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.
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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
TFF says it will prioritize development of its tacrolimus DPI
TFF Pharmaceuticals says that it will prioritize development of TFF TAC inhaled dry powder tacrolimus for the prevention of lung transplant rejection after receiving positive data from an ongoing Phase 2 trial. The company will now de-prioritize development of TFF VORI inhaled dry powder voriconazole for the treatment of invasive pulmonary aspergillosis. According … [Read more...] about TFF says it will prioritize development of its tacrolimus DPI
RDD 2024 to cover the latest OINDP development trends
From May 5-9, RDD 2024 will welcome an international gathering of OINDP experts to the JW Marriott Starr Pass Resort and Spa in Tucson, AZ, which previously hosted RDD 2018. According to Richard Dalby of RDD Online, registration for the meeting so far has been strong, with a higher-than-usual contingent of delegates from outside of North America and Europe … [Read more...] about RDD 2024 to cover the latest OINDP development trends
AstraZeneca follows Boehringer Ingelheim in capping inhaler costs for some US patients
AstraZeneca has announced that it will "expand the savings programs for its entire US inhaled respiratory portfolio," capping costs at $35 per month for "eligible patients" as of June 1, 2024, while noting that "terms and conditions apply." Inhalers covered by the program include Airsupra albuterol / budesonide MDI, Bevespi Aerosphere glycopyrrolate / formoterol … [Read more...] about AstraZeneca follows Boehringer Ingelheim in capping inhaler costs for some US patients