Former CinCor execs reunite to helm new biotech startup
Dive Brief: AllRock Bio, a biotechnology startup founded by a team of former CinCor Pharma executives, launched Tuesday with $50...
Medicine
CSL nabs option to acquire a startup and its blood-clotting drug
Dive Brief: Just weeks after announcing a major restructuring, Australian drugmaker CSL struck a deal that may lead to the...
A key CDC panel meets this week to discuss vaccines. Here’s what to know.
A federal vaccine panel will meet this week for the second time since it was remade by Health and Human...
ATyr shares plunge on trial miss in inflammatory lung disease
Dive Brief: An experimental drug from biotechnology company aTyr Pharma missed its main goal in a Phase 3 trial, failing...
[Podcast] The Progress Profile: Alzheimer’s Research in Focus
This compelling four-part podcast series, “The Progress Profile: Alzheimer’s Research in Focus,” brings together world-renowned experts to explore the latest...
Novo Nordisk to lay off 9,000 workers in major restructuring
Dive Brief: Novo Nordisk on Wednesday announced plans to lay off about 11% of its workforce as competition for top-selling...
Kriya, Odyssey secure ‘megarounds’; Amgen boosts R&D leadership
Today, a brief rundown of news involving Kriya Therapeutics and Odyssey Therapeutics, as well as updates from Amgen, Regeneron and...
FDA shares guidance to drugmakers developing non-opioid pain medicines
Dive Brief: The Food and Drug Administration on Wednesday issued draft recommendations for drugmakers interested in developing new non-opioid options...
Ozempic for cancer? Signs point to potential benefits of GLP-1s in oncology
What could GLP-1 drugs, known for their powerful weight loss benefits, have to do with oncology? Potentially “everything,” according to...
Takeda poaches top Lilly exec; Maze soars on early PKU drug data
Today, a brief rundown of news involving Takeda Pharmaceutical and Maze Therapeutics, as well as updates from Intercept Pharmaceuticals, Soleno...
Child dies in Capsida study of rare disease gene therapy
Dive Brief: Capsida Biotherapeutics has suspended a recently begun clinical trial of an experimental gene therapy after the first participant...
Prasad regains role as FDA’s top doctor, scientist
Senior Food and Drug Administration official Vinay Prasad has reclaimed a role as the agency’s top doctor and scientist six...
LB Pharmaceuticals raises $285M in first major biotech IPO since February
LB Pharmaceuticals raised $285 million in an initial public offering on Wednesday, marking the first sizable new stock offering for...
FDA clears J&J’s drug-device combo for bladder cancer
Dive Brief: The Food and Drug Administration on Tuesday approved a drug-device combination for bladder cancer that its developer, Johnson...
Lilly to give biotech startups access to AI tools
Eli Lilly will give small biotechnology companies a chance to use artificial intelligence models trained on years of the pharmaceutical...
Novartis to gain heart drug in $1.4B deal for Tourmaline Bio
Dive Brief: Novartis on Tuesday said it will pay $1.4 billion to acquire the New York-based biotechnology company Tourmaline Bio...
BioNTech says dual-acting lung cancer drug helped shrink tumors
Dive Brief: BioNTech’s experimental bispecific cancer drug pumitamig helped shrink tumors in three-quarters of people with small cell lung cancer...
A UK biotech takes aim at Parkinson’s, ALS by drugging mitochondria
British biotechnology company NRG Therapeutics on Monday said it raised £50 million, or about $67 million, to advance its lead...
A drug discovery startup banks $150M for immune and obesity drugs
Dive Brief: Enveda Biosciences said Thursday it raised $150 million in Series D financing, doubling the cash it’s pulled in...
Sanofi’s touted eczema drug hits study goal, but data fall short of expectations
Dive Brief: Sanofi shares dropped after the French drugmaker reported results from a highly anticipated study of a new kind...
FDA outlines new review pathway for drugs treating ultra-rare diseases
Dive Brief: The Food and Drug Administration plans to work more closely and flexibly with developers of drugs for certain...
Atlas Venture reels in $400M to grow its biotech startups
Prolific biotechnology investment firm Atlas Venture said Thursday it raised $400 million to pump into its existing portfolio of drug...
FDA to publish CRLs in real time; PEPFAR to distribute Gilead’s Yeztugo
Today, a brief rundown of news involving the Food and Drug Administration and Gilead Sciences, as well as updates from...
Bravehart, a stealthy startup, looks to China to challenge Bristol Myers heart drug
A newly launched startup is the latest young company to build itself around a drug discovered in Chinese laboratories. Hengrui...
At Senate hearing, lawmakers express dissatisfaction with RFK Jr.’s vaccine moves
U.S. lawmakers clashed with Health and Human Services Secretary Robert F. Kennedy Jr. over his changes to the country’s vaccine...
Secretive startup Treeline unveils first clinical candidates, $200M in new funding
For the past four years or so, veteran drug hunters Josh Bilenker and Jeff Engelman have kept tightly under wraps...
Biohaven’s rare disease drug is ‘ready to ship on Day 1’ following FDA approval
Biohaven’s top executive said his team is well-prepared to sell a therapy that could be not only the first approved...
Novartis thinks Arrowhead brain drug can succeed where others couldn’t
Novartis is once again taking aim at Parkinson’s disease, through a deal with Arrowhead Pharmaceuticals that could be worth billions...
Amgen to invest $600M in new US center; Sanofi drug for ITP approved
Today, we’re catching up after a long weekend on news involving Amgen and Replimune, as well as updates from Sanofi,...
Startup Corsera Health aims to bring preventive heart medicine to the masses
The biotechnology careers of John Maraganore and Clive Meanwell have brought them into collaboration time and time again. As the...
Why an FDA decision on Stealth’s Barth drug could ripple through the rare disease field
The case of Stealth BioTherapeutics and its rare disease drug could become a regulatory bellwether for other biotechnology companies seeking...
Startup Wugen raises $115M for ‘off-the-shelf’ CAR-T
Dive Brief: Wugen said Wednesday that it brought in $115 million in a new financing round that will help the...
Amylyx drug comes up short; Sanofi names new CMO
Today, a brief rundown of news involving Amylyx Pharmaceuticals and Sanofi, as well as updates from Novartis, Roche and Eisai...
Novo strikes RNA drug deal with startup Replicate
Dive Brief: Novo Nordisk is again looking for help outside its own laboratories as it works to build on the...
CDC panel to discuss COVID, hepatitis B shots in meeting next month
A federal vaccine panel recently remade by Health and Human Services Secretary Robert F. Kennedy Jr. will meet in September...
Lilly says breast cancer drug extended survival in study
Dive Brief: People with early breast cancer who were treated in a late-stage study with Eli Lilly’s drug Verzenio and...
FDA approves updated COVID boosters, but narrows use
The Food and Drug Administration on Wednesday approved updated COVID-19 vaccines that target a commonly circulating coronavirus strain, but narrowed...
RNA drug from Regeneron, Alnylam succeeds in rare autoimmune disease trial
Dive Brief: An RNA medicine developed by Regeneron Pharmaceuticals and Alnylam Pharmaceuticals helped control symptoms of the chronic autoimmune disease...
Lilly to submit obesity pill after hitting goal in third late-stage trial
Dive Brief: Eli Lilly on Tuesday said it is ready to ask the Food and Drug Administration for approval of...
FDA suspends license for Valneva’s chikungunya shot
The Food and Drug Administration has suspended the license of Valneva’s chikungunya vaccine following new reports of serious adverse reactions,...
Royalty Pharma buys BeOne stake in Amgen lung cancer drug sales
Dive Brief: Royalty Pharma has grabbed rights to a share in revenue from lung cancer drug Imdelltra, announcing Monday it...
MAHA may take aim at pharma DTC ads
A much-anticipated report from the Make America Healthy Again Commission was postponed earlier this month. But nestled within leaked documents...
Rocket can resume gene therapy trial after FDA lifts hold
Dive Brief: Rocket Pharmaceuticals plans to restart a Phase 2 gene therapy trial for a rare heart disease after working...
US, EU agree to terms of framework trade pact
The United States and the European Union formalized the terms of the framework trade agreement the two trading partners announced...
Sarepta pushes off debt payments in bid to regain financial footing
Dive Brief: Sarepta on Thursday said it’s reached agreements that remove about $700 million from a pile of debt due...
FDA cancels adcomm on Biohaven drug; Catalent lays off staff
Today, a brief rundown of news involving Biohaven and Catalent, as well as updates from Stealth Biotherapeutics, Jazz Pharmaceuticals and...
Gilead dives into ‘in vivo’ cell therapy with $350M buyout of Interius
Dive Brief: Gilead Sciences is deepening its investment in cancer cell therapy, announcing Thursday a deal to pay $350 million...
FDA approves Ionis’ hereditary angioedema drug
The Food and Drug Administration on Thursday approved a drug Ionis Pharmaceuticals developed for the rare genetic disease hereditary angioedema,...
Lilly searching for new neuro chief as White set to retire
Eli Lilly is searching for a new neuroscience chief after announcing Wednesday that the division’s current head, Anne White, will...
Xoma, a drug royalty specialist, buys another ‘zombie’ biotech
Xoma Royalty Corp. is acquiring another struggling biotechnology company in further sign of interest among certain firms in buying floundering...
CSL to separate vaccine business, cut jobs
Dive Brief: Australian drugmaker CSL is separating its vaccine business, Seqirus, into a standalone company as part of a sweeping...
Viking shares sink as obesity pill misses expectations in key study
Dive Brief: An experimental weight loss pill from Viking Therapeutics helped people with obesity lose up to 12% of their...
Omega’s Otello Stampacchia on the ‘reset’ changing biotech for the better
Otello Stampacchia has watched the biotechnology industry survive many dark days in the two decades he’s led one of its...
Stealth resubmits rare disease drug to FDA
Dive Brief: Stealth BioTherapeutics is once again seeking U.S. approval of a drug for the rare condition Barth syndrome, claiming...
Navigating the oncology patent cliff: Strategic imperatives for big pharma
Over the next five years, several blockbuster oncology drugs from leading pharmaceutical companies will lose patent protection, ushering in a...
With FDA PreCheck, drugmakers may get a manufacturing boost
The Trump administration recently added to an ongoing push to boost pharmaceutical manufacturing in the U.S., launching a new program...
Vedanta, PureTech’s microbiome startup, to cut staff after study setback
Vedanta Biosciences, a startup working on microbiome drug research for more than a decade, will lay off nearly a fifth...
Merck KGaA ventures into new territory in the US
Merck KGaA has been making moves to propel itself into becoming what CEO Belén Garijo described as a “globally diversified...
Precigen wins immunotherapy approval; Pfizer sickle cell drug fails trial
Today, a brief rundown of news involving Precigen and Pfizer, as well as updates from the Institute for Clinical and...
HHS revives defunct task force on childhood vaccine safety
The Department of Health and Human Services announced Thursday it will reinstate a disbanded task force on childhood immunizations, claiming...
Sarepta sells Arrowhead shares as partnership, debt payments loom
Dive Brief: Sarepta on Wednesday announced the divestment of its entire equity stake in partner Arrowhead Pharmaceuticals as the company...
Lilly says it will raise drug prices in Europe, responding to Trump threats
Eli Lilly on Thursday responded to a Trump administration plan to lower U.S. drug costs by issuing a statement claiming...
Vor says drug licensed from RemeGen succeeded in Sjögren’s study
Dive Brief: Vor Biopharma on Wednesday said a late-stage study run in China by its partner RemeGen succeeded, showing that...
AbbVie to build API plant in Illinois as it steps up US production
AbbVie plans to spend $195 million to build a new facility to produce active pharmaceutical ingredients in its hometown of...
PureTech launches new biotech built around lung disease drug
Dive Brief: PureTech Health, a biotechnology firm with a web of startup subsidiaries, announced Tuesday the launch of a new...
Insmed gains US approval of lung disease drug forecast to be blockbuster
Dive Brief: Insmed has gained approval for its second lung disease medicine, announcing Tuesday Food and Drug Administration clearance of...
IO Biotech sees path forward for skin cancer vaccine despite study setback
An experimental cancer vaccine fell short of its main objective in a Phase 3 trial in melanoma, causing shares of...
Strand raises another $153M to make ‘programmable’ mRNA drugs
Strand Therapeutics has raised a $153 million Series B round fresh off unveiling early, but promising results for a cancer...
Novo pushes back against obesity drug compounders as competition intensifies
Novo Nordisk is battling back against the threats to its obesity drug business, saying in an earnings report Wednesday that...
HHS abandons mRNA vaccine research
The Department of Health and Human Services is canceling nearly $500 million in contracts for the development of messenger RNA...
US biotech needs government support to match China’s gains, Pfizer CEO says
Lawmakers in Washington share U.S. drugmakers’ angst about being surpassed by China’s fast-progressing biotechnology sector, but aren’t raising alarms over...
Pharma prepared to work with Trump on DTC drug sales: Pfizer CEO
Pfizer and other large pharmaceutical companies are taking seriously President Donald Trump’s demand that drugmakers make more of their medicines...
A brain biotech slumps even with ‘best case’ seizure data
A brain-focused biotechnology company saw a double-digit stock drop Monday morning even as it unveiled clinical trial results that some...
Gates Foundation pledges $2.5B toward women’s health research
The Gates Foundation on Monday said it is committing to invest $2.5 billion over the next five years to accelerate...
The race to scale to 1,000 liters and beyond in gene therapy manufacturing
Viral-based gene therapies (GTs) represent a new frontier in medicine, offering hope to patients who previously had few, if any,...
Venture firm Frazier closes $1.3B fund for early-stage biotech investing
Frazier Life Sciences on Thursday said it has closed a new venture capital fund for startup creation and investing in...
In rumored AbbVie deal, Wall Street sees momentum for psychedelics M&A
Biotechnology companies specializing in psychedelics research saw their share prices rise after rumors of a billion-dollar acquisition hinted that big...
Experts ousted from CDC panel warn of damage to US vaccine policy
The 17 vaccine advisers fired by Robert F. Kennedy Jr. last month called Wednesday for an alternative to the panel...
US to install country-specific tariffs Aug. 7
The U.S. plans to lift its pause on country-specific tariffs while implementing a range of new rates for specific trading...
Regeneron cancer bispecific rejected again; Allogene discloses trial death
Today, a brief rundown of news involving Regeneron Pharmaceuticals and Allogene Therapeutics, as well as updates from Bristol Myers Squibb,...
Trump redoubles threats in attempt to strongarm drugmakers on prices
President Donald Trump on Thursday threatened 17 large drugmakers with “every tool in arsenal” if they don’t take steps to...
Alnylam reaches new highs on strong sales of closely watched rare disease drug
Dive Brief: Sales of an Alnylam Pharmaceuticals rare disease medicine substantially outpaced Wall Street expectations in the drug’s first full...
Vinay Prasad’s ouster leaves biotech guessing at FDA direction
Vinay Prasad’s sudden resignation from the Food and Drug Administration Tuesday once again leaves the biopharmaceutical industry, which has spent...
Madrigal buys into GLP-1 from CSPC; Apellis wins expanded drug approval
Today, a brief rundown of news involving Madrigal Pharmaceuticals and Viridian Therapeutics, as well as updates from Apellis Pharmaceuticals, PTC...
Vinay Prasad, controversial FDA official, abruptly departs agency
Vinay Prasad, the controversial head of the Food and Drug Administration office that oversees vaccines and gene therapy, has abruptly...
Merck plans spending shift to boost business beyond Keytruda
Dive Brief: Merck & Co. is launching a new cost-cutting program, announcing Tuesday a plan to redirect by the end...
FDA allows Sarepta to resume some Elevidys shipments
The Food and Drug Administration has given Sarepta Therapeutics a green light to resume shipping its gene therapy Elevidys to...
Celcuity shares triple on late-stage results for breast cancer therapy
Biotechnology firm Celcuity said Monday a late-stage trial testing its experimental breast cancer therapy in combination with other drugs succeeded, positioning...
AstraZeneca drug acquired in Alexion deal succeeds in autoimmune disease trial
An experimental drug from AstraZeneca succeeded in a late-stage trial in an autoimmune condition called generalized myasthenia gravis, positioning the...
Rocket lays off staff; Abivax capitalizes on immune drug data
Today, a brief rundown of news involving Rocket Pharmaceuticals and Atara Biotherapeutics, as well as updates from Abivax, Gate Bioscience...
Sarepta woes mount as Duchenne gene therapy knocked back in Europe
European drug regulators on Friday recommended rejecting Sarepta Therapeutics’ Elevidys in the latest setback for the struggling biotechnology company and...
In reversal, European regulators take positive view on Lilly Alzheimer’s drug
A key committee that helps decide what new medicines enter the European market has changed its mind about a closely...
FDA delays approval decision for Bayer menopause therapy
The Food and Drug Administration has delayed its review of a Bayer therapy for hot flashes related to menopause, telling...
Bristol Myers shuffles its executive ranks with new CMO
AstraZeneca executive Cristian Massacesi will join Bristol Myers Squibb as its chief medical officer, replacing outgoing executive Samit Hirawat, the...
Galapagos, having backtracked on split, weighs sale of cell therapy business
Dive Brief: Galapagos on Wednesday said it’s considering selling its cell therapy business, which previously had been the centerpiece of...
A TCG offshoot pulls in $400M for biotech startup creation
TCG Labs Soleil, a venture firm building narrowly focused biotechnology startups and readying them for partnerships, said Thursday it raised...
RFK Jr. adopts CDC panel recommendation to remove thimerosal from flu shots
Health and Human Services Secretary Robert F. Kennedy Jr. on Wednesday endorsed a federal advisory committee’s recommendation to remove a...
Roche stops shipping Sarepta gene therapy in some countries outside US
Dive Brief: Roche is pausing sales of the Duchenne gene therapy Elevidys in some countries outside the U.S. after partner...
Replimune drug rejected by FDA; Omega raises $647M biotech fund
Today, a brief rundown of news involving Replimune Group and Johnson & Johnson, as well as updates from Omega Funds,...
Sanofi to acquire vaccine biotech in billion-dollar deal
Dive Brief: French pharmaceutical giant Sanofi said Tuesday it will pay $1.15 billion to acquire the privately held London-based private...
AstraZeneca grows US presence with $50B in spending plans
WASHINGTON — AstraZeneca, the U.K.’s third biggest company by market value, is making itself a bit more American. On Monday,...
5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis
One month ago, a 51-year-old man treated in a clinical trial with an experimental gene therapy became dangerously sick. The...
J&J absorbs Stelara, tariff hits to deliver beat-and-raise quarter
Johnson & Johnson on Wednesday reported quarterly prescription drug sales that for the first time surpassed $15 billion, highlighting the...
Bristol Myers, Pfizer to offer Eliquis at a discount for some patients
Bristol Myers Squibb and Pfizer will begin offering their top-selling heart medicine Eliquis through a new online service at a...
Sarepta reports patient death in limb-girdle trial, compounding concerns on gene therapy risks
Another person treated with a Sarepta Therapeutics gene therapy has died, compounding concerns about the safety of the company’s genetic...
Bristol Myers’ Reblozyl falls short in Phase 3; Blenrep voted down by FDA panel
Today, a brief rundown of news involving Bristol Myers Squibb and the Food and Drug Administration, as well as updates...
Panel urges FDA to remove warnings on hormonal menopause therapy
A panel of medical experts called for the removal of warning labels on hormone therapy for menopausal women during a...
FDA to ask Sarepta to stop shipping Duchenne gene therapy
The Food and Drug Administration will ask Sarepta Therapeutics to halt all shipments of its marketed gene therapy for Duchenne...
Biotech startup funding dried up in second quarter, HSBC finds
Dive Brief: New data from HSBC Innovation Banking add further evidence venture capital funding for private biotechnology companies has slid...
Novartis CEO says resolution on Trump plan to cut US drug prices will take time
Novartis is exploring options to meet the Trump administration’s goal of bringing U.S. drug prices down to match what European...
Sarepta to lay off about 500 employees after Duchenne gene therapy setbacks
Sarepta Therapeutics is laying off roughly 500 employees in an extensive workforce reduction that follows a series of setbacks and...
AstraZeneca rare disease drug fails key trial tests
An experimental rare disease drug from AstraZeneca failed in two late-stage trials, though the company said Wednesday there were signs...
Hengrui, Kailera say dual-acting obesity shot succeeds in China study
Dive Brief: An experimental, dual-acting obesity drug from Hengrui Pharma and biotechnology startup Kailera Therapeutics succeeded in a Phase 3...
Cancer drugmaker LaNova to sell to China’s Sino Biopharm
Dive Brief: LaNova Medicines, a cancer drugmaker that previously licensed medicines to Merck & Co. and AstraZeneca, has agreed to...
Private equity firms back PCI Pharma in bet on drug production
A group of private equity firms are pouring funding into PCI Pharma Services, betting the contract drug development and manufacturing...
AstraZeneca blood pressure drug succeeds in late-stage trial
Dive Brief: An experimental drug being developed by AstraZeneca significantly reduced blood pressure versus placebo in a Phase 3 study...
Renasant Bio, chasing drugs for ADPKD, raises $55M in seed funding
The drug industry’s efforts to develop a treatment for a rare kidney condition known in shorthand as ADPKD have come...
AbbVie to pay $700M for trispecific drug from Ichnos Glenmark
Dive Brief: AbbVie agreed to pay Ichnos Glenmark $700 million upfront for rights to an early-stage experimental trispecific antibody that...
FDA, in policy shift, publishes some drug rejection letters
The Food and Drug Administration on Thursday published more than 200 drug rejection letters in a notable policy shift it...
FDA turns back Capricor’s Duchenne cell therapy
The Food and Drug Administration has rejected what was set to be the first treatment for heart-related complications of Duchenne...
With Verona deal, Merck wagers on strength of lung drug’s patents
Merck & Co.’s $10 billion acquisition of Verona Pharma Wednesday is a dramatic outcome for a company that’s spent 20...
Jazz names new CEO; Ultragenyx, Mereo shares slide on trial update
Today, a brief rundown of news involving Valneva and Jazz Pharmaceuticals, as well as updates from Ultragenyx Pharmaceutical, Nuclidium and...
Soleno sales of new Prader-Willi drug rise faster than expected
The first marketed treatment for the insatiable hunger associated with Prader-Willi disease is selling more quickly than Wall Street analysts...
Moderna COVID vaccine gets full approval for children
Dive Brief: The Food and Drug Administration on Thursday granted full approval for Moderna’s COVID-19 vaccine Spikevax in children aged...
Merck to buy Verona and its lung drug in $10B deal
Merck & Co. has agreed to pay $10 billion to buy London-based Verona Pharma, scooping up a potential multibillion-dollar new...
Lilly gets FDA OK of modified dosing for Alzheimer’s drug
Dive Brief: The Food and Drug Administration has approved a modified dosing schedule for Eli Lilly’s Alzheimer’s disease drug Kisunla,...
Trump says pharmaceutical, copper tariffs coming ‘very soon’
President Donald Trump is planning to introduce tariffs of 50% on copper imports and levies “at a very, very high...
Novartis gets approval of first malaria medicine for newborns
Dive Brief: Novartis won regulatory approval Tuesday of the first malaria medicine for newborns and the youngest infants, who until...
Medical groups, pregnant doctor sue RFK Jr. over vaccine changes
Six medical groups and a pregnant physician have sued Health and Human Services Secretary Robert F. Kennedy Jr. and his...
After delay, Kalvista wins FDA OK for drug to treat rare swelling disorder
Dive Brief: After a delay due to “resource constraints,” the Food and Drug Administration on Monday approved Kalvista Pharmaceuticals’ pill...
AbbVie to buy CAR-T developer Capstan in deal worth up to $2.1B
Dive Brief: Abbvie has agreed to acquire cell therapy developer Capstan Therapeutics in a deal worth up to $2.1 billion,...
Moderna flu shot outperforms marketed vaccines in large late-stage trial
Dive Brief: Moderna’s seasonal influenza vaccine met its main goal in a large Phase 3 trial, reducing the risk of...
Acadia CEO sets sights on ‘much more assertive’ deals to invigorate pipeline
Acadia Pharmaceuticals, the brain-focused drug developer, surprised some on Wall Street last week with a pair of predictions. The first:...
Organon drug for endometriosis falls short in mid-stage study
Dive Brief: Organon’s experimental treatment for endometriosis failed to improve pelvic pain for women in a Phase 2 study, leading...
Regeneron bispecific approved for myeloma; Concentra to buy IGM
Today, a brief rundown of news involving Regeneron Pharmaceuticals, IGM Biosciences and Catalio Capital, as well as updates from Roche,...
Sodium channel blockers for pain: New opportunities after Vertex’s ‘watershed’ moment
In the notoriously expensive business of drug development, SiteOne Therapeutics made do with little. The biotechnology startup formed in 2010,...
Atai and Beckley, set to merge, reveal study success for psychedelic drug
Dive Brief: Atai Life Sciences and Beckley Psytech are making plans to push the psychedelic drug mebufotenin into Phase 3...
Sage to lay off most staff amid Supernus buyout
Dive Brief: Sage Therapeutics will lay off 338 employees, the vast majority of its workforce, while in the process of...
Incyte replaces CEO Hoppenot with dealmaker Meury
Dive Brief: Incyte has named veteran pharmaceutical executive Bill Meury as its new CEO, replacing longtime head Hervé Hoppenot, who...
Acadia’s ‘very bullish’ sales forecast restores some confidence on Wall Street
Acadia Pharmaceuticals has proposed that its pipeline of experimental medicines could, if eventually brought to market, peak at $12 billion...
Congress should reconsider breaking up PBMs, experts say
Bipartisan policies in Congress meant to lower drug costs by targeting middlemen in the pharmaceutical supply chain are likely to...
Supreme Court upholds ACA preventive services mandate
The Supreme Court on Friday upheld a popular provision of the Affordable Care Act that requires private insurers cover a range...
Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules
Today, a brief rundown of news involving Biocryst and Peter Marks, as well as updates from UCB and Altimmune that...
FDA takes major step to ease access to CAR-T therapy
Dive Brief: The Food and Drug Administration is easing limitations it imposed around the complex cancer drugs known as CAR-T therapies,...
Vor, with new CEO, changes course to target autoimmune disease
Dive Brief: Vor Biopharma is licensing rights to an immune disease drug from Chinese biotechnology company RemeGen, it said Wednesday,...
RFK Jr.-appointed panel recommends flu shots be free of contested preservative
Dive Brief: Advisers to the Centers for Disease Control and Prevention recommended Thursday that influenza vaccines used in the coming...
Kymera adds Gilead as research partner, while advancing new candidate with Sanofi
Dive Brief: Kymera Therapeutics and Gilead Sciences will develop oral molecular glue degraders under a deal announced Wednesday, which could...
CDC panel, newly remade by RFK Jr., questions vaccine evidence
Robert F. Kennedy Jr.’s newly hand-picked panel of federal vaccine advisers met for the first time Wednesday since the Health...
Hundreds of laid-off HHS staff have been reinstated, RFK Jr. says
Hundreds of Health and Human Services employees have been reinstated after mass layoffs at the department earlier this year, according...
FDA investigating Elevidys safety; Nektar shares spike on eczema data
Today, a brief rundown of news involving Sarepta Therapeutics, Capricor Therapeutics and Nektar Therapeutics, as well as updates from AstraZeneca,...
Top drug official at FDA reportedly set to exit next month
Dive Brief: A top Food and Drug Administration official responsible for overseeing drug reviews is reportedly retiring from the agency,...
Relentless innovation: Bold exploration in advancing therapeutic options for every patient, every discovery
On the heels of the BIO International Convention and as I reflect on the passion for innovation that drives this...
The rise of GLP-1 drugs: Transforming weight loss treatment
In the last episode of the podcast Balancing the Future, hosted by Chai Nussbaumer and Micah Schweizer from Mettler Toledo,...
FDA clears CSL’s swelling disease drug; Regeneron loses 23andMe auction
Today, a brief rundown of news involving CSL and Intellia Therapeutics, as well as updates from Eli Lilly and 23andme...
A startup banks $66M to pursue ‘inclusive precision medicine’
Dive Brief: Actio Biosciences, a San Diego-based biotechnology startup, announced Wednesday it raised a $66 million Series B financing to...
Gene therapy faces fresh uncertainty as two more top FDA officials depart
Dive Brief: Two senior officials at the Food and Drug Administration office that regulates gene therapies have reportedly been placed...
Prothena to lay off majority of staff; Zealand shares obesity drug data
Today, a brief rundown of news involving Prothena and Zealand Pharma, as well as updates from Biogen and Sanofi that...
A longer ‘winter’: Public funding slowdown heightens pressure on biotech startups
Biotechnology industry watchers were hopeful at the start of 2025. Venture funding appeared to be rebounding after a lengthy slump,...
Draig, a brain drug startup, debuts with $140M to treat depression
Psychiatric medicine remains one of the more challenging and risky areas of drug research. Many prospects show initial promise only...
Scholar Rock drug preserves muscle in obesity trial
Dive Brief: A medicine developed to treat a genetic muscle-wasting disease can improve results for patients taking GLP-1 weight-loss medicines,...
FDA approves twice-yearly shot of Gilead drug for HIV prevention
The Food and Drug Administration has approved a new way to prevent HIV, clearing a Gilead Sciences drug that requires...
FDA to speed reviews for drugs supporting ‘national interests’
Food and Drug Administration Commissioner Martin Makary has proposed a dramatic expansion of the agency’s powers to speed up drug...
Lilly to acquire Verve in $1B bet on gene editing for heart disease
Dive Brief: Eli Lilly agreed to buy Verve Therapeutics for $1 billion, betting on the promise of one-and-done gene therapies...
Roche, waving off study failures, commits to Phase 3 trials for Parkinson’s drug
Dive Brief: Roche will advance an experimental Parkinson’s disease drug with a mixed track record into late-stage development, announcing Monday...
Could the FDA take an indirect approach to regulate lab developed tests?
When the deadline to appeal the court decision that blocked the Food and Drug Administration’s final rule regulating laboratory developed...
FDA to miss approval deadline for Kalvista drug due to ‘resource constraints’
Dive Brief: Kalvista Therapeutics said Friday that the Food and Drug Administration will miss a deadline to approve its experimental...
Insmed surges on lung drug data; Recursion cuts staff
Today, a brief rundown of news involving Insmed and Recursion Pharmaceuticals, as well as updates from Odyssey Therapeutics, Gilead Sciences...
Pharma’s wins and losses in the budget bill
The budget bill currently under consideration in Congress is big — and it’s complicated. The 1,000-plus page document is full...
AstraZeneca forms an AI deal in China; Third Harmonic advances liquidation plans
Listen to the article 4 min This audio is auto-generated. Please let us know if you have feedback. Today, a...
Moderna wins FDA OK to widen use of RSV vaccine
The Food and Drug Administration has approved wider use of Moderna’s respiratory syncytial virus vaccine in a boost for a...
Novo, searching for a spark, plans late-stage trials for amylin drug
Dive Brief: Novo Nordisk is planning Phase 3 clinical trials for a obesity drug combination called amycretin, adding another emerging...
RFK Jr. reveals picks for influential vaccine panel
Health and Human Services Secretary Robert F. Kennedy Jr. on Wednesday continued his efforts to alter the government structure supporting...
BioNTech buys mRNA, courtroom rival CureVac in all-stock deal
Dive Brief: COVID vaccine maker BioNTech is buying rival CureVac, announcing Thursday an all-stock deal weeks before the two companies were...
Bristol Myers bolsters radiopharma portfolio with PhiloChem deal
Dive Brief: Bristol Myers agreed to pay $350 million up front to Philochem for worldwide rights to an experimental radiopharmaceutical...
SpliceBio lands $135M for a new kind of eye gene therapy
SpliceBio, a Spanish biotechnology company working on next-generation gene therapies, said Wednesday it raised $135 million in a Series B...
Vaccine makers face fresh uncertainty after firing of CDC panel
Dive Brief: Health and Human Services secretary Robert F. Kennedy Jr., has abruptly fired all members of the committee guiding...
Scorpion, fresh off Lilly deal, spins out startup Antares
Fresh off a multibillion-dollar deal with Eli Lilly, cancer drug startup Scorpion Therapeutics is trying for an encore, debuting a...
National Resilience, a well-funded manufacturing startup, to scale back operations
Dive Brief: National Resilience, a startup that launched in 2020 to help young biotechnology companies produce complex medicines, said Monday...
Merck antibody drug for RSV approved by FDA
The Food and Drug Administration has cleared a new treatment designed to protect infants from respiratory syncytial virus. Called Enflonsia...
[Podcast] Trial Trailblazers: Behind clinical breakthroughs
In this three-part podcast series, "Trial Trailblazers: Behind clinical breakthroughs," gain rare insight into the human stories driving innovative clinical...
Lilly partners with Camurus in search of a long-lasting obesity drug
Dive Brief: Looking to defend its giant cardiometabolic health franchise, Eli Lilly is licensing a technology from Swedish biotechnology firm...
Biotech funding plummets as Trump policies unnerve investors: Jefferies
The amount of funding going into biotechnology companies has fallen off over the last couple months, a trend the investment...
FDA’s AI tool ‘Elsa’ is here, and the industry has questions
The Food and Drug Administration aims to roll out its new AI tool, called Elsa, “ahead of schedule and under...
Otsuka tops Vera with kidney drug data; Regenxbio sinks on Duchenne update
Today, a brief rundown of news involving Otsuka Pharmaceutical and Arvinas, as well as updates from Regenxbio, Vigil Neuroscience and...
FDA meeting gives window into gene therapy field’s angst
Anyone looking for evidence of genetic medicine’s enormous promise need only read of KJ Muldoon. The 10-month-old infant headed home...
Bispecific cancer drugs, data caveats and funding alarms: 3 takeaways from ASCO
New drugs, however heralded, take time to embed into clinical care. Enhertu, the powerful antibody-drug conjugate from Daiichi Sankyo and...
Cullinan doubles down on bispecifics for autoimmune disease with Genrix deal
Dive Brief: After changing its name and focus, Cullinan Therapeutics is beefing up its autoimmune disease pipeline by licensing an...
Daiichi Sankyo struck gold with ‘ADC’ cancer drugs. Its new CEO has to figure out what’s next.
CHICAGO — Hiroyuki Okuzawa holds an enviable position. The veteran Daiichi Sankyo executive took over as the Japanese drugmaker’s new...
FDA to use new review tool on Sarepta’s gene therapy work
Dive Brief: The Food and Drug Administration has awarded Sarepta Therapeutics a new kind of fast pass that could help...
J&J data support earlier use of combo pill in prostate cancer
CHICAGO — A Johnson & Johnson drug currently used for advanced prostate cancer can help keep the disease from progressing in...
Bayer drug could ease side effects of common breast cancer treatment, detailed data show
An experimental, non-hormonal drug from Bayer can reduce the hot flashes and other menopausal side effects many women taking a...
Bispecific competition, debating oral SERDs and a bold GLP-1 prediction
CHICAGO — The American Society of Clinical Oncology’s annual meeting is a forum for data. On Monday, it was also...
Kymera, with new data, takes early step toward a Dupixent-like pill
Dive Brief: An experimental protein-degrading drug from Kymera Therapeutics appeared safe and able to affect its intended target in an...
Bristol Myers allies with BioNTech on bispecific cancer drug
Bristol Myers Squibb is making sure it won’t miss out on a new type of cancer immunotherapy that’s drawn immense...
A funding flashpoint, Pfizer’s $1B poster and AstraZeneca advertising
CHICAGO — Funding cancer research isn't usually a political flashpoint. But as the Trump administration signals its desire to drastically...
At ASCO, Enhertu cements growing role in stomach cancer care
AstraZeneca and Daiichi Sankyo’s targeted cancer medicine Enhertu helped participants in a late-stage clinical trial with a type of advanced...
FDA clears Moderna’s new COVID vaccine, but with limits
The Food and Drug Administration has granted an approval to Moderna’s next-generation COVID-19 vaccine, but with limits that will restrict...
Keros lays off nearly half its staff; Astellas buys into a China biotech’s ADC
Today, a brief rundown of news involving Astellas Pharma and Keros Therapeutics, as well as updates from Stealth Biotherapeutics, PepGen...
New Summit data could slow US approval plans for PD-1/VEGF drug
Dive Brief: A dual-acting drug developed by Summit Therapeutics and Akeso delayed tumor progression in a Phase 3 lung cancer...
Intellia filing spurs safety concerns over CRISPR drug
Dive Brief: Intellia Therapeutics shares dropped 25% early Thursday after the gene-editing company disclosed that one patient in an ongoing...
