According to Hovione, the United States Patent and Trademark Office (USPTO) has granted the company a patent for its XCAPs capsule-based dry powder inhaler. The European Patent Office granted the company a patent for the inhaler in September, 2013. Hovione VP Peter Villax, who is a co-inventor of the DPI, commented, “We give our customers an edge in speed of … [Read more...] about Hovione gets US patent for XCaps inhaler
News
PDUFA date for Afrezza now July 15, 2014
The FDA has extended the Prescription Drug User Fee Act (PDUFA) date for MannKind's Afrezza inhaled insulin by three months, according to MannKind. The original date was April 15, 2014; the new date is July 15, 2014. The agency's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommended approval of Afrezza on April 2, 2014. The delay was … [Read more...] about PDUFA date for Afrezza now July 15, 2014
FDA issues draft guidance for fentanyl citrate nasal spray
On April 2, 2014, the FDA issued a draft guidance for fentanyl citrate nasal spray. The guidance offers an in vitro option, saying, "If the test product is qualitatively (Q1) and quantitatively (Q2) the same as the reference product, then bioequivalence may be documented by an in vitro approach in lieu of an in vivo approach." If bioequivalence cannot be … [Read more...] about FDA issues draft guidance for fentanyl citrate nasal spray
Meda rejects Mylan offer
Swedish pharmaceutical company Meda has confirmed that Mylan approached the company with a takeover offer and that Meda rejected the offer. According to Meda, "All continued discussions between Meda and Mylan have been terminated without further actions." In June 2013, Meda denied that it was in talks to be acquired by Sun Pharmaceuticals. Meda's products … [Read more...] about Meda rejects Mylan offer
Recipharm begins trading on Stockholm stock exchange
Swedish CDMO Recipharm, which has a dedicated DPI manufacturing facility in the UK, has begun trading on the Stockholm stock exchange, according to NASDAQ OMX. Recipharm had announced the IPO in March 2014. Recipharm CEO Thomas Eldered said, “Today marks the beginning of a new phase in Recipharm’s life. We welcome all our new shareholders who have demonstrated their … [Read more...] about Recipharm begins trading on Stockholm stock exchange
Insmed announces management changes
In anticipation of the potential commercialization of its Arikayce inhaled liposomal amikacin, Insmed has announced a number of management changes designed to "better align the organization with the company's growth opportunities." Those changes are: Renu Gupta, currently Executive VP of Development and Chief Medical Officer, will become Special Advisor to the … [Read more...] about Insmed announces management changes
FDA announces funding opportunity for research on realistic mouth-throat models
The FDA has announced a funding opportunity for a research project titled "Development of Clinically Relevant In Vitro Performance Test for Generic OIDPs: Physiologically Relevant Models for Aerodynamic Particle Size Distribution Analysis." Two grants of $500,000 each are available. The stated goal of the project is "to investigate if realistic physical … [Read more...] about FDA announces funding opportunity for research on realistic mouth-throat models
FDA advisory committee votes in favor of Afrezza inhaled insulin
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted in favor of MannKind's Afrezza inhaled insulin for both Type 1 and Type 2 diabetes. The vote was 13-1 in agreement that the product is safe and effective for Type 1 diabetes, with 1 abstention; 14 -0 in agreement that it is safe and effective for Type 2 diabetes. MannKind Chairman and … [Read more...] about FDA advisory committee votes in favor of Afrezza inhaled insulin
GSK plans to make respiratory drugs more available in sub-Saharan Africa
As part of a planned five-year initiative to improve healthcare in Africa, GlaxoSmithKline has announced that it plans to make more of its existing drugs available in Africa and has specified the Ventolin albuterol inhaler as an example. The company's announcement also said that it would invest up to £100 million in its existing manufacturing facilities in Kenya and … [Read more...] about GSK plans to make respiratory drugs more available in sub-Saharan Africa
Skyepharma revenues up on increased Flutiform sales, looks to raise £112 million
Skyepharma revenues were up 25% in 2013, the company said, in large part due to increased sales of its Flutiform fluticasone/formoterol MDI. The company also announced that it will seek to raise £112 million through a firm placing and a placing and open offer of over 58,680,000 ordinary shares at a price of 191 pence. Skyepharma CEO Peter Grant commented, "2013 … [Read more...] about Skyepharma revenues up on increased Flutiform sales, looks to raise £112 million