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464 stories matching this filter · ← front page

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  • Rezolute’s phase 3 trial of ersodetug meets primary endpoint in tumor hyperinsulinism
    Rezolute reported that its phase 3 Uplift study of ersodetug in tumor hyperinsulinism achieved its primary endpoint. The trial required at least nine of 16 patients to show a 50% or greater reduct…
    Fierce Biotech · 11h agoPositive readoutPositive↗ source
  • Virtuoso Surgical receives FDA De Novo clearance for robotic bladder lesion removal system
    Virtuoso Surgical's Virtuoso Endoscopy System received FDA De Novo authorization, marking the first device in a new classification for electromechanical surgical technologies that use robotic instr…
    Fierce Biotech · 17h agoApprovalPositive↗ source
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  • American Cancer Society updates prostate cancer screening guidance
    For the first time in 16 years, the American Cancer Society (ACS) has updated its guideline for prostate cancer screening as it drives to boost detection of the disease before it spreads.
    Fierce Biotech · 13h ago↗ source
  • Bristol Myers Squibb reshuffles R&D leadership as chief research officer departs and CMO takes over combined unit
    Bristol Myers Squibb announced a restructuring of its research and development organization, merging the separate research and development divisions into a single unit. The new combined R&D unit w…
    Fierce Biotech · 1d agoNeutral↗ source
  • Pfizer taps Blackstone for up to $1.5B to pave path to GLP-1's obesity launch
    Pfizer has secured up to $1.5 billion from Blackstone Life Sciences to fund development of its monthly GLP-1 receptor agonist.
    Fierce Biotech · 1d agoNeutral↗ source
  • BioNTech spends $205 million on FDA priority review voucher to accelerate oncology pipeline
    BioNTech has agreed to pay $205 million to acquire an FDA priority review voucher, a tool that can shorten the agency's standard review period from ten months to six months. The voucher was previo…
    Fierce Biotech · 2d agoDealPositive↗ source
  • Flagship-backed Valo Health merges with Montai Therapeutics to boost AI-driven drug pipeline
    Valo Health and Montai Therapeutics announced they will combine under the Valo brand, creating a larger AI-focused biotech aimed at accelerating early-stage drug discovery. Valo, launched in 2020…
    Fierce Biotech · 2d agoDealPositive↗ source
  • Dual targeting of GPCRs and mutated Gαq/11 shows promise for uveal melanoma
    Researchers at Thomas Jefferson University reported a new strategy to disrupt signaling in uveal melanoma, a rare eye cancer. The study found that simultaneously inhibiting the G protein-coupled r…
    Fierce Biotech · 2d agoPositive readoutPositive↗ source
  • FDA releases draft guidance for early-phase first-in-human studies of solid-tumor therapies
    The U.S. Food and Drug Administration has issued draft guidance to help sponsors design early-phase first-in-human IND studies for investigational drugs and biologics targeting solid tumors. The g…
    raps · 2d agoRegulatoryNeutral↗ source
  • Start Center for Cancer Research launches Italy’s first early-phase oncology trial site with IFO
    Start Center for Cancer Research has opened its first early-phase cancer clinical trial site in Italy, partnering with the public research hospital group Istituti Fisioterapici Ospitalieri (IFO).…
    Fierce Biotech · 3d agoDealPositive↗ source
  • Acting FDA commissioner reports strong public interest in new expedited IND pilot
    Acting FDA Commissioner Kyle Diamantas told attendees at the Friends of Cancer Research annual meeting that the agency’s newly launched Expedited IND pilot has attracted considerable public attenti…
    raps · 3d agoRegulatoryPositive↗ source
  • 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 · 3d agoLayoffsNeutral↗ source
  • Novocure's Optune Mya device denied FDA approval over efficacy concerns
    Novocure received a "not approvable" letter from the FDA for its Optune Mya system, which was being evaluated for patients with brain metastases from non‑small cell lung cancer after stereotactic r…
    Fierce Biotech · 3d agoRegulatoryNegative↗ source
  • Rivia unveils AI-driven DataFindings module to accelerate clinical trial data cleaning, Scancell adopts early
    Swiss CRO Rivia introduced an AI-powered DataFindings module that integrates with its Rivia Core platform to automate continuous review of clinical trial data. The tool uses AI agents to help user…
    Fierce Biotech · 4d agoPositive↗ 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 · 4d ago↗ source
  • Chinese biotech CEOs target creation of up to ten global Big Pharma firms within a decade
    Chinese drug developers have shifted from generic manufacturing to aiming for a seat at the global Big Pharma table, according to recent interviews. The country now ranks second after the United S…
    Fierce Biotech · 6d agoPositive↗ source
  • 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 · 7d agoPositive readoutPositive↗ source
  • Experts warn US Treasury's biotech investment ban on China could backfire
    The U.S. Treasury released a draft policy to implement the Comprehensive Outbound Investment National Security (COINS) Act, proposing to add pharmaceutical compounds to an outbound investment black…
    Fierce Biotech · 6d agoRegulatoryNegative↗ 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 · 7d 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 · 7d 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 · 7d 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 · 7d agoPositive readoutPositive↗ 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 · 8d 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 · 9d 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 · 9d agoNegative readoutNegative↗ source