Europe – EMA update on shortages of antibiotics in the EU
EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) met on Thursday to discuss the progress made and to agree on the next...
International – WHO recommends risk management plans for high-risk excipients
The World Health Organization (WHO) has released two draft appendices to a recent draft guideline on good manufacturing practices (GMPs) for excipients. The first...
Europe – EFPIA: EU pharma manufacturing would ‘grind to a halt’ under proposed PFAS...
The European Union’s proposed restriction on the use of per- and polyfluoroalkyl substances (PFAS), also known as “forever chemicals,” would have grave implications on...
USA – FDA plans to release AI drug development guidance this year
The US Food and Drug Administration (FDA) plans to release a draft guidance this year on the use of artificial intelligence/machine learning (AI/ML) to...
International – WHO decision improves children’s access to safer polio vaccine
Three years after it received its Emergency Use Listing (EUL) and with 950 million doses now delivered worldwide, nOPV2 has been prequalified by the WHO,...
France – Définition des conditions méthodologiques requises pour la prise d’un pari lors d’une...
Le bilan des procédures accélérées aux Etats-Unis, qui s’appuie sur plus de 30 ans d’expérience de la FDA, a montré que les études confirmatoires...
UK – Bayer’s Nubeqa combination recommended by NICE to treat metastatic prostate cance
The final draft guidance from NICE specifically recommends Nubeqa tablets in combination with androgen deprivation therapy (ADT) and docetaxel.
The decision follows the Medicines and...
International – WHO proposes updated excipient GMPs in wake of contaminated cough syrup
The World Health Organization (WHO) recently proposed updated guidance to assist pharmaceutical manufacturers in assessing the quality of excipients after child deaths were reported...
Europe – EMA and ECDC statement on updating COVID-19 vaccines to target new SARS-CoV-2...
The European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) have issued a joint statement on adapted COVID-19 vaccines and considerations...
UK – NICE recommends Pfizer’s rimegepant for preventing episodic migraine attacks
The National Institute for Care and Excellence (NICE) has announced that it has recommended an oral treatment for the prevention of episodic migraines for...
