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Ex‑BioMarin execs launch Mendra with $82M to buy rare assets
Former BioMarin executives launched Mendra, a Bay Area biotech that raised $82 million to acquire rare‑disease assets and apply AI to accelerate development. The new company will seek undervalued...
Two IND clears hit solid‑tumor pipeline — Neok and Avacta
The FDA cleared investigational new drug (IND) applications enabling first‑in‑human studies for two solid‑tumor programs. Neok Bio’s bispecific ADC NEOK‑001 received IND clearance and plans a...
Congress carves Medicare path for MCED tests in spending bill
The federal appropriations bill under discussion in Congress includes a provision creating a streamlined pathway for Medicare coverage of FDA‑approved multi‑cancer early detection (MCED) tests. If...
GSK buys Rapt for $2.2B — adds long‑acting IgE drug
GSK agreed to acquire Rapt Therapeutics for $2.2 billion to secure ozureprubart, a long‑acting anti‑IgE monoclonal antibody in Phase IIb. The deal, announced Jan. 20, consolidates GSK’s position...
FDA readies MRD pathway: draft guidance released
The U.S. Food and Drug Administration released draft guidance outlining how measurable residual disease (MRD) negativity and complete response measures could support accelerated approval in...
BMS pens $850M pact with Janux — $50M up front
Bristol Myers Squibb agreed to an up-to-$850 million collaboration with T‑cell engager company Janux Therapeutics focused on a tumor‑activated therapeutic, with $50 million payable immediately....
Erasca upsizes equity raise — $225M priced, $150M filed
Erasca priced an upsized public offering of 22.5 million shares at $10.00 per share to raise approximately $225 million, with an underwriter option for another 3.375 million shares. The financing...
Think Bioscience nets $55M to target ‘undruggable’ proteins
Think Bioscience raised $55 million in a Series A led by Regeneron Ventures and other prominent investors to advance small‑molecule programs against targets considered historically ‘undruggable.’...
BioMarin veterans launch new rare‑disease biotech with $82M
A startup founded by former BioMarin executives closed an $82 million financing to acquire and develop rare‑disease programs that need new homes or fresh development strategies. The Bay Area firm...
CMS backs Illumina test — and Guardant partners with Merck
CMS granted reimbursement for Illumina’s TruSight Oncology Comprehensive assay at $2,989.55 per test, effective Jan. 1, 2026, removing a major access barrier for comprehensive genomic profiling in...
Valneva withdraws chikungunya vaccine from US amid safety probe
Valneva voluntarily withdrew its U.S. marketing application and suspended its halted post‑marketing study for the chikungunya vaccine Ixchiq after the FDA placed a clinical hold tied to a newly...
Next‑gen biomanufacturing: self‑sufficient CHO cells and 3D‑printed bioreactors
Danish researchers engineered CHO cell lines that produce two essential amino acids (threonine and histidine) and demonstrate reduced lactate and ammonia waste, promising simpler feeding...
China opens faster trial routes — global CROs circle the market
Regulatory reforms in China have replaced slow, open‑ended IND approvals with an ‘implied approval’ framework and other measures that dramatically shortened review timelines, analysts said,...
GSK buys Rapt: $2.2B deal adds long‑acting anti‑IgE
GSK agreed to acquire Rapt Therapeutics for $2.2 billion to add ozureprubart, a long‑acting anti‑IgE monoclonal antibody in Phase IIb, to its allergy pipeline. The buyer expects the candidate to...
FDA issues MRD draft guidance: Accelerated approval path clarified
The U.S. Food and Drug Administration released draft guidance describing how measurable residual disease (MRD) negativity and complete response rates may be used to support accelerated approvals...
Erasca prices upsized offering: $225M cash infusion for RAS/MAPK programs
Erasca priced an upsized public offering of 22.5 million shares at $10 each, generating gross proceeds of approximately $225 million to fund its precision‑oncology programs targeting RAS/MAPK...
Corvus pill…phase I surge: Oral ITK inhibitor posts strong eczema readout
Corvus Pharmaceuticals reported positive Phase I data for soquelitinib, an oral ITK inhibitor, in moderate‑to‑severe atopic dermatitis cohorts, showing deepening responses at eight weeks and...
Illumina wins CMS reimbursement: TruSight Oncology gets $2,989 rate
CMS granted reimbursement for Illumina's TruSight Oncology Comprehensive assay at $2,989.55 per test, effective Jan. 1, 2026. The FDA‑cleared comprehensive genomic profiling test covers >500 genes...
Valneva withdraws U.S. chikungunya dossier: Safety concerns prompt exit
Valneva voluntarily withdrew its U.S. authorization for the chikungunya vaccine Ixchiq and pulled the associated post‑marketing study after the FDA placed the product under clinical hold following...
Congress moves MCED coverage: Medicare pathway included in spending bill
A provision in the federal spending package would create a streamlined Medicare coverage pathway for FDA‑approved multi‑cancer early detection (MCED) tests, enabling reimbursement without prior...