Regulatory

Samumed's SM04646 inhaled Wnt pathway inhibitor has been granted orphan drug designation by the FDA, the company has announced. The company recently announced positive Phase 1 results for SM04646, which it is developing for the treatment of ideopathic pulmonary fibrosis. According to Samumed, SM04646 has the potential for use as either as a combination therapy … [Read more...] about Samumed’s inhaled Wnt pathway inhibitor gets orphan drug designation

GlaxoSmithKline and Innoviva have announced the filing of a submission to the EMA for the use of the Relvar Ellipta fluticasone furoate/vilanterol DPI (marketed as Breo Ellipta in the US) by patients whose asthma is adequately controlled with the use of an ICS/LABA combination. Relvar Ellipta was approved in the EU for the treatment of asthma not adequately … [Read more...] about GSK submits application to allow use of Relvar Ellipta for adequately controlled asthma

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the reclassification of Nasonex mometasone furoate nasal spray from a "POM," or "prescription only medicine," to a "P" medicine, available over the counter at pharmacies with pharmacist supervision. The product is approved for the treatment of allergic rhinitis. Bayer, which acquired … [Read more...] about MHRA reclassifies Nasonex nasal spray for other the counter sales in UK

Functional respiratory imaging (FRI) specialist Fluidda has requested a Critical Path Innovation Meeting (CPIM) with the FDA as part of an initiative for approval of its FRI technology as a biomarker, the company said. According to Fluidda CEO Jan de Backer, the company will use the CPIM to bring the FDA up to date on development and validation of FRI, which the … [Read more...] about Fluidda requests Critical Path Innovation Meeting with FDA as part of biomarker approval initiative

The FDA has accepted for review Sunovion's resubmission of the NDA for SUN-101/eFlow glycopyrrolate inhalation solution for the treatment of COPD, the company said. Sunovion received a complete response letter to the previously submitted NDA in May 2017. The PDUFA date for the resubmitted NDA is December 15, 2017. The original NDA was accepted for review in … [Read more...] about Sunovion has resubmitted the NDA for SUN-101/eFlow glycopyrrolate inhalation solution

Acorda Therapeutics has submitted a 505(b)(2) new drug application for Inbrija (CVT-301) levodopa for the treatment of symptoms during OFF periods in Parkinson's disease patients, the company said. According to the company, the FDA is expected to inform the company whether or not the application has been accepted by the end of September. In May 2017, Acorda … [Read more...] about Acorda submits NDA for Inbrija inhaled levodopa for Parkinson’s disease

Boehringer Ingelheim has filed a citizen petition with the FDA asking the agency to "request the Commissioner of Food and Drugs to ensure that any New Drug Application (“NDA”) for a fixed-dose, triple-combination, inhaled drug product intended for the treatment of patients with chronic obstructive pulmonary disease (“COPD”) is not approved as safe and effective unless … [Read more...] about Boehringer Ingelheim files citizen petition challenging GSK’s NDA for triple combination DPI

Medical Developments International (MVP) has announced that Health Canada has accepted its submission for the Penthrox methoxyflurane inhaler, triggering a $250,000 Canadian milestone payment to MVP from Purdue Pharma Canada. In September 2016, MVP announced that Purdue Pharma Canada would pay $3 million Canadian for Canadian rights to Penthrox for the treatment of … [Read more...] about Health Canada accepts Penthrox regulatory submission for review

According to Novartis, the FDA has accepted Sandoz's abbreviated new drug application for its generic version of the Advair Discus (Seretide Accuhaler) fluticasone propionate/salmeterol DPI for the treatment of asthma and COPD. The company acquired the product when it acquired Oriel Therapeutics in 2010. In October 2016, Sandoz filed a citizen petition with the … [Read more...] about FDA accepts Sandoz’s ANDA for generic version of Advair Diskus