Teva (NYSE:TEVA) said yesterday that it won EC Marketing Authorization for its Ajovy pre-filled syringe injection meant to serve as a prophylaxis for migraines in adults who experience at least four migraine days per month. The Israel-based company said that Ajovy is a humanized monoclonal antibody that binds to the calcitonin gene-related peptide ligand and blocks […]
Teva launches generic for Pfizer’s Flector pain patch
Teva (NYSE:TEVA) said last week that it launched a generic version of Pfizer‘s (NYSE:PFE) Flector diclofenac epolamine patch. Using a nonsteroidal anti-inflammatory drug, the topical patch is designed to treat acute pain due to minor strains, sprains and contusions. Get the full story at our sister site, Drug Delivery Business News.
Teva aims for 25% of U.S. EpiPen market by 2020
Teva (NYSE:TEVA) expects its generic EpiPen auto-injector to claim 25% of the U.S. market by the end of this year, according to a report from Seeking Alpha. For years, Mylan‘s (NSDQ:MYL) brand-name emergency allergy device has dominated the markets. But the company faced widespread criticism in 2016 when reports revealed that Mylan hiked the price of the EpiPen […]
FDA approves Teva’s digital COPD, asthma inhaler
Teva (NYSE:TEVA) said this week that the FDA approved its ProAir Digihaler device – a digital inhaler that uses sensors to connect to a companion mobile app for people with asthma and chronic obstructive pulmonary disease. The company’s device features built-in sensors that can measure inspiratory flow and detect when the inhaler is used. After the […]
Teva launches generic EpiPen at the same price as existing device
Teva (NYSE:TEVA) this week launched its generic version of Mylan‘s (NSDQ:MYL) EpiPen auto-injector and announced that it would sell the emergency allergy therapy for $300 – the same price as Mylan’s own generic EpiPen product. The price for Teva’s product inspired some head-scratching among patient advocates and healthcare professionals. After all, when the FDA first approved Teva’s […]
Teva wins FDA nod for migraine prevention drug
Teva (NYSE:TEVA) last week won FDA approval for its humanized monoclonal antibody, Ajovy, designed to prevent migraines. The treatment, which blocks the receptor for a protein that is linked to migraine pain, is available in quarterly and monthly-injection options. Amgen‘s (NSDQ:AMGN) competitive once-monthly product won FDA approval earlier this year. Get the full story at our sister site, […]
Teva wins FDA nod for sublingual film to treat opioid dependence
The FDA last week approved Teva Pharmaceuticals’ Cassipa buprenorphine and naloxone sublingual film as a maintenance treatment for opioid dependence. There are a number of brand name and generic versions of buprenorphine and naloxone therapies that are delivered via a sublingual film. Teva’s product contains 16 milligrams buprenorphine and 4 milligrams of naloxone, bringing a […]
FDA approves first generic Epipen
The FDA this week approved the first generic version of Mylan‘s (NSDQ:MYL) Epipen emergency allergy auto-injector. Teva Pharmaceuticals (NYSE:TEVA), which won the historic approval, plans to market the generic epinephrine auto-injector in 0.3mg and 0.15mg doses. There are other epinephrine auto-injectors on the market in the U.S., but Teva’s is the first that’s approved to directly substitute […]
FDA recalls heart failure, blood pressure drugs due to cancerous contaminant
The FDA announced last week a voluntary recall of several high blood pressure and heart failure medications containing valsartan due to a cancerous impurity. Some valsartan drugs were found to contain N-nitrosodimethylamine (NDMA), a compound that is classified as a probable human carcinogen. Get the full story at our sister site, Drug Delivery Business News.
With groundbreaking approval, Amgen launches new class of medicine for migraine patients
Amgen (NSDQ:AMGN) won FDA approval this week for its once-monthly Aimovig injection designed to prevent the onset of migraines in adults. The drug is the first of its kind – a molecule that blocks the receptor for a protein that is linked to migraine pain, the calcitronin gene-related peptide. Other major pharmaceutical companies like Eli Lilly (NYSE:LLY) […]
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 […]
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