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Japan backs two iPSC therapies under early‑approval pathway
Japan’s regulatory advisory body recommended conditional approvals for two induced pluripotent stem cell (iPSC)‑derived therapies: Amchepry (raguneprocel) from Sumitomo Pharma/Racthera and Reheart...
Ionis halts Alzheimer candidate for Down syndrome
Ionis Pharmaceuticals discontinued development of a candidate intended to prevent Alzheimer’s disease in people with Down syndrome, the company confirmed following reporting by Endpoints. Ionis...
Stanford mucosal vaccine protects mice from diverse respiratory threats
Researchers at Stanford reported a nasal vaccine in Science that produced broad protection in mice against multiple respiratory viruses, bacteria and even allergen challenge. The intranasal...
Cryo‑EM maps CSN5i‑3 binding — orthosteric molecular‑glue revealed
A structural study using cryo‑electron microscopy detailed how CSN5i‑3 binds within the intact COP9 signalosome (CSN) complex, defining its orthosteric molecular‑glue mechanism. The work clarifies...
New structural insights into bacterial DNA synthesis control point to antimicrobial target
Researchers reported structural and mechanistic characterization of NrdR, a bacterial transcriptional regulator that controls ribonucleotide reductase (RNR) expression and thus dNTP supply for DNA...
Grail’s Galleri flops in NHS study: shares tumble
Grail reported that its large NHS-Galleri multicancer early detection (MCED) trial failed to meet the study's primary endpoint, triggering a sharp sell-off in the company's stock. The company...
FDA formalizes one-trial default: NEJM authors set new standard
Top FDA officials signaled a formal policy shift: the agency will now default to accepting a single well-controlled pivotal clinical trial as sufficient evidence for drug approval, supplemented by...
Moderna’s flu vaccine review reverses course: FDA will now review
Moderna secured a last-minute regulatory reprieve: the FDA reversed an initial Refusal to File and will now accept review of the company’s mRNA influenza vaccine, mRNA-1010, after a Type A...
Danaher shells out $10B for Masimo — diagnostics consolidation accelerates
Danaher announced a definitive agreement to acquire Masimo for approximately $10 billion in cash, expanding Danaher’s footprint in patient monitoring and diagnostics. The deal values Masimo at...
Guardant ramps screening business, buys MetaSight — Shield growth accelerated
Guardant Health projected material screening revenue growth for 2026 and disclosed the acquisition of MCED startup MetaSight Diagnostics for $59 million upfront (plus up to $90 million...
Altesa raises $75M to reboot antiviral vapendavir program
Altesa BioSciences closed a $75 million Series B to advance vapendavir, an antiviral targeting rhinovirus, into larger mid-stage trials focused on chronic lung disease populations. The financing...
Japan backs two iPSC therapies under conditional approval pathway
Japan’s regulatory advisory panel recommended conditional approvals for two induced pluripotent stem cell (iPSC)-derived products — Amchepry (raguneprocel) and Reheart — under the country’s...
Novartis to sell India unit — keeps R&D and commercial operations separate
Novartis will divest its 70.68% stake in Novartis India Limited to a private-equity consortium for about $159 million while retaining separate in-country commercial and R&D operations through...
Disordered lipid nanoparticles boost cargo release — delivery rethink
New research from the University of Copenhagen suggests that internal disorder within lipid nanoparticles (LNPs) improves intracellular release of RNA cargo. Using a high-throughput,...
Element unveils Vitari: $100 genome on 36‑hour runs
Element Biosciences introduced Vitari, its first high-throughput sequencing platform designed to generate 3 Tb per paired-end 150 bp run in 36 hours and to deliver a 30× human genome for roughly...
Grail's Galleri misses NHS goal — market rout follows
Grail reported that its large NHS-Galleri multicancer early detection trial failed to meet the study's primary endpoint of a statistically significant reduction in late-stage (Stage III–IV)...
FDA formalizes single‑trial default — NEJM perspective
Top FDA officials published a New England Journal of Medicine perspective formalizing a new default: one adequate and well‑controlled pivotal trial can serve as the basis for approval,...
FDA reverses Moderna refusal — review resumes
The FDA reversed a recent refusal‑to‑file decision and agreed to review Moderna’s mRNA seasonal flu vaccine after a Type A meeting between the company and regulators. The agency had initially...
Guardant buys MetaSight; Shield screening set to scale
Guardant Health acquired early cancer‑detection startup MetaSight Diagnostics for $59 million upfront plus up to $90 million in contingent payments, expanding its multiomics screening portfolio as...
Altesa raises $75M to advance vapendavir trials
Altesa BioSciences closed a $75 million Series B led by Forbion to advance vapendavir, an antiviral targeting rhinovirus, into larger trials for chronic lung disease. The financing — which...