News

UCB has received a positive opinion from the CHMP for Kygevvi, marking a potential first-in-class treatment for the ultra-rare mitochondrial disease thymidine kinase 2 deficiency across Europe.

Pharmaceutical companies are accelerating M&A and TrumpRx deals amid dual pressures from patent expirations risking $230B in sales and new government pricing interventions.[1]

Tanabe Pharma Corporation revealed strategic organizational and personnel changes on February 2, 2026, aimed at enhancing efficiency in pharmaceutical R&D, manufacturing, and regulatory compliance across its Asian operations.

The European Medicines Agency has updated its training module EV-M8, focusing on considerations for the international transfer of personal health data in Individual Case Safety Reports (ICSRs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) originating in the EU.

Merck has begun construction on a $3 billion manufacturing facility in Virginia as part of its $70 billion U.S. investment to expand domestic production and mitigate tariff risks.

Suzhou-based Alphamab's KN-026 combined with chemotherapy reduced disease progression risk by 75% in HER2-positive gastric cancer patients, positioning it as a potential new standard of care.

Morgan Lewis has strengthened its global life sciences capabilities by recruiting Dr. Alexander Meier, former VP and head of legal regulatory strategy at Moderna, to its Munich office, enhancing regulatory advisory for pharmaceutical and biotech clients in Europe.

The Trump administration has selected 15 high-cost drugs, including Trulicity and Biktarvy, for Medicare price negotiations, enabling direct haggling with manufacturers to reduce costs starting in 2028.

The China-ASEAN Regional Medical Products Trading Platform finalized its inaugural 2026 transaction exceeding 10 million yuan between Qilu Pharmaceutical and a Thai buyer, enhancing cross-border pharma trade.

Denmark's Laegemiddelstyrelsen announces the launch of the FAST-EU pilot on January 30, 2026, streamlining procedures for multi-national clinical trials via CTIS to boost EU clinical research efficiency.