Category: Medicine

Medicine

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

Medicine

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

Medicine

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

Medicine

Pfizer, BioNTech showcase new data supporting COVID booster

Dive Brief: Pfizer and partner BioNTech said Monday their updated COVID-19 booster spurred strong immune responses against currently circulating coronavirus

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

Biohaven’s rare disease drug is ‘ready to ship on Day 1’ following FDA approval

Biohaven’s top executive said his team is well-prepared to sell a therapy that could be not only the first approved

Medicine

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

Medicine

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,

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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,

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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,

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

Iovance cuts staff amid slow sales start for ‘TIL’ cell therapy

Iovance Biotherapeutics will lay off staff in a restructuring that follows a significant cut to its revenue forecasts earlier this

Medicine

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

Medicine

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

Medicine

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

Medicine

David Altshuler, geneticist who helped transform Vertex, to retire next year

Dive Brief: David Altshuler, the renowned geneticist who’s helped shape Vertex Pharmaceuticals’ research strategy over the last decade, will step

Medicine

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

Medicine

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,

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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,

Medicine

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

Medicine

Trump redoubles threats in attempt to strongarm drugmakers on prices

President Donald Trump on Thursday threatened 17 large drugmakers with “every tool in [the federal government’s] arsenal” if they don’t

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

Bavarian Nordic agrees to $3B take-private deal

Vaccine maker Bavarian Nordic on Monday said it has agreed in principle to a roughly $3 billion take-private offer from

Medicine

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

Medicine

GSK pays $500M to enter drugmaking alliance with Hengrui

GSK is turning to a China-based biotechnology company in search of its next blockbuster medicine, announcing Monday a broad drugmaking

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

Dispatch emerges with $216M and plans for a ‘universal’ solid tumor therapy

Dive Brief: A new biotechnology company debuted Wednesday with a hefty bankroll and an immunotherapy approach it claims has the

Medicine

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

Medicine

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,

Medicine

Former biotech executive appointed to lead FDA drug review office

Dive Brief: The Food and Drug Administration on Monday appointed George Tidmarsh, a Stanford University physician with long experience in

Medicine

From bench to batch: AAV manufacturing for the next-generation of gene therapies

The AAV-based therapeutic market continues to evolve rapidly. The past few years have seen multiple high-profile FDA approvals for AAV-based

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

From data to decisions: How pharma can move faster without sacrificing trust

In a race where every day counts, speed has become a defining metric for pharmaceutical innovation. But as timelines compress,

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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,

Medicine

Actithera draws new investors to radiopharma drug pitch

Dive Brief: Actithera, a radiopharmaceutical drugmaker based in Oslo, Norway and Cambridge, Massachusetts, has raised just under $76 million in

Medicine

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

Medicine

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

Medicine

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

Medicine

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,

Medicine

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:

Medicine

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

Medicine

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,

Medicine

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,

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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,

Medicine

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,

Medicine

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

Medicine

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

Medicine

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

Medicine

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,

Medicine

Lexeo to help launch spinout around RNA drugs for the heart

Dive Brief: Perceptive Xontogeny Venture Funds and venBio Partners are contributing up to $40 million to a spinout of genetic

Medicine

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,

Medicine

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

Medicine

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

Medicine

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

Medicine

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,

Medicine

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

Medicine

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

Medicine

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

Medicine

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,

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche

Dive Brief: The Food and Drug Administration has approved a new oral medication for an uncommon kind of tumor, clearing

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

Metsera shares climb on early data for amylin-targeting obesity shot

Dive Brief: An experimental weight loss drug developed by Metsera helped people with obesity lose up to 8% of their

Medicine

Regeneron makes obesity push; Atai, Alto ink brain drug deals

Today, a brief rundown of news involving Regeneron and Bluebird bio, as well as updates from Atai Life Sciences, Alto

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

AstraZeneca drug could help keep a common breast cancer at bay

CHICAGO — Too often, cancer has a way of evading treatment. Tumors that were held in check begin to spread

Medicine

A funding flashpoint, Pfizer’s $1B poster and AstraZeneca advertising

Funding cancer research isn’t usually a political flashpoint. But as the Trump administration signals its desire to drastically cut the

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

HHS terminates Moderna contract to develop bird flu vaccine

The U.S. The Department of Health and Human Services has canceled a contract with Moderna to develop messenger RNA vaccines

Medicine

Muscle-sparing obesity drug safe for Phase 3 trial, Veru says

Dive Brief: Veru’s muscle-preserving obesity drug enobosarm, when combined with Novo Nordisk’s Wegovy, may have less gastrointestinal side effects at

Medicine

Cancer drugmaker iTeos to shut down

Dive Brief: Cancer drugmaker iTeos Therapeutics said Wednesday it plans to wind down operations and seek to sell the company’s

Medicine

Lilly to buy pain drug developer SiteOne, challenging Vertex

Eli Lilly is wagering up to $1 billion on a private biotechnology company developing new, non-opioid pain drugs that have

Medicine

FDA sets COVID vaccine formula as RFK Jr. narrows guidance for shots

Dive Brief: The Food and Drug Administration on Thursday recommended COVID-19 vaccine manufacturers tailor their shots for the upcoming fall and

Medicine

FDA panel backs Darzalex for early stage multiple myeloma

Expert advisers to the Food and Drug Administration on Tuesday backed Johnson & Johnson’s Darzalex for people with an asymptomatic

Medicine

FDA advisers pan Pfizer’s PARP drug; Sarepta to resume Duchenne study

Today, a brief rundown of news involving Pfizer and Sarepta Therapeutics, as well as updates from UroGen Pharma, Altos Labs

Medicine

Novo pressures GLP-1 compounders as FDA ban takes hold

Novo Nordisk is ramping up its war on compounders making versions of its top-selling semaglutide medicine as the regulatory grace

Medicine

House passes reconciliation bill with massive Medicaid cuts

The House passed Republicans’ “big, beautiful bill” on Thursday in a razor-thin 215-214 vote, sending the legislation — which includes the most

Medicine

AI tool could help doctors ID breast cancers vulnerable to Enhertu

For decades now, doctors tasked with diagnosing breast cancer have peered into microscopes and pored over slides, hunting for signs

Medicine

Zepzelca, Tecentriq combo extends survival in hard-to-treat lung cancer

A combination of Roche’s cancer immunotherapy Tecentriq and a drug called Zepzelca helped extend survival in people with a hard-to-treat

Medicine

FDA panel recommends keeping COVID shots targeted to same strain as last year

Advisers to the Food and Drug Administration have recommended COVID-19 vaccine makers continue to target their shots to the so-called

Medicine

Sanofi gains experimental Alzheimer’s drug through Vigil buyout

Sanofi has agreed to spend $470 million to take control of a young biotechnology company and its experimental drug for

Medicine

Reproductive health startup raises $65M for infertility drugs

ReproNovo, a biotechnology company specializing in reproductive medicine, has raised $65 million to advance two drugs it thinks could help

Medicine

Moderna pulls application for combo COVID, flu shot

Dive Brief: After discussions with the Food and Drug Administration, Moderna on Wednesday said it has voluntarily withdrawn its application