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697 stories matching this filter · ← front page

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  • ARPA-H awards $160 M to accelerate bespoke gene‑editing therapies for rare diseases
    ARPA-H announced a $160 million, five‑year investment through its THRIVE program to speed the development of personalized gene‑editing treatments for rare genetic conditions. The awardees include…
    BioPharma Dive · 1mo agoNeutral↗ source
  • FDA proposes streamlined registration rule for hub-and-spoke drug manufacturing networks
    The FDA released a proposed rule that would let distributed drug manufacturing facilities using a hub-and-spoke model register as a single establishment. Under current regulations each site must r…
    fda press · 1mo agoRegulatoryPositive↗ source
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Infectious Disease364
  • GSK, Hansoh ADC extends survival in lung cancer study
    GSK claimed the result was a first for an ADC aimed at the “B7-H3” protein, an increasingly popular target of late among cancer drugmakers.
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • AstraZeneca and Ionis report failure of eplontersen in ATTR-CM trial
    AstraZeneca and Ionis said their nucleic‑acid drug eplontersen did not meet the primary goal in a large study of patients with transthyretin‑mediated amyloid cardiomyopathy (ATTR‑CM). Over a 140‑we…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • GSK ends $2.2 billion brain drug partnership with Alector after trial failures
    GSK and California‑based biotech Alector have ended their collaboration after both experimental brain drugs failed to meet development milestones. The partnership, announced in July 2021, gave GSK…
    BioPharma Dive · 1mo agoDealNegative↗ source
  • HHS launches Operation Trialblazer to accelerate U.S. drug research amid growing competition from China
    The Department of Health and Human Services introduced a new initiative called Operation Trialblazer aimed at speeding early-stage drug research in the United States. The plan calls for coordinate…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Roche scraps two Ionis-partnered Huntington’s drugs
    The Swiss pharmaceutical giant told patient groups tominersen didn't delay disease progression in one trial, while a study of a second drug was scrapped because of a safety signal in animal testing.
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • AstraZeneca and GSK strike new China partnerships with Sino Biopharm
    Sino Biopharm announced two separate agreements with the United Kingdom's largest drugmakers, AstraZeneca and GSK, to deepen their presence in the Chinese market. AstraZeneca will license rights t…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Arbitration panel rules Prime Medicine did not breach Beam deal over AATD therapy
    An arbitration panel has ruled that Prime Medicine did not violate its 2019 collaboration agreement with Beam Therapeutics by advancing a treatment for alpha‑1 antitrypsin deficiency (AATD). The de…
    BioPharma Dive · 1mo agoNeutral↗ source
  • FDA grants accelerated approval to Vera Therapeutics' Trutakna for IgA nephropathy
    The FDA has granted accelerated approval to Trutakna (formerly known as atacicept) from Vera Therapeutics for adult patients with IgA nephropathy, a chronic kidney disease that can progress to rena…
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • Vertex to buy Crinetics for $10 billion, expanding into endocrine disease drugs
    Vertex announced an agreement to acquire Crinetics Pharmaceuticals for $10 billion in cash, paying $85 per share. The purchase brings two recently launched drugs for a rare hormonal disorder into…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Oberland invests up to $400M in MeiraGTx eye gene‑therapy pipeline
    Oberland Capital Management announced a financing package that could total $400 million to support MeiraGTx's development of gene therapies for inherited eye disorders. The arrangement includes up…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Kailera's oral GLP-1 pill shows ~10% weight loss in Chinese Phase 3 trial
    Kailera Therapeutics reported that its oral GLP-1 candidate HRS-7535 achieved about 10% average weight loss over 44 weeks in a Phase 3 study in China. The highest daily dose led to a mean 9.8% red…
    BioPharma Dive · 1mo agoPositive readoutNeutral↗ source
  • Novartis to buy Myricx Bio for up to $1.5 billion, adding two novel ADCs to its oncology portfolio
    Novartis announced it will acquire Myricx Bio, a UK‑based biotech that develops antibody drug conjugates (ADCs), in a move to broaden its oncology pipeline. The transaction is valued at up to $1.5…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Cancer and immune-focused biotech firms capture over $3.9 billion of H1 2026 venture capital
    BioPharma Dive data show that cancer and immune disease biotech companies accounted for more than 40% of the biotech firms receiving venture funding in the first half of 2026. Of the roughly $9 bi…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Gene-editing biotech Scribe Therapeutics files for Nasdaq IPO
    Scribe Therapeutics, a California-based biotechnology startup developing genetic medicines for cardiometabolic disorders, announced plans to go public on the Nasdaq under the ticker SCTX. The comp…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Lancaster County emerges as new biotech hub as Boston faces layoffs
    Boston’s biotech sector is experiencing layoffs and vacant lab space, signaling a slowdown in the region that has long been a biotech stronghold. In contrast, Lancaster County, Pennsylvania, is wi…
    BioPharma Dive · 1mo agoNeutral↗ source
  • Roche’s divarasib shows survival benefit over Amgen and BMS drugs in KRAS G12C lung cancer trial
    Roche reported that its experimental KRAS G12C inhibitor divarasib extended overall survival and progression‑free survival in a Phase 3 head‑to‑head study against Amgen’s Lumakra and Bristol Myers…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Celea Therapeutics raises $180 million to advance next-generation IPF drug deupirfenidone
    Celea Therapeutics, a PureTech Health spinout, announced a $180 million venture round to fund development of its next-generation idiopathic pulmonary fibrosis (IPF) therapy, deupirfenidone. The ro…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • FDA Grants First Gene-Therapy Approval for Children 2+ with Sickle Cell Disease
    The U.S. Food and Drug Administration issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged two years and older who have sickle cell disease with recurrent vaso-oc…
    fda press · 1mo agoApprovalPositive↗ source
  • Ipsen to acquire Swiss biotech Memo Therapeutics in up to €800 million deal for BK virus drug
    Ipsen announced it will purchase Memo Therapeutics, a Swiss biotech, in a transaction valued at up to about €800 million. The agreement provides Memo investors with €200 million upfront and potent…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • BridgeBio secures up to $1 billion in preferred equity as United Therapeutics invests $140 million to acquire Thymmune
    BridgeBio Pharma announced that Sixth Street Partners and HealthCare Royalty will provide up to $1 billion in preferred equity to support its upcoming product launches. The financing is structured…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • 5 FDA decisions to watch in the third quarter of 2026
    A group of coming decisions could provide important insights into how flexible the agency is willing to be under new leadership.
    BioPharma Dive · 1mo ago↗ source
  • Abivax shares surge as worries subside over immune drug’s cancer risk
    According to Abivax, fresh data suggest malignancy rates in its trials were no higher than "background" ones for people with ulcerative colitis, clearing a key safety concern.
    BioPharma Dive · 1mo ago↗ source
  • FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer Patients
    The U.S. Food and Drug Administration today approved TREGZI, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult pat…
    fda press · 1mo ago↗ source