Avanir Pharmaceuticals, which just received a complete response letter from the FDA for its AVP-825 intranasal sumatriptan powder, has announced that it will be acquired by Otsuka Pharmaceutical for approximately $3.5 billion. Avanir will become an independent subsidiary of Otsuka America. Otsuka Pharmaceutical President and Representative Director Taro Iwamoto … [Read more...] about Otsuka Pharmaceuticals to acquire Avanir
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Skyepharma announces launches in Spain, Italy, and Japan
Skyepharma has announced that Mundipharma has launched the Flutiform fluticasone/formoterol MDI for the treatment of asthma in Spain, triggering a milestone payment of €2.0 million. In addition, Mundipharma marketing partner Zambon Italia has now launched the same product in Italy under the brand name Abriff. Mundipharma Italy has been marketing the inhaler as … [Read more...] about Skyepharma announces launches in Spain, Italy, and Japan
Avanir gets Complete Response Letter for intranasal sumatriptan
According to Avanir Pharmaceuticals, it has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for AVP-825 intranasal sumatriptan for the treatment of migraine. The company had recently warned that its NDA was unlikely to be approved by the PDUFA date due to FDA concerns about human factors issues. In the CRL, "the FDA … [Read more...] about Avanir gets Complete Response Letter for intranasal sumatriptan
Verona Pharma names David Ebsworth as Non-Executive Chairman of the Board of Directors
Respiratory drug developer Verona Pharma has named former Galenica CEO David Ebsworth as Non-Executive Chairman of the Board of Directors. Ebsworth succeeds Clive Page, who founded the company in 2006. The company's lead product, RPL554, is an inhaled PDE3/PDE4 inhibitor being developed for the treatment of asthma, COPD, and cystic fibrosis. In September 2014, … [Read more...] about Verona Pharma names David Ebsworth as Non-Executive Chairman of the Board of Directors
QIDP designation for two Bayer inhaled antibiotics
According to Bayer, its Amikacin Inhale inhalation solution and its ciprofloxacin DPI have both been granted qualified infectious disease product (QIDP) designation by the FDA. Both products are currently in Phase 3 development. Bayer HealthCare Pharmaceuticals VP and Head Dario Mirski commented, "We welcome the QIDP designation for Ciprofloxacin DPI and Amikacin … [Read more...] about QIDP designation for two Bayer inhaled antibiotics
Positive Phase 1 results for Milestone’s intranasal calcium channel antagonist
Milestone Pharmaceuticals has announced that a Phase 1 clinical trial of an intranasal formulation of its MSP-2017 calcium channel antagonist for possible treatment of paroxysmal supraventricular tachycardia (PSVT) showed that the drug has a rapid onset, along with other promising PK properties, and was well tolerated at doses up to 140 mg. The company said that it … [Read more...] about Positive Phase 1 results for Milestone’s intranasal calcium channel antagonist
Endo acquires rights to Trimel’s intranasal testosterone
Endo International has acquired exclusive US and Mexican rights to Trimel BioPharma's Natesto testosterone nasal gel, which was approved by the the FDA in May 2014 as a replacement treatment for men with low levels of endogenous testosterone. Endo is paying $25 million up front plus potential milestone payments. In addition, Endo will manufacture and supply the … [Read more...] about Endo acquires rights to Trimel’s intranasal testosterone
Duaklir Genuair gets European marketing authorization
According to AstraZeneca, the European Commission has approved the Duaklir Genuair aclidinium bromide/formoterol fumarate DPI for the treatment of COPD. The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of the product in September 2014, and AstraZeneca acquired the rights to commercialize the inhaler in the EU when it acquired … [Read more...] about Duaklir Genuair gets European marketing authorization
Two more approvals for AirFluSal Forspiro
According to Sandoz, Ireland and the Czech Republic have approved marketing applications for the AirFluSal Forspiro salmeterol/fluticasone DPI in 50-250 and 50-500 µg dosage forms for the treatment of asthma and/or COPD. The Czech approval triggers a €1.5 million milestone payment from Sandoz to Vectura. Sandoz Head of Global Respiratory Jan-Torsten Tews said, “We … [Read more...] about Two more approvals for AirFluSal Forspiro
GSK Australia to add Ventolin nebules production capacity
GSK Australia has announced that it plans to invest AUD31 million in blow-fill-seal equipment for the manufacture of Venolin salbutamol nebules at its facility in Boronia, a suburb of Melbourne. The company cited increasing demand for asthma treatments from Turkey, Brazil, and China as the reason for the retrofit. The Boronia site is GSK's largest liquid product … [Read more...] about GSK Australia to add Ventolin nebules production capacity