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India Inc Calls For Regulatory Easing; Looks To Biosimilar Launches Including Keytruda

Speaking of an impending launch of new biosimilars, including pembrolizumab, panelists at a recent event in India asked for regulatory easing from a waiver of Phase III trials for biosimilars to a single body for pre-clinical and trial approvals. The chicken and egg question of VC funding also came up.

Commercial Business Strategies

New Zealand Gets Cracking On NZD$604m Drug Funding Boost; Starts Repealing Landmark Law

Two targeted treatments for six different types of cancer and two antifungal drugs are the first products that Pharmac has proposed should be funded after it received a boost to its budget in June. Separately, the government is seeking feedback on a bill to repeal the sweeping new therapeutic products law that was passed by its predecessor.

New Zealand Market Access

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.

Europe Drug Review

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.

Europe Drug Review
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