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EU's CHMP Clears Selincro And Perjeta, Rejects Kynamro And Fanaptum

 
• By John Davis

Europe's top scientific advisory panel backed Lundbeck's alcoholism therapy Selincro (nalmefene) and Roche's next-generation breast cancer therapy Perjeta (pertuzumab) but rejected Genzyme/Isis' antisense therapy Kynamro (mipomersen) and Vanda's Fanaptum (oral iloperidone).

Two new molecular entities, Lundbeck's Selincro (nalmefene) for the treatment of alcoholism and Roche's Perjeta (pertuzumab) for breast cancer, and a new antipsychotic formulation, Alexza Pharmaceuticals Inc.'s Adasuve (inhaled loxapine) were granted positive opinions Dec. 14 by Europe's Committee for Medicinal Products for Human Use (CHMP).

However, [Genzyme BV]/Ionis Pharmaceuticals Inc.'s antisense lipid-lowering therapy Kynamro (mipomersen) and Vanda Pharmaceuticals Inc.’s atypical antipsychotic Fanaptum (oral...

More from Europe

Pharma’s Protests Fall Flat As UK Locks In High Rebate Rates

 
• By Neena Brizmohun

Despite pushback by industry, the government is standing by its new statutory scheme rebate rates for branded medicines, including one that doubles the rate that companies must repay on the sales of newer products to the National Health Service to 31.3%.

EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

 
• By Eliza Slawther

EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.

Trial Cancellations And Delays Persist For CROs Amid Biotech Slowdown

 
• By Vibha Sharma

The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.

UK MHRA Helps Sponsors Prepare For ‘World’s First’ Decentralized Manufacturing Framework

 
• By Neena Brizmohun

The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.

More from Geography

EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

 
• By Eliza Slawther

EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.

Trial Cancellations And Delays Persist For CROs Amid Biotech Slowdown

 
• By Vibha Sharma

The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.

Citeline Japan Awards 2025 - Enter Now!

 
• By Ian Haydock and Lisa Takagi

The 14 July deadline for the Citeline Japan Awards 2025 in Tokyo is approaching fast, so here's a reminder to take a look at the categories and criteria and be sure to get your submissions in by this date. Sponsorship opportunities and tables for the event are also available.