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RSS FeedPosted by Michael Wonder on 28 Nov 2020
Protalix BioTherapeutics and Chiesi Global Rare Diseases announce extension of PDUFA date for pegunigalsidase alfa for the proposed treatment of Fabry disease
27 November 2020 - Protalix BioTherapeutics today announced that the U.S. FDA has extended the Prescription Drug User Fee Act (PDUFA) ...
Posted by Michael Wonder on 25 Nov 2020
Pfizer vaccine distribution could kick off within weeks pending FDA approval, Azar says
24 November 2020 - A FDA panel will meet on 10 December to consider Pfizer’s emergency use authorisation application for its ...
Posted by Michael Wonder on 23 Nov 2020
COVID-19 shots could reach first Americans by mid-December, top health official says
23 November 2020 - U.S. health care workers and others recommended for the nation’s first COVID-19 inoculations could start getting shots ...
Posted by Michael Wonder on 09 Nov 2020
Liminal BioSciences announces FDA extension of review period for Ryplazim (plasminogen) BLA
9 November 2020 - PDUFA date extended by FDA from 5 March 2021 to 5 June 2021. ...
Posted by Michael Wonder on 20 Oct 2020
Roche CEO warns against high hopes for speedy Covid vaccines
20 October 2020 - Many people’s hopes for a speedy coronavirus vaccine are still too high, Roche Holding AG Chief ...
Posted by Michael Wonder on 19 Oct 2020
All eyes on a hurdle race for a SARS-CoV-2 vaccine
19 October 2020 - Leading COVID-19 vaccine candidates have progressed through laboratory tests at record speed. ...
Posted by Michael Wonder on 18 Oct 2020
Pfizer to seek FDA approval for COVID-19 vaccine in November
16 October 2020 - US group and German partner BioNTech prepare to submit trial results next month. ...
Posted by Michael Wonder on 15 Oct 2020
Testing requirements are likely slowing biosimilar entries in the US
14 October 2020 - Biosimilars have been slow to enter the US market for complex reasons ranging from the manipulation ...
Posted by Michael Wonder on 12 Oct 2020
Pfizer trying to defuse critics amid push for vaccine before Election Day
10 October 2020 - The company behind President Donald Trump’s last hope for a vaccine by Election Day has quietly ...
Posted by Michael Wonder on 11 Oct 2020
Can Trump really speed approval of COVID treatments?
10 October 2020 - In a five minute video posted to his Twitter account on Wednesday, President Trump stood in ...
Posted by Michael Wonder on 05 Oct 2020
Moderna CEO says COVID-19 vaccine will be ready for FDA submission in late November
5 October 2020 - Company will seek emergency use authorisation for experimental vaccine. ...
Posted by Michael Wonder on 02 Oct 2020
Development of COVID-19 vaccine won’t be affected by politics, Pfizer CEO says
1 October 2020 - Albert Bourla sent an all-hands letter saying company won’t bow to political pressure. ...
Posted by Michael Wonder on 23 Sep 2020
FDA poised to announce tougher standards for a COVID-19 vaccine that make it unlikely one will be cleared by Election Day
23 September 2020 - The guidance is part of an effort to boost transparency and public trust as polls show many ...
Posted by Michael Wonder on 17 Sep 2020
Coronavirus vaccine: Donald Trump contradicts CDC director Robert Redfield
17 September 2020 - Donald Trump has issued an extraordinary public rebuke to his own government’s top health official, labelling him ...
Posted by Michael Wonder on 16 Sep 2020
Up is down — pharmaceutical industry caution versus federal acceleration of COVID-19 vaccine approval
15 September 2020 - Nine pharmaceutical company leaders took the unprecedented step on 8 September 2020, of stating that they would ...