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134 stories matching this filter · ← front page

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  • Expedition Therapeutics secures $115M Series B to advance China-origin COPD drug
    Expedition Therapeutics, a biotech that licenses drugs from Chinese firms, announced a $115 million Series B financing that will fund mid-stage testing of its experimental COPD candidate. The fund…
    BioPharma Dive · 3h agoDealPositive↗ source
  • Merck’s anti‑TL1A antibody misses SSc‑ILD trial but hits primary endpoints in hidradenitis suppurativa
    Merck's anti‑TL1A monoclonal antibody, tulisokibart, was evaluated in two phase 2 studies. In the systemic sclerosis‑associated interstitial lung disease (SSc‑ILD) trial, the primary endpoint was…
    Fierce Biotech · 1d agoNeutral↗ source
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fda recalls29
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Vaccines538
Endocrinology & Metabolism307
Ophthalmology283
Infectious Disease270
Pain267
  • J&J pharma chief Jennifer Taubert to retire; Krystal Biotech shares plunge after gene therapy revenue shortfall
    Johnson & Johnson announced that Jennifer Taubert will step down as head of its pharmaceutical division after a 21‑year tenure. During her time she oversaw commercial strategy, dealmaking and the…
    BioPharma Dive · 1d agoNegative↗ source
  • Merck's anti-TL1A antibody shows benefit in hidradenitis suppurativa but misses endpoint in rare lung disease trial
    Merck reported mixed results from its anti‑TL1A antibody, a product of its $10.8 billion acquisition of Prometheus Biosciences. In a mid‑stage study for hidradenitis suppurativa, the antibody met…
    Endpoints · 1d agoNeutral↗ source
  • Merck to test experimental sac-TMT antibody-drug conjugate with Keytruda in lung cancer trial
    Merck announced it will start a clinical trial testing its experimental antibody-drug conjugate sac-TMT together with the immunotherapy Keytruda in patients with lung cancer. The study will assess…
    Endpoints · 21h agoNeutral↗ source
  • Sanofi-backed Expedition uses $115M series B to advance COPD drug on phase 2 journey
    Expedition Therapeutics has secured an oversubscribed $115 million series B financing from a line-up of big-name investors to propel its lead DPP1 inhibitor through phase 2.
    Fierce Biotech · 1d ago↗ source
  • Analyst warns AstraZeneca-BMS merger could spark regulatory hurdles and job cuts
    Angus Liu writes an editorial warning that talks of a merger between AstraZeneca and Bristol Myers Squibb could create more problems than benefits. He notes that the two companies have only discuss…
    Fierce Biotech · 2d agoDealNegative↗ source
  • BioNTech appoints Sobi head Guido Oelkers as new CEO to steer oncology shift
    BioNTech announced that Guido Oelkers, who has led the rare‑disease focused Swedish company Sobi since 2017, will become its next chief executive officer. Oelkers is slated to take over the role b…
    BioPharma Dive · 1d agoNeutral↗ source
  • BlossomHill Therapeutics targets $112 million IPO to fund EGFR lung-cancer drug BH-30643
    BlossomHill Therapeutics, a San Diego oncology biotech, announced plans for an initial public offering to raise about $112 million. The company intends to sell 7.8 million shares at $15-$17 each,…
    Fierce Biotech · 2d agoDealPositive↗ source
  • After 5-month wait, BioNTech announces Sobi CEO will take on top job at mRNA company
    One of the most closely watched vacancies in biopharma has now been filled, with Sobi CEO Guido Oelkers, Ph.D., moving across to take up the top job at mRNA pioneer BioNTech.
    Fierce Biotech · 2d agoNeutral↗ source
  • Sanofi’s new CEO vows deeper review of late-stage pipeline after series of trial failures
    Sanofi appointed Belén Garijo as chief executive in February with a clear mandate to tighten R&D governance and boost productivity. The board tasked her with bringing more rigor to the company’s st…
    Fierce Biotech · 6d agoNegative readoutNegative↗ source
  • Biogen beats revenue expectations, lifts investor confidence with 3% sales rise
    Biogen reported $2.7 billion in revenue for the April‑June quarter, a 3% increase year over year, surpassing analysts' consensus estimate of $2.5 billion. Adjusted earnings per share came in at $3.…
    BioPharma Dive · 7d agoEarningsPositive↗ source
  • Merck briefly lists, then removes, phase 2 trial of PD-1xVEGF bispecific with TROP2 ADC
    Merck & Co. posted a clinical trial listing for a phase‑2 study combining its PD‑1xVEGF bispecific antibody (MK‑2010) with the TROP2‑directed antibody‑drug conjugate sac‑TMT. The listing, shown as…
    Fierce Biotech · 7d agoNeutral↗ source
  • Hansoh and GSK's B7-H3 ADC shows progression-free survival benefit in phase 3 osteosarcoma trial in China
    Hansoh Pharmaceutical, in partnership with GSK, announced that its B7‑H3‑directed antibody‑drug conjugate (ADC) met the primary endpoint in a phase 3 study of relapsed osteosarcoma patients in Chin…
    Fierce Biotech · 8d agoPositive readoutPositive↗ source
  • GSK announces $2.5 billion annual cost-cutting plan to offset upcoming patent cliff
    GSK disclosed in its latest quarterly earnings that it will launch a three-year restructuring aimed at saving about £1.9 billion ($2.5 billion) each year. The plan is intended to cushion the impac…
    BioPharma Dive · 7d agoLayoffsNeutral↗ source
  • GSK launches three-year £1.9bn savings plan to boost late-stage R&D and relocate research HQ
    GSK announced a three-year cost-saving programme designed to free cash for its late-stage research and development pipeline while moving its research headquarters. The plan targets annual savings…
    Fierce Biotech · 8d agoNeutral↗ source
  • Gossamer ends $486M PAH partnership with Chiesi after phase 3 miss
    Gossamer Bio announced it is terminating its collaboration and licensing agreement with Italy's Chiesi, regaining worldwide development and commercial rights to its pulmonary arterial hypertension…
    Fierce Biotech · 9d agoDealNegative↗ source
  • AstraZeneca says it remains confident in its ADC pipeline after dropping two underperforming candidates
    AstraZeneca executives told Fierce they are very confident in their internally developed antibody‑drug conjugate (ADC) program despite recent setbacks. The company has discontinued two ADC candida…
    Fierce Biotech · 9d agoNegative readoutNeutral↗ source
  • American Regent recalls one lot of Papaverine Hydrochloride injection over glass particles
    American Regent announced a voluntary nationwide recall of a single lot of its Papaverine Hydrochloride Injection, USP 60 mg/2 mL, after detecting visible particulate matter. The particles were id…
    fda recalls · 12d agoCRLNegative↗ source
  • Baxter voluntarily recalls Cefazolin in Dextrose injection after cardboard particles found
    Baxter International announced a voluntary nationwide recall of Lot LD175708 of its Cefazolin in Dextrose Injection, a single-dose infusion bag. The recall follows a report that cardboard particle…
    fda recalls · 12d agoCRLNegative↗ source
  • Formation Bio appoints veteran biotech leader Michael Ehlers as chief scientific officer
    Formation Bio, an AI-focused biotech, announced the hiring of Michael Ehlers, M.D., Ph.D., as its chief scientific officer and head of research and development. Ehlers brings a blend of academic a…
    Fierce Biotech · 12d agoPositive↗ source
  • GSK lung cancer drug gets speedy approval following $10.6B deal
    The clearance is GSK’s first for a lung cancer medicine and the latest step forward in a yearslong push by the British drugmaker into oncology.
    BioPharma Dive · 13d ago↗ source
  • FDA approves Nuvalent's cancer drug, a week after GSK closed $10.6B buyout
    GSK's $10.6 billion acquisition of Nuvalent is delivering surprisingly early results. The FDA on Wednesday approved one of Nuvalent's lung cancer medicines two months earlier than projected, and th…
    Endpoints · 13d ago↗ source
  • Summit counters PD-1/VEGF skeptics; Celldex drug fails skin disease study
    A new analysis could address some doubts investors have had about ivonescimab, one analyst said. Elsewhere, Gilead and Merck debuted data for a once-weekly HIV tablet and a new pyschedelics competi…
    BioPharma Dive · 14d ago↗ source
  • BMS expands AI footprint with Nvidia, aiming for ‘most powerful AI factory in life sciences’
    Bristol Myers Squibb has entered into an expanded collaboration with Nvidia to create the biggest supercomputer for drug R&D, according to the announcement.
    Fierce Biotech · 16d ago↗ source