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902 stories matching this filter · ← front page

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  • Roche signs $1.53 billion licensing deal with Simcere for preclinical B-cell antibody
    Roche announced a licensing agreement with China's Simcere Zaiming, paying $75 million upfront and potentially up to $1.53 billion in total, for worldwide rights to a preclinical trispecific antibo…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • GSK's mRNA flu vaccine shows stronger immune response than standard shots in phase 2, prompting phase 3 launch
    GSK reported that its experimental mRNA seasonal influenza vaccine generated higher immune responses than both standard and high-dose flu shots in a phase-2 study involving nearly 1,000 adults. Th…
    Fierce Biotech · 2mo agoPositive readoutPositive↗ source
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  • Medtronic recalls Bravo CF reflux monitoring capsule after 184 serious injuries reported
    Medtronic has issued a recall of its Bravo CF esophageal pH monitoring capsule, a wireless device used to assess acid reflux. The recall follows an FDA early alert after the company identified a pr…
    Fierce Biotech · 2mo agoCRLNegative↗ source
  • Boston Scientific stops sales of Imager II catheters after tip defect linked to two injuries
    Boston Scientific issued a letter on August 24 advising customers to remove all Imager II angiographic catheters from use or sale after discovering a manufacturing problem. The problem involves re…
    Fierce Biotech · 2mo agoCRLNegative↗ source
  • Arsenal Biosciences cuts 99 jobs as it pivots to in-vivo CAR-T therapy
    Arsenal Biosciences announced a major restructuring, laying off 99 employees, which represents the majority of its workforce across all teams and locations. The company is ending development of it…
    Fierce Biotech · 2mo agoLayoffsNegative↗ source
  • Alumis' lupus trial misses endpoints, but company eyes phase 3 in IFNGS‑high subgroup
    Alumis reported that its phase 2b study of the TYK2 inhibitor envudeucitinib failed to meet both the primary and secondary efficacy endpoints in patients with moderate to severe systemic lupus eryt…
    Fierce Biotech · 2mo agoNegative readoutNegative↗ source
  • Novocure cyberattack exposes data of over 1,400 U.S. patients and staff
    Novocure disclosed a cyberattack in an SEC filing, saying unauthorized access to some information systems was discovered in mid‑August. The breach exposed internal patient ID numbers for more than…
    Fierce Biotech · 2mo agoNegative↗ source
  • Absci CEO envisions AI-driven, consumer-focused drug platform, eyeing hair loss, endometriosis and future GLP-1 combos
    Absci, an AI‑focused biotech founded about 15 years ago in Vancouver, Washington, is led by CEO Sean McClain, who likens his ambition for the company to creating the Apple of biotech. The surge in…
    Fierce Biotech · 2mo agoPositive↗ source
  • Medline recalls neonatal and infant heated wire breathing circuits over connector failures
    Medline has issued a recall for specific neonatal and infant heated wire breathing circuits after identifying failures in the electrical connector. The FDA has classified the issue as potentially…
    fda medwatch · 2mo agoCRLNegative↗ source
  • Eli Lilly to acquire Merida Biosciences for up to $2.88 billion, adding autoimmune antibody-degrading pipeline
    Eli Lilly announced a transaction to purchase Merida Biosciences for up to $2.875 billion, combining an upfront cash payment with future milestone payments. Merida, which emerged from stealth last…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Novartis and Bristol Myers pause multiple autoimmune CAR-T trials after serious immune adverse events
    Novartis and Bristol Myers Squibb announced a temporary halt to several CAR-T cell therapy trials targeting autoimmune diseases. The pause involves Novartis’s autologous CD19 CAR-T candidate rapca…
    Fierce Biotech · 2mo agoRegulatoryNegative↗ source
  • Analysts see opportunity for Alnylam’s RNAi therapy after AstraZeneca/Ionis ATTR-CM trial fails
    AstraZeneca and its partner Ionis reported a disappointing Phase 3 result for the antisense drug Wainua in transthyretin amyloid cardiomyopathy (ATTR-CM). The unexpected outcome was a focal point o…
    Fierce Biotech · 2mo agoNegative readoutNeutral↗ source
  • Electra Therapeutics files for Nasdaq IPO to fund phase 2/3 immunology and cancer programs
    Electra Therapeutics, based in South San Francisco, announced it has filed a registration statement to list its shares on the Nasdaq Global Select Market under the ticker ETRA. The company says th…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • AstraZeneca's oral relaxin agonist shows positive phase 2b results in chronic heart failure
    AstraZeneca presented phase 2b data from its Luminara trial at the European Society of Cardiology Congress in Munich. The study evaluated the oral relaxin agonist AZD5462 in patients with chronic h…
    Fierce Biotech · 2mo agoPositive readoutPositive↗ source
  • Natera partners with Angiex to evaluate Signatera blood test in AGX101 cancer trial
    Natera announced a collaboration with biotech Angiex to assess its Signatera circulating tumor DNA blood test in the context of Angiex’s early‑stage clinical trial of AGX101. Angiex, based in Camb…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Ana Salazar Modela Tu Cuerpo recalls Lipofit Extreme Fat Burner 2.0 after FDA finds undeclared fluoxetine and DNP
    Ana Salazar Modela Tu Cuerpo Inc. announced a voluntary nationwide recall of its Lipofit Extreme Fat Burner 2.0 on August 27, 2026, targeting the lot with expiration in September 2027. FDA laborat…
    fda medwatch · 2mo agoCRLNegative↗ source
  • FDA approves Mimrylo, first hepcidin-mimicking drug for polycythemia vera
    The U.S. Food and Drug Administration announced approval of Mimrylo (rusfertide) for adult patients with polycythemia vera, a rare blood disorder that causes excess red blood cells. The drug mimic…
    fda press · 2mo agoApprovalPositive↗ source
  • AusperBio secures $120 million Series C to push hepatitis B antisense therapy into Phase 3
    AusperBio Therapeutics announced it has closed a $120 million Series C financing round aimed at moving its hepatitis B antisense oligonucleotide candidate toward late‑stage trials and eventual mark…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Roche pays $190 million for rights to Hanmi's UCN2 analog targeting obesity with muscle-preserving effects
    Roche's Genentech unit has agreed to pay $190 million upfront for rights to HM17321, a urocortin‑2 analog developed by South Korea’s Hanmi Pharmaceutical, covering markets outside South Korea. The…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Genentech pays $45M upfront to DualityBio for ADC platform targeting resistant cancers
    Genentech has agreed to pay DualityBio $45 million upfront for rights to its antibody‑drug conjugate (ADC) technology, with the agreement offering more than $1 billion in potential milestone paymen…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • BioNTech-Genentech halts colorectal cancer vaccine trial after higher death rate in vaccine arm
    BioNTech and Genentech stopped a phase 2 trial of their personalized mRNA vaccine BNT122 in patients with stage 2 or 3 colorectal cancer after an independent data safety monitoring board found more…
    Fierce Biotech · 2mo agoNegative readoutNegative↗ source
  • FDA alerts on possible Aspergillus contamination in Avid Medical IV start kits
    The FDA’s Center for Devices and Radiological Health has issued an Early Alert warning that certain IV start kits from Avid Medical may be contaminated with the fungus Aspergillus penicillioides, a…
    fda medwatch · 2mo agoRegulatoryNegative↗ source
  • Boston Scientific recalls Imager II angiographic catheters over tip detachment risk
    FDA's CDRH issued an Early Alert about Boston Scientific's Imager II angiographic catheters due to a manufacturing problem that can cause the catheter tip to detach. The company sent a letter on A…
    fda medwatch · 2mo agoRegulatoryNegative↗ source
  • Teva named stalking horse bidder to acquire BioXcel's neuroscience assets for $57.5 million
    BioXcel Therapeutics, a Connecticut biotech focused on neuroscience, filed for Chapter 11 bankruptcy after running out of cash to fund operations through August. In the filing, the company selecte…
    Fierce Biotech · 2mo agoDealNeutral↗ source
  • CEPI pledges up to $16.5M to advance Egyptian biotech's Ebola vaccine candidate
    CEPI has committed up to $16.5 million to help bring Minapharm’s Bundibugyo Ebola vaccine candidate into clinical testing. The funding will support preclinical work and an early-stage human trial…
    Fierce Biotech · 2mo agoDealPositive↗ source