The UK Medicines and Healthcare products Regulatory Agency (MHRA) is warning consumers against using a "fake tan nasal spray" marketed as Ubertan. According to the agency, the product comes in two versions, one of which contains "melanotan II, an unlicensed medicine with no evidence of safety, quality or that it works, and with unknown side effects" and another that … [Read more...] about MHRA issues warning on Ubertan nasal spray
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Clinical hold placed on Arikace trials
The US FDA has notified Insmed that it has placed a clinical hold on Insmed's trials of Arikace liposomal amikacin for inhalation. The ongoing Phase 3 program for the use of Arikace in cystic fibrosis (CF) patients with P. aeruginosa lung infections and patients with non-tuberculous mycobacterial (NTM) lung disease will be suspended pending review of additional data … [Read more...] about Clinical hold placed on Arikace trials
FDA accepts NDA submission for the Levadex dry powder inhaler
A goal date of March 26, 2012 has been set for the NDA submitted to the FDA for MAP Pharmaceuticals' Levadex inhaled dihydroergotamine (DHE) for the treatment of migraine in adults. The acceptance triggered a $20 million milestone payment to MAP from Allergan, which has partnered with MAP on development of the product in the US. Ownership of the NDA will be retained … [Read more...] about FDA accepts NDA submission for the Levadex dry powder inhaler
Sanofi licenses Flutiform in Mexico and in Central and South America
SkyePharma has announced that it has entered into a development, license, and marketing agreement for its Flutiform fluticasone and formoterol combination MDI with Sanofi in Mexico, Central America and South America. Sanofi will submit marketing authorization applications for Flutiform in the region, including in Brazil, Mexico, Venezuela, Argentina, and Colombia. The … [Read more...] about Sanofi licenses Flutiform in Mexico and in Central and South America
Asthma drug costs more than doubled for US children over a decade
According to the US Health and Human Service Department's Agency for Healthcare Research and Quality (AHRQ), the average annual cost of prescription drugs to treat a child with asthma in the US rose from $349 to $838 over a ten-year period. The AHRQ study looked at costs in 1997-98 compared to 2007-08. Over the same period, the average overall cost of treatment … [Read more...] about Asthma drug costs more than doubled for US children over a decade
Armstrong advises customers to stock up on Primatene Mist
Armstrong Pharmaceuticals is advising customers to stockpile its Primatene Mist epinephrine MDI before the FDA ban on CFC formulations takes effect on December 31, 2011. The company says that it is "actively finalizing its internal development" of an HFA formulation but warns that there is likely to be a period of time after the ban goes into effect before the new … [Read more...] about Armstrong advises customers to stock up on Primatene Mist
Almirall submits MAA for aclidinium bromide in Europe
According to Almirall, it has submitted a marketing authorization application to the European Medicines Agency (EMA) for its aclidinium bromide DPI for the treatment of COPD. Aclidinium bromide is a long-acting inhaled muscarinic antagonist; the dry powder formulation is delivered by the Genuair inhaler. Almirall and Forest Labs, which owns the US rights to the … [Read more...] about Almirall submits MAA for aclidinium bromide in Europe
Bend Research names Nightingale as president
Jim Nightingale has been promoted from Senior VP for Business Development and Strategic Alliances to President of drug development company Bend Research. Rod Ray is stepping down as President but will remain as CEO and chairman of the board. David Lyon, current VP of Research will assume the Business Development responsibilities. Until two years ago, Bend … [Read more...] about Bend Research names Nightingale as president
US sales of Cayston double
A small portion of Gilead's 11% increase in revenue for the second quarter of 2011 compared to the same quarter in 2010 is attributable to a 105% increase in the US sales of Cayston astreonam inhalation solution over that period. The company's revenues for the quarter totaled $2.14 billion. Sales of Cayston for the treatment of P. aeruginosa infections in cystic … [Read more...] about US sales of Cayston double
DDL and RDD abstract submission deadlines approaching
Abstract submission deadlines for the two largest scientific meetings of OINDP specialists are approaching rapidly. The 22nd Drug Delivery to the Lungs (DDL) meeting will take place December 7-9, 2011 in Edinburgh, UK; Respiratory Drug Delivery (RDD) 2012 will take place May 13-17, 2012 in Phoenix, AZ. Full abstracts for podium and poster submissions for DDL 22 … [Read more...] about DDL and RDD abstract submission deadlines approaching