Sandoz has announced that it received marketing authorization for the AirFluSal Forspiro salmeterol/fluticasone DPI for the treatment of asthma and COPD from Sweden and Hungary. The company's version of Advair has also been approved by Denmark and Germany in the past month. Sweden approved both the 50-500µg and 50-250µg dosage forms, while Hungary approved only … [Read more...] about More approvals for AirFluSal Forspiro
News
Micro-Sphere and NanoMaterials Technology team up to provide development, manufacturing services
Swiss spray-drying specialist Micro-Sphere and Singapore-based NanoMaterials Technology (NMT) have announced a new technology partnership to provide development and manufacturing services. The companies say that Micro-Sphere will contribute its emulsification and spray drying technology to the partnership, and NMT will contribute its high gravity controlled … [Read more...] about Micro-Sphere and NanoMaterials Technology team up to provide development, manufacturing services
AirFluSal Forspiro gets German market authorization
Sandoz has received German marketing authorization for the AirFluSal Forspiro salmeterol/fluticasone DPI for the treatment of asthma and COPD, the company has announced. The German approval is for the 50/500 µg version of the inhaler. Denmark approved both the 50/250 µg and 50/500 µg versions of the product in December 2013. The German authorization triggers a $2 … [Read more...] about AirFluSal Forspiro gets German market authorization
Anoro Ellipta approved in Canada
GlaxoSmithKline and Theravance have announced that Canadian regulators approved the Anoro Ellipta umeclidinium/vilanterol DPI for the treatment of COPD on December 23, 2013, shortly after the US FDA approved the product. The dosage approved for Canada is 62.5/25mcg. GSK Canada President Paul Lirette commented, “The market authorization of Anoro Ellipta in Canada … [Read more...] about Anoro Ellipta approved in Canada
FDA committee review of Afrezza tentatively set for April 1
MannKind Corporation has announced that a meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee for a review of the company's NDA for Afrezza insulin inhalation powder has been scheduled tentatively for April 1, 2014. The FDA set a PDUFA date of April 15, 2014 for Afrezza after MannKind resubmitted its NDA for the product in October 2013. … [Read more...] about FDA committee review of Afrezza tentatively set for April 1
FDA advisory committees to discuss Primatene HFA
The FDA's Nonprescription Drugs Advisory Committee and Pulmonary Allergy Drugs Advisory Committee (PADAC) will meet on February 25, 2014 to consider a new drug application submitted by Armstrong Pharmaceuticals for an OTC epinephrine inhalation aerosol for the treatment of mild asthma. Armstrong, which is owned by Amphastar, marketed the Primatene Mist OTC epinephrine … [Read more...] about FDA advisory committees to discuss Primatene HFA
Iliad Biotechnologies to collaborate with French organizations on intranasal pertussis vaccine
Iliad Biotechnologies has licensed technology from Institut Pasteur de Lille, Inserm, National University of Singapore, and National University of Ireland Maynooth related to a live attenuated Bordetella pertussis vaccine, and the company says that it will work with the French National Institute of Health and Medical Research's subsidiary Inserm Transfert and Institut … [Read more...] about Iliad Biotechnologies to collaborate with French organizations on intranasal pertussis vaccine
Civitas Therapeutics appoints Timothy S. Nelson as Chairman of the Board
Civitas Therapeutics has announced the appointment of former MAP Pharmaceuticals CEO Timothy S. Nelson as Chairman of the board of directors. Nelson commented, “Civitas has a highly-validated drug inhalation platform, a potentially transformative Parkinson’s therapy with important upcoming clinical data and a management team with an exceptional record of … [Read more...] about Civitas Therapeutics appoints Timothy S. Nelson as Chairman of the Board
Forest Laboratories acquires Aptalis
Forest Laboratories has agreed to pay $2.9 billion cash for Aeroquin developer Aptalis. Aeroquin inhaled levofloxacin for the treatment of P. aeruginosa infections in CF patients, which is in Phase 3 development, was acquired by Axcan when it acquired Mpex in 2011. Axcan and Eurand Pharmaceuticals later merged and renamed the combined company Aptalis in … [Read more...] about Forest Laboratories acquires Aptalis
Philips acquires nebulizer technology from Aerogen
Aerogen and Philips have announced an agreement that "includes the acquisition of select assets solely related to Aerogen’s home-care business" by Philips. The announcement appears to refer to Aerogen's Aeroneb Go vibrating mesh nebulizer. Philips made an undisclosed upfront payment and will make royalty payments "based on exploitation of the licensed technology." … [Read more...] about Philips acquires nebulizer technology from Aerogen