Category: Medicine

Medicine

Lyell, in search of a turnaround, to buy cell therapy startup ImmPact

Lyell Immunopharma, a cell therapy developer that has struggled to match its high profile, is acquiring a biotechnology startup and

Medicine

Pfizer’s RSV vaccine cleared by FDA for use in some younger adults

Dive Brief: The Food and Drug Administration on Tuesday expanded the approval of Pfizer’s RSV vaccine Abrysvo to include adults

Medicine

Alto hits new low as depression drug flunks key test

Alto Neuroscience, a young biotechnology company developing medicines for the brain, lost much of its value Wednesday as negative results

Medicine

Starboard makes case for change at Pfizer, citing research, M&A missteps

Starboard Value, the activist investor agitating for change at Pfizer, called on the pharmaceutical giant’s board of directors to hold the

Medicine

FDA names Tarver as new head of device center

The Food and Drug Administration on Tuesday named Michelle Tarver as the permanent director of the agency’s device center. Tarver

Medicine

Oral version of Novo diabetes drug protects heart health in large study

Dive Brief: Novo Nordisk’s diabetes pill Rybelsus cut the risk of heart attacks, strokes and cardiovascular death by 14% in

Medicine

Sanofi moves ahead with CD&R deal for stake in consumer business

Dive Brief: French pharmaceutical company Sanofi is proceeding with plans to sell U.S.-based private equity firm Clayton Dubilier & Rice

Medicine

Harnessing the power of upstream platform integration to accelerate biopharma innovation

The biopharmaceutical industry has been a hotbed of innovation in recent years, with an increasing number of novel recombinant protein

Medicine

After rejections, AbbVie secures approval for Parkinson’s drug

People with advanced Parkinson’s disease have a new treatment option, as the Food and Drug Administration on Thursday approved a

Medicine

CVS replaces CEO Karen Lynch with Caremark head

Dive Brief: CVS Health on Thursday replaced CEO Karen Lynch as the healthcare and pharmacy giant’s financial challenges mount. CVS’ new

Medicine

PTC rebuffed again by EMA; Novartis licenses China-based biotech’s cancer drug

Today, a brief rundown of news from PTC Therapeutics and Novartis, as well as updates from Amylyx Pharmaceuticals and Intercept

Medicine

Gilead withdraws Trodelvy in bladder cancer

Dive Brief: Gilead will no longer sell its combination drug Trodelvy to treat bladder cancer, announcing Friday it had agreed

Medicine

Merck antibody reduces RSV-related disease, hospitalizations in trial

Dive Brief: An experimental antibody drug developed by Merck & Co. significantly reduced the incidence of disease due to respiratory

Medicine

Sage to cut one-third of workforce, streamline drug pipeline

Sage Therapeutics is restructuring yet again, announcing Thursday a company shakeup that will involve layoffs for about one-third of its

Medicine

Wave sees RNA editing validation in early trial results

Clinical trial results released by Wave Life Sciences Wednesday appear to provide early validation for the company’s newest drugmaking technology

Medicine

Novocure wins FDA approval for electric field device in lung cancer

Dive Brief: The Food and Drug Administration on Tuesday approved a new device to treat non-small cell lung cancer, Novocure’s

Medicine

Forbion follows string of startup exits with $2.2B fundraise

Dive Brief: European life sciences venture firm Forbion on Tuesday said it has raised 2 billion euros, or more than

Medicine

Lundbeck to buy brain drug developer Longboard for $2.6B

Danish drugmaker Lundbeck has agreed to spend $2.6 billion acquiring a young biotechnology company with an experimental brain medicine that

Medicine

FDA, facing pressure, to review position on Zepbound, Mounjaro shortage

The Food and Drug Administration has temporarily deflected a lawsuit alleging it violated federal law by removing Eli Lilly’s obesity

Medicine

Choosing the right hub partner: A blueprint for decision-makers

An effective launch sets the stage for a new drug’s long-term success. It shapes provider and patient perceptions, drives medication

Medicine

The number of AI medical devices has spiked in the past decade

The number of medical devices with artificial intelligence technology has risen sharply in the past decade. The Food and Drug

Medicine

Ex-Pfizer execs ‘threatened’ for supporting plans to shake up company, Starboard says

Two former Pfizer executives announced late Wednesday night that they won’t support efforts by activist investor Starboard Value to shake

Medicine

Upstream prices $255M IPO in bid to challenge Amgen, AstraZeneca asthma drug

Dive Brief: Upstream Bio announced Thursday it priced its initial public offering, raising $255 million to fund development of an antibody

Medicine

FDA clears Roche breast cancer drug; Turnstone lays off 60% of staff

Today, a brief rundown of news from Roche and Turnstone Biologics, as well as updates from Sanofi, Pfizer and Flagship

Medicine

Sanofi may have found a buyer for its consumer health business

For the past year, French pharmaceutical giant Sanofi has been searching for a buyer to take control of its consumer

Medicine

Upstream prices $255M IPO in bid to challenge Amgen, AstraZeneca asthma drug

Dive Brief: Upstream Bio announced Thursday it priced its initial public offering, raising $255 million to fund development of an antibody

Medicine

UnitedHealth, CVS push to remove FTC Chair Lina Khan from PBM case

Dive Brief: UnitedHealth Group and CVS Health want Federal Trade Commission Chair Lina Khan and two other commissioners to recuse

Medicine

Lilly partners with AI specialist Insitro to develop metabolic medicines

Dive Brief: Eli Lilly and Insitro said they have entered into three drug development deals that offer a “new paradigm”

Medicine

Purespring raises $105M to advance gene therapy for kidney disease

Biotechnology company Purespring Therapeutics has raised about $105 million to fund its development of gene therapies for diseases of the

Medicine

GSK says RSV vaccine protects against disease over three seasons

Dive Brief: Vaccine maker GSK unveiled new data Tuesday showing its respiratory syncytial virus vaccine Arexvy protected older adults over

Medicine

Sage continues downslide as Alzheimer’s study fails

Alzheimer’s disease remains one of the world’s most indomitable illnesses, and on Tuesday it defeated yet another potential treatment in

Medicine

Scholar Rock scores with ‘surprise’ success in SMA drug study

Dive Brief: An experimental, muscle-preserving therapy from Scholar Rock succeeded in a Phase 3 trial in spinal muscular atrophy, positioning

Medicine

GSK’s ViiV to expand supply of HIV drug in Africa

Dive Brief: GSK-backed ViiV Healthcare on Monday said it plans to triple the amount of its HIV prevention therapy it

Medicine

Blue Shield of California sidesteps PBMs with new Humira biosimilar deal

Dive Brief: A major California health plan has struck a novel deal with a drug manufacturer for a cheaper version

Medicine

FDA makes end of Zepbound, Mounjaro shortage official

Dive Brief: Shortages affecting the availability of Eli Lilly’s top-selling diabetes and weight-loss drugs have now been resolved, the Food

Medicine

An Alzheimer’s drugmaker is accused of data manipulation. Should its trials be stopped?

Cassava Sciences has faced intense regulatory scrutiny over alleged clinical impropriety in studies of its experimental Alzheimer’s disease drug. Most

Medicine

Opdivo gets ‘perioperative’ approval; pharmas cut jobs in New Jersey, Ireland

Today, a brief rundown of news from Bristol Myers Squibb and Johnson & Johnson, as well as updates from Bayer,

Medicine

Sanofi’s rare disease drug finds yet another home

Over the past decade, the medicine Enjaymo has been passed around no less than five times by developers large and

Medicine

Editas trades Vertex fees for upfront cash in DRI deal

Dive Brief: Gene editing company Editas Medicines has sold off license fees and future payments it’s owed under an agreement

Medicine

Medicare tweaks rules for second round of drug price talks

The U.S. government is fine-tuning the rules for how it will negotiate drug prices within Medicare when the second round

Medicine

Gilead agrees to license new HIV drug in low-income countries

Dive Brief: Gilead on Wednesday said it signed royalty-free licensing agreements with six generic drugmakers to produce and sell its

Medicine

IGM lays off staff in autoimmune pivot; Metsera ramps up obesity drug supply

Today, a brief rundown of news from IGM Biosciences and Metsera, as well as updates from Gritstone Bio, UCB and

Medicine

The top biopharma conferences in 2025

With rare exceptions, biotechnology and pharmaceutical companies validate their business plans through clinical trials, results from which are often presented

Medicine

Roche turns to a startup in search for new breast cancer drugs

Dive Brief: Roche on Monday agreed to pay $850 million to acquire two experimental breast cancer drugs being developed by

Medicine

Pfizer to pull sickle cell drug from market, shut down trials

Dive Brief: Pfizer is pulling the sickle cell disease drug Oxbryta off the market and ending clinical trials of the

Medicine

Lawmakers call for investigation of former FDA device director

Dive Brief: Two House Democrats have called for an investigation of former Food and Drug Administration device director Jeff Shuren

Medicine

Approval in hand, Bristol Myers sets out to sell first-of-its-kind schizophrenia drug

For the first time in more than two decades, a completely new form of antipsychotic medication will be available in

Medicine

FDA, after delay, clears Regeneron and Sanofi drug for COPD

The Food and Drug Administration on Friday approved Regeneron Pharmaceuticals and Sanofi’s inflammatory disease drug Dupixent for a common lung

Medicine

J&J builds case for Talvey; FDA panel questions PD-1 drugs for certain cancers

Today, a brief rundown of news from J&J and the FDA, as well as updates from Sage Therapeutics, Roche and

Medicine

An Italian biotech gets $52M to advance pediatric gene therapies

Genespire, an Italy-based biotechnology startup making “off-the-shelf” gene therapies treatment for rare pediatric genetic conditions, has raised €46.6 million euros,

Medicine

Bluebird to lay off another 25% of workforce in latest restructuring

Struggling gene therapy developer Bluebird bio is again cutting costs, announcing Tuesday a plan to lay off about a quarter

Medicine

Novo CEO pressed by Senate to cut prices of obesity, diabetes drugs

Novo Nordisk’s top executive vowed to reopen price negotiations with insurers covering the company’s obesity and diabetes drugs at a

Medicine

Biogen, UCB get the lupus data they’ve waited two decades for

After more than two decades of work, partners Biogen and UCB say they finally have positive results from a late-stage

Medicine

AstraZeneca, Daiichi’s Enhertu successor faces more questions after latest stumble

Dive Brief: An experimental medicine from AstraZeneca and Daiichi Sankyo failed to help people with a common form of breast

Medicine

The golden era of GLP-1 drugs: Where we are and what comes next

Glucagon-like peptide 1 (GLP-1) receptor agonists (RAs) are entero-pancreatic hormone-based treatments first approved in 2005 for type 2 diabetes (T2D).

Medicine

Startup from George Church’s lab raises $75M to develop ‘supercell’ medicines

A new company born out of research done by top Harvard genetic scientist George Church is promising to “revolutionize cell

Medicine

23andMe’s independent board directors resign

Dive Brief: 23andMe’s independent board directors resigned on Tuesday amid uncertainty about the DNA testing company’s future. In a letter

Medicine

Apellis eye drug again turned back in Europe

European drug regulators have officially turned back a first-of-its-kind eye drug from Apellis Pharmaceuticals despite multiple attempts by the company

Medicine

Novo sinks on obesity drug results; Sanofi reveals anticipated MS data

Today, a brief rundown of news from Sanofi and Novo Nordisk, as well as updates from The Lasker Foundation, Edgewise

Medicine

FTC sues major pharmacy benefit managers over insulin prices

Dive Brief: The Federal Trade Commission has filed suit against the three largest pharmacy benefit managers in the country for

Medicine

Roche’s Xofluza reduces flu transmission in Phase 3 study

Dive Brief: Roche’s antiviral drug Xofluza reduced influenza transmission among household contacts in a large Phase 3 study, the company

Medicine

4D Molecular data ‘bode well’ for eye gene therapy, but shares fall

Dive Brief: People with a common form of macular degeneration needed far fewer injections to manage their eye condition following

Medicine

Roivant dermatology subsidiary to be acquired by Organon

Dive Brief: Organon has agreed to buy Roivant’s dermatology subsidiary Dermavant for $175 million upfront plus more than $1 billion

Medicine

Novartis’ Kisqali gets expanded FDA OK; Mene Pangalos joins Omega Funds

Today, a brief rundown of news from Novartis and GSK, as well as updates from Omega Funds, Serán Bioscience and

Medicine

Ascendis trial data piles pressure on BioMarin

BioMarin Pharmaceutical, after months of layoffs, spending cuts and research reorganizations, has staked its future on the continued success of its

Medicine

ADC developed by Daiichi, Merck outperforms chemo in lung cancer trial

Dive Brief: An antibody-drug conjugate developed by Daiichi Sankyo and Merck & Co. met the main goal of a Phase

Medicine

Sanofi readies to meet US demand for RSV antibody

Sanofi said it’s ready to meet demand for its RSV shot Beyfortus this year, announcing Monday the clearance by the

Medicine

ESMO24: A cancer cachexia drug, VEGF enthusiasm and immunotherapy’s survival impact

Over the weekend at the European Society for Medical Oncology’s annual meeting in Barcelona, cancer researchers unveiled results from scores

Medicine

Bridging science and humanity: How systems thinking should shape clinical trial execution

For novel therapeutics, the path to marketing authorization is narrow and treacherous. Among promising drug candidates, fewer than 15% make it all

Medicine

Ten-year survival data show long-term benefit of immunotherapy in melanoma

A decade of follow-up on people with melanoma who were treated with cancer immunotherapy shows how two drugs have dramatically

Medicine

Gene therapy startup emerges with green light for first-of-its-kind trial

Vironexis Biotherapeutics emerged from stealth with plans to start what it claims will be the first-ever clinical trial testing a

Medicine

TIGIT drug from iTeos shrinks lung tumors in trial

Small biotechnology company iTeos Therapeutics could succeed where larger drugmakers have fallen short, should study results it presented Saturday at

Medicine

Subcutaneous Tecentriq gets FDA OK; Gilead shot succeeds in second HIV trial

Today, a brief rundown of news from Roche and Gilead Sciences, as well as updates from Eli Lilly, Biogen and

Medicine

Moderna, trailing rivals, checks its RSV shot expectations

Months after winning approval of a new vaccine for respiratory syncytial virus, Moderna is acknowledging that wresting market share from

Medicine

Three biotechs raise $700M in rare burst of IPO activity

Three drug startups collectively raised more than $700 million in initial public offerings Thursday, a flurry of activity after a

Medicine

Fulcrum shares collapse as Sanofi-partnered muscular dystrophy drug fails key test

Dive Brief: An experimental drug Fulcrum Therapeutics has been testing against a type of muscular dystrophy failed a Phase 3

Medicine

Dupixent succeeds in chronic hives study, giving Sanofi, Regeneron a chance to rebound

Dive Brief: Sanofi and Regeneron plan to make a second attempt at expanding use of their blockbuster drug Dupixent to

Medicine

BridgeBio trims gene therapy budget after seeing data on adrenal gland medicine

Dive Brief: BridgeBio Pharma plans to trim its spending on gene therapy research by more than $50 million after early-stage

Medicine

Investors are waking up to Centessa’s sleepiness drug

Early results from a small study have convinced Centessa Pharmaceuticals to “rapidly advance” an experimental drug it believes could be

Medicine

Bain closes $3B biotech fund amid flurry of startup buyouts

Bain Capital Life Sciences said Tuesday it has secured about $3 billion for its fourth fund, bringing the private investment

Medicine

Early study data puts Terns among obesity drug contenders

Dive Brief: An experimental weight loss pill developed by biotechnology company Terns Pharmaceuticals helped some people with obesity lose more

Medicine

Relay breast cancer drug shows potential in early trial

Dive Brief: An experimental drug regimen for breast cancer being developed by Relay Therapeutics delayed tumor growth by a median

Medicine

A decade of cancer immunotherapy: Keytruda, Opdivo and the drugs that changed oncology

Nine years ago, Lisa Haines got news no one wants to hear. Her doctors said her lung cancer, which chemotherapy

Medicine

Summit lung cancer drug shows ‘striking’ benefit over Keytruda

An experimental medicine from a small biotechnology company cut the risk of lung cancer progression in half when tested against

Medicine

Novartis builds out radiopharma production with expansion, new factory

Dive Brief: Novartis said Wednesday it’s expanding a manufacturing site in Indianapolis and building a new plant in California in

Medicine

GSK antibody drug reduces COPD attacks in trial

Dive Brief: GSK on Friday said its Nucala medicine succeeded in a Phase 3 study of patients with chronic obstructive

Medicine

Obesity drug startup raises $67M; Vor’s ‘shielded transplant’ shows promise

Today, a brief rundown of news from OrsoBio, as well as updates from Boehringer Ingelheim, Novartis and Vaxcyte that you

Medicine

Judge orders J&J to pay Auris investors more than $1B for merger violations

Dive Brief: A Delaware judge ruled Wednesday that Johnson & Johnson must pay Auris Health’s former investors more than $1

Medicine

Lilly builds case for weekly insulin shot

Eli Lilly on Thursday revealed new data that could help it catch rival Novo Nordisk in a race between the

Medicine

Lykos CEO to depart after FDA rejection, layoffs

The CEO of Lykos Therapeutics will step down after the company’s efforts to win a milestone approval for MDMA as

Medicine

BioMarin, having retrenched, outlines plans for growth

BioMarin Pharmaceutical has brought eight rare disease drugs to market over the past 25 years, a record few companies in

Medicine

High-dose Spinraza meets study goal; Top Dyne executives exit

Today, a brief rundown of news from Biogen, as well as updates from Dyne Therapeutics, Denali Therapeutics and Novo Nordisk

Medicine

Vaxcyte’s “best-case” data for pneumococcal vaccine boost shares

Dive Brief: Shares in vaccine developer Vaxcyte soared by over 35% Tuesday after the company unveiled results from a large

Medicine

New research could ease concerns over suicide risk of obesity drugs

Regulators in the U.S. and Europe recently determined that a popular group of drugs for weight loss and diabetes don’t

Medicine

After an FDA rejection, here’s what’s next in the psychedelics pipeline

The psychedelic drug field hit a setback this month when the Food and Drug Administration rejected Lykos Therapeutics’ application for

Medicine

PBM executives threatened with fines for alleged perjury in House hearing

The chair of the powerful House Committee on Oversight and Accountability is threatening the leaders of the three largest pharmacy

Medicine

Cell and gene therapy investment, once booming, is now in a slump

Investment in developers of cell and gene therapies has nosedived this year, a sharp drop-off that investors and analysts say

Medicine

J&J submits touted autoimmune disease drug for FDA approval

Johnson & Johnson is asking the Food and Drug Administration to approve a new medicine the company believes can eventually

Medicine

Full study data back Alnylam heart drug’s benefit, but leave doctors with tough choices

Two months ago, Alnylam Pharmaceuticals revealed that a medicine it’s been developing for people with a deadly heart condition succeeded

Medicine

Novo builds heart failure case for semaglutide; Ventyx CFO departs

Today, a brief rundown of news from Novo Nordisk and Ventyx Biosciences, as well as updates from Novartis and Pfizer

Medicine

Keytruda fails lung and skin cancer trials, limiting further expansion

Dive Brief: Merck & Co.’s drug Keytruda failed to help people with cancer in two clinical trials, both using the

Medicine

BioMarin to lay off over 200 employees

Amid a major corporate shakeout, BioMarin Pharmaceutical intends to lay off over 200 staff, according to a regulatory filing made

Medicine

Bayer partners with RNA drugmaker to develop new cancer therapies

Bayer and biotechnology company NextRNA Therapeutics on Wednesday said they have partnered to develop a new kind of small molecule

Medicine

Neurocrine’s mixed schizophrenia data disappoint Wall Street

Neurocrine Biosciences on Wednesday reported results from a schizophrenia drug study that, despite one bright spot, mostly disappointed investors. The

Medicine

Lilly rolls out Zepbound vials at a discount price

Dive Brief: Eli Lilly is now distributing a single-dose vial form of its popular weight loss medicine Zepbound that it

Medicine

Pfizer launches DTC service for migraine, COVID drugs

Pfizer on Tuesday launched a direct-to-consumer service it claims will help people schedule telehealth appointments, fill prescriptions and access savings

Medicine

Tome Biosciences to lay off over 100 employees

Genetic medicines startup Tome Biosciences is letting go of much of its staff after hitting setbacks following a buzzy launch

Medicine

Regeneron gains European approval for bispecific lymphoma drug

Dive Brief: The European Commission has authorized Regeneron’s dual-acting drug odronextamab to treat two types of lymphoma, clearing it for

Medicine

Employers foresee higher health costs next year due to rising pharmacy spend

Large employers are bracing for a substantial increase in healthcare costs next year, driven by higher spending on medicines like

Medicine

BioMarin taps Amgen, Roche vets in executive reshuffle

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

Medicine

Versant reimagines its Chinook success with newest startup launch

Chinook Therapeutics ranks among Versant Ventures’ most successful biotechnology bets. The kidney disease drug developer, which Versant founded in 2019

Medicine

UK approves Leqembi, but reimbursement may not follow

Leqembi’s benefits are “too small to justify the significant cost to the NHS,” said the head of a UK agency

Medicine

FDA to convene immunotherapy panel; Tome scales back operations

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

Medicine

Two antibody startups file for IPOs amid summer slump

Dive Brief: A pair of U.S. biotechnology companies on Thursday filed plans for initial public offerings, testing a market that’s

Medicine

Updated COVID shots from Pfizer, Moderna cleared by FDA

Dive Brief: The Food and Drug Administration on Thursday cleared new versions of Pfizer’s and Moderna’s COVID-19 vaccines that are

Medicine

FDA defends med device chief’s tenure after report raises ethics concerns

The Food and Drug Administration is defending the record of Jeff Shuren, former director of the agency’s medical device center,

Medicine

BridgeBio sends rare disease drugs to new company

BridgeBio Pharma has transferred several preclinical and early clinical-stage drugs to a new company, GondolaBio, that’s drawn $300 million in

Medicine

Regeneron confirms FDA won’t approve myeloma drug over manufacturing issues

Dive Brief: After warning investors earlier this month of a possible delay, Regeneron Pharmaceuticals on Tuesday confirmed that U.S. regulators

Medicine

Avidity, Kymera raise fresh funds; Walgreens partners with BARDA

Today, a brief rundown of stock sales by Avidity Biosciences and Kymera Therapeutics, as well as a new partnership between

Medicine

J&J drug combo for lung cancer approved by FDA

Dive Brief: The Food and Drug Administration has approved a new combination drug regimen from Johnson & Johnson to treat

Medicine

Novo plans new plant as it races to meet drug demand

A subsidiary of Danish drugmaker Novo Nordisk is investing 1.5 billion Danish kroner, or about $220 million, to build a

Medicine

FDA lifts partial hold on study of BioNTech-partnered ADC

BioNTech partner MediLink Therapeutics can resume enrollment of a Phase 1 clinical trial testing an antibody-drug conjugate in people with

Medicine

Medicare reveals results of drug price negotiations

The U.S. government on Thursday said it stands to save taxpayers $6 billion on the prices it will pay for

Medicine

FDA clears Gilead drug acquired in $4.3B buyout

Dive Brief: Gilead Sciences has won Food and Drug Administration approval to sell Livdelzi, a new medicine for a rare

Medicine

Medicare drug price cuts could have limited early impact, but grow with time

The Biden administration struck a triumphant tone on Thursday in rolling out the first drug price cuts negotiated by Medicare,

Medicine

Zealand, Arrowhead advance obesity drugs; Bluebird narrows guidance

Today, a brief rundown of news from Zealand Pharma and Bluebird Bio, as well as updates from Boundless Bio and

Medicine

Pfizer, BioNTech stumble in effort to develop combination flu, COVID shot

Dive Brief: Pfizer and BioNTech on Friday said a combination flu and COVID-19 shot they’ve been developing met one of

Medicine

Lykos to cut 75% of staff after FDA rejection of MDMA-based therapy

Lykos Therapeutics plans to lay off about 75% of its staff as part of a larger shake-up at the California-based

Medicine

Incyte builds out its arsenal of post-transplant drugs

The Food and Drug Administration has approved another medicine for a rare condition that arises after a bone marrow or

Medicine

Evotec, citing research spending slowdown, cuts jobs and exits gene therapy

Dive Brief: Evotec, a German drug discovery and contract development and manufacturing company, is restructuring amid a slowdown in early-stage

Medicine

Grail to shed 350 workers in restructuring

Dive Brief: Grail said it will lay off about 350 employees in a restructuring that comes less than two months

Medicine

Acelyrin shifts from main drug, lays off staff

Dive Brief: Acelyrin, the biotechnology company behind the sector’s largest initial public offering last year, is shifting away from the

Medicine

Galderma wins FDA approval for skin condition treatment

Dive Brief: Galderma on Tuesday said the Food and Drug Administration has approved its antibody drug Nemluvio for adults with

Medicine

Pfizer builds case for RSV shot with data from immunocompromised adults

Dive Brief: Pfizer on Monday said its RSV vaccine Abrysvo led to strong immune responses in immunocompromised adults given the

Medicine

Following FDA rejection, a journal retracts papers on MDMA-assisted therapy

A day after the Food and Drug Administration rejected MDMA as a therapy aid for post-traumatic stress disorder, a scientific

Medicine

Lilly boosts outlook on rising Zepbound revenue

Dive Brief: Eli Lilly on Tuesday raised its revenue forecast for the year by $3 billion as it reported second-quarter

Medicine

Recursion to absorb Exscientia in ‘techbio’ deal

Dive Brief: Recursion and Exscientia, two artificial intelligence firms, on Thursday announced that they would combine, betting their complementary skills

Medicine

Zepbound shortages ease, but Lilly cautions pharmacy availability may remain ‘choppy’

Eli Lilly is making progress resolving the supply strains that for months have made its in-demand obesity and diabetes medicines

Medicine

With pharma in ‘catbird seat,’ biotechs get less upfront in drug partnerships

The recent downturn in the biotechnology sector affected startups in many ways, from the availability of financing to the types

Medicine

In tone-setting verdict, FDA rejects MDMA as a therapy aid for PTSD

The Food and Drug Administration has rejected a bid to get MDMA approved as a therapy aid for people with

Medicine

Merck bets $700M on an antibody drug’s potential in immune diseases

Merck & Co. on Friday acquired an experimental drug designed to wipe out the immune system’s B cells in a

Medicine

Merck TIGIT drug fails another trial; Intellia therapy succeeds in HAE study

Today, a brief rundown of news from Merck & Co. and Cabaletta Bio, as well as updates from Intellia Therapeutics,

Medicine

Apellis plans FDA filing after drug success in kidney trial

Dive Brief: Treatment with an Apellis Pharmaceuticals drug appeared to benefit people with one of two uncommon kidney diseases, according

Medicine

Novo shares tumble on lower-than-expected obesity drug sales

Dive Brief: Novo Nordisk shares tumbled 7% in early trading Wednesday after the company reported lower-than-expected revenue from its blockbuster

Medicine

Amgen talks obesity drug ‘differentiation’; Servier brain cancer drug approved by FDA

Today, a brief rundown of news from Amgen and Servier, as well as updates from Merck & Co., Precigen and

Medicine

Roche licenses Sangamo’s technology for another shot at Alzheimer’s drugs

Despite decades of research and many millions of dollars invested, Roche still has yet to develop a drug that works

Medicine

Biotech Red Queen launches with $55M to build versatile antivirals

Venture firm Apple Tree Partners has invested $55 million in a new biotechnology company developing antiviral treatments capable of working

Medicine

Bristol Myers sends TIGIT drug back to Agenus

Bristol Myers Squibb has returned an experimental cancer immunotherapy to Agenus, ending an alliance that could’ve been worth more than

Medicine

Zepbound, Mounjaro back in supply as Lilly resolves shortage

Dive Brief: All doses of tirzepatide, the drug Eli Lilly sells as Zepbound for obesity and Mounjaro for diabetes, are

Medicine

Cigna CEO promises ‘aggressive’ defense of pharmacy benefit managers

Dive Brief: Cigna’s chief executive is pledging to be more aggressive in defending its pharmacy benefit manager amid mounting public

Medicine

Moderna shares fall amid lower sales outlook for RSV, COVID shots

Shares of Moderna fell nearly 20% on Thursday after the company lowered its 2024 financial forecasts amid slowing sales and

Medicine

Lilly obesity drug shows heart benefit in late-stage trial

Eli Lilly’s tirzepatide, the in-demand drug sold as Zepbound for weight loss, has for the first time been shown in

Medicine

Jim Wilson, prominent gene therapy researcher, to depart UPenn

Prominent gene therapy researcher Jim Wilson will depart the University of Pennsylvania, where he led one of the field’s largest

Medicine

Vir retreats from infectious disease; Vertex shelves AATD drugs

Today, a brief rundown of news from Vir Biotechnology and Vertex Pharmaceuticals, as well as updates from Neurocrine Biosciences, Alnylam

Medicine

First-of-its-kind cell therapy approved by FDA for rare soft tissue cancer

The Food and Drug Administration on Thursday approved a new type of cellular medicine, clearing a therapy developed by the

Medicine

UniQure restructuring to claim 300 jobs

Dive Brief: Gene therapy developer UniQure will shrink its workforce by 65%, cutting 300 roles across the company alongside the

Medicine

As sales climb, Biogen ‘convinced’ the worst is over for Leqembi

After a slow start, the launch of Biogen’s prized drug for Alzheimer’s disease is picking up, which has given company

Medicine

GSK cuts vaccine forecasts, while predicting faster overall growth

Dive Brief: GSK on Wednesday lowered its forecast for vaccine sales this year, citing inventory changes and shifting retail prioritization

Medicine

Biotech startup Airna raises $60M for RNA editing medicines

Dive Brief: RNA editing startup Airna is adding more funds to its Series A round, raising another $60 million as

Medicine

Pfizer’s Bourla confident in company’s obesity drug position, despite delays

Pfizer missed its first chance at following Novo Nordisk and Eli Lilly into the fast-growing market for GLP-1 obesity drugs.

Medicine

GSK leans on Flagship for help finding new drugs, vaccines

Dive Brief: GSK is the latest pharmaceutical company to form a drug-hunting partnership with Flagship Pioneering, announcing Monday a deal

Medicine

How a Mubadala partner views investing in biotech’s new normal

After a dramatic post-pandemic downturn, a sense of stabilization has returned to biotech, and more healthcare professionals feel optimistic about

Medicine

Boehringer adds to cancer drug pipeline with deal for startup Nerio

Boehringer Ingelheim is investing again in immuno-oncology, announcing Monday a deal to acquire the San Diego-based biotechnology startup Nerio Therapeutics

Medicine

Leqembi voted down by European regulators

A key regulatory committee that influences whether new drugs enter the European market has voted against Leqembi, Eisai and Biogen’s

Medicine

Two biotechs cut staff; AbbVie weathers biosimilar threat

Today, a brief rundown of news from AbbVie and AstraZeneca as well as updates from Glycomimetics, Cue Biopharma and Confo

Medicine

Bristol Myers’ beat completes strong week of pharma earnings

Bristol Myers Squibb on Friday raised its forecast for revenue and profit per share this year after a second quarter

Medicine

Roche says it’ll move quickly with ‘differentiated’ obesity drugs

Roche is best known for the cancer drugs that still account for much of its drug revenue. But the Swiss

Medicine

Biogen, Sage tremor drug fails key trial

In 2020, Biogen wagered more than $1 billion on two experimental drugs developed in the labs of Sage Therapeutics, a

Medicine

Merck claims late-stage study success for RSV antibody

Dive Brief: An experimental Merck & Co. drug designed to protect infants from illness caused by respiratory syncytial virus succeeded

Medicine

Breakthroughs in immunotherapy: glycoproteins as predictive biomarkers for therapeutic response

Recent advancements in immune checkpoint inhibitors (ICIs) targeting PD-1 or CTLA4 have shown significant success in treating various advanced cancers

Medicine

Lilly alone in bidding for Morphic; Novartis won’t yet file MorphoSys drug

Today, a brief rundown of news from Morphic Holding as well as updates from Novartis, the Parker Institute and Agenus

Medicine

Global tech outage hits US hospitals

Cybersecurity firm CrowdStrike triggered a massive IT outage on Friday, disrupting businesses, including healthcare, after issuing what was supposed to be a

Medicine

FTC to sue three largest PBMs over drug price practices: WSJ

Dive Brief: The Federal Trade Commission is preparing to sue the three largest pharmacy benefit managers in the U.S. —

Medicine

AbbVie names new R&D head; Arcutis eczema cream approved

Today, a brief rundown of news from AbbVie and Skyhawk Therapeutics, as well as updates from Arcutis Biotherapeutics and Zevra

Medicine

SciRhom pulls in $70M for a new type of immune disease drug

SciRhom, a German biotechnology startup focused on autoimmune diseases, has raised a $70 million Series A funding round that will

Medicine

FTC criticizes PBM power over prescription drug market

The Federal Trade Commission on Tuesday released a long-awaited report criticizing the pharmacy benefit manager industry for manipulating the drug

Medicine

HilleVax’s norovirus vaccine ineffective in large trial of infants

Dive Brief: Biotechnology company HilleVax on Monday said it will halt development of an experimental norovirus vaccine in infants after

Medicine

Lilly to buy Morphic in $3B bet on inflammation drug

Eli Lilly plans to spend $3.2 billion acquiring a Massachusetts-based biotechnology company and its experimental pill for inflammatory bowel disease.

Medicine

With revised IPO pitch, Artiva touts ‘natural killer’ cell therapy for autoimmune disease

Dive Brief: Two years after canceling an initial public offering, Artiva Biotherapeutics has filed a new proposal centered around plans

Medicine

Cartesian data add to progress, questions for CAR-T in autoimmune disease

Dive Brief: Cartesian Therapeutics on Tuesday said an experimental cell therapy it’s developing succeeded in a mid-stage clinical trial of

Medicine

5 FDA decisions to watch in the third quarter

Two of last year’s largest biotechnology company acquisitions centered on a new type of treatment for schizophrenia. By the end

Medicine

Beacon raises $170M for eye gene therapy; J&J confirms Carvykti survival benefit

Today, a brief rundown of news from Beacon Therapeutics and Regeneron Pharmaceuticals, as well as updates from Vertex Pharmaceuticals, Johnson

Medicine

CureVac cuts jobs, licenses out vaccines to GSK

Dive Brief: CureVac, a specialist in messenger RNA-based therapies, disclosed Wednesday plans to lay off 30% of its workforce as

Medicine

Moderna gets US funding for bird flu vaccine development

The U.S. government has awarded $176 million to vaccine maker Moderna for development of an mRNA-based influenza shot. The funding

Medicine

Lilly drug for Alzheimer’s approved by FDA

The Food and Drug Administration on Tuesday approved a new Alzheimer’s disease drug from Eli Lilly, several weeks after a

Medicine

Eisai and Bristol Myers cancel cancer ADC deal

Dive Brief: Eisai and Bristol Myers Squibb will cancel a collaboration on a dual-acting drug being developed to treat lung

Medicine

Eli Lilly inks another radiopharma deal, gaining option to buy startup

Dive Brief: Eli Lilly is expanding further into radiopharmaceuticals, inking a deal with Radionetics Oncology that gives it an option

Medicine

UniQure, with sale of plant, outsources Hemgenix manufacturing

Dive Brief: UniQure will sell a gene therapy production plant in Lexington, Massachusetts, to contract manufacturer Genezen in a deal

Medicine

2seventy slims down with sale of hemophilia assets to Novo

Dive Brief: 2seventy Bio is shrinking further, announcing Thursday the sale of a hemophilia A research program, along with associated

Medicine

Supreme Court overturns Chevron doctrine, limiting reach of federal agencies

Dive Brief: The U.S. Supreme Court overturned the Chevron doctrine on Friday in a decision that could dramatically limit federal

Medicine

PTC faces another Duchenne drug rejection; Coherus sells Humira biosimilar

Today, a brief rundown of news from PTC Therapeutics, Esperion Therapeutics and Coherus Biosciences, as well as updates from Sanofi,

Medicine

Rocket gene therapy rejected by FDA over manufacturing

Dive Brief: The Food and Drug Administration has rejected a gene therapy developed by Rocket Pharmaceuticals for a rare type

Medicine

Merck’s pneumococcal vaccine gets CDC panel backing

Dive Brief: Advisers to the Centers for Disease Control and Prevention on Thursday unanimously recommended Merck & Co.’s recently approved

Medicine

Alumis cuts IPO size, but nets $250M for immune drug work

Immune drug developer Alumis has raised $210 million in one of the biotechnology sector’s largest initial public offerings this year.

Medicine

RSV vaccine makers’ shares fall as CDC adjusts shot guidance

Dive Brief: Shares of Moderna, Pfizer and GSK fell as advisers to the Centers for Disease Control and Prevention discussed

Medicine

These microscopic tunnels are a goldmine for new medicines

After months of searching, the drug hunters had tracked down the prized game they believed could help launch the next

Medicine

Novo nixes trial of blood pressure drug it bought in deal worth $1.3B

Dive Brief: Novo Nordisk will end a Phase 3 clinical trial of a hypertension drug it bought for up to

Medicine

After 33 years, Geron’s first approval marks a turn in Nobel-winning science

Faye Feller, executive vice president and chief medical officer of the biotechnology company Geron, was giving her child a bath

Medicine

Novo to spend $4B on US plant, adding to obesity drug production push

Dive Brief: Novo Nordisk will spend $4.1 billion to build a new U.S. factory in North Carolina, the latest multibillion-dollar

Medicine

Exsilio debuts with $82M, pitching a ‘leap’ forward for genetic medicine

Exsilio Therapeutics, a biotechnology startup led by a former Moderna executive, emerged from stealth Tuesday with an approach it claims