therapeutics and Coherus Biosciences, as well as updates from Sanofi, Lantheus Holdings and Forbion that you may have missed. Drug regulators in Europe have, for a third time, recommended against…
Rocket gene therapy rejected by FDA over manufacturing
Dive Brief: The Food and Drug Administration has rejected a gene therapy developed by Rocket Pharmaceuticals for a rare type of inherited immunodeficiency, the biotechnology company disclosed Friday. According to Rocket, the FDA asked for “limited additional” information on what’s…
Merck’s pneumococcal vaccine gets CDC panel backing
Dive Brief: Advisers to the Centers for Disease Control and Prevention on Thursday unanimously recommended Merck & Co.’s recently approved pneumococcal vaccine for use in adults aged 65 years and older and in younger adults with certain health conditions who…
2seventy slims down with sale of hemophilia assets to Novo
Dive Brief: 2seventy Bio is shrinking further, announcing Thursday the sale of a hemophilia A research program, along with associated technology rights, to partner Novo Nordisk. 2seventy and Novo first teamed up in 2019 to develop a gene editing therapy…
RSV vaccine makers’ shares fall as CDC adjusts shot guidance
Dive Brief: Shares of Moderna, Pfizer and GSK fell as advisers to the Centers for Disease Control and Prevention discussed updated guidelines for RSV vaccination at a Wednesday meeting. The expert panel recommended adults over 75 years should receive a…
Women with a common hormonal disorder have few good treatment options. Could GLP-1 drugs help?
Ozempic and GLP-1 drugs like it became household names due to their potent weight loss benefits, and are now proving useful in a slew of other chronic conditions. Women are noticing other benefits, too, including some that may be flying…
Novo nixes trial of blood pressure drug it bought in deal worth $1.3B
Dive Brief: Novo Nordisk will end a Phase 3 clinical trial of a hypertension drug it bought for up to $1.3 billion last year because treatment didn’t appear to be working, the company said Wednesday. The decision was based on…
Wave, with new data, plots path forward for Huntington’s drug
Dive Brief: Wave Life Sciences on Tuesday said it will meet with regulators to discuss what kind of evidence would be needed to support an accelerated approval application for an experimental drug it’s developing for Huntington’s disease. The biotechnology company…
Novo to spend $4B on US plant, adding to obesity drug production push
Dive Brief: Novo Nordisk will spend $4.1 billion to build a new U.S. factory in North Carolina, the latest multibillion-dollar investment by the Danish drugmaker to expand production of its fast-selling weight loss and diabetes drugs Wegovy and Ozempic. Funding…
Exsilio debuts with $82M, pitching a ‘leap’ forward for genetic medicine
Exsilio Therapeutics, a biotechnology startup led by a former Moderna executive, emerged from stealth Tuesday with an approach it claims can solve some of the shortcomings of genetic medicines. The Boston-based company is debuting with $82 million from a group…
Obesity drugs from Altimmune, Hengrui show potential; Lilly details Zepbound sleep apnea data
Today, a brief rundown of news from Altimmune, Jiangsu Hengrui, Eli Lilly and others that you might have missed from over the weekend, when the American Diabetes Association held its annual meeting. After an early setback for Altimmune’s obesity shot pemvidutide,…
Bridging science and humanity: Systems thinking in clinical trial design
Diseases aren’t just disorders in physiological systems, and it’s not possible to cure them simply by discovering molecules with therapeutic effects on cellular targets. Instead, as research from the National Institutes of Health (NIH) reminds us, diseases affect individuals who…
Amazon expands drug subscription program to Medicare members
Dive Brief: Amazon has expanded its generic drug savings program to Prime members on Medicare, throwing open the program’s doors to a major population of medication users — if Amazon is able to get them to sign up. The subscription…
Twice-yearly shots of Gilead HIV drug effective in large prevention study
Dive Brief: Twice-yearly shots of a Gilead Sciences HIV drug were so effective at preventing infections in a large late-stage clinical trial that study monitors recommend the company stop testing early and offer the drug to all participants. The trial,…
FDA lifts hold on PTC Huntington’s disease trial
Dive Brief: PTC Therapeutics said Thursday it can resume a Phase 2 trial of its Huntington’s disease drug in the U.S., following the Food and Drug Administration’s review of data showing the pill reduced a mutant protein linked to the…
Jazz drug for tremor fails study; Radiopharma drug developer ITM swaps CEOs
Today, a brief rundown of news from Jazz Pharma, Vanda Pharmaceuticals, ITM, Ashibio and Novartis that you might have missed from earlier in the week. An experimental medicine that Jazz Pharmaceuticals picked up in 2019 has failed a mid-stage study…
Duchenne approval exposes FDA rift over Sarepta gene therapy
Peter Marks is again at the center of a controversial Food and Drug Administration decision on a gene therapy for Duchenne muscular dystrophy. Twice now, the high-ranking FDA leader has pushed aside objections from agency reviewers to grant an approval…
Obesity drug from Zealand shows potential in early trial
An experimental weight loss shot developed by Denmark-based Zealand Pharma helped people with obesity lose as much as 9% of their body weight over four months, results the company said support further research on a medicine it hopes could compete…
Sarepta Duchenne gene therapy wins broader use from FDA
The Food and Drug Administration has loosened limits on the first gene therapy for Duchenne muscular dystrophy in a decision that could greatly expand its use even as questions remain about its effectiveness. The agency on Thursday made the therapy,…
Roche partners with RNA editing biotech Ascidian
Roche has partnered with Ascidian Therapeutics to develop so-called “RNA exon editing” drugs, the latest foray by the Swiss pharmaceutical company to shore up its neurology pipeline. Under the deal, announced by the companies Tuesday, Roche will pay Ascidian $42…
Sanofi taps Belharra for immune drug research; AstraZeneca’s new cancer drug falls short
Today, a brief rundown of news from Belharra Therapeutics, AstraZeneca, Regenxbio and Tasyha Gene Therapies. Sanofi will work with biotechnology startup Belharra Therapeutics to develop small molecule drugs for inflammatory diseases, the companies announced Tuesday. Belharra will get $40 million…
Intra-Cellular depression drug succeeds in second late-stage study
Dive Brief: Intra-Cellular Therapies plans to seek clearance to sell its medicine Caplyta for patients with depression after a second-late stage study of the drug succeeded. Caplyta, also known as lumateperone, is currently approved for patients suffering from schizophrenia and…
Merck wins FDA OK for vaccine rival to Pfizer’s pneumococcal shot
Dive Brief: The Food and Drug Administration on Monday approved a new vaccine from Merck & Co. that protects against 21 types of the bacteria that causes pneumococcal disease. The vaccine, cleared for use in adults 18 and older, will…
Syncona melds two gene therapy biotechs for better shot at new nervous system treatments
Two gene therapy developers backed by Syncona, an investment firm focused on life sciences, are combining to create a new company that will take aim at central nervous system diseases. Through a deal announced Monday, Freeline Therapeutics is acquiring SwanBio…
Takeda drug for rare types of epilepsy misses goal in late-stage trial
Dive Brief: An experimental pill developed by Takeda to treat the rare epilepsies Dravet and Lennox-Gastaut syndromes missed the main goals of two Phase 3 trials, failing to reduce the frequency of seizures after four months of treatment, the company…
The critical role of comprehensive RNA sequencing in liquid biopsy for biomarker discovery and clinical trials
The advent of liquid biopsy, especially using targeted RNA sequencing from cell-free RNA in body fluids, is transforming cancer research. This minimally invasive approach significantly enhances cancer management at various stages, from early detection to therapy selection and disease monitoring….
Radiopharma drugmaker Telix pulls US IPO plans
Dive Brief: Telix, an Australia-based developer of radiopharmaceutical drugs for cancer, has canceled plans to raise roughly $200 million via an initial public offering on the Nasdaq stock exchange. The company, which is already publicly traded in Australia, cited the…
AbbVie joins in latest gastrointestinal drug chase
AbbVie is securing its place in an emerging gastrointestinal disease drug field, paying China-based FutureGen Biopharmaceutical $150 million in immediate and near-term fees for rights to an antibody drug targeting TL1A, a molecule linked to heightened immune responses in inflammatory…
Moderna says next-gen COVID shot effective in study
Dive Brief: Moderna said its next-generation COVID-19 vaccine succeeded in a Phase 3 study, offering increased effectiveness for adults. The vaccine, known as mRNA-1283, is designed to fight newer strains of coronavirus that have emerged since the development of Moderna’s…
Supreme Court preserves access to abortion pill in unanimous ruling
The Supreme Court on Thursday unanimously ruled an anti-abortion group contesting the Food and Drug Administration’s approval of the abortion pill mifepristone does not have a legal basis to sue, putting an end to a high-profile court battle. Justices held…
Pfizer gene therapy for Duchenne fails to meet goals of key trial
Pfizer’s experimental gene therapy for Duchenne muscular dystrophy didn’t improve the motor function of young boys enrolled in a late-stage trial meant to provide a decisive verdict on the treatment’s potential. Results from a final analysis showed the treatment failed…
Regenxbio CEO to step down after 15 years
Kenneth Mills, the CEO and founder of Regenxbio, will step down from his role next month after spending a decade and a half leading the prolific gene therapy developer. He will be replaced on July 1 by Curran Simpson, currently…
Ipsen drug for rare liver disease approved by FDA
Dive Brief: The Food and Drug Administration on Monday cleared a new treatment option for the rare liver disease primary biliary cholangitis, granting an accelerated approval to Ipsen’s drug Iqirvo. The agency’s OK was based on clinical trial data showing…
Donanemab approval would fuel growth of amyloid-blocking Alzheimer’s drugs, analysts say
Approval of Eli Lilly’s experimental Alzheimer’s disease drug donanemab would help drive sales of Eisai and Biogen’s rival medicine Leqembi, analysts wrote after a Food and Drug Administration panel on Monday supported clearance of donanemab. “A rising tide lifts all…
Lilly Alzheimer’s drug gets unanimous backing of FDA panel
An experimental and closely watched medicine for Alzheimer’s disease is one step closer to approval, after receiving support from a panel of experts who advise the Food and Drug Administration. On Monday, the panel unanimously voted that the medicine, developed…
Moderna says combination flu, COVID shot succeeds in study
Dive Brief: Moderna on Monday said a combination flu and COVID-19 shot it’s developing met the goal of a late-stage study, eliciting higher immune responses to the two viruses than did available vaccines when tested among adults 50 years or…
Germany’s ITM raises $205M as radiopharma field booms
Dive Brief: Radiopharmaceutical drug developer ITM has raised 188 million euros, or about $205 million, to fund its development of the targeted radiation therapies for cancer. Announced by ITM Thursday, the financing is the latest evidence of the substantial investment…
Seres, indebted and in need of cash, agrees to sell microbiome pill to Nestle
Dive Brief: Seres Therapeutics plans to sell all the rights to its microbiome pill to Nestlé Health Science as it struggles to fund operations. Under a nonbinding memorandum of understanding announced Thursday, the Swiss company will acquire all the product…
FDA advisers back updating COVID shots to target JN.1 virus family
A group of advisers to the Food and Drug Administration on Wednesday unanimously recommended that COVID-19 vaccines be updated to cover coronavirus strains with a family known as JN.1 ahead of the fall. The committee, which had originally been scheduled…
As biotech recovers, venture firms’ preferences appear to shift
After a turbulent few years, 2024 has given the biotechnology industry some signs of a return to normalcy. For one, venture investment appears to have stabilized at levels seen prior to a pandemic-era spike. Data presented by the Biotechnology Innovation…
Geron wins long-sought drug approval; Califf talks China, GLP-1s at BIO
Today, several brief updates from BioPharma Dive Reporter Gwendolyn Wu, who spent this week attending BIO’s annual meeting in San Diego, as well as notes on Geron, AbbVie and Deerfield Management. Food and Drug Administration Commissioner Robert Califf, speaking on…
After ‘sobering’ FDA panel, psychedelics supporters wonder what’s next
Long dismissed by top scientists and drug regulators, the use of psychedelics to treat mental health conditions has finally gained momentum over the last several years. But some proponents believe that progress was undercut this week, when one of the…
GSK acquires oligonucleotide drug startup Elsie
Listen to the article 2 min This audio is auto-generated. Please let us know if you have feedback. British drugmaker GSK is investing further in nucleic acid drug development, reaching a deal to buy the San Diego-based Elsie Biotechnologies for…
In review of Lilly Alzheimer’s drug, FDA staff focus on safety, patient selection
Dive Brief: Expert advisers to the Food and Drug Administration will need to weigh whether Eli Lilly’s experimental Alzheimer’s disease drug donanemab is widely effective or should be restricted only to people who have deposits in their brains of a…
Lilly CFO leaves to join Alphabet
Dive Brief: Anat Ashkenazi will leave Eli Lilly’s executive suite at the end of July to become CFO and senior vice president of Google and Alphabet, the companies said Wednesday. Ashkenazi has been CFO at Lilly since 2021 and originally…
Lilly details MASH data for tirzepatide; Cytokinetics comments on past sale talks
Today, a brief rundown of news from Eli Lilly, Cytokinetics and AbbVie, as well as updates from Gilead and the National Institutes of Health that you may have missed from earlier this week. Eli Lilly’s drug tirzepatide — sold as…
FDA panel votes against MDMA therapy for PTSD, citing muddy data and safety concerns
Medical experts who advise the Food and Drug Administration are not convinced MDMA is ready for general use to help treat post-traumatic stress disorder, recommending at a meeting Tuesday the agency hold off on an approval. The experts convened at…
BridgeBio data show sustained benefit for achondroplasia drug
Dive Brief: An experimental drug from BridgeBio Pharma helped accelerate growth in height among a dozen people with achondroplasia, the most common cause of disproportionate short stature. The results, from one group of a mid-stage clinical trial, showed that treatment…
ASCO24: Tagrisso in the spotlight, Caribou’s adjustment and Lilly’s KRAS competitor
BioPharma Dive is testing out a new format rounding up smaller updates from around the industry. Have thoughts on what could make this type of story better? Drop us a line! Over the weekend at the American Society of Clinical…
A true liquid biopsy hub – Menarini Silicon Biosystem
Liquid biopsy has emerged as a revolutionary tool for clinical trials, offering cellular and cell-free methods that provide valuable insights into disease progression and treatment response. Circulating tumor cells (CTCs) and cell-free DNA and cell-free RNA (cfDNA/cfRNA) allow for detecting…
AstraZeneca immunotherapy extends survival by two years in rarer type of lung cancer
AstraZeneca’s immunotherapy Imfinzi helped people in the early stages of a type of lung cancer live 23 months longer than those who received just chemoradiotherapy, according to clinical trial data released Sunday. The finding should help the U.K.-based pharmaceutical company…
With new Enhertu data, an ADC could overtake chemo in breast cancer
Two years ago, a drug called Enhertu changed the way doctors thought about treating an aggressive form of breast cancer, making it important to know not only whether their patients’ tumors express a protein known as HER2, but how much….
Gilead’s Trodelvy misses goal in bladder cancer study
An accelerated approval for Gilead Sciences’ cancer drug Trodelvy could be in question after the company disclosed Thursday afternoon that a confirmatory trial failed to meet its main objective. In the trial, called TROPiCS-04, Trodelvy did not significantly extend survival versus…
Moderna wins FDA approval for RSV vaccine
The Food and Drug Administration on Friday approved a third vaccine for respiratory syncytial virus, clearing a shot from biotechnology company Moderna one year after granting a green light to vaccines from GSK and Pfizer. The vaccine, dubbed mResvia, is…
FDA delays decision on Dupixent in COPD; Summit makes a bold claim
BioPharma Dive is testing out a new format rounding up smaller updates from around the industry. Have thoughts on what could make this type of story better? Drop us a line! Today, a brief rundown of news from Regeneron, Summit…
FDA staff outline shortcomings of Lykos data for MDMA therapy
Food and Drug Administration scientists have reservations about a potential new treatment for post-traumatic stress disorder that’s currently up for approval. Developed by an unusual company called Lykos Therapeutics, the ecstasy-based treatment has been tested across a handful of clinical…
Otsuka defies digital health downturn with new company
Otsuka America, a subsidiary of the Japanese drug and device maker, this month launched a new company focused on digital health. The firm, called Otsuka Precision Health, will roll out its first product this summer, a prescription digital therapeutic for…
Immunovant changes up plans for closely watched autoimmune drugs
Dive Brief: Immunovant told investors Wednesday that it’s shifting resources to focus on a less advanced experimental autoimmune disease treatment that appears more promising for future development. The company now plans to extend a trial of its former lead asset,…
A biotech working on a new approach to IVF raises $33M in fresh funding
Dive Brief: Gameto, a biotechnology company developing new treatments for fertility, has raised $33 million in venture capital funding to advance technology it says could shorten in vitro fertilization cycles, as well as replace the hormonal injections currently used in…
Merck to buy eye drug developer for $1.3B
Dive Brief: Merck & Co. on Wednesday said it has agreed to buy privately held eye drug developer EyeBio for $1.3 billion in cash upfront and as much as $1.7 billion in future milestone payments. Backed by SV Health Investors,…
Insmed shares double as lung drug data convince Wall Street
New Jersey-based drugmaker Insmed gained more than $3 billion in market value Tuesday after reporting clinical trial results for an experimental lung disease drug that impressed analysts. Data from the trial, a Phase 3 study called Aspen, showed that Insmed’s drug…
J&J gains another bispecific antibody with $1.25B skin drug buy
Dive Brief: Johnson & Johnson is adding to its portfolio of dual-targeting antibody drugs, announcing on Tuesday a deal to acquire an experimental skin disease medicine for $1.25 billion. Per deal terms, J&J will buy Yellow Jersey Therapeutics, a spinout…
Cytokinetics secures up to $575M in royalty deal, frustrating investors
Dive Brief: Shares in Cytokinetics sank by about one-fifth Thursday on news of a funding deal the biotechnology company struck with Royalty Pharma, in which it traded away a stake in future sales of its experimental heart drug for upfront…
Merck KGaA to buy gene therapy tools maker for $600M
Dive Brief: German drugmaker Merck KGaA agreed to buy Mirus Bio for $600 million to build expertise in a critical part of viral vector-based gene therapy production. Merck KGaA is making the purchase through its U.S. and Canadian life sciences…
Orna, a circular RNA specialist, acquires a buzzy startup
Orna Therapeutics, a young biotechnology company focused on a flashy area of genetic research, is expanding through the acquisition of another well-funded startup. As its name suggests, the startup, ReNAgade Therapeutics, was built around technology designed to more effectively deliver…
Lilly to pour $5B more into expanding Zepbound, Mounjaro production
Eli Lilly plans to spend another $5.3 billion building production capacity for its popular obesity and diabetes drugs, responding to immense demand for the medicines with what it claims is now the largest investment of its kind in U.S. history….
How does a Torch Disposable compare to other lighting tools?
Torch Disposable compare to other lighting tools A Torch Disposable offers a convenient and hassle-free vaping experience that is perfect for on-the-go users. With its sleek design and generous e-liquid capacity, this device is sure to satisfy flavor enthusiasts and…
With Duchenne decision ahead, FDA’s Marks pushes for speedy gene therapy approvals
A top Food and Drug Administration official on Friday again advocated for the speedy approval of gene therapies for rare diseases. But he didn’t drop any clues on where the agency stands on a coming decision to possibly broaden use…
ASCO24: An early look at cancer drug study results
BioPharma Dive is testing out a new format rounding up smaller updates from around the industry. Have thoughts on what could make this type of story better? Drop us a line! Today, we’re interrupting our usual rundown of industry news…
Certain menopausal hormone therapy could raise ovarian cancer risk, study finds
An older form of hormone therapy taken to ease the symptoms of menopause could increase the risk of ovarian cancer, according to results released Thursday from two studies involving tens of thousands of women. Another hormonal regimen didn’t seem to…
Regeneron faces new biosimilar threats; an AI biotech lays off staff
BioPharma Dive is testing out a new format rounding up smaller updates from around the industry. Have thoughts on what could make this type of story better? Drop us a line! Today, a brief rundown of news from Boehringer Ingelheim,…
Pfizer expands cost cuts with new $1.5B target
Pfizer, already in the midst of an aggressive effort to trim spending, on Wednesday disclosed new plans to cut at least $1.5 billion in additional costs over the next several years. The program is meant to reduce what Pfizer spends…
Biogen, looking to diversify, acquires immune drugmaker HI-Bio for $1.15B
Dive Brief: Biogen is scooping up a closely held immunology startup to bring more diversity to a pipeline best known for neurology products. Per deal terms, Biogen will pay $1.15 billion in cash up front to acquire Human Immunology Biosciences,…
AstraZeneca’s $80B sales plan leans on cancer drug expansion
Dive Brief: AstraZeneca’s plan to reach $80 billion in sales by 2030 relies heavily on a slate of roughly one dozen cancer drugs it expects will become blockbuster sellers at their peak, according to a presentation to investors that executives…
AltruBio lands up to $225M after shift to immune drug research
Dive Brief: Biotechnology startup AltruBio on Tuesday raised a Series B round that could hand it up to $225 million, cashing in again on a decision four years ago to change its development strategy. Originally known as AbGenomics Holdings, the startup…
Forbion-backed biotech Progentos debuts with $65M for MS drug
Forbion, a well-known backer of life sciences startups, is leading an investment round for a newly launched biotechnology company focused on diseases that affect nerve cells. The company, Progentos Therapeutics, has raised $65 million through a Series A financing that…
Therapies designed to dismantle cancer’s escape mechanisms show promise for patients
Dr. Zocca brings more than 20 years of experience in the biotechnology field and has founded and co-founded several biotech spinouts. Her focus on translational and clinical immune oncology has led to the development of important investigational immunotherapies for a…
Biogen, Ionis shelve ALS drug following study failure
Biogen and Ionis Pharmaceuticals are stopping development of an experimental drug for ALS following new clinical trial results that didn’t meet the companies’ expectations. The trial, which enrolled almost 100 people with the nerve-destroying disorder, found the drug actually worked…
Roche keeps pace in obesity drug field with early study data
Dive Brief: An experimental Roche drug helped people with obesity lose an average of nearly 19% of their body weight over six months, after adjusting for placebo, in an early-stage trial, the company said Thursday. Roche is awaiting additional data…
Lilly’s once-weekly insulin matches daily shots in late-stage tests
A once-weekly form of insulin being developed by Eli Lilly proved just as effective at controlling blood sugar in adults with diabetes as commonly used daily injections, according to results from two clinical trials that were released by the drugmaker…
Investors put $400M into biotech licensing obesity drugs from China
Four life science investors are pouring $400 million into a new biotechnology startup that’s licensed a portfolio of weight loss medicines from Chinese drugmaker Jiangsu Hengrui Pharmaceuticals, according to a disclosure posted on the Shanghai Stock Exchange Thursday. The newly…
FDA approves Amgen drug for tough-to-treat form of lung cancer
Dive Brief: The Food and Drug Administration on Thursday granted accelerated approval to a new dual-acting drug from Amgen to treat small cell lung cancer in people whose disease has progressed following chemotherapy. The drug, which will be sold as…
Erasca restructures; Novartis moves to complete MorphoSys deal
BioPharma Dive is testing out a new format rounding up smaller updates from around the industry. Have thoughts on what could make this type of story better? Drop us a line! Today, a brief rundown of news from Erasca and…
Detailed trial data show Bayer drug alleviates menopause symptoms
New data from two late-stage studies of an experimental Bayer drug show it reduced the frequency and severity of common symptoms of menopause, supporting the company’s case for seeking regulatory approval. The results were disclosed by Bayer Thursday and will…
J&J to buy Proteologix and its dual-targeting antibody drugs for $850M
Dive Brief: Johnson & Johnson agreed to buy biotechnology startup Proteologix for $850 million in cash, gaining a portfolio of bispecific antibodies the privately held company has been developing for immune diseases. With the acquisition announced Thursday, J&J will obtain…
Eisai sets new revenue target for Alzheimer’s drug Leqembi
One of the developers behind the Alzheimer’s disease drug Leqembi has set new revenue expectations that some analysts see as more practical than previous guidance. On Wednesday, Japan-based Eisai predicted revenue from the drug would hit 56.5 billion yen, or…
FogPharma, Artbio join forces to design a different radiopharma drug
FogPharma and Artbio, two buzzy biotechnology companies, are betting they can combine their respective technologies to design a new type of radiopharmaceutical drug for cancer. The companies didn’t disclose financial terms for the alliance they announced Tuesday, but said they…
Bayer details layoffs as company shake-up continues
German pharmaceutical company Bayer eliminated 1,500 roles during the first three months of the year as part of a company makeover CEO Bill Anderson promised last year. Speaking on a first quarter earnings call Tuesday, Anderson said about two-thirds of…
Sanofi gambles $80M on Fulcrum’s muscular dystrophy drug
Listen to the article 3 min This audio is auto-generated. Please let us know if you have feedback. Dive Brief: Sanofi is adding to its portfolio of rare disease therapies, agreeing on Monday to acquire partial rights to an experimental…
Takeda nabs option to license Alzheimer’s immunotherapies from AC Immune
Takeda Pharmaceutical is betting potentially billions of dollars on drugs designed to slow Alzheimer’s disease by harnessing the immune system. Through a deal announced Monday, Takeda has secured an exclusive option to license “active immunotherapies” from the Swiss biotechnology company…
NewVale, an unorthodox investment firm, sets out to support biotech’s ‘infrastructure’
Dive Brief: An unorthodox life sciences investment firm closed its inaugural fund on Monday, a $167 million bankroll that will support investments in companies providing pharmaceutical services to young drugmakers. Called NewVale Capital and based in Boulder, Colo., the firm…
AstraZeneca withdraws COVID-19 vaccine, citing declining demand
Dive Brief: AstraZeneca will no longer manufacture or supply its COVID-19 vaccine Vaxzevria, announcing Tuesday it is voluntarily withdrawing the shot due to a “decline in demand,” a spokesperson wrote in an email to BioPharma Dive. Prior to the announcement, the…
Royalty Pharma pays startup $525M for stake in Sanofi MS drug
Dive Brief: Royalty Pharma will pay biotechnology startup ImmuNext $525 million for the right to earn royalties and milestone payments from an autoimmune disease drug the privately held company licensed to Sanofi. Sanofi acquired the medicine from ImmuNext in 2017…
Novavax gets a lifeline with Sanofi vaccine pact
Dive Brief: Sanofi will pay vaccine maker Novavax $500 million and take a small equity stake in the Maryland-based company as part of a broad COVID-19 shot alliance, the companies announced Friday. Through the deal, Sanofi will gain rights to co-market…
FDA delays decision on Moderna RSV vaccine
Moderna on Friday said the Food and Drug Administration has postponed an approval decision on its experimental vaccine for respiratory syncytial virus due to “administrative constraints,” extending a review the regulator had expected to complete by Sunday. According to Moderna’s…
iTeos shares jump on TIGIT update; Acelyrin swaps CEOs
BioPharma Dive is testing out a new format rounding up smaller updates from around the industry. Have thoughts on what could make this type of story better? Drop us a line! Today, a brief rundown of news from iTeos Therapeutics,…
Maze lands new partner for Pompe drug, after Sanofi pact came apart
Dive Brief: Biotechnology startup Maze Therapeutics has licensed a Pompe disease drug to Shionogi, five months after a challenge from the Federal Trade Commission caused Sanofi to back out of a similar deal for the same medicine. Per deal terms…
Takeda targets ‘efficiency’ in restructuring, pipeline cuts
Dive Brief: Takeda plans to simplify how its workforce is organized, cut spending and slim down its drug pipeline in a restructuring aimed at improving its profit margin over the next several years. The Japanese pharmaceutical company revealed its plans…
Novo taps another Flagship startup in search for next obesity drugs
Novo Nordisk is again turning to a Flagship Pioneering startup to find new weight loss drugs, announcing on Thursday a deal with Metaphore Biotechnologies to develop up to two medicines for obesity. Through the partnership, Novo could pay the startup…
Drug patents protect pharma profits. Track when they’ll expire here.
Patents reward drugmakers for their inventions and, effectively, the large sums of money they invest in research and development. The legal monopoly that patents provide keeps generic copies at bay for many years, even decades, and allows pharmaceutical companies to…
Verve moves forward with backup base editing therapy
Dive Brief: Verve Therapeutics has treated the first participant in a recently begun clinical trial of the company’s backup gene editing therapy for heart disease, about one month after a safety setback derailed what had been its lead candidate. The…
Patient dies in Pfizer study of Duchenne gene therapy
A young boy enrolled in a clinical trial testing an experimental Pfizer gene therapy for Duchenne muscular dystrophy has died, the company revealed Tuesday in a letter posted online by a patient advocacy group. The boy, who received the therapy…
Prologue, Flagship’s newest startup, looks to mine viruses for new drugs
Dive Brief: Flagship Pioneering on Tuesday launched Prologue Medicines, a new biotechnology startup aiming to make drugs by closely studying the proteins of viruses. Prologue is starting out with $50 million and what it claims is the largest known database…
Gossamer sells rights to drug it hopes can rival a new Merck therapy
Gossamer Bio has sold rights to an experimental drug that could rival a new medicine from Merck & Co., in a deal at least one analyst believes “bodes well” for the company. On Monday, Gossamer and the Italy-based Chiesi Farmaceutici…
As drug shortages reach record highs, regulators weigh next steps
Drug shortages hit a new high in the first quarter of 2024, forcing patients and doctors to scramble to secure ADHD medications, cancer treatments and other needed drugs. While shortages have been rising for some time, the persisting struggle to…
BridgeBio spinout launches with $200M for KRAS cancer drugs
Dive Brief: A group of well-known biotechnology investors is putting $200 million into a newly launched spinout of BridgeBio Pharma developing drugs that target two common cancer genes. BridgeBio Oncology Therapeutics, which was previously organized as a BridgeBio subsidiary called…
Moderna ends gene editing alliance with Metagenomi
Dive Brief: The gene editing company Metagenomi, which went public earlier this year, said a development partnership struck with Moderna in 2021 has ended after the two companies “mutually agreed” to part ways. As part of the original deal, Moderna…
CG follows big IPO with new results for bladder cancer drug
Dive Brief: An experimental drug from CG Oncology has driven bladder cancers into remission in about three-quarters of people who received it in a Phase 3 trial, matching results the biotechnology company disclosed from a smaller number of study participants…
Why selling to Novartis made sense for Mariana
Mariana Oncology arrived at the J.P. Morgan Healthcare Conference this past January with momentum. The radiopharmaceutical drug developer had secured $175 million in fresh funding four months prior and, in the time since, seen two competitors in its field acquired…
Amgen shares soar as executives outline obesity drug push
Dive Brief: Amgen shares soared by double digits Friday following its announcement an obesity drug it’s developing has shown enough promise to warrant advancing into late-stage testing. On an earnings call with analysts Thursday, CEO Robert Bradway said the company…
Novartis to buy Mariana Oncology in radiopharmaceutical expansion
Dive Brief: Novartis is expanding its pipeline of radiopharmaceutical drugs, announcing Thursday it has agreed to pay $1 billion to acquire biotechnology company Mariana Oncology. Mariana, which specializes in the targeted radiation medicines, could receive up to $750 million more…
Novo sees Wegovy sales dip on lower price, tight supply
Dive Brief: Sales of Novo Nordisk’s obesity drug Wegovy slowed over the first three months of 2024, compared to the fourth quarter last year, as lower realized prices and continued supply constraints curbed growth from the in-demand medicine. Still, the…
Delphia starts up with $67M to make a new type of cancer drug
Cancer research is always evolving, as scientists search for ways to combat the tricks tumors use to evade drug therapies. In the last decade alone, immunotherapies, targeted therapies, antibody-drug conjugates and radiopharmaceuticals have become standard treatment for a variety of…
GSK raises forecasts on strong vaccine, HIV drug sales
Dive Brief: GSK on Wednesday raised its financial forecasts for the year following strong quarterly sales of its vaccines and HIV medicines. GSK said vaccine sales surged 16% compared to the same period a year ago, a number driven by revenue…
Astellas adds to ‘off-the-shelf’ cell therapy capabilities with Poseida deal
Astellas Pharma is betting again on cell therapy, announcing Wednesday a deal with Poseida Therapeutics to develop donor-derived treatments for cancer. Through the partnership, the companies aim to create two allogeneic, or “off-the-shelf,” cell therapies for solid tumors. Astellas will…
Lilly counts on manufacturing scale-up to unstick obesity drug supply
Eli Lilly expects that, by the second half of this year, it will be able to manufacture at least 50% more sellable doses of the main ingredient in its GLP-1 medicines Zepbound and Mounjaro than it could during the same…
Enlaza reels in another $100M for covalent biologics
Enlaza Therapeutics, a San Diego-based startup, has raised a $100 million Series A round to develop biologic cancer drugs designed to latch onto their targets through covalent bonds. The new funding announced Tuesday and led by the life sciences investment…