Regulatory

The European Parliament has voted to regulate e-cigarettes under less stringent rules than drug delivery products, unless the products make medical claims. The Parliament voted to prohibit sales of e-cigarettes to any one under 18… Read more . . .

According to Eleison Pharmaceuticals, the European Commission has granted Orphan Drug Designation for the company’s inhaled lipid-complexed cisplatin (ILC) for the treatment of osteosarcoma. The sustained-release inhalation solution, which Eleison licensed from Insmed in 2011,… Read more . . .

Just days after its approval in Japan, Novartis has announced that the Ultibro Breezhaler indacaterol/glycopyrronium (QVA149) DPI has been approved in Europe for the treatment of COPD. The approval triggers $10 million milestone payments to… Read more . . .

According to AstraZeneca, it has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for its Fluenz Tetra intranasal four-strain live attenuated influenza vaccine developed by its MedImmune subsidiary.… Read more . . .

Sosei Group and Vectura have announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Ultibro glycopyrronium/indacaterol inhalation capsules, which are delivered using the Breezhaler DPI, for treatment of COPD. Ultibro, also… Read more . . .

The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 11 to 2 in favor of approval for GSK’s Anoro Ellipta umeclidinium/vilanterol dry powder inhaler for the treatment of COPD, according to GlaxoSmithKline and Theravance. The… Read more . . .

The FDA has issued a draft guidance on bioequivalence recommendations for generic fluticasone propionate/salmeterol xinafoate inhalers. Notice of the draft guidance appeared in the Federal Register for September 10, 2013. According to the agency, public… Read more . . .

Forest Laboratories and Almirall have announced that a planned 4th quarter 2013 NDA submission for their aclidinium bromide/formoterol dry powder inhaler will be delayed due to the need to address FDA concerns regarding chemistry, manufacturing… Read more . . .

Health Canada has announced that it is withdrawing marketing authorization for calcitonin nasal sprays as of October 1, 2013 due to concerns about cancer risks associated with the products. Injectable calcitonin products will continue to… Read more . . .