Menarini Asia-Pacific Holdings has signed a multi-year licensing agreement with Orion Corporation for distribution and commercialization of Easyhaler DPI products in China, Hong Kong, Philippines, Malaysia, Indonesia, Thailand, Singapore, Vietnam, Taiwan, and South Korea, the companies said. In 2016, Menarini and Orion announced that Menarini would co-market … [Read more...] about Menarini to market Orion DPIs in Asia-Pacific region
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US appeals court affirms ruling on validity of Zomig nasal spray patents
Amneal Pharmaceuticals announced that the US Court of Appeals for the Federal Circuit has upheld a March 2017 ruling finding that Lannett infringed on US patents 6,750,237 and 7,220,767, which are related to Zomig zolmitriptan nasal spray. Impax Laboratories, an Amneal subsidiary, and AstraZeneca filed suit against Lannett after Lannett filed an ANDA for a generic … [Read more...] about US appeals court affirms ruling on validity of Zomig nasal spray patents
Lupin launches generic tobramycin inhalation solution in US
Lupin has launched its generic version of Tobi inhalation solution in the US, the company said. The FDA granted final approval of Lupin's ANDA for its tobramycin inhalation inhalation solution in March 2017. The 300 mg/5 ml inhalation solution is indicated for the treatment of P. aeruginosa lung infections in cystic fibrosis patients. Read the Lupin press … [Read more...] about Lupin launches generic tobramycin inhalation solution in US
Pivot Pharmaceuticals signs option agreement for Trivair device for delivery of dry powder cannabinoid formulations
Pivot Pharmaceuticals has announced that the company signed an option agreement with IP Med Inc. for an exclusive worldwide license for use of TriVair nasal and pulmonary breath-propelled devices for delivery of dry powder cannabinoid formulations. Pivot will have 6 months to evaluate the use of the device for delivery of its Ready-To-Infuse-Cannabis ("RTIC") to … [Read more...] about Pivot Pharmaceuticals signs option agreement for Trivair device for delivery of dry powder cannabinoid formulations
Apotex recalls lot of fluticasone nasal spray in US
Apotex has issued a voluntarily recall for one lot of fluticasone propionate nasal spray (lot NJ4501), which was shipped to wholesalers and distributors throughout the US and has an expiration date of July 2020. Apotex said that the FDA is aware of the recall and wholesalers and distributors have been notified. According to the company, a consumer complaint … [Read more...] about Apotex recalls lot of fluticasone nasal spray in US
Dry powder nitric oxide release formulation reduces bacterial load of NTM by 99% in preclinical study
Vast Therapeutics, which recently changed its name from Novoclem Therapeutics, has announced that its BIOC51 dry powder nitric oxide (NO)-release formulation reduced the bacterial load of nontuberculous mycobacteria (NTM) in the lungs of mice by 99% in a study conducted with Colorado State University. According to the company, BIOC51 has eradicated every bacterial … [Read more...] about Dry powder nitric oxide release formulation reduces bacterial load of NTM by 99% in preclinical study
Windtree Therapeutics gets $700,000 for follow-up to Phase 2b Aerosurf study
Windtree Therapeutics has received the remaining $700,000 from a Small Business Innovation Research Grant (SBIR) from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) that was initially awarded in 2016 for Phase 2 development of Aerosurf. The company previously received a total of $1.9 million from that award, an … [Read more...] about Windtree Therapeutics gets $700,000 for follow-up to Phase 2b Aerosurf study
Cipla to market and distribute Afrezza inhaled insulin in India
MannKind Corporation announced that it has signed a deal with Cipla for marketing and distribution of Afrezza inhaled insulin in India. Cipla will be responsible for getting regulatory approval in India and will pay MannKind $2.2 million up front, plus milestone payments, minimum purchase commitment revenue and royalties on sales in India. Cipla Ltd. Global CEO … [Read more...] about Cipla to market and distribute Afrezza inhaled insulin in India
NanoBio changes name to BlueWillow, raises $10 million for development of intranasal vaccines
US biopharmaceutical company NanoBio Corporation has changed its name to BlueWillow Biologics, which the company says "reflects its evolution to a vaccines-focused company, and commitment to advancing its novel intranasal technology to develop new vaccines for several respiratory and sexually transmitted diseases." The company also announced the closing of a $10 … [Read more...] about NanoBio changes name to BlueWillow, raises $10 million for development of intranasal vaccines
Avadel launches Noctiva desmopressin nasal spray
Avadel Pharmaceuticals has announced the launch of Noctiva desmopressin nasal spray for the treatment of nocturia due to nocturnal polyuria (overproduction of urine at night) in adults. Avadel acquired US and Canadian rights to Noctiva from Serenity Pharmaceuticals in September 2017 for $50 million up front, plus milestone payments and royalties. A $20 million … [Read more...] about Avadel launches Noctiva desmopressin nasal spray