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1,218 stories matching this filter · ← front page

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  • Backed by NVIDIA, Basecamp bags $140M to advance AI-designed drugs
    Basecamp Research joins the growing group of AI-forward biotechs that in recent months have brought in notable sums from investors, including Isomorphic Labs and Enveda.
    BioSpace · 26d ago↗ source
  • Convenience Kit Correction: Becton Dickinson Issues Correction for Kits and Procedure Trays Containing Recalled Sodium Chloride Ampules
    BD is correcting convenience kits and procedural trays containing recalled Huons Co. sodium chloride ampules
    fda medwatch · 27d ago↗ source
  • Roche and Ionis report Phase 3 success for RNA therapy sefaxersen in IgA nephropathy
    A late‑stage Phase 3 trial of the Roche‑Ionis RNA‑targeted drug sefaxersen met its primary endpoint, showing a statistically significant reduction in proteinuria for patients with primary IgA nephr…
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Pain654
Nephrology634
BioSpace · 27d agoPositive readoutPositive↗ source
  • Ionis and Otsuka's RNA therapy Ulefnersen shows functional and survival gains in rare FUS-ALS in Phase 3 trial
    Ionis Pharmaceuticals and Otsuka Pharmaceutical reported that their antisense oligonucleotide drug Ulefnersen improved both functional impairment scores and overall survival in a Phase 3 study of p…
    BioSpace · 27d agoPositive readoutPositive↗ source
  • Roche and Ionis report positive Phase 3 interim results for IgA nephropathy drug sefaxersen
    Roche and Ionis announced that their experimental RNA therapy sefaxersen met its primary endpoint in an interim analysis of a Phase 3 trial for IgA nephropathy. The trial showed statistically sign…
    BioPharma Dive · 27d agoPositive readoutPositive↗ source
  • European pharma CEOs warn of biotech decline as R&D share drops to 31% and call for faster trials and stronger IP protection
    Nine leading European pharma board chairs issued an open letter warning that Europe is losing its biotech edge. They note that Europe's share of global pharma R&D fell from 43% in 1990 to 31% toda…
    BioPharma Dive · 27d agoNegative↗ source
  • China’s $522 bn biotech push fuels US competition and partnership opportunities
    Chinese biotech is entering a rapid growth phase, with the government’s new five-year plan targeting about $522 billion in revenue by 2030 and aiming for at least 25% of first-in-class drugs worldw…
    BioSpace · 28d agoDealPositive↗ source
  • Amgen's Sjögren's drug dazodalibep meets primary endpoint in Phase 3 trial
    Amgen reported that its experimental therapy for Sjögren's disease, dazodalibep, achieved the primary goal in a late‑stage study. The Phase 3 OASIZ 301 trial enrolled roughly 621 patients with mod…
    BioSpace · 27d agoPositive readoutPositive↗ source
  • Novartis signs up to $900 million deal with China's BoomRay for preclinical radioligand therapy
    Novartis has licensed a preclinical radioligand therapy from BoomRay Pharmaceuticals, a Suzhou‑based biotech, in a deal that could be worth up to $900 million. The agreement includes an undisclose…
    BioSpace · 27d agoDealPositive↗ source
  • FDA issues early alert on React Health VOCSN ventilators over connector fault
    The FDA's Center for Devices and Radiological Health has posted an early alert about a potential high‑risk problem with certain VOCSN ventilator units made by Ventec Life Systems, operating as Reac…
    fda medwatch · 28d agoRegulatoryNeutral↗ source
  • AI-driven biotech Enveda secures $311 million Series E to advance plant-derived drug candidates
    Enveda Biosciences, a Colorado AI drug discovery company, announced a $311 million Series E financing round, one of the larger biotech raises this year. The firm uses artificial intelligence to sc…
    BioPharma Dive · 27d agoDealPositive↗ source
  • Novo outlines $23B revenue goal, cuts 4,000 jobs and expands Wegovy manufacturing amid investor skepticism
    Novo held its Capital Markets Day to detail a plan to reach $23 billion in sales by 2035. The company announced another round of layoffs, trimming its workforce by 4,000 people and leaving the head…
    BioSpace · 28d agoNeutral↗ source
  • FDA issues early alert on Abiomed Impella controller safety issue
    The FDA Center for Devices and Radiological Health (CDRH) has posted an Early Alert about a potential high risk problem with certain Abiomed Impella automated controllers. Abiomed has sent a lette…
    fda medwatch · 28d agoRegulatoryNegative↗ source
  • Job postings in Pennsylvania’s biopharma sector surge 213% as nine companies ramp up hiring
    Job postings for biopharma roles in Pennsylvania have jumped dramatically, with BioSpace reporting a 213% year‑over‑year increase in August and overall postings tripling compared with the previous…
    BioSpace · 28d agoPositive↗ source
  • Pharma companies compete for scarce manufacturing talent as reshoring ramps up
    As pharmaceutical firms expand or add U.S. manufacturing sites to bring production back home, they are finding it hard to staff the plants. The industry faces a limited pool of qualified workers,…
    BioSpace · 28d agoNeutral↗ source
  • AI drug hunter Enveda raises $311M for late-stage obesity, inflammatory disease push
    Tech darling Enveda has raised a total of $845 million in the past six years. The latest funding round is intended to pave the way for an IPO someday.
    BioSpace · 27d agoRegulatoryNeutral↗ source
  • Immunovant halts lupus program after Phase 2b trial fails to meet efficacy endpoints
    Immunovant announced that its anti‑FcRn drug imeroprubart (IMVT‑1402) did not achieve the primary endpoint in a Phase 2b study in patients with cutaneous lupus erythematosus. The double‑blind tria…
    BioSpace · 27d agoNegative readoutNegative↗ source
  • ReCode Therapeutics appoints Heather Clark as CEO to lead cystic fibrosis and primary ciliary dyskinesia programs
    ReCode Therapeutics announced that Heather Clark will take over as chief executive officer, succeeding founder Shehnaaz Suliman. The transition was presented as a move to keep momentum after the co…
    BioSpace · 28d agoPositive↗ source
  • Berlin Seeds recalls 950 lbs of alfalfa sprouting seed over possible STEC and Salmonella contamination
    Berlin Seeds of Millersburg, Ohio announced a recall of 950 pounds of its alfalfa sprouting seed. The recall was triggered because the seed could be contaminated with Shiga toxin‑producing Escheri…
    fda recalls · 27d agoRegulatoryNegative↗ source
  • Viking Therapeutics’ VK2735 shows 17.7% weight loss in Phase 1 and maintains effect with less frequent dosing
    Viking Therapeutics reported Phase 1 results for its injectable GLP-1/GIP dual agonist VK2735, showing an average 17.7% reduction in body weight after 21 weeks of weekly dosing in a placebo-control…
    BioSpace · 28d agoPositive readoutPositive↗ source
  • AI becomes core to biopharma R&D, driving efficiency and faster drug development
    AI is now regarded as essential to everyday operations in the biopharma sector, helping to reduce the time and cost of drug development. Pfizer CEO Albert Bourla said AI played a key role in integ…
    BioSpace · 29d agoPositive↗ source
  • Amgen's Dazodalibep Shows Positive Results in First Phase 3 Trial for Sjögren’s Syndrome
    Amgen announced that its experimental drug dazodalibep, acquired through the Horizon Therapeutics acquisition, met the primary endpoint in the first of two Phase 3 trials for Sjögren’s syndrome, a…
    BioPharma Dive · 28d agoPositive readoutPositive↗ source
  • Celldex shares drop as Phase 3 data for barzolvolimab show efficacy but raise anaphylaxis safety concerns
    Celldex reported Phase 3 results for barzolvolimab in chronic spontaneous urticaria, showing strong efficacy against hives and itching. Two cases of life-threatening anaphylaxis were observed amon…
    BioPharma Dive · 28d agoNegative readoutNegative↗ source
  • Novo aims to increase oral Wegovy manufacturing capacity tenfold by 2030
    Novo announced at its Capital Markets Day that it plans to expand the manufacturing capacity for its oral GLP-1 drug Wegovy by a factor of ten by the end of the decade. The company said about 1.5…
    BioSpace · 28d agoPositive↗ source
  • Four biotech firms file for IPOs as 2026 biotech listing surge continues
    2026 has seen more than 25 biotech companies debut on public markets, marking the highest number of IPOs since 2021. The wave of listings has helped the sector recover from a slowdown in 2025. Fou…
    BioSpace · 28d agoDealPositive↗ source