According to MannKind Corporation, it remains committed to gaining approval for its Afrezza inhaled insulin despite continuing requests from the FDA for additional data. The company announced that it is restructuring in order to focus on the Afrezza approval, resulting in a layoff of 41% of its workforce. MannKind's net loss for 2010 was more than $170 million. Read … [Read more...] about Mannkind cuts more than 40% of workforce
Business
Teva respiratory drug sales down slightly in 2010
According to Teva, its worldwide sales of respiratory drugs, including the Pro-Air albuterol and QVAR beclomethasone inhalers, were down 3% from 2009, to $875 million. Of that amount, $556 million is attributable to sales in the US, where ProAir has a nearly 50% market share and QVAR is the 2nd place inhaled ICS. Read the company's press release … [Read more...] about Teva respiratory drug sales down slightly in 2010
Altair Therapeutics is no more
Isis Pharmaceuticals has reportedly closed down Altair Therapeutics, which it had spun off in 2007 to develop AIR645, an inhaled IL-4 and IL-13 inhibitor for the treatment of asthma. The drug, which was the only one in Altair's pipeline, failed its latest trial in the fall of 2010. Altair had seven employees. Read an article. … [Read more...] about Altair Therapeutics is no more
Gateway Analytical grand opening postponed due to weather
A severe winter storm has necessitated postponement of Gateway Analytical's grand opening ceremony from February 1 to April 12. Gateway is a subsidiary of ChemImage and offers particle analysis services including ingredient-specific particle sizing for MDIs and nasal sprays. Read the company's press release. … [Read more...] about Gateway Analytical grand opening postponed due to weather
Allergan to co-promote Levadex with MAP
Assuming that MAP Pharmaceuticals' Levadex inhaled dihydroergotamine for the treatment of migraine receives FDA approval, Allergan will market the product to pain specialists and neurologists in the US. MAP will handle marketing to primary care physicians in the United States and will retain all rights outside the US. MAP plans to submit an NDA for Levadex by the … [Read more...] about Allergan to co-promote Levadex with MAP
CyDex acquired by Ligand Pharmaceuticals
California-based biotech company Ligand Pharmaceuticals has acquired CyDex Pharmaceuticals and its Captisol solubility-enhancing technology. CyDex's pipeline includes a Captisol-enhanced budesonide/azelastine nasal spray. Ligand will operate CyDex as a wholly-owned subsidiary. Read the company's press release. … [Read more...] about CyDex acquired by Ligand Pharmaceuticals
Dutch court rules against GSK in Advair patent case
A court in The Hague has ruled in favor of Sandoz and Hexal, both units of Novartis, agreeing that the Dutch portion of GSK's European patent for Advair is not valid. GSK may appeal the ruling. Read a Reuters article. … [Read more...] about Dutch court rules against GSK in Advair patent case
Alexza says it will resubmit AZ-004 NDA in July 2011
According to Alexza Pharmaceuticals, it plans to resubmit its NDA for AZ-004 (Staccato loxapine) for the treatment of agitation in schizophrenic patients in July 2011. The company received a complete response letter (CRL) for the product from the FDA in October 2010. The FDA CRL cited safety concerns due to decreases in FEV1 after inhalation of a dose. Read the … [Read more...] about Alexza says it will resubmit AZ-004 NDA in July 2011
Indian company gets patent for anti-emetic nasal spray
According to reports, Lincoln Pharmaceuticals of Ahmedabad, India has been awarded an Indian patent for a nasal formulation of ondansetron hydrochloride intended to prevent nausea and vomiting for chemotherapy patients. The company says that it will begin marketing the product in India within the next few months and intends to market it internationally in the … [Read more...] about Indian company gets patent for anti-emetic nasal spray
Dance and Aerogen developing inhaled insuin product
Aerogen has licensed its OnQ nebulizer technology to a San Francisco, California company, Dance Pharmaceuticals for development of a new inhaled insulin solution product. Dance founder John S. Patton was a co-founder of Inhale Therapeutics, which later became Nektar and developed Exubera inhaled insulin. Read the companies' press release. … [Read more...] about Dance and Aerogen developing inhaled insuin product