Therapix Biosciences has signed a licensing agreement with Yissum Research Development Company for nasal drug delivery technology that it plans to use for intranasal delivery of cannabinoids, the company said. Yissum Research Development Company is Hebrew University's technology transfer company. In 2016, Therapix announced that it had licensed an intranasal … [Read more...] about Therapix Biosciences licenses nasal drug delivery tech for delivery of cannabinoids
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Sunovion launches Utibron Neohaler in US
Sunovion has launched the Utibron Neohaler indacaterol/glycopyrrolate DPI for the treatment of COPD in the United States, the company announced. Sunovion acquired the US rights to the Utibron, Seebri, and Arcapta Neohalers from Novartis in December 2016. Utibron Neohaler, which is marketed as Ultibro Breezhaler outside of the US, was approved by the FDA in … [Read more...] about Sunovion launches Utibron Neohaler in US
Verona Pharma announces development agreements, appointment of Richard Hennings as Commercial Director
Verona Pharma has announced a clinical development services agreement with QuintilesIMS for Verona's RPL554, an inhaled PDE3/PDE4 inhibitor for the treatment of acute exacerbations in COPD patients. The company also said that it is planning to develop RPL554 as both an MDI and as a DPI in partnership with two European technology companies. In addition, Verona … [Read more...] about Verona Pharma announces development agreements, appointment of Richard Hennings as Commercial Director
Lannett found to have infringed on patents related to Zomig nasal spray
Judge Richard G. Andrews of the US District Court, District of Delaware, has found that Lannett has infringed on the US patents 6,750,237 and 7,220,767 related to Zomig zolmitriptan nasal spray, Impax Laboratories has announced. In 2014, Impax filed suit against Lannett after Lannett filed an ANDA for a generic version of Zomig nasal spray. In 2012, Impax … [Read more...] about Lannett found to have infringed on patents related to Zomig nasal spray
Capsugel adds DPI capsule filling capacity
Capsugel has added a new Harro HÓ§fliger Modu-C MS encapsulation unit with a capacity of over 72,000 capsules per hour for late-stage clinical trial and commercial production of dry powder inhaler formulations, the company said. The new system installed at the company's Bend, Oregon facility (formerly known as Bend Research) features 100 percent dosed powder mass … [Read more...] about Capsugel adds DPI capsule filling capacity
Mylan gets complete response letter for generic Advair ANDA
Mylan has announced that it received a complete response letter from the FDA in regards to its ANDA for a generic version of GlaxoSmithKline's Advair Diskus fluticasone/salmeterol DPI. The company said that it is reviewing the CRL and will comment further once it has discussed it with the FDA. In February 2016, Mylan announced that the FDA had accepted its ANDA for … [Read more...] about Mylan gets complete response letter for generic Advair ANDA
Positive Phase 3 results for Glenmark’s mometasone/olopatadine nasal spray
Glenmark Pharmaceuticals says that data from a Phase 3 study of its GSP 301 mometasone furoate/olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis show statistically significant and clinically meaningful improvement in symptoms compared to placebo and to the individual components. The two-week study enrolled 1,176 patients 12 … [Read more...] about Positive Phase 3 results for Glenmark’s mometasone/olopatadine nasal spray
FDA responds to Sandoz’s citizen petition on Advair bioequivalence recommendations
The FDA has denied a citizen petition filed by Sandoz in October 2016 in which Sandoz challenged the agency's 2013 bioequivalence recommendations for generic versions of Advair Diskus fluticasone propionate/salmeterol xinafoate. However, in a copy of the March 10, 2017 response letter posted by Fierce Pharma, the FDA said that it "has made no final determination … [Read more...] about FDA responds to Sandoz’s citizen petition on Advair bioequivalence recommendations
FDA approves Lupin’s generic TOBI inhalation solution
Lupin announced that the FDA has granted final approval for the company's tobramycin inhalation solution, a generic version of Novartis's TOBI 300 mg/5 ml inhalation solution for the treatment of P. aeruginosa lung infections in cystic fibrosis patients. The company noted that US sales of tobramycin inhalation solution in 2016 totaled $133.6 million. Read the … [Read more...] about FDA approves Lupin’s generic TOBI inhalation solution
Opiant initiates Phase 2 trial of intranasal naloxone for the treatment of bulimia nervosa
Opiant Pharmaceuticals (formerly Lightlake Therapeutics) has announced the initiation of a Phase 2 trial of its OPNT001 intranasal naloxone for the treatment of bulimia nervosa. In 2014, the company licensed its Narcan intranasal naloxone for the reversal of opioid overdose to Adapt Pharma, and that product was approved in the US in November 2015. The upcoming … [Read more...] about Opiant initiates Phase 2 trial of intranasal naloxone for the treatment of bulimia nervosa