FDA
FDA approves BioCryst’s Orladeyo for reducing hereditary angioedema attacks
December 4, 2020Medical Communications, Sales and Marketing BioCryst, FDA, Orladeyo
BioCryst has scored FDA for its therapy Orladeyo (berotralstat) for reducing or preventing hereditary angioedema (HAE) attacks in patients over …
Roche secures emergency FDA approval for COVID-19 antibody test
December 3, 2020Sales and Marketing COVID-19, FDA, Roche
The FDA has awarded Emergency Use Authorization to Roche’s COVID-19 test to allow users in the US to analyse the …
FDA greenlights Gavreto for advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer in over-12s
December 2, 2020Research and Development, Sales and Marketing FDA, Gavreto, Roche
The FDA has awarded accelerated approval to Roche and Blueprint Medicines’ Gavreto (pralsetinib) for the treatment of advanced or metastatic …
FDA expands approval of Genentech’s Xofluza for post-exposure prevention of influenza
November 24, 2020Manufacturing and Production, Sales and Marketing FDA, Xofluza, influenza
Genentech has secured FDA approval for Xofluza (baloxavir marboxil) for the post-exposure prevention of influenza in patients at least 12 …
Pharmafile.com’s weekly COVID-19 news round-up
November 6, 2020Medical Communications COVID, COVID-19, EC, FDA, coronavirus
The top ten news stories this week focus on regulatory approvals as the European Commission has approved GlaxoSmithKline’s Zeljula as …
FDA approves Gilead’s remdesivir for hospitalised COVID-19 patients
October 23, 2020Medical Communications, Sales and Marketing COVID-19, FDA, Gilead, remdesivir
The FDA has approved Gilead’s antiviral therapy Veklury (remdesivir) for the treatment of hospitalised COVID-19 patients, making it the first …
Eli Lilly refutes FDA quality concerns at New Jersey facility producing COVID-19 drug
October 21, 2020Manufacturing and Production, Research and Development COVID-19, Eli Lilly, FDA, pharma
Eli Lilly has rebutted reports of FDA quality assurance concerns at its manufacturing facility in Branchburg, New Jersey, where it …
FDA grants priority review to AstraZeneca’s Tagrisso as an adjuvant for early-stage EGFR-mutated non-small cell lung cancer
October 20, 2020Manufacturing and Production, Sales and Marketing AstraZeneca, FDA, Tagrisso
The FDA has revealed its decision to grant Priority Review to AstraZeneca’s Tagrisso (osimertinib) as an adjuvant treatment of patients …
FDA approves Venclexta combo in acute myeloid leukaemia, despite it missing main study goal
October 19, 2020Sales and Marketing AbbVie, FDA, Roche, Venclexta, pharma
The FDA has given approval to AbbVie and Roche’s jointly-developed BCL-2 inhibitor Venclexta (venetoclax) in combination with azacitidine, decitabine, or low-dose …
Sun Pharma issues recall of its generic diabetes drug in US market
October 12, 2020Sales and Marketing FDA, diabetes, recall
Sun Pharma is recalling 747 bottles of its generic diabetes drug Riomet ER in the US.This is due to an …
Eli Lilly’s antibody COVID-19 therapy reduces virus levels and hospitalisations
October 8, 2020Manufacturing and Production Eli Lilly, FDA
Eli Lilly is seeking Emergency Use Authorization from the FDA after releasing interim data based on early trial results.
White House halts release of new FDA standards for the Emergency Use Authorization of COVID-19 vaccine
October 6, 2020Manufacturing and Production FDA, Trump, Vaccine, coronavirus vaccines
The Trump White House is blocking new federal guidance for the emergency release of coronavirus vaccines that would essentially ensure …
Bristol Myers Squibb agrees $13 billion deal to acquire MyoKardia
October 6, 2020Manufacturing and Production BSM, FDA, MyoKardia
Bristol Myers Squibb (BMS) is to purchase MyoKardia for $13 billion to boost its heart disease treatments portfolio. The deal …
FDA defies advisory panel recommendation, rejecting Mesoblast’s Ryoncil in paediatric steroid-refractory acute graft versus host disease
October 5, 2020Sales and Marketing FDA, Mesoblast, Ryoncil
The FDA has issued a surprising rejection of Mesoblast’s Ryoncil (remestemcel-L) as a treatment for paediatric steroid-refractory acute graft versus …
FDA pauses the planning stages of Inovio’s late-stage COVID-19 vaccine trials
September 29, 2020Manufacturing and Production COVID-19 vaccine, FDA, coronavirus vaccines
The FDA has put Inovio’s planning stages for the final trials of its coronavirus vaccine on hold as the regulator …
