Regulatory

Biohaven Pharmaceuticals said that it has filed an investigational new drug application for its BHV-3500 intranasal calcitonin gene-related peptide (CGRP) receptor antagonist, which it is developing for the prevention and treatment of migraine. BHV-3500, which… Read more . . .

Glenmark Pharmaceuticals announced that it has received marketing approval from German authorities for its generic version of Seretide Accuhaler and said that the product will be marketed in Germany as “Salflutin.” The company acquired development… Read more . . .

Johnson & Johnson subsidiary Janssen Pharmaceutical has submitted an NDA for esketamine nasal spray for the treatment of treatment-resistant depression in adults, the company said. Janssen said that it plans to submit an MAA to… Read more . . .

insys Therapeutics’ epinephrine nasal spray for the treatment of anaphylaxis has received Fast Track designation from the FDA, the company said. In June 2018, Insys said that a Phase 1 study of the nasal spray… Read more . . .

Medical Developments International (MVP), which announced in July 2018 that it was expecting a clinical hold letter from the FDA regarding its US clinical program for its Penthrox methoxyflurane inhaler, said that it has now… Read more . . .

The FDA has granted fast track designation to NeuroproteXeon (NPXe) and Mallinckrodt’s inhaled xenon gas for the treatment of post-cardiac arrest syndrome (PCAS), the companies said. A Phase 3 trial of inhaled xenon for that… Read more . . .

Evoke Pharma has announced that the FDA has accepted the company’s 505(b)(2) NDA for Gimoti metoclopramide nasal spray for the treatment of acute and recurrent diabetic gastroparesis in adult women, which Evoke submitted in June… Read more . . .

According to Circassia Pharmaceuticals, the FDA has accepted its NDA for the Duaklir aclidinium/formoterol DPI for the treatment of COPD and an sNDA for the Tudorza aclidinium bromide DPI, with a PDUFA date of March… Read more . . .

US-based Onspira Therapeutics has announced that its OSP-101, an inhaled interleukin-1 receptor antagonist (IL-1Ra) for the treatment of bronchiolitis obliterans, has been granted orphan drug designation by the FDA. Onspira is a private company created… Read more . . .

UCB announced that the FDA has accepted its new drug application for USL261 midazolam nasal spray for the rescue treatment of seizures in epilepsy patients. The company announced in April 2018 that it had acquired… Read more . . .