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151 stories matching this filter · ← front page

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  • Amgen deploys patients to defend troubled Tavneos in FDA hearing request
    Facing pressure around the world to withdraw the rare kidney disease drug Tavneos, Amgen has launched a robust defense with real-world evidence to support the product’s benefit-risk profile.
    BioSpace · 3d ago↗ source
  • Study of Yescarta patients reveals genetic red flags for CAR-T therapy side effects
    A new analysis of patients who took part in clinical trials for Kite Pharma’s CAR-T cell therapy Yescarta has revealed genetic signatures of toxicity risk, potentially providing a path forward for…
    Fierce Biotech · 3d ago↗ source
  • Lilly’s $3.8B psychedelics bet won’t open the M&A floodgates
    Eli Lilly’s $3.8 billion play for AtaiBeckley has fueled speculation that Big Pharma is ready to embrace psychedelics. But while the acquisition does validate the drug class, analysts say it is unl…
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Hematology6
Pulmonology5
Infectious Disease4
Ophthalmology3
Dermatology2
BioSpace · 3d ago↗ source
  • Summit has less than a year of cash runway left as PD-1/VEGF verdict nears
    Summit’s star asset is the PD-1/VEGF bispecific ivonescimab, which this week produced promising survival data from a late-stage global trial in non-small cell lung cancer. The FDA review is ongoing…
    BioSpace · 3d ago↗ source
  • Roche cans one Carmot obesity asset as another shows best-in-class potential
    Acmopatide met the main goal of a Phase 2 study in type 1 diabetes, but Roche is axing the investigational drug to prioritize enicepatide for weight loss, type 2 diabetes and cardiovascular outcome…
    BioSpace · 3d ago↗ source
  • Merck stages expanded access to monthly HIV PrEP pill ahead of approval
    Following in the footsteps of Gilead, Merck has signed voluntary licensing agreements to enable access to its investigational HIV PrEP pill alimatravir ahead of any regulatory submissions.
    Fierce Biotech · 3d ago↗ source
  • Sanofi abandons plan to seek approval for eczema drug from $1.1B Kymab buyout
    Sanofi has abandoned plans to seek approval for amlitelimab in atopic dermatitis, admitting that a drug once tipped as a potential blockbuster “would not represent a meaningful improvement” to exis…
    Fierce Biotech · 3d ago↗ source
  • Scribe records upsized $129M IPO to bankroll lipid-lowering genetic meds
    In vivo gene editing outfit Scribe Therapeutics has priced its IPO at $128.7 million, surpassing the $96 million goal set out earlier this week.
    Fierce Biotech · 3d ago↗ source
  • This Week at FDA: Diamantas touts onshoring efforts, grants for DHTs, and more
    <p>Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This…
    raps · 3d ago↗ source
  • FDA advisory committee backs two more peptides, rejects one for compounding list
    <p>By the end of a two-day meeting that concluded Friday afternoon, an advisory committee to the US Food and Drug Administration (FDA) voted in favor of adding six of the seven peptides it was task…
    raps · 3d ago↗ source
  • Update: FDA does not freeze CRL trove as ‘radical transparency’ push hits speedbump
    An unnamed pharma filed a citizen petition in April seeking reforms to the way the FDA publicly releases rejection letters, alleging that the policy “contravenes decades of agency practice.”
    BioSpace · 4d ago↗ source
  • Chutes & Ladders—Biogen R&D vet gets in Formation
    AI-focused Formation Bio has found a new chief scientist with extensive experience in biotech, Big Pharma and academia. Michael Ehlers, M.D., Ph.D., is joining the 2025 Fierce 15 honoree as chief s…
    Fierce Biotech · 4d ago↗ source
  • BeOne commits $300M to US manufacturing expansion, creating 120 new jobs
    The addition of small molecule capacity at BeOne Medicines’ Hopewell site will support the company’s hematology efforts and bring total investment in the campus to more than $1 billion.
    BioSpace · 4d ago↗ source
  • Lilly preps FDA run for ‘triple-G’ weight loss drug with Phase 3 data
    With weight loss topping 20% at 80 weeks in the Phase 3 TRIUMPH-2 and TRIUMPH-3 trials, Eli Lilly plans to file for retatrutide’s approval in the first quarter of 2027. Previously a filing was expe…
    BioSpace · 4d ago↗ source
  • Roche's late stage pipeline 'so full,' CEO Schinecker not feeling pressure to add on
    Roche has 19 investigational medicines that could launch by 2030—and even if not all of them make it to market, the company is “well set-up for growth into the next decade,” CEO Thomas Schinecker s…
    BioSpace · 4d ago↗ source
  • GSK’s $10.6B Nuvalent bet pays off early as FDA approves lung cancer drug
    Jideytro is GSK’s first approved product for lung cancer. With its takeover of Nuvalent Bio last month and a deal with Hansoh Pharmaceutical in 2023, the pharma now has several other lung cancer as…
    BioSpace · 4d ago↗ source
  • Nordic biotech’s next act: From fragmentation to global force
    In this episode of Denatured, you’ll hear from Ester Sklarsky, principal at Sound Bioventures and João Ribas, partner at Novo Holdings Seed Investments. In this episode, we explore the diverging tr…
    BioSpace · 4d ago↗ source
  • Scancell to go public after winning reverse merger bid for troubled Neuphoria
    Scancell and Neuphoria have made their union official via a reverse merger that will result in a Nasdaq listing for Scancell and a resolution for Neuphoria’s shareholders after the biotech ended it…
    Fierce Biotech · 4d ago↗ source
  • Lilly’s triple-G drug hits 22.6% weight loss, but impact on reducing cardio risk is less clear
    Eli Lilly’s triple-G drug retatrutide has hit the primary endpoints of a pair of phase 3 obesity trials, although the peak weight loss fell short of previous trials while failing to prove the drug…
    Fierce Biotech · 4d ago↗ source
  • Roche Diagnostics growth remains muted amid China headwinds
    Roche’s Diagnostics division continues to battle growth headwinds, notching a 3% increase in sales.
    Fierce Biotech · 4d ago↗ source
  • Make or break: Commercial hires critical for success
    With the stakes for successful launches high, and demand for commercial roles increasing, biopharmas must thoughtfully approach not only hiring but also retention. During a BioSpace webinar, experi…
    BioSpace · 4d ago↗ source
  • Biopharma layoffs must double in H2 for 2026 to match 2025 cuts
    With fewer biopharmas making or planning workforce reductions so far year over year, layoff round size and M&A impact on headcounts will likely shape the number of employees who are ultimately on t…
    BioSpace · 4d ago↗ source
  • Australian biopharma Clinuvel to shed up to 20% of workforce in move to US
    Australian biopharma Clinuvel Pharmaceuticals is moving its headquarters to the U.S.— but up to a fifth of the company’s workforce won’t be staying for the trans-Pacific pivot.
    Fierce Biotech · 4d ago↗ source
  • Roche drops TCE for lupus, but hasn’t given up on autoimmune cell therapies
    Roche may have scrapped work on a T-cell engager being evaluated for lupus, but the company’s head of pharma told Fierce that still has a strategy for developing cell therapies for autoimmune disea…
    Fierce Biotech · 4d ago↗ source
  • FDA clears Johnson & Johnson’s surgical robot for ‘the next era in surgery’
    The FDA has authorized Johnson & Johnson’s Ottava Robotic Surgical System as the company looks to compete with Intuitive Surgical and Medtronic.
    Fierce Biotech · 4d ago↗ source