Liquidia Corporation announced today that the expiration of United Therapeutics' new clinical investigation exclusivity for the use of Tyvaso treprostinil to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD) on March 31, 2024, along with court rulings on March 28 and March 29, has cleared the way for the FDA to issue final … [Read more...] about Liquidia says FDA is now free to issue final FDA approval of Yutrepia treprostinil DPI
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Teva partners with Launch Therapeutics on development of TEV-‘248 fluticasone / albuterol DPI, with funding from Abingworth
Launch Therapeutics will take over management of clinical trials of Teva’s TEV-‘248 fluticasone / albuterol (salbutamol) DPI for the treatment of asthma, the companies have announced. In addition, Carlyle Group subsidiary Abingworth, a Launch Therapeutics backer, will invest up to $150 million toward funding continued development of TEV-'248 and would receive … [Read more...] about Teva partners with Launch Therapeutics on development of TEV-‘248 fluticasone / albuterol DPI, with funding from Abingworth
Milestone Pharmaceuticals resubmits NDA for etripamil nasal spray for the treatment of PSVT
Milestone Pharmaceuticals announced that it has resubmitted its NDA for etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). The FDA had issued a Refuse to File letter in December 2023 in response to the NDA, which the company had submitted in October 2023. In February 2024, Milestone announced that it had held a Type A meeting … [Read more...] about Milestone Pharmaceuticals resubmits NDA for etripamil nasal spray for the treatment of PSVT
Beckley announces data from Phase 2a trial of BPL-003 intranasal dry powder synthetic 5-MeO-DMT in people with treatment resistant depression.
Beckley Psytech says that more than half of people with moderate-to-severe treatment resistant depression who received a single 10mg dose of BPL-003 intranasal synthetic dry powder 5-MeO-DMT (mebufotenin) in a Phase 2a trial experienced a reduction in depressive symptoms and almost half remained in remission at day 85 post dose. The Phase 2a study, which was initiated … [Read more...] about Beckley announces data from Phase 2a trial of BPL-003 intranasal dry powder synthetic 5-MeO-DMT in people with treatment resistant depression.
FTC tells court hearing Teva’s patent infringement case against Amneal that Teva patents listed for ProAir HFA should be de-listed
The US Federal Trade Commission (FTC) recently filed an amicus brief in a patent infringement case filed by Teva against Amneal after Amneal submitted an ANDA for a generic version of Teva's ProAir HFA albuterol MDI in July 2023. In the brief, the FTC contends that the court should grant Amneal's motion to force device and dose counter patents asserted by Teva to be … [Read more...] about FTC tells court hearing Teva’s patent infringement case against Amneal that Teva patents listed for ProAir HFA should be de-listed
Marinomed announces deals for Carragelose nasal sprays in Hungary and in Gulf countries
Marinomed Biotech has announced a new agreement with VitaPlus for distribution of one of Marionomed's Carragelose nasal sprays in Hungary and another agreement with GAIA Healthcare for marketing of two Carragelose nasal sprays in the Gulf region. According to the announcement, VitaPlus could launch the nasal spray by the end of this year, and GAIA will be submitting … [Read more...] about Marinomed announces deals for Carragelose nasal sprays in Hungary and in Gulf countries
Intravacc announces data from Phase 1 study of Avacc 10 intranasal SARS-CoV-2 vaccine as a booster
Intravacc has announced that a Phase 1 study of Avacc 10 intranasal vaccine as a booster against SARS-CoV-2 induced a mucosal response in subjects who received the higher of two doses tested, and the vaccine was well tolerated. The company announced in November 2022 that it was initiating the Phase 1 study of Avacc 10. According to Intravacc, the study enrolled 36 … [Read more...] about Intravacc announces data from Phase 1 study of Avacc 10 intranasal SARS-CoV-2 vaccine as a booster
Tonix gets Rare Pediatric Disease Designation for TNX-2900 intranasal potentiated oxytocin for PWS
According to Tonix Pharmaceuticals, the FDA has granted Rare Pediatric Disease Designation to TNX-2900 intranasal potentiated oxytocin for the treatment of Prader-Willi syndrome (PWS) in children and adolescents. Tonix licensed TNX-2900 from the French National Institute of Health and Medical Research (Inserm) in February 2021, and the FDA granted orphan drug … [Read more...] about Tonix gets Rare Pediatric Disease Designation for TNX-2900 intranasal potentiated oxytocin for PWS
Blue Lake announces preliminary data from Phase 1/2a trial of BLB201 intranasal RSV vaccine in young children
Blue Lake Biotechnology has announced initial results from a Phase 1/2a clinical trial of its BLB201 intranasal vaccine against severe respiratory syncytial virus disease in children aged 8 months to 59 months with or without prior RSV infection. The company has previously announced results from a Phase 1 trial BLB201 in adults aged 18-59 and 60-75. In 2022, the FDA … [Read more...] about Blue Lake announces preliminary data from Phase 1/2a trial of BLB201 intranasal RSV vaccine in young children
Inhalon reports data from Phase 1b trial of IN-006 inhaled regdanvimab
Inhalon Biopharma announced that a Phase 1b study that evaluated the company's IN-006 nebulized regdanvimab in healthy volunteers demonstrated successful delivery of the inhaled antibodies throughout the respiratory tract, achieving uniform distribution and significantly higher concentrations than for intravenous regdanvimab. The study was funded by the United States … [Read more...] about Inhalon reports data from Phase 1b trial of IN-006 inhaled regdanvimab