CHMP Backs 13 New Medicines, Maintains Negative Opinion of Sarepta’s Exondys

Europe – CHMP Backs 13 New Medicines, Maintains Negative Opinion of Sarepta’s Exondys

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended thirteen new medicines for EU approval and reaffirmed...
Drugmakers Raise Issues With FDA’s Field Alert Report Submissions Guidance

USA – Drugmakers Raise Issues With FDA’s Field Alert Report Submissions Guidance

Drugmakers GlaxoSmithKline (GSK), Sanofi and Perrigo are calling on the US Food and Drug Administration (FDA) to make changes to its recently released draft...
Third Form 483 Surfaces for China Company at Center of Valsartan Contamination

China – Third Form 483 Surfaces for China Company at Center of Valsartan Contamination

Just days since FDA, EMA and Health Canada announced that a second impurity, called N-nitrosodiethylamine (NDEA), has been found in valsartan manufactured by Zhejiang Huahai Pharmaceuticals...
End of the eCTD? FDA Pushes for New KASA System to Improve Assessments

USA – End of the eCTD? FDA Pushes for New KASA System to Improve...

The US Food and Drug Administration’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee met Thursday to discuss the positive aspects of adopting a Knowledge-aided...
J&J files ‘breakthrough’ bladder cancer drug in US

USA – J&J files ‘breakthrough’ bladder cancer drug in US

The new drug candidate – selective fibroblast growth factor receptor inhibitor erdafitinib – is an oral, once daily treatment for the second-line treatment of...
CDRH Finalizes Guidance to Reduce Heparin Product Overdose Errors

USA – CDRH Finalizes Guidance to Reduce Heparin Product Overdose Errors

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) issued final guidance Wednesday to aid manufacturers in reducing the...
NICE rejects Novartis’ CAR-T Kymriah for adult lymphoma

Europe – NICE rejects Novartis’ CAR-T Kymriah for adult lymphoma

The draft guidance recommends against its use for adults after two or more lines of systemic therapy, concluding that it is not cost effective...
AFAR : soirée BREXIT

France – AFAR : soirée BREXIT

BREXIT : Impacts réglementaires et qualité sur les organisations pharmaceutiques (maison-mère et filiale)... Bulletin d'inscription
Data Integrity a Top Concern for Manufacturers, FDA Says

USA – Data Integrity a Top Concern for Manufacturers, FDA Says

When a pharmaceutical or active pharmaceutical ingredient manufacturer has data integrity issues, that’s likely the tip of the iceberg, Sarah Barkow, of FDA’s Office...
Takeda gets China's approval for $62 billion Shire purchase

China – Takeda gets China’s approval for $62 billion Shire purchase

Takeda Pharmaceutical Co Ltd said on Friday China approved its purchase of Shire Plc, the latest regulator to clear the $62 billion deal and...

NOS PROCHAINES FORMATIONS