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266 stories matching this filter · ← front page

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  • 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 · 7d ago↗ source
  • FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food
    The U.S. Food and Drug Administration today announced two actions targeting petroleum-based color additives in food, continuing the agency’s broader efforts to Make America Healthy Again.
    fda press · 7d 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
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fda press21
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· 7d 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 · 7d 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 · 7d 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 · 7d 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 · 7d 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 · 7d 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 · 8d 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 · 8d 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 · 8d 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 · 8d ago↗ source
  • Dyne gets early 2027 decision date for Duchenne therapy, analysts expect ‘smooth’ review
    If approved, Dyne Therapeutics’ zeleciment rostudirsen could “capture the majority” of the exon-51 Duchenne muscular dystrophy market, given its better efficacy and dosing profile versus Sarepta Th…
    BioSpace · 8d ago↗ source
  • Axiom plans Hong Kong IPO, hoping to carve new path for US biotechs
    Axiom Biosciences is thinking outside of the box, betting on a public debut in Hong Kong to raise capital and grow into a global company.
    BioSpace · 8d ago↗ source
  • Lilly’s AtaiBeckley buy validates space as Big Pharma takes note of psychedelics
    Eli Lilly’s proposed acquisition of AtaiBeckley is “the clearest strategic validation to date” of psychedelics as an emerging pharmaceutical category, according to H.C. Wainwright. The analyst caut…
    BioSpace · 9d ago↗ source
  • FDA’s radical transparency policy for rejections runs into legal uncertainty
    Having started to publish CRLs without consulting the public, the FDA is under pressure to change course amid concerns it failed to openly and fully evaluate a complex issue.
    BioSpace · 9d ago↗ source
  • 2026 IPO class blooms again as BlossomHill, Latigo set sights on Nasdaq
    Eighteen companies have gone public this year so far, putting 2026 on pace to record the highest number of IPOs since the pandemic-driven high of 2021.
    BioSpace · 9d ago↗ source
  • Vertex’s IgA nephropathy drug derisked after Novartis, Vera approvals
    The FDA is currently reviewing Vertex Pharmaceuticals’ povetacicept, with a target action date of Nov. 30. If approved, the drug could benefit from campaigns from Novartis and Vera Therapeutics for…
    BioSpace · 9d ago↗ source
  • Type 1 diabetes pipeline making ‘remarkable progress’ toward insulin independence
    After the trailblazing approval of Sanofi’s Tzield for stage 3 type 1 diabetes, several companies, including SAB Biotherapeutics and Eledon Pharmaceuticals, are vying for a spot in the landscape wi…
    BioSpace · 9d ago↗ source
  • How Kyverna rode CAR T’s autoimmune wave to the FDA’s door
    Poised to become the first company to achieve a regulatory filing for a cell therapy in autoimmune disease, Kyverna Therapeutics is building a pipeline-in-a-product to change the treatment paradigm.
    BioSpace · 9d ago↗ source
  • FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol
    The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), as an adjunct to diet and exercise to reduc…
    fda press · 12d ago↗ source
  • India’s life sciences sector at turning point for innovation: Report
    Structural gaps in areas including clinical execution and funding limit India’s ability to scale up innovation, according to a report from Boston Consulting Group and HealthKois.
    BioSpace · 12d ago↗ source
  • GSK culls cough program for drug at the heart of $2B Bellus bet after Phase 3 fail
    Camlipixant, which GSK picked up in its $2 billion buyout of Bellus Health in April 2023, “is unlikely to transform patient care,” the pharma said.
    BioSpace · 12d ago↗ source
  • Insmed moves closer to $6B opportunity as PAH drug shows long-term durability
    Insmed’s inhalable candidate showed “impressive” long-term efficacy in pulmonary arterial hypertension, according to analysts at Guggenheim Partners, with functional and biomarker improvements thro…
    BioSpace · 12d ago↗ source
  • FDA disavows Makary, Prasad’s papers as lawmaker blasts ‘shoot-from-the-hip’ policymaking
    Journal publications that suggested changes in FDA guidelines do not “communicate FDA policy or interpretation of a regulatory issue,” acting director Kyle Diamantas wrote in a letter to House Ener…
    BioSpace · 12d ago↗ source