New study offers hints of GLP-1 drugs’ potential in curbing alcohol cravings
Scientists believe GLP-1 drugs like Novo Nordisk’s Ozempic help people with obesity lose weight in part because they can help quell food cravings. Intriguing evidence these drugs may also help people with alcohol use disorder limit drinking has motivated some…
Novartis pays $925M to reel in a startup it helped launch
Novartis is wagering more than $3 billion that a startup it helped launch six years ago has developed a better blood thinner than what’s now available. The Swiss drugmaker on Tuesday announced a deal to acquire Anthos Therapeutics, a Boston-based…
Merck KGaA pursuing Springworks; BridgeBio wins EU drug OK
Today, a brief rundown of news involving Merck KGaA and BridgeBio Pharma, as well as updates from Biohaven, Third Harmonic Bio and AdvanCell that you might have missed. Merck KGaA is in discussions with SpringWorks Therapeutics about a possible acquisition,…
Vertex COO Arbuckle to step down later this year
Stuart Arbuckle, Vertex’s chief operating officer and one of the company’s longest-tenured leaders, will retire from his role in July. He will be replaced by Charlie Wagner, who will become COO in addition to his role as CFO. Duncan McKechnie,…
AbbVie, Pfizer gain FDA OK for novel antibiotic
Dive Brief: The Food and Drug Administration on Friday approved a new combination antibiotic developed by AbbVie and Pfizer for tough-to-treat bacterial infections. The drug, named Emblaveo, is cleared for use alongside the antibiotic metronidazole in adults who have either…
Amgen obesity drug on hold; Regeneron sets first dividend
Today, a brief rundown of news involving Amgen and Regeneron, as well as updates from Valneva, Turnstone Biologics and AdvanCell that you might have missed. The Food and Drug Administration has put an obesity study run by Amgen on clinical…
Pfizer taps former Novartis exec to lead cancer drug push
Listen to the article 4 min This audio is auto-generated. Please let us know if you have feedback. Pfizer on Wednesday named a longtime Novartis executive the leader of an oncology division it is leaning on to win back the…
Bristol Myers gives first peek at closely watched launch of schizophrenia drug
Sales of Cobenfy, a new mind-stabilizing medicine, totaled $10 million in the final months of last year, results that fell in line with analyst expectations. Bristol Myers Squibb, which acquired Cobenfy through its $14 billion purchase of Karuna Therapeutics, gave…
Eli Lilly’s earnings, shares lifted by obesity drug sales
Dive Brief: Eli Lilly’s profit doubled in the fourth quarter as the Indianapolis-based drugmaker raked in revenue from diabetes and obesity drugs. Net income rose to $4.4 billion, or $4.88 a share, from $2.2 billion, or $2.42 a share, in…
Immune drugmakers Alumis and Acelyrin to merge
Dive Brief: Alumis and Acelyrin are merging, the biotechnology companies said Thursday afternoon, in an all-stock deal that leaves the combined company with a bigger cash balance and three drugs in clinical testing. Per deal terms, Acelryin stockholders will receive 0.4274…
Bain buys Mitsubishi pharma unit; Bausch + Lomb deal talks come up empty
Today, a brief rundown of news involving Mitsubishi Tanabe Pharma and Bausch + Lomb, as well as updates from Roche, Viracta Therapeutics and X4 Pharmaceuticals that you might have missed. Investment firm Bain Capital agreed on Friday to acquire Mitsubishi Tanabe…
Vertex challenger Sionna prices $191M IPO
Sionna Therapeutics on Thursday raised $191 million in an initial public offering that will fund its plan to challenge Vertex Pharmaceuticals’ dominant cystic fibrosis franchise. The company sold nearly 10.6 million shares at $18 apiece, more than it projected in a…
Bristol Myers, bracing for key patent losses, deepens cost-cutting plan
Dive Brief: Bristol Myers Squibb is expanding its plan to cut costs, announcing alongside quarterly earnings on Thursday that it will slash an additional $2 billion in annual expenses by the end of 2027. The announcement builds on cutbacks Bristol…
Novo outlines new late-stage study of obesity drug CagriSema
Dive Brief: Novo Nordisk is planning a new Phase 3 trial of its next-generation obesity drug CagriSema that will test different doses and longer duration of treatment, the company said Wednesday. The announcement comes six weeks after the Denmark-based company…
GSK, Pfizer sales of RSV shots slow as vaccination rates ebb
Dive Brief: Sales of both GSK’s and Pfizer’s vaccines for respiratory syncytial virus dropped significantly in the last three months of 2024, compared the same period one year before. In a earnings report Tuesday, Pfizer said sales of its vaccine…
RFK Jr. secured support of key Republican with vaccine pledges
Listen to the article 3 min This audio is auto-generated. Please let us know if you have feedback. Robert F. Kennedy Jr. made Senator Bill Cassidy a raft of promises to secure the Louisiana Republican’s support in a key committee…
Flagship-backed Omega signals it’s headed toward bankruptcy
Dive Brief: Omega Therapeutics, a genetic medicines maker originally backed by Flagship Pioneering, plans to soon file for Chapter 11 bankruptcy as it enters a restructuring agreement with Flagship’s “Pioneering Medicines” initiative. In a securities filing Monday, the company outlined…
Pfizer drug acquired in $11B buyout confirms benefit in colon cancer
Dive Brief: Adding Pfizer’s cancer drug Braftovi to standard treatments helped people with a form of colorectal cancer live longer without their disease worsening than those who got the typical care alone in a Phase 3 trial, the company said…
Shares of psychedelics biotech nearly double on depression data
In a little more than a week’s time, a drug developed by a small psychedelics company was able to significantly curb hard-to-treat depression in a mid-stage clinical trial. That’s according to high-level results announced Monday. The trial recruited 81 people…
Cargo to drop lead CAR-T therapy, lay off staff after study setback
Dive Brief: Cell therapy developer Cargo Therapeutics will scrap its top program and lay off half of its staff after study results showing the treatment, which was being tested in a form of lymphoma, doesn’t have a “competitive risk-benefit profile,”…
23andMe considers a sale as cash runs low
Dive Brief: 23andMe said Tuesday it is exploring “strategic alternatives,” which could include the sale of the company, a business combination or restructuring. The genetic testing company ended 2024 with $79 million and told investors it will need to raise…
RFK Jr. fumbles Medicare basics during second confirmation hearing
Robert F. Kennedy Jr., President Donald Trump’s health secretary nominee, showed limited knowledge about Medicare during his second confirmation hearing on Thursday. It was the second time in two days Kennedy appeared confused about the massive insurance program, which covers…
Vertex’s non-opioid pain drug gets FDA approval in milestone for company and research
The movement to steer pain treatment away from opioids notched a major victory Thursday, as the Food and Drug Administration approved a new, highly anticipated drug from Vertex Pharmaceuticals. The culmination of decades of work, Vertex’s Journavx is now cleared…
Novartis sets ‘ambitious’ target; Skyrizi, Rinvoq sales climb
Today, a brief rundown of news involving Novartis and AbbVie, as well as updates from Biogen, Merck & Co. and Sanofi that you may have missed. Novartis on Friday reported fourth quarter and full year results that beat analyst forecasts,…
A new, non-opioid pain drug is here. Getting it to patients could be agony.
For the last quarter century, one of the world’s most capable drug developers toiled to make a new, non-addictive kind of painkiller. The journey was fittingly excruciating. Pain, as Vertex Pharmaceuticals found out, is wildly complex. It starts simple enough,…
Metsera, Maze secure combined $415 million in IPOs
Metsera and Maze Therapeutics are the second and third biotechnology firms this year to go public, raising $275 million and $140 million, respectively, in a pair of new stock offerings priced Thursday. Metsera, an obesity drug developer, sold nearly 15.3…
Christophe Weber, veteran Takeda CEO, to retire next year
Takeda CEO Christophe Weber plans to retire next year after a decade steering the Japanese drugmaker, a tenure in which he led Takeda through one of the largest pharmaceutical mergers in history and a major research and development revamp. Julie…
RFK Jr. signals he’ll back Trump abortion policies, despite prior stance
Robert F. Kennedy Jr. on Wednesday told U.S. lawmakers that, if confirmed as the nation’s health secretary, he would support policies from President Donald Trump that would restrict abortion. As head of the Department of Health and Human Services, Kennedy…
Judge halts Trump freeze on grants as states report healthcare payment portals back online
A federal judge on Tuesday temporarily halted the Trump administration’s freeze on federal financial assistance, bringing to a close arguably the most chaotic day in Washington since the president assumed power. U.S. District Judge Loren AliKhan blocked Trump’s aid freeze…
Lawmakers report states shut out of Medicaid payment portals following Trump funding freeze
Multiple lawmakers in Congress reported Tuesday that states were shut out of Medicaid payment portals after the Trump administration enacted a freeze on all federal financial assistance — despite a new White House fact sheet saying Medicaid is not subject…
Rival radiopharma drug to Novartis’ Lutathera succeeds in trial, ITM says
Dive Brief: A radiopharmaceutical medicine developed by Germany’s ITM outperformed everolimus, an older chemotherapy, in a late-stage study of people with a rare type of neuroendocrine tumor, the biotechnology company said Tuesday. ITM’s statement contained no data. But the company…
Sage rebuffs Biogen bid to take it over
Dive Brief: Sage Therapeutics’ board of directors has turned back partner Biogen’s opportunitistic attempt at a takeover, unanimously rejecting a $469 million offer from Biogen it said “significantly undervalues” the company. Earlier this month, Biogen proposed to buy Sage for…
Akero says MASH drug reverses liver damage in study, doubling shares
Dive Brief: Treatment with an experimental drug from Akero Therapeutics substantially reversed liver damage in a mid-stage study of people with cirrhosis due to metabolic dysfunction-associated steatohepatitis, a common disease that was formerly known as NASH. Announced Monday by Akero,…
BridgeBio’s Neil Kumar on an underdog drug launch and wooing deal-hungry investors
Neil Kumar has for years contended his unorthodox drug company is overlooked by biotechnology investors. He may not have that problem for much longer. The company he leads, BridgeBio Pharma, is in the early stages of launching a treatment for…
AI in medtech is taking off. Here are 4 trends to watch in 2025.
Artificial intelligence was a topic of focus for the medical device industry in 2024. Companies including GE Healthcare, Medtronic and Dexcom touted new AI features, and others like Stryker and Quest Diagnostics added AI assets through M&A. Meanwhile, conversations about…
Mixed results for Keytruda; AbbVie to work with Neomorph
Today, a brief rundown of news involving Merck & Co. and AstraZeneca, as well as updates from AbbVie, Stealth BioTherapeutics and Vigil Neuroscience that you may have missed. A regimen of cancer drugs Keytruda and Lenvima extended progression-free survival over…
The biopharma industry outlook on 2025: Uncertainty and change
As the first major drug industry conference each year, the J.P. Morgan Healthcare Conference is regularly described as a barometer of expectations for the year ahead. This year, JPM delivered the dealmaking analysts and investors always say they hope to see:…
Sara Brenner, FDA device official, named agency’s acting head
Sara Brenner, a Food and Drug Administration official within the agency’s medical device division, has been named the FDA’s acting commissioner, according to an update made to a webpage listing leadership biographies. The FDA declined to comment, citing a communications…
Novo shares climb on early data for dual-acting obesity drug
Dive Brief: An experimental obesity drug from Novo Nordisk helped people lose an average of up to 22% of their body weight over 36 weeks in an early-stage trial, results that, if reproduced in further testing, could rival medicines Eli…
Ascentage prices first biotech IPO of 2025, raising $126M
Dive Brief: Ascentage Pharma, a cancer drug developer based in Suzhou, China, on Thursday raised just over $126 million in the first U.S. initial public offering by a biotechnology company this year. The company, which is already publicly traded in…
Senate sets date to vet RFK Jr.’s nomination to lead HHS
Prominent vaccine skeptic Robert F. Kennedy Jr. will testify before the Senate Finance Committee on Jan. 29 as he attempts to calm concerns from Democrats and Republicans about his nomination to be the nation’s top health official. Though controversy has…
J&J oncology sales grow, but shares slide on outlook
Dive Brief: Johnson & Johnson on Wednesday reported modestly higher-than-expected earnings for the fourth quarter, while cautioning that unfavorable currency exchange rates would temper sales growth this year. Adjusted earnings per share reached $2.04 in the fourth quarter, higher than…
J&J joins Pfizer in detailing impact of Part D redesign
Johnson & Johnson expects changes in Medicare’s prescription drug benefit will negatively impact its sales by about $2 billion this year, a modest headwind for a pharmaceuticals division the company anticipates will otherwise continue growing. The changes are the result…
Moderna gets $590M from US government for bird flu vaccine
Moderna will receive some $590 million from the U.S. government to develop messenger RNA vaccines for influenza strains, such as H5N1, that are seen as potential pandemic risks. Announced Friday as one of the Biden administration’s final acts, the funding…
AstraZeneca, Daiichi’s Enhertu successor gets first FDA OK in breast cancer
Dive Brief: The Food and Drug Administration on Friday approved AstraZeneca and Daiichi Sankyo’s Datroway for use in people with a common type of breast cancer that has advanced despite two earlier lines of treatment. Datroway, previously known as datopotamab…
Federal watchdog cites concerns with FDA’s accelerated approval process
Dive Brief: The Food and Drug Administration needs stricter standards for the accelerated approval process to ensure patients and the healthcare system don’t waste money on ineffective treatments, according to a report issued Tuesday from a federal watchdog Spurred by…
JPM25: The FDA’s future, AbbVie’s second thoughts and Lilly’s lesson
SAN FRANCISCO — With the close of J.P. Morgan Healthcare Conference, attention turns to next week’s inauguration of President-elect Donald Trump, and what his administration might mean for the Food and Drug Administration and the Department of Health and Human…
Lilly’s Omvoh approved by FDA for Crohn’s
Dive Brief: Eli Lilly won Food and Drug Administration approval to sell its Omvoh medicine for adults with Crohn’s disease, adding to the potential market for a drug first approved in 2023. Omvoh is already available for adults with ulcerative…
Ozempic, Ibrance among next drugs picked by Medicare for price talks
Semaglutide, the popular drug sold by Novo Nordisk as Ozempic for diabetes and Wegovy for weight loss, is among a group of widely used medicines selected by the U.S. government for the next round of price negotiations under a 2022…
Novo shares high-dose Wegovy results; Amgen, AstraZeneca drugs get expanded OKs
Today, a brief rundown of news involving Novo Nordisk and AstraZeneca, as well as updates from Amgen, Atara Biotherapeutics and Boehringer Ingelheim that you may have missed. A high-dose form of Novo Nordisk’s obesity drug Wegovy, together with lifestyle intervention,…
Medicare will negotiate Novo’s GLP-1 drug price. Here’s what that means for Ozempic, Wegovy.
Medicare’s next drug price negotiations will treat Novo Nordisk’s semaglutide as a single product, regardless of whether the metabolic disease medicine is used to treat diabetes or heart risk, and whether it is delivered by shot or pill. Semaglutide was…
Roche’s new deals head tries to navigate a more ‘complicated’ and ‘expensive’ biotech world
Roche has a big problem. With competition threatening some of its older and most lucrative biologic drugs, the Swiss pharmaceutical giant expects that, in three years time, sales from these assets will decline by roughly $8 billion. Despite this looming…
‘The bar has risen’: China’s biotech gains push US companies to adapt
Soon after starting a new biotechnology company, David Li realized he needed to rethink his strategy. Li had been conducting the competitive research biotech entrepreneurs typically undertake before soliciting investment. He drew up a list of drug targets that his…
J&J files a potential blockbuster; Lykos shakes up its board
This week, the J.P. Morgan Healthcare Conference has brought a torrent of updates from drugmakers large and small. We’re highlighting a few here, but for the rest check out our reporters’ coverage from San Francisco here and here. Also below…
At JPM, Biogen CEO tries to take down the deal temperature
On Tuesday morning, Biogen hosted an event for Wall Street analysts to better understand the company. One of the key topics discussed, according to Brian Abrahams of RBC Capital Markets, was business development. Biogen’s top drugs have been on the…
JPM25: Amgen’s defense, Merck’s patent ‘hill’ and Viking’s long-term planning
For any hopes the dealmaking that started the J.P. Morgan Healthcare Conference would give the overall biotechnology sector a running start to 2025, Eli Lilly deflated them Tuesday. The company, which rose to new heights on the success of its…
Lilly blames slower-than-expected growth for 2024 sales miss
Dive Brief: Eli Lilly on Tuesday said the company’s revenue in 2024 totaled about $45 billion, a 32% jump on 2023’s total but less than what it had estimated in October. Third quarter sales of Mounjaro and Zepbound, its GLP-1…
JPM25: Deals, Summit’s bravado and gene therapy headwinds
Every January, the Westin St. Francis in San Francisco is, for a few days, the center of the universe for the healthcare industry. It’s the site of the J.P. Morgan Healthcare Conference, where hundreds of companies pitch investors, negotiate deals…
Biogen’s ‘cold and calculated’ offer to buy Sage receives a mixed reaction on Wall Street
Late last week, Biogen made an unsolicited offer to buy one of its partners, brain drug developer Sage Therapeutics. The two biotechnology companies have worked together over the past four years on a mood-stabilizing medicine known as Zurzuvae. They split…
Tune raises $175M for hepatitis B medicine, epigenetic research
Genetic medicine startup Tune Therapeutics has raised another $175 million to develop therapies capable of “tuning” genes to treat disease, rather than editing them by cutting or replacing DNA directly. Tune disclosed the Series B round on Sunday, the eve…
Bayer says menopause drug succeeds in breast cancer study
Dive Brief: An experimental menopause drug from Bayer succeeded in a late-stage trial in women taking drugs to treat or prevent breast cancer, the company said Thursday. Bayer said the drug, elinzanetant, significantly reduced the frequency of hot flashes and…
Ouro, backed by GSK, joins hunt to bring bispecifics to autoimmune disease
Dive Brief: Ouro Medicines, a new biotechnology startup, launched Friday with $120 million in funding to develop antibody drugs for chronic inflammatory conditions. Ouro plans to use so-called T cell engagers to rebalance the immune systems of people with autoimmune…
Intellia to stop work on rare disease therapy, lay off staff
Dive Brief: Intellia Therapeutics will stop work on one of its principal drug research programs and lay off more than one-quarter of its staff in a restructuring meant to prioritize resources around its two most advanced experimental medicines. The discontinued…
Patrizia Cavazzoni, key FDA official, to leave agency
Patrizia Cavazzoni, an influential Food and Drug Administration official who oversees much of the agency’s drug review work, will leave her role next week, according to an email sent to staff. Her departure follows announcements by several other high-ranking FDA…
Pfizer’s PD-1 drug succeeds; AbbVie writes down $3.5B in Cerevel assets
Today, a brief rundown of news involving Pfizer, AbbVie and Royalty Pharma, as well as updates from Biogen and Alkeus Pharmaceuticals that you may have missed. Pfizer on Friday said its PD-1 inhibitor sasanlimab, when combined with standard therapy in…
IGM’s autoimmune pivot backfires as top drug disappoints in testing
IGM Biosciences will scrap its top two drugs and lay off nearly three-quarters of its workforce after reporting study results that fell short of the company’s expectations. In an announcement Thursday, IGM said it halted development of experimental therapies known…
5 questions facing pharma in 2025
Typically, the election of a Republican to the White House is welcome news for the biotechnology and pharmaceutical sectors. The incoming administration is a more uncertain prospect, however. President-elect Donald Trump has signaled disruption with unorthodox nominations for key healthcare…
Kidney disease drugmaker Maze files for IPO
Maze Therapeutics on Tuesday filed plans for an initial public offering that could become the biotechnology sector’s first of the year, depending on how quickly the deal comes together. If Maze is successful, its IPO would continue a trend that…
FDA adds warning to RSV shots from GSK, Pfizer
GSK’s and Pfizer’s vaccines for respiratory syncytial virus must carry labels warning of a possible increased risk of a rare neurological disorder, the Food and Drug Administration said Tuesday. The FDA has not determined a causal link between the shots…
Metsera reveals data supporting long-acting obesity shot
Dive Brief: Privately-held biotechnology startup Metsera said Tuesday a long-acting GLP-1 shot it’s developing helped people who are overweight or have obesity lose more weight than placebo recipients in a Phase 2 trial. Study participants who received the shot, dubbed…
Vertex, startup Orna to partner on gene editing research
Dive Brief: Vertex Pharmaceuticals will work together with Orna Therapeutics over the next three years to develop technology that would help enable “in vivo” gene therapies for sickle cell disease and beta thalassemia. Under the deal announced Tuesday, Vertex will…
An evolution in leadership and vision for this pharma company
About four years ago, Sheldon Koenig was thinking about retiring. After spending decades in leadership roles at different pharmaceutical companies, he’d led a successful career focused largely on cardiovascular therapeutics. Along the way, he’d endured his own personal challenges with…
Orbis raises $93M to turn popular biologics into pills
Dive Brief: Orbis Medicines, a European biotechnology startup, has raised 90 million euros, or about $93 million, in a Series A round announced Monday that will fund development of oral peptide drugs. Orbis is focused on “macrocycles,” a class of…
10 clinical trials to watch in the first half of 2025
Incretin drugs have been so successful in clinical testing they’re akin to a pharmaceutical Swiss Army knife. Already, medicines from Novo Nordisk and Eli Lilly approved to treat obesity and diabetes have proven beneficial for heart failure, sleep apnea and…
FDA approves drugs from Vertex, Novo, Bristol Myers to wrap 2024
The Food and Drug Administration ended 2024 with a quartet of notable drug approvals, including three of new medicines that Vertex Pharmaceuticals, Novo Nordisk and Bristol Myers Squibb developed for cystic fibrosis, hemophilia and cancer, respectively. The approvals concluded a…
Neumora plummets on depression drug data
Neumora Therapeutics, a well-funded biotechnology company, lost more than 80% of its value Thursday because its most advanced drug failed a major test. After seeing positive signs in a smaller study in 2023, Neumora pushed the drug into a trio…
Pfizer exits Sangamo pact; Roche, Ideaya strike ADC deals
Happy New Year! We hope you had a restful holiday; If you took a break from keeping up with biotech news, we’ve got you covered with a brief rundown of the most important updates from the past week and a…
Ottimo raises $140M to compete in chase for new type of cancer drug
David Epstein was ready to retire when an opportunity came along he couldn’t pass up. Epstein had just sold Seagen, a large cancer drugmaker, to Pfizer for $43 billion and thought it a fitting capstone to a career that included…
Novartis shutters MorphoSys sites, lays off staff
Swiss pharmaceutical company Novartis plans to close MorphoSys sites in the U.S. and Germany in a “strategic decision” that will affect 330 jobs. The move, which was first reported by the German magazine WirtschaftsWoche, stems from Novartis’ evaluation of its…
Vertex ‘ends the year in pain’ as latest non-opioid drug data disappoint
Vertex Pharmaceuticals lost more than $15 billion in value Thursday as new data on its closely watched pain drug disappointed Wall Street. The medication is meant to be a non-addictive alternative to opioids, and has shown in multiple clinical trials…
Regeneron says study data support big bet on new blood thinners
Dive Brief: Regeneron Pharmaceuticals intends to advance two blood-thinning drugs into Phase 3 testing next year after mid-stage study results showed they matched or surpassed marketed medicines at preventing blood clots following knee replacement surgery. Regeneron’s drugs block a clotting…
A venture firm breathes new life into an old NGM drug
KdT Ventures is launching a new biotechnology startup based on a drug it’s licensing from NGM Biopharmaceuticals, the companies announced Thursday. The deal hands the Austin-based venture firm’s currently unnamed startup worldwide rights to an experimental drug called NGM313, which…
Novo’s next-gen obesity drug misses expectations in closely watched trial
A new type of obesity drug being developed by Novo Nordisk has fallen short of expectations set by the company in a closely watched Phase 3 trial, causing shares to lose nearly a fifth of their value in early trading…
Ionis gets a milestone approval; Another top FDA official to step down
Today, a brief rundown of news involving Ionis Pharmaceuticals and the Food and Drug Administration, as well as updates from Zealand Pharma, Sangamo Biosciences and Novartis that you may have missed. The Food and Drug Administration on Thursday made Ionis…
Roche sticks with Parkinson’s drug despite second study failure
An experimental drug for Parkinson’s disease that Roche has been developing for more than a decade just flunked another key clinical trial. But in spite of those failures, the drug’s future isn’t clear. Roche’s Chief Medical Officer, Levi Garraway, said…
Zepbound, Mounjaro shortages are resolved, FDA confirms
The Food and Drug Administration on Thursday reaffirmed its assessment that Mounjaro and Zepbound, popular drugs for diabetes and obesity, are no longer in shortage, The agency’s decision will largely prevent so-called compounding pharmacies from making off-brand copies of the…
Merck moves into obesity with deal for Hansoh’s GLP-1 pill
Dive Brief: Merck & Co. has made its first big move in obesity treatment, announcing Wednesday it is paying Hansoh Pharma $112 million for rights outside China to a preclinical pill that works similarly to the popular injection Wegovy. Per…
Tessera gets sickle cell funding; Corvus shares slide on eczema data
Today, a brief rundown of news involving Tessera Therapeutics and Corvus Pharmaceuticals, as well as updates from Sarepta Therapeutics, Cara Therapeutics and Johnson & Johnson that you may have missed. The Bill & Melinda Gates Foundation will invest as much…
Namandjé Bumpus, FDA’s No. 2 official, to depart agency at end of year
Namandjé Bumpus, the Food and Drug Administration’s second-in-command, will depart the regulator at the end of the year, according to an email FDA Commissioner Robert Califf sent to agency staff on Tuesday. Bumpus has served as principal deputy commissioner since…
Pfizer predicts stability, to Wall Street’s relief
Dive Brief: Pfizer on Tuesday said it anticipates bringing in between $61 billion and $64 billion in revenue next year, matching this year’s expected sum and within range of Wall Street forecasts. The pharmaceutical company boosted its 2024 guidance two…
Jazz to search for new chief as CEO plans retirement
Jazz Pharmaceuticals on Monday said it will begin searching for a successor to CEO Bruce Cozadd, who plans to retire from the company he helped start more than two decades ago. Cozadd will stay on as CEO until Jazz finds…
Novo Holdings’ purchase of Catalent set to close after regulators’ green light
Dive Brief: Novo Holdings can complete its $16.5 billion acquisition of contract drug manufacturer Catalent after antitrust regulators in the U.S. declined to challenge the deal before the expiry of a deadline, the companies said Saturday. The decision by the…
Keros shares collapse on ‘unanticipated’ setback for lung disease drug
Dive Brief: Keros Therapeutics shares plummeted Thursday after the company said researchers conducting a Phase 2 study have stopped giving patients the two highest doses of its lead experimental drug because of reports of excess fluid buildup in the pericardial…
FDA flags additional injury risk for Intercept’s liver drug
The Food and Drug Administration has identified additional safety concerns associated with use of a drug used to treat a rare liver condition in the latest sign of trouble for a medicine once seen as a future blockbuster. The agency…
Dietmar Berger is Gilead’s new CMO; Padlock investors sue Bristol Myers
Today, a brief rundown of news involving Gilead and Padlock Therapeutics, as well as updates from Boundless Bio, Lonza and Bausch + Lomb that you may have missed. Investors of Padlock Therapeutics have sued Bristol Myers Squibb for allegedly refusing to…
FDA panel seeks more data on RSV vaccine safety in infants
A panel of experts convened by the Food and Drug Administration called for more data to be collected on the safety of vaccines for respiratory syncytial virus in infants, indicating caution after the agency partially paused enrollment of clinical trials…
CMS says private Medicare plans can’t automatically deny Biogen’s ALS drug
In a rare move, the U.S. agency behind Medicare is warning insurers who provide Medicare Advantage plans that they can’t automatically deny coverage of Qalsody, a Biogen drug approved to treat amyotrophic lateral sclerosis. Medicare Advantage, or MA, plans are…
AbbVie to acquire Roche spinout Nimble in immune drug deal
Dive Brief: AbbVie will pay $200 million to acquire privately held Nimble Therapeutics and its pipeline of oral peptide drugs for immune diseases like psoriasis and inflammatory bowel disease, the pharmaceutical company said Friday. Chief among that pipeline is an…
Editas to lay off staff after search for sickle cell partner comes up empty
Dive Brief: Editas Medicine will lay off 180 employees, or about two-thirds of its workforce, over the next six months as part of a broader pivot to focus its drug research on “in vivo” gene editing, the biotechnology company said…
‘Research that’s desperately needed’: White House conference spotlights women’s health
Research into women’s health has long gone underfunded in the U.S. But there’s some optimism that might be changing, attendees to the first conference hosted by the White House on women’s health research said Wednesday. Both President Joe Biden and…
Q32 Bio battered by study failure of immune drug
Dive Brief: Shares of Q32 Bio lost two-thirds of their value Wednesday after the company reported disappointing study results for an experimental medicine in two indications. The drug, bempikibart, is an antibody designed to interfere with two cytokines that play…
With new data, Lilly sets pace for next wave of breast cancer drugs
An experimental breast cancer drug developed by Eli Lilly met its main goal in a Phase 3 study, helping people with a form of HER2-negative, ER-positive disease stay alive and progression free for longer than standard hormone-suppressing therapies, according to…
ASH24: Leukemia drug sequencing, sickle cell questions and a new kind of CAR-T
The American Society of Hematology’s annual meeting continued Monday with important presentations and discussions on the latest blood disease research, several of which we’ve summarized here. Sequencing BTK inhibitors in leukemia In the years since the approval of Imbruvica for…
Endometriosis drug research, long underfunded, confronts familiar problems in women’s health
Ally Schott felt lonely when she was diagnosed with endometriosis at the age of 12. With few treatment options and limited information to go on, she and her family had to become self-taught medical researchers. Even the diagnosis was the…
ASH24: Darzalex in smoldering myeloma, Merck’s ADC data and Novo’s sickle cell drug
This weekend, thousands of researchers and physicians descended on San Diego for the American Society of Hematology’s annual meeting. While BioPharma Dive wasn’t on site this year, we’ve summarized a few of the most notable datasets from the past two…
Gene therapy uptake in sickle cell stays slow, despite patient interest
One year on from the landmark U.S. approval of two powerfully effective gene therapies for sickle cell disease, the treatments have been barely used, a sluggish start that reflects the myriad challenges of launching them. While some five dozen people…
Atea plans Phase 3 study for hepatitis C drug after mid-stage results
Dive Brief: Atea Pharmaceuticals said Wednesday that its experimental combination regimen to treat the hepatitis C virus succeeded in a Phase 2 trial, clearing the way for Phase 3 research to begin early next year. In the Phase 2 study,…
GSK taps a startup for shot at Alzheimer’s drug
Inside every human cell are thousands of snippets of genetic code that serve as the directions for creating proteins. And over the past four years, a small biotechnology company has been trying to prove that, by looking closely enough at…
BioAge shares tumble after decision to halt obesity drug study
Dive Brief: BioAge Labs said it is terminating a mid-stage study of its obesity drug candidate azelaprag in combination with Eli Lilly’s tirzepatide due to safety concerns, causing its share price to slide by three-quarters in after-hours trading Friday. Eleven…
Lilly adds to obesity drug production push with $3B investment
Eli Lilly will spend $3 billion to expand a manufacturing facility in Wisconsin it bought in April, adding new capabilities to produce injectable medicines like its fast-selling weight loss and diabetes drugs Zepbound and Mounjaro, the company said Thursday. The…
With conflicts of interest in focus, Trump’s pick to run FDA could face scrutiny of his own industry ties
Robert F. Kennedy Jr., chosen by President-elect Donald Trump to be the next health secretary, has made it his mission to dissipate what he describes as a “smothering cloud of corporate capture” within agencies like the Food and Drug Administration….
AstraZeneca, Daiichi build cancer drug case; Amgen invests $1B
Today, a brief rundown of news involving Daiichi Sankyo, Agenus and Amgen, as well as updates from the U.S. PTO, Bluebird bio and Merus that you may have missed. AstraZeneca and Daiichi Sankyo on Friday revealed new study results supporting…
Atlas doubles down on ‘disciplined’ biotech investing with latest fundraise
Dive Brief: Atlas Venture said Thursday that it’s raised $450 million for its 14th fund, through which the firm will continue to seed and grow new biotechnology companies. Partner Bruce Booth called the fundraising round the smoothest and most efficient…
Nuvig pulls in $161M to make better immune drugs
Biotechnology startup Nuvig Therapeutics is the latest emerging immune drug developer to attract investors’ attention, announcing Thursday a $161 million Series B round to bring its lead candidate into mid-stage testing. The company, which is based in Menlo Park, California,…
Dewpoint, Mitsubishi partner on ALS drug in deal worth up to $480M
Dewpoint Therapeutics, a young biotechnology company, could receive nearly half a billion dollars if all goes to plan in a new partnership focused on its experimental medicine for ALS. Through a deal announced Wednesday, Dewpoint has given Mitsubishi Tanabe Pharma…
Antag, a startup backed by Versant and Novo, joins hunt for obesity drug alternatives
Antag Therapeutics, a seven-year-old Danish startup investigating a hotly debated approach to treating obesity, has raised 80 million euros, or about $84 million, to advance its first weight loss drug into clinical testing. Announced Wednesday, the Series A round will…
Janux impresses Wall Street with new prostate cancer drug results
Shares of Janux Therapeutics surged to record highs following the release of study results for a drug that, if ultimately successful in testing, would represent a new type of therapy for prostate cancer. The findings come from an early-stage study…
Note from the Editor-in-Chief | BioPharma Dive
Dear reader, Today, Industry Dive, the company behind BioPharma Dive, is combining with TechTarget’s technology websites and Informa Tech’s storied media brands to create a new company: Informa TechTarget. Our editorial footprint is greatly expanding. The combined Informa TechTarget newsroom…
Diabetes advocacy group discourages use of compounded GLP-1 drugs
The American Diabetes Association, a high-profile advocacy group, is warning against widespread use of compounded versions of popular weight loss and diabetes drugs like Wegovy and Zepbound. The group on Monday released an official guidance statement that recommends doctors avoid…
Applied’s rare disease drug rejected by FDA
The Food and Drug Administration has rejected Applied Therapeutics’ application to approve its experimental treatment for classic galactosemia, a rare metabolic disorder the affects the body’s ability to process sugar. News of the rejection, which came late Wednesday, sent Applied…
Biohaven muscle drug misses goal of SMA study, but advances in obesity
Dive Brief: An experimental, muscle-preserving drug from Biohaven fell short of its goal in a Phase 3 study of people with spinal muscular atrophy, but showed enough promise in its effects on body composition that the company plans to advance…
Roche to buy cell therapy developer Poseida for $1B
Swiss pharmaceutical giant Roche is spending around $1 billion to acquire a San Diego-based biotechnology company that’s trying to treat certain cancers and rare diseases with a slate of cell therapies and genetic medicines. The deal, announced Tuesday, has Roche…
Roche’s TIGIT-targeting drug for cancer fails its biggest test
Roche’s long-running bet on a new kind of cancer immunotherapy has, after years of shrinking optimism and second-guessing by analysts on Wall Street, come up empty — at least for now. On Tuesday, Roche said that much-anticipated results from a…
Kronos, Idorsia plan layoffs; PTC shelves ALS drug
Today, a brief rundown of news involving Kronos Bio, Idorsia and PTC Therapeutics, as well as updates from Alnylam Pharmaceuticals and Soleno Therapeutics that you may have missed. Kronos Bio will lay off 83% of its workforce by year’s end…
Sarepta rebuilds drug pipeline with Arrowhead deal
Dive Brief: Sarepta Therapeutics has turned to dealmaking to restock a drug pipeline analysts worried was growing thin, announcing Tuesday a deal with Arrowhead Pharmaceuticals that will give it four clinical-stage treatments and three others still in preclinical testing. In…
How Intra-Cellular surprised Wall Street by breaking character
For drug companies, predicting how much money a product will make is a risky endeavor. If the estimate ends up being far off, then investors may question how well a developer understands its own business or the markets in which…
Amgen obesity drug cuts weight in study, but results miss Wall Street’s high mark
Dive Brief: Amgen on Tuesday said its weight loss drug MariTide helped people with obesity lose up to 20% of their body weight over one year in a Phase 2 trial, paving the way for the company to initiate a…
Biden administration proposes Medicare, Medicaid coverage of pricey weight loss drugs
The Biden administration on Tuesday proposed a rule that would allow Medicare and Medicaid to cover weight loss drugs for patients with obesity. The rule — if kept by the incoming Trump administration — would dramatically expand access to drugs…
Alector turns to layoffs as Alzheimer’s drug fails
Brain drug developer Alector is laying off staff after one of its most advanced experimental medicines failed to show enough promise as a treatment for Alzheimer’s disease. For the past few years, researchers have been testing the medicine, known as…
New data could help Merck expand use of cardiovascular drug
Dive Brief: Adding Merck & Co.’s new cardiovascular drug Winrevair to background therapy helped people with severe lung hypertension stay alive and avoid invasive medical care longer than those who only received background therapy, the company said Monday. Data from…
Amgen picks prolific biotech founder Chang as new top scientist
Howard Chang, a top biotechnology researcher and longtime professor at Stanford University, will join Amgen as chief scientific officer on Dec. 16, the company said Wednesday. Chang will also assume the title of senior vice president of research and will…
Will Walgreens’ store closures disrupt its clinical trial aims?
Retail pharmacy giants have been straining under the intense headwinds hitting the industry this year — and Walgreens’ most recent earnings provided another case in point. The company said in October that it plans to close about 1,200 lower-performing stores…
Lexicon to disband sales team, lay off 60% of staff
Dive Brief: Lexicon Pharmaceuticals will lay off 60% of its workforce and eliminate its commercial organization in a restructuring meant to save $100 million in operating costs next year. The shakeup follows Lexicon’s receipt of a letter from the Food…
Halozyme drops Evotec buyout bid; Patient dies in Neurogene trial
Today, a brief rundown of news involving Halozyme and Neurogene, as well as updates from Argenx and Kura Oncology that you may have missed. Halozyme Therapeutics on Friday said it withdrew an offer to buy Evotec after the German drug…
Johns Hopkins surgeon Makary is Trump’s pick to lead FDA
President-elect Donald Trump on Friday named Johns Hopkins University surgeon Marty Makary to lead the Food and Drug Administration, choosing a prolific medical researcher who bucked consensus on the necessity of frequent vaccination during the COVID-19 pandemic. As FDA commissioner,…
BridgeBio heart drug approved by FDA, setting up battle with Pfizer
The Food and Drug Administration has approved a new medicine for a deadly genetic heart condition, boosting its developer, BridgeBio Pharma, and teeing up a battle for control of a lucrative market targeted by several drugmakers. The agency on Friday…
Novartis wagers more than $1B on gene therapies for the nervous system
Through a new deal, Novartis has added a handful of experimental gene therapies to its neuroscience research pipeline. Novartis is betting the gene therapy technologies developed by Kate Therapeutics, a biotechnology startup founded four years ago, can lead to treatments…
Biotech startups are built on venture capital. Track funding rounds here.
Drug development is an expensive, risky endeavor. Biotechnology companies just starting out are many years away from seeing profits, if ever. So more often than not, a startup’s success turning science into medicines can come down to how much money…
Pfizer, under pressure to change, names oncology head as new R&D chief
Pfizer on Wednesday said it will promote Chris Boshoff to chief scientific officer and president of research and development as the giant drugmaker struggles to win back the faith of investors. Boshoff will assume his new post on Jan. 1,…
Sage’s string of research failures continues
Sage Therapeutics is shelving one of its most important experimental drugs, after a last-ditch effort to prove it can be useful in nerve-destroying disorders ended in failure. On Wednesday, Sage disclosed the drug, known as dalzanemdor or SAGE-718, didn’t meet…
Flagship, Pfizer alliance yields two more startup deals
Dive Brief: Pfizer will work with two more startups incubated by Flagship Pioneering, which on Wednesday announced that Montai Therapeutics and Ampersand Biomedicines would hunt for drug candidates under an existing collaboration with the pharmaceutical giant. Montai aims to unearth…
Under-the-skin Keytruda comparable to infused version in Phase 3 study, Merck says
Dive Brief: An experimental under-the-skin injection of Merck & Co.’s cancer immunotherapy Keytruda showed similar characteristics as the current intravenous formulation in a Phase 3 clinical trial, the company said Tuesday. The drugmaker plans to discuss data from the trial,…
CRISPR therapy from Intellia may ameliorate rare heart disorder, data suggest
Dive Brief: A single infusion of a CRISPR therapy developed by Intellia Therapeutics showed promising signs of stabilizing a heart disorder caused by the rare disease transthyretin amyloidosis, buoying the company’s hopes of finding success in late-stage clinical trials. Phase…
Syndax secures FDA OK for new kind of leukemia drug
Dive Brief: Massachusetts-based Syndax Pharmaceuticals won Food and Drug Administration approval Friday for a new kind of drug to treat an aggressive form of leukemia in adults and some children. The oral drug, which Syndax will sell as Revuforj, is the…
Leveraging NGS to move precision oncology forward, from CDx to commercialization
Advances in precision oncology have allowed patients to access innovative life-saving therapies when they previously had few, or no, other treatment options. But highly personalized medicine raises new challenges too, as developers must develop companion diagnostics (CDx) assays alongside novel…
PTC wins US approval of gene therapy for fatal enzyme disorder
Dive Brief: PTC Therapeutics on Wednesday won Food and Drug Adminitration approval for Kebilidi, the first gene therapy cleared in the U.S. for direct administration to the brain. The treatment is designed for patients with aromatic L-amino acid decarboxylase, or…
Halozyme bids for Evotec; BeiGene gets a new name
Today, a brief rundown of news involving Evotec, Bluebird bio and the company formerly known as BeiGene, as well as updates from Leerink Partners and Abeona Therapeutics that you may have missed. Halozyme Therapeutics has made an unsolicited bid to…
Surviving in biotech’s new normal: 5 tips from industry VCs and CEOs
Market downturns take a toll. For many young biotechnology companies, the past few years have been a lesson in survival, as the evaporation of the sector’s pandemic-era boom brought cutbacks to the investment they so desperately need. “Platform” companies, so…
‘Find any advantage’: 3 biotech leaders on driving R&D success
Failure is more common than success for young biotechnology companies attempting to get a new drug onto the market. Drug development is rife with pitfalls, from disappointing clinical trial results to funding woes that can end a program prematurely. Companies…
How a Biogen drug set the stage for a new biotech targeting ALS
Trace Neuroscience, a freshly launched startup, is developing a type of genetic medicine it believes could help most, if not all, people with ALS. It’s a bold idea, considering nearly every attempt to combat the nerve-destroying disease has ended in…
Eisai wins over European regulators on Alzheimer’s drug Leqembi
In an unusual reversal, key drug regulators in Europe are now saying Leqembi, a high-profile medicine for Alzheimer’s disease, should be approved there, though only for patients less likely to experience a certain kind of concerning side effect. Leqembi’s primary…
Trump names RFK Jr. as his pick to lead HHS
President-elect Donald Trump plans to nominate Robert F. Kennedy Jr. to lead the Department of Health and Human Services in a controversial choice that would elevate the prominent vaccine skeptic to a position overseeing the nation’s leading health agencies, including…
Metsera raises $215M to accelerate obesity drug plans
Dive Brief: Metsera, already a well-funded biotech startup, added another $215 million to its coffers as investors responded to the promise of its obesity drug pipeline. Wellington Management and Venrock Healthcare Capital Partners led the latest round of financing, the…
Amgen shares sink on obesity drug concerns; AstraZeneca to spend $3.5B on manufacturing
Today, a brief rundown of news involving Amgen and AstraZeneca, as well as updates from Roche, Novartis, and Centessa Pharmaceuticals that you may have missed. Amgen lost $12 billion in market value Tuesday after a Wall Street analyst published a…
TRex Bio raises $84M to compete in crowded immune drug field
Dive Brief: TRex Bio, a California biotechnology company that’s partnered with Eli Lilly and Johnson & Johnson, has raised $84 million in a Series B round meant to advance its immune drug research, the company said Wednesday. The new funds…
GSK partners with Flagship startup to hunt for Parkinson’s drugs
Flagship Pioneering startup Vesalius Therapeutics has signed a deal with GSK, the companies announced Tuesday, for the British pharma to use its technology to find medicines for neurodegenerative disorders. Under the terms of the deal, GSK will hand Vesalius $80…
FDA approves new CAR-T competitor to Gilead’s Tecartus
Dive Brief: The Food and Drug Administration on Friday approved a new cell therapy for a type of leukemia. Called Aucatzyl, the CAR-T was developed by U.K.-based Autolus Therapeutics to treat people with B-cell precursor acute lymphoblastic leukemia whose disease…
On Wall Street, ‘flat out’ failure of AbbVie schizophrenia drug leaves analysts stunned
Through a recent, nearly $9 billion acquisition, AbbVie surged to the front of a new wave of antipsychotic drugs that Wall Street expects to become big sellers. But on Monday, the company’s plans came crashing down. AbbVie said the main…
7 steps to selecting the right global central lab
For sponsors and CROs, reducing time-to-market and improving patient access to innovative treatments remain pressing challenges and top priorities. From regulatory hurdles and logistical complexities to patient recruitment and retention, the road to a successful trial across multiple regions and…
With Trump victorious, biotech industry’s focus turns to his plans for FDA, FTC
Donald Trump’s victory in the U.S. presidential election Tuesday means change is coming for federal health agencies and the industries they regulate. It’s just not quite clear yet how dramatic that change might be. Trump has pledged to “make America…
What RFK Jr.’s influence on Trump could mean for pharma
With the U.S. presidential election decided, one name is suddenly circulating in healthcare: Robert F. Kennedy Jr. President-elect Donald Trump has promised Kennedy a large role in his new administration, signaling he could be handed influence guiding some of the…
Athira exploring strategic alternatives after Alzheimer’s failure
Dive Brief: Athira Pharma, a small drugmaker focused on neuroscience, is looking into the different paths it could take to “maximizing stockholder value,” after the company’s most advanced experimental medicine flunked a key study. In early September, Athira disclosed high-level…
Tezspire succeeds in chronic rhinosinusitis; Gilead writes down Trodelvy value
Today, a brief rundown of news from AstraZeneca, Amgen and Jazz Pharmaceuticals, as well as updates from Geron, Gilead Sciences and Avid Bioservices that you may have missed. AstraZeneca and Amgen’s drug Tezspire reduced nasal congestion and the size of…
Was sind die Hauptmerkmale des Tornado Vape 12000 züge?
Tornado Vape 12000 züge Der Bang Tornado 12000 Puffs ist ein leistungsstarkes und vielseitiges Einweg-Vaping-Gerät. Es bietet eine Reihe von Geschmacksrichtungen und passt den Nikotingehalt von 0 % bis 5 % an, um ein personalisiertes Erlebnis zu gewährleisten. Es unterstützt…
Kalaris to go public via reverse merger with AlloVir
Public biotechnology company AlloVir has agreed to merge with the privately held Kalaris Therapeutics, nearly one year after a clinical setback sunk its stock price and its options. Through a reverse merger announced Friday, the two companies will combine to…
Sarepta scraps a Duchenne drug as gene therapy sales rise
Dive Brief: Sarepta Therapeutics is giving up on an experimental drug for Duchenne muscular dystrophy as sales rocket for its approved gene therapy for the disease. The decision to discontinue SRP-5051 was based on several factors, company executives told analysts…
Moderna earnings beat forecasts, but analysts question whether sales spike will last
Dive Brief: Moderna on Thursday reported third quarter sales of its COVID-19 vaccine that substantially outperformed analyst expectations. The company didn’t raise its financial outlook for the year, however, suggesting revenue could decline over the last three months of 2024….
Acadia sells speedy drug review voucher for $150M
Acadia Pharmaceuticals agreed to sell a priority review voucher to an undisclosed buyer for $150 million, a price tag on the high end for the coveted passes that speed up Food and Drug Administration reviews of new medicines. The company…
Novo sees Wegovy sales rise as supply constraints ease
Dive Brief: Dive Insight: Novo and Lilly are racing to build on their dominant obesity drug businesses. Both are working to broaden use of their therapies, while also working on newer medications that are meant to be more potent and…
Sana to lay off staff, deepen autoimmune focus in latest retrenchment
Sana Biotechnology will lay off staff and shift its research focus in the latest retrenchment for a company only three years removed from one of the biotechnology sector’s most lucrative initial stock offerings. The company on Monday announced plans to…
Cancer cell therapy from Arcellx, Gilead shows promise in early data
Dive Brief: A cancer cell therapy developed by Arcellx and Gilead Sciences helped reduce or eliminate signs of multiple myeloma in 95% of people in advanced stages of disease, the companies said Monday. The data, from trial volunteers whose cancer…
Viking data provide latest test of oral obesity drug potential
Dive Brief: New results from a small study of Viking Therapeutics’ oral obesity drug raised expectations among Wall Street analysts that the experimental tablet could prove superior among the growing ranks of would-be competitors to the popular weight loss treatments…
Neurogene secures $200M ahead of anticipated study readout
Neurogene, a gene therapy developer focused on rare neurological diseases, has secured $200 million through a private funding deal that will extend its cash reserves into late 2027. The company on Monday signed an agreement to raise the funds in…
Empowering versatile applications of digital PCR with standardized, validated assays
As the third generation of PCR technology, digital PCR introduced powerful new capabilities to countless research applications. Features such as improved precision and sensitivity, absolute quantification of nucleic acids, and tolerance to common PCR inhibitors set digital PCR apart, but…
FDA’s new device chief faces challenges. Patient groups, industry are still optimistic.
Michelle Tarver, the new leader of the Food and Drug Administration’s medical device center, faces significant challenges. Tarver is taking over as director of the Center for Devices and Radiological Health as the regulator grapples with questions around artificial intelligence…
Evommune raises $115M to accelerate immune drug tests
California biotechnology startup Evommune has raised $115 million to advance a pair of medicines it’s developing for chronic immune conditions. The Series C funding announced Thursday will support a trio of Phase 2 trials that should all produce results by…
Compass delays anticipated psilocybin readout, cuts staff
Dive Brief: Compass Pathways said it will lay off 30% of its workforce, narrow its research focus and explore selling its digital technologies after pushing back the timeline for its lead medicine, a psychedelic treatment for depression. The company now…
Regeneron battles Wall Street uncertainty; Madrigal extends fast launch of MASH drug
Today, a brief rundown of news from Regeneron Pharmaceuticals and Madrigal Pharmaceuticals, as well as updates from UCB, AbbVie and PTC Therapeutics that you may have missed. Shares of Regeneron Pharmaceuticals fell nearly 10% amid growing uncertainty about the future…
Novo, with new results, to seek approval for obesity drug in MASH
Novo Nordisk will seek regulatory approval of semaglutide, the key ingredient in its popular weight loss medicine, in a common liver disease following positive results in a Phase 3 trial, the company said Friday. Summary results disclosed in a press…
Jade, another biotech spinout of Paragon, to merge with Aerovate
Dive Brief: Jade Biosciences, a privately held developer of immune disease drugs, will combine with Aerovate Therapeutics in a reverse merger that gives Jade a fast pass to trade on public markets. Prior to the merger, which the companies announced…
Roche weighs whether speedy approval path is open for latest Alzheimer’s drug
Dive Brief: Roche may seek an accelerated U.S. approval of its experimental Alzheimer’s disease drug trontinemab if the therapy continues to show in testing it can significantly lower levels of a protein linked to cognitive decline, executives said in a…
GSK vaccine sales sink on lower demand for RSV, shingles shots
Sales of GSK’s top-selling vaccines fell sharply during the third quarter amid lower demand, sending shares in the British pharmaceutical company down 3% in U.S. trading Wednesday. GSK, which had downgraded its vaccine sales forecasts in July, did so again…
Novo takes big step toward ending Ozempic, Wegovy shortages
All doses of Novo Nordisk’s popular GLP-1 medicines Ozempic and Wegovy are available in the U.S. and being regularly shipped to wholesalers, the drugmaker confirmed Wednesday. One dose form or another of both drugs, which respectively treat diabetes and obesity,…
Paragon spinout joins hunt for new type of cancer immunotherapy
Paragon Therapeutics, a biotechnology company creator with a web of spinouts, is taking a new startup public to develop an emerging type of cancer immunotherapy. The startup, Crescent Biopharma, on Tuesday announced a reverse merger with GlycoMimetics, a struggling, publicly…
Pfizer sales of RSV vaccine ebb, but company gains market share
Sales of Pfizer’s new vaccine for respiratory syncytial virus were lower in the third quarter than during the same period last year, but the company pointed to signs of growing market share as reason for confidence in the shot’s market…
Monte Rosa joins with Novartis in ‘molecular glue’ drug deal
Dive Brief: Novartis will pay $150 million to gain rights to “molecular glue degraders” being developed by biotechnology company Monte Rosa Therapeutics to target an immune signaling protein, known as VAV1, that has long been considered “undruggable.” The deal, announced…
AbbVie to acquire a J&J-backed brain drugmaker for $1.4B
AbbVie has agreed to acquire a young company with drugmaking technology from Johnson & Johnson and an experimental treatment for Alzheimer’s disease that’s in the first stage of human testing. The deal, announced Monday, is expected to close by the…
Don’t let your samples slip: Why every clinical trial needs biospecimen management
Managing biospecimens is a critical, yet often overlooked, part of ensuring a clinical trial’s success. Biospecimen managers are a resource that provides full lifecycle biospecimen oversight, from collection to sample disposition or long-term storage of those specimens for future exploratory…
With $92M, Kivu sets out to make ‘kinder, gentler’ ADCs
Dive Brief: Kivu Biosciences, a San Francisco-based biotechnology startup developing targeted drugs for cancer, has raised $92 million in a Series A round, the company said Monday. Kivu will use the funds to advance technology it claims can help address…
Intellia data spark debate about CRISPR drug’s potential
Dive Brief: Intellia Therapeutics on Thursday released detailed Phase 2 results from a study of a gene-editing therapy for hereditary angioedema, drawing mixed reactions from investors and experts. The therapy, dubbed NTLA-2002, is based on the CRISPR gene editing technology…
Merck, Pfizer lifted as CDC backs broader use of pneumococcal vaccines
A panel of advisers to the Centers for Disease Control and Prevention on Wednesday recommended lowering the age for routine pneumococcal vaccination from 65 to 50 years of age, boosting the sales potential for multiple shots on the market or…
GSK invests $800M in manufacturing; Amgen sets small discount for Eylea biosimilar
Today, a brief rundown of news from GSK and Amgen, as well as updates from Roche, AbbVie, and Marinus Pharmaceuticals that you may have missed. Amgen set a list price of $1,665 per shot for its biosimilar version of Regeneron’s…
Sanofi earnings boosted by Beyfortus, earlier vaccine sales
Sanofi reported a 25% boost in sales for its vaccines division during the third quarter, helped by earlier-than-anticipated orders of its flu shots as well as rising revenue from Beyfortus, its RSV antibody for infants. Announcing earnings Friday, the French…
GPCR drugmaker Septerna amasses $288M in IPO
Septerna, a developer of medicines that target a ubiquitous family of proteins, on Thursday priced a $288 million initial public offering that again showed investors’ support of biotechnology companies that have reached clinical testing. The company sold 16 million shares…
Lyell, in search of a turnaround, to buy cell therapy startup ImmPact
Lyell Immunopharma, a cell therapy developer that has struggled to match its high profile, is acquiring a biotechnology startup and streamlining research in a bid to focus on a slate of cellular immunotherapies for cancer. The company on Thursday said…
Pfizer’s RSV vaccine cleared by FDA for use in some younger adults
Dive Brief: The Food and Drug Administration on Tuesday expanded the approval of Pfizer’s RSV vaccine Abrysvo to include adults aged 18 to 59 years who are at an increased risk of disease from respiratory syncytial virus. The vaccine was…
Alto hits new low as depression drug flunks key test
Alto Neuroscience, a young biotechnology company developing medicines for the brain, lost much of its value Wednesday as negative results from a clinical trial raised doubts about the future of its most advanced research program. That program revolves around an…
Starboard makes case for change at Pfizer, citing research, M&A missteps
Starboard Value, the activist investor agitating for change at Pfizer, called on the pharmaceutical giant’s board of directors to hold the company’s executives responsible for what it described as a yearslong pattern of underperformance. In a presentation delivered at an investor…
FDA names Tarver as new head of device center
The Food and Drug Administration on Tuesday named Michelle Tarver as the permanent director of the agency’s device center. Tarver was appointed as acting director of the Center for Devices and Radiological Health in July, when longtime leader Jeff Shuren…
Oral version of Novo diabetes drug protects heart health in large study
Dive Brief: Novo Nordisk’s diabetes pill Rybelsus cut the risk of heart attacks, strokes and cardiovascular death by 14% in a Phase 3 trial of people with diabetes and established heart or kidney disease, the company said Monday. The study,…