OINDPnews


Copley Scientific banner

Business

Evoke announces modification of agreement with Mallinckrodt on Gimoti development

Evoke Pharma announced that an amendment of its agreement with Mallinckrodt allows for deferral of milestone payments due on acceptance of review of the company's NDA for Gimoti intranasal metoclopramide for the treatment of gastroparesis in women and on final approval. The agreement now allows for a single milestone payment that will be due a year after FDA approval … [Read more...] about Evoke announces modification of agreement with Mallinckrodt on Gimoti development

Windtree and Eleison Pharmaceuticals partner on potential development of inhaled lipid cisplatin

Windtree Therapeutics and Eleison Pharmaceuticals will jointly evaluate the feasibility of delivering Eleison's inhaled lipid cisplatin (ILC) for the treatment of lung cancer via Windtree's proprietary pulmonary aerosol delivery system (ADS), the companies said. A formulation of ILC incorporating Windtree's KL4 surfactant will also be considered. Eleison, which has … [Read more...] about Windtree and Eleison Pharmaceuticals partner on potential development of inhaled lipid cisplatin

Avillion says it has deal to co-develop Pearl’s PT027 for the treatment of asthma

UK-based Avillion announced that it has signed a deal with AstraZeneca subsidiary Pearl Therapeutics for development of Pearl's PT027 budesonide/albuterol MDI for the treatment of asthma. Avillion will finance clinical development and the regulatory submission. Avillion CEO Allison Jeynes-Ellis commented, “This new collaboration is another great example of how our … [Read more...] about Avillion says it has deal to co-develop Pearl’s PT027 for the treatment of asthma

Savara discontinues development of Aironite after Phase 2 trial fails to meet primary endpoint

Savara has announced that the Phase 2 INDIE study of Aironite sodium nitrite inhalation solution for the treatment of heart failure with preserved ejection fraction (HFpEF) failed meet its primary endpoint and, as a result, the company is discontinuing development of the product. Mast Therapeutics acquired Aironite when it acquired Aires Pharmaceuticals in 2014; … [Read more...] about Savara discontinues development of Aironite after Phase 2 trial fails to meet primary endpoint

Ventolin, Seretide Diskus/Accuhalers recalled in multiple countries

Less than a week after GSK Canada said that it had recalled a lot of Ventolin Diskus in Canada due to “a manufacturing issue that may result in a small number of Ventolin Diskus devices not delivering the full number of doses in the device,” the MHRA announced a recall of 2 lots of Ventolin Accuhaler and 1 lot of Seretide Accuhaler in the UK due to the same issue. … [Read more...] about Ventolin, Seretide Diskus/Accuhalers recalled in multiple countries

HCmed partners with Pharos to market the Deepro vibrating mesh nebulizer in Indonesia

HCmed has announced that a partnership with pharmaceutical company Pharos Indonesia has led to approval for its Deepro vibrating mesh nebulizer from the Indonesian National Drug and Food Control Agency (BPOM), and the companies will now launch the Deepro device in Indonesia. Earlier this year, HCmed announced that it had received a strategic investment from Vivo … [Read more...] about HCmed partners with Pharos to market the Deepro vibrating mesh nebulizer in Indonesia

Insmed gets additional US patent for ALIS amikacin liposome inhalation suspension

The US Patent and Trademark Office has issued US Patent Number 9,895,385, titled "Methods for treating pulmonary non-tuberculous mycobacterial infections" to Insmed Incorporated, the company said. According to Insmed, the patent is the 9th for ALIS and extends patent coverage for the formulation from January 2034 to May 2035. The patent covers the use of nebulized … [Read more...] about Insmed gets additional US patent for ALIS amikacin liposome inhalation suspension

Opiant Pharmaceuticals developing intranasal nalmefene for the treatment of opioid overdose

Opiant Pharmaceuticals has announced that, based on feedback from the FDA and positive data from a Phase I clinical study, the company plans to pursue a 505(b)(2) development path for its OPNT003 intranasal nalmefene for the treatment of opioid overdose. OPNT003 is formulated using Aegis Therapeutics' Intravail absorption enhancer, which Opiant licensed in 2017. … [Read more...] about Opiant Pharmaceuticals developing intranasal nalmefene for the treatment of opioid overdose