Sandoz announced that it is in-licensing the commercial distribution rights to a respiratory inhalation medicine from Kindeva Drug Delivery. Princeton, N.J.-based Sandoz in-licensed the rights to the brand and authorized generic of Proventil HFDA (albuterol sulfate) inhalation aerosol, which is immediately available to U.S. patients, according to a news release. Albuterol sulfate is used to […]
sandoz
Novartis unit spikes Pear Therapeutics deal
Novartis (NYSE:NVS) unit Sandoz said this week that Pear Therapeutics will take sole responsibility for the commercialization of their prescription digital therapeutics program for treating substance and opioid use disorders. In April 2018, Pear announced that it agreed to deal commercialization rights of its digital therapeutics to Sandoz. The companies did not disclose financial details, but […]
Smiths Medical, United Therapeutics conspired to stifle generic Remodulin, Sandoz alleges
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 […]
Sandoz launches PFS alternative to epinephrine auto-injector
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. Sandoz described Symjepi as an “affordable” alternative to EpiPens but did not disclose the product’s price. “The Symjepi device is small in size and […]
Sandoz, Pear launch digital therapy for opioid use disorder
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 […]
Novartis steps in to compete with Mylan’s Epipen
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 […]
Pear Therapeutics, Sandoz ink deal for prescription digital therapeutics
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 wins FDA nod for generic, injectable MS drug
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. The 20 mg/mL version of the MS treatment has been available in the […]
FDA rejects Novartis’ Advair generic, leaving GSK without rival
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. GSK said in […]
Novartiz unit Sandoz seeks FDA nod for generic Advair Diskus
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 […]
