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Proveris Scientific

Regulatory

US Centers for Disease Control (CDC) advises against using FluMist for 2016-17

The Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) has recommended against the use of MedImmune's FluMist Quadrivalent Live Attenuated Influenza Vaccine (FluMist Quadrivalent) for the 2016-2017 influenza season because the intranasal vaccine has failed to demonstrate significant effectiveness in children … [Read more...] about US Centers for Disease Control (CDC) advises against using FluMist for 2016-17

Phase 3 study shows GSK’s FF/UMEC/VI combination improves lung function and quality of life better than Symbicort

GlaxoSmithKline and Innoviva have presented data from the FULFIL study of its fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) DPI versus Symbicort for COPD, reiterating that the data support the company's plans to file an NDA for the product by the end of the year as recently announced as well as filing for approval in the EU by the end of 2016. The study met … [Read more...] about Phase 3 study shows GSK’s FF/UMEC/VI combination improves lung function and quality of life better than Symbicort

Insmed withdraws MAA for Arikayce for nontuberculous mycobacteria (NTM)

Insmed has announced the withdrawal of its marketing authorization application for Arikayce inhaled liposomal amikacin for the treatment of nontuberculous mycobacteria (NTM) lung disease. The MAA was submitted to the European Medicines Agency in 2014, prior to the beginning of a Phase 3 study. According to the company, the Committee for Medicinal Products for … [Read more...] about Insmed withdraws MAA for Arikayce for nontuberculous mycobacteria (NTM)

Chiesi reports positive preliminary results from pivotal studies of triple combination MDI

Chiesi says that it is on track with planned regulatory submissions in the EU for its ICS/LAMA/LABA MDI for the treatment of COPD by the end of 2016 after successful completion of two 12-month Phase 3 studies. According to the company, preliminary results from the studies of the extrafine beclamethasone/formoterol/glycopyrronium combination therapy in more than 4,000 … [Read more...] about Chiesi reports positive preliminary results from pivotal studies of triple combination MDI

GSK to file NDA for FF/UMEC/VI combination by the end of 2016

GlaxoSmithKline plc (LSE:GSK) and Innoviva have announced that the planned submission of an NDA for a triple therapy DPI for the treatment of COPD has been moved up from the first half of 2018 to the end of 2016, following discussions with the FDA. The fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) combination is delivered using the Ellipta inhaler. The … [Read more...] about GSK to file NDA for FF/UMEC/VI combination by the end of 2016

Innovus Pharmaceuticals updates on plans for OTC FlutiCare nasal spray

California-based Innovus Pharmaceuticals announced that it has signed a manufacturing agreement for its FlutiCare fluticasone propionate nasal spray in anticipation of FDA approval, which it expects in the 3rd quarter of 2016. No details were revealed. The company acquired rights to the nasal spray in February 2015; an ANDA for the OTC version had been filed by … [Read more...] about Innovus Pharmaceuticals updates on plans for OTC FlutiCare nasal spray

Teva says DCP for Braltus tiotropium DPI results in “positive conclusion”

According to Teva Pharmaceutical, a decentralized procedure for its Braltus tiotropium bromide DPI for the treatment of COPD has reached "a positive conclusion." The tiotropium formulation is delivered using the new Zonda inhaler, the company said. No additional information was released other than the company's statement that "National Marketing Authorizations and … [Read more...] about Teva says DCP for Braltus tiotropium DPI results in “positive conclusion”

Perrigo and Hikma get FDA approval for and launch generic fluticasone propionate nasal spray

Perrigo and Hikma subsidiary West-Ward Pharmaceuticals have launched an OTC fluticasone propionate nasal spray, a generic version of Flonase, in the US after receiving approval for the product from the FDA, the companies said. The nasal spray will be marketed under store brand names. Flonase was approved for over-the-counter sales in the US in 2014. Hikma … [Read more...] about Perrigo and Hikma get FDA approval for and launch generic fluticasone propionate nasal spray

FDA issues new draft guidance for developing COPD drugs

The FDA has issued a new draft guidance titled "Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment," a revision of a 2007 draft guidance with the same title. Among other changes, the 2016 revision includes an appendix regarding use of the St. George’s Respiratory Questionnaire (SGRQ) in COPD studies. In the Federal Register announcement, the … [Read more...] about FDA issues new draft guidance for developing COPD drugs