Inhaled insulin developer Aerami Therapeutics (formerly Dance Biopharm) has announced the appointment of Timm Crowder as Chief Operating Officer. Crowder, who was most recently Chief Operating Officer of Spyryx Biosciences, was a co-founder of DPI developer Oriel Therapeutics. Following Oriel's acquisition by Sandoz in 2010, Crowder held a series of manufacturing … [Read more...] about Timm Crowder named Chief Operating Officer of Aerami Therapeutics
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Nemera’s Safe’n’Spray wins Pharmapack 2020 innovation award
Drug delivery device maker Nemera said that its Safe’n’Spray concept intranasal device has won the "Best Innovation In Drug Delivery Device" Award at Pharmapack. In addition to being a connected device that allows for usage monitoring and analysis, the Safe’n’Spray utilizes electronic fingerprint identification and locking to control dosing of potent drugs, with the … [Read more...] about Nemera’s Safe’n’Spray wins Pharmapack 2020 innovation award
Koura announces clinical trial plans for Zephex 152a
Koura (formerly Mexichem Fluor) announced that the FDA has cleared the company's IND for Zephex HFA 152a MDI propellant, and the company plans to initiate clinical trials of the propellant this month. In December 2019, Chiesi announced that it intended to bring a Zephex 152a inhaler to market by the end of 2025. At DDL 2016, Koura presented data suggesting the … [Read more...] about Koura announces clinical trial plans for Zephex 152a
Verona Pharma appoints David Zaccardelli as President and CEO
Verona Pharma has announced the appointment of former United Therapeutics executive David Zaccardelli as President and CEO, succeeding Jan-Anders Karlsson, who is retiring. Zaccardelli was most recently President and CEO of Dova Pharmaceuticals, which was acquired by Sobi in November 2019. The company also announced the appointment of Mark W. Hahn as Chief Financial … [Read more...] about Verona Pharma appoints David Zaccardelli as President and CEO
CHMP recommends approval of Teva’s budesonide/formoterol DPI
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
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