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Pfizer’s monthly obesity regimen expands clinical case
Pfizer used ADA to extend clinical evidence that berobenatide, acquired from Metsera, can be dosed monthly after an initial weekly phase. In the VESPER-3 mid-stage study, patients took...
EU/US regulatory and reimbursement pressure on faster FDA trial starts
A House Appropriations Committee directive pushes the FDA to accelerate the IND sign-off process for new clinical trials, according to the report. The move is framed around maintaining US...
Advance of Ebola diagnostics and outbreak response scaling
The World Health Organization unveiled a six-month plan to stamp out the ongoing Bundibugyo Ebola virus outbreak, including a scale-up of point-of-care molecular diagnostics. WHO said it will...
ADC momentum at ASCO with first-in-human pipeline emphasis
A BioCentury analysis of 137 first-in-human studies highlighted antibody-drug conjugates as the modality driving a large share of early clinical activity at ASCO. The report says ADCs accounted...
Takeda pay-for-delay setback reshapes 2025 financial outlook
Takeda took a major legal charge after a federal jury in Boston found the company liable in a pay-for-delay antitrust case. The company revised fiscal year 2025 results to reflect a 402.5 billion...
Biotech restructures after FDA concerns on sickle cell candidate
Fulcrum Therapeutics announced a large-scale restructure after discontinuing development of pociredir, its sickle cell disease candidate, following FDA concerns about risk-benefit in the...
Regulatory precedent for ‘skinny label’ generic competition
The U.S. Supreme Court sided unanimously with Hikma in a ‘skinny label’ patent dispute over Amarin’s Vascepa. The court held Hikma’s generic version did not infringe patents tied to Amarin’s...
Dealmaking to advance a phase III-ready cancer inhibitor into new ownership
Agios Pharmaceuticals moved to expand its oncology pipeline with a potentially $665 million deal for Oscotec’s cevidoplenib. The transaction grants Agios exclusive global rights to develop and...
Diagnostics and analytics collaboration for bispecific and biosimilar characterization
Bio-Techne and Refeyn launched an integrated workflow designed to improve characterization of bispecific antibodies and biosimilars. The solution links Bio-Techne’s MauriceFlex imaged capillary...
Regulatory & compliance actions
The FDA faced sharp scrutiny over its Commissioner’s National Priority Voucher (CNPV) pilot at a June 4 listening session, with stakeholders offering mixed reviews of the program’s accelerated...
Clinical data & drug safety in obesity/diabetes
Eli Lilly disclosed additional safety and tolerability data on retatrutide, including arrhythmia and major cardiovascular event rates, as the company continues to position its next-generation...
Obesity pipeline in motion: Roche’s compound pairing
Roche said it plans to begin a Phase 2 trial combining petrelintide and enicepatide this year, betting that dual-incretin or multi-mechanism targeting could deliver a safety and efficacy...
Obesity megadeals and payer-grade differentiation: Pfizer’s berobenatide
At the ADA meeting, Pfizer presented detailed VESPER-3 data reinforcing the case for berobenatide dosing on a monthly schedule after an initial weekly lead-in. The company reported ongoing weight...
Biotech restructures after FDA risk concerns
Fulcrum Therapeutics moved to sharply reduce operations after discontinuing development of its sickle cell disease candidate pociredir, citing an FDA assessment of the drug’s benefit-risk profile....
Biotech financing and public market momentum
New biopharma listings remained strong in May, with the sector continuing to attract capital as public financings held up through the first five months of 2026. One high-profile datapoint: Hemab...
M&A and licensing: Travere brings BTK inhibitor into rare kidney disease
Travere Therapeutics licensed global rights to civorebrutinib, a covalent reversible BTK inhibitor, in a deal valued at up to $1.14 billion. The transaction brings additional rare kidney disease...
Targeted cancer imaging: CAIX PET tracer advances preclinical
MD Anderson Cancer Center reported preclinical work on CBT-001-2334, a carbonic anhydrase IX (CAIX/CA9)-targeted PET tracer designed for gallium labeling and potential therapeutic isotope pairing....
Immunotherapy enablers: bispecific antibody characterization workflow
Bio-Techne and Refeyn launched an integrated workflow combining MauriceFlex imaged capillary isoelectric focusing (icIEF) with Refeyn’s TwoMP mass photometry to characterize charge and size...
Universal vaccination strategy for sarbecoviruses
Researchers at the University of Cambridge and spin-out DIOSynVax completed the first human clinical trial of a universal vaccine targeting Sarbeco coronaviruses, a group that includes SARS-CoV-2...
FDA/Regulatory policy
The House Appropriations Committee directed the FDA to reform how it signs off on new clinical trials, pushing for an IND process designed to keep the US pace with global competitors. The move...