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19 stories matching this filter · ← front page

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  • BioMarin to buy Alesta Therapeutics for $275M, adding rare bone disease drug to pipeline
    BioMarin announced Tuesday that it will acquire privately held Alesta Therapeutics, paying $275 million upfront with potential additional payments tied to milestones. The deal, expected to close b…
    BioPharma Dive · 1d agoDealPositive↗ source
  • BMS to build $2.3 B Houston plant as MHRA clears Lilly's weight-loss drug; IMDRF issues PCCP guidance
    Bristol Myers Squibb announced a plan to invest about $2.3 billion in a new manufacturing facility in Houston. The site is expected to expand the company’s production capacity for its pipeline and…
    raps · 10d agoRegulatoryNeutral↗ source
73
fda recalls47
fda medwatch36
fda press28
Psychiatry & CNS710
Ophthalmology419
Endocrinology & Metabolism377
Pain371
Infectious Disease346
  • Fresenius Kabi recalls one lot of Morphine Sulfate Injection after labeling error mixes Dilaudid syringes
    Fresenius Kabi announced a voluntary recall of a single lot of its Morphine Sulfate Injection USP, Simplist 2 mg/1 mL product. The recall stems from a labeling mistake where the MicroVault contain…
    fda medwatch · 15d agoCRLNegative↗ source
  • Vertex posts strong Q2 earnings, but upcoming Sionna cystic fibrosis data casts a shadow
    Vertex reported Q2 revenue from its cystic fibrosis portfolio exceeding $3.2 billion, beating estimates and prompting an upward revision of full‑year revenue guidance to $13.1‑$13.2 billion. Analy…
    BioPharma Dive · 15d agoEarningsNeutral↗ source
  • Vertex and AbCellera team up to develop next-generation T-cell engagers for autoimmune diseases
    Vertex Pharmaceuticals has entered a partnership with AbCellera to create next-generation T-cell engagers aimed at autoimmune diseases. AbCellera will receive an upfront payment of $28 million, wit…
    BioPharma Dive · 21d agoDealPositive↗ source
  • Biotech confidence surges in 2026 as China leads growth and deal activity spikes
    Industry observers noted a marked shift in tone at two major 2026 biotech gatherings – the DIA China meeting in Shanghai and the BIO International Convention in San Diego – where participants expre…
    BioPharma Dive · 24d agoPositive↗ source
  • Arrowhead’s plozasiran cuts triglycerides up to 81% in late-stage trials, shows promise for severe hypertriglyceridemia
    Arrowhead Pharmaceuticals reported positive data from two late-stage studies of its RNA-based drug plozasiran in adults with severe hypertriglyceridemia. The trials used a subcutaneous injection e…
    BioPharma Dive · 28d agoPositive readoutPositive↗ source
  • Vertex's $10 billion Crinetics buyout draws investor doubts over premium price
    Vertex was the lone bidder in a planned $10 billion acquisition of Crinetics Pharmaceuticals, a California company that focuses on endocrine medicines. Crinetics currently markets a therapy for a…
    BioPharma Dive · 28d agoDealNegative↗ source
  • Kailera says obesity pill succeeds in late-stage trial in China
    The drug spurred about 10% weight loss over 10 months, though that finding came alongside high rates of gastrointestinal side effects that “alarmed” one analyst.
    BioPharma Dive · 1mo ago↗ source
  • Vertex to acquire Crinetics in $10B foray into endocrine disease drugs
    Vertex claimed the two drugs in the deal could eventually bring in more than $5 billion annually. Still, the high price it paid stirred debate among analysts and investors.
    BioPharma Dive · 1mo ago↗ source
  • 10 clinical trials to watch in the second half of 2026
    The biotechnology sector’s upswing accelerated in the first half. Positive results from anticipated trials in lung cancer, Alzheimer’s and multiple autoimmune conditions could add to the momentum.
    BioPharma Dive · 1mo ago↗ source
  • Alkermes’ incoming CEO has a plan to outplay Lilly and Takeda
    Blair Jackson says the next 12 months may be the most important in Alkermes’ history, as the brain drugmaker races to join an “orexin” market that analysts see as a multibillion-dollar opportunity.
    BioPharma Dive · 1mo ago↗ source
  • Celcuity breast cancer drug misses ‘lofty’ expectations in ASCO-spotlighted trial
    Gedatolisib could “establish a new standard of care” for PIK3CA-mutated breast cancer, an investigator said, but the results nonetheless appeared to disappoint investors.
    BioPharma Dive · 2mo ago↗ source
  • Servier buys into muscular dystrophy with potentially $2.7B deal
    The French drugmaker has agreed to acquire an experimental tablet from Edgewise Therapeutics that some bullish analysts say could eventually hit peak sales of over $2 billion.
    BioPharma Dive · 2mo ago↗ source
  • Novo hikes guidance on Wegovy pill’s fast sales start
    In its latest earnings report, the Danish drugmaker said sales and profit should shrink less than the company originally anticipated thanks to strong prescription numbers for its new obesity pill.
    BioPharma Dive · 3mo ago↗ source
  • Avalo shares spike on skin drug data; BioNTech to cut staff
    Avalo reported study success in what’s proven to be a tough-to-treat skin disease. Elsewhere, BioNTech announced plans to close multiple plants and Madrigal picked up an RNA-based drug for MASH.
    BioPharma Dive · 3mo ago↗ source
  • Arvinas’ ‘Protac’ breast cancer drug cleared by FDA
    Known as Veppanu, the drug is the first of its kind to get to market. But Arvinas and partner Pfizer are still searching for a new partner to sell it.
    BioPharma Dive · 3mo ago↗ source
  • Boehringer dual-acting obesity shot hits mark in Phase 3 trial
    Survodutide spurred weight loss Wall Street analysts referred to as “Wegovy-like,” and showed signs it might help preserve muscle mass as well.
    BioPharma Dive · 3mo ago↗ source
  • Biotech investors gamble on M&A. Some drugmakers are betting on themselves instead.
    Young biotechs usually get acquired instead of profitably selling their own medicines. A growing number are proving they can, which could make the sector more broadly appealing to investors, some say.
    BioPharma Dive · 3mo ago↗ source