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...
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...
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...
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...
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Dive Brief: After discussions with the Food and Drug Administration, Moderna on Wednesday said it has voluntarily withdrawn its application...
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...
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...
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...
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...
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...
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...
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...
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...
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...
Tourmaline shares fall on Phase 2 data; Schrödinger cuts staff
Today, a brief rundown of news involving Tourmaline Bio, Schrödinger and Beckley Psytech, as well as updates from CRISPR Therapeutics...
FDA sets stricter approval standards for COVID vaccines
The Food and Drug Administration is changing how it reviews new COVID-19 vaccines, setting out stricter standards in place of...
Novavax’s COVID vaccine gets FDA approval, but with limits
Novavax has at last gained full Food and Drug Administration approval for its COVID-19 vaccine, but the OK comes with...
Prime Medicine claims ‘proof of concept,’ but lays off staff in pivot
Prime Medicine will lay off one-quarter of its workforce and deprioritize its clinical-stage program for a rare genetic disease as...
Stopping a ‘moral obscenity’: Senate Judiciary Committee expresses support for PBM reform
There’s still significant support in Congress for overhauling the pharmacy benefit manager industry, after reforms almost made it across the...
Sanofi to pour more than $20B into US drug research and manufacturing
Dive Brief: Sanofi plans to invest at least $20 billion in the U.S. over the next five years as the...
FDA delays approval decision for Biohaven rare disease drug
Connecticut-based Biohaven has been developing what it hopes will be the first medicine for a group of rare, nerve-destroying diseases....
Novo CEO to depart as obesity drugmaker’s challenges rise
Novo Nordisk CEO Lars Fruergaard Jørgensen, who led the Danish drugmaker to new heights through its development of powerful medicines...
BioMarin to buy rare disease drugmaker Inozyme for $270M
BioMarin Pharmaceutical has agreed to spend $270 million to take control of a Boston-based drug company with complementary expertise in...
Regeneron defeats Amgen in PCSK9 case; 2 cell therapy biotechs cut staff
Today, a brief rundown of news involving Amgen and Regeneron, as well as updates from Travere Therapeutics, Allogene and Kyverna...
A bespoke CRISPR therapy suggests a blueprint for treating ‘N-of-1’ diseases
A group of scientists successfully made a bespoke gene editing medicine for a critically ill baby in just a few...
AbbVie stakes $335M on a startup’s RNAi drugs
AbbVie is staking hundreds of millions of dollars on RNA interference, agreeing on Wednesday to work with biotechnology startup ADARx...
Novo to work with Septerna in hunt for oral obesity drugs
Dive Brief: Novo Nordisk on Wednesday said it will collaborate with biotechnology startup Septerna to hunt new obesity drug prospects,...
5 questions on Trump’s plan to lower US drug prices
President Donald Trump’s declaration Monday that the Department of Health and Human Services will pursue a plan to “equalize” drug...
Women’s health faces growing headwinds, despite jump in venture investment
The women’s health field has a long way to go addressing persistent deficits in research and treatment. Common conditions that...
Trump revives ‘most favored nation’ plan in effort to cut US drug prices
The Trump administration is resurrecting a controversial policy that aims to tamp down some pharmaceutical costs in the U.S. by...
FDA follows EMA in limiting use of Valneva shot
Safety concerns have spurred the Food and Drug Administration and Centers for Disease Control and Prevention to recommend suspending use...
Innovating a healthier tomorrow: Entering a new era of medicine
The number of registered US clinical trials has almost tripled in the last decade, from over 180,000 in 2015 to...
[Podcast] Behind the Breakthroughs: How Almac Powers Clinical Trial Success with Care
Emerging biopharma companies are now taking the lead on drug development, with smaller and more agile firms able to meet...
Haya banks $65M to scour the ‘dark genome’ for new drugs
Scientists long believed the human genome consisted mostly of useless DNA. These sequences, after all, aren’t translated into proteins, making...
Biotech is guessing how Vinay Prasad might change the FDA. His research, writing offer clues.
To hear Vinay Prasad tell it, U.S. healthcare is too ready to intervene unnecessarily, use prescription drugs without sufficient evidence...
Gilead, bracing for tariffs, joins peers in US drug production push
Dive Brief: Gilead on Wednesday became the latest U.S. drugmaker to pledge new investments in U.S. manufacturing, as President Trump...
Eli Lilly extends Purdue alliance; EMA investigates Valneva shot
Today, a brief rundown of news involving Eli Lilly and Valneva, as well as updates from CRISPR Therapeutics, Vivo Capital...
Viatris’ new form of old pain drug scores in large trials
Pittsburgh-based pharmaceutical firm Viatris on Thursday said a pain drug it’s been developing succeeded in two large clinical trials, setting...
4 more biotechs cut staff amid market tumult
Four biotechnology companies are laying off staff in the latest examples of cutbacks in a sector struggling to hold its...
Novo cuts forecasts as compounded GLP-1s weigh on sales
Dive Brief: While revenue and profit rose year-over-year during the first quarter at Novo Nordisk, the Danish drugmaker on Wednesday...
FDA set to meet this month on COVID vaccines
A panel of Food and Drug Adminsitration advisers will meet May 22 to discuss updating the formula of COVID-19 vaccines...
Prasad’s FDA appointment pressures cell and gene therapy stocks
Shares in more than a dozen gene and cell therapy developers tumbled by double digits Wednesday after a well-known critic...
Vinay Prasad, a physician and FDA critic, to lead agency center overseeing vaccines
Vinay Prasad, a prolific academic and longtime critic of U.S. drug policies, was named Wednesday as the new leader of...
AI specialist Recursion trims pipeline in latest shakeup
AI drug discovery specialist Recursion Pharmaceuticals is shelving three of its most advanced drug prospects in an effort to cut...
PTC stock slides on new data for Huntington’s drug
Dive Brief: Shares in PTC Therapeutics fell by double-digits Monday morning as investors parsed new clinical trial results for an...
Madrigal’s MASH drug sales again top Wall Street projections
Dive Brief: Madrigal Pharmaceuticals said its pioneering medicine for a common liver disease brought in $137.3 million in the first...
AstraZeneca quietly exits neuroscience | BioPharma Dive
AstraZeneca on Tuesday confirmed it has closed down its neuroscience research group to direct resources toward more “high value” projects....
Arvinas, Entrada cut staff; Merck builds US hub for Keytruda
Today, a brief rundown of news involving Arvinas and Biogen, as well as updates from Merck & Co., Entrada Therapeutics...
CVS strikes Wegovy deal with Novo Nordisk
Dive Brief: CVS Health’s pharmacy benefit manager Caremark reached an agreement with Danish drugmaker Novo Nordisk to give its weight...
Cytokinetics reveals unexpected delay; AstraZeneca combo therapy hits in asthma
Today, a brief rundown of news involving Cytokinetics and AstraZeneca, as well as updates from Repare Therapeutics, Amicus Therapeutics and...
Amgen’s Stelara biosimilar gets off to fast start
Dive Brief: Amgen on Thursday said its just-launched biosimilar of Johnson & Johnson’s autoimmune drug Stelara recorded $150 million in...
Moderna combination flu, COVID shot delayed amid FDA scrutiny
The Food and Drug Administration has asked Moderna for additional data before it will consider approving a combination shot the...
Pharma downplays tariff threat, even as risks remains unclear
The threat of tariffs on pharmaceuticals imported to the U.S. hasn’t yet pushed drugmakers off course, with many of the...
J&J secures FDA OK for immune drug touted as future blockbuster
The Food and Drug Administration on Wednesday approved an antibody drug that developer Johnson & Johnson expects will eventually become...
Novartis to acquire Regulus in deal for kidney disease drug
Novartis will pay $800 million upfront to acquire Regulus Therapeutics, a San Diego biotechnology company that launched nearly two decades...
Acelyrin should liquidate instead of merging with Alumis, investor says
A shareholder of immune drug developer Acelyin believes the company is better off shutting down and returning cash to shareholders...
Pfizer’s Bourla ‘cautiously optimistic’ on looming US pharma tariffs
Pfizer will maintain its 2025 financial forecasts for now, but warned Tuesday it can’t predict the impact of any tariffs...
Merck KGaA to buy biotech SpringWorks for $3.9B
Dive Brief: Merck KGaA has agreed to buy biotechnology company SpringWorks Therapeutics, announcing Monday a $3.9 billion deal after months...
Novavax says vaccine application still ‘approvable,’ despite FDA delay
Novavax claims it can surmount the latest regulatory hurdle hindering its quest to win full U.S. clearance of its COVID-19...
Versant startup Granite debuts with $100M and two immune drugs
Venture capitalists have been scouring the globe in search of better immunology drugs. Biotech startup creator Versant Ventures is among...
Sanofi stays on course amid tariff turmoil
Dive Brief: Sanofi’s first-quarter sales and profit exceeded analyst expectations, but the company held tight on its full-year guidance amid...
Caribou, in reversal, scraps autoimmune cell therapy and cuts staff
Caribou Biosciences is laying off about a third of its staff and stopping work on an experimental lupus treatment in...
Halozyme sues Merck; FDA blames cuts for Vanda delay
Today, a brief rundown of news involving Merck and Vanda Pharmaceuticals, as well as updates from Sanofi and Novo Holdings...
Biohaven stock slides on withdrawal of European marketing application
Biohaven lost close to $400 million in market value Friday on news that the Connecticut-based drug developer had withdrawn an...
Gilead leans on HIV drugs as oncology sales slow
Dive Brief: Gilead Sciences on Thursday reported $6.7 billion in revenue in the first quarter, missing consensus Wall Street estimates...
Merck takes $200M tariff hit, trimming its gross profits
Dive Brief: Merck & Co. “absorbed” $200 million in addition expenses related to U.S. and overseas tariffs in the first...
Bristol Myers says schizophrenia drug launch ‘off to a solid start’
A new, closely watched schizophrenia medication from Bristol Myers Squibb sold well in its first full quarter on the market,...
Bristol Myers’ prized schizophrenia drug stumbles in testing
A brain drug at the center of a recent $14 billion acquisition has failed a large clinical trial, leading some...
German antibody maker valued at $1.6B in blank-check merger
Dive Brief: Veraxa Biotech, a cancer therapy developer backed by Swiss incubator Xlife Sciences, will go public through a combination...
The Trump administration is remaking HHS. Track the changes here.
The Trump administration is radically revising the scale and scope of the federal health workforce. Approximately 1 in 4 employees...
Roche, answering tariff threat, pledges $50B to US drug production
Dive Brief: Roche is the latest drugmaking planning to expand drug production in the U.S., announcing Tuesday a pledge to...
Enhertu combo tops standard drugs in first-line HER2 breast cancer
A two-drug regimen involving AstraZeneca and Daiichi Sankyo’s Enhertu topped standard therapy in a large study in HER2-positive breast cancer,...
Novo says it’s submitted obesity pill for FDA approval
Dive Brief: Novo Nordisk asked the Food and Drug Administration to approve a pill version of its popular weight loss...
A judge blocked the FDA’s plan to regulate lab developed tests. What now?
The Food and Drug Administration’s attempt to increase regulatory scrutiny over laboratory developed tests appears to be dead, much to...
FDA cuts outlined in draft HHS budget
A draft budget document shows the Trump administration’s plan to slash funding to the Department of Health and Human Services...
GSK prepares to relaunch Blenrep; Activists challenge another ‘zombie’ biotech
Today, a brief rundown of news involving GSK and Bristol Myers Squibb, as well as updates from Elevation Oncology, Bayer...
Sanofi, Regeneron win FDA nod for Dupixent in chronic hives
The Food and Drug Administration on Friday approved a new use for Sanofi and Regeneron’s top-selling immune disease drug Dupixent,...
An investment fund sets out to free biotech’s ‘trapped capital’
A British investment fund has launched with plans to extract tens of billions of dollars it believes to be “trapped”...
Makary seeks to limit industry’s role in FDA advisory panels
The Food and Drug Administration will aim to limit the participation of industry experts in the advisory committees that the...
Sanofi licenses immune disease drugs from startup Earendil
Dive Brief: French drugmaker Sanofi agreed to pay $125 million to startup Earendil Labs for two drug candidates designed to...
Lilly’s obesity pill scores in large diabetes trial
Dive Brief: Eli Lilly’s weight loss pill orforglipron succeeded in a Phase 3 clinical trial in diabetes, helping study participants...
Bluebird says Ayrmid missed deadline for rival takeover bid
Bluebird bio is still waiting on a binding takeover bid from Ayrmid Ltd., three weeks after the company said it...
Leqembi finally secures EU clearance; Sandoz sues Amgen over Enbrel patents
Today, a brief rundown of news involving Eisai, Sarepta Therapeutics and Sandoz, as well as updates from Mural Oncology, Cyprumed...
J&J keeps forecasts steady as pharma confronts tariff threat
Johnson & Johnson is confident it can manage the impact of tariffs on its pharmaceuticals and medical device businesses this...
Bristol Myers stumbles in bid to widen heart drug’s use
Dive Brief: Bristol Myers Squibb on Monday said its drug Camzyos failed a Phase 3 trial in people with a...
US launches probe that could set stage for pharma tariffs
The Trump administration is investigating the effects of pharmaceutical imports on national security, disclosing Monday a probe that is likely...
Mining the hidden gems in unstructured EMR data
Pharma companies are increasingly turning to real-world data to answer their commercial business questions, but not all realize that unstructured...
Medtech industry pressures White House to exempt devices from tariffs
AdvaMed and nine other healthcare organizations continue to pressure the White House to exempt medical devices and critical supplies from...
Trump says ‘major’ tariffs coming on pharmaceuticals
Dive Brief: President Trump on Tuesday said he’s planning soon to announce “a major tariff on pharmaceuticals,” which were exempted...
Tempest seeks strategic alternatives as cash runs out for Phase 3 trial
Dive Brief: Tempest Therapeutics is seeking a buyer or partner, saying Wednesday it has hired financial advisers to “advance its...
FDA plans to phase out animal testing for some drugs
Dive Brief: The Food and Drug Administration aims to phase out animal toxicology testing for experimental drugs, announcing Thursday a...
Amgen says Imdelltra extended survival; Parker Institute adds new leaders
Today, a brief rundown of news involving Amgen and the Parker Institute, as well as updates from J&J, Alzheon and...
Biotech CEOs, VCs urge Cassidy, Senate to ease impact of FDA cuts
Dive Brief: Biotech executives and venture capital investors are banding together to press Congress to act on Food and Drug...
Amid tariff turmoil, Novartis commits to spending $23B on U.S. manufacturing
Dive Brief: Novartis will substantially expand its U.S. footprint, announcing Thursday plans to spend $23 billion over five years to...
Ferring gene therapy sales grow; ASH calls for restoration of cut CDC division
Today, a brief rundown of news involving Ferring Pharmaceuticals and Solu Therapeutics, as well as updates from the American Society...
Trump pauses most reciprocal tariffs, hikes China’s further
The U.S. is pausing most country-specific tariffs for 90 days while raising duties on imports from China to 125%, President...
Rallybio discontinues lead drug for rare maternal disorder
Dive Brief: The biotechnology company Rallybio is discontinuing its lead candidate for a rare blood disorder in pregnant women after...
US risks losing biotech edge to China, report warns
The U.S. risks losing a once-decisive edge over China in biotechnology unless the federal government prioritizes the sector’s advancement with...
Judge permanently blocks Trump admin plan to cap NIH funding, setting up appeals battle
Dive Brief: Research universities won an extended reprieve Friday when a federal judge permanently barred the National Institutes of Health...
Tango Therapeutics cuts nearly one-fifth of staff
Oncology drugmaker Tango Therapeutics has cut about 20% of its staff, following a year in which it twice trimmed its...
New genetic medicine CDMO acquires Landmark Bio
Dive Brief: Artis BioSolutions emerged from stealth Wednesday, announcing that it has acquired Landmark Bio, an alliance of academic institutions,...
Biotech ‘megarounds’ hold steady as startups, VCs wait on IPOs
Biotechnology company funding rounds remain larger than they were in 2022 and 2023, in a sign venture firms continue to...
FDA misses approval deadline for Novavax’s COVID-19 vaccine
The Food and Drug Administration review deadline for Novavax’s COVID-19 vaccine has come and gone without a decision amid a...
Oz confirmed by Senate to lead CMS
Mehmet Oz, a physician and TV personality, was confirmed Thursday by the U.S. Senate to lead the Centers for Medicare...
Trial monitors recommend Elevidys studies continue; Novartis kidney drug approved
Today, a brief rundown of news involving Sarepta Therapeutics, Novartis and Allakos, as well as updates from CSL Behring and...
Tariffs send healthcare industry into ‘unchartered waters’
Healthcare industry groups and analysts are reeling after President Donald Trump unveiled a sweeping tariff policy Wednesday that could impact...
M&A recap: Big pharma starts the year mostly avoiding billion-dollar deals
The world’s largest pharmaceutical companies mostly steered clear of billion-dollar acquisitions in the early months of this year, perhaps indicating...
Roche halts testing of Sarepta Duchenne gene therapy in Europe
Dive Brief: Roche has stopped enrolling and treating patients in three studies of the gene therapy Elevidys following the death...
Leqembi’s EU review drags on; Sanofi gets a new development head
Today, a brief rundown of news involving Eisai, Biogen and Sanofi, as well as updates from Opthea, Novartis, and PTC...
Trump installs sweeping new tariffs, but pharma appears to dodge blow
The U.S. will implement a universal baseline tariff of 10%, effective April 5, along with increased tariff rates on various...
Judge overturns FDA’s lab developed test regulation, siding with industry
A Texas federal court on Monday struck down the Food and Drug Administration’s new rule regulating laboratory developed tests as...
HHS begins layoffs in chaotic fashion
Employees across the Department of Health and Human Services began receiving layoff notices Tuesday, following days of anxious waiting to...
Isomorphic raises $600M on big ambitions for AI drugmaking tech
Isomorphic Labs, a British company developing new ways to design and develop medicines, said Monday it raised $600 million to...
Cell, gene therapy makers lose a champion at FDA with exit of Peter Marks
Over the past decade, several dozen cell and gene therapies have reached market in the U.S., bringing with them the...
How discoverable, comparable and explorable is your data?
If you’re a discovery scientist, you’re probably familiar with the fierce competition that dominates the landscape of biomarker identification. As...
‘Everything is word of mouth’: HHS employees face uncertainty in looming Trump layoffs
Just before 9 a.m. Thursday in Washington, D.C, the Department of Health and Human Services sent out a press release...
FDA broadens use of Novartis’ radiopharma drug Pluvicto
Dive Brief: Novartis’ radiopharmaceutical drug Pluvicto can now be used much more widely to treat men with a type of...
Peter Marks, FDA’s top vaccine official, resigns
Peter Marks, the Food and Drug Administration’s top vaccine official, abruptly resigned from the agency on Friday, citing disagreement with...
Bluebird gets rival takeout offer from Ayrmid
Bluebird bio on Friday received a new buyout offer that surpasses a take-private bid the pioneering gene therapy developer received...
FDA approves first-of-its-kind RNA drug for hemophilia
The Food and Drug Administration approved on Friday a new type of medicine for people with the rare bleeding disorder...
Alcon buys majority stake in IPO-seeking cell therapy startup Aurion
The leading eye-care company Alcon on Wednesday said it has acquired a majority stake in Aurion Biotech, capping months of...
Nkarta to lay off staff, senior leadership, in bid to advance autoimmune cell therapy
Nkarta is laying off a third of its workforce, and more than half its executive team, in a bid to...
First Prader-Willi drug to reduce hunger approved by FDA
The Food and Drug Administration on Wednesday approved the first treatment for the insatiable hunger associated with the rare disease...
Makary confirmed by Senate as FDA commissioner
The U.S. Senate on Tuesday confirmed Johns Hopkins University surgeon Martin Makary to be commissioner of the Food and Drug...
Character Biosciences raises $93M with an eye on vision loss drugs
Character Biosciences, a biotechnology startup developing treatments for vision loss, said Tuesday it raised $93 million in a Series B...
Merck bets $200M on a new type of heart pill
Dive Brief: Merck & Co. has entered a competitive race for a new type of heart drug, announcing Tuesday it...
23andMe files for bankruptcy as CEO Anne Wojcicki resigns
Dive Brief: 23andMe, the DNA testing company once valued at $6 billion, filed for Chapter 11 bankruptcy protection on Sunday...
Verve gets FDA green light to expand base editing trial into US
Verve Therapeutics is expanding a gene editing trial for a cholesterol and heart disease treatment into the U.S., the company...
Sanofi wagers $600M on a dual-targeting antibody drug for autoimmune disease
Dive Brief: Sanofi agreed to pay $600 million for a therapy in early human testing that may have the ability...
J&J boosts US manufacturing as big pharma reshores
Dive Brief: Johnson & Johnson is planning a major U.S. expansion, announcing Friday it will spend $55 billion over the...
Alnylam prices heart drug at premium to rivals
Alynlam Pharmaceuticals will sell its drug for a life-threatening heart disease at almost double the cost of other treatments available...
Optum Rx is reforming how it pays pharmacies
Dive Brief: Optum Rx is shifting to a new pharmacy reimbursement model that should result in pharmacies being paid more...
AstraZeneca deepens China investment; Editas loses CFO to Dyne
Today, a brief rundown of news involving AstraZeneca and Novartis, as well as updates from Editas, Adaptimmune and Pfizer that...
Delayed CDC meeting on vaccines is rescheduled to April
A postponed meeting of vaccine advisers to the Centers for Disease Control and Prevention is now scheduled to take place...
Alnylam drug gets long-awaited FDA approval in deadly heart disease
The Food and Drug Administration on Thursday approved an Alnylam Pharmaceuticals medicine for a serious heart condition, a decision that...
Novartis builds case for new SMA gene therapy
On Wednesday, Novartis gave a more detailed look at long-awaited clinical data that the company believes will help secure a...
Immunovant claims study success for immune disease drug but holds off on submission
Dive Brief: Immunovant gave investors a mixed set of news Wednesday, touting late-stage results for an experimental autoimmune disease drug...
Optum Rx says it will eliminate some prior authorization requirements
Dive Brief: Optum Rx is moving to eliminate prior authorization requirements for dozens of drugs, the UnitedHealth-owned pharmacy benefit manager...
Stoke CEO exits; Medicare drug price talks advance
Today, a brief rundown of news involving executive changes at Stoke Therapeutics and the Centers of Medicare and Medicaid Services,...
Prime sets sights on liver, lung disease as next target for its gene editing tech
Dive Brief: Prime Medicine will test its gene editing technology as treatment for a rare liver and lung disorder, revealing...
Orca Bio to seek approval of T cell transplant after positive trial data
Dive Brief: An experimental cellular medicine developed by Orca Bio outperformed a standard stem cell transplant in treating people with...
Taiho buys Swiss biotech and its ADC tech for $400M
Japan-based Taiho Pharmaceuticals on Monday said it will acquire Switzerland’s Araris Biotech and its antibody-drug conjugate technology for $400 million...
IRA reforms could be on the table. Will Trump and the GOP pursue them?
The Inflation Reduction Act seems to be sticking around under the new Trump administration, but potential reforms could be coming....
Ono pays $280M to license Ionis rare disease drug
Dive Brief: Ionis Pharmaceuticals is licensing out another experimental medicine, entering an agreement with Ono Pharmaceutical that offers $280 million...
Makary advances to full senate vote; Acelyrin, Pliant adopt ‘poison pills’
Today, a brief rundown of news involving Martin Makary, as well as updates from Pliant Therapeutics, Acelyrin and Sutro Biopharma...
FDA sets flu shot recommendations without input of outside advisers
The Food and Drug Administration on Thursday recommended to influenza vaccine manufacturers which virus strains to include in next season’s...
Mallinckrodt, Endo to combine in $7B deal
Dive Brief: Mallinckrodt and Endo Pharmaceuticals, which have struggled through bankruptcies related to opioid litigation, said Thursday that they will...
MeiraGTx spins Parkinson’s, obesity gene therapies into AI startup
Gene therapy specialist MeiraGTx is spinning some of its experimental medicines for the central nervous system into a startup that...
A new obesity biotech launches; Gilead plans to quickly advance once-yearly PrEP for HIV
Today, a brief rundown of news involving Harbour BioMed and Gilead Sciences, as well as updates from Geron, Biogen and...
Roche broadens obesity drug plans with $1.65B Zealand deal
Dive Brief: Roche has raised its bet on obesity, agreeing to pay Zealand Pharma $1.65 billion to license an experimental...
Merck opens $1B vaccine plant in North Carolina
Merck & Co. on Tuesday opened a new vaccine manufacturing plant in Durham, North Carolina, that will boost the company’s...
Viking inks CordenPharma deal to boost obesity drug supply
Dive Brief: Viking Therapeutics is secure production capacity for its experimental obesity drug, announcing Tuesday it will prepay contract manufacturer CordenPharma...
Novo’s Wegovy successor disappoints in second large trial
Dive Brief: Novo Nordisk’s experimental drug CagriSema helped people who are overweight or obese and have diabetes lose about 14%...
Beam base editing therapy gets ‘proof of concept’ in rare lung disease
Preliminary results from a small clinical trial suggest that a cutting-edge genetic medicine developed by Beam Therapeutics can repair the...
Federal judge extends block on Trump plan to limit NIH payouts
A federal judge on Wednesday blocked the National Institutes of Health from cutting billions of dollars in payments to research...
Following FDA cuts, Trump nominee Makary vows ‘independent’ staff review
Marty Makary, President Donald Trump’s nominee to run the Food and Drug Administration, said he would undertake an “assessment” of...
Walgreens to be acquired in $10B take-private deal
Dive Brief: Walgreens has entered into a definitive agreement to be acquired by private equity firm Sycamore Partners and leave...
Nimbus swaps CEOs and turns to new leader for ‘next chapter’
Jeb Keiper, the longtime head of Nimbus Therapeutics, is stepping down in a planned transition that will promote the biotechnology...
Roche launches new Boston center; NIH centralizes peer review
This week has brought enough announcements and updates to fill a third news roundup. Today, we’ve got a rundown of...
J&J scraps depression testing for potential blockbuster drug
Johnson & Johnson is terminating some research for an experimental drug that the company previously predicted could be a multibillion-dollar...
Vertex’s new pain drug gets first coverage nod from major insurer
Optum Rx, a pharmacy benefit manager owned by one of the country’s largest insurance companies, UnitedHealth Group, has added a new,...
Makary, under review to run FDA, evades pressure to reinstate canceled vaccine meeting
Marty Makary, the Johns Hopkins surgeon who President Donald Trump chose to lead the Food and Drug Administration, fended off pressure...
Bayer braces for ‘difficult’ year before turnaround pays dividends
Dive Brief: Bayer CEO Bill Anderson is asking investors to bear with the German conglomerate through one more challenging year...
Jazz expands in oncology with $935M deal for Chimerix
Jazz Pharmaceuticals is expanding its foothold in cancer drug research, announcing Wednesday it will pay $935 million to buy Chimerix...
Neumora bids farewell to R&D head; Biohaven’s ‘one step forward, one step back’ data
Today, a brief rundown of news involving Acelyrin and Neumora Therapeutics, as well as updates from Biohaven, Lexicon Pharmaceuticals and...
Sofinnova secures €1.2B for new biotech investments
European venture capital firm Sofinnova Partners has raised 1.2 billion euros, or nearly $1.3 billion, in fresh funds to invest...
AbbVie gets into obesity with $350M deal for once-weekly shot
Dive Brief: AbbVie is joining the industry’s rush to develop new obesity medicines, announcing Monday a deal with Denmark-based Gubra...
Biotech startup pulls in $187M to make ‘multi-payload’ ADCs
Dive Brief: Callio Therapeutics on Monday launched with $187 million in Series A funding and a license to a technology...
Eikon raises $351M in one of the year’s largest biotech venture rounds
Eikon Therapeutics, a well-funded drug startup run by Merck & Co.’s former research chief, has raised one of the biggest venture...
Lilly expands US manufacturing build-out with $50B target
Eli Lilly will invest tens of billions more dollars in U.S. drug manufacturing in a significant enlargement of plans the...
Praxis hits trial setback; Bristol Myers lays off staff in New Jersey
Today, a brief rundown of news involving Praxis Medicines and Bristol Myers Squibb, as well as updates from Eli Lilly...
BridgeBio oncology spinout to go public in blank-check merger
BridgeBio Oncology Therapeutics, a cancer drug startup spun out of biotechnology company BridgeBio Pharma, will go public by merging with...
Leqembi, after delay, gets back on track toward EU approval
Dive Brief: European drug reviewers have “reaffirmed" their positive view of Eisai and Biogen’s Alzheimer’s disease drug Leqembi, clearing the...
Vertex ends gene editing research pact with Verve
Dive Brief: Vertex Pharmaceuticals has pulled out of a planned four-year collaboration with Verve Therapeutics, returning all rights to a...
FDA meeting on flu vaccine composition is canceled
A meeting of Food and Drug Administration advisers to determine the composition of flu vaccines for the upcoming season has...
Lilly CEO wields manufacturing plans to push pharma-friendly policies
Eight years ago, Eli Lilly CEO David Ricks stood in front of a red banner emblazoned with the words “Invested...
AstraZeneca’s next breast cancer drug; Madrigal’s accelerating MASH launch
Today, a brief rundown of news involving AstraZeneca and Madrigal Pharmaceuticals, as well as updates from Lava Therapeutics, PepGen and...
Regeneron gene therapy helps deaf children hear in small study
Ten of 11 children born profoundly deaf experienced some degree of hearing improvement after receiving an experimental gene therapy developed...
Drug compounders sue FDA over declaration ending Wegovy shortage
Dive Brief: Drug compounders are suing the Food and Drug Administration again over obesity and diabetes drugs, claiming in a...
FDA brings back some fired device office staff
Many people who were fired from the Food and Drug Administration’s medical device center last week had their termination letters...
Mirum drug for rare genetic disease gains FDA approval
Dive Brief: The Food and Drug Administration on Friday approved a drug from Mirum Pharmaceuticals to treat a rare genetic...
Device industry scrambles amid concern FDA layoffs will cause delays
The sudden firing of Food and Drug Administration employees this past week is already affecting medical device companies. The layoffs...
In FDA job cuts, experts see threat of far-reaching impact
The firing of possibly thousands of people working in U.S. health agencies this past week is likely to ripple across...
Bluebird, at risk of default, agrees to take-private deal
Bluebird bio, a pioneering gene therapy developer that in recent years has struggled to stay afloat, has agreed to be...
Pfizer stops selling hemophilia gene therapy, citing weak demand
Dive Brief: Weak demand for Pfizer’s hemophilia gene therapy Beqvez has led the pharmaceutical company to “cease further development and...
Ozempic, Wegovy shortage resolved; Pfizer CEO is PhRMA’s new chair
Today, a brief rundown of news involving Novo Nordisk, Acelyrin and Intra-Cellular Therapies, as well as updates from Gilead Sciences...
CDC vaccine meeting, set to be first since RFK Jr. sworn in, is postponed
An upcoming meeting of vaccine advisers to the Centers for Disease Control and Prevention has been postponed, delaying what was...
FTC case against PBMs can move forward, judge rules
Dive Brief: Dive Insight: The FTC’s lawsuit against Caremark, Express Scripts and Optum Rx — known as the “big three”...
Advamed CEO warns FDA job cuts put patients, industry at risk
Advamed CEO Scott Whitaker warned the Department of Health and Human Services that job cuts made over the weekend at...
Sanofi reaches consumer health deal; Supernus antidepressant fails study
Today, a brief rundown of news involving Sanofi and Supernus Pharmaceuticals, as well as updates from Arcus Biosciences, Gilead Sciences...
Biogen buys rights to Stoke’s rare epilepsy drug
Dive Brief: Through a new deal, Biogen has bought access to a potentially first-of-its-kind drug that some doctors and analysts...
Solid says early data suggest ‘differentiated’ Duchenne gene therapy
Dive Brief: An experimental Duchenne muscular dystrophy gene therapy from Solid Biosciences showed potential in a small clinical trial, leading...
Trump orders agencies to plan for ‘large-scale’ job cuts
The Trump administration has directed federal agencies to “undertake plans for large-scale reductions in force” as part of a sweeping...
Biogen inks royalty deal to gain funding for lupus drug R&D
Dive Brief: Biogen is set to receive as much as $250 million in funding to develop a late-stage experimental lupus...
Judge orders FDA, health agencies to restore removed webpages
A federal judge on Tuesday ordered the Food and Drug Administration and other federal health agencies to restore websites that...
Sanofi to take $250M charge on study failure for E. coli vaccine
Dive Brief: Sanofi and Johnson & Johnson are ending a Phase 3 study of an experimental E. coli vaccine after...
A brain biotech launches with Roche’s spare parts
A startup focused on brain drugs officially launched Thursday, backed by $94 million from a group of investors that includes...
‘It’s not for the faint of heart.’ How 3 CEOs took their biotechs public
Drug development is a notoriously expensive business. Discovering, testing and advancing a medicine can cost hundreds of millions of dollars,...
Neumora shakes up its C-suite; Biogen cuts early-stage pipeline
Today, a brief rundown of news involving Neumora Therapeutics and Pliant Therapeutics, as well as updates from Biogen, AbbVie and...
