Category: Medicine

Medicine

Bain buys Mitsubishi pharma unit; Bausch + Lomb deal talks come up empty

Today, a brief rundown of news involving Mitsubishi Tanabe Pharma and Bausch + Lomb, as well as updates from Roche,

Medicine

Vertex challenger Sionna prices $191M IPO

Sionna Therapeutics on Thursday raised $191 million in an initial public offering that will fund its plan to challenge Vertex

Medicine

Bristol Myers, bracing for key patent losses, deepens cost-cutting plan

Dive Brief: Bristol Myers Squibb is expanding its plan to cut costs, announcing alongside quarterly earnings on Thursday that it

Medicine

Novo outlines new late-stage study of obesity drug CagriSema

Dive Brief: Novo Nordisk is planning a new Phase 3 trial of its next-generation obesity drug CagriSema that will test

Medicine

GSK, Pfizer sales of RSV shots slow as vaccination rates ebb

Dive Brief: Sales of both GSK’s and Pfizer’s vaccines for respiratory syncytial virus dropped significantly in the last three months

Medicine

RFK Jr. secured support of key Republican with vaccine pledges

Listen to the article 3 min This audio is auto-generated. Please let us know if you have feedback. Robert F.

Medicine

Flagship-backed Omega signals it’s headed toward bankruptcy

Dive Brief: Omega Therapeutics, a genetic medicines maker originally backed by Flagship Pioneering, plans to soon file for Chapter 11

Medicine

Pfizer drug acquired in $11B buyout confirms benefit in colon cancer

Dive Brief: Adding Pfizer’s cancer drug Braftovi to standard treatments helped people with a form of colorectal cancer live longer

Medicine

Shares of psychedelics biotech nearly double on depression data

In a little more than a week’s time, a drug developed by a small psychedelics company was able to significantly

Medicine

Cargo to drop lead CAR-T therapy, lay off staff after study setback

Dive Brief: Cell therapy developer Cargo Therapeutics will scrap its top program and lay off half of its staff after

Medicine

23andMe considers a sale as cash runs low

Dive Brief: 23andMe said Tuesday it is exploring “strategic alternatives,” which could include the sale of the company, a business

Medicine

RFK Jr. fumbles Medicare basics during second confirmation hearing

Robert F. Kennedy Jr., President Donald Trump’s health secretary nominee, showed limited knowledge about Medicare during his second confirmation hearing

Medicine

Vertex’s non-opioid pain drug gets FDA approval in milestone for company and research

The movement to steer pain treatment away from opioids notched a major victory Thursday, as the Food and Drug Administration

Medicine

Novartis sets ‘ambitious’ target; Skyrizi, Rinvoq sales climb

Today, a brief rundown of news involving Novartis and AbbVie, as well as updates from Biogen, Merck & Co. and

Medicine

A new, non-opioid pain drug is here. Getting it to patients could be agony.

For the last quarter century, one of the world’s most capable drug developers toiled to make a new, non-addictive kind

Medicine

Metsera, Maze secure combined $415 million in IPOs

Metsera and Maze Therapeutics are the second and third biotechnology firms this year to go public, raising $275 million and

Medicine

Christophe Weber, veteran Takeda CEO, to retire next year

Takeda CEO Christophe Weber plans to retire next year after a decade steering the Japanese drugmaker, a tenure in which

Medicine

RFK Jr. signals he’ll back Trump abortion policies, despite prior stance

Robert F. Kennedy Jr. on Wednesday told U.S. lawmakers that, if confirmed as the nation’s health secretary, he would support

Medicine

Judge halts Trump freeze on grants as states report healthcare payment portals back online

A federal judge on Tuesday temporarily halted the Trump administration’s freeze on federal financial assistance, bringing to a close arguably

Medicine

Lawmakers report states shut out of Medicaid payment portals following Trump funding freeze

Multiple lawmakers in Congress reported Tuesday that states were shut out of Medicaid payment portals after the Trump administration enacted

Medicine

Rival radiopharma drug to Novartis’ Lutathera succeeds in trial, ITM says

Dive Brief: A radiopharmaceutical medicine developed by Germany’s ITM outperformed everolimus, an older chemotherapy, in a late-stage study of people

Medicine

Sage rebuffs Biogen bid to take it over

Dive Brief: Sage Therapeutics’ board of directors has turned back partner Biogen’s opportunitistic attempt at a takeover, unanimously rejecting a

Medicine

Akero says MASH drug reverses liver damage in study, doubling shares

Dive Brief: Treatment with an experimental drug from Akero Therapeutics substantially reversed liver damage in a mid-stage study of people

Medicine

BridgeBio’s Neil Kumar on an underdog drug launch and wooing deal-hungry investors

Neil Kumar has for years contended his unorthodox drug company is overlooked by biotechnology investors. He may not have that

Medicine

AI in medtech is taking off. Here are 4 trends to watch in 2025.

Artificial intelligence was a topic of focus for the medical device industry in 2024. Companies including GE Healthcare, Medtronic and

Medicine

Mixed results for Keytruda; AbbVie to work with Neomorph

Today, a brief rundown of news involving Merck & Co. and AstraZeneca, as well as updates from AbbVie, Stealth BioTherapeutics

Medicine

The biopharma industry outlook on 2025: Uncertainty and change

As the first major drug industry conference each year, the J.P. Morgan Healthcare Conference is regularly described as a barometer

Medicine

Sara Brenner, FDA device official, named agency’s acting head

Sara Brenner, a Food and Drug Administration official within the agency’s medical device division, has been named the FDA’s acting

Medicine

Novo shares climb on early data for dual-acting obesity drug

Dive Brief: An experimental obesity drug from Novo Nordisk helped people lose an average of up to 22% of their

Medicine

Ascentage prices first biotech IPO of 2025, raising $126M

Dive Brief: Ascentage Pharma, a cancer drug developer based in Suzhou, China, on Thursday raised just over $126 million in

Medicine

Senate sets date to vet RFK Jr.’s nomination to lead HHS

Prominent vaccine skeptic Robert F. Kennedy Jr. will testify before the Senate Finance Committee on Jan. 29 as he attempts

Medicine

J&J oncology sales grow, but shares slide on outlook

Dive Brief: Johnson & Johnson on Wednesday reported modestly higher-than-expected earnings for the fourth quarter, while cautioning that unfavorable currency

Medicine

J&J joins Pfizer in detailing impact of Part D redesign

Johnson & Johnson expects changes in Medicare’s prescription drug benefit will negatively impact its sales by about $2 billion this

Medicine

Moderna gets $590M from US government for bird flu vaccine

Moderna will receive some $590 million from the U.S. government to develop messenger RNA vaccines for influenza strains, such as

Medicine

AstraZeneca, Daiichi’s Enhertu successor gets first FDA OK in breast cancer

Dive Brief: The Food and Drug Administration on Friday approved AstraZeneca and Daiichi Sankyo’s Datroway for use in people with

Medicine

Federal watchdog cites concerns with FDA’s accelerated approval process

Dive Brief: The Food and Drug Administration needs stricter standards for the accelerated approval process to ensure patients and the

Medicine

JPM25: The FDA’s future, AbbVie’s second thoughts and Lilly’s lesson

SAN FRANCISCO — With the close of J.P. Morgan Healthcare Conference, attention turns to next week’s inauguration of President-elect Donald

Medicine

Lilly’s Omvoh approved by FDA for Crohn’s

Dive Brief: Eli Lilly won Food and Drug Administration approval to sell its Omvoh medicine for adults with Crohn’s disease,

Medicine

Ozempic, Ibrance among next drugs picked by Medicare for price talks

Semaglutide, the popular drug sold by Novo Nordisk as Ozempic for diabetes and Wegovy for weight loss, is among a

Medicine

Novo shares high-dose Wegovy results; Amgen, AstraZeneca drugs get expanded OKs

Today, a brief rundown of news involving Novo Nordisk and AstraZeneca, as well as updates from Amgen, Atara Biotherapeutics and

Medicine

Medicare will negotiate Novo’s GLP-1 drug price. Here’s what that means for Ozempic, Wegovy.

Medicare’s next drug price negotiations will treat Novo Nordisk’s semaglutide as a single product, regardless of whether the metabolic disease

Medicine

Roche’s new deals head tries to navigate a more ‘complicated’ and ‘expensive’ biotech world

Roche has a big problem. With competition threatening some of its older and most lucrative biologic drugs, the Swiss pharmaceutical

Medicine

‘The bar has risen’: China’s biotech gains push US companies to adapt

Soon after starting a new biotechnology company, David Li realized he needed to rethink his strategy. Li had been conducting

Medicine

J&J files a potential blockbuster; Lykos shakes up its board

This week, the J.P. Morgan Healthcare Conference has brought a torrent of updates from drugmakers large and small. We’re highlighting

Medicine

At JPM, Biogen CEO tries to take down the deal temperature

On Tuesday morning, Biogen hosted an event for Wall Street analysts to better understand the company. One of the key

Medicine

JPM25: Amgen’s defense, Merck’s patent ‘hill’ and Viking’s long-term planning

For any hopes the dealmaking that started the J.P. Morgan Healthcare Conference would give the overall biotechnology sector a running

Medicine

Lilly blames slower-than-expected growth for 2024 sales miss

Dive Brief: Eli Lilly on Tuesday said the company’s revenue in 2024 totaled about $45 billion, a 32% jump on

Medicine

JPM25: Deals, Summit’s bravado and gene therapy headwinds

Every January, the Westin St. Francis in San Francisco is, for a few days, the center of the universe for

Medicine

Biogen’s ‘cold and calculated’ offer to buy Sage receives a mixed reaction on Wall Street

Late last week, Biogen made an unsolicited offer to buy one of its partners, brain drug developer Sage Therapeutics. The

Medicine

Tune raises $175M for hepatitis B medicine, epigenetic research

Genetic medicine startup Tune Therapeutics has raised another $175 million to develop therapies capable of “tuning” genes to treat disease,

Medicine

Bayer says menopause drug succeeds in breast cancer study

Dive Brief: An experimental menopause drug from Bayer succeeded in a late-stage trial in women taking drugs to treat or

Medicine

Ouro, backed by GSK, joins hunt to bring bispecifics to autoimmune disease

Dive Brief: Ouro Medicines, a new biotechnology startup, launched Friday with $120 million in funding to develop antibody drugs for

Medicine

Intellia to stop work on rare disease therapy, lay off staff

Dive Brief: Intellia Therapeutics will stop work on one of its principal drug research programs and lay off more than

Medicine

Patrizia Cavazzoni, key FDA official, to leave agency

Patrizia Cavazzoni, an influential Food and Drug Administration official who oversees much of the agency’s drug review work, will leave

Medicine

Pfizer’s PD-1 drug succeeds; AbbVie writes down $3.5B in Cerevel assets

Today, a brief rundown of news involving Pfizer, AbbVie and Royalty Pharma, as well as updates from Biogen and Alkeus

Medicine

IGM’s autoimmune pivot backfires as top drug disappoints in testing

IGM Biosciences will scrap its top two drugs and lay off nearly three-quarters of its workforce after reporting study results

Medicine

5 questions facing pharma in 2025

Typically, the election of a Republican to the White House is welcome news for the biotechnology and pharmaceutical sectors. The

Medicine

Kidney disease drugmaker Maze files for IPO

Maze Therapeutics on Tuesday filed plans for an initial public offering that could become the biotechnology sector’s first of the

Medicine

FDA adds warning to RSV shots from GSK, Pfizer

GSK’s and Pfizer’s vaccines for respiratory syncytial virus must carry labels warning of a possible increased risk of a rare

Medicine

Metsera reveals data supporting long-acting obesity shot

Dive Brief: Privately-held biotechnology startup Metsera said Tuesday a long-acting GLP-1 shot it’s developing helped people who are overweight or

Medicine

Vertex, startup Orna to partner on gene editing research

Dive Brief: Vertex Pharmaceuticals will work together with Orna Therapeutics over the next three years to develop technology that would

Medicine

An evolution in leadership and vision for this pharma company

About four years ago, Sheldon Koenig was thinking about retiring. After spending decades in leadership roles at different pharmaceutical companies,

Medicine

Orbis raises $93M to turn popular biologics into pills

Dive Brief: Orbis Medicines, a European biotechnology startup, has raised 90 million euros, or about $93 million, in a Series

Medicine

10 clinical trials to watch in the first half of 2025

Incretin drugs have been so successful in clinical testing they’re akin to a pharmaceutical Swiss Army knife. Already, medicines from

Medicine

FDA approves drugs from Vertex, Novo, Bristol Myers to wrap 2024

The Food and Drug Administration ended 2024 with a quartet of notable drug approvals, including three of new medicines that

Medicine

Neumora plummets on depression drug data

Neumora Therapeutics, a well-funded biotechnology company, lost more than 80% of its value Thursday because its most advanced drug failed

Medicine

Pfizer exits Sangamo pact; Roche, Ideaya strike ADC deals

Happy New Year! We hope you had a restful holiday; If you took a break from keeping up with biotech

Medicine

Zepbound, Mounjaro shortages are resolved, FDA confirms

The Food and Drug Administration on Thursday reaffirmed its assessment that Mounjaro and Zepbound, popular drugs for diabetes and obesity,

Medicine

Novartis shutters MorphoSys sites, lays off staff

Swiss pharmaceutical company Novartis plans to close MorphoSys sites in the U.S. and Germany in a “strategic decision” that will

Medicine

Vertex ‘ends the year in pain’ as latest non-opioid drug data disappoint

Vertex Pharmaceuticals lost more than $15 billion in value Thursday as new data on its closely watched pain drug disappointed

Medicine

Regeneron says study data support big bet on new blood thinners

Dive Brief: Regeneron Pharmaceuticals intends to advance two blood-thinning drugs into Phase 3 testing next year after mid-stage study results

Medicine

A venture firm breathes new life into an old NGM drug

KdT Ventures is launching a new biotechnology startup based on a drug it’s licensing from NGM Biopharmaceuticals, the companies announced

Medicine

Ionis gets a milestone approval; Another top FDA official to step down

Today, a brief rundown of news involving Ionis Pharmaceuticals and the Food and Drug Administration, as well as updates from

Medicine

Novo’s next-gen obesity drug misses expectations in closely watched trial

A new type of obesity drug being developed by Novo Nordisk has fallen short of expectations set by the company

Medicine

Roche sticks with Parkinson’s drug despite second study failure

An experimental drug for Parkinson’s disease that Roche has been developing for more than a decade just flunked another key

Medicine

Ottimo raises $140M to compete in chase for new type of cancer drug

David Epstein was ready to retire when an opportunity came along he couldn’t pass up. Epstein had just sold Seagen,

Medicine

Merck moves into obesity with deal for Hansoh’s GLP-1 pill

Dive Brief: Merck & Co. has made its first big move in obesity treatment, announcing Wednesday it is paying Hansoh

Medicine

Merck targets 2025 RSV season with antibody now under FDA review

Dive Brief: Doctors could have a new treatment option for protecting newborn infants from respiratory syncytial virus if the Food

Medicine

Namandjé Bumpus, FDA’s No. 2 official, to depart agency at end of year

Namandjé Bumpus, the Food and Drug Administration’s second-in-command, will depart the regulator at the end of the year, according to

Medicine

Edgewise weighs fast approval path for muscular dystrophy drug

Dive Brief: Edgewise Therapeutics plans to meet with regulators in the U.S. and Europe to discuss how much clinical trial

Medicine

Jazz to search for new chief as CEO plans retirement

Jazz Pharmaceuticals on Monday said it will begin searching for a successor to CEO Bruce Cozadd, who plans to retire

Medicine

Are we overlooking something critical in cell and gene therapy research?

Cell & gene therapy stands at the forefront of modern medicine, promising transformative treatments for previously intractable diseases. But, as

Medicine

‘Research that’s desperately needed’: White House conference spotlights women’s health

Research into women’s health has long gone underfunded in the U.S. But there’s some optimism that might be changing, attendees

Medicine

AbbVie to acquire Roche spinout Nimble in immune drug deal

Dive Brief: AbbVie will pay $200 million to acquire privately held Nimble Therapeutics and its pipeline of oral peptide drugs

Medicine

Dietmar Berger is Gilead’s new CMO; Padlock investors sue Bristol Myers

Today, a brief rundown of news involving Gilead and Padlock Therapeutics, as well as updates from Boundless Bio, Lonza and Bausch

Medicine

FDA panel seeks more data on RSV vaccine safety in infants

A panel of experts convened by the Food and Drug Administration called for more data to be collected on the

Medicine

CMS says private Medicare plans can’t automatically deny Biogen’s ALS drug

In a rare move, the U.S. agency behind Medicare is warning insurers who provide Medicare Advantage plans that they can’t

Medicine

FDA flags additional injury risk for Intercept’s liver drug

The Food and Drug Administration has identified additional safety concerns associated with use of a drug used to treat a

Medicine

Editas to lay off staff after search for sickle cell partner comes up empty

Dive Brief: Editas Medicine will lay off 180 employees, or about two-thirds of its workforce, over the next six months

Medicine

Q32 Bio battered by study failure of immune drug

Dive Brief: Shares of Q32 Bio lost two-thirds of their value Wednesday after the company reported disappointing study results for

Medicine

With new data, Lilly sets pace for next wave of breast cancer drugs

An experimental breast cancer drug developed by Eli Lilly met its main goal in a Phase 3 study, helping people

Medicine

Chroma, Nvelop merge to marry genetic medicine ‘cargo’ to delivery

Epigenetic editing startup Chroma Medicine is merging with Nvelop Therapeutics in a deal that will also bring in $75 million

Medicine

ASH24: Leukemia drug sequencing, sickle cell questions and a new kind of CAR-T

The American Society of Hematology’s annual meeting continued Monday with important presentations and discussions on the latest blood disease research,

Medicine

Gene therapy uptake in sickle cell stays slow, despite patient interest

One year on from the landmark U.S. approval of two powerfully effective gene therapies for sickle cell disease, the treatments

Medicine

ASH24: Darzalex in smoldering myeloma, Merck’s ADC data and Novo’s sickle cell drug

This weekend, thousands of researchers and physicians descended on San Diego for the American Society of Hematology’s annual meeting. While

Medicine

Endometriosis drug research, long underfunded, confronts familiar problems in women’s health

Ally Schott felt lonely when she was diagnosed with endometriosis at the age of 12. With few treatment options and

Medicine

Atea plans Phase 3 study for hepatitis C drug after mid-stage results

Dive Brief: Atea Pharmaceuticals said Wednesday that its experimental combination regimen to treat the hepatitis C virus succeeded in a

Medicine

AstraZeneca, Daiichi build cancer drug case; Amgen invests $1B

Today, a brief rundown of news involving Daiichi Sankyo, Agenus and Amgen, as well as updates from the U.S. PTO,

Medicine

BioAge shares tumble after decision to halt obesity drug study

Dive Brief: BioAge Labs said it is terminating a mid-stage study of its obesity drug candidate azelaprag in combination with

Medicine

Lilly adds to obesity drug production push with $3B investment

Eli Lilly will spend $3 billion to expand a manufacturing facility in Wisconsin it bought in April, adding new capabilities

Medicine

With conflicts of interest in focus, Trump’s pick to run FDA could face scrutiny of his own industry ties

Robert F. Kennedy Jr., chosen by President-elect Donald Trump to be the next health secretary, has made it his mission

Medicine

GSK taps a startup for shot at Alzheimer’s drug

Inside every human cell are thousands of snippets of genetic code that serve as the directions for creating proteins. And

Medicine

Atlas doubles down on ‘disciplined’ biotech investing with latest fundraise

Dive Brief: Atlas Venture said Thursday that it’s raised $450 million for its 14th fund, through which the firm will

Medicine

Nuvig pulls in $161M to make better immune drugs

Biotechnology startup Nuvig Therapeutics is the latest emerging immune drug developer to attract investors’ attention, announcing Thursday a $161 million

Medicine

Dewpoint, Mitsubishi partner on ALS drug in deal worth up to $480M

Dewpoint Therapeutics, a young biotechnology company, could receive nearly half a billion dollars if all goes to plan in a

Medicine

Coherus, sharpening immuno-oncology focus, sells another biosimilar for over $500M

Coherus BioSciences has reached a deal to sell another one of its biosimilars as part of a plan to make

Medicine

Janux impresses Wall Street with new prostate cancer drug results

Shares of Janux Therapeutics surged to record highs following the release of study results for a drug that, if ultimately

Medicine

Novocure device succeeds in pancreatic cancer study; FDA sets Cytokinetics decision date

Today, a brief rundown of news involving Novocure and Merus, as well as updates from Cytokinetics, Fate Therapeutics and Bluebird

Medicine

Diabetes advocacy group discourages use of compounded GLP-1 drugs

The American Diabetes Association, a high-profile advocacy group, is warning against widespread use of compounded versions of popular weight loss

Medicine

Are You Using Next-Gen Sequencing to inform AAV product and process quality? Here are 4 reasons you should

Evolving technology has helped advance the field of gene therapy, and today, more and more biopharmaceutical innovators are using groundbreaking

Medicine

Alector turns to layoffs as Alzheimer’s drug fails

Brain drug developer Alector is laying off staff after one of its most advanced experimental medicines failed to show enough

Medicine

Roche to buy cell therapy developer Poseida for $1B

Swiss pharmaceutical giant Roche is spending around $1 billion to acquire a San Diego-based biotechnology company that’s trying to treat

Medicine

Roche’s TIGIT-targeting drug for cancer fails its biggest test

Roche’s long-running bet on a new kind of cancer immunotherapy has, after years of shrinking optimism and second-guessing by analysts

Medicine

Kronos, Idorsia plan layoffs; PTC shelves ALS drug

Today, a brief rundown of news involving Kronos Bio, Idorsia and PTC Therapeutics, as well as updates from Alnylam Pharmaceuticals

Medicine

Sarepta rebuilds drug pipeline with Arrowhead deal

Dive Brief: Sarepta Therapeutics has turned to dealmaking to restock a drug pipeline analysts worried was growing thin, announcing Tuesday

Medicine

How Intra-Cellular surprised Wall Street by breaking character

For drug companies, predicting how much money a product will make is a risky endeavor. If the estimate ends up

Medicine

Amgen obesity drug cuts weight in study, but results miss Wall Street’s high mark

Dive Brief: Amgen on Tuesday said its weight loss drug MariTide helped people with obesity lose up to 20% of

Medicine

Biden administration proposes Medicare, Medicaid coverage of pricey weight loss drugs

The Biden administration on Tuesday proposed a rule that would allow Medicare and Medicaid to cover weight loss drugs for

Medicine

Biohaven muscle drug misses goal of SMA study, but advances in obesity

Dive Brief: An experimental, muscle-preserving drug from Biohaven fell short of its goal in a Phase 3 study of people

Medicine

New data could help Merck expand use of cardiovascular drug

Dive Brief: Adding Merck & Co.’s new cardiovascular drug Winrevair to background therapy helped people with severe lung hypertension stay

Medicine

Amgen picks prolific biotech founder Chang as new top scientist

Howard Chang, a top biotechnology researcher and longtime professor at Stanford University, will join Amgen as chief scientific officer on

Medicine

Will Walgreens’ store closures disrupt its clinical trial aims?

Retail pharmacy giants have been straining under the intense headwinds hitting the industry this year — and Walgreens’ most recent

Medicine

Lexicon to disband sales team, lay off 60% of staff

Dive Brief: Lexicon Pharmaceuticals will lay off 60% of its workforce and eliminate its commercial organization in a restructuring meant

Medicine

BridgeBio heart drug approved by FDA, setting up battle with Pfizer

The Food and Drug Administration has approved a new medicine for a deadly genetic heart condition, boosting its developer, BridgeBio

Medicine

Johns Hopkins surgeon Makary is Trump’s pick to lead FDA

President-elect Donald Trump on Friday named Johns Hopkins University surgeon Marty Makary to lead the Food and Drug Administration, choosing

Medicine

Halozyme drops Evotec buyout bid; Patient dies in Neurogene trial

Today, a brief rundown of news involving Halozyme and Neurogene, as well as updates from Argenx and Kura Oncology that

Medicine

Novartis wagers more than $1B on gene therapies for the nervous system

Through a new deal, Novartis has added a handful of experimental gene therapies to its neuroscience research pipeline. Novartis is

Medicine

Biotech startups are built on venture capital. Track funding rounds here.

Drug development is an expensive, risky endeavor. Biotechnology companies just starting out are many years away from seeing profits, if

Medicine

Pfizer, under pressure to change, names oncology head as new R&D chief

Pfizer on Wednesday said it will promote Chris Boshoff to chief scientific officer and president of research and development as

Medicine

Sage’s string of research failures continues

Sage Therapeutics is shelving one of its most important experimental drugs, after a last-ditch effort to prove it can be

Medicine

Astellas application rejected by FDA; Cytokinetics strikes licensing deal with Bayer

Today, a brief rundown of news involving Astellas and Cytokinetics, as well as updates from Cybin, Neurogene and Novartis that

Medicine

Under-the-skin Keytruda comparable to infused version in Phase 3 study, Merck says

Dive Brief: An experimental under-the-skin injection of Merck & Co.’s cancer immunotherapy Keytruda showed similar characteristics as the current intravenous

Medicine

CRISPR therapy from Intellia may ameliorate rare heart disorder, data suggest

Dive Brief: A single infusion of a CRISPR therapy developed by Intellia Therapeutics showed promising signs of stabilizing a heart

Medicine

Syndax secures FDA OK for new kind of leukemia drug

Dive Brief: Massachusetts-based Syndax Pharmaceuticals won Food and Drug Administration approval Friday for a new kind of drug to treat an

Medicine

Leveraging NGS to move precision oncology forward, from CDx to commercialization

Advances in precision oncology have allowed patients to access innovative life-saving therapies when they previously had few, or no, other

Medicine

PTC wins US approval of gene therapy for fatal enzyme disorder

Dive Brief: PTC Therapeutics on Wednesday won Food and Drug Adminitration approval for Kebilidi, the first gene therapy cleared in

Medicine

Halozyme bids for Evotec; BeiGene gets a new name

Today, a brief rundown of news involving Evotec, Bluebird bio and the company formerly known as BeiGene, as well as

Medicine

Surviving in biotech’s new normal: 5 tips from industry VCs and CEOs

Market downturns take a toll. For many young biotechnology companies, the past few years have been a lesson in survival,

Medicine

‘Find any advantage’: 3 biotech leaders on driving R&D success

Failure is more common than success for young biotechnology companies attempting to get a new drug onto the market. Drug

Medicine

How a Biogen drug set the stage for a new biotech targeting ALS

Trace Neuroscience, a freshly launched startup, is developing a type of genetic medicine it believes could help most, if not

Medicine

Trump names RFK Jr. as his pick to lead HHS

President-elect Donald Trump plans to nominate Robert F. Kennedy Jr. to lead the Department of Health and Human Services in

Medicine

Eisai wins over European regulators on Alzheimer’s drug Leqembi

In an unusual reversal, key drug regulators are now saying Leqembi, a high-profile medicine for Alzheimer’s disease, should be approved

Medicine

Metsera raises $215M to accelerate obesity drug plans

Dive Brief: Metsera, already a well-funded biotech startup, added another $215 million to its coffers as investors responded to the

Medicine

Amgen shares sink on obesity drug concerns; AstraZeneca to spend $3.5B on manufacturing

Today, a brief rundown of news involving Amgen and AstraZeneca, as well as updates from Roche, Novartis, and Centessa Pharmaceuticals

Medicine

Biotech investors, including Third Rock, pump $100M into a startup’s genetic medicine for ALS

Third Rock Ventures, the well-known backer of biotechnology companies, is leading a nine-figure fundraising round for a startup that aims

Medicine

GSK partners with Flagship startup to hunt for Parkinson’s drugs

Flagship Pioneering startup Vesalius Therapeutics has signed a deal with GSK, the companies announced Tuesday, for the British pharma to

Medicine

On Wall Street, ‘flat out’ failure of AbbVie schizophrenia drug leaves analysts stunned

Through a recent, nearly $9 billion acquisition, AbbVie surged to the front of a new wave of antipsychotic drugs that

Medicine

FDA approves new CAR-T competitor to Gilead’s Tecartus

Dive Brief: The Food and Drug Administration on Friday approved a new cell therapy for a type of leukemia. Called

Medicine

Moderna said to shuffle sales leadership; Vertex records first Casgevy sale

Today, a brief rundown of news from Moderna, Intra-Cellular Therapies and Vertex Pharmaceuticals, as well as updates from Syndax Pharmaceuticals

Medicine

With Trump victorious, biotech industry’s focus turns to his plans for FDA, FTC

Donald Trump’s victory in the U.S. presidential election Tuesday means change is coming for federal health agencies and the industries

Medicine

What RFK Jr.’s influence on Trump could mean for pharma

With the U.S. presidential election decided, one name is suddenly circulating in healthcare: Robert F. Kennedy Jr. President-elect Donald Trump

Medicine

Athira exploring strategic alternatives after Alzheimer’s failure

Dive Brief: Athira Pharma, a small drugmaker focused on neuroscience, is looking into the different paths it could take to

Medicine

Tezspire succeeds in chronic rhinosinusitis; Gilead writes down Trodelvy value

Today, a brief rundown of news from AstraZeneca, Amgen and Jazz Pharmaceuticals, as well as updates from Geron, Gilead Sciences

Medicine

Kalaris to go public via reverse merger with AlloVir

Public biotechnology company AlloVir has agreed to merge with the privately held Kalaris Therapeutics, nearly one year after a clinical

Medicine

Sarepta scraps a Duchenne drug as gene therapy sales rise

Dive Brief: Sarepta Therapeutics is giving up on an experimental drug for Duchenne muscular dystrophy as sales rocket for its

Medicine

Moderna earnings beat forecasts, but analysts question whether sales spike will last

Dive Brief: Moderna on Thursday reported third quarter sales of its COVID-19 vaccine that substantially outperformed analyst expectations. The company

Medicine

Acadia sells speedy drug review voucher for $150M

Acadia Pharmaceuticals agreed to sell a priority review voucher to an undisclosed buyer for $150 million, a price tag on

Medicine

Novo sees Wegovy sales rise as supply constraints ease

Dive Brief: Dive Insight: Novo and Lilly are racing to build on their dominant obesity drug businesses. Both are working

Medicine

Sana to lay off staff, deepen autoimmune focus in latest retrenchment

Sana Biotechnology will lay off staff and shift its research focus in the latest retrenchment for a company only three

Medicine

Cancer cell therapy from Arcellx, Gilead shows promise in early data

Dive Brief: A cancer cell therapy developed by Arcellx and Gilead Sciences helped reduce or eliminate signs of multiple myeloma

Medicine

Viking data provide latest test of oral obesity drug potential

Dive Brief: New results from a small study of Viking Therapeutics’ oral obesity drug raised expectations among Wall Street analysts

Medicine

Neurogene secures $200M ahead of anticipated study readout

Neurogene, a gene therapy developer focused on rare neurological diseases, has secured $200 million through a private funding deal that

Medicine

GSK vaccine sales sink on lower demand for RSV, shingles shots

Sales of GSK’s top-selling vaccines fell sharply during the third quarter amid lower demand, sending shares in the British pharmaceutical

Medicine

FDA’s new device chief faces challenges. Patient groups, industry are still optimistic.

Michelle Tarver, the new leader of the Food and Drug Administration’s medical device center, faces significant challenges. Tarver is taking

Medicine

Evommune raises $115M to accelerate immune drug tests

California biotechnology startup Evommune has raised $115 million to advance a pair of medicines it’s developing for chronic immune conditions.

Medicine

Compass delays anticipated psilocybin readout, cuts staff

Dive Brief: Compass Pathways said it will lay off 30% of its workforce, narrow its research focus and explore selling

Medicine

Regeneron battles Wall Street uncertainty; Madrigal extends fast launch of MASH drug

Today, a brief rundown of news from Regeneron Pharmaceuticals and Madrigal Pharmaceuticals, as well as updates from UCB, AbbVie and

Medicine

Novo, with new results, to seek approval for obesity drug in MASH

Novo Nordisk will seek regulatory approval of semaglutide, the key ingredient in its popular weight loss medicine, in a common

Medicine

Roche weighs whether speedy approval path is open for latest Alzheimer’s drug

Dive Brief: Roche may seek an accelerated U.S. approval of its experimental Alzheimer’s disease drug trontinemab if the therapy continues

Medicine

Jade, another biotech spinout of Paragon, to merge with Aerovate

Dive Brief: Jade Biosciences, a privately held developer of immune disease drugs, will combine with Aerovate Therapeutics in a reverse

Medicine

Novo takes big step toward ending Ozempic, Wegovy shortages

All doses of Novo Nordisk’s popular GLP-1 medicines Ozempic and Wegovy are available in the U.S. and being regularly shipped

Medicine

Investors put $115M into Axonis amid revived interest in brain drugs

Axonis Therapeutics, a young biotechnology company, has raised $115 million to support its efforts to make first-of-their-kind medicines for neurological

Medicine

Pfizer sales of RSV vaccine ebb, but company gains market share

Sales of Pfizer’s new vaccine for respiratory syncytial virus were lower in the third quarter than during the same period

Medicine

Paragon spinout joins hunt for new type of cancer immunotherapy

Paragon Therapeutics, a biotechnology company creator with a web of spinouts, is taking a new startup public to develop an

Medicine

Monte Rosa joins with Novartis in ‘molecular glue’ drug deal

Dive Brief: Novartis will pay $150 million to gain rights to “molecular glue degraders” being developed by biotechnology company Monte

Medicine

AbbVie to acquire a J&J-backed brain drugmaker for $1.4B

AbbVie has agreed to acquire a young company with drugmaking technology from Johnson & Johnson and an experimental treatment for

Medicine

Intellia data spark debate about CRISPR drug’s potential

Dive Brief: Intellia Therapeutics on Thursday released detailed Phase 2 results from a study of a gene-editing therapy for hereditary

Medicine

With $92M, Kivu sets out to make ‘kinder, gentler’ ADCs

Dive Brief: Kivu Biosciences, a San Francisco-based biotechnology startup developing targeted drugs for cancer, has raised $92 million in a

Medicine

Merck, Pfizer lifted as CDC backs broader use of pneumococcal vaccines

A panel of advisers to the Centers for Disease Control and Prevention on Wednesday recommended lowering the age for routine

Medicine

GPCR drugmaker Septerna amasses $288M in IPO

Septerna, a developer of medicines that target a ubiquitous family of proteins, on Thursday priced a $288 million initial public

Medicine

Sanofi earnings boosted by Beyfortus, earlier vaccine sales

Sanofi reported a 25% boost in sales for its vaccines division during the third quarter, helped by earlier-than-anticipated orders of

Medicine

GSK invests $800M in manufacturing; Amgen sets small discount for Eylea biosimilar

Today, a brief rundown of news from GSK and Amgen, as well as updates from Roche, AbbVie, and Marinus Pharmaceuticals

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

Dengue is spreading and Sanofi is pulling the market’s only vaccine. What’s next?

Derek Wallace, president, global vaccine business unit, Takeda Permission granted by Takeda Derek Wallace was in a dengue-focused ICU

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

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

RNA editing: emerging from CRISPR’s shadow

Thorsten Stafforst remembers being told to stop wasting his time. It was early last decade and scientists across the world

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

Sanofi, expanding in radiopharma, strikes a joint venture deal

Dive Brief: Sanofi will invest 300 million euros, or about $325 million, for a roughly 16% stake in a new

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

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

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

Tremfya, Carvykti sales grow as J&J prepares for Stelara patent loss

Dive Brief: Sales of Johnson & Johnson’s cancer therapy Carvykti and immune disease drug Tremfya grew strongly during the third

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