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 […]
Mylan
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 to […]
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% compared […]
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. Get the […]
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. Get the full story at our sister site, […]
Tribe looks to stop patent board’s review of Restasis IP
Allergan (NYSE:AGN) and the St. Regis Mohawk Tribe asked the Federal Circuit last week to stop the U.S. Patent Trial and Appeal Board from reviewing the IP for Allergan’s blockbuster eye drug, Restasis. The move comes in response to the board’s February decision that sovereign immunity does not shield tribes from patent challenges. Get the full […]
Senate bill looks to block tribal patent deals with pharma
Months after Allergan (NYSE:AGN) struck a controversial patent deal with a Native American tribe in New York, lawmakers are angling to make sure that it can’t happen again. Sens. Tom Cotton (R-Ar), Claire McCaskill (D-Mo) David Perdue (R-Ga), Joni Ernst (R-Ia) and Pat Toomey (R-Pa) introduced a bill this week that would prevent patent owners from claiming sovereign immunity […]
Adamis Pharma’s EpiPen alternative succeeds in human factors study
Adamis Pharmaceuticals (NSDQ:ADMP) has positioned its emergency allergy treatment as a cheaper alternative to Mylan‘s (NSDQ:MYL) EpiPen device. The company has also set out to prove that its epinephrine injector is easy to use, even by people using an auto-injector for the first time. Data from a human factors study conducted by Adamis were presented this week at […]
Mylan: Generic competition pushes EpiPen sales down
Mylan (NSDQ:MYL) revealed in its annual report yesterday that EpiPen sales in the U.S. were down $655.4 million last year compared to 2016. The company, which faces continued backlash over the price of its emergency allergy treatment, cited the launch of a generic version of its device, higher governmental rebates and increased competition as reasons for […]
Patent board rules Mohawk tribe is not immune to challenges over Restasis IP
The U.S. Patent Trial and Appeal Board ruled last week that the tribal immunity granted to Native American tribes in the U.S. does not shield tribes from patent challenges. The ruling is a setback for Allergan (NYSE:AGN); the pharmaceutical company transferred patent rights for its blockbuster eye drug, Restasis, to the St. Regis Mohawk Tribe last year […]
FDA to review Theravance’s application for once-daily COPD med
The FDA has accepted Theravance Biopharma‘s (NSDQ:TBPH) marketing application for revefenacin, an inhaled long-acting muscarinic antagonist designed to treat chronic obstructive pulmonary disease. The FDA is slated to make a decision about the once-daily treatment by Nov. 13. Get the full story at our sister site, Drug Delivery Business News.