Regulation

Onspira’s bronchiolitis obliterans treatment secures FDA orphan drug status

Onspira Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for its investigational product, OSP-101, to treat Bronchiolitis Obliterans (BO).

AHF files review petition with US Supreme Court on Gilead AIDS drug patent case

AIDS Healthcare Foundation (AHF) has filed a petition for writ of certiorari (a petition for review) with the Supreme Court of the US, seeking the Court’s review of the dismissal of a federal lawsuit filed by AHF in January 2016 against Gilead Sciences and other defendants alleging its patent for a key HIV/AIDS drug, tenofovir alafenamide (TAF) is invalid because Gilead manipulated the patent system.

Roche’s Xolair gets FDA breakthrough status for food allergies

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Roche's Xolair (omalizumab) for the prevention of severe allergic reactions after accidental exposure to one or more foods in people with allergies.

FDA approves Alnylam’s Onpattro to treat polyneuropathy of hATTR amyloidosis

Alnylam Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its RNA interference (RNAi) therapeutic, Onpattro (patisiran) lipid complex injection, to treat polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.

AstraZeneca to pay $110m to settle Texas whistleblower drug lawsuits

AstraZeneca has agreed to pay $110m to settle Texas drugs lawsuit claims of fraudulently marketing Seroquel and Crestor.

BioCryst’s HAE drug BCX7353 gets FDA fast track designation

BioCryst Pharmaceuticals’ plasma kallikrein inhibitor BCX7353 has been given fast track designation by the US Food and Drug Administration (FDA) for the prevention of angioedema attacks in patients having hereditary angioedema (HAE).

UK’s MHRA grants early access to Alnylam’s patisiran

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Alnylam Pharmaceuticals’ patisiran, an investigational RNAi therapeutic for the treatment of hATTR amyloidosis, a positive scientific opinion through the Early Access to Medicines Scheme (EAMS).

EMA grants orphan designation to selumetinib to treat neurofibromatosis type 1

The European Medicines Agency (EMA) has granted orphan designation to selumetinib, a MEK 1/2 inhibitor which is being developed by AstraZeneca and Merck to treat neurofibromatosis type 1 (NF1).

Pfizer secures European approval for Xeljanz to treat ulcerative colitis

Pfizer has secured approval from the European Commission (EC) for its Xeljanz (tofacitinib citrate) for the treatment of moderately to severely active ulcerative colitis (UC).