The FDA today released an update to a warning on Novartis (NYSE:NVS) subsidiary Alcon’s CyPass glaucoma stents, saying that clinicians should still refrain from using the stents and should monitor patients who’ve received them for endothelial cell density loss. In August, Alcon voluntarily pulled the stents from the global market based on an analysis of five-year post-surgery […]
The 20 largest medical device companies in the world
The medical device industry saw even more consolidation over the past year, as evidenced by Medical Design & Outsourcing‘s newest Big 100 list. It used to be that a company had to have at least $100 million in annual revenue to make it on the list. This time around, No. 100 on the list is […]
Alcon withdraws all CyPass micro-stents, says it will not affect spin-off
Novartis (NYSE:NVS)’s Alcon said this week it is voluntarily withdrawing its CyPass micro-stents from the global market, but that the withdrawal will not affect its planned spin-out. The decision to pull the devices comes off the analysis of five-year post-surgery data from the Compass-XT study of the device, which showed that patients treated with the stent had […]
Novartis posts Q2 beat, promises to hold off on drug price hikes
Shares in Novartis (NYSE:NVS) were up today after the company beat expectations on Wall Street with its second-quarter financial results. The Switzerland-based company posted profits of $7.77 billion, or $3.34 per share, on sales of $13.16 billion for the three months ended June 30. Novartis saw its quarterly sales climb 7% compared with the same period last […]
Cingulate raises $7.5m for controlled-release ADHD therapy
Cingulate Therapeutics said today that it landed a $7.5 million investment to help fund the development of its controlled-release ADHD drugs. The Kansas City-based company is working on a set of therapies that utilize its ‘Precision Time Release’ drug-delivery platform. Cingulate’s CEO, Shane Schaffer, told Drug Delivery Business News that his company set out to create an ADHD therapy that tackles all […]
Mylan launches generic drug-delivery patch for dementia patients
Mylan (NSDQ:MYL) announced today the U.S. launch of its rivastigmine transdermal drug-delivery patch, a generic version of Novartis‘ (NYSE:NVS) Exelon therapy. The company’s rivastigmine therapy is indicated for the treatment of dementia associated with Alzheimer’s disease and Parkinson’s disease. Get the full story at our sister site, Drug Delivery Business News.
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 caused an Epipen shortage in […]
Novartis to spin out Alcon ophthalmic subsidiary
Novartis (NYSE:NVS) said today that it’s planning to spin its Alcon ophthalmology subsidiary into a publicly traded company after years of speculation that it wanted to sell the ill-starred division. The Swiss pharma giant said it intends to hold on to Alcon’s $4.6 billion ophthalmic pharmaceuticals business under the Novartis Innovative Medicines umbrella, continuing a […]
FDA rejects Mylan’s Advair generic in win for GSK
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 […]
EMA committee recommends approval for migraine prevention drug
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 […]
Here are the pharma companies accused of blocking generic competition
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 […]
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