Regulation

Abeona gets orphan drug status in EU for ABO-101 gene therapy in Sanfilippo syndrome type B

Abeona Therapeutics has secured orphan drug designation from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products for its gene therapy program ABO-101 for children impacted by Sanfilippo syndrome type B (MPS IIIB).

ProMetic’s alstrom syndrome treatment gets orphan drug status in Europe

The European Commission has granted orphan drug designation to ProMetic Life Sciences' PBI-4050 drug for the treatment of Alström Syndrome.

European Commission approves Suliqua to treat adults with type 2 diabetes

Sanofi has secured approval from the European Commission for Suliqua, the once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes.

Biogen to pay Forward Pharma $1.25bn to settle multiple sclerosis drug case

US-based Biogen has agreed to pay Danish firm Forward Pharma $1.25bn to resolve a dispute over a patent on multiple sclerosis drug.

Heron submits CINVANTI NDA to FDA for CINV prevention

Heron Therapeutics has submitted its New Drug Application (NDA) to the US Food and Drug Administration (FDA) for CINVANTI (HTX-019), a polysorbate 80-free, intravenous formulation of aprepitant for the prevention of Chemotherapy-Induced Nausea and Vomiting (CINV).

Gilead gets European approval for hepatitis B drug Vemlidy

Gilead Sciences has received marketing authorization from the European Commission for Vemlidy (tenofovir alafenamide, TAF) 25 mg, a once-daily tablet for chronic hepatitis B virus (HBV) infection treatment in adults and adolescents (aged 12 years and older with body weight at least 35 kg).

FDA grants orphan drug status for Sangamo’s SB-318 genome editing treatment for MPS I

Sangamo Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for its genome editing product candidate, SB-318, to treat Mucopolysaccharidosis Type I (MPS I).

FDA accepts Merck’s sBLA for lung cancer combo therapy

The US Food and Drug Administration (FDA) has accepted for review Merck's supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, plus chemotherapy (pemetrexed plus carboplatin) for the first-line treatment of patients with metastatic or advanced non-squamous non-small cell lung cancer (NSCLC) regardless of PD-L1 expression and with no EGFR or ALK genomic tumor aberrations.

FDA grants priority review for Bayer’s Stivarga marketing application for liver cancer

The US Food and Drug Administration (FDA) has granted priority review status for Bayer's supplemental New Drug Application (sNDA) for Stivarga (regorafenib) tablets for the second-line systemic treatment of patients with hepatocellular carcinoma (HCC).