EU
EMA could approve Gilead’s streamlined remdesivir application for COVID-19 “within weeks”
June 9, 2020Manufacturing and Production, Sales and Marketing COVID-19, EU, Gilead, coronavirus, remdesivir
The European Medicines Agency has received the application from Gilead for the first conditional marketing authorisation (CMA) of its antiviral …
BMS’ Zeposia becomes first S1P receptor modulator available in Europe for relapsing remitting multiple sclerosis
May 28, 2020Sales and Marketing Avonex, Bristol-Myers Squibb, EU, Europe, Zeposia, bristol myers squibb, multiple sclerosis
Bristol Myers Squibb is celebrating after its oral therapy Zeposia (ozanimod), secured European Commission for the treatment of relapsing remitting …
Positive CHMP opinion for BMS and Acceleron’s Reblozyl in transfusion-dependent anaemia sub-populations
May 1, 2020Medical Communications, Sales and Marketing Acceleron, Bristol-Myers Squibb, EU, Reblozyl
Bristol Myers Squibb and Acceleron Pharma’s Reblozyl (luspatercept) has secured a positivr opinion from the European Medicines Agency’s Committee for Medicinal …
EU approval for Novartis’ Cosentyx in active non-radiographic axial spondyloarthritis
April 29, 2020Research and Development, Sales and Marketing Cosentyx, EU, Novartis, axial spondyloarthritis, pharma
Novartis has revealed that the European Commission has moved to approve Cosentyx (secukinumab) for the treatment of active non-radiographic axial …
Boehringer’s nintedanib approved in Europe for systemic sclerosis-associated interstitial lung disease
April 22, 2020Research and Development, Sales and Marketing Boehringer Ingelheim, EU, nintedanib, pharma
The European Commission has moved to authorise Boehringer Ingelheim’s nintedanib in Europe for the treatment of systemic sclerosis-associated interstitial lung …
Drug launches across Europe will be affected by coronavirus
March 20, 2020Medical Communications, Sales and Marketing EU, Europe, coronavirus, pharma
The COVID-19 pandemic will affect European launches of drugs for a host of diseases including HIV, cancer and sickle cell …
European Commission offers €80m to CureVac to develop coronavirus vaccine
March 17, 2020Manufacturing and Production, Research and Development, Sales and Marketing CureVac, EU, US, coronavirus
Following confirmation of reports that US President Donald Trump sought to persuade a biotech to provide US-exclusivity for a potential …
Sanofi secures expanded European approval for Toujeo in type 1 diabetes
January 10, 2020Medical Communications, Sales and Marketing EU, Sanofi, pharma, toujeo
Sanofi has revealed that the European Commission has expanded the existing label for Toujeo (insulin glargine 300 units/mL) to include …
AbbVie granted EU marketing authorisation for new arthritis drug
December 19, 2019Business Services AbbVie, EC, EU, arthritis, rheumatoid arthritis
AbbVie have announced that the European Commission (EC) have granted marketing authorisation for RINVOQ (upadacitnib). It’s a daily selective reversible …
Transactions in the pharma sector: Through the EU merger review looking-glass
December 9, 2019Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EU, feature, mergers & acquisitions, pharma
With mergers and acquisitions back in full swing after a period of drought, Alec Burnside (Partner) and Delphine Strohl (Associate) …
AstraZeneca’s Qtrilment scores European authorisation in type 2 diabetes
November 15, 2019Medical Communications, Sales and Marketing AstraZeneca, EU, Europe, Qtrilmet, diabetes, pharma, type 2 diabetes
Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) has secured approval in Europe, its manufacturer AstraZeneca has revealed, as a therapy to …
Promising Phase 3 data for Sanofi’s Toujeo secures CHMP recommendation of label expansion in type 1 diabetes
November 4, 2019Research and Development, Sales and Marketing EU, Sanofi, Type 1 diabetes, diabetes, pharma, toujeo
Sanofi took the opportunity at the International Society for Pediatric and Adolescent Diabetes 45th Annual Conference in Boston, Massachusetts to …
European Commission approves Sanofi’s Dupixent in chronic rhinosinusitis with nasal polyposis
October 30, 2019Research and Development, Sales and Marketing Dupixent, EU, Sanofi, pharma
Sanofi’s Dupixent (dupilumab) has secured European approval for the treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP), it has emerged. …
“No deal” Brexit and life sciences: What happens?
October 21, 2019Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EU, Europe, UK, brexit, no deal, no-deal, pharma
Prime Minister Boris Johnson may have agreed a withdrawal agreement with the European Union at the 11th hour, but despite …
Celltrion’s subcutaneous infliximab biosimilar secures CHMP recommendation
September 24, 2019Manufacturing and Production, Sales and Marketing EMA, EU, Europe, biosimilar, celltrion, infliximab, pharma
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has given its recommendation to Celltrion’s CT-P13 SC, the subcutaneous …
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