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Regeneron COVID-19 Therapeutic, Novavax Vaccine Get BARDA Funding To Boost Manufacturing

 
• By Brenda Sandburg

US government to own doses of Regeneron's investigational cocktail antibody REGN-COV2 manufactured under a $450m contract and 100 million doses of Novavax's investigational vaccine under a $1.6bn agreement.

Manufacturing and Covid-19 virus, symbolized by viruses destroying word Manufacturing to picture that coronavirus outbreak destroys Manufacturing, blurred background, 3d illustration
Government Funds Manufacturing Of COVID-19 Therapeutic And Vaccine • Source: Shutterstock

The US government's Operation Warp Speed is providing $450m to Regeneron Pharmaceuticals, Inc. to support large-scale manufacturing of its investigational COVID-19 therapeutic and $1.6bn to Novavax, Inc. for late-stage clinical development and large-scale manufacturing of its COVID-19 vaccine candidate.

The awards are a boon for the companies, as ramping up production for worldwide supply of COVID-19 products is a daunting hurdle

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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.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Pharma Predicts Modest Tariff Impact, Depending On What Comes Next

 
• By Jessica Merrill

Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.

More from Compliance

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Pharma Predicts Modest Tariff Impact, Depending On What Comes Next

 
• By Jessica Merrill

Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.

Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.