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Altesa raises $75M to advance antivirals — Giroir leads Series B
Altesa BioSciences closed a $75 million Series B to advance vapendavir, an oral antiviral targeting rhinoviruses, into larger clinical testing for respiratory disease and COPD exacerbation...
Novartis commits $100M to macrocycle startup — peptide frontier expands
Novartis committed $100 million to Unnatural Products to advance macrocyclic peptide technology aimed at previously undruggable targets, joining existing collaborations the startup holds with...
FDA reverses Moderna refusal — agency turmoil lands in Washington
The FDA reversed an initial Refuse‑to‑File decision and agreed to review Moderna’s mRNA influenza vaccine application after a Type A meeting between agency staff and the company. The U‑turn...
AI to lab-in‑loop: Insilico, Lilly and rapid evolution reshape R&D
Insilico Medicine and Lilly published a framework envisioning a fully autonomous “prompt-to-drug” pipeline integrating generative AI across design, synthesis, and testing. Parallel advances are...
High‑throughput sequencing race heats up — Element’s Vitari and new platforms
Element Biosciences unveiled Vitari, a high‑throughput sequencer that promises $100 30× genomes by delivering 3 Tb per run; at the same time vendors are launching spatial and single‑cell platforms...
Grail’s Galleri misses NHS endpoint — shares collapse
Grail reported that its NHS‑Galleri multicancer early detection (MCED) trial did not meet the primary endpoint of a statistically significant reduction in late‑stage (Stage III–IV) cancers. The...
FDA makes single pivotal trial the default — NEJM chiefs explain
Top FDA officials wrote in the New England Journal of Medicine that the agency will adopt a single‑pivotal‑trial default for drug approvals, signalling an explicit policy shift from the...
Japan backs two iPSC therapies under early‑approval pathway
Japan’s regulatory advisory body recommended conditional, time‑limited approvals for two iPSC‑derived therapies: Amchepry (raguneprocel) and Reheart, positioning them to become the first iPSC...
Altesa closes $75M Series B to push antivirals into COPD trials
Altesa BioSciences closed a $75 million Series B to advance vapendavir, an oral antiviral that targets rhinovirus, into larger COPD‑focused clinical testing. The round, led by Forbion with...
Korsana emerges with $175M to pursue Alzheimer’s brain‑shuttle antibody
Korsana Biosciences launched from stealth with $175 million to develop KRSA‑028, an antibody engineered to cross the blood‑brain barrier and clear amyloid plaques. The Boston company’s financing...
Guardant ramps screening push — Shield demand and MetaSight buy
Guardant Health set 2026 guidance forecasting a major ramp in Shield screening volumes and disclosed the acquisition of MetaSight Diagnostics to expand its cancer screening portfolio. Executives...
Danaher to buy Masimo — diagnostics M&A accelerates
Danaher agreed to acquire Masimo for approximately $9.9 billion in cash, a deal aimed at broadening Danaher’s acute‑care diagnostics and patient monitoring footprint. The acquisition reflects...
Novartis to sell India generics arm to PE — keeps R&D presence
Novartis agreed to sell its 70.68% stake in Novartis India Limited to a private equity consortium for about $159 million while retaining a separate commercial and R&D footprint in the country. The...
Roche gets FDA decision date for SERD giredestrant; leadership shuffle
Roche announced an FDA target action date of Dec. 18 for giredestrant, its investigational oral SERD for ER‑positive, HER2‑negative breast cancer, based on Phase 3 data showing progression‑free...
MULTI‑evolve and lab‑in‑loop frameworks speed complex protein design
Researchers introduced MULTI‑evolve, an ML‑guided, lab‑in‑the‑loop platform that accelerates the directed evolution of multi‑mutant proteins by combining protein language models, targeted...
Galleri misses primary goal—Grail shares plunge after NHS trial
Grail reported that its NHS‑Galleri multicancer early detection (MCED) trial did not meet the study’s primary endpoint of a statistically significant reduction in stage III–IV cancers. The topline...
FDA formalizes one‑trial default: approval bar lowered as NEJM piece sets tone
FDA leaders published a New England Journal of Medicine perspective stating the agency will adopt a new default that a single well‑controlled clinical trial can serve as the pivotal basis for drug...
Guardant buys MetaSight—screens set to scale with Shield guidance
Guardant Health disclosed the $59 million upfront acquisition of MetaSight Diagnostics and offered ambitious 2026 screening guidance tied to its Shield colorectal cancer screening test. Management...
Danaher moves on Masimo: $10B takeover to bulk up diagnostics and monitoring
Danaher agreed to acquire Masimo in a roughly $10 billion cash deal aimed at strengthening its acute‑care monitoring and diagnostics portfolio. The acquisition will fold Masimo’s pulse oximetry...
Japan backs first iPSC drugs—conditional clearances eyed under CEA pathway
Japan’s regulatory advisory committee recommended conditional approvals for two induced pluripotent stem cell (iPSC)‑derived therapies — Amchepry (Sumitomo/Racthera) and Reheart (Cuorips) — under...