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Proveris Scientific

Regulatory

GSK submits EU regulatory application for UMEC monotherapy

GlaxoSmithKline says that it has submitted a Marketing Authorisation Application (MAA) to the EMA for umeclidinium bromide (UMEC) monotherapy to be delivered using the Ellipta DPI for the treatment of COPD. UMEC is a long-acting muscarinic antagonist (LAMA). GSK and Theravance recently submitted an application in Japan for the Anoro Ellipta UMEC/vilanterol inhaler, … [Read more...] about GSK submits EU regulatory application for UMEC monotherapy

FDA advisory committee recommends approval of Breo Ellipta

The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted to recommend approval of of GSK and Theravance's Breo Ellipta fluticasone furoate/vilanterol (FF/VI) DPI for the treatment of COPD. The PADAC meeting had been rescheduled from an earlier date due to weather. During the rescheduled meeting on April 17, the committee voted in favor of approval … [Read more...] about FDA advisory committee recommends approval of Breo Ellipta

Allergan acquires Exemplar, gets Complete Response Letter for Levadex

Allergan, which recently acquired MAP Pharmaceuticals, has announced that it has received a Complete Response Letter (CRL) from the FDA in regard to its NDA for Levadex inhaled dihydroergotamine for the treatment of migraines. The company also announced that it has acquired CMO Exemplar, which had previously received a form 483 for problems with Levadex … [Read more...] about Allergan acquires Exemplar, gets Complete Response Letter for Levadex

Discovery Labs says Aerosurf program “currently remains on track”

According to Discovery Laboratories its Aerosurf aerosolized surfactant development program "currently remains on track for the Phase 2 clinical program in the fourth quarter of 2013" and is unaffected by the FDA's recent questions about product specifications for Discovery Labs' Surfaxin intratracheal suspension surfactant. The company says that it will respond to … [Read more...] about Discovery Labs says Aerosurf program “currently remains on track”

FDA draft guidance on albuterol MDI bioequivalence includes recommendations for in vivo and in vitro studies

The FDA draft guidance on albuterol sulfate MDIs published April 8, 2013 includes recommendations for a total of 7 studies, including 5 in vitro studies, 1 PK study, and 1 PD study to establish bioequivalence. The recommendations for in vitro testing cover single actuation content, aerodynamic particle size distribution (APSD), spray pattern, plume geometry, and … [Read more...] about FDA draft guidance on albuterol MDI bioequivalence includes recommendations for in vivo and in vitro studies

Insmed gets orphan drug designation for Arikace, appoints new chief commercial officer

According to Insmed Incorporated, the US FDA has granted orphan drug designation to its Arikace liposomal amikacin for inhalation for the treatment of non-tuberculous mycobacteria (NTM) infections. Insmed is also developing Arikace for the treatment of P. aeruginosa infections in cystic fibrosis patients. The company also has announced the appointment of Matthew Pauls … [Read more...] about Insmed gets orphan drug designation for Arikace, appoints new chief commercial officer

NICE issues final guidance on Tobi Podhaler and Colobreathe for some CF patients

The UK's National Institute for Health and Care Excellence (NICE) has issued a final guidance recommending Novartis's Tobi Podhaler tobramycin DPI and Forest Lab's Colobreathe colistimethate sodium DPI for the treatment of P. aeruginosa lung infections in cystic fibrosis patients when patients are unable to use other treatments. In January 2013, NICE issued a final … [Read more...] about NICE issues final guidance on Tobi Podhaler and Colobreathe for some CF patients