Insys Therapeutics has announced the resignation of President and CEO Michael L. Babich and the appointment of John N. Kapoor to those positions, effective November 4, 2015. The company also named Daniel Brennan as Executive VP and COO. The effective date of the CEO change is the same day that CNBC aired an investigative report about Insys, which is under … [Read more...] about Insys Therapeutics announces management changes
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Discovery Labs provides update on Aerosurf development
Discovery Laboratories has provided an update on its clinical development program for Aerosurf aerosolized KL4 surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants. In March 2015, the company announced that it was restructuring to focus all its attention on Aerosurf. According to Discovery Labs, enrollment in a Phase 2a expansion … [Read more...] about Discovery Labs provides update on Aerosurf development
Acerus changes course on Tefina intranasal testosterone gel, says Endo “de-priotizing” Natesto
Acerus (formerly Trimel) has announced that it will pursue development of its Tefina nasal testosterone for the treatment of hypoactive sexual desire disorder (HSDD) instead of for female orgasmic disorder (FOD). In May 2014, the company announced positive results from a Phase 2 study of Tefina for FOD. The decision to switch course came after meeting with the FDA … [Read more...] about Acerus changes course on Tefina intranasal testosterone gel, says Endo “de-priotizing” Natesto
Alexza to reacquire US rights to Adasuve from Teva
Alexza Pharmaceuticals has announced that it plans to reacquire US rights for Adasuve loxapine inhalation powder from Teva Pharmaceuticals USA by January 1, 2016. According to the company, "Alexza and Teva are working on a transition agreement to continue product availability to patients and health care providers after the return of the rights to Alexza." Adasuve … [Read more...] about Alexza to reacquire US rights to Adasuve from Teva
FDA approves Utibron and Seebri Neohaler DPIs
Novartis has announced FDA approval for the Seebri Neohaler glycopyrrolate DPI and the Utibron Neohaler indacaterol/glycopyrrolate DPI for the treatment of COPD. According to the company, both inhalers should be available in the first quarter of 2016. The company's indacaterol monotherapy DPI, marketed in the US as Arcapta Neohaler, was approved by the FDA in … [Read more...] about FDA approves Utibron and Seebri Neohaler DPIs
AstraZeneca launches Duaklir Genuair in Canada
AstraZeneca Canada has announced the availability of the Duaklir Genuair aclidinium bromide/formoterol fumarate DPI in Canada for the treatment of COPD. Health Canada issued a Notice of Compliance for Duaklir Genuair on April 2, 2015. AstraZeneca acquired Canadian rights to Duaklir Genuair from Actavis in February 2015. In Europe, the inhaler was approved for the … [Read more...] about AstraZeneca launches Duaklir Genuair in Canada
GSK announces that Advair Diskus meets primary endpoint in safety study
GlaxoSmithKline has announced results from the 26-week AUSTRI postmarketing study comparing the safety of Advair Diskus fluticasone propionate/salmeterol DPI to fluticasone propionate monotherapy for the treatment of asthma. According to GSK, the study demonstrated that Advair Diskus was non-inferior to FP at three different dosage strengths for the risk of serious … [Read more...] about GSK announces that Advair Diskus meets primary endpoint in safety study
Glenmark makes deal with Celon to market fluticasone/salmeterol DPI in parts of Europe
Glenmark Pharmaceuticals announced that it has obtained semi-exclusive rights develop and market a generic fluticasone/salmeterol DPI in 15 European countries as part of an agreement with Polish pharmaceutical company Celon Pharma. The countries covered in the deal include the UK, Germany, Norway, Sweden, and Romania. Glenmark will pay an undisclosed amount up front, … [Read more...] about Glenmark makes deal with Celon to market fluticasone/salmeterol DPI in parts of Europe
Upcoming INTFG meeting will feature talk on nose-to-brain drug delivery
The business meeting of AAPS's Inhalation and Nasal Technology Focus Group (INTFG), which will take place on October 27 during the 2015 AAPS Annual Meeting in Orlando, FL, will include a talk by Next Breath Co-Founder and President Julie Suman. Suman will present an overview of "Nose to Brain Drug Delivery" that will include a discussion of the rationale for … [Read more...] about Upcoming INTFG meeting will feature talk on nose-to-brain drug delivery
Meda announces launch of Dymista nasal spray in Canada
Meda Pharmaceuticals in Canada has announced that Health Canada has approved Dymista azelastine hydrochloride/fluticasone propionate nasal spray for the treatment of moderate-to-severe seasonal allergic rhinitis for patients age 12 years old and older who do not achieve sufficient symptom relief with either antihistamines or intranasal corticosteroids. According … [Read more...] about Meda announces launch of Dymista nasal spray in Canada