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Servier shells out $2.5B for Day One – picks up pediatric glioma drug
Servier agreed to acquire Day One Biopharmaceuticals for roughly $2.5 billion in cash, buying the company’s marketed pediatric glioma therapy Ojemda (tovorafenib) and its development-stage...
Prasad exits FDA in April — tenure marked by high‑profile clashes
Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), will leave the agency at the end of April after a contentious tenure characterized by stringent reviews and...
FDA doubles down: uniQure told to run sham‑controlled Huntington’s trial
The FDA told uniQure that a sham‑controlled randomized trial is required for its surgically delivered gene therapy AMT‑130 for Huntington’s disease, with an unnamed senior official clarifying that...
Roche/Zealand amylin falls short — petrelintide’s weight loss underwhelms
Mid‑stage results for petrelintide, an amylin analog developed by Zealand with Roche, produced placebo‑adjusted weight loss of about 9.0% (10.7% mean reduction vs 1.7% placebo) at 42 weeks—below...
FDA greenlights J&J Tecvayli‑Darzalex combo under priority pathway — approval comes fast
The FDA approved Johnson & Johnson’s Tecvayli plus Darzalex Faspro combination for previously treated multiple myeloma and converted Tecvayli’s accelerated monotherapy approval to full approval...
Japan clears first iPSC‑derived therapy for Parkinson’s — regulatory milestone for regenerative medicine
Japan’s regulator approved the world’s first induced pluripotent stem cell (iPSC)‑derived therapy for Parkinson’s disease, marking a regulatory first for iPSC‑based regenerative treatments and...
Illumina expands alliance dataset — adds 50,000 genomes with paired proteomics
Illumina announced an expansion of the Alliance for Genomic Discovery dataset to include 50,000 additional genomes with paired proteomic data, generated using Illumina’s Protein Prep assay in...
Alnylam inks cardio pact with Tenaya — $10M upfront, $1.13B potential
Alnylam signed a collaboration with Tenaya Therapeutics to access up to 15 novel genetic targets for cardiovascular disease discovery. The deal includes $10 million up front and up to $1.13...
Kestrel wins IND for oral pan‑KRAS inhibitor KST‑6051 — first‑in‑human trial imminent
Kestrel Therapeutics secured FDA clearance for an IND to begin a first‑in‑human Phase I trial of KST‑6051, an oral pan‑KRAS inhibitor targeting KRAS‑driven cancers. The company plans to initiate...
Perimeter wins FDA clearance for Claire — AI‑powered margin imaging for breast surgery
Perimeter Medical Imaging AI secured FDA premarket approval for Claire, its wide‑field optical coherence tomography device integrated with AI to image excised tissue margins during...
Servier buys Day One for $2.5B — Gains pediatric glioma drug and pipeline
Servier agreed to acquire Day One Biopharmaceuticals for about $2.5 billion in cash, gaining marketed pediatric glioma therapy Ojemda (tovorafenib) and a pipeline of oncology programs. The...
FDA vaccine and biologics chief Vinay Prasad to leave at month end — Agency transition underway
Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), will depart the agency at the end of April, FDA and news reports confirmed. Prasad’s tenure drew repeated...
FDA doubles down on sham‑control for uniQure’s Huntington’s gene therapy — Tensions escalate
A senior FDA official publicly defended reviewers’ demand that uniQure run a randomized, sham‑controlled trial for its surgically delivered Huntington’s gene therapy AMT‑130, rejecting the...
Zealand’s amylin fails to match Lilly’s benchmark — Market punishes shares
Roche‑partnered petrelintide produced up to 10.7% mean weight loss at 42 weeks in a Phase II study but missed investor expectations for placebo‑corrected efficacy and was judged inferior in...
FDA grants fast approval to J&J two‑drug myeloma combo — National priority pathway used
The FDA issued a rapid approval for Johnson & Johnson’s Tecvayli plus Darzalex regimen in relapsed or refractory multiple myeloma under the Commissioner’s National Priority Voucher (CNPV) pilot,...
Kestrel clears IND for oral pan‑KRAS inhibitor — First‑in‑human trial planned
Kestrel Therapeutics obtained FDA clearance to begin a first‑in‑human Phase I trial of KST‑6051, an oral, pan‑KRAS small‑molecule intended for KRAS‑driven cancers. The company expects to start the...
Illumina expands pharma genomics with proteomics add‑on — 50K genomes to gain paired proteome
Illumina announced it will add 50,000 genomes with matched proteomics to the Alliance for Genomic Discovery dataset, expanding the pharmaceutical‑accessible resource for target discovery and...
Lonza sells capsule and health‑ingredients unit for $2.2B — Portfolio reshaped
Lonza agreed to divest its capsules and health‑ingredients business to a UK investment firm for $2.2 billion upfront, executing a strategic separation of its consumer health manufacturing assets....
PepGen faces partial FDA hold on DM1 trial — US sites paused, global program continues
PepGen reported that the FDA placed a partial clinical hold on the Freedom2‑DM1 Phase II multiple‑ascending‑dose trial of PGN‑EDODM1 in myotonic dystrophy type 1, citing concerns in preclinical...
Merck KGaA trims oncology pipeline after SpringWorks buyout — Two programs cut
Merck KGaA removed several clinical‑stage oncology assets acquired via its SpringWorks purchase, including a Hippo pathway inhibitor (SW‑682) and a PARP1 inhibitor (M9466), after a strategic...