Lonza has announced that its Center of Excellence for respiratory formulations in Bend, OR, US can now offer kilogram scale spray drying of proteins for inhalation. With the latest expansion, the company is now able to serve customers who need clinical and/or commercial manufacturing for protein DPI formulations. Lonza Director, Respiratory Delivery, Kimberly … [Read more...] about Lonza now offers spray drying of proteins for inhalation
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Bespak spins out from Recipharm, will focus on LGWP transition
Bespak will go forward as a standalone CDMO after separating from former parent company Recipharm in order to focus on the transition to lower global warming potential (LGWP) propellants, the company announced. The new Bespak Group will be led by the former President of Recipharm's Advanced Delivery Systems Business Unit, Chris Hirst, as CEO, and former Teva CEO Kåre … [Read more...] about Bespak spins out from Recipharm, will focus on LGWP transition
Acorda files for Chapter 11 bankruptcy, will sell rights to Inbrija levodopa DPI and other assets
Acorda Therapeutics announced that it has filed to begin Chapter 11 bankruptcy proceedings and said that Merz Therapeutics will serve as a "stalking horse" bidder for Acorda's assets, including the rights to Inbrija inhaled dry powder levodopa. Other potential buyers can submit bids for the company's assets, with the court-supervised sale expected to be completed by … [Read more...] about Acorda files for Chapter 11 bankruptcy, will sell rights to Inbrija levodopa DPI and other assets
Vistagen initiates Phase 3 PALISADE-3 trial of fasedienol nasal spray in people with social anxiety disorder
Vistagen has announced the initiation of the Phase 3 PALISADE-3 public speaking trial of fasedienol (PH94B) nasal spray in people with social anxiety disorder. In August 2023, the company announced that the Phase 3 PALISADE-2 trial had met its primary endpoint although that study was closed early and enrolled only about 2/3 of the expected number of subjects. The … [Read more...] about Vistagen initiates Phase 3 PALISADE-3 trial of fasedienol nasal spray in people with social anxiety disorder
Liquidia says FDA is now free to issue final FDA approval of Yutrepia treprostinil DPI
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
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