The United States Patent and Trademark Office (USPTO) has issued US Patent No. 7,994,197, titled "Method of Therapeutic Administration of DHE to Enable Rapid Relief of Migraine while Minimizing Side Effect Profile," to MAP Pharmaceuticals for its Levadex inhaled dihydroergotamine (DHE) technology. The patent will expire in 2028. "We have designed LEVADEX to … [Read more...] about MAP Pharmaceuticals gets US patent for Levadex inhaled DHE
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MannKind and FDA agree on design of new inhaled insulin trials
After a meeting with the FDA, MannKind Corporation has announced that the company and the agency have confirmed protocols for new efficacy and safety studies of Afrezza inhaled insulin. The original studies of Afrezza were conducted with MedTone inhaler, and in May, the FDA asked MannKind to conduct new trials with the new Dreamboat inhaler in patients with type 1 … [Read more...] about MannKind and FDA agree on design of new inhaled insulin trials
Akela discontinues inhaled fentanyl development program
Akela Pharma is looking for a buyer for its Taifun fentanyl development program after Teikoku Seiyaku returned Japanese rights to the product. The dry powder inhaler (DPI) was being developed for the treatment of breakthrough pain in cancer patients. Akela is also in negotiations with another development partner, Janssen Pharmaceutica, for the return of the remaining … [Read more...] about Akela discontinues inhaled fentanyl development program
MAP hires Frederick Graff to lead launch of inhaled migraine drug
MAP Pharmaceuticals has hired Frederick H. Graff as VP, Commercial Operations, a position newly created in anticipation of a potential launch of the company's Levadex inhaled dihydroergotamine (DHE) for the treatment of migraine. Graff was previously Senior VP of Sales at Sepracor, where he led the launch of Xopenex levalbuterol inhalation solution. The announcement … [Read more...] about MAP hires Frederick Graff to lead launch of inhaled migraine drug
FDA accepts NDA for Teva HFA “dry” nasal spray
The US FDA has accepted the new drug application (NDA) filed by Teva on May 24, 2011 for its beclomethasone dipropionate (BDP) hydrofluoroalkane nasal spray for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). The BDP Nasal HFA spray uses the same formulation as Teva's Qvar inhalation aerosol, an inhaled corticosteroid (ICS) … [Read more...] about FDA accepts NDA for Teva HFA “dry” nasal spray
FBI raids developer of inhaled dry powder vaccine
According to news reports, the US Federal Bureau of Investigation (FBI) has raided the San Diego, California headquarters of vaccine developer NexBio and removed papers. FBI agent Darrell Foxworth is quoted as saying that the search warrant was in regard to " an ongoing investigation involving violations of criminal law." No arrests were reported. A local … [Read more...] about FBI raids developer of inhaled dry powder vaccine
Vectura announces additional licensing agreement for VR315
Two days after announcing that it had licensed VR315 in the US to an undisclosed pharmaceutical company, Vectura announced that Sandoz has licensed the product in the rest of the world. Sandoz already has an existing agreement with Vectura to market the DPI product in Europe. VR315, delivered by the Gyrohaler dry powder inhaler, is a fixed dose combination product for … [Read more...] about Vectura announces additional licensing agreement for VR315
Nycomed and Orion to co-market Easyhaler DPI products for asthma and COPD
Finnish pharmaceutical company Orion Corporation will co-market combination products delivered by its Easyhaler dry powder inhaler with Nycomed. The agreement covers major European countries, the Middle East, and North Africa. Orion will manufacture the products and will maintain exclusive rights in the UK, Eastern Europe, and the Nordic countries. Each company will … [Read more...] about Nycomed and Orion to co-market Easyhaler DPI products for asthma and COPD
NIH-developed antigen licensed for intranasal RSV vaccine
University of Michigan spin-off NanoBio has licensed a novel respiratory syncytial virus (RSV) from the US National Institutes of Health (NIH). NIH developed the antigen using proprietary technology. No approved vaccine for RSV currently exists; several previous RSV vaccine candidates have failed after they led to advanced respiratory disease. “We are very pleased … [Read more...] about NIH-developed antigen licensed for intranasal RSV vaccine
Undisclosed pharmaceutical company licenses Vectura generic DPI in US
Vectura is not saying which international pharmaceutical company's US division has entered into a "collaboration, development, and license agreement" for the VR315 dry powder inhaler. VR315 is a fixed dose combination therapy for asthma and COPD, delivered using the Gyrohaler DPI. The new partner will develop, manufacture, and commercialize the product in the US in … [Read more...] about Undisclosed pharmaceutical company licenses Vectura generic DPI in US