OptiNose has won the Oslo regional competition of the DnB NOR Innovation Award for its nasal drug delivery technology, and the company will compete in the Norwegian national competition in September. The regional award includes a prize of 200,000 NOK (~$36,000), and the national prize is 1 million NOK. The competition is sponsored by the Norwegian bank … [Read more...] about OptiNose wins innovation award for nasal delivery technology
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Shortage of acetylcysteine inhalation solution
The FDA has announced a shortage of acetylcysteine inhalation solution in the US due to increased demand and manufacturing delays. Acetylcysteine is a mucolytic agent. According to the FDA web site, two manufacturers, Hospira and Roxanne Laboratories are experiencing shortages of 200 mg/ml vials as a result of increased demand and expect to release new product by … [Read more...] about Shortage of acetylcysteine inhalation solution
Takeda confirms Nycomed acquisition
One day after issuing a denial (for the second time) regarding rumors of a deal for Nycomed, Takeda has confirmed its acquisition of the Swiss company for €9.6 billion (~$13.7 billion). The deal does not include Nycomed's US dermatology business, which will be spun off. Yasuchika Hasegawa, President & CEO of Takeda, said: “Takeda is committed to transforming our … [Read more...] about Takeda confirms Nycomed acquisition
Daiichi-Sankyo and Regency launch Sprix nasal spray
Regency Therapeutics, a division of Luitpold Pharmaceuticals, and Daiichi-Sankyo, Inc. have announced the launch of Sprix ketorolac tromethamine nasal spray "for the short-term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level." The US FDA approved Sprix in May 2010. In December 2010, Luitpold, a subsidiary of … [Read more...] about Daiichi-Sankyo and Regency launch Sprix nasal spray
GSK and AstraZeneca collaborate on research center
GSK and AstraZeneca have announced that the two companies, along with the University of Manchester, are working together to create the Manchester Collaborative Centre for Inflammation Research (MCCIR) to facilitate translational research in inflammatory diseases, including COPD and asthma. The center will recruit scientists in time to open the new facility at the … [Read more...] about GSK and AstraZeneca collaborate on research center
Takeda reportedly pursuing Nycomed
According to reports, Takeda Pharmaceutical is looking to buy Swiss pharma company Nycomed, which manufactures several OINDPs, including the Alvesco ciclesonide MDI and Omnaris ciclesonide nasal spray. Nycomed is also developing a ciclesonide HFA nasal aerosol in partnership with Sunovion (formerly Sepracor); that product is currently in Phase 3. Takeda is … [Read more...] about Takeda reportedly pursuing Nycomed
MannKind reveals details of latest FDA review meeting
Five days after its end of review meeting with the FDA on May 4 regarding its Afrezza inhaled insulin, MannKind Corporation held a conference call to update its progress and financial situation. During the call, Alfred Mann characterized the meeting as "positive and collaborative, resulting in a redirection of the Type 2 trial that should enable us to support use of … [Read more...] about MannKind reveals details of latest FDA review meeting
Hovione announces successful GMP inspections
Over the past 8 months, says API developer and manufacturer Hovione, its facilities have undergone a total of 6 inspections by the US FDA, the Japanese PMDA, and the Portuguese authorities. Pre-approval inspections for 2 new products for customer synthesis, and for existing molecules used in new formulations, took place at the company's facilities in New Jersey, … [Read more...] about Hovione announces successful GMP inspections
Pfizer returns rights to Rigel’s inhaled syk inhibitor
Rigel Pharmaceuticals says it will assume development responsibilities for R343, an inhaled syk inhibitor for the treatment of allergic asthma after Pfizer returned all rights to the program. Pfizer had licensed R343, along with other inhaled syk inhibitors, from Rigel in 2005. R343 works by binding to syk, a protein tyrosine kinase in mast cells involved in IgE … [Read more...] about Pfizer returns rights to Rigel’s inhaled syk inhibitor
GSK makes additional investment in Theravance
According to reports, GlaxoSmithKline has invested an additional $6.7 million in Theravance, its partner in developing a number of inhaled asthma and COPD drugs. The purchase of common stock gives GSK approximately 19% of Theravance's outstanding shares. GSK and Theravance have worked together on inhalation product development since 2002 and have their Relovair … [Read more...] about GSK makes additional investment in Theravance