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1,869 stories matching this filter · ← front page

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  • 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 · 28d agoDealPositive↗ source
  • Kyverna reports year-long efficacy and clean safety for miv-cel CAR-T in autoimmune trials
    Kyverna Therapeutics released one-year data for its CAR-T candidate miv-cel in stiff person syndrome and 18-month data in generalized myasthenia gravis. The single dose showed durable clinical ben…
    Fierce Biotech · 28d agoPositive readoutPositive↗ source
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  • 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 · 29d agoNeutral↗ source
  • Boehringer Ingelheim boosts Variant Bio partnership with $250 million for cardiovascular research
    Boehringer Ingelheim announced an expansion of its collaboration with Variant Bio. The partnership will now include cardiovascular disease research, broadening its original scope. The deal value…
    Fierce Biotech · 29d agoDealPositive↗ source
  • Human‑centric testing methods promise safer, cheaper drug development but repeatability remains a key obstacle
    Regulators such as the FDA, EMA and ICH are urging drug developers to replace animal safety studies with New Approach Methodologies that use human‑relevant models. Early research shows these models…
    Fierce Biotech · 28d agoNeutral↗ 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 · 29d 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 · 29d 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 · 28d agoRegulatoryNeutral↗ source
  • Immunovant halts cutaneous lupus program after phase 2 failure
    Immunovant announced it is discontinuing development of its anti-FcRn antibody IMVT-1402 for cutaneous lupus erythematosus. The decision follows a mid-phase trial that did not meet its primary end…
    Fierce Biotech · 29d agoNegative readoutNegative↗ 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 · 28d 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 · 29d 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 · 28d agoRegulatoryNegative↗ source
  • Trump's Department of War bets $47M on Flagship biotechs to develop countermeasures
    The Department of War has awarded Flagship Pioneering $47 million to develop medical countermeasure technologies against emerging threats.
    Fierce Biotech · 29d agoNeutral↗ 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 · 29d 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 · 1mo agoPositive↗ source
  • Roche’s dual GLP-1/GIP drug enicepatide lowers HbA1c in phase 2 trial, sparking best-in-disease hopes
    Roche reported that its dual GLP-1/GIP receptor agonist, enicepatide, met the primary goals of a phase 2 study in patients with type 2 diabetes. The top 24‑mg weekly dose reduced HbA1c by 2.65% ove…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • GSK pursues China-centric growth after successful Hansoh licensing deals show promise
    GSK says it is following a "balance West and East" strategy, increasingly looking to China for drug licensing opportunities. In 2023 the company paid a combined $270 million upfront to Hansoh Phar…
    Fierce Biotech · 29d agoDealPositive↗ source
  • Celldex reports dual Phase 3 successes for barzolvolimab in refractory chronic spontaneous urticaria
    Celldex Therapeutics announced that its monoclonal antibody barzolvolimab achieved positive results in two Phase 3 studies of patients with treatment-refractory chronic spontaneous urticaria. The E…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Otsuka and Ionis report ALS drug ulefnersen meets primary endpoint in phase 3 trial
    Otsuka and Ionis have completed the Fusion phase 3 trial of ulefnersen, an RNA‑targeted therapy for ALS patients with mutations in the FUS gene. The study enrolled 89 participants, with 73 forming…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ 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 · 29d 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 · 29d 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 · 29d 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 · 29d agoDealPositive↗ source
  • Alkermes reports early proof-of-concept for orexin-2 drug in ADHD
    Alkermes announced early-stage trial results for ALKS 7290, an orexin‑2 receptor agonist originally being developed for narcolepsy, showing proof of concept in ADHD. The study reported dose‑depend…
    BioPharma Dive · 29d agoPositive readoutPositive↗ source
  • Roche’s enicepatide shows dose-dependent blood sugar and weight loss in Phase 2 diabetes trial
    Roche reported that its injectable GLP-1/GIP dual agonist enicepatide, acquired through the Carmot Therapeutics purchase, achieved reductions in blood glucose and body weight in a Phase 2 study of…
    BioSpace · 29d agoPositive readoutPositive↗ source