Smiths Medical allegedly conspired with United Therapeutics to stifle a generic version of pulmonary arterial hypertension drug Remodulin, according to a lawsuit filed this week by Novartis (NYSE:NVS) unit Sandoz. The Smiths Group (LON:SMIN) subsidiary, which is slated for a spinout as a separately traded company next year, makes the infusion pumps and single-use cartridges for the PAH drug treprostinil, sold […]
Novartis (NYSE:NVS) division Sandoz said today that it launched its Symjepi epinephrine pre-filled syringe in the U.S. The company’s product is designed as an alternative to epinephrine auto-injectors to treat emergency allergic reactions. Get the full story at our sister site, Drug Delivery Business News.
Novartis (NYSE:NVS) division Sandoz and Pear Therapeutics this week kicked off the U.S. commercial launch of the first FDA-cleared prescription digital therapy for people with opioid use disorder. The companies partnered to commercialize a 12-week cognitive behavioral therapy intended to be used in tandem with outpatient treatment. The therapy includes transmucosal buprenorphine and contingency management designed to reinforce positive behaviors, […]
Adamis Pharmaceuticals (NSDQ:ADMP) said this week that it inked an exclusive deal with Novartis‘ (NYSE:NVS) Sandoz unit to distribute and commercialize its Symjepi emergency allergy treatment. The agreement puts Novartis in the position to compete directly with Mylan‘s (NSDQ:MYL) EpiPen auto-injector. The pharma giant has been under pressure in recent months thanks to manufacturing delays that have caused an Epipen shortage in […]
Pear Therapeutics revealed yesterday that it agreed to deal commercialization rights of its digital therapeutics to Novartis (NYSE:NVS) division Sandoz. The company’s reSET substance use disorder therapy became the first prescription digital therapeutic approved by the FDA in September last year. reSET-O, a digital therapeutic designed for people suffering from opioid use disorder, is under review […]
Sandoz said today that the FDA has approved its Glatopa glatiramer acetate injection as a generic version of Copaxone to treat relapsing forms of multiple sclerosis. The therapy, which is given three days per week, is administered using the Glatopaject injection device. Get the full story at our sister site, Drug Delivery Business News.
GlaxoSmithKline (NYSE:GSK) was granted a temporary win today after Novartis‘ (NYSE:NVS) Sandoz unit reported that the FDA rejected its application for a generic version of the company’s blockbuster lung treatment, Advair. The regulatory agency reportedly told Novartis that it needs to submit additional clinical data before the FDA can make its final decision. Get the full story […]
Novartis (NYSE:NVS) unit Sandoz said today that the FDA has accepted the abbreviated new drug application for its generic version of Advair Diskus. The fluticasone propionate/salmeterol device is designed to treat asthma in patients ages 4 and older, as well as provide maintenance treatment of airflow obstruction and reduce exacerbations in patients with chronic obstructive […]