Reduction In Flights Hits Global Supply Chain

Global And European Bodies Call For Urgent Action Amid Coronavirus

Urgent action is needed to reopen air freight routes so that the global off-patent industry can deliver critical medicines and supplies amid the coronavirus pandemic, international industry representatives have insisted.

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Maintaining air freight routes is essential to tackle the coronavirus pandemic • Source: Shutterstock

Urgent international action is needed by governments and pharmaceutical supply chain stakeholders to reopen air freight routes used by the global off-patent industry so that critical medicines can be supplied to help tackle the coronavirus pandemic, according to the International Generic and Biosimilar Medicines Association.

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Biosimilars Industry Buoyed By EMA Paper On Reducing Clinical Trials

 
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The EMA’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam. Generics Bulletin discusses the new draft reflection paper and its significance for industry, reports on reactions from the event, and reveals the next steps unveiled by EMA officials.

Key FDA Officials From Generics And Biosimilars User Fee Programs Laid Off, Said AAM

 

Off-patent drug trade groups expressed their concerns that personnel and expertise cuts will affect the agency’s ability to review and approve generics and biosimilars.

Another One Bites The Dust: FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 

The US FDA has deemed certain CRO Raptim Research’s in vitro bioequivalence studies as “not acceptable” and raised concerns over its in vivo study methods. Will other agencies follow suit?

EMA Validates Henlius’ Pertuzumab Biosimilar Application

 
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The EMA has accepted for review Henlius’ Perjeta biosimilar, which is to be commercialized by the Chinese company’s global partner Organon in the EU.

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US FDA Staffing Uncertainty Could Impact Upcoming User Fee Negotiations

 

FDA staffing cuts are making negotiation preparations more difficult, but also could mean the result is a smaller user fee renewal package.

Another One Bites The Dust: FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 

The US FDA has deemed certain CRO Raptim Research’s in vitro bioequivalence studies as “not acceptable” and raised concerns over its in vivo study methods. Will other agencies follow suit?

EMA Validates Henlius’ Pertuzumab Biosimilar Application

 
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The EMA has accepted for review Henlius’ Perjeta biosimilar, which is to be commercialized by the Chinese company’s global partner Organon in the EU.