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FDA approval for first-in-class rare disease drug
The FDA approved Mimrylo (rusfertide) for polycythemia vera, clearing Takeda’s first-in-class therapy developed by Protagonist Therapeutics. Takeda’s broader-than-expected label gives the drug a...
Lilly’s continued immunology M&A push
Eli Lilly agreed to acquire Merida Biosciences for up to $2.88 billion, extending the company’s deal-driven strategy to build out immunology capabilities. The acquisition gives Lilly MER511, an Fc...
FDA disclosure shift on CRLs
A major FDA transparency shift is underway for complete response letters (CRLs), with the agency expanding public posting of non-approval letters and improving how sponsors can be held accountable...
CAR-T autoimmune pause – second confirmation
Novartis and Bristol Myers Squibb have both halted autoimmune CAR-T development after immune-related adverse events in early testing, according to the report. The news follows safety scrutiny that...
Deal: Merida takeout coverage (duplicate event, retained distinct ID)
Lilly’s acquisition of Merida Biosciences is being positioned as a strategic extension into Fc-based therapies that can directly address pathogenic autoantibodies, with the deal framed as valued...
Venture financing: ARCH targets $3B raise
ARCH Venture Partners has outlined plans for a new $3 billion fund, described as its 14th, aiming to raise one of the largest venture capital batches in biotech investing. The move signals...
Clinical trial execution risk and CRO oversight
A Tufts Center for the Study of Drug Development analysis found sponsors and CROs struggle with an “execution translation gap,” where risks are identified but not effectively acted on during...
Biotech IPO: Electra Therapeutics files
Sanofi-backed Electra Therapeutics filed for an IPO after the Labor Day holiday to fund an immunology and cancer pipeline, including a Phase 2/3 trial for ipsoprubart (formerly ELA026). The filing...
Takeda/Pivotal performance: heart failure phase 2b results
AstraZeneca’s oral relaxin agonist produced encouraging Phase 2b signals in chronic heart failure, according to coverage of data from ESC 2026. The results reportedly improved measures of cardiac...
Regulatory approval
FDA has cleared Takeda’s Mimrylo (rusfertide) for polycythemia vera, marking a first-in-class engineered peptide treatment for a rare blood cancer. The therapy targets erythrocytosis, a core...
Biopharma M&A
Eli Lilly announced it will buy Merida Biosciences for up to $2.88 billion, extending its immunology push into a platform designed to bind and eliminate pathogenic autoantibodies. The acquisition...
Clinical safety – CAR-T holds
Novartis and Bristol Myers Squibb have paused autoimmune CAR-T development after immune-related adverse events in ongoing trials. Novartis reportedly halted multiple indications for its...
Biotech funding – IPO filing
Sanofi-backed Electra Therapeutics filed to go public to fund Phase 2/3 development of its immunology and cancer programs. The company says it plans to list on Nasdaq under the ticker ETRA after...
Clinical trial execution – CRO/sponsor performance gap
A Tufts Center for the Study of Drug Development analysis finds sponsors and CROs are increasingly identifying clinical trial risks but struggling to implement effective corrective action. The...
Drug pricing – MFN expansions
The White House announced additional voluntary “most-favored nation” (MFN) drug pricing deals, extending the framework to more biopharma companies. New entrants include Alcon, Astellas, BeOne,...
Platform tech – multiplex microscopy reagent workflow
Molecular Instruments’ HiFi Encoder kit is making multiplex fluorescent microscopy faster for researchers who need multiple primary antibodies from the same species. At the Marine Biological...
Cancer biology – resistance reversal concept
Researchers at Medical University of South Carolina Hollings Cancer Center reported a two-step preclinical strategy to counter triple-negative breast cancer resistance. The team led by Ozgur Sahin...
Diagnostics innovation – at-home CRISPR-style testing workflow
A team at The Hong Kong University of Science and Technology (HKUST) developed TEMPO, a one-pot nucleic-acid testing platform intended to bring laboratory sensitivity to at-home use. The approach...
AI + genomics – multimodal foundation modeling in healthcare
Verily Health, collaborating with NVIDIA and the NIH All of Us Research Program, built an early multimodal foundation model that integrates electronic health record and genomic data. The work...
CAR-T safety pauses
Novartis halted multiple autoimmune CAR-T trials, and Bristol Myers Squibb voluntarily paused its zola-cel program, following immune-related adverse events observed in early testing. The actions...