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 years old, to limit products to 30mg/ml of nicotine, and to require health warnings. Linda McAvan, the member designated as the lead … [Read more...] about European Parliament rejects regulation of e-cigarettes as medicines

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, is currently in a Phase 2 clinical trial. Eleison Chief Medical Officer Forrest Anthony … [Read more...] about Orphan drug designation for inhaled lipid-complexed cisplatin

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 Sosei and Vectura. Novartis Pharmaceuticals Division Head David Epstein commented, "We are very pleased that the European … [Read more...] about European approval for Ultibro Breezhaler

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. Fluenz Tetra includes two strains of influenza A and two strains of influenza B. If approved, the vaccine would replace … [Read more...] about Positive opinion on Fluenz Tetra from CHMP

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 known as QVA149, was developed by Novartis, which filed the Japanese marketing application in November 2012. … [Read more...] about Ultibro inhalation capsules approved in Japan

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 committee voted 10-3 in agreement that the safety of the UMEC/VI inhaler has been demonstrated and 13-0 on the question of … [Read more...] about FDA advisory committee recommends approval of umeclidinium/vilanterol inhaler

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 responses to the draft guidance will be considered before the agency responds to a December 2009 citizen petition … [Read more...] about FDA issues draft guidance on BE for fluticasone propionate/salmeterol xinafoate

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 and control (CMC) specifications. The companies said that they "are working with the FDA regarding the CMC related comments … [Read more...] about NDA filing for aclidinium bromide/formoterol DPI delayed

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 be available with additional warnings on the labels. The agency announced in July 2012 that it would conduct a safety review of … [Read more...] about Sales of calcitonin nasal sprays in Canada to end