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. The board’s ruling […]
Mylan
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 […]
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 […]
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 […]
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. “The acceptance of our NDA moves us closer to providing COPD patients with access to once-daily, nebulized […]
European committee backs Mylan’s insulin glargine biosimilar
Mylan (NSDQ:MYL) and Biocon announced today that a European Medicines Agency committee has recommended approval for its biosimilar insulin glargine, Semglee. The committee’s positive opinion brings the product one step closer to approval. The European Commission is slated to make a final decision in April. “We are pleased with CHMP’s decision to recommend approval of Mylan […]
EpiPen shortage in Canada to last until March
Pfizer Canada (NYSE:PFE) has warned Health Canada that there is a shortage of 0.3 mg EpiPen auto-injectors due to a manufacturing disruption. The company, which licenses the emergency allergy treatment from Mylan (NSDQ:MYL), reported that the problem should be resolved by March 2. There are no alternative auto-injectors available on the market in Canada for patients at […]
Mylan, Momenta take aim at Regeneron’s Eylea with biosimilar
Momenta Pharmaceuticals (NSDQ:MNTA) and Mylan (NSDQ:MYL) announced yesterday that they plan to launch a pivotal trial in the first half of 2018 for a proposed biosimilar to Regeneron‘s (NSDQ:REGN) blockbuster drug, Eylea. Eylea, a VEGF-inhibitor designed to treat wet age-related macular degeneration and diabetic macular edema, has little competition on today’s market. The drug brought in […]
Appeal board to review Sanofi’s Lantus insulin injection patents
The U.S. Patent and Trademark Appeal Board has instituted inter partes review on all claims against two patents owned by Sanofi (NYSE:SNY) for the company’s Lantus insulin glargine injection. Sanofi filed a patent infringement suit against Mylan (NSDQ:MYL) in October after the EpiPen-maker submitted an NDA for a pre-filled insulin glargine pen, challenging the patents listed for Sanofi’s Lantus […]
