Iliad Biotechnology has announced the appointment of Cheryl Keech as Chief Medical Officer and Executive VP of Clinical Research; she will be responsible for clinical studies of the company's pipeline products, including the BPZE1 live attenuated intranasal pertussis vaccine. The company said that a Phase 2b trial of BPZE1 has completed enrollment. Keech was most … [Read more...] about Iliad Biotechnologies appoints Cheryl Keech as Chief Medical Officer and Executive VP of Clinical Research
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Hovione Technology completes pilot scale manufacturing for Papillon DPI blisters
Hovione Technology said that the company has completed pilot-scale blister manufacturing and filling for its Papillon dry powder inhaler. The company announced in April 2019 that it had acquired the rights to the DPI from its inventor, Klaus-Dieter Beller. The Papillon DPI, which is formed from a single plastic part and is reusable, can hold doses of up to 50 mg … [Read more...] about Hovione Technology completes pilot scale manufacturing for Papillon DPI blisters
Recipharm to acquire Consort Medical
Swedish CDMO Recipharm has announced that it will acquire Consort Medical, the parent company of device maker Bespak and CDMO Aesica, in order to "Become a Leading Inhalation Company and Top Five Global CDMO Player." According to Recipharm, the companies have agreed on a cash offer of £505 million. In the past few years, Recipharm has aggressively expanded its … [Read more...] about Recipharm to acquire Consort Medical
Levo’s intranasal carbetocin for PWS gets Fast Track designation
Levo Therapeutics has announced that the FDA has granted Fast Track designation to its LV-101 intranasal carbetocin for the treatment of Prader-Willi syndrome (PWS). In December 2018, Levo said that it was initiating the CARE-PWS Phase 3 study of LV-101 for PWS; the company says that the study is currently enrolling participants. The company also said that it has … [Read more...] about Levo’s intranasal carbetocin for PWS gets Fast Track designation
Seelos gets Fast Track designation for its intranasal racemic ketamine
According to Seelos Therapeutics, the FDA has granted Fast Track designation to its SLS-002 intranasal racemic ketamine for the treatment of acute suicidal ideation and behavior in patients with major depressive disorder. The company also said that it expects data from a Phase 1 study of SLS-002 in early 2020. In October 2019, Seelos announced that it had amended … [Read more...] about Seelos gets Fast Track designation for its intranasal racemic ketamine
Savara appoints Badrul Chowdhury Chief Medical Officer
Savara has announced the appointment of Badrul Chowdhury, as Chief Medical Officer, a newly created position. From 2002-2018, Chowdhury was the Director of the FDA's Division of Pulmonary, Allergy, and Rheumatology Products, Center for Drug Evaluation and Research (CDER). Most recently, he was Senior VP, Chief Physician-Scientist for Respiratory, Inflammation, … [Read more...] about Savara appoints Badrul Chowdhury Chief Medical Officer
Biocorp announces deal with Vitrobio for manufacturing of intranasal product
French drug delivery device company Biocorp announced that it has entered into a 10-year strategic partnership with Vitrobio Pharma regarding manufacturing of a new intranasal polymeric product that the company says "acts as a barrier on the nasal surface and prevents contact with pollutants and allergens, while eliminating histamines and harmful proteins through … [Read more...] about Biocorp announces deal with Vitrobio for manufacturing of intranasal product
Aquestive files citizen petition asking FDA to delay approval of Valtoco nasal spray
On November 1, 2019, Aquestive Therapeutics filed a citizen petition asking the FDA to stay approval of a 505(b)(2) NDA submitted by Neurelis in September 2018 for Valtoco diazepam nasal spray for the treatment of cluster seizures in epilepsy. Aquestive, which is developing a diazepam buccal oral film for the treatment of breakthrough seizures, says the agency … [Read more...] about Aquestive files citizen petition asking FDA to delay approval of Valtoco nasal spray
Insmed announces appointment of new board member, promotions of two executives
Insmed Incorporated has announced the appointment of Clementia Pharmaceuticals President and CEO Clarissa Desjardins to its board of directors and the promotions of Roger Adsett to Chief Operating Officer and Drayton Wise to Senior VP, Head of United States. The company also recently announced the appointment of Martina Flammer as Chief Medical Officer and provided an … [Read more...] about Insmed announces appointment of new board member, promotions of two executives
Inhaler sensor company Adherium gets $1.1 million in new financing round
According to Adherium, the company has received $1.1 million in a second round of secured debt note financing, and the subscriber for this round is new strategic investor Trudell Medical Limited, parent company of respiratory device companies Trudell Medical International, Monaghan Medical, and NasoNeb. Adherium said that the funds would be used for working … [Read more...] about Inhaler sensor company Adherium gets $1.1 million in new financing round