Virpax Pharmaceuticals has announced the successful completion of a pre-IND meeting with the FDA regarding the company's NES100 intranasal enkephalin formulation for the management of acute and chronic pain. NES100 is a molecular envelope technology (MET) formulation licensed from Nanomerics and is delivered via a cartridge-based device. In January 2020, Virpax … [Read more...] about Virpax announces completion of pre-IND meeting for its intranasal enkephalin
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Neurelis launches Valtoco nasal spray in the US
Neurelis has announced the launch of Valtoco diazepam nasal spray for the treatment of seizure clusters in the US. The FDA approved Valtoco for the treatment of acute repetitive seizures in epilepsy patients aged 6 and older in January 2020. According to the company, patients can now obtain Valtoco through Maxor Specialty Pharmacy, which has already started filling … [Read more...] about Neurelis launches Valtoco nasal spray in the US
Altavant Sciences appoints Howard M. Lazarus as Chief Medical Officer
Sumitovant Biopharma subsidiary Altavant Sciences has announced the appointment of Howard M. Lazarus as Chief Medical Officer, a newly created position. Lazarus was most recently Medical Expert/Executive Director in Clinical Development and Medical Affairs at Boehringer Ingelheim and was previously Director, Medical Affairs for Pulmonary Hypertension at Gilead … [Read more...] about Altavant Sciences appoints Howard M. Lazarus as Chief Medical Officer
Hikma to distribute Ryaltris nasal spray in the US
Hikma Pharmaceuticals has signed an agreement with Glenmark Pharmaceuticals for exclusive US rights to Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis, the companies said. According to the announcement, the deal includes an upfront payment, milestone payments, and royalties; the amounts were not … [Read more...] about Hikma to distribute Ryaltris nasal spray in the US
EMA accepts GSK submission to expand use of Trelegy Ellipta to asthma
GSK and Innoviva have announced that the EMA accepted a regulatory submission to expand the use of Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI to add the treatment of asthma in adults as an indication. Trelegy Ellipta has been approved in Europe for the treatment of COPD since November 2017. A previous Type II variation application was approved in … [Read more...] about EMA accepts GSK submission to expand use of Trelegy Ellipta to asthma
Otitopic announces planned PK/PD study of its Asprihale aspirin DPI
Otitopic announced that it has held discussions with the FDA regarding a pivotal PK/PD study of its Asprihale aspirin dry powder inhaler and now expects to initiate the study in the fourth quarter of 2020. Results are expected by the end of 2021, the company said. Otitopic is developing Asprihale for the treatment of myocardial infarction and has indicated that it … [Read more...] about Otitopic announces planned PK/PD study of its Asprihale aspirin DPI
FDA approves Perrigo’s generic version of Teva’s ProAir albuterol MDI (updated)
The FDA has announced the approval of Perrigo's ANDA for a generic of Teva's ProAir HFA albuterol MDI for the treatment of asthma in patients 4 years old and older. Perrigo initially filed its ANDA for the generic version of ProAir HFA in 2012; Teva responded with a patent infringement suit. In 2014, the companies reached a settlement that would give Perrigo … [Read more...] about FDA approves Perrigo’s generic version of Teva’s ProAir albuterol MDI (updated)
Phase 3 trial of Tyvaso inhaled treprostinil in patients with PH-ILD meets primary endpoint
United Therapeutics has announced that the Phase 3 INCREASE study of Tyvaso treprostinil inhalation solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) met its primary endpoint, demonstrating statistically significant improvement in six-minute walk distance (6MWD). All secondary endpoints for the study were also … [Read more...] about Phase 3 trial of Tyvaso inhaled treprostinil in patients with PH-ILD meets primary endpoint
Teva’s ArmonAir Digihaler approved by the FDA
The FDA has approved Teva's ArmonAir Digihaler fluticasone propionate DPI for the treatment of asthma in patients aged 12 and older, the company said. ArmonAir Respiclick was approved for that indication in January 2017. Three doses were approved for twice daily inhalation: 55 mcg, 113 mcg and 232 mcg. The Digihaler device includes a built-in usage monitoring … [Read more...] about Teva’s ArmonAir Digihaler approved by the FDA
Grifols agrees to acquire all assets related to Aradigm’s inhaled ciprofloxacin programs
Aradigm Corporation, which filed for bankruptcy in February 2019, said that it will sell all of its assets related to Lipoquin inhaled ciprofloxacin, Apulmiq (Linhaliq) dual release inhaled ciprofloxacin, and other inhaled ciprofloxacin candidates to Grifols, subject to approval by the bankruptcy court. The deal also leaves Aradigm "free to accept higher and better … [Read more...] about Grifols agrees to acquire all assets related to Aradigm’s inhaled ciprofloxacin programs