Regulation

Novartis’ Sandoz to appeal US district court ruling on biosimilar Erelzi

Novartis’ Sandoz said that it will appeal the ruling of a US district court pertaining to the patent infringement case on Erelzi (etanercept-szzs), the company’s biosimilar to Amgen’s Enbrel (etanercept).

Kala Pharmaceuticals receives FDA complete response letter for KPI-121 0.25% NDA

Kala Pharmaceuticals announced that it received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding the company’s new drug application (NDA) for KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease.

Stoke Therapeutics granted FDA orphan drug designation for STK-001 for Dravet Syndrome

Stoke Therapeutics, a biotechnology company pioneering a new way to treat the underlying cause of genetic diseases by precisely upregulating protein expression, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its lead product candidate, STK-001, an investigational new treatment for Dravet syndrome.

Alnylam’s givosiran gets FDA priority review for acute hepatic porphyria

Alnylam Pharmaceuticals’ investigational RNAi therapeutic givosiran has been granted priority review by the US Food and Drug Administration (FDA) for the treatment of acute hepatic porphyria (AHP).

FDA approves Daiichi Sankyo’s Turalio for rare joint tumour

Daiichi Sankyo has secured approval from the US Food and Drug Administration (FDA) for the use of Turalio (pexidartinib) for the treatment of symptomatic tenosynovial giant cell tumor (TGCT).

GSK gets EC approval for new administration options of asthma treatment Nucala

GlaxoSmithKline (GSK) has secured marketing authorisation from the European Commission (EC) for two new administration options of Nucala (mepolizumab) to treat patients with severe eosinophilic asthma.

Bayer gets FDA approval for prostate cancer drug Nubeqa

Bayer has secured approval from the US Food and Drug Administration (FDA) for its Nubeqa (darolutamide) to treat patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

ViiV Healthcare submits regulatory application to EMA for investigational Cabotegravir to be used in combination with Rilpivirine for HIV

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi Limited as shareholders, announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for the investigational, once-monthly, injectable cabotegravir, which will be used in combination with Janssen’s once-monthly, injectable rilpivirine to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine.

NeuroVive’s NeuroSTAT Project receives FDA fast track designation

NeuroVive Pharmaceutical AB announced that the company's candidate drug NeuroSTAT, in development for treatment of moderate to severe traumatic brain injury, TBI, has received Fast Track designation from the US Food and Drug Administration, FDA, facilitating its clinical development and path forwards to market.