Impax Specialty Pharma has received approval from the FDA to market Zomig zolmitriptan nasal spray for the treatment of migraine in patients 12-17 years of age, the company says. Impax acquired the US rights to Zomig nasal spray from AstraZeneca in 2012. Impax Laboratories President and CEO Fred Wilkinson commented, "Treatment options have been limited for … [Read more...] about FDA approves Zomig nasal spray for pediatric patients
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Pulmatrix announces financing, development deal with Mylan, new lead candidate
Pulmatrix has issued a series of announcements regarding financing and its trading status on the NASDAQ exchange, a development deal for its PUR0200 inhaled COPD drug, and a new DPI it is developing, using its iSPERSE dry powder technology, for the treatment of pulmonary fungal infections in cystic fibrosis patients. Earlier this year, the company announced that it … [Read more...] about Pulmatrix announces financing, development deal with Mylan, new lead candidate
Study shows ICS treatment failures increase with age
A study published online June 11 2015 in the American Journal of Respiratory and Critical Care Medicine showed that asthma patients over 30 years of age who were using inhaled corticosteroids experienced a greater proportion of treatment failures than younger patients. Data from 10 clinical trials between 1993 and 2003 gathered by the Asthma Clinical Research … [Read more...] about Study shows ICS treatment failures increase with age
United Therapeutics says it will defend Tyvaso patents
According to United Therapeutics, the company has received notice that Watson Laboratories, a subsidiary of Allergan, has submitted an Abbreviated New Drug Application (ANDA) for a generic version of United Therapeutics' Tyvaso treprostinil inhalation solution. The notice letter cites three patents, US Patent Nos. 6,521,212; 6,756,033; and 8,497,393 as invalid … [Read more...] about United Therapeutics says it will defend Tyvaso patents
Milestone raises $17 million for Phase 2 development of intranasal calcium channel antagonist
Milestone Pharmaceuticals has raised $17 million in a Series B financing round, the company said. According to the company, it will use the money for Phase 2 clinical development of MSP-2017, its intranasal calcium channel antagonist for the treatment of paroxysmal supraventricular tachycardia (PSVT). In November 2014, Milestone announced positive Phase 1 results … [Read more...] about Milestone raises $17 million for Phase 2 development of intranasal calcium channel antagonist
AmpliPhi study demonstrates viability of bacteriophages after nebulization
AmpliPhi BioSciences has announced that a study performed in conjunction with the Royal Brompton Hospital and Imperial College, UK showed that a variety of bacteriophages remain viable against P. aeruginosa after nebulization. Three different commercially available nebulizers were used to test four different bacteriophages. Earlier this year, AmpliPhi announced … [Read more...] about AmpliPhi study demonstrates viability of bacteriophages after nebulization
VARI partners with Nativa on MDIs
Russian pharmaceutical company Nativa announced recently that it has partnered with Italian metering valve manufacturer VARI, a subsidiary of the Lindal Group, for development of metered dose inhaler products. The announcement said that the two companies signed an agreement at CPhI Russia 2015, which took place in April. According to the company's web site, Nativa … [Read more...] about VARI partners with Nativa on MDIs
Mylan launches Sirdupla salmeterol/fluticasone MDI in the UK
Mylan has launched the Sirdupla salmeterol xinafoate/fluticasone propionate MDI, its bioequivalent version of GlaxoSmithKline's Seretide (Advair) Evohaler, for the treatment of asthma in the UK, the company announced. The product, which is being marketed in 125/25 mcg and 250/25 mcg versions, is manufactured by 3M Drug Delivery Systems. Mylan President Rajiv Malik … [Read more...] about Mylan launches Sirdupla salmeterol/fluticasone MDI in the UK
Adapt Pharma initiates rolling NDA submission for intranasal naloxone
Adapt Pharma has initiated a rolling NDA submission for intranasal naloxone for the treatment of opioid overdose, the company said. Adapt licensed the intranasal naloxone formulation from Lightlake Therapeutics in December 2014 and received Fast Track Designation for the product from the FDA in February 2015. Lightlake CEO Roger Crystal said, "This is a very … [Read more...] about Adapt Pharma initiates rolling NDA submission for intranasal naloxone
Kitabis Pak wins American Package Design Award
PARI Respiratory Equipment has announced that its Kitabis Pak, tobramycin inhalation solution packaged with a PARI LC Plus nebulizer for the treatment of cystic fibrosis, has won a 2015 American Package Design Award, presented by Graphic Design USA. The FDA approved Kitabis Pak in December 2014 and rated the product as a therapeutic equivalent of TOBI in March … [Read more...] about Kitabis Pak wins American Package Design Award