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Moderna seeks approvals for mRNA flu vaccine — regulatory push for respiratory franchise
Moderna filed regulatory applications in the U.S., EU, Canada and Australia for its mRNA seasonal influenza vaccine mRNA‑1010, targeting adults aged 50 and older. The company pitched faster design...
CRISPR–Cas3 enables long deletions to silence TTR in vivo — new gene‑editing route
Researchers reported CRISPR–Cas3 genome editing as an alternative to Cas9 for transthyretin (TTR) amyloidosis, using Cas3 to generate long-range deletions that abolished TTR expression. In vitro...
CHANGE‑seq‑BE profiles base‑editor off‑targets — safety tool adopted for emergency FDA case
St. Jude Children’s Research Hospital developed CHANGE‑seq‑BE, an unbiased and resource‑efficient genome‑wide method to map off‑target activity of base editors. The team published the method in...
Inhalable bispecific exosomes activate T cells — preclinical reversal of PD‑1 resistance
A Nature Biotechnology paper described engineered inhalable exosomes that deliver a bispecific T‑cell activator into the tumor microenvironment to treat pembrolizumab‑resistant metastatic melanoma...
Deep Intelligent Pharma Raises $50M – AI to automate clinical trials
Deep Intelligent Pharma (DIP) closed a $50 million Series D round to scale an AI platform that its founders say automates clinical trial design and execution. The Singapore-based company will use...
Moderna seeks approval for mRNA flu shot: mRNA-1010 filed globally
Moderna filed regulatory applications in the US, EU, Canada and Australia seeking approval of mRNA‑1010, its seasonal influenza vaccine for people 50 and older. The company pitched the shot as a...
Sanofi to buy Dynavax for $2.2B: Adds Hep B vaccine and shingles candidate
Sanofi agreed to acquire Dynavax Technologies for roughly $2.2 billion in cash to bolster its adult immunization portfolio. The deal, approved by Dynavax’s board, values shares at $15.50 each and...
Sanofi doubles down on Earendil – $160M pact for AI‑designed bispecifics
Sanofi struck a new collaboration with AI‑driven biologics developer Earendil Labs, committing up to $160 million in upfront and near‑term payments to apply Earendil’s predictive protein modeling...
Zenas’ obexelimab clears Phase 3 endpoint – market punishes outcome
Zenas Biopharma reported that obexelimab met the primary endpoint in a Phase 3 trial for IgG4‑related disease, delivering a statistically significant reduction in flares versus placebo. The...
CRISPR–Cas3 enables large deletions and 80% serum TTR knockdown in mouse model
Researchers demonstrated CRISPR–Cas3 as a distinct genome‑editing modality for transthyretin (TTR) amyloidosis, producing long directional deletions that abolished TTR expression in vitro and...
Inhalable bispecific exosomes activate T cells – new approach for ICI‑resistant tumors
Two teams published complementary advances engineering inhalable exosome platforms that deliver bispecific T‑cell activators to resistant tumors. Reports in Nature Biotechnology show inhalable,...
Salus Biomed’s rapid clinical sequencer cleared by China NMPA
Salus Biomed obtained Category III medical device registration from China’s NMPA for its Saluseq Nimbo rapid next‑generation sequencer, clearing the platform for clinical applications in China....
OraSure submits 30‑minute CT/NG rapid test to FDA: at‑home collection also filed
OraSure Technologies submitted a 510(k) application to the FDA for a rapid, disposable test for Chlamydia trachomatis and Neisseria gonorrhoeae that uses Sherlock Biosciences technology to deliver...
Comanche raises $40M to fund preeclampsia siRNA into first human trials
Comanche Biopharma secured an additional $40 million to advance an siRNA injectable program aimed at treating preeclampsia—the company says the funding will enable initiation of human trials...
Zenas' Phase 3 hits primary endpoint – stock halves after rival comparison
Zenas BioPharma reported that obexelimab met the primary endpoint in its Phase 3 Indigo study for IgG4-related disease, but the topline 56% reduction in flare risk compared unfavorably to Amgen’s...
Sanofi doubles down on Earendil – $160M near‑term pact could reach $2.56B
Sanofi agreed to a new collaboration with AI-driven biologics developer Earendil Labs that provides roughly $160 million in upfront and near‑term payments and carries potential downstream value...
Salus wins NMPA nod – rapid clinical sequencer cleared for China use
Salus Biomed obtained Category III medical device registration from China’s NMPA for its Saluseq Nimbo sequencer, clearing the platform for clinical applications nationwide. The Saluseq Nimbo uses...
OraSure seeks FDA 510(k) for 30‑minute CT/NG self‑test and urine kit
OraSure Technologies submitted a 510(k) to the FDA for a rapid, disposable self‑test for chlamydia and gonorrhea built on Sherlock Biosciences’ technology, along with a Colli‑Pee at‑home urine...
Cas3 genome editing slashes TTR in vivo – long deletions, lower off‑targets
Researchers applying CRISPR–Cas3 achieved substantial targeted deletions at the TTR locus and robust reductions in circulating transthyretin in mouse models. A single lipid‑nanoparticle delivery...
Aktis targets Nasdaq raise up to $209M – funds miniprotein radiopharma trials
Aktis Oncology filed to go public in the U.S., aiming to raise roughly $181.7 million at a $16–$18 per‑share range with an option that could lift proceeds to about $209.6 million. The company...