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FDA shake‑up: Pazdur signals exit—Tracy Hoeg named acting CDER chief
The FDA is undergoing rapid leadership change: Richard Pazdur filed to retire as director of the agency’s drug center, and the FDA named Tracy Beth Høeg as acting director of the Center for Drug...
Crescent inks two‑way Kelun pact—raises $185M for PD‑1xVEGF and ADC programs
Crescent Biopharma announced a strategic two‑way collaboration with Kelun‑Biotech and completed an $185 million financing to accelerate its PD‑1xVEGF asset and antibody‑drug conjugate (ADC)...
FDA leadership turmoil: Høeg installed as Pazdur signals exit
The FDA has undergone rapid leadership change this week as Tracy Beth Høeg, M.D., Ph.D., was named acting director of the agency’s Center for Drug Evaluation and Research and Richard Pazdur filed...
FDA retools approvals and fees: one pivotal trial and user-fee incentives
FDA leaders signaled a substantive shift in regulatory practice by proposing a default approval pathway that accepts one pivotal clinical trial in many cases and by floating user-fee changes to...
Capricor’s deramiocel shocks market: Phase III success revives approval bid
Capricor Therapeutics reported positive topline results from its pivotal Phase III HOPE‑3 trial of deramiocel in Duchenne muscular dystrophy (DMD), meeting its primary functional endpoint and a...
Pharvaris clinches Phase III: oral HAE pill positions to file in 2026
Pharvaris reported that deucrictibant, its oral bradykinin B2 receptor antagonist, met primary and secondary endpoints in a Phase III on‑demand study for hereditary angioedema (HAE). Topline...
Protego raises $130M to fund pivotal AL amyloidosis program
Protego Biopharma closed a $130 million Series B to advance PROT‑001, an oral small‑molecule kinetic stabilizer targeting lambda light chains in AL amyloidosis, into a pivotal trial slated to...
Triana raises $120M to push molecular glue degrader toward clinic
Triana Biomedicines secured a $120 million Series B, led by venture investors including Pfizer‑affiliated funds, to generate proof‑of‑concept data and support its lead molecular glue degrader into...
Regeneron and Tessera agree $150M pact to pursue gene‑writing therapy
Regeneron and Tessera Therapeutics struck a strategic collaboration worth $150 million upfront to co‑develop TSRA‑196, a gene‑writing therapeutic candidate for alpha‑1 antitrypsin deficiency...
Data and design: Illumina pivots to data sales as protein design goes open
Illumina announced BioInsight, a business unit offering sequencing‑intensive, pharma‑grade data packages that Illumina will develop and temporarily exclusivize for partners — a step that moves the...
FDA reduces primate testing: draft guidance aims to curb monkey use in mAb programs
The FDA issued draft recommendations and discussion documents indicating it will reduce or remove the routine requirement for nonhuman primate testing in some monoclonal antibody development...
Pegcetacoplan shows major clinical effect in C3 glomerulopathy — NEJM report
A Phase III trial of the complement inhibitor pegcetacoplan in C3 glomerulopathy (C3G) reported striking results in the New England Journal of Medicine: the drug produced a 68% reduction in urine...
Capricor’s Phase III win — deramiocel meets muscle and heart endpoints
Capricor reported positive topline results from its pivotal Phase III HOPE-3 trial showing deramiocel met both its primary functional endpoint and a key cardiac secondary endpoint. The company...
Pharvaris clocks Phase III win: oral HAE pill hits primary and secondary goals
Pharvaris announced that deucrictibant met primary and secondary endpoints in a pivotal Phase III study as an on‑demand oral therapy for hereditary angioedema (HAE) attacks, reporting faster...
FDA upheaval: top drug regulator to retire as acting appointments shift
Richard Pazdur, the newly installed head of the FDA’s Center for Drug Evaluation and Research, filed paperwork to retire at month‑end, compounding turnover at the agency’s senior ranks. The...
Regeneron inks $150M deal with Tessera — gene writing push for AATD
Regeneron agreed to invest in Tessera Therapeutics and to jointly develop TSRA‑196, a gene‑writing candidate designed to correct mutations that cause alpha‑1 antitrypsin deficiency (AATD)....
Illumina pivots to data services — BioInsight targets pharma and AI models
Illumina announced plans to expand beyond sequencing reagents into data‑as‑a‑service through a new BioInsight unit aimed at pharma customers. The company proposed running large, complex sequencing...
FDA proposes cutting primate tests for antibodies — new draft guidance surfaces
The FDA released draft guidance recommending ways to reduce or avoid nonhuman primate testing for certain monoclonal antibodies, signaling a regulatory shift aimed at modernizing preclinical...
Cedars‑Sinai researchers unveil TY1 — an RNA exomer that boosts DNA repair in heart injury
Cedars‑Sinai scientists published a paper in Science Translational Medicine describing TY1, a synthetic RNA‑based molecule modeled on exosomal sequences that augments TREX1 activity in macrophages...
Pegcetacoplan shows strong benefit in C3 glomerulopathy — first targeted complement therapy
A Phase III trial published in the New England Journal of Medicine showed pegcetacoplan, a C3 complement inhibitor, produced substantial reductions in proteinuria and stabilized kidney function in...