Regulatory

MannKind Corporation has announced that a meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee for a review of the company’s NDA for Afrezza insulin inhalation powder has been scheduled tentatively for April 1,… Read more . . .

The FDA’s Nonprescription Drugs Advisory Committee and Pulmonary Allergy Drugs Advisory Committee (PADAC) will meet on February 25, 2014 to consider a new drug application submitted by Armstrong Pharmaceuticals for an OTC epinephrine inhalation aerosol… Read more . . .

Daiichi Sankyo has announced that Japanese regulators have approved its Inavir laninamivir octanoate hydrate DPI for the prevention of the flu. In August 2012, the company had announced positive Phase 3 results for that indication.… Read more . . .

Sandoz has received Danish marketing authorization for the AirFluSal Forspiro inhaler for the treatment of asthma and/or COPD in 50-250µg and 50-500µg versions. Sandoz acquired European rights to the product (formerly known as VR-315) from… Read more . . .

The FDA has announced the approval of GSK and Theravance’s Anoro Ellipta umeclidinium/vilanterol inhalation powder for the treatment of COPD. The approval triggers a $30 million milestone payment from Theravance to GSK. Theravance will pay… Read more . . .

FLUIDDA has announced that it will meet with the FDA on January 17, 2014 to present its Functional Respiratory Imaging (FRI) technology for screening respiratory drugs. The FDA is evaluating FRI as part of its… Read more . . .

Savara Pharmaceuticals has announced that its AeroVanc inhaled vancomycin has received Fast Track designation from the FDA and been designated as a Qualified Infectious Disease Product (QIDP) for the treatment of methicillin-resistant Staphylococcus aureus (MRSA)… Read more . . .

The European Commission (EC) has approved MedImmune’s Fluenz Tetra intranasal four-strain live attenuated influenza vaccine for the prevention of flu in children aged 24 months to 18 years, parent company AstraZeneca has announced. Fluenz Tetra… Read more . . .

Taiwan’s FDA has canceled marketing authorizations for calcitonin nasal sprays effective December 1 2013, and the products must be recalled within two months. According to the China Post, calcitonin nasal spray was first licensed in… Read more . . .

GSK and Theravance have announced that the European Commission has approved Relvar Ellipta fluticasone furoate/vilanterol (FF/VI) DPI for the treatment of asthma for patients whose disease is not adequately controlled by ICS plus an as-needed… Read more . . .