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First Lucentis Biosimilar Among Drugs Awaiting Verdict On EU Approval Filings

 
• By Vibha Sharma

Sponsors of several new medicines, including the first ever CAR-T for multiple myeloma, will find out this week if their products are on track to get EU marketing authorizations. Also, three sponsors might be asked to address outstanding issues about their products in the final stages of review.

AMD Screening
Lucentis Fuelled A Revolution In Retinal Care When It Launched In 2006 • Source: Shutterstock

The European Medicines Agency is deciding this week whether to recommend pan-EU approval for several new medicines, including Samsung Bioepis/Biogen's SB11, the first biosimilar referencing Roche’s Lucentis (ranibizumab), for treating neovascular age-related macular degeneration (AMD).

Ranibizumab is an anti-vascular endothelial growth factor (VEGF) therapy for retinal vascular disorders, which are a leading cause of blindness

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More from Europe

EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
• By Eliza Slawther

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs And Indications

 
• By Eliza Slawther

England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.

EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
• By Eliza Slawther

European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.

More from Geography

EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
• By Eliza Slawther

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.