HHS terminates Moderna contract to develop bird flu vaccine

HHS terminates Moderna contract to develop bird flu vaccine

    30 May 2025

The U.S. The Department of Health and Human Services has canceled a contract with...

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

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

    29 May 2025

Dive Brief: Veru’s muscle-preserving obesity drug enobosarm, when combined with Novo Nordisk’s Wegovy, may...

Cancer drugmaker iTeos to shut down

Cancer drugmaker iTeos to shut down

    29 May 2025

Dive Brief: Cancer drugmaker iTeos Therapeutics said Wednesday it plans to wind down operations...

Lilly to buy pain drug developer SiteOne, challenging Vertex

Lilly to buy pain drug developer SiteOne, challenging Vertex

    28 May 2025

Eli Lilly is wagering up to $1 billion on a private biotechnology company developing...

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

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

    28 May 2025

Dive Brief: The Food and Drug Administration on Thursday recommended COVID-19 vaccine manufacturers tailor their...

Navigating the evolving landscape of fill/finish: Challenges and what’s ahead

Navigating the evolving landscape of fill/finish: Challenges and what’s ahead

    27 May 2025

As the pharmaceutical and biotech industries continue to innovate at a rapid pace, the...

Moderna pulls application for combo COVID, flu shot

Moderna pulls application for combo COVID, flu shot

    26 May 2025

Dive Brief: After discussions with the Food and Drug Administration, Moderna on Wednesday said...

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

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

    26 May 2025

Today, a brief rundown of news involving Pfizer and Sarepta Therapeutics, as well as...

Novo pressures GLP-1 compounders as FDA ban takes hold

Novo pressures GLP-1 compounders as FDA ban takes hold

    25 May 2025

Novo Nordisk is ramping up its war on compounders making versions of its top-selling...

House passes reconciliation bill with massive Medicaid cuts

House passes reconciliation bill with massive Medicaid cuts

    25 May 2025

The House passed Republicans’ “big, beautiful bill” on Thursday in a razor-thin 215-214 vote, sending the...

Sanofi gains experimental Alzheimer’s drug through Vigil buyout

Sanofi gains experimental Alzheimer’s drug through Vigil buyout

    24 May 2025

Sanofi has agreed to spend $470 million to take control of a young biotechnology...

AI tool could help doctors ID breast cancers vulnerable to Enhertu

AI tool could help doctors ID breast cancers vulnerable to Enhertu

    24 May 2025

For decades now, doctors tasked with diagnosing breast cancer have peered into microscopes and...

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

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

    23 May 2025

Advisers to the Food and Drug Administration have recommended COVID-19 vaccine makers continue to...

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

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

    23 May 2025

A combination of Roche’s cancer immunotherapy Tecentriq and a drug called Zepzelca helped extend...

FDA panel backs Darzalex for early stage multiple myeloma

FDA panel backs Darzalex for early stage multiple myeloma

    22 May 2025

Expert advisers to the Food and Drug Administration on Tuesday backed Johnson & Johnson’s...

Reproductive health startup raises $65M for infertility drugs

Reproductive health startup raises $65M for infertility drugs

    22 May 2025

ReproNovo, a biotechnology company specializing in reproductive medicine, has raised $65 million to advance...

Tourmaline shares fall on Phase 2 data; Schrödinger cuts staff

Tourmaline shares fall on Phase 2 data; Schrödinger cuts staff

    21 May 2025

Today, a brief rundown of news involving Tourmaline Bio, Schrödinger and Beckley Psytech, as...

FDA sets stricter approval standards for COVID vaccines

FDA sets stricter approval standards for COVID vaccines

    21 May 2025

The Food and Drug Administration is changing how it reviews new COVID-19 vaccines, setting...

Novavax’s COVID vaccine gets FDA approval, but with limits

Novavax’s COVID vaccine gets FDA approval, but with limits

    20 May 2025

Novavax has at last gained full Food and Drug Administration approval for its COVID-19...

Prime Medicine claims ‘proof of concept,’ but lays off staff in pivot

Prime Medicine claims ‘proof of concept,’ but lays off staff in pivot

    20 May 2025

Prime Medicine will lay off one-quarter of its workforce and deprioritize its clinical-stage program...

Bridging the data gaps that impact retail and specialty-lite success

Bridging the data gaps that impact retail and specialty-lite success

    19 May 2025

Retail and specialty-lite brand teams are facing a paradox – they’re drowning in data...

AbbVie stakes $335M on a startup’s RNAi drugs

AbbVie stakes $335M on a startup’s RNAi drugs

    19 May 2025

AbbVie is staking hundreds of millions of dollars on RNA interference, agreeing on Wednesday...

Sanofi to pour more than $20B into US drug research and manufacturing

Sanofi to pour more than $20B into US drug research and manufacturing

    18 May 2025

Dive Brief: Sanofi plans to invest at least $20 billion in the U.S. over...

Novo CEO to depart as obesity drugmaker’s challenges rise

Novo CEO to depart as obesity drugmaker’s challenges rise

    18 May 2025

Novo Nordisk CEO Lars Fruergaard Jørgensen, who led the Danish drugmaker to new heights...

Regeneron defeats Amgen in PCSK9 case; 2 cell therapy biotechs cut staff

Regeneron defeats Amgen in PCSK9 case; 2 cell therapy biotechs cut staff

    17 May 2025

Today, a brief rundown of news involving Amgen and Regeneron, as well as updates...

BioMarin to buy rare disease drugmaker Inozyme for $270M

BioMarin to buy rare disease drugmaker Inozyme for $270M

    17 May 2025

BioMarin Pharmaceutical has agreed to spend $270 million to take control of a Boston-based...

FDA delays approval decision for Biohaven rare disease drug

FDA delays approval decision for Biohaven rare disease drug

    16 May 2025

Connecticut-based Biohaven has been developing what it hopes will be the first medicine for...

A bespoke CRISPR therapy suggests a blueprint for treating ‘N-of-1’ diseases

A bespoke CRISPR therapy suggests a blueprint for treating ‘N-of-1’ diseases

    16 May 2025

A group of scientists successfully made a bespoke gene editing medicine for a critically...

GSK to buy liver disease drug for $1.2B

GSK to buy liver disease drug for $1.2B

    15 May 2025

Dive Brief: British drugmaker GSK has agreed to pay privately held Boston Pharmaceuticals $1.2...

Novo to work with Septerna in hunt for oral obesity drugs

Novo to work with Septerna in hunt for oral obesity drugs

    15 May 2025

Dive Brief: Novo Nordisk on Wednesday said it will collaborate with biotechnology startup Septerna...

5 questions on Trump’s plan to lower US drug prices

5 questions on Trump’s plan to lower US drug prices

    14 May 2025

President Donald Trump’s declaration Monday that the Department of Health and Human Services will...

Women’s health faces growing headwinds, despite jump in venture investment

Women’s health faces growing headwinds, despite jump in venture investment

    14 May 2025

The women’s health field has a long way to go addressing persistent deficits in...

Trump revives ‘most favored nation’ plan in effort to cut US drug prices

Trump revives ‘most favored nation’ plan in effort to cut US drug prices

    13 May 2025

The Trump administration is resurrecting a controversial policy that aims to tamp down some...

FDA follows EMA in limiting use of Valneva shot

FDA follows EMA in limiting use of Valneva shot

    13 May 2025

Safety concerns have spurred the Food and Drug Administration and Centers for Disease Control...

Innovating a healthier tomorrow: Entering a new era of medicine

Innovating a healthier tomorrow: Entering a new era of medicine

    12 May 2025

The number of registered US clinical trials has almost tripled in the last decade,...

[Podcast] Behind the Breakthroughs: How Almac Powers Clinical Trial Success with Care

[Podcast] Behind the Breakthroughs: How Almac Powers Clinical Trial Success with Care

    12 May 2025

Emerging biopharma companies are now taking the lead on drug development, with smaller and...

Haya banks $65M to scour the ‘dark genome’ for new drugs

Haya banks $65M to scour the ‘dark genome’ for new drugs

    11 May 2025

Scientists long believed the human genome consisted mostly of useless DNA. These sequences, after...

Biotech is guessing how Vinay Prasad might change the FDA. His research, writing offer clues.

Biotech is guessing how Vinay Prasad might change the FDA. His research, writing offer clues.

    11 May 2025

To hear Vinay Prasad tell it, U.S. healthcare is too ready to intervene unnecessarily,...

Gilead, bracing for tariffs, joins peers in US drug production push

Gilead, bracing for tariffs, joins peers in US drug production push

    10 May 2025

Dive Brief: Gilead on Wednesday became the latest U.S. drugmaker to pledge new investments...

Eli Lilly extends Purdue alliance; EMA investigates Valneva shot

Eli Lilly extends Purdue alliance; EMA investigates Valneva shot

    10 May 2025

Today, a brief rundown of news involving Eli Lilly and Valneva, as well as...

4 more biotechs cut staff amid market tumult

4 more biotechs cut staff amid market tumult

    09 May 2025

Four biotechnology companies are laying off staff in the latest examples of cutbacks in...

Viatris’ new form of old pain drug scores in large trials

Viatris’ new form of old pain drug scores in large trials

    09 May 2025

Pittsburgh-based pharmaceutical firm Viatris on Thursday said a pain drug it’s been developing succeeded...

Novo cuts forecasts as compounded GLP-1s weigh on sales

Novo cuts forecasts as compounded GLP-1s weigh on sales

    08 May 2025

Dive Brief: While revenue and profit rose year-over-year during the first quarter at Novo...

FDA set to meet this month on COVID vaccines

FDA set to meet this month on COVID vaccines

    08 May 2025

A panel of Food and Drug Adminsitration advisers will meet May 22 to discuss...

Prasad’s FDA appointment pressures cell and gene therapy stocks

Prasad’s FDA appointment pressures cell and gene therapy stocks

    07 May 2025

Shares in more than a dozen gene and cell therapy developers tumbled by double...

Vinay Prasad, a physician and FDA critic, to lead agency center overseeing vaccines

Vinay Prasad, a physician and FDA critic, to lead agency center overseeing vaccines

    07 May 2025

Vinay Prasad, a prolific academic and longtime critic of U.S. drug policies, was named...

AI specialist Recursion trims pipeline in latest shakeup

AI specialist Recursion trims pipeline in latest shakeup

    06 May 2025

AI drug discovery specialist Recursion Pharmaceuticals is shelving three of its most advanced drug...

PTC stock slides on new data for Huntington’s drug

PTC stock slides on new data for Huntington’s drug

    06 May 2025

Dive Brief: Shares in PTC Therapeutics fell by double-digits Monday morning as investors parsed...

Madrigal’s MASH drug sales again top Wall Street projections

Madrigal’s MASH drug sales again top Wall Street projections

    05 May 2025

Dive Brief: Madrigal Pharmaceuticals said its pioneering medicine for a common liver disease brought...

AstraZeneca quietly exits neuroscience | BioPharma Dive

AstraZeneca quietly exits neuroscience | BioPharma Dive

    05 May 2025

AstraZeneca on Tuesday confirmed it has closed down its neuroscience research group to direct...

Arvinas, Entrada cut staff; Merck builds US hub for Keytruda

Arvinas, Entrada cut staff; Merck builds US hub for Keytruda

    04 May 2025

Today, a brief rundown of news involving Arvinas and Biogen, as well as updates...

CVS strikes Wegovy deal with Novo Nordisk

CVS strikes Wegovy deal with Novo Nordisk

    04 May 2025

Dive Brief: CVS Health’s pharmacy benefit manager Caremark reached an agreement with Danish drugmaker...

Cytokinetics reveals unexpected delay; AstraZeneca combo therapy hits in asthma

Cytokinetics reveals unexpected delay; AstraZeneca combo therapy hits in asthma

    03 May 2025

Today, a brief rundown of news involving Cytokinetics and AstraZeneca, as well as updates...

Amgen’s Stelara biosimilar gets off to fast start

Amgen’s Stelara biosimilar gets off to fast start

    03 May 2025

Dive Brief: Amgen on Thursday said its just-launched biosimilar of Johnson & Johnson’s autoimmune...

Moderna combination flu, COVID shot delayed amid FDA scrutiny

Moderna combination flu, COVID shot delayed amid FDA scrutiny

    02 May 2025

The Food and Drug Administration has asked Moderna for additional data before it will...

Pharma downplays tariff threat, even as risks remains unclear

Pharma downplays tariff threat, even as risks remains unclear

    02 May 2025

The threat of tariffs on pharmaceuticals imported to the U.S. hasn’t yet pushed drugmakers...

J&J secures FDA OK for immune drug touted as future blockbuster

J&J secures FDA OK for immune drug touted as future blockbuster

    01 May 2025

The Food and Drug Administration on Wednesday approved an antibody drug that developer Johnson...

Novartis to acquire Regulus in deal for kidney disease drug

Novartis to acquire Regulus in deal for kidney disease drug

    01 May 2025

Novartis will pay $800 million upfront to acquire Regulus Therapeutics, a San Diego biotechnology...

Acelyrin should liquidate instead of merging with Alumis, investor says

Acelyrin should liquidate instead of merging with Alumis, investor says

    30 Apr 2025

A shareholder of immune drug developer Acelyin believes the company is better off shutting...

Pfizer’s Bourla ‘cautiously optimistic’ on looming US pharma tariffs

Pfizer’s Bourla ‘cautiously optimistic’ on looming US pharma tariffs

    30 Apr 2025

Pfizer will maintain its 2025 financial forecasts for now, but warned Tuesday it can’t...

Merck KGaA to buy biotech SpringWorks for $3.9B

Merck KGaA to buy biotech SpringWorks for $3.9B

    29 Apr 2025

Dive Brief: Merck KGaA has agreed to buy biotechnology company SpringWorks Therapeutics, announcing Monday...

Novavax says vaccine application still ‘approvable,’ despite FDA delay

Novavax says vaccine application still ‘approvable,’ despite FDA delay

    29 Apr 2025

Novavax claims it can surmount the latest regulatory hurdle hindering its quest to win...

Versant startup Granite debuts with $100M and two immune drugs

Versant startup Granite debuts with $100M and two immune drugs

    28 Apr 2025

Venture capitalists have been scouring the globe in search of better immunology drugs. Biotech...

Sanofi stays on course amid tariff turmoil

Sanofi stays on course amid tariff turmoil

    28 Apr 2025

Dive Brief: Sanofi’s first-quarter sales and profit exceeded analyst expectations, but the company held...

Caribou, in reversal, scraps autoimmune cell therapy and cuts staff

Caribou, in reversal, scraps autoimmune cell therapy and cuts staff

    27 Apr 2025

Caribou Biosciences is laying off about a third of its staff and stopping work...

Halozyme sues Merck; FDA blames cuts for Vanda delay

Halozyme sues Merck; FDA blames cuts for Vanda delay

    27 Apr 2025

Today, a brief rundown of news involving Merck and Vanda Pharmaceuticals, as well as...

Gilead leans on HIV drugs as oncology sales slow

Gilead leans on HIV drugs as oncology sales slow

    26 Apr 2025

Dive Brief: Gilead Sciences on Thursday reported $6.7 billion in revenue in the first...

Biohaven stock slides on withdrawal of European marketing application

Biohaven stock slides on withdrawal of European marketing application

    26 Apr 2025

Biohaven lost close to $400 million in market value Friday on news that the...

Merck takes $200M tariff hit, trimming its gross profits

Merck takes $200M tariff hit, trimming its gross profits

    25 Apr 2025

Dive Brief: Merck & Co. “absorbed” $200 million in addition expenses related to U.S....

Bristol Myers says schizophrenia drug launch ‘off to a solid start’

Bristol Myers says schizophrenia drug launch ‘off to a solid start’

    25 Apr 2025

A new, closely watched schizophrenia medication from Bristol Myers Squibb sold well in its...

Bristol Myers’ prized schizophrenia drug stumbles in testing

Bristol Myers’ prized schizophrenia drug stumbles in testing

    24 Apr 2025

A brain drug at the center of a recent $14 billion acquisition has failed...

German antibody maker valued at $1.6B in blank-check merger

German antibody maker valued at $1.6B in blank-check merger

    24 Apr 2025

Dive Brief: Veraxa Biotech, a cancer therapy developer backed by Swiss incubator Xlife Sciences,...

The Trump administration is remaking HHS. Track the changes here.

The Trump administration is remaking HHS. Track the changes here.

    23 Apr 2025

The Trump administration is radically revising the scale and scope of the federal health...

Roche, answering tariff threat, pledges $50B to US drug production

Roche, answering tariff threat, pledges $50B to US drug production

    23 Apr 2025

Dive Brief: Roche is the latest drugmaking planning to expand drug production in the...

Enhertu combo tops standard drugs in first-line HER2 breast cancer

Enhertu combo tops standard drugs in first-line HER2 breast cancer

    22 Apr 2025

A two-drug regimen involving AstraZeneca and Daiichi Sankyo’s Enhertu topped standard therapy in a...

Novo says it’s submitted obesity pill for FDA approval

Novo says it’s submitted obesity pill for FDA approval

    22 Apr 2025

Dive Brief: Novo Nordisk asked the Food and Drug Administration to approve a pill...

A judge blocked the FDA’s plan to regulate lab developed tests. What now?

A judge blocked the FDA’s plan to regulate lab developed tests. What now?

    21 Apr 2025

The Food and Drug Administration’s attempt to increase regulatory scrutiny over laboratory developed tests...

FDA cuts outlined in draft HHS budget

FDA cuts outlined in draft HHS budget

    21 Apr 2025

A draft budget document shows the Trump administration’s plan to slash funding to the...

GSK prepares to relaunch Blenrep; Activists challenge another ‘zombie’ biotech

GSK prepares to relaunch Blenrep; Activists challenge another ‘zombie’ biotech

    20 Apr 2025

Today, a brief rundown of news involving GSK and Bristol Myers Squibb, as well...

Makary seeks to limit industry’s role in FDA advisory panels

Makary seeks to limit industry’s role in FDA advisory panels

    20 Apr 2025

The Food and Drug Administration will aim to limit the participation of industry experts...

An investment fund sets out to free biotech’s ‘trapped capital’

An investment fund sets out to free biotech’s ‘trapped capital’

    19 Apr 2025

A British investment fund has launched with plans to extract tens of billions of...

Sanofi, Regeneron win FDA nod for Dupixent in chronic hives

Sanofi, Regeneron win FDA nod for Dupixent in chronic hives

    19 Apr 2025

The Food and Drug Administration on Friday approved a new use for Sanofi and...

Sanofi licenses immune disease drugs from startup Earendil

Sanofi licenses immune disease drugs from startup Earendil

    18 Apr 2025

Dive Brief: French drugmaker Sanofi agreed to pay $125 million to startup Earendil Labs...

Lilly’s obesity pill scores in large diabetes trial

Lilly’s obesity pill scores in large diabetes trial

    18 Apr 2025

Dive Brief: Eli Lilly’s weight loss pill orforglipron succeeded in a Phase 3 clinical...

Bluebird says Ayrmid missed deadline for rival takeover bid

Bluebird says Ayrmid missed deadline for rival takeover bid

    17 Apr 2025

Bluebird bio is still waiting on a binding takeover bid from Ayrmid Ltd., three...

New research kindles excitement around stem cell therapies for Parkinson’s

New research kindles excitement around stem cell therapies for Parkinson’s

    17 Apr 2025

The most effective drug for Parkinson’s disease hasn’t changed in 50 years. But fresh...

Health department layoffs may be illegal, experts say

Health department layoffs may be illegal, experts say

    16 Apr 2025

The mass layoffs that swept the U.S. health department this month were chaotic and...

J&J keeps forecasts steady as pharma confronts tariff threat

J&J keeps forecasts steady as pharma confronts tariff threat

    15 Apr 2025

Johnson & Johnson is confident it can manage the impact of tariffs on its...

US launches probe that could set stage for pharma tariffs

US launches probe that could set stage for pharma tariffs

    15 Apr 2025

The Trump administration is investigating the effects of pharmaceutical imports on national security, disclosing...

Safety worries spur Pfizer to drop another obesity pill

Safety worries spur Pfizer to drop another obesity pill

    14 Apr 2025

Dive Brief: Pfizer is scrapping another obesity pill, announcing Monday it will stop testing...

Medtech industry pressures White House to exempt devices from tariffs

Medtech industry pressures White House to exempt devices from tariffs

    13 Apr 2025

AdvaMed and nine other healthcare organizations continue to pressure the White House to exempt...

Trump says ‘major’ tariffs coming on pharmaceuticals

Trump says ‘major’ tariffs coming on pharmaceuticals

    13 Apr 2025

Dive Brief: President Trump on Tuesday said he’s planning soon to announce “a major...

Tempest seeks strategic alternatives as cash runs out for Phase 3 trial

Tempest seeks strategic alternatives as cash runs out for Phase 3 trial

    12 Apr 2025

Dive Brief: Tempest Therapeutics is seeking a buyer or partner, saying Wednesday it has...

FDA plans to phase out animal testing for some drugs

FDA plans to phase out animal testing for some drugs

    12 Apr 2025

Dive Brief: The Food and Drug Administration aims to phase out animal toxicology testing...

Amgen says Imdelltra extended survival; Parker Institute adds new leaders

Amgen says Imdelltra extended survival; Parker Institute adds new leaders

    11 Apr 2025

Today, a brief rundown of news involving Amgen and the Parker Institute, as well...

Amid tariff turmoil, Novartis commits to spending $23B on U.S. manufacturing

Amid tariff turmoil, Novartis commits to spending $23B on U.S. manufacturing

    11 Apr 2025

Dive Brief: Novartis will substantially expand its U.S. footprint, announcing Thursday plans to spend...

Biotech CEOs, VCs urge Cassidy, Senate to ease impact of FDA cuts

Biotech CEOs, VCs urge Cassidy, Senate to ease impact of FDA cuts

    10 Apr 2025

Dive Brief: Biotech executives and venture capital investors are banding together to press Congress...

Trump pauses most reciprocal tariffs, hikes China’s further

Trump pauses most reciprocal tariffs, hikes China’s further

    10 Apr 2025

The U.S. is pausing most country-specific tariffs for 90 days while raising duties on...

Ferring gene therapy sales grow; ASH calls for restoration of cut CDC division

Ferring gene therapy sales grow; ASH calls for restoration of cut CDC division

    09 Apr 2025

Today, a brief rundown of news involving Ferring Pharmaceuticals and Solu Therapeutics, as well...

Rallybio discontinues lead drug for rare maternal disorder

Rallybio discontinues lead drug for rare maternal disorder

    09 Apr 2025

Dive Brief: The biotechnology company Rallybio is discontinuing its lead candidate for a rare...

US risks losing biotech edge to China, report warns

US risks losing biotech edge to China, report warns

    08 Apr 2025

The U.S. risks losing a once-decisive edge over China in biotechnology unless the federal...

Tango Therapeutics cuts nearly one-fifth of staff

Tango Therapeutics cuts nearly one-fifth of staff

    08 Apr 2025

Oncology drugmaker Tango Therapeutics has cut about 20% of its staff, following a year...

GSK targets neurodegenerative diseases with latest licensing deal

GSK targets neurodegenerative diseases with latest licensing deal

    07 Apr 2025

GSK is betting potentially billions of dollars that a smaller drug company’s technology can...

New genetic medicine CDMO acquires Landmark Bio

New genetic medicine CDMO acquires Landmark Bio

    07 Apr 2025

Dive Brief: Artis BioSolutions emerged from stealth Wednesday, announcing that it has acquired Landmark...

Biotech ‘megarounds’ hold steady as startups, VCs wait on IPOs

Biotech ‘megarounds’ hold steady as startups, VCs wait on IPOs

    06 Apr 2025

Biotechnology company funding rounds remain larger than they were in 2022 and 2023, in...

Oz confirmed by Senate to lead CMS

Oz confirmed by Senate to lead CMS

    06 Apr 2025

Mehmet Oz, a physician and TV personality, was confirmed Thursday by the U.S. Senate...

M&A recap: Big pharma starts the year mostly avoiding billion-dollar deals

M&A recap: Big pharma starts the year mostly avoiding billion-dollar deals

    05 Apr 2025

The world’s largest pharmaceutical companies mostly steered clear of billion-dollar acquisitions in the early...

Trial monitors recommend Elevidys studies continue; Novartis kidney drug approved

Trial monitors recommend Elevidys studies continue; Novartis kidney drug approved

    05 Apr 2025

Today, a brief rundown of news involving Sarepta Therapeutics, Novartis and Allakos, as well...

Tariffs send healthcare industry into ‘unchartered waters’

Tariffs send healthcare industry into ‘unchartered waters’

    04 Apr 2025

Healthcare industry groups and analysts are reeling after President Donald Trump unveiled a sweeping...

FDA misses approval deadline for Novavax’s COVID-19 vaccine

FDA misses approval deadline for Novavax’s COVID-19 vaccine

    04 Apr 2025

The Food and Drug Administration review deadline for Novavax’s COVID-19 vaccine has come and...

Roche halts testing of Sarepta Duchenne gene therapy in Europe

Roche halts testing of Sarepta Duchenne gene therapy in Europe

    03 Apr 2025

Dive Brief: Roche has stopped enrolling and treating patients in three studies of the...

Trump installs sweeping new tariffs, but pharma appears to dodge blow

Trump installs sweeping new tariffs, but pharma appears to dodge blow

    03 Apr 2025

The U.S. will implement a universal baseline tariff of 10%, effective April 5, along...

Leqembi’s EU review drags on; Sanofi gets a new development head

Leqembi’s EU review drags on; Sanofi gets a new development head

    02 Apr 2025

Today, a brief rundown of news involving Eisai, Biogen and Sanofi, as well as...

Judge overturns FDA’s lab developed test regulation, siding with industry

Judge overturns FDA’s lab developed test regulation, siding with industry

    02 Apr 2025

A Texas federal court on Monday struck down the Food and Drug Administration’s new...

HHS begins layoffs in chaotic fashion

HHS begins layoffs in chaotic fashion

    01 Apr 2025

Employees across the Department of Health and Human Services began receiving layoff notices Tuesday,...

Cell, gene therapy makers lose a champion at FDA with exit of Peter Marks

Cell, gene therapy makers lose a champion at FDA with exit of Peter Marks

    01 Apr 2025

Over the past decade, several dozen cell and gene therapies have reached market in...

FDA official’s ouster sends shares of vaccine makers sliding

FDA official’s ouster sends shares of vaccine makers sliding

    31 Mar 2025

Shares of several prominent vaccine makers fell Monday morning after the resignation late Friday...

‘Everything is word of mouth’: HHS employees face uncertainty in looming Trump layoffs

‘Everything is word of mouth’: HHS employees face uncertainty in looming Trump layoffs

    31 Mar 2025

Just before 9 a.m. Thursday in Washington, D.C, the Department of Health and Human...

FDA broadens use of Novartis’ radiopharma drug Pluvicto

FDA broadens use of Novartis’ radiopharma drug Pluvicto

    30 Mar 2025

Dive Brief: Novartis’ radiopharmaceutical drug Pluvicto can now be used much more widely to...

Peter Marks, FDA’s top vaccine official, resigns

Peter Marks, FDA’s top vaccine official, resigns

    30 Mar 2025

Peter Marks, the Food and Drug Administration’s top vaccine official, abruptly resigned from the...

Bluebird gets rival takeout offer from Ayrmid

Bluebird gets rival takeout offer from Ayrmid

    29 Mar 2025

Bluebird bio on Friday received a new buyout offer that surpasses a take-private bid...

FDA approves first-of-its-kind RNA drug for hemophilia

FDA approves first-of-its-kind RNA drug for hemophilia

    29 Mar 2025

The Food and Drug Administration approved on Friday a new type of medicine for...

Lilly hits same Alzheimer’s roadblock in Europe as Eisai, Biogen

Lilly hits same Alzheimer’s roadblock in Europe as Eisai, Biogen

    28 Mar 2025

Eli Lilly plans to appeal a verdict from key drug regulators who say the...

Alcon buys majority stake in IPO-seeking cell therapy startup Aurion

Alcon buys majority stake in IPO-seeking cell therapy startup Aurion

    28 Mar 2025

The leading eye-care company Alcon on Wednesday said it has acquired a majority stake...

Nkarta to lay off staff, senior leadership, in bid to advance autoimmune cell therapy

Nkarta to lay off staff, senior leadership, in bid to advance autoimmune cell therapy

    27 Mar 2025

Nkarta is laying off a third of its workforce, and more than half its...

First Prader-Willi drug to reduce hunger approved by FDA

First Prader-Willi drug to reduce hunger approved by FDA

    27 Mar 2025

The Food and Drug Administration on Wednesday approved the first treatment for the insatiable...

Makary confirmed by Senate as FDA commissioner

Makary confirmed by Senate as FDA commissioner

    26 Mar 2025

The U.S. Senate on Tuesday confirmed Johns Hopkins University surgeon Martin Makary to be...

Character Biosciences raises $93M with an eye on vision loss drugs

Character Biosciences raises $93M with an eye on vision loss drugs

    26 Mar 2025

Character Biosciences, a biotechnology startup developing treatments for vision loss, said Tuesday it raised...

Merck bets $200M on a new type of heart pill

Merck bets $200M on a new type of heart pill

    25 Mar 2025

Dive Brief: Merck & Co. has entered a competitive race for a new type...

Verve gets FDA green light to expand base editing trial into US

Verve gets FDA green light to expand base editing trial into US

    25 Mar 2025

Verve Therapeutics is expanding a gene editing trial for a cholesterol and heart disease...

Novo adds to obesity drug pipeline via $200M deal with China-based biotech

Novo adds to obesity drug pipeline via $200M deal with China-based biotech

    24 Mar 2025

Dive Brief: Novo Nordisk is expanding its pipeline of obesity medicines, announcing Monday it...

Novartis builds case for new SMA gene therapy

Novartis builds case for new SMA gene therapy

    24 Mar 2025

On Wednesday, Novartis gave a more detailed look at long-awaited clinical data that the...

J&J boosts US manufacturing as big pharma reshores

J&J boosts US manufacturing as big pharma reshores

    23 Mar 2025

Dive Brief: Johnson & Johnson is planning a major U.S. expansion, announcing Friday it...

Optum Rx is reforming how it pays pharmacies

Optum Rx is reforming how it pays pharmacies

    23 Mar 2025

Dive Brief: Optum Rx is shifting to a new pharmacy reimbursement model that should...

AstraZeneca deepens China investment; Editas loses CFO to Dyne

AstraZeneca deepens China investment; Editas loses CFO to Dyne

    22 Mar 2025

Today, a brief rundown of news involving AstraZeneca and Novartis, as well as updates...

Delayed CDC meeting on vaccines is rescheduled to April

Delayed CDC meeting on vaccines is rescheduled to April

    22 Mar 2025

A postponed meeting of vaccine advisers to the Centers for Disease Control and Prevention...

Alnylam prices heart drug at premium to rivals

Alnylam prices heart drug at premium to rivals

    21 Mar 2025

Alynlam Pharmaceuticals will sell its drug for a life-threatening heart disease at almost double...

Alnylam drug gets long-awaited FDA approval in deadly heart disease

Alnylam drug gets long-awaited FDA approval in deadly heart disease

    21 Mar 2025

The Food and Drug Administration on Thursday approved an Alnylam Pharmaceuticals medicine for a...

Sanofi wagers $600M on a dual-targeting antibody drug for autoimmune disease

Sanofi wagers $600M on a dual-targeting antibody drug for autoimmune disease

    20 Mar 2025

Dive Brief: Sanofi agreed to pay $600 million for a therapy in early human...

Optum Rx says it will eliminate some prior authorization requirements

Optum Rx says it will eliminate some prior authorization requirements

    20 Mar 2025

Dive Brief: Optum Rx is moving to eliminate prior authorization requirements for dozens of...

Cargo shelves cell therapy research and lays off almost all staff

Cargo shelves cell therapy research and lays off almost all staff

    19 Mar 2025

Dive Brief: Cell therapy developer Cargo Therapeutics is laying off 90% of its workforce...

Prime sets sights on liver, lung disease as next target for its gene editing tech

Prime sets sights on liver, lung disease as next target for its gene editing tech

    19 Mar 2025

Dive Brief: Prime Medicine will test its gene editing technology as treatment for a...

Duchenne patient dies after receiving Sarepta gene therapy

Duchenne patient dies after receiving Sarepta gene therapy

    18 Mar 2025

A young man with Duchenne muscular dystrophy has died following treatment with Sarepta Therapeutics’...

Taiho buys Swiss biotech and its ADC tech for $400M

Taiho buys Swiss biotech and its ADC tech for $400M

    18 Mar 2025

Japan-based Taiho Pharmaceuticals on Monday said it will acquire Switzerland’s Araris Biotech and its...

AstraZeneca adds ‘in vivo’ cell therapy capabilities with EsoBiotech deal

AstraZeneca adds ‘in vivo’ cell therapy capabilities with EsoBiotech deal

    17 Mar 2025

AstraZeneca is bolstering its cell therapy capabilities, agreeing on Monday to pay up to...

IRA reforms could be on the table. Will Trump and the GOP pursue them?

IRA reforms could be on the table. Will Trump and the GOP pursue them?

    16 Mar 2025

The Inflation Reduction Act seems to be sticking around under the new Trump administration,...

Ono pays $280M to license Ionis rare disease drug

Ono pays $280M to license Ionis rare disease drug

    16 Mar 2025

Dive Brief: Ionis Pharmaceuticals is licensing out another experimental medicine, entering an agreement with...

Makary advances to full senate vote; Acelyrin, Pliant adopt ‘poison pills’

Makary advances to full senate vote; Acelyrin, Pliant adopt ‘poison pills’

    15 Mar 2025

Today, a brief rundown of news involving Martin Makary, as well as updates from...

FDA sets flu shot recommendations without input of outside advisers

FDA sets flu shot recommendations without input of outside advisers

    15 Mar 2025

The Food and Drug Administration on Thursday recommended to influenza vaccine manufacturers which virus...

Mallinckrodt, Endo to combine in $7B deal

Mallinckrodt, Endo to combine in $7B deal

    14 Mar 2025

Dive Brief: Mallinckrodt and Endo Pharmaceuticals, which have struggled through bankruptcies related to opioid...

MeiraGTx spins Parkinson’s, obesity gene therapies into AI startup

MeiraGTx spins Parkinson’s, obesity gene therapies into AI startup

    14 Mar 2025

Gene therapy specialist MeiraGTx is spinning some of its experimental medicines for the central...

A new obesity biotech launches; Gilead plans to quickly advance once-yearly PrEP for HIV

A new obesity biotech launches; Gilead plans to quickly advance once-yearly PrEP for HIV

    13 Mar 2025

Today, a brief rundown of news involving Harbour BioMed and Gilead Sciences, as well...

Roche broadens obesity drug plans with $1.65B Zealand deal

Roche broadens obesity drug plans with $1.65B Zealand deal

    13 Mar 2025

Dive Brief: Roche has raised its bet on obesity, agreeing to pay Zealand Pharma...

Merck opens $1B vaccine plant in North Carolina

Merck opens $1B vaccine plant in North Carolina

    12 Mar 2025

Merck & Co. on Tuesday opened a new vaccine manufacturing plant in Durham, North...

Viking inks CordenPharma deal to boost obesity drug supply

Viking inks CordenPharma deal to boost obesity drug supply

    12 Mar 2025

Dive Brief: Viking Therapeutics is secure production capacity for its experimental obesity drug, announcing...

Novo’s Wegovy successor disappoints in second large trial

Novo’s Wegovy successor disappoints in second large trial

    11 Mar 2025

Dive Brief: Novo Nordisk’s experimental drug CagriSema helped people who are overweight or obese...

Beam base editing therapy gets ‘proof of concept’ in rare lung disease

Beam base editing therapy gets ‘proof of concept’ in rare lung disease

    11 Mar 2025

Preliminary results from a small clinical trial suggest that a cutting-edge genetic medicine developed...

3 ways to accelerate development and de-risk cell and gene therapy manufacturing

3 ways to accelerate development and de-risk cell and gene therapy manufacturing

    10 Mar 2025

Cell and gene therapy innovators are after “a gene and a dream.” Those are...

Makary, under review to run FDA, evades pressure to reinstate canceled vaccine meeting

Makary, under review to run FDA, evades pressure to reinstate canceled vaccine meeting

    10 Mar 2025

Marty Makary, the Johns Hopkins surgeon who President Donald Trump chose to lead the...

Walgreens to be acquired in $10B take-private deal

Walgreens to be acquired in $10B take-private deal

    09 Mar 2025

Dive Brief: Walgreens has entered into a definitive agreement to be acquired by private...

Nimbus swaps CEOs and turns to new leader for ‘next chapter’

Nimbus swaps CEOs and turns to new leader for ‘next chapter’

    09 Mar 2025

Jeb Keiper, the longtime head of Nimbus Therapeutics, is stepping down in a planned...

Roche launches new Boston center; NIH centralizes peer review

Roche launches new Boston center; NIH centralizes peer review

    08 Mar 2025

This week has brought enough announcements and updates to fill a third news roundup....

J&J scraps depression testing for potential blockbuster drug

J&J scraps depression testing for potential blockbuster drug

    08 Mar 2025

Johnson & Johnson is terminating some research for an experimental drug that the company...

Following FDA cuts, Trump nominee Makary vows ‘independent’ staff review

Following FDA cuts, Trump nominee Makary vows ‘independent’ staff review

    07 Mar 2025

Marty Makary, President Donald Trump’s nominee to run the Food and Drug Administration, said...

Vertex’s new pain drug gets first coverage nod from major insurer

Vertex’s new pain drug gets first coverage nod from major insurer

    07 Mar 2025

Optum Rx, a pharmacy benefit manager owned by one of the country’s largest insurance companies,...

Bayer braces for ‘difficult’ year before turnaround pays dividends

Bayer braces for ‘difficult’ year before turnaround pays dividends

    06 Mar 2025

Dive Brief: Bayer CEO Bill Anderson is asking investors to bear with the German...

Jazz expands in oncology with $935M deal for Chimerix

Jazz expands in oncology with $935M deal for Chimerix

    06 Mar 2025

Jazz Pharmaceuticals is expanding its foothold in cancer drug research, announcing Wednesday it will...

Neumora bids farewell to R&D head; Biohaven’s ‘one step forward, one step back’ data

Neumora bids farewell to R&D head; Biohaven’s ‘one step forward, one step back’ data

    05 Mar 2025

Today, a brief rundown of news involving Acelyrin and Neumora Therapeutics, as well as...

Sofinnova secures €1.2B for new biotech investments

Sofinnova secures €1.2B for new biotech investments

    05 Mar 2025

European venture capital firm Sofinnova Partners has raised 1.2 billion euros, or nearly $1.3...

Blocking PD-1 and VEGF: The bispecific cancer drugs that could best Keytruda

Blocking PD-1 and VEGF: The bispecific cancer drugs that could best Keytruda

    04 Mar 2025

Merck & Co.’s cancer immunotherapy Keytruda is one of the pharmaceutical industry’s biggest successes....

Biotech startup pulls in $187M to make ‘multi-payload’ ADCs

Biotech startup pulls in $187M to make ‘multi-payload’ ADCs

    04 Mar 2025

Dive Brief: Callio Therapeutics on Monday launched with $187 million in Series A funding...

Lilly expands US manufacturing build-out with $50B target

Lilly expands US manufacturing build-out with $50B target

    02 Mar 2025

Eli Lilly will invest tens of billions more dollars in U.S. drug manufacturing in...

Praxis hits trial setback; Bristol Myers lays off staff in New Jersey

Praxis hits trial setback; Bristol Myers lays off staff in New Jersey

    02 Mar 2025

Today, a brief rundown of news involving Praxis Medicines and Bristol Myers Squibb, as...

BridgeBio oncology spinout to go public in blank-check merger

BridgeBio oncology spinout to go public in blank-check merger

    01 Mar 2025

BridgeBio Oncology Therapeutics, a cancer drug startup spun out of biotechnology company BridgeBio Pharma,...

Leqembi, after delay, gets back on track toward EU approval

Leqembi, after delay, gets back on track toward EU approval

    01 Mar 2025

Dive Brief: European drug reviewers have “reaffirmed” their positive view of Eisai and Biogen’s...

Vertex ends gene editing research pact with Verve

Vertex ends gene editing research pact with Verve

    28 Feb 2025

Dive Brief: Vertex Pharmaceuticals has pulled out of a planned four-year collaboration with Verve...

FDA meeting on flu vaccine composition is canceled

FDA meeting on flu vaccine composition is canceled

    28 Feb 2025

A meeting of Food and Drug Administration advisers to determine the composition of flu...

AstraZeneca’s next breast cancer drug; Madrigal’s accelerating MASH launch

AstraZeneca’s next breast cancer drug; Madrigal’s accelerating MASH launch

    27 Feb 2025

Today, a brief rundown of news involving AstraZeneca and Madrigal Pharmaceuticals, as well as...

Lilly CEO wields manufacturing plans to push pharma-friendly policies

Lilly CEO wields manufacturing plans to push pharma-friendly policies

    27 Feb 2025

Eight years ago, Eli Lilly CEO David Ricks stood in front of a red...

Eikon raises $351M in one of the year’s largest biotech venture rounds

Eikon raises $351M in one of the year’s largest biotech venture rounds

    26 Feb 2025

Eikon Therapeutics, a well-funded drug startup run by Merck & Co.’s former research chief, has...

Drug compounders sue FDA over declaration ending Wegovy shortage

Drug compounders sue FDA over declaration ending Wegovy shortage

    26 Feb 2025

Dive Brief: Drug compounders are suing the Food and Drug Administration again over obesity...

‘Fear and uncertainty’: Biotech investors warn of impact from NIH research cuts

‘Fear and uncertainty’: Biotech investors warn of impact from NIH research cuts

    25 Feb 2025

The biotechnology sector’s foundations rest on basic scientific research. Early experiments done in academic...

FDA brings back some fired device office staff

FDA brings back some fired device office staff

    25 Feb 2025

Many people who were fired from the Food and Drug Administration’s medical device center...

Partnering for success in early phase clinical development

Partnering for success in early phase clinical development

    24 Feb 2025

Early-phase clinical trials, including phase 1 and some phase 2a studies, serve as a...

Bluebird, at risk of default, agrees to take-private deal

Bluebird, at risk of default, agrees to take-private deal

    24 Feb 2025

Bluebird bio, a pioneering gene therapy developer that in recent years has struggled to...

Pfizer stops selling hemophilia gene therapy, citing weak demand

Pfizer stops selling hemophilia gene therapy, citing weak demand

    23 Feb 2025

Dive Brief: Weak demand for Pfizer’s hemophilia gene therapy Beqvez has led the pharmaceutical...

Ozempic, Wegovy shortage resolved; Pfizer CEO is PhRMA’s new chair

Ozempic, Wegovy shortage resolved; Pfizer CEO is PhRMA’s new chair

    23 Feb 2025

Today, a brief rundown of news involving Novo Nordisk, Acelyrin and Intra-Cellular Therapies, as...

In FDA job cuts, experts see threat of far-reaching impact

In FDA job cuts, experts see threat of far-reaching impact

    21 Feb 2025

The firing of possibly thousands of people working in U.S. health agencies this past...

CDC vaccine meeting, set to be first since RFK Jr. sworn in, is postponed

CDC vaccine meeting, set to be first since RFK Jr. sworn in, is postponed

    21 Feb 2025

An upcoming meeting of vaccine advisers to the Centers for Disease Control and Prevention...

Sanofi reaches consumer health deal; Supernus antidepressant fails study

Sanofi reaches consumer health deal; Supernus antidepressant fails study

    20 Feb 2025

Today, a brief rundown of news involving Sanofi and Supernus Pharmaceuticals, as well as...

Advamed CEO warns FDA job cuts put patients, industry at risk

Advamed CEO warns FDA job cuts put patients, industry at risk

    20 Feb 2025

Advamed CEO Scott Whitaker warned the Department of Health and Human Services that job...

Solid says early data suggest ‘differentiated’ Duchenne gene therapy

Solid says early data suggest ‘differentiated’ Duchenne gene therapy

    19 Feb 2025

Dive Brief: An experimental Duchenne muscular dystrophy gene therapy from Solid Biosciences showed potential...

Biogen buys rights to Stoke’s rare epilepsy drug

Biogen buys rights to Stoke’s rare epilepsy drug

    19 Feb 2025

Dive Brief: Through a new deal, Biogen has bought access to a potentially first-of-its-kind...

Beyond copays: Redefining assistance for those with rare diseases and chronic conditions

Beyond copays: Redefining assistance for those with rare diseases and chronic conditions

    18 Feb 2025

The Financial Burden of Care Navigating healthcare is challenging for most individuals and families,...

Trump orders agencies to plan for ‘large-scale’ job cuts

Trump orders agencies to plan for ‘large-scale’ job cuts

    17 Feb 2025

The Trump administration has directed federal agencies to “undertake plans for large-scale reductions in...

Biogen inks royalty deal to gain funding for lupus drug R&D

Biogen inks royalty deal to gain funding for lupus drug R&D

    17 Feb 2025

Dive Brief: Biogen is set to receive as much as $250 million in funding...

New study offers hints of GLP-1 drugs’ potential in curbing alcohol cravings

New study offers hints of GLP-1 drugs’ potential in curbing alcohol cravings

    16 Feb 2025

Scientists believe GLP-1 drugs like Novo Nordisk’s Ozempic help people with obesity lose weight...

Sanofi to take $250M charge on study failure for E. coli vaccine

Sanofi to take $250M charge on study failure for E. coli vaccine

    16 Feb 2025

Dive Brief: Sanofi and Johnson & Johnson are ending a Phase 3 study of...

RFK Jr. confirmed by Senate as health secretary

RFK Jr. confirmed by Senate as health secretary

    15 Feb 2025

Robert F. Kennedy Jr., a prominent vaccine critic who President Donald Trump has directed...

‘It’s not for the faint of heart.’ How 3 CEOs took their biotechs public

‘It’s not for the faint of heart.’ How 3 CEOs took their biotechs public

    15 Feb 2025

Drug development is a notoriously expensive business. Discovering, testing and advancing a medicine can...