GlaxoSmithKline and Theravance have announced that a 12-week double-blind, parallel group Phase 3 study of their fluticasone furoate (FF)/vilanterol (VI) DPI (Breo/Relvar Ellipta) in almost 1,000 patients with moderate to severe asthma met its primary endpoint. According to the companies, both the 100/25mcg FF/VI and 200/25mcg FF/VI showed statistically significant … [Read more...] about Positive results for Phase 3 study of FF/VI for asthma
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Almirall announces reorganization
Spanish pharmaceutical company Almirall has issued a statement saying that the company will "reorganize" its European operations as a result of "economic driven decisions, made by country’s health authorities that have negatively affected the growth of those markets and the introduction and uptake of new products." The press release does not specify what the … [Read more...] about Almirall announces reorganization
Hovione adds to its DPI capsule filling capabilities
Hovione has announced that the addition of a MG2 FlexaLAB capsule filling machine will allow the company to expand its inhalation drug product development services. The FlexaLAB can fill up to 3,000 capsules per hour with 100% net weight unit verification and, according to the company, "is the last step in Hovione’s plan to offer development services in all quadrants … [Read more...] about Hovione adds to its DPI capsule filling capabilities
Study finds modest benefit of intranasal corticosteroids for acute sinusitis
A study by the Cochrane Acute Respiratory Infections Group examined data from four studies involving almost 2,000 patients with acute sinusitis and determined that the benefits of intranasal corticosteroids (INCS) are "modest but clinically important." According to the authors, the evidence is limited but "supports the use of INCS as a monotherapy or as an adjuvant … [Read more...] about Study finds modest benefit of intranasal corticosteroids for acute sinusitis
Gateway Analytical invites DDL 24 attendees to V.I.P. event
Going to DDL 24 in Edinburgh next week? Gateway Analytical is inviting meeting attendees to a V.I.P. event at The Scotch Whisky Experience on the evening of December 11. The event includes a tour and whisky tasting, canapes and cocktails, and a gift bag. Anyone planning to attend DDL 24 who would like to attend the Gateway event should RSVP by December 10. … [Read more...] about Gateway Analytical invites DDL 24 attendees to V.I.P. event
Positive results for Lightlake intranasal naloxone study
According to Lightlake Therapeutics, initial results from a two-week PK study of intranasal naloxone for the treatment of opioid overdose shows that the nasal spray gets naloxone into the bloodstream as fast as injection. The study, which began September 23, 2013, was conducted in conjunction with the National Institute on Drug Abuse (NIDA). Lightlake CFO Kevin … [Read more...] about Positive results for Lightlake intranasal naloxone study
Taiwan FDA withdraws marketing authorization for calcitonin nasal spray
Taiwan's FDA has canceled marketing authorizations for calcitonin nasal sprays effective December 1 2013, and the products must be recalled within two months. According to the China Post, calcitonin nasal spray was first licensed in Taiwan in 1990. The Taiwan FDA is the latest regulatory agency to act on concerns about cancer risks posed by calcitonin nasal … [Read more...] about Taiwan FDA withdraws marketing authorization for calcitonin nasal spray
Bespak gets DPI contract
According to Bespak parent company Consort Medical, Bespak will construct a new dedicated facility at it's King's Lynn, UK site in order to meet production demands after signing a contract to manufacture a proprietary dry powder inhaler. The multi-year contract relates to a development project known as DEV610 for "a global pharma company whose details remain … [Read more...] about Bespak gets DPI contract
Study finds out-of-hospital intranasal fentanyl safe and effective
A study by Danish researchers published online November 25, 2013 by the Annals of Emergency Medicine found that intranasal fentanyl administered by ambulance workers prior to delivery of patients to the hospital appeared to be safe and effective. The study involved over 900 patients, including adults and children older than 8, who were in severe pain. The patients … [Read more...] about Study finds out-of-hospital intranasal fentanyl safe and effective
Inhaled drug start-up Pulmocide gets £17 million in funding
Imperial Innovations Group has announced that it is contributing £4.25 million towards a total of £17 million ($27.5 million) in funding for a new inhaled drug discovery and development company called Pulmocide. Other investors in the consortium include SV Life Sciences, Fidelity Biosciences, and Johnson & Johnson Development Corporation. The new London-based … [Read more...] about Inhaled drug start-up Pulmocide gets £17 million in funding