Regulation

Dr. Reddy’s gets favorable decision in buprenorphine and naloxone sublingual film patent case

Dr. Reddy’s Laboratories said that the US Court of Appeals for the Federal Circuit issued a decision in its favor by concluding that Indivior had not shown that it is likely to succeed on the merits of its infringement case on US Patent No. 9,931,305.

Sobi, Novimmune secure FDA approval for Gamifant to treat HLH

Swedish Orphan Biovitrum (Sobi) and Novimmune have secured approval from the US Food and Drug Administration (FDA) for their monoclonal antibody Gamifant (emapalumab-lzsg) for the treatment of primary hemophagocytic lymphohistiocytosis (HLH).

Aries Pharmaceuticals gets FDA nod for Aemcolo to treat Travelers’ Diarrhea

The US Food and Drug Administration (FDA) has approved Aries Pharmaceuticals’ Aemcolo (rifamycin) 194mg delayed-release tablets, a new minimally-absorbed antibiotic that is delivered to the colon, for the treatment of adult patients with Travelers’ Diarrhea caused by non-invasive strains of Escherichia coli.

GSK seeks paediatric indication for Nucala in severe eosinophilic asthma

GlaxoSmithKline (GSK) has filed a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for an additional indication for Nucala (mepolizumab) as an add-on treatment for severe eosinophilic asthma in paediatric patients aged six to 11 years.

FDA approves Novartis drug Promacta for first-line SAA

The US Food and Drug Administration (FDA) has expanded the label for Novartis’ Promacta (eltrombopag) to include first-line treatment for adults and pediatric patients two years and older with SAA in combination with standard immunosuppressive therapy (IST).

BMS secures positive CHMP opinion for Opdivo- Yervoy combo in RCC

Bristol-Myers Squibb (BMS) said that European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion regarding the approval of Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) combination to include first-line treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC).

Janssen applies for expanded approval for IMBRUVICA in Europe

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted two Type II variation applications to the European Medicines Agency (EMA) regarding approval for the expanded use of IMBRUVICA (ibrutinib).

FDA grants priority review to Tecentriq combo for triple-negative breast cancer

Roche has secured priority review from the US Food and Drug Administration (FDA) for Tecentriq (atezolizumab) in combination with chemotherapy as the first-line treatment of a form of triple-negative breast cancer (TNBC).

Pain Therapeutics appeals FDA decision on abuse-deterrent opioid Remoxy

Clinical-stage biopharmaceutical firm Pain Therapeutics has petitioned the Food and Drug Administration (FDA) regarding a complete response Letter (CRL) for Remoxy issued in August this year.