Regulation

AstraZeneca, Merck’s Lynparza gets FDA ODD for pancreatic cancer

AstraZeneca and Merck have secured the orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for their poly ADP-ribose polymerase (PARP) inhibitor Lynparza (olaparib) to treat pancreatic cancer.

FDA panel recommends approval of Rituxan biosimilar

The US Food and Drug Administration’s (FDA) advisory committee has recommended approval of Celltrion and Teva Pharmaceutical’s biosimilar of Roche’s blood cancer drug Rituxan (rituximab).

Silence Therapeutics launches interim European injunction application against Alnylam’s Onpattro

Silence Therapeutics has received a notice of intention to grant for a new European divisional patent, EP 3 222 724B, and started a new cross-border interim injunction application in the Netherlands against Alnylam's Onpattro (patisiran).

FDA and EMA accept Novartis’ filings for MS drug Siponimod

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted Novartis’ new drug application (NDA) and marketing authorization application (MAA) for multiple sclerosis drug siponimod (BAF312).

FDA expands use of Merck’s Gardasil 9 HPV vaccine up to age 45

The US Food and Drug Administration (FDA) has approved Merck’s human papillomavirus (HPV) 9-valent vaccine, Gardasil 9, to be used as treatment for women and men aged from 27 years to 45 years.

Roche gets FDA approval for Hemlibra for haemophilia A without factor VIII inhibitors

Roche has secured approval from the US Food and Drug Administration (FDA) for Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients of all ages having haemophilia A without factor VIII inhibitors.

Shield Therapeutics submits NDA in US for Feraccru to treat iron deficiency

Shield Therapeutics has submitted a new drug application (NDA) with the US Food and Drug Administration (FDA) for its lead product Feraccru to treat iron deficiency.

Regeneron, Sanofi secure FDA nod for skin cancer drug Libtayo

Regeneron Pharmaceuticals and Sanofi have secured approval from the US Food and Drug Administration (FDA) for their Libtayo (cemiplimab-rwlc) to treat patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

US DEA reschedules GW Pharmaceuticals’ Epidiolex to Schedule V

GW Pharmaceuticals said that EPIDIOLEX (cannabidiol) oral solution has been transferred to Schedule V restriction classification, by the US Drug Enforcement Administration (DEA).