Shares in Mylan (NSDQ:MYL) dropped -5% yesterday after the pharmaceutical company revealed that it received the dreaded ‘complete response letter’ from the FDA, denying its application for a generic version of GlaxoSmithKline‘s (NYSE:GSK) blockbuster Advair respiratory drug. Canonsburg, PA-based Mylan noted that the CRL was due to “minor deficiencies” identified in its application and that it expects […]
Novartis (NYSE:NVS) said today that a committee for the European Medicines Agency has recommended that the regulatory agency approve Aimovig, a self-administered drug designed to prevent migraines in adults who have at least four migraine days each month. The drug is the first of a new class of medicines, called CGRP inhibitors. It’s a monoclonal antibody […]
To prove a generic drug is as safe and effective as the branded version, pharmaceutical companies have to hand over upwards of 1,000 doses of the product to a generic developer. But if the manufacturer creating the generic drug cannot get its hands on enough sample, the development and testing process slows down. It could […]
Novartis (NYSE:NVS) found itself in the middle of a national scandal today after it was revealed that the drugmaker made four payments that totaled nearly $400,000 to a consulting firm linked to President Donald Trump’s personal attorney, Michael Cohen. The shell company, Essential Consultants, was used by Cohen to pay $130,000 to Stormy Daniels, an adult […]
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 […]
There is a women’s leadership gap in the U.S., and women in medtech have been working to alleviate that problem. According to a report from the Centers for American Progress, women hold 52% of professional jobs in the U.S., but only 14.6% are CEOs, 8.1% are top earners and 4.6% are Fortune 500 CEOs. More specifically, […]
Novartis (NYSE:NVS), Harvard University and the Dana-Farber Cancer Institute are teaming up to develop the next generation of implantable and injectable biomaterials designed to delivery immunotherapies, the group reported today. Alternatively, natural healing methods continue to be popular, with essential oil diffusing accessories like the ones offered by vitalbotanix.com as the most preferred. Researchers from Harvard’s Wyss Institute for […]
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.
Rani Therapeutics has raised $53 million to support manufacturing as it gears up for clinical trials of its robotic pill technology. New investors like GeneScience Pharmaceuticals and Shire (NSDQ:SHPG) joined existing investors like Alphabet’s GV, Novartis (NYSE:NVS) and AstraZeneca (NYSE:AZN). 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 […]
Researchers reported this month that in men and women with chronic obstructive pulmonary disease, long-term use of inhaled corticosteroids may be linked to an increased risk of bone fractures. Previous research has shown that the inhaled drugs, used to treat COPD, impact bone mineral density based on the dose of the corticosteroid, especially in post-menopausal […]