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463 stories matching this filter · ← front page

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  • Coherus Oncology cuts 30% of staff to focus on esophageal cancer combo
    Coherus Oncology announced another round of layoffs, reducing its workforce by about 30% as it narrows its development program. The cuts follow the presentation of phase 1b data on a combination o…
    Fierce Biotech · 8h agoLayoffsNeutral↗ source
  • Recon: FDA orders new eye risk warnings for Ozempic, Zepbound; FDA launches investigation of Novartis’ Zolgensma after cancer ca...
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 1d ago↗ source
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Marea Therapeutics reports promising Phase 2b results for MAR001 in hypertriglyceridemia
Marea Therapeutics, which recently merged with oncology firm Lisata Therapeutics, disclosed data from the first part of its phase 2b trial of the drug candidate MAR001. The study enrolled patients…
Fierce Biotech · 4d agoPositive readoutPositive↗ source
  • Moderna pauses norovirus vaccine trial after missing interim analysis
    Moderna announced it will not enroll a new cohort in the phase 3 trial of its mRNA-1403 norovirus vaccine. The decision follows a July interim analysis that showed the vaccine missed its predefine…
    Fierce Biotech · 4d agoNegative readoutNegative↗ source
  • Faeth Therapeutics reports 33% response rate in phase 2 endometrial cancer combo trial
    Faeth Therapeutics presented topline results from its phase 2 study of an oral combination targeting the PI3K/AKT/mTOR pathway in patients with advanced or recurrent endometrial cancer. The regimen…
    Fierce Biotech · 4d agoPositive readoutPositive↗ source
  • Merck ends Sutro partnership on IL-2 agonist MK-1484 amid routine pipeline prioritization
    Merck announced it is discontinuing development of MK-1484, an interleukin-2 agonist created in partnership with Sutro Biopharma. The drug entered clinical testing in 2022 as a monotherapy and in…
    Fierce Biotech · 4d agoNegative↗ source
  • Onchilles reports that direct tumor injection of N17350 clears distant lesions in solid tumor models
    Onchilles, a San Diego biotech, presented data on its therapeutic elastase N17350, a vaccine‑like agent injected directly into solid tumors. In preclinical studies the intratumoral injection not o…
    Fierce Biotech · 3d agoPositive readoutPositive↗ source
  • FDA grants accelerated approval for Rybrevant Faspro in recurrent/metastatic head and neck cancer
    The U.S. Food and Drug Administration granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carci…
    fda press · 4d agoApprovalPositive↗ source
  • Recon: Sino, Boehringer ink cancer drug deal worth $7B; CVS to split pharmacy business from insurance
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 5d ago↗ source
  • Boehringer Ingelheim strikes $7.4 billion deal with Sino Biopharma for preclinical ADC and TCE programs
    Boehringer Ingelheim announced a major licensing agreement with China's Sino Biopharmaceutical, paying $358 million upfront for a six‑program option covering preclinical antibody‑drug conjugates an…
    Fierce Biotech · 6d agoDealPositive↗ source
  • Servier’s $1.55 B Edgewise muscular dystrophy trial fails to meet primary and secondary endpoints
    Servier invested roughly $1.55 billion in Edgewise Therapeutics' muscular dystrophy program and, five months after the deal, announced that the pivotal phase 2 trial in Becker muscular dystrophy di…
    Fierce Biotech · 6d agoNegative readoutNegative↗ source
  • AbbVie pays $100M upfront in $1.4B deal for Nxera's phase-1 IBD candidate
    AbbVie has agreed to pay $100 million upfront for the worldwide rights to Nxera's oral EP4 receptor agonist, designated NXE0033744, with the total deal value potentially reaching $1.4 billion throu…
    Fierce Biotech · 6d agoDealPositive↗ source
  • Charles River partners with Ipsen to employ virtual control groups in toxicology studies
    Charles River Laboratories and French biopharma Ipsen announced a collaboration to use Charles River’s virtual control group (VCG) database in an upcoming toxicology study. The VCG approach aims t…
    Fierce Biotech · 5d agoDealPositive↗ source
  • T-Therapeutics secures $133M Series B to advance TCR-CD3 bispecifics with major pharma investors
    T-Therapeutics announced a $133 million Series B financing round backed by several of the world’s largest drug developers, including Eli Lilly, Johnson & Johnson, Merck KGaA and Sanofi, along with…
    Fierce Biotech · 6d agoDealPositive↗ source
  • Pfizer drops phase 2 pulmonary arterial hypertension candidate amid pipeline cut
    Pfizer has discontinued its phase 2 pulmonary arterial hypertension (PAH) program, PF-07868489, citing business reasons rather than safety or efficacy concerns. The drug, which targets BMP9 inhibi…
    Fierce Biotech · 7d agoNegative↗ source
  • AbbVie commits £120 million to new Oxford R&D hub, boosting UK life‑science footprint
    AbbVie announced a £120 million ($160 million) investment to expand its research footprint in the United Kingdom. The company will open a new 12,000‑square‑foot R&D facility in Oxford, joining its…
    Fierce Biotech · 7d agoDealPositive↗ source
  • AbbVie halts development of livmoniplimab after deeming benefit limited
    AbbVie announced it is discontinuing the phase 2 development of its monoclonal antibody livmoniplimab (ABBV-151) after concluding the drug is unlikely to outperform existing therapies. The drug wa…
    Fierce Biotech · 7d agoNegative↗ source
  • Karyopharm files Chapter 11 and taps Irish biotech Ayrmid as lead bidder for merger
    Karyopharm Therapeutics, a Massachusetts-based biopharma, entered Chapter 11 bankruptcy as part of a plan to merge with Irish hematology biotech Ayrmid. The move follows a cash crisis revealed in…
    Fierce Biotech · 8d agoDealNegative↗ source
  • Molecular Partners to cut up to 44% of staff as it shifts focus to radiotherapy pipeline
    Molecular Partners announced it will lay off up to 44% of its workforce, affecting as many as 55 positions, as the Swiss biotech redirects its limited cash toward a radiotherapeutic program. The c…
    Fierce Biotech · 11d agoLayoffsNegative↗ source
  • AstraZeneca drops two early-phase prostate cancer programs
    AstraZeneca announced it is terminating development of two early-phase prostate cancer candidates, AZD9750 and AZD8359, as part of a quarterly pipeline review. AZD9750, an oral androgen-receptor d…
    Fierce Biotech · 11d agoNegative↗ source
  • Bambusa Therapeutics exceeds IPO target raising $169 million, while Aspen Neuroscience falls short with $141 million
    Bambusa Therapeutics announced that its initial public offering was upsized, selling more shares at the midpoint of its $15‑$17 range and raising about $168.9 million, exceeding the $150.4 million…
    Fierce Biotech · 11d agoDealNeutral↗ source
  • Roche launches VENTANA BAP1 test to improve mesothelioma diagnosis
    Roche announced the global launch of its VENTANA BAP1 (SP527) test, an automated ready‑to‑use immunohistochemistry assay designed for differential diagnosis of mesothelioma. The assay targets the…
    Fierce Biotech · 11d agoPositive↗ source
  • Third Rock partner’s brain cancer diagnosis highlights personal impact of biotech drug development
    Jigar Raythatha, a partner at Third Rock Ventures, was diagnosed with a rare form of brain cancer in 2023 after a routine MRI. On the same day his diagnosis was confirmed, Servier announced posit…
    Fierce Biotech · 11d agoPositive↗ source
  • Gilead places partial clinical hold on two KITE-753 CAR-T trials in diffuse large B-cell lymphoma
    Gilead announced on its third-quarter earnings call that it has placed a partial clinical hold on two CAR-T trials for KITE-753 targeting diffuse large B-cell lymphoma (DLBCL). The hold affects th…
    Fierce Biotech · 11d agoRegulatoryNegative↗ source
  • Merck says 2027 will focus on pipeline and new product launches despite recent trial wins
    Merck's chief financial officer said the company views 2027 as another year of investment, emphasizing its expanding pipeline and upcoming product launches rather than short‑term margin growth. Th…
    Fierce Biotech · 12d agoEarningsNeutral↗ source