The EMA has announced that its Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion regarding a marketing authorization application submitted by Teva Pharma B.V. for a budesonide/formoterol DPI for the treatment of asthma and COPD. The budesonide/formoterol DPI will be available in 160 µg/4.5 μg and 320 μg/9 μg strengths. The … [Read more...] about CHMP recommends approval of Teva’s budesonide/formoterol DPI
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Pulmazole inhaled itraconazole for ABPA gets Fast Track designation
Pulmatrix has announced that its Pulmazole (PUR1900) dry powder itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma has received Fast Track designation from the FDA. The company initiated a Phase 2 trial of Pulmazole for that indication in July 2019. Pulmatrix CEO Ted Raad said, "Patients with asthma-ABPA have … [Read more...] about Pulmazole inhaled itraconazole for ABPA gets Fast Track designation
Sandoz has discontinued its US generic Advair Diskus program
According to Novartis's 2019 annual report, Novartis subsidiary Sandoz has discontinued development of a generic version of the Advair Diskus fluticasone propionate/salmeterol DPI for the treatment of asthma and COPD for the US market as of January 2020. In October 2016, Sandoz filed a citizen petition with the FDA asking that the agency delay approval of any … [Read more...] about Sandoz has discontinued its US generic Advair Diskus program
Pulmotect says that preclinical testing of its PUL-042 inhaled immune stimulant shows potential against coronavirus infections
Pulmotect has announced that preclinical testing in mouse models has demonstated that a single dose of its PUL-042 inhaled immunostimulant, which is made up of Toll-like receptor ligands, could protect against infection by SARS-associated coronavirus and by MERS-associated coronavirus. Post-infection, PUL-042 also reduced the amount of virus in the lungs for both of … [Read more...] about Pulmotect says that preclinical testing of its PUL-042 inhaled immune stimulant shows potential against coronavirus infections
NICE declines to recommend Spravato nasal spray for the treatment of treatment-resistant depression
The UK's National Institute for Health and Care Excellence (NICE) has announced that it is not recommending the use of Janssen's Spravato esketamine nasal spray for the treatment of treatment-resistant depression due to concerns about clinical benefits and cost effectiveness. NICE will accept comments on the draft guidance through its web site until February 18, … [Read more...] about NICE declines to recommend Spravato nasal spray for the treatment of treatment-resistant depression
Hovione Technology announces the receipt of patent grants for its TwinMax DPI
According to Hovione Technology, the company has received patent grants for its TwinMax large dose DPI in a number of new territories. CEO Peter Villax said, “We achieved unchallenged patent grants for TwinMax in the United States, Europe, Japan, China and other territories. Our patented TwinMax will enable pharmaceutical partners to license them and to develop and … [Read more...] about Hovione Technology announces the receipt of patent grants for its TwinMax DPI
Liquidia submits NDA for LIQ861 treprostinil DPI for the treatment of PAH
Liquidia Technologies said that it has submitted a 505(b)(2) NDA for its LIQ861 inhaled dry powder treprostinil for the treatment of pulmonary arterial hypertension (PAH). The company announced in March 2019 that the Phase 3 INSPIRE trial of LIQ861 had met its primary endpoint. Liquidia CEO Neal Fowler commented, "The submission of the NDA for LIQ861 in the US is … [Read more...] about Liquidia submits NDA for LIQ861 treprostinil DPI for the treatment of PAH
CapMedic inhaler sensor gets FDA clearance
Cognita Labs has received FDA clearance for its CapMedic digital inhaler sensor for use with metered dose inhalers, the company said. The CapMedic device, which fits over the top of the MDI actuator and includes a built in spirometer, provides audio and visual instruction to patients to encourage correct inhaler use. The device also connects to a smartphone app, … [Read more...] about CapMedic inhaler sensor gets FDA clearance
Evoke announces commercialization deal with Eversana for Gimoti nasal spray
Days after announcing that the FDA has accepted its NDA resubmission for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis, Evoke Pharma said that the company has cancelled a previously announced commercialization deal with Novus Growth Partners and has signed a new 5-year deal with Eversana for commercialization and distribution of Gimoti … [Read more...] about Evoke announces commercialization deal with Eversana for Gimoti nasal spray
Baqsimi intranasal glucagon approved in Canada
Health Canada has approved Baqsimi intranasal dry powder glucagon for the treatment of severe hypoglycemia in patients with Type 1 or Type 2 diabetes, Eli Lilly Canada has announced. Baqsimi is now available in Canadian pharmacies with or without a prescription. Lilly acquired worldwide rights to the intranasal glucagon formulation from Locemia, which is based in … [Read more...] about Baqsimi intranasal glucagon approved in Canada