Category: Medicine

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

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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.

Medicine

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

Medicine

GSK to buy liver disease drug for $1.2B

Dive Brief: British drugmaker GSK has agreed to pay privately held Boston Pharmaceuticals $1.2 billion upfront and as much as

Medicine

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,

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

Sarepta shares plummet as lower sales outlook adds to gloom over FDA’s new biologics hire

Dive Brief: Sarepta Therapeutics shares slid 19% early Wednesday after the biotechnology company lowered its sales forecast for the year

Medicine

[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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

Facing ‘uncertainty on steroids,’ biotech dealmakers tread more cautiously

Coming into the year, deal experts were optimistic that, after months without a flashy buyout, the pharmaceutical industry was ready

Medicine

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

Medicine

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

Medicine

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

Medicine

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.

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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,

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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,

Medicine

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

Medicine

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

Medicine

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

Medicine

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,

Medicine

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”

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

CDC panel mulls changes to COVID shot recommendations

Vaccine advisers to the Centers for Disease Control and Prevention, who met Tuesday for the first time since Robert F.

Medicine

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

Medicine

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

Medicine

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

Medicine

Pharma bosses face down investor angst on tariffs, HHS chaos

Pharmaceutical executives are likely to get asked many variations on the same few questions this earnings season as Wall Street

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

Trump rejects Biden-era plan to let Medicare cover obesity drugs

Dive Brief: The Trump administration will not permit Medicare to pay for obesity drugs directly, declining Friday to finalize a

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

RNA editing biotech Airna adds $155M in funding

Dive Brief: Airna, a biotechnology startup developing RNA editing treatments, said Tuesday it raised $155 million in a Series B

Medicine

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

Medicine

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

Medicine

‘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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

Epicrispr banks $68M to test epigenetic editing on rare muscle disease

Dive Brief: Epicrispr Biotechnologies has raised $68 million in pursuit of a first-of-its-kind genetic medicine for a rare neuromuscular disorder

Medicine

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

Medicine

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

Medicine

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

Medicine

Leveraging clinical and financial data sets to guide investment strategies in 2025’s biopharma market

To say global markets have been choppy in 2025 is an understatement. Unsurprisingly, biopharma remains one of the most dynamic

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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,

Medicine

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

Medicine

Arbor raises $74M amid genetic medicine’s funding slump

Arbor Biotechnologies on Tuesday announced a new $74 million fundraise that comes as many of its peers in genetic medicine

Medicine

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

Medicine

NGS is changing GxP compliance. Will you adapt?

Discover NGS for GxP compliance with full audit trails, operational control and robust data security.

Medicine

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.

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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%

Medicine

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

Medicine

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

Cell and gene therapy innovators are after “a gene and a dream.” Those are the words of Hugh Murray, Senior

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Optum, a pharmacy benefit manager owned by one of the country’s largest insurance companies, UnitedHealth Group, has added a new,

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Merck & Co.’s cancer immunotherapy Keytruda is one of the pharmaceutical industry’s biggest successes. The drug’s arrival in 2014 introduced

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

Partnering for success in early phase clinical development

Early-phase clinical trials, including phase 1 and some phase 2a studies, serve as a pivotal step for biotech companies, laying

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

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

The Financial Burden of Care Navigating healthcare is challenging for most individuals and families, but for those facing rare or

Medicine

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

Medicine

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

Medicine

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

Medicine

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

Medicine

RFK Jr. confirmed by Senate as health secretary

Robert F. Kennedy Jr., a prominent vaccine critic who President Donald Trump has directed to “go wild” on healthcare, was

Medicine

‘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,

Medicine

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

Medicine

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

Medicine

Aardvark prices $94M IPO to fund Prader-Willi, obesity drug work

Dive Brief: Aardvark Therapeutics on Wednesday night raised $94 million in an initial public offering that will support development of

Medicine

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

Scientists believe GLP-1 drugs like Novo Nordisk’s Ozempic help people with obesity lose weight in part because they can help

Medicine

Novartis pays $925M to reel in a startup it helped launch

Novartis is wagering more than $3 billion that a startup it helped launch six years ago has developed a better

Medicine

Merck KGaA pursuing Springworks; BridgeBio wins EU drug OK

Today, a brief rundown of news involving Merck KGaA and BridgeBio Pharma, as well as updates from Biohaven, Third Harmonic

Medicine

Vertex COO Arbuckle to step down later this year

Stuart Arbuckle, Vertex’s chief operating officer and one of the company’s longest-tenured leaders, will retire from his role in July.

Medicine

AbbVie, Pfizer gain FDA OK for novel antibiotic

Dive Brief: The Food and Drug Administration on Friday approved a new combination antibiotic developed by AbbVie and Pfizer for

Medicine

Amgen obesity drug on hold; Regeneron sets first dividend

Today, a brief rundown of news involving Amgen and Regeneron, as well as updates from Valneva, Turnstone Biologics and AdvanCell

Medicine

Pfizer taps former Novartis exec to lead cancer drug push

Listen to the article 4 min This audio is auto-generated. Please let us know if you have feedback. Pfizer on

Medicine

Bristol Myers gives first peek at closely watched launch of schizophrenia drug

Sales of Cobenfy, a new mind-stabilizing medicine, totaled $10 million in the final months of last year, results that fell

Medicine

Eli Lilly’s earnings, shares lifted by obesity drug sales

Dive Brief: Eli Lilly’s profit doubled in the fourth quarter as the Indianapolis-based drugmaker raked in revenue from diabetes and

Medicine

Immune drugmakers Alumis and Acelyrin to merge

Dive Brief: Alumis and Acelyrin are merging, the biotechnology companies said Thursday afternoon, in an all-stock deal that leaves the