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Big pharma closes lung-cancer M&A wave with Nuvalent
GSK moved to lock in a late-stage lung-cancer franchise by agreeing to buy Nuvalent for about $10.6 billion in cash, targeting two programs under FDA review: ROS1 inhibitor zidesamtinib and ALK...
Hematology M&A intensifies as Incyte grabs a Phase III von Willebrand candidate
Incyte agreed to acquire Vega Therapeutics for up to $2 billion, adding VGA039, a Phase III monoclonal antibody for von Willebrand disease (VWD). Vega039 is designed to modulate Protein S to...
Next weekly HIV pill inches closer after phase 3 success
Merck and Gilead reported two phase 3 trials showing efficacy for a once-weekly oral HIV regimen combining Merck’s islatravir with Gilead’s lenacapavir. The companies said both studies met primary...
Sanofi exits an autoimmune Phase 3 program early
Sanofi halted a Phase 3 autoimmune trial after an interim analysis indicated the therapy was “unlikely to provide sufficient efficacy.” The early termination eliminates a late-stage opportunity...
AI reaches clinical viability in neuro-oncology diagnostics
Researchers in Heidelberg unveiled Hetairos, an AI system designed to classify brain tumors using standard histology tissue sections, producing results in minutes rather than weeks for diagnostic...
Conglomerate deal-making continues as biotechs seek public-market cash
Parabilis’ IPO surged to $670 million, the largest listing in the biotech sector’s history, as the company formerly known as FogPharma prepares to fund clinical programs including zolucatetide....
Rare-disease regulation proposal targets authorization and market access together
The UK’s MHRA proposed pairing trial authorization with market access for very rare diseases, aiming to create a flexible approval pathway while acknowledging that reimbursement remains...
Infectious disease: dual Lassa–rabies vaccine reports early human data
University of Maryland’s Center for Vaccine Development and Global Health reported interim phase 1 data for a dual vaccine targeting both Lassa fever and rabies, combining inactivated rabies...
Genomics platform: Personalis gets CE-IVD marking for blood collection kits
Personalis received CE-IVD marking for its EDTA blood collection kit and cfDNA blood collection kit under the EU In Vitro Diagnostic Regulation, enabling marketing and sale in the region. The kits...
Major pharma M&A lifts late-stage oncology pipeline
GSK is set to expand its near-commercial oncology lineup with a $10.6 billion acquisition of Nuvalent, adding two lung cancer assets under FDA review—ROS1 inhibitor zidesamtinib and ALK blocker...
Trop-2 ADC failure reshapes first-line NSCLC strategy
Gilead and Merck shut down the phase 3 Evoke-03 trial after interim analyses indicated Trodelvy plus Keytruda was unlikely to meet the progression-free survival endpoint in first-line PD-L1-high...
HIV innovation moves toward the first weekly oral regimen
Merck and Gilead reported positive phase 3 results for a weekly oral HIV regimen combining Merck’s islatravir and Gilead’s lenacapavir. In both Islend-1 and Islend-2, the study met its primary...
New blood-disorder bet: Incyte snaps up Vega for Phase III VWD antibody
Incyte agreed to acquire Vega Therapeutics for up to $2 billion, adding VGA039, a Phase III monoclonal antibody candidate in von Willebrand disease. The deal is designed to bolster Incyte’s...
Oncology diagnostics scale-up: CRUK and Guardant expand ctDNA access
Cancer Research UK partnered with the Royal Marsden NHS Foundation Trust and Guardant Health to make ctDNA testing freely available to hundreds of advanced solid-tumor patients across the ECMC...
Product innovation: Personalis receives CE-IVD for blood collection kits
Personalis won CE-IVD marking for its EDTA and cfDNA blood collection kits in the EU, clearing the way to market the specimen products that support its ultrasensitive NeXT Personal assay. The kits...
Clinical prevention push: Dual Lassa-rabies vaccine shows early immunogenicity and safety
Researchers from the University of Maryland School of Medicine’s Center for Vaccine Development and Global Health reported interim phase 1 data for a dual Lassa fever–rabies vaccine candidate...
IPO and public-market access: Parabilis eyes potentially record-breaking financing
Parabilis Medicines moved to upsize its IPO plans, signaling intent to pursue a potentially record-setting $637 million fundraising. The company’s plans arrive amid sustained demand in biotech...
Reverse merger: Treeline plans Nasdaq debut with Standard BioTools
Treeline Biosciences announced plans to go public through a reverse merger with Standard BioTools, creating a combined company expected to trade on the Nasdaq under the Treeline name. The deal...
Emerging platform and funding: City Therapeutics drives RNAi pipeline with Series B
City Therapeutics closed a $99.5 million Series B financing to advance its RNA interference pipeline and fund expansion of its next-generation RNAi engineering platform. The company said it will...
Large-cap oncology M&A accelerates lung cancer franchises
GSK moved to bolster its near-commercial lung cancer pipeline, agreeing to buy Nuvalent for about $10.6 billion in cash. The acquisition adds two programs under FDA review—zidesamtinib (ROS1) and...