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46 stories matching this filter · ← front page

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  • 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 · 5h ago↗ source
  • CLINUVEL will cut up to 20% of staff, relocate HQ to New York
    Follow along as BioSpace tracks job cuts and restructuring initiatives.
    BioSpace · 8h 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 · 8h ago↗ source
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  • 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 · 9h 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 · 10h 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 · 10h 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 · 12h 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 · 15h 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 · 15h ago↗ source
  • Webinar: From Clinical to Commercial: Talent Strategies for Biopharma Growth
    This webinar provides an assessment of recent job market activity across biopharma and explores how companies approaching commercial readiness or building out sales and marketing teams can navigate…
    BioSpace · 1d ago↗ source
  • Summit and Akeso sharpen case for ivonescimab with new Western data
    Summit Therapeutics and Akeso are answering questions raised about ivonescimab’s ability to translate to Western populations, though the partners have yet to share if the new findings are statistic…
    BioSpace · 1d ago↗ source
  • Arrowhead puts pressure on Ionis with positive data for triglyceride lowering drug
    With Phase 3 data showing what analysts called a “potentially best-in-class profile,” Arrowhead Pharmaceuticals plans to submit for FDA approval of plozasiran by the end of the year—hoping to follo…
    BioSpace · 1d ago↗ source
  • Repligen strikes $1.5B BioLife buyout to bag cell therapy product pharmas rely on
    Top-selling cell therapies from BMS, J&J and Gilead depend on a BioLife product, positioning Repligen to use the takeover to increase its exposure to the modality.
    BioSpace · 1d ago↗ source
  • 6 companies hiring in Cambridge now
    Looking for a biopharma job in Cambridge? Roles posted on BioSpace have more than doubled compared to last year.
    BioSpace · 1d ago↗ source
  • US ‘eroding’ lead in rare diseases a matter of national security: Report
    A Congressional advisory panel recommends the U.S. government put supportive policies in place for rare disease drug development, such as a finalized platform designation from the FDA and the allow…
    BioSpace · 1d ago↗ source
  • 2026 IPO stock tracker: How newly public biotechs are performing
    BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.
    BioSpace · 1d ago↗ source
  • Novartis scraps mid-stage radiopharma asset as Pluvicto soars
    The discontinued asset, being trialed for breast cancer and solid tumors, had yielded disappointing data, leading to Novartis’ decision to abandon development, according to a company spokesperson.
    BioSpace · 1d ago↗ source
  • Q2 earnings underway, FDA’s CRL kerfuffle, IPOs full speed ahead in H2
    Second quarter earnings continue to roll with Novartis and Roche reporting this week; Eli Lilly’s AtaiBeckley buy for up to $3.8 billion offers clear “validation” for the fledgling psychedelics spa…
    BioSpace · 1d ago↗ source
  • From Big Pharma to specialty: why moving closer to the patient changes everything
    Working at a Big Pharma has its benefits, but there are limitations too. SERB Pharmaceuticals’ Thomas Kolaras discusses how moving to a midsize company creates new opportunities for sharpened think…
    BioSpace · 1d ago↗ source
  • AI data becomes sticking point in biopharma dealmaking
    As drug hunting gets more complex, where and how data is generated in partnerships between Big Pharmas and AI biotechs is becoming a headache for dealmakers.
    BioSpace · 1d ago↗ source
  • Wainua flop narrows AstraZeneca’s path to $80B goal ahead of high-risk readouts
    With a Phase 3 failure denting the rare disease drug’s prospects, AstraZeneca has little room for error as it plots a path toward its ambitious 2030 sales target.
    BioSpace · 1d ago↗ source
  • Samsung Biologics targets $1.8B PolyPeptide buyout to expand in obesity
    With PolyPeptide manufacturing peptides such as GLP-1 medicines, Samsung Biologics has identified the deal as a way to tap into fast-growing demand for obesity drug production services.
    BioSpace · 2d ago↗ source
  • Agios axes next-gen sickle cell candidate after it fails to best Novo’s asset
    Agios Pharmaceuticals’ sickle cell disease candidate didn’t prove any better than Novo Nordisk’s investigational PK activator or the biopharma’s own asset that is currently under FDA review for the…
    BioSpace · 2d ago↗ source
  • Novartis stays 'geography-agnostic' in dealmaking amid flurry of China deals
    Novartis will continue to be on the lookout for bolt-on deals below $2 billion, CEO Vas Narasimhan said Tuesday on the pharma's second quarter earnings call—though major pickups aren’t completely o…
    BioSpace · 2d ago↗ source
  • The FDA’s 505(b)(2) pathway is an underestimated engine of value creation
    The biopharma industry would do well to re-embrace the 505(b)(2) path, which allows sponsors to draw on previous findings around an existing drug even as they propose modifications to it.
    BioSpace · 2d ago↗ source