Author: PharmaSignal News Desk

Lilly CSL $100M deal involves licensing a monoclonal antibody targeting IL-6, with CSL retaining rights for end-stage kidney disease.

BMS FDA Review: The FDA has accepted BMS’s protein degrader for review, potentially impacting the US market with new treatment options.

Moderna FDA review progresses for mRNA flu vaccine after a Type A meeting, impacting the US market.

COMP360 psilocybin FDA application progresses with Phase 3 data, aiming to be the first classic psychedelic approved in the U.S.

FDA removes box warning from six hormone replacement therapies, impacting millions of menopausal women in the US.

PharmaSignal Take This week’s events signal a continued focus on strategic M&A and licensing deals, particularly in genetic medicine and RNAi therapeutics. Lilly’s acquisitions and alliance with Innovent Biologics stress-test the assumption of platform scalability and integration readiness. Meanwhile, regulatory decisions are impacting market access and launch timing for a number of assets. The PharmaSignal Weekly Brief – Global Pharma Roundup captures these themes, providing insights into the strategic decisions and execution risks faced by global pharma leaders. M&A and Strategic Deals Lilly’s acquisition of Orna for $2.4B and partnership with Innovent Biologics for $9B underscore the company’s push into…

Madrigal RNAi drug deal involves a $4.4 billion agreement with a China-based biotech for six preclinical medicines.

Moderna mRNA flu vaccine faces a setback as the FDA refuses to review its application, citing inconsistencies with prior communications.

Regenxbio FDA rejection impacts its gene therapy for Hunter Syndrome, marking a significant regulatory setback.

Lilly acquires Orna for $2.4 billion, enhancing its genetic medicine portfolio with in vivo CAR-T technology.