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Novartis pays $2 billion — buys mutant‑selective PI3Kα to shore up breast‑cancer franchise
Novartis agreed to acquire Synnovation’s Pikavation unit, paying $2 billion up front for a next‑generation, mutation‑selective PI3Kα inhibitor meant to defend and extend its HR+/HER2‑ breast...
Earendil hauls in $787 million — AI‑powered biologics blitz expands pipeline
Earendil Labs closed a $787 million financing to scale an AI‑driven biologics discovery engine and advance a broad pipeline of antibody, bispecific and ADC candidates across autoimmune disease and...
Retatrutide: Lilly’s triple‑agonist delivers on glucose and weight — phase III win
Eli Lilly reported positive phase III data for retatrutide, a triple‑agonist targeting GLP‑1, GIP and glucagon receptors, showing robust A1C reductions and substantial weight loss in patients with...
FDA clears high‑dose Wegovy under voucher — Novo pushes to reclaim market share
The U.S. Food and Drug Administration approved a higher‑dose Wegovy injectable formulation following an accelerated review under the commissioner’s voucher program, delivering clearance roughly...
Genentech, Roche halt muscle‑growth program — late‑stage failure prompts pipeline cull
Genentech (Roche) announced it has stopped development of an experimental muscle‑building antibody after key studies failed to show consistent improvements in muscle growth and function. The...
FDA asks uniQure for sham‑surgery randomized trial for Huntington’s gene therapy — ethical alarm
The FDA told uniQure that its AMT‑130 gene‑silencing therapy for Huntington’s disease will require a prospective, randomized, double‑blind, sham‑surgery‑controlled study to support marketing...
Tumor whole‑genome sequencing shows real‑world clinical utility — Nature Medicine dataset
A real‑world study of paired tumor‑normal whole‑genome sequencing (WGS) in 888 solid‑tumor patients demonstrated high technical success, rapid turnaround (median 6 working days), and substantial...
NCCN adds genomic profiling recommendation for pancreatic cancer — NGS use expands
The National Comprehensive Cancer Network updated pancreatic adenocarcinoma guidelines to recommend tumor molecular profiling, preferably by DNA and RNA next‑generation sequencing (NGS), to detect...
Excalipoint raises $68.7M — Shanghai startup advances trispecific T‑cell engagers for solid tumors
Excalipoint Therapeutics closed a $68.7 million seed financing to develop masked, co‑stimulating and multispecific T‑cell engager platforms targeting solid tumors. The Shanghai‑based biotech...
Abbott closes $23 billion Exact Sciences acquisition — diagnostics push accelerates
Abbott completed its $23 billion acquisition of Exact Sciences after securing regulatory clearances, bringing the Cologuard multi‑cancer and colorectal screening products, Oncotype DX, and other...
Measles resurgence: U.S. records sustained transmission after vaccination declines
U.S. public-health researchers report that measles has been continuously circulating nationwide for more than a year, with 1,300 confirmed infections already in 2026 and outbreaks spanning...
ACIP upheaval – court injunction fuels claims of panel reshuffle
An outspoken member of the CDC’s Advisory Committee on Immunization Practices (ACIP) claimed the panel had been disbanded following a federal judge’s temporary injunction, then retracted the...
FDA demands sham-controlled trial for life‑prolonging Huntington’s gene therapy
The U.S. Food and Drug Administration told uniQure it expects a prospective, randomized, double-blind, sham-surgery–controlled study to support approval of AMT‑130, a one-time AAV-based gene...
Earendil raises $787M... AI-driven biologics startup scales toward clinic
AI-native biotech Earendil Labs secured $787 million in private funding to accelerate a large pipeline of biologics across autoimmune and oncology programs and to expand R&D operations in the U.S....
Retatrutide hits phase III endpoints — triple‑agonist shows A1C and weight gains
Eli Lilly announced positive top-line results from Transcend‑T2D‑1: retatrutide—a triple agonist targeting GIP, GLP‑1 and glucagon receptors—met primary and key secondary endpoints in a Phase III...
Wegovy HD approved: FDA uses commissioner voucher to speed review
The FDA approved Novo Nordisk’s high‑dose Wegovy (7.2 mg) under a commissioner voucher program that expedited the review to roughly 54 days. The clearance expands dosing options for adults with...
Novartis pays $2B for next‑generation PI3Kα to shore up breast‑cancer franchise
Novartis agreed to acquire Pikavation Therapeutics—a Synnovation subsidiary—paying $2 billion upfront for a selective, pan‑mutant PI3Kα inhibitor (SNV‑4818) aimed at breast cancer, with up to $1...
Engineered esophagus integrates in growing pigs—functional graft restores feeding
A Nature Biotechnology study from Great Ormond Street Hospital and UCL reports an autologous engineered esophageal segment that restored oral feeding and peristalsis in growing minipigs without...
Tumor whole‑genome sequencing shows routine clinical impact in solid cancers
A real‑world series of 888 patients in a comprehensive cancer center—reported in Nature Medicine—shows paired tumor‑normal whole‑genome sequencing (WGS) succeeded in 89% of cases with a median...
FDA seeks public input on commissioner’s voucher pilot ahead of summer meeting
The FDA opened a request for feedback ahead of a public meeting to evaluate an expedited review voucher pilot that has already accelerated four drug approvals. The agency is soliciting stakeholder...