OINDPnews


Aptar Pharma banner

News

Alexza announces PDUFA goal date for Staccato loxapine

After the FDA's acceptance of Alexza Pharmaceuticals's resubmitted NDA for Adasuve, the company has announced that the Prescription Drug User Fee Act (PDUFA) goal date will be February 4, 2012. Alexza had received a complete response letter for the Staccato inhaled loxapine product in October 2010 and resubmitted the application for approval of Adasuve as a treatment … [Read more...] about Alexza announces PDUFA goal date for Staccato loxapine

FDA approves mometasone nasal implant for chronic sinusitis

The FDA has approved a pre-market approval (PMA) application from Intersect ENT for its Propel mometasone furoate drug delivery implant for the treatment of chronic sinusitis. The dissolvable device is inserted in the sinus cavity during surgery and maintains the opening of the ethnoid sinus while it delivers the corticosteroid to the sinus lining. David W. … [Read more...] about FDA approves mometasone nasal implant for chronic sinusitis

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

NexBio reports clinical trial results for inhaled antiviral

NexBio, which was recently raided by the US Federal Bureau of Investigation (FBI), has announced results from a Phase 2 clinical trial of its Fludase inhaled antiviral for the treatment of influenza. According to the company, the dry powder formulation, also known as DAS181, demonstrated a significant reduction of viral load in patients infected with influenza. The … [Read more...] about NexBio reports clinical trial results for inhaled antiviral

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

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