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
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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
FDA advisory committee document raises questions about Afrezza efficacy, safety
Meeting documents for the upcoming April 1 meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) on MannKind's Afrezza inhaled insulin include questions about the efficacy of Afrezza compared to subcutaneous insulin and about data showing that use of the product reduces lung function over time. Discussion topics for the meeting … [Read more...] about FDA advisory committee document raises questions about Afrezza efficacy, safety
Summit Biosciences announces successful preapproval inspection for nasal spray
Summit Biosciences has announced the successful completion of an FDA preapproval inspection of its Lexington, KY manufacturing facility. The company, a spin-off of the University of Kentucky College of Pharmacy, said that the inspection is for a new nasal spray. In early 2011, Summit announced that it had received a federal grant for development of a synthetic THC … [Read more...] about Summit Biosciences announces successful preapproval inspection for nasal spray
Next Breath certified by ANVISA as Center for Pharmaceutical Equivalence
Contract research organization Next Breath has announced that it has been certified as a Center for Pharmaceutical Equivalence (EQFAR) by the Brazilian National Health Surveillance Agency (ANVISA) subsequent to a week-long audit of its quality systems by ANVISA conducted in November 2013. The certification means that Next Breath is now the only laboratory outside of … [Read more...] about Next Breath certified by ANVISA as Center for Pharmaceutical Equivalence