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Oncology: FDA priority review for subcutaneous amivantamab-hyaluronidase in post-platinum head and neck cancer
Johnson & Johnson said the FDA granted Priority Review to a supplemental Biologics License Application for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) in adults with recurrent or...
Radiopharmaceuticals: Curium agrees to buy Lantheus in up-to-$8B deal
Curium announced it has entered into a definitive agreement to acquire Lantheus for up to $8 billion, combining Curium’s radiopharmaceutical manufacturing network and theranostics pipeline with...
CNS M&A: Supernus and Indivior sign “merger of equals” to form a CNS-focused pharma
Supernus Pharmaceuticals and Indivior have signed an all-stock, tax-free merger agreement to form a new CNS-focused company. The deal, described as a “merger of equals,” will combine Supernus’...
Digital health + clinical operations: CU Anschutz trial shows AI-controlled oxygen delivery improves time in range
A clinical trial reported by researchers at CU Anschutz found that an AI-driven automated oxygen delivery system helped hospitalized patients stay within prescribed oxygen ranges for a...
Diagnostics and companion testing: Sophia Genetics expands with AstraZeneca CDx collaboration as revenue rises
Sophia Genetics reported a 27% year-over-year Q2 revenue increase, driven by growth in U.S. customers and liquid biopsy sales. The company also announced a new collaboration with AstraZeneca to...
Precision oncology + biomarker workflows: QuantHealth raises $45M Series B to simulate clinical trials before enrollment
QuantHealth secured $45 million in Series B funding to expand its AI platform that simulates clinical trials before patients enroll. The company’s approach aims to predict patient outcomes and...
Company performance + consolidation: Personalis Q2 revenue jumps as Medicare coverage expands; Tempus acquisition pending
Personalis reported a 30% year-over-year increase in second-quarter revenue, driven by higher pharma testing services and clinical test growth. The company linked the clinical increase to Medicare...
Biopharma portfolio + regulatory shift: FDA expands Pluvicto use with hormone therapy in broader metastatic prostate cancer population
Novartis said the FDA approved Pluvicto for use alongside hormone therapy in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC), widening the eligible population...
Company finance + restructuring: GeneDx cuts ~75 jobs as Q2 revenue improves 11%
GeneDx said it completed a reorganization during Q2 that included layoffs affecting approximately 75 employees. The Gaithersburg, Maryland-based genetic diagnostics company reported improved...
Rare disease gene therapy oversight: Death in Shanghai gene-editing trial triggers fresh ethics scrutiny
A death following a brain-directed gene-editing therapy administered at Xinhua Hospital in Shanghai has reignited debate over how regulators should oversee first-in-human personalized gene...
Radiopharmaceuticals M&A
Curium agreed to buy Lantheus in a deal valued at up to $8 billion, combining Curium’s global manufacturing and theranostics platform with Lantheus’ U.S. radiodiagnostics footprint. Curium will...
CNS pharma consolidation
Supernus and Indivior signed an all-stock “merger of equals” to form a new CNS-focused company, combining portfolios across addiction, depression, attention-deficit/hyperactivity disorder, and...
AI-driven clinical trial simulation
QuantHealth raised $45 million in Series B funding to expand an AI platform that simulates clinical trials before patients enroll and predicts outcomes for pharma sponsors. The company says the...
Oncology precision diagnostics and reimbursement tailwinds
Personalis reported a 30% year-over-year jump in Q2 revenue, driven by higher pharma testing services and a surge in clinical tests following Medicare reimbursement expansion. The company also...
Diagnostic platform partnerships
Sophia Genetics reported Q2 revenue growth alongside a new AstraZeneca collaboration covering companion diagnostics in both solid and hematologic cancers. Sophia said the pact will support...
Regulatory action for a blockbuster radioligand
The FDA expanded Novartis’ Pluvicto label to include patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC), advancing the radioligand earlier in the disease course. The...
Biotech AI/ADC licensing expansion
Pathos AI signed a large licensing package with China’s Alphamab Oncology for an additional TROP2/HER3 bispecific ADC and separately aligned with AstraZeneca on a protein degrader from...
Pipeline update in obesity
Amgen discontinued its early-stage obesity candidate AMG-513, leaving the company to reallocate resources and increase pressure on late-stage competitors. The company did not provide detailed...
Clinical drug development beat in HIV prevention
Gilead said its twice-yearly HIV PrEP injection Yeztugo topped Wall Street expectations as sales exceeded $1 billion for the franchise. In Q2, Yeztugo generated $232 million versus estimates of...
Regulatory controversy in gene editing oversight
A death of a 6-year-old girl after receiving an experimental brain-directed gene-editing therapy at Xinhua Hospital in Shanghai has reopened debate over how regulators oversee personalized,...