Inhalation Asia 2017, which will take place September 13-15, has announced a change of venue from Hong Kong to Macau. The meeting will now take place on the campus of the University of Macau. Dr. Ying Zheng of the University of Macau will be one of Inhalation Asia's plenary speakers, giving a talk titled, "Inhalation Therapy of Traditional Chinese Medicine." Other … [Read more...] about Inhalation Asia 2017 relocates to Macau
News
Hikma gets CRL for its generic version of Advair Diskus
According to Vectura, its partner Hikma Pharmaceuticals has received a complete response letter from the FDA to its ANDA for VR315 fluticasone propionate/salmeterol DPI, a generic version of GSK's Advair Diskus. Vectura said that the CRL was categorized as "Major" and added, "Based on the initial assessment no material issues were raised regarding the substitutability … [Read more...] about Hikma gets CRL for its generic version of Advair Diskus
Savara to modify Phase 2/3 Molgradex trial to qualify as pivotal study in US
The IMPALA Phase 2/3 trial for Savara's Molgradex inhaled molgramostim for the treatment of autoimmune pulmonary alveolar proteinosis (PAP) will be modified in order to qualify as a pivotal study for a US regulatory submission, the company said. According to Savara, the FDA has provided guidance on increasing enrollment and changing endpoint hierarchy and analysis … [Read more...] about Savara to modify Phase 2/3 Molgradex trial to qualify as pivotal study in US
Chiesi to distribute Pharmaxis’s Bronchitol mannitol DPI in Italy
Pharmaxis has announced that Chiesi Farmaceutici will take over marketing and distribution of Bronchitol mannitol DPI in Italy. Bronchitol has been approved in the EU for the treatment of cystic fibrosis in patients 18 years old and older since 2012. In 2015, Pharmaxis and Chiesi announced an agreement for distribution rights to Bronchitol in the UK, Ireland, and … [Read more...] about Chiesi to distribute Pharmaxis’s Bronchitol mannitol DPI in Italy
Dalton Pharma Services announces development and manufacturing agreement with Arch Biopartners for AB569
Dalton Pharma Services will take responsibility for GMP preparation and filling into glass vials of Arch Biopartners' AB569 bactericidal inhalation solution for an upcoming Phase 1 trial, the companies have announced. Dalton will provide a range of services, including formulation development, method development and validation, and quality control release testing in … [Read more...] about Dalton Pharma Services announces development and manufacturing agreement with Arch Biopartners for AB569
Pulmatrix gets US patent covering PUR0200 tiotropium bromide formulation
Pulmatrix has announced the receipt of US patent No. 9,642,798, titled "Monovalent metal cation dry powders for inhalation," which covers its PUR0200 dry powder formulation of tiotropium bromide for the treatment of COPD. In July 2016, Pulmatrix announced positive Phase 1 results for PUR0200. The company has previously received a number of patents for its iSPERSE … [Read more...] about Pulmatrix gets US patent covering PUR0200 tiotropium bromide formulation
OptiNose raises $37 million to prepare for launch of OPN-375
According to intranasal drug developer OptiNose, the company has raised $37 million in a Series D financing round led by Fidelity Management and Research Company. The company said that it plans to use the money to prepare for the US launch of OPN-375 intranasal fluticasone propionate if approved. OptiNose submitted an NDA for OPN-375 for the treatment of nasal … [Read more...] about OptiNose raises $37 million to prepare for launch of OPN-375
Innovus Pharmaceuticals acquires US rights to fluticasone propionate nasal spray from West-Ward
Innovus Pharmaceuticals will launch a fluticasone propionate nasal spray under the brand name FlutiCare in the US by the end of 2017 after acquiring rights to the product from West-Ward Pharmaceuticals International Limited (WWPIL). The 50μg per spray FlutiCare is equivalent to GSK's Flonase, and the company said that it expects revenue from sales of the product in … [Read more...] about Innovus Pharmaceuticals acquires US rights to fluticasone propionate nasal spray from West-Ward
Savara receives US and Canadian patents for AeroVanc
The US Patent and Trademark Office has issued US Patent No. 9,572,774, titled "Dry Powder Vancomycin Compositions and Associated Methods," to inhaled drug developer Savara, Inc., the company said. In its statement, the company added, "This affords Savara important composition of matter protection for its AeroVanc program in the US, the largest market for the … [Read more...] about Savara receives US and Canadian patents for AeroVanc
Salford Lung Study data show increased effectiveness of Relvar Ellipta for asthma compared to usual care
GlaxoSmithKline and Innoviva have announced that data from the real world Salford Lung Study show that asthma patients using Relvar (Breo) Ellipa fluticasone furoate/vilanterol 100/25μg or 200/25μg had improved asthma control compared to those using their usual care, either ICS or ICS/LABA combinations. Relvar Ellipta was approved for the treatment of asthma in the … [Read more...] about Salford Lung Study data show increased effectiveness of Relvar Ellipta for asthma compared to usual care