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Pink Sheet reporters and editors consider the implications of a Democratic Congress for the pharma industry, ongoing problems with slow coronavirus vaccination rates, and the high CDER novel approval count in 2020.

Pink Sheet reporters and editors look at the UK MHRA’s surprising approval of the Pfizer/BioNTech coronavirus vaccine, as well as the US reaction, and discuss President-elect Joe Biden’s potential US FDA commissioner nominees.

Pink Sheet reporters and editors discuss their take-aways from the recent advisory committee meeting on coronavirus vaccine development and approval, as well as the upcoming FDA hearing on Makena’s withdrawal.

With some studies about to finish and others on clinical hold, the coronavirus vaccine field approaches an inflection point as the US FDA prepares for its first advisory committee on the topic. Our charts and graphics offer a quick look at what stands where.

Pink Sheet reporters and editors discuss the surprise US complete response letter for a new gene therapy and the specialists who may be added to the FDA’s coronavirus vaccine advisory committee, and also look at facility inspections during the pandemic.