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Biopharma COVID-19 Collaborations May Avoid Antitrust Hurdles, FTC And DOJ Suggest

 
• By Brenda Sandburg

FTC and DoJ issue guidance for businesses working together to tackle coronavirus pandemic; BIO is 'pleased' they intend to help facilitate critical partnerships.

scientist in biohazard protection clothing analyzing covid 19 sample with microscope and holding coronavirus covid 19 blood sample tube on hand in laboratory, coronavirus covid 19 vaccine research
FTC and DOJ to accelerate review of COVID-19 collaborations for antitrust issues

As biopharma companies begin collaborating on development of treatments for COVID-19, the US Federal Trade Commission and Department of Justice offer assurance that they will get speedy answers to any antitrust questions.

The FTC and DOJ issued a joint statement on 24 March saying they would respond quickly to requests for...

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BIO CEO On Industry And US FDA, Trump’s Vaccine Views And MFN Counter Proposals

 
• By Sarah Karlin-Smith

John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.

UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 
• By Eliza Slawther

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

 
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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.

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.

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New EFPIA President Hopes ‘Sanity Will Prevail’ In EU Pharma Reform Dialogs

 
• By Eliza Slawther

Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.

UK Pilots Faster Setup Of Early Phase Oncology Trials

 
• By Vibha Sharma

Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.

US CDC Vaccine Committee Revives Thimerosal Debate: A Portent Of Things To Come?

 
• By Bridget Silverman

The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.