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Takeda Pharmaceuticals International GmbH

www.nycomed.com

Latest From Takeda Pharmaceuticals International GmbH

Nicotine Gummies Sold For Smoking Cessation Doused Under US FDA Tobacco Regulations

FDA says warning to VPR Brands could be its first move to reign in sales of nicotine gummies. Statements on brand’s site could indicate sales of nicotine gummies for smoking cessation are on the rise even though the claim isn’t approved.

FDA OTC Drugs

EU Accelerated Assessment Tracker

EU marketing authorization applications from Bayer for copanlisib and from Takeda for maribavir will be reviewed under standard timelines at the European Medicines Agency. 

Europe Review Pathway

WHO Chief Scientist Warns Of 'Pandemic Within A Pandemic', Calls For New R&D Models

A high profile panel including the WHO's chief scientist and ministers of Norway and South Africa discussed critical dimensions pertaining to coronavirus vaccines and risks of a “pandemic within a pandemic” with the emergence of  SARS-CoV-2 variants. Funding gaps at the ACT Accelerator and extending the shelf life of vaccines were also deliberated.

Research & Development Coronavirus COVID-19

2020 In Review: Despite Pandemic, The US FDA Issued Just 20% Fewer Drug GMP Warning Letters

The US FDA managed to issue 94 drug GMP warning letters last year despite the pandemic, with fewer expected for 2021. Top issue areas included lack of sterility assurance, nitrosamine impurities, poor data integrity and basic GMP failures.

Manufacturing Quality
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