ANDA Sponsors Could Lose Exclusivity Because COVID-19 Prevented An Inspection … Or Not
Source : 'The Pink Sheet'
US Food and Drug Administration officials gave the all-to-common “it depends” answer to questions about generic drug exclusivity forfeiture caused by the COVID-19 pandemic, maintaining the uncertainty surrounding the issue...
Pharma Pushes For Stronger ‘March In’ Rule Despite Changing Political Dynamics, COVID Complications
Source : 'The Pink Sheet'
The brand pharmaceutical industry is asking the US government to tighten manufacturer’s patent rights on brand name drugs, pushing the new US political leadership under President Joe Biden to go...
Regulators Reassure On AZ Vaccine Safety After Rare Side Effect Deemed Plausible
Source : 'The Pink Sheet'
The safety profile of AstraZeneca PLC’s COVID-19 vaccine has received backing from medicines regulators in the EU and the UK, even though both concluded it is likely to...
Sputnik V COVID-19 Vaccine Causing A Stir In The EU
Source : 'The Pink Sheet'
Amid renewed concern over COVID-19 vaccine supplies following warnings by European regulators about the risk of rare blood clots with the Oxford/AstraZeneca PLC vaccine, EU countries are increasingly...