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Latest From MSD
First Nasal Adrenaline Spray Among 10 Products Heading For EU-Wide Approval
The June meeting of the European Medicines Agency's human medicines committee brought mixed fortunes for companies. 10 new products were recommended for pan-EU approval, two drugs were rejected, while the conditional approval of one drug is set to be revoked. PTC Therapeutics again faced disappointment regarding its Duchenne muscular dystrophy drug Translarna, but has vowed to fight back.
US Rejected Drug Odronextamab Among 11 EU Marketing Hopefuls
Regeneron, whose blood cancer treatment odronextamab was recently turned down by the US regulator but not for reasons relating to efficacy or safety, could soon learn whether its product will be among the drugs to get the thumbs up from the CHMP, the European Medicines Agency’s human medicines committee.
Diversification Gains Momentum As Companies Look To Derisk China
Quietly but unambiguously, pharma firms are accelerating their diversification away from China and are now looking to other emerging markets for growth, a strategy that reflects increasing pressures from China's volume-based procurement scheme but also US-China tensions and other geopolitical risks.
Japan Regulatory Update: Revised Law Widens RWD Scope, Price Revisions/Listings
Japan now allows pseudonymized personal data for medical use under a licensing system for wider use of real-world data. Meanwhile, a national cost-effectiveness assessment scheme has slashed reimbursement prices for Lagevrio and Kerendia, and Alexion’s Voydeya has been added to the reimbursement tariff.
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