Category: Medicine

Medicine

Stelara biosimilar from Alvotech, Teva approved by FDA

Dive Brief: Alvotech and Teva on Tuesday won Food and Drug Administration approval for Selarsdi, the second biosimilar poised to

Medicine

Sage’s cognition drug fails in Parkinson’s study

An experimental drug designed to improve brain function in people with nerve-degrading disorders has failed a mid-stage study that tested

Medicine

Cerevel, in ‘major surprise,’ finds success in late-stage Parkinson’s study

Cerevel Therapeutics, a biotechnology company in the midst of being acquired by AbbVie, on Thursday said a Parkinson’s disease treatment

Medicine

Roche wins FDA OK for Alecensa in early lung cancer

The Food and Drug Administration has made a medicine from Roche the first specifically available for early treatment of lung

Medicine

Alvotech deal could heighten biosimilar pressure on Humira

Dive Brief: Alvotech and U.S. commercial partner Teva have signed a “long-term agreement” with an unspecified company to boost access

Medicine

Vertex begins bid for US approval of non-opioid painkiller

Vertex Pharmaceuticals is vying for approval of an experimental and closely watched painkiller that could become an alternative to addictive

Medicine

23andMe CEO plans to take company private

Dive Brief: 23andMe CEO Anne Wojcicki plans to take the DNA testing company private, according to a Wednesday filing with

Medicine

Metsera, a well-funded obesity drug startup, sees chance to challenge Lilly, Novo

Dive Brief: Metsera, a richly funded biotechnology startup, launched Thursday with a portfolio of weight loss drugs the company claims

Medicine

Lilly obesity drug shows benefit in sleep disorder study, pointing to new use

Fresh clinical trial results for Eli Lilly’s drug Zepbound point to a new use for the weight loss medicine in

Medicine

Intra-Cellular builds case for depression drug with late-stage trial win

An antipsychotic drug from Intra-Cellular Therapies appears to also work as an add-on therapy for depression, according to clinical trial

Medicine

J&J sees mixed performance from new multiple myeloma drugs

Dive Brief: Sales of Johnson & Johnson’s multiple myeloma medicine Tecvayli more than doubled in the first quarter versus the

Medicine

Biotech landlord Alexandria on research clusters and the sector’s recovery

Joel Marcus built a real estate empire on the life sciences industry’s steady growth. Over three decades, his company Alexandria

Medicine

Roche reports survival data for new dual-acting lymphoma drug

Dive Brief: Roche’s new dual-acting blood cancer drug Columvi combined with chemotherapy helped people with a type of lymphoma live

Medicine

Keeping cleanrooms clean: Choosing the right laboratory equipment is key

Many of the newest and most promising treatments for what were once incurable diseases incorporate living cells and human tissues.

Medicine

New postpartum depression drugs are here. Diagnosis, treatment hurdles still stand in the way.

When Katherine Wisner began studying postpartum mental health in the 1980s, the field barely existed. Relatively little research was focused

Medicine

Novartis pauses enrollment in some Kisqali trials to fix manufacturing

Dive Brief: Novartis will pause enrollment in certain clinical trials of its breast cancer drug Kisqali in order to meet

Medicine

Roche, Adaptimmune part ways on cell therapy research

Dive Brief: Genentech, the research subsidiary of Swiss pharmaceutical giant Roche, has decided to cut short a partnership focused on

Medicine

Biotech IPOs bounced back in first quarter, but backlog remains

Initial public offerings by biotechnology companies reached pre-pandemic levels during the first quarter, with nine drugmakers collectively raising more than

Medicine

European regulator concludes no suicide link to obesity drugs

Dive Brief: Novo Nordisk and Eli Lilly drugs to treat diabetes and obesity have no “causal association” with suicidal thoughts

Medicine

US sues Regeneron, alleging false price reporting on Eylea

The U.S. Department of Justice on Wednesday accused Regeneron of defrauding Medicare by knowingly inflating the average sales price for

Medicine

Century buys a startup, raises funding in cell therapy expansion

Dive Brief: Biotechnology company Century Therapeutics is expanding its autoimmune disease research with a pair of deals that will hand

Medicine

J&J, Rallybio partner on drug development for rare fetal condition

Dive Brief: Biotechnology company Rallybio is partnering with Johnson & Johnson, announcing a collaboration Wednesday to develop new treatments for

Medicine

Vertex to buy kidney disease drugmaker Alpine for $4.9B

Dive Brief: Vertex Pharmaceuticals on Wednesday said it would buy biotechnology company Alpine Immune Sciences and its experimental kidney disease

Medicine

Pfizer, with new study results, seeks to bring RSV shot to adults aged 18-59

Dive Brief: Pfizer on Tuesday said it plans to ask regulators to broaden the approval of its vaccine for respiratory

Medicine

PureTech launches Seaport, hoping to create Karuna 2.0

Hoping to repeat a recent success story, the biotechnology startup creator PureTech Health has launched a new company aimed at

Medicine

Trial shows Wegovy can ease heart failure symptoms

Dive Brief: Novo Nordisk’s weight loss drug Wegovy helped people with obesity, diabetes and heart failure have fewer cardiovascular symptoms

Medicine

Private biotech funding ticks up as venture firms deploy cash

Private funding for biotechnology startups rose during the first three months of the year, suggesting some of the sector’s momentum

Medicine

Diagonal starts up with $128M to make better ‘activator’ antibody drugs

Dive Brief: Diagonal Therapeutics, a biotechnology startup focused on creating antibodies that activate, rather than block, their targets, emerged from

Medicine

Amylyx to pull ALS drug from market in rare move

Amylyx Pharmaceuticals is pulling from market one of the few approved treatments for ALS. Rarely do drugmakers voluntarily withdraw products.

Medicine

FDA approves new antibiotic for several hard-to-treat infections

Dive Brief: Swiss drugmaker Basilea Pharmaceutica on Wednesday won Food and Drug Administration approval for its drug Zevtera in a

Medicine

J&J to acquire Shockwave Medical for $13.1B

Johnson & Johnson has agreed to acquire Shockwave Medical for approximately $13.1 billion, the companies announced Friday morning. The deal

Medicine

Bristol Myers CAR-T therapy approved by FDA for earlier myeloma use

Dive Brief: The Food and Drug Administration has cleared Bristol Myers Squibb and 2seventy Bio’s multiple myeloma cell therapy for

Medicine

Boehringer Ingelheim to lay off staff amid biosimilar challenges

Dive Brief: Boehringer Ingelheim is laying off staff in response to sluggish adoption of its Humira biosimilar Cyltezo, a company

Medicine

Contineum prices biotech’s latest IPO, raising $110M for neuroinflammatory drugs

Contineum Therapeutics has raised $110 million in an initial public offering, the biotechnology industry’s 10th of the year, to advance

Medicine

Merck puts KRAS cancer drug competitor to the test

Dive Brief: Merck & Co. has begun a large clinical trial testing an experimental cancer drug it’s developing for tumors

Medicine

Genmab buys ProfoundBio for $1.8B, adding to ADC dealmaking flurry

Dive Brief: Genmab said Wednesday it’s agreed to pay $1.8 billion for ProfoundBio, gaining access to the biotechnology startup’s technology

Medicine

Paragon’s hub-and-spoke biotech model yields another reverse merger

Dive Brief: A third biotechnology company from the startup creator Paragon Therapeutics is heading to the public markets. Paragon’s Oruka

Medicine

Acorda files for bankruptcy, reveals asset sale plan

Dive Brief: Acorda Therapeutics has filed for bankruptcy and, on Monday, announced it has reached an agreement to sell essentially

Medicine

Roivant reveals positive immune drug data, share buyback plans

Dive Brief: An experimental drug being developed by a subsidiary of Roivant Sciences succeeded in a Phase 2 trial testing

Medicine

5 FDA decisions to watch in the second quarter

The year started well for the biotechnology industry. Steady dealmaking coupled with a rebound in initial public offerings helped lift

Medicine

Vertex moves kidney disease drug into late-stage testing

Dive Brief: Vertex Pharmaceuticals on Monday said it will advance an experimental kidney disease drug into Phase 3 testing and

Medicine

FDA approves Merck lung disease drug acquired in $11B deal

The Food and Drug Administration on Tuesday approved a new Merck & Co. drug to treat pulmonary arterial hypertension. Called

Medicine

European study finds popular ALS drug ineffective

A large clinical trial has found that a drug commonly used by patients with ALS is not effective at treating

Medicine

Biotech veteran Art Krieg postpones retirement to build an unorthodox drug startup

Two years after Art Krieg sold his last biotechnology company to Regeneron Pharmaceuticals, the scientific entrepreneur and industry veteran is

Medicine

‘The heart is back,’ says Cardior CEO, as Novo’s $1B deal boosts field

When the Food and Drug Administration expanded approval of Novo Nordisk’s weight loss medicine Wegovy to also protect heart health,

Medicine

Bristol Myers says KRAS drug succeeds in key trial

Dive Brief: Bristol Myers Squibb’s cancer pill Krazati helped people with a certain kind of non-small cell lung cancer live

Medicine

Gilead bets on Xilio cancer drug as biotech restructures

Dive Brief: Gilead Sciences will pay $30 million and invest another $13.5 million in Xilio Therapeutics to access an experimental

Medicine

FDA approves Akebia anemia pill, two years after rejection

Dive Brief: The Food and Drug Administration has approved Akebia Therapeutics’ blood-boosting pill Vafseo for people with anemia from chronic kidney

Medicine

Boundless Bio breaks IPO lull with $100M fundraise

Dive Brief: Boundless Bio, a cancer drug developer backed by Bayer and Arch Venture Partners, has raised $100 million in

Medicine

Moderna gets Blackstone backing for flu vaccine R&D

Dive Brief: Blackstone Life Sciences will invest as much as $750 million on influenza vaccine research and development by Moderna,

Medicine

Supreme Court weighs abortion opponents’ standing in mifepristone case

The Supreme Court on Tuesday heard legal arguments in a high-profile case involving the Food and Drug Administration’s expanded approval

Medicine

Viking stays in obesity drug race with early data for weight loss pill

Dive Brief: A dual-acting weight loss pill from Viking Therapeutics helped people with obesity lose up to 5% of their

Medicine

Axsome drug succeeds in narcolepsy symptoms trial

An experimental drug from Axsome Therapeutics was successful in a late-stage clinical trial evaluating it as a treatment for narcolepsy

Medicine

AbbVie to buy immune drug developer Landos

Dive Brief: Abbvie is expanding its pipeline of inflammatory disease drugs, announcing Monday a small deal to acquire biotechnology company

Medicine

Capstan heats up ‘in vivo’ cell therapy chase with $175M fundraise

Capstan Therapeutics, a biotechnology startup developing medicines that reprogram cells inside the body, has raised another $175 million to bring

Medicine

Mirador debuts with $400M, picking up where immune drugmaker Prometheus left off

The executives behind autoimmune drug developer Prometheus Biosciences are back, armed with more than $400 million to launch their latest

Medicine

Bayer streamlines pharma leadership team amid company shakeup

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

Medicine

Thermo Fisher, Bayer partner to develop companion diagnostics

Dive Brief: Thermo Fisher Scientific said Wednesday that it has partnered with Bayer to develop companion diagnostic assays for the

Medicine

Medicare to cover Novo’s obesity drug for some patients

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

Medicine

FDA clears first-of-its-kind Duchenne drug for broad use

Dive Brief: The Food and Drug Administration on Thursday approved a first-of-its-kind drug for Duchenne muscular dystrophy, clearing Duvyzat, a

Medicine

NextCure to lay off 37% of staff, dial back research plans

Cancer immunotherapy developer NextCure is laying off 37% of its staff and streamlining its research plans, the company said Thursday.

Medicine

Roche autoimmune disease drug disappoints in closely watched trial

An autoimmune disease drug from Roche and Chugai Pharmaceutical hit its main goal in a closely watched trial, but the

Medicine

Orchard sets out to sell world’s priciest gene therapy

Dive Brief: Orchard Therapeutics said Wednesday it will offer a new gene therapy to children with a rare, devastating disease

Medicine

Acelyrin eye drug heads to late-stage testing after trial win

A young biotechnology company plans to move an experimental medicine for a rare eye disease into late-stage testing after results

Medicine

Orchard follows buyout with FDA approval of rare disease gene therapy

Dive Brief: Orchard Therapeutics on Monday won Food and Drug Administration approval for the first gene therapy to treat a

Medicine

With new data, Bayer readies rival to Astellas menopause drug

Dive Brief: Bayer on Tuesday said it plans to seek regulatory approval of a drug for symptoms of menopause following

Medicine

Give HCPs a proactive way to reach your field team: Add inbound

Ask a healthcare professional (HCP), and chances are good that they’d like an easy way to reach out to biopharma

Medicine

Bluebird, short on cash, takes on $175M in debt financing

Gene therapy developer Bluebird bio has raised a large debt financing in a bid to extend its cash runway for

Medicine

German biotech Tubulis cashes in on ADC ‘momentum’ with €128M financing

Dive Brief: Tubulis, a German biotechnology startup developing antibody-drug conjugates, brought in €128 million, or about $140 million, to bring

Medicine

J&J, Novo support Asgard’s push to make ‘in vivo’ cell therapies

Asgard Therapeutics has become the latest emerging developer of “in vivo” cell therapies to attract the attention of large drugmakers.

Medicine

AstraZeneca adds another rare disease drug in $800M buyout of startup Amolyt

Dive Brief: AstraZeneca is bolstering its rare disease division with the purchase of Amolyt Pharma, an endocrine disease specialist backed

Medicine

Madrigal, FDA approval in hand, outlines plan to sell MASH drug

The first drug for metabolic dysfunction-associated steatohepatitis will cost $47,400 per year, its developer, Madrigal Pharmaceuticals, said Thursday. Madrigal revealed

Medicine

FDA panel backs broader use of J&J, Bristol Myers cell therapies for myeloma

Advisers to the Food and Drug Administration have endorsed the use of two cellular medicines for multiple myeloma earlier in

Medicine

Bristol Myers cell therapy wins first-of-its-kind approval

Dive Brief: For the first time, the Food and Drug Administration has approved a cell therapy for hard-to-treat forms of

Medicine

Madrigal wins FDA approval of first drug for MASH

The Food and Drug Administration has approved the first medicine for a common liver disease that’s been a top target

Medicine

BIO changes stance, backs bill to limit China’s role in US biotech

Dive Brief: The Biotechnology Innovation Organization on Wednesday backed legislation aiming to limit the industry’s association with Chinese life sciences

Medicine

Merck reveals plans to develop newer HPV shots

Dive Brief: Merck on Wednesday announced plans to start clinical trials testing a newer version of its vaccine for human

Medicine

FDA to focus on ‘early deaths’ in meeting on broader CAR-T use in myeloma

Two cellular medicines for multiple myeloma were associated with an increased risk of early death in clinical testing, raising questions

Medicine

Allogene taps Arbor in pursuit of ‘off-the-shelf’ CAR-T therapies for autoimmune disease

Allogene Therapeutics is turning to gene editing startup Arbor Biotechnologies for help developing “off-the-shelf” cell therapies for autoimmune diseases, the

Medicine

After surprise trial failure, ALS doctors brace for one less treatment option

For Rick Bedlack, director of the ALS clinic at Duke University, tough times come with the job. He and his

Medicine

Roche, following setbacks, turns to its next Alzheimer’s drug

Dive Brief: Roche’s experimental Alzheimer’s disease drug trontinemab showed “best-in-class” potential based on its ability to quickly clear clumps of

Medicine

Amylyx CEOs look for a path forward following major setback

In 2020, a small clinical trial had a big impact. The study evaluated whether a drug from a young and

Medicine

Boundless Bio, a Bayer-backed cancer biotech, seeks an IPO

Boundless Bio, an oncology startup backed by Bayer and Arch Venture Partners, on Wednesday became the first biotechnology company to

Medicine

Novo’s latest obesity pill spurs major weight loss in small trial

Dive Brief: An experimental pill developed by Novo Nordisk helped obese people lose 13% of their body weight after three

Medicine

Amylyx ALS drug fails crucial study, putting company’s future in doubt

A large clinical trial meant to confirm the benefits of a new ALS medication has instead failed, dealing a major

Medicine

FDA delays decision on Lilly’s closely watched Alzheimer’s drug

Dive Brief: The Food and Drug Administration is delaying an approval decision on Eli Lilly’s experimental medicine for Alzheimer’s disease

Medicine

FDA clears use of Novo’s obesity drug to protect heart health

The Food and Drug Administration has expanded the label for Novo Nordisk’s fast-selling weight loss drug Wegovy following study results

Medicine

Why Cigna is capping cost increases for pricey obesity drugs

Cigna is moving to limit how much health insurance providers and employers have to pay for pricey and in-demand obesity

Medicine

NodThera says inflammation drug has positive effect in Parkinson’s

A Boston-based biotechnology company on Thursday said its most advanced drug showed positive effects in a clinical trial of Parkinson’s

Medicine

Biden proposes strengthening Medicare’s drug pricing power

Dive Brief: President Biden is taking on a bipartisan bogeyman ahead of a critical State of the Union speech, targeting

Medicine

European VC Invivo readies its latest fund to back new biotechs

Dive Brief: Barcelona-based venture capital firm Invivo Partners is preparing to close an expected fund of 100 million euros, or

Medicine

Sionna raises another $182M to challenge Vertex in cystic fibrosis

Dive Brief: Sionna Therapeutics, a Waltham, Massachusetts biotechnology startup, announced Wednesday it raised a $182 million Series C round to

Medicine

Alnylam, Roche blood pressure drug scores in second mid-stage trial

Dive Brief: An experimental RNA-based medicine developed by Alnylam Pharmaceuticals, when added to standard drugs, helped lower blood pressure significantly

Medicine

Apogee data hint at potential for long-lasting eczema drug

Dive Brief: Apogee Therapeutics plans to start a Phase 2 study of an experimental eczema treatment in the first half

Medicine

Nocion, chasing GSK, pulls in $62M for chronic cough drug

Investors have poured $62 million into a biotechnology startup developing a drug to treat chronic cough. Nocion Therapeutics, headquartered in

Medicine

Akero strengthens MASH drug’s case with new study data

Dive Brief: The effects of an experimental medicine for a common liver disease strengthened with time in a clinical trial,

Medicine

Abingworth invests in Trodelvy development in deal with Gilead

Dive Brief: Abingworth, a venture capital group owned by Carlyle, will invest as much as $210 million to help Gilead

Medicine

With BlossomHill, former Turning Point execs take aim at cancer, autoimmune disease

A good track record can be valuable in the uncertain and risky world of drug development. For a group of

Medicine

CDC panel mulls changes to RSV vaccine recommendation

Advisers to the Centers for Disease Control and Prevention are weighing updates to their recommendation older adults get vaccinated for

Medicine

FogPharma pulls in $145M to support cancer drug research

Dive Brief: Cancer drug developer FogPharma has raised $145 million in fresh funding, the company revealed Friday, announcing a Series

Medicine

Pfizer, looking for a jumpstart, leans into cancer drug research

Pfizer believes the answer to its sliding valuation lies in oncology. The company, which is coming off one of the

Medicine

Gritstone to lay off 40% of workforce after costly study delay

Gritstone Bio will lay off about 40% of its workforce after missing out on funding it expected to receive this

Medicine

Cure Ventures backs a cell therapy startup targeting Parkinson’s

Kenai Therapeutics, a San Diego-based biotechnology company, has raised $82 million to support its work developing cell therapies for nervous

Medicine

Women’s health company Obseva to wind down, lay off staff

Dive Brief: ObsEva, a women’s health drug developer, on Wednesday said it plans to wind down its business and let

Medicine

Incannex says psilocybin therapy lowered anxiety in small study

An Australian-based biotechnology company says a mid-stage clinical trial has shown that psilocybin, a psychedelic compound found in many mushroom

Medicine

Ginkgo adds gene editing tools in buyout of Feng Zhang-founded startup

Ginkgo Bioworks has acquired a biotechnology startup co-founded by gene editing pioneer Feng Zhang, part of the cell engineering company’s

Medicine

Viking data suggest obesity drug could rival Zepbound, Wegovy

Dive Brief: An experimental weight loss drug developed by Viking Therapeutics helped overweight and obese people lose up to 15%

Medicine

GSK drug meets goal in late-stage gonorrhea study

Dive Brief: GSK said Monday that its oral antibiotic succeeded in a late-stage trial in gonorrhea, proving to be as effective

Medicine

Humira biosimilar from Alvotech, Teva wins FDA approval on third attempt

Dive Brief: The Food and Drug Administration on Saturday approved Alvotech and Teva Pharmaceuticals’ Simlandi, a biosimilar of the most

Medicine

Choosing laboratory equipment with workplace experience in mind

The creativity and expertise of the researchers, technicians and assistants working in healthcare and biopharmaceutical laboratories are critical for every

Medicine

ORI Capital, the venture firm behind CG’s big IPO, raises new biotech fund

ORI Capital, the China- and U.S.-based venture investor behind the biotechnology sector’s largest initial public offering this year, has raised

Medicine

Novavax agrees to pay Gavi in settlement over COVID vaccine contract

Dive Brief: Novavax will pay as much as $475 million to settle a dispute with Gavi, the Vaccine Alliance over

Medicine

Moderna pitches RSV shot, new vaccines after ‘difficult year of transition’

Dive Brief: Moderna shares rose by as much as 10% Thursday morning after the COVID-19 vaccine developer reported fourth quarter

Medicine

BioMarin preaches patience amid slow sales for hemophilia gene therapy

Dive Brief: BioMarin Pharmaceutical is struggling to sell the first marketed gene therapy for the most common form of hemophilia,

Medicine

J&J secures EMA backing for earlier CAR-T use in multiple myeloma

Dive Brief: The European Medicine Agency’s main drug review committee on Friday supported expanding the approval of Johnson & Johnson

Medicine

Biden administration pledges $100M toward women’s health research

The Biden Administration, through the Advanced Research Projects Agency for Health, has committed to invest $100 million into women’s health

Medicine

Frontier gets $80M, Galapagos’ backing to make a better KRAS drug

Biotechnology startup Frontier Medicines has pulled in $80 million in new funding to support a targeted cancer drug the company

Medicine

Vir, in midst of restructuring, loses its chief medical officer

Infectious disease drug developer Vir Biotechnology on Tuesday disclosed that chief medical officer Phil Pang is stepping down from his

Medicine

NEJM paper fills in details on ‘remarkable’ CAR-T result in autoimmune disease

A new research paper offers the most thorough look yet at a study that sparked the drug industry’s recent experimentation

Medicine

AstraZeneca gets new Tagrisso OK as drug succeeds in another trial

Dive Brief: AstraZeneca’s targeted cancer therapy Tagrisso can now be used alongside chemotherapy to treat a common type of locally

Medicine

FDA puts hold on Rapt trials of drug for eczema, asthma

Dive Brief: Shares of Rapt Therapeutics fell sharply Tuesday after the company disclosed U.S. regulators ordered a halt of two

Medicine

Translating complex data into actionable insights, to create big value for smaller biotech companies

Lisa Benincosa is senior vice president of clinical pharmacology strategy at the specialized Clinical Research Organization (CRO), Allucent. Here she

Medicine

Ipsen drug approved by FDA for early pancreatic cancer

Dive Brief: The Food and Drug Administration has approved a new regimen for pancreatic cancer, clearing Ipsen’s Onivyde to be

Medicine

Aurinia to cut research after sale process fails to find a buyer

Dive Brief: Aurinia Pharmaceuticals will restructure its operations and give money back to shareholders after failing to find a buyer

Medicine

Astellas teams up with startup Kelonia to make ‘in vivo’ cell therapies

Astellas Pharma is delving deeper into cell therapies for cancer, announcing Thursday a research deal to develop a pair of

Medicine

Gilead reviewing drug acquired in $5B buyout after latest setback

Gilead Sciences is evaluating the future of a cancer drug acquired in a multibillion-dollar deal following a new setback the

Medicine

FDA to review expanded use of Sarepta Duchenne gene therapy

Dive Brief: The Food and Drug Administration will decide by June 21 whether to loosen the restrictions surrounding use of

Medicine

ALS drug from Denali, Sanofi falls short in mid-stage study

Dive Brief: An experimental drug being developed by Denali Therapeutics and partner Sanofi for ALS failed to meet its goal

Medicine

Intellia, ReCode partner on genetic medicines for cystic fibrosis

Intellia Therapeutics will work with a private biotechnology company to develop genetic medicines for cystic fibrosis, with an initial focus

Medicine

Alnylam changes to heart drug trial spark doubts, sinking shares

Dive Brief: Alnylam Pharmaceuticals is delaying the readout of a closely watched Phase 3 trial in the heart disease transthyretin

Medicine

Versant-backed Firefly Bio wants to make the next generation of ADCs

Dive Brief: Firefly Bio, a startup working to develop a new kind of cancer medicine, announced Thursday it had raised

Medicine

Sage offers details on launch of new postpartum depression pill

Sage Therapeutics said its new medicine, the first oral treatment for postpartum depression, is off to an encouraging start, with

Medicine

Hunting a non-opioid painkiller, a biotech startup reveals plans to chase Vertex

A little over four years ago, biotechnology giant Amgen retreated from neuroscience research, halting much of its work developing treatments

Medicine

BioAge raises $170M to back Phase 2-ready obesity drug

Dive Brief: Biotechnology startup BioAge Labs has raised $170 million to support an experimental pill it plans to test alongside

Medicine

Two GV partners on biotech’s reset and building their next drug startups

As the venture arm of Alphabet, GV can be thought of as a technology investor. But over the last 15

Medicine

Alys launches with $100M and a pipeline of skin disease drugs

Six biotechnology startups are merging into a new skin drug developer called Alys Pharmaceuticals, which launched on Monday with $100

Medicine

Chart a course for sustainable growth

As life sciences and pharma services companies forge ahead in 2024, they find themselves at a critical juncture―realizing unparalleled opportunities

Medicine

Obesity drug mania takes over Amgen’s earnings call

Amgen is a global pharmaceutical company worth more than $160 billion. Nine of its marketed medicines are blockbuster products by

Medicine

BioNTech partners with Autolus to boost cell therapy manufacturing

BioNTech will pay $50 million and make a $200 million investment in Autolus Therapeutics as the company most famous for

Medicine

Neurona raises another $120M for brain disease cell therapies

Dive Brief: Neurona Therapeutics, a San Francisco-based biotechnology company, has raised another $120 million to fuel its research into cell

Medicine

Kyverna CEO Peter Maag on courting investors in a ‘volatile’ IPO market

Biotechnology initial public offerings are showing sustained signs of life for the first time in two years, and Kyverna Therapeutics’

Medicine

Takeda speeds narcolepsy drug to late-stage testing

Takeda Pharmaceutical plans to quickly begin late-stage testing of an experimental drug for narcolepsy, which, if successful, could help the

Medicine

Gene editing biotech Metagenomi pulls off nearly $94M IPO

Dive Brief: Metagenomi, a gene editing startup spun out of research at the University of California, Berkeley, brought in about

Medicine

Pharma CEOs, pressed by Senate panel, refuse to commit to price cuts

The CEOs of three major drugmakers defended the prices they charge U.S. patients in a Senate committee hearing Thursday, claiming

Medicine

Kyverna IPO adds to biotech momentum with $319M fundraise

Dive Brief: Kyverna Therapeutics raised $319 million in a larger-than-expected initial public offering Thursday, adding to an early, but notable,

Medicine

BridgeBio sells partial rights to dwarfism drug for $100M

Dive Brief: BridgeBio Pharma is selling partial rights to an experimental drug for a common form of dwarfism to Japanese

Medicine

Venture firm Scion Life Sciences launches with $310M to back new biotechs

Dive Brief: Scion Life Sciences on Wednesday made its debut as a venture firm, announcing the close of a $310

Medicine

Lilly sales surge on obesity, diabetes drug demand

Sales of Eli Lilly’s diabetes drug Mounjaro exceeded $5 billion in 2023, its first full year on the market, the

Medicine

Khosla Ventures’ Alex Morgan on biotech’s challenges and solving drug delivery

To hear venture capitalist Alex Morgan tell it, investors shouldn’t be in the business of predicting trends. “There’s often a

Medicine

Novo Holdings to buy contract drugmaker Catalent for $16.5B

Novo Holdings, the controlling shareholder of Danish drugmaker Novo Nordisk, will buy contract manufacturer Catalent for $16.5 billion in a

Medicine

Biogen quits Aduhelm, handing back rights to original developer

In 2021, the Food and Drug Administration for the first time approved a medicine meant to slow the progression of

Medicine

Avrobio’s road ends in reverse merger with Tim Springer-backed startup

Dive Brief: The gene therapy company Avrobio agreed to a reverse merger with startup Tectonic Therapeutic after years of struggling

Medicine

Roche shuffles early stage pipeline as it joins obesity rush

Roche is reshaping its early-stage pipeline of experimental drugs, jettisoning eight drug candidates in neurological conditions and oncology as it

Medicine

Takeda pays $300M to license Protagonist drug for blood disorder

Dive Brief: Protagonist Therapeutics, a biotechnology company focused on peptide drugs, is teaming up with Takeda Pharmaceutical on an experimental,

Medicine

Brain drug developer Alto Neuroscience prices $129M IPO

Another biotechnology company has hit Wall Street via an initial public offering, the third to do so this year in

Medicine

Arch, a prolific biotech creator, is raising $3B for startup investing

Arch Venture Partners, one of the biotechnology sector’s most prolific company creators, is raising a new $3 billion fund, according

Medicine

Merck keeps deal focus with Keytruda patent cliff on horizon

Merck & Co. plans to continue seeking out multibillion-dollar biotechnology deals to supplement its own drug research as it prepares

Medicine

Sanofi appoints Nestlé executive as new finance chief

Nestlé veteran François-Xavier Roger will succeed Sanofi chief financial officer Jean-Baptiste Chasseloup de Chatillon on April 1, the French pharmaceutical

Medicine

New CMS pilot to test payment scheme for pricey sickle cell gene therapies

The U.S. government will test whether centrally coordinating insurance coverage can help people with sickle cell disease access expensive new

Medicine

GSK sales of RSV vaccine stay strong, beating forecast

GSK on Wednesday reported higher-than-expected sales of its RSV vaccine Arexvy, providing further evidence of the product’s strong uptake. The

Medicine

Cour gets $105M, pharma help to ‘reprogram’ autoimmune disease

Dive Brief: Biotechnology startup Cour Pharmaceuticals has raised $105 million to advance a portfolio of medicines for autoimmune diseases. The

Medicine

Gilead deepens investment in Arcus and TIGIT drugs

Dive Brief: Gilead has bought a bigger stake in cancer drug developer Arcus Biosciences, announcing Monday it will spend $320

Medicine

CAR-T for lupus: the ‘tip of the iceberg’ for cell therapy in autoimmune disease

The clue came, as they often do, from an unexpected source. Some sixteen months ago, a small study of five

Medicine

Bristol Myers gets positive data in subcutaneous Opdivo trial

Dive Brief: An experimental, under-the-skin shot of Bristol Myers Squibb’s immunotherapy Opdivo appeared to work similarly to the approved, intravenous

Medicine

J&J focuses on newer meds to offset Stelara patent cliff

Johnson & Johnson CEO Joaquin Duato sold 2023 as a “remarkable year” on an earnings call with investors Tuesday. But

Medicine

Novo strikes another obesity drug deal

Dive Brief: Novo Nordisk is adding yet another prospect to its obesity drug pipeline, this time from a biotech company

Medicine

BenevolentAI appoints former Bayer R&D chief as CEO

After a rocky year that featured a restructuring, job cuts and the resignation of its CFO, BenevolentAI is looking to

Medicine

RayzeBio drew other pharma interest before Bristol Myers deal

Radiopharmaceutical drugmaker RayzeBio drew interest from two other large drugmakers before agreeing to a $4.1 billion buyout by Bristol Myers

Medicine

PTC Duchenne drug approval set to be revoked in Europe

European authorities are set to rescind the approval of a Duchenne muscular dystrophy drug that’s been on the market there

Medicine

EMA recommends earlier use of Bristol Myers cell therapy for multiple myeloma

Dive Brief: Bristol Myers Squibb’s cell therapy for multiple myeloma, Abecma, should be approved for use in patients whose disease

Medicine

Cancer drugmaker ArriVent follows on CG’s heels with $175M IPO

Dive Brief: ArriVent Biopharma is the second biotechnology company to go public this year, raising $175 million in an initial

Medicine

At FDA meeting, experts wrestle with hurdles to developing preterm birth drugs

The Food and Drug Administration this week convened a group of experts to discuss ways to develop new drugs for

Medicine

CG Oncology prices larger-than-expected $380M IPO in hopeful sign for biotech

Cancer drug developer CG Oncology has raised $380 million in an initial public offering than was larger than it expected, a

Medicine

Lilly gene therapy finding puts focus on hearing loss treatment pipeline

An 11-year-old boy who was born deaf can hear after receiving an experimental gene therapy, developer Eli Lilly reported on

Medicine

Sanofi to buy Inhibrx in deal worth up to $2.2B

Sanofi on Tuesday said it will acquire San Diego biotechnology company Inhibrx in a complex deal that could be worth

Medicine

FDA orders new cancer warnings for CAR-T therapies

Dive Brief: The makers of CAR-T cell therapies will need to warn about the risk of new blood cancer, the

Medicine

Coherus sells Lucentis biosimilar to Sandoz for $170M

Dive Brief: Coherus Biosciences on Monday said it has agreed to sell its approved biosimilar Cimerli, along with supporting staff,

Medicine

Gilead ADC medicine misses goal in closely watched lung cancer study

Dive Brief: Gilead Sciences on Monday said its cancer drug Trodelvy missed the main goal of a Phase 3 trial

Medicine

Bayer signals ‘significant’ layoffs in plan to shrink bureaucracy

As part of a makeover promised last year, Bayer is beginning a process of staff reductions that aims to slice

Medicine

BridgeBio strikes drug royalty deal for cash infusion

BridgeBio Pharma has agreed to sell future royalties on an experimental rare disease drug in exchange for $500 million if

Medicine

Five years after Shire deal, Takeda hopes to reap rewards of latest reinvention

Five years ago this month, Takeda Pharmaceuticals completed a $62 billion acquisition of Shire — one of the largest deals

Medicine

Ikena Oncology to lay off 35% of staff

Biotechnology company Ikena Oncology on Thursday said it would lay off staff and reallocate resources toward two experimental cancer drugs.

Medicine

Sanders threatens to subpoena J&J, Merck CEOs over drug prices

A Congressional committee may subpoena the CEOs of Johnson & Johnson and Merck & Co. to testify about the differences

Medicine

Novartis details first-line data for radiopharma drug Lutathera

A radiopharmaceutical drug from Novartis kept a rare type of neuroendocrine cancer at bay for longer than did standard therapy,

Medicine

Gene therapy biotech Jaguar spins out manufacturing company

Jaguar Gene Therapy is spinning out part of its business to handle the specialized work of manufacturing cell and gene

Medicine

A South Korean investment firm starts first US biotech fund

Mirae Asset Capital Life Science, a new venture capital fund, launched on Thursday, joining several other new firms that have

Medicine

Kyverna sets plans for IPO in test of biotech enthusiasm

Dive Brief: Kyverna Therapeutics on Tuesday revealed plans to go public, testing the waters in a biotechnology market that hasn’t

Medicine

Comanche Biopharma raises $75M to fund preeclampsia drug testing

Dive Brief: Massachusetts-based startup Comanche BioPharma has raised $75 million in new venture funding to advance an experimental treatment targeting

Medicine

FDA widens approval of Vertex’s CRISPR medicine to treat beta thalassemia

The Food and Drug Administration on Tuesday approved Vertex Pharmaceuticals’ CRISPR-based medicine Casgevy for the inherited blood condition beta thalassemia, expanding

Medicine

The biopharma industry outlook on 2024: Guarded optimism for a rebound

Guarded optimism seems to be the mood of the biopharmaceutical industry to start 2024. Last year brought a stock market

Medicine

GSK to buy asthma drug startup Aiolos for $1B

Over the span of five months, biotechnology startup Aiolos Bio launched, raised initial funding from venture investors and negotiated a

Medicine

Newly optimistic, biotech investors weigh lessons of sector’s downturn

The J.P. Morgan Healthcare Conference, a yearly temperature taker for the biotechnology industry, had a different feel in 2024. For

Medicine

FDA says no ‘clear relationship’ between GLP-1 drugs and suicide risk

Dive Brief: The use of GLP-1-based drugs to treat obesity and diabetes has no “clear relationship” with the risk of

Medicine

Recursion’s Chris Gibson on AI in biotech and ‘virtuous cycles’

Chris Gibson, the CEO of Recursion Pharmaceuticals, thinks the future of drug discovery lies within a ChatGPT-like interface. At a

Medicine

Backed by billionaires, a new biomedical institute tests an unorthodox approach

A group of high-profile scientists and billionaire financiers are building a new biomedical research institute that they claim will offer

Medicine

EU regulators to consult advisers in review of Eisai Alzheimer’s drug

European regulators will seek outside advice before making a decision on approval of Eisai and Biogen’s Leqembi medicine for Alzheimer’s

Medicine

Venture funding, dealmaking slowed in biotech last year: Pitchbook

Dive Brief: The number and amount of biotechnology financings dipped in 2023, with venture firms investing 25% fewer dollars in

Medicine

JPM24: Novartis’ head start, FTC fallout and Bluebird’s price defense

The mood shifts on the third day of the J.P. Morgan Healthcare Conference. Deals have been announced and news peters

Medicine

5 questions facing pharma in 2024

The arrival of powerful new drugs for obesity has reshaped the pharmaceutical industry, transforming Eli Lilly and Novo Nordisk into

Medicine

JPM24: Pfizer’s tough sell, the next Karuna and building a biotech platform

Biotechnology’s embrace of artificial intelligence was never more literal than Tuesday at the J.P. Morgan Healthcare Conference, when AI drug