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Guardant buys MetaSight, lifts 2026 screening outlook
Guardant Health acquired early cancer-detection startup MetaSight Diagnostics for $59 million upfront plus up to $90 million in contingent payments, and announced aggressive 2026 guidance for its...
Japan backs two iPSC therapies under conditional approval pathway
Japan’s regulatory advisers recommended conditional, time-limited endorsements for two induced pluripotent stem cell (iPSC) therapies—Amchepry (raguneprocel) and Reheart—paving the way for them to...
FDA sets Dec. 18 decision date for Roche’s oral SERD giredestrant
The U.S. Food and Drug Administration has set a Dec. 18 decision date on Roche’s giredestrant for ER-positive, HER2-negative breast cancer, based on a Phase 3 dataset that showed progression‑free...
Industry leadership churn: Daiichi names John Tsai; CFO hires surge
Daiichi Sankyo appointed John Tsai, former CMO at Novartis and Amgen, to lead global R&D effective April 1 as Ken Takeshita steps down. Tsai’s hiring signals a strategic tilt toward experienced,...
Ionis halts Alzheimer’s candidate for people with Down syndrome
Ionis Pharmaceuticals has discontinued development of an early investigational Alzheimer’s candidate intended for people with Down syndrome, the company confirmed to industry press. The program’s...
Disordered lipid nanoparticles boost delivery efficiency – new evidence
New experimental work shows that a subpopulation of amorphous, disorganized lipid nanoparticles (LNPs) releases RNA cargo more efficiently inside cells than highly organized particles. A...
Structural control of bacterial DNA synthesis reveals new antimicrobial target
Researchers revealed structural mechanisms bacteria use to control ribonucleotide reductase (RNR) expression, identifying the transcriptional regulator NrdR as a bacteria‑specific node for...
Insilico-Lilly blueprint and synthetic data push AI deeper into drug R&D
Insilico Medicine and Eli Lilly published a vision for a fully autonomous “prompt‑to‑drug” pipeline that integrates generative AI across design, synthesis and testing—outlining technical and...
Grail’s Galleri misses UK goal – shares collapse
Grail reported that its large NHS-Galleri multicancer early detection (MCED) trial did not meet the study’s primary endpoint, prompting a dramatic market reaction. The company disclosed top-line...
FDA reverses course on Moderna’s mRNA flu shot
The FDA rescinded an initial Refusal to File and agreed to review Moderna’s seasonal mRNA influenza vaccine mRNA‑1010 after a Type A meeting, setting a PDUFA target date in August. Moderna...
Guardant accelerates screening push, buys MetaSight
Guardant Health signaled aggressive expansion of its screening business and disclosed the acquisition of early cancer detection startup MetaSight Diagnostics for $59 million upfront plus up to $90...
Danaher to acquire Masimo; diagnostic contractors tapped by CDC
In industry briefings, Danaher disclosed a definitive agreement to acquire Masimo for roughly $9.9 billion, consolidating patient‑monitoring and oximetry technologies into Danaher’s diagnostics...
Roche gets FDA decision date on oral SERD giredestrant
Roche announced the FDA will decide by Dec. 18 whether to approve giredestrant, its oral selective estrogen receptor degrader (SERD) for ER‑positive, HER2‑negative breast cancer. The submission...
Ionis halts Alzheimer’s candidate for people with Down syndrome
Ionis Pharmaceuticals discontinued development of an investigational Alzheimer’s therapy targeted to people with Down syndrome, according to company statements reported by Endpoints News. The move...
Bioversys shows early clinical proof‑of‑concept in tuberculosis
Antibiotics specialist Bioversys reported Phase IIa early bactericidal activity for alpibectir (BVL‑GSK098) in combination with ethionamide for pulmonary tuberculosis, with findings published in...
New structural insights open target space in bacterial DNA control
Researchers revealed structural and mechanistic details of bacterial regulation of ribonucleotide reductase (RNR) expression via the NrdR regulator, illuminating a control node unique to...
Insilico and Lilly map a ‘prompt‑to‑drug’ autonomous R&D future
Insilico Medicine and Eli Lilly published a framework in ACS Central Science outlining a vision for fully autonomous 'prompt‑to‑drug' pharmaceutical R&D that stitches generative AI models into...
Japan backs first iPSC‑derived therapies under conditional approvals
Japan’s regulatory advisory body recommended conditional early approvals for Amchepry (raguneprocel) and Reheart, positioning them to become the world’s first iPSC‑derived therapies to receive...
FDA reverses: Moderna’s mRNA flu shot moved back into review
The FDA agreed to reconsider Moderna’s seasonal mRNA influenza vaccine mRNA-1010 after a rapid Type A meeting, setting a target PDUFA date of August 5. Moderna proposed an age‑stratified...
Grail’s Galleri misses primary goal — market rout follows
Grail’s large NHS‑Galleri multicancer early detection (MCED) trial did not meet its primary endpoint of a statistically significant reduction in combined stage III–IV cancers, top‑line results...