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. For the 12 months ending May 31, 2018, rivastigmine transdermal systems brought in $248 million in sales […]
Mylan
Mylan launches injectable Angiomax generic
Mylan (NSDQ:MYL) today launched its bivalirudin injection in the U.S. as a generic version of The Medicines Co.‘s (NSDQ:MDCO) Angiomax product. The medicine is a direct thrombin inhibitor designed as an anticoagulant. Mylan’s bivalirudin single-dose vial was approved by the FDA for patients with unstable angina undergoing percutaneous transluminal coronary angioplasty. The product is also indicated […]
FDA approves first generic sublingual film to treat opioid addiction
The FDA this week approved the first generic version of Indivior‘s (LON:INDV) billion-dollar opioid addiction treatment, Suboxone. The generic buprenorphine and naloxone sublingual film, sold by Dr. Reddy’s Laboratories (NYSE:RDY) and Mylan (NSDQ:MYL), is designed to suppress withdrawal symptoms that crop in people addicted to opioids, as well as block the neurochemical effects of opioids. “The FDA […]
Insys Therapeutics reports positive preliminary data for allergy nasal spray
Shares in Insys Therapeutics (NSDQ:INSY) jumped yesterday after the company reported positive data for its investigational epinephrine nasal spray designed as a needle-free treatment for anaphylaxis. In a 60-person pharmacokinetics study, early data show that the company’s intranasal formulation of epinephrine boasted similar bioavailability to epinephrine delivered via Mylan‘s (NSDQ:MYL) EpiPen auto-injector. “Because epinephrine is […]
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 […]
Tribe taking steps to ‘ramp up’ drug patent business
The Native American tribe wrapped up in litigation with generic pharmaceutical companies is trying to prove that its arrangement with Allergan (NYSE:AGN) reflects a legitimate move to boost its economy, according to court documents. The St. Regis Mohawk Tribe of New York found itself it the middle of a controversial deal this year after it agreed […]
Mylan misses estimates on The Street with Q1 results
Shares in Mylan (NSDQ:MYL) rose slightly this morning after the pharmaceutical company reported its first-quarter financial results, missing analysts’ sales and earnings estimates. The company posted profits of $87.1 million, or 17¢ per share, on sales of $2.68 billion for the 3 months ended March 31, for bottom-line growth of 31% on sales loss of -1% […]
Manufacturing delays lead to Epipen shortage in U.S.
At least 400 people across the U.S. have had trouble getting their hands on an Epipen in recent weeks, according to a survey from the advocacy group Food Allergy Research & Education. Mylan (NSDQ:MYL), which makes the emergency allergy auto-injector, reportedly told the FDA months ago that manufacturing delays were straining its Epipen supply. Some patients […]
Mylan acquires fast-acting, non-opioid painkiller
Mylan (NSDQ:MYL) acquired global development and marketing rights to a fast-acting, non-opioid pain relief drug formulated by Prayog Labs, the company announced today. The pharma giant is positioning the medication, Meloxicam, as a non-addictive treatment option for patients experiencing acute pain following dentistry procedures or following a surgery. Prayog Labs has finished initial development work on […]
EU, Australia approve insulin glargine biosimilar
Mylan (NSDQ:MYL) and Biocon touted today that Semglee, their co-developed insulin glargine biosimilar, won approval in the European Union and in Australia. The product will be sold in a pre-filled disposable pen and is the first biosimilar from Biocon and Mylan to be cleared in Europe. Semglee will launch in Australia later this year, Mylan reported, […]
