According to the FDA's latest update on the ongoing acetylcysteine inhalation solution shortage, all of American Regent/Luitpold's product is still on back order due to "manufacturing delays," and the company is still unable to estimate a release date for any inhalation solution. The company's Shirley, NY facility was shut down in April 2011 over safety concerns. … [Read more...] about Latest update on acetylcysteine inhalation solution shortage
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Court upholds validity of Unigene’s patent for Fortical nasal spray
The United States Court of Appeals has upheld a patent for Fortical calcitonin nasal spray held by Unigene Laboratories. Fortical, a bioequivalent of Novartis's Miacalcin, is marketed in the US by Unigene subsidiary Upsher-Smith for the treatment of postmenopausal osteoporosis. The court denied an appeal by Apotex of a summary judgment by the New York federal court … [Read more...] about Court upholds validity of Unigene’s patent for Fortical nasal spray
Aegis Therapeutics gets patent for GLP-1 peptide analog formulations for intranasal delivery
Aegis Therapeutics has received US Patent No. 7,998,927 for stabilized formulations of GLP-1 peptide analogs that can be delivered by a variety of different routes, including intranasal. All currently available GLP-1 formulations, which can control blood sugar and affect weight, such as Lilly-Amylin's Byetta and Novo Nordisk's Victoza require once- or twice-daily … [Read more...] about Aegis Therapeutics gets patent for GLP-1 peptide analog formulations for intranasal delivery
Pulmatrix gets $14 million for inhaled COPD and CF therapy development
Massacheusetts biotech company Pulmatrix has secured $14 million in additional funding from its existing investors, including Polaris Venture Partners, 5AM Ventures, Arch Venture Partners, and Novartis Venture Fund, bringing its total to $60 million. Terry McGuire, General Partner of Polaris Venture Partners commented, “We believe that Pulmatrix’s iCALM products have … [Read more...] about Pulmatrix gets $14 million for inhaled COPD and CF therapy development
MAP Pharmaceuticals gets US patent for Levadex inhaled DHE
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
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
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