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. Teva studied Ajovy in two Phase […]
Teva wins FDA nod for sublingual film to treat opioid dependence
The FDA last week approved Teva Pharmaceuticals (NYSE:TEVA) Cassipa 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 of buprenorphine and 4 milligrams of naloxone, bringing a new dosage […]
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 […]
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. Not all drugs containing valsartan were recalled, the FDA noted. Teva Pharmaceuticals (NYSE:TEVA), […]
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. The board’s ruling […]
Sen. McCaskill: Teva is “stonewalling” Senate investigation into opioid crisis
Sen. Claire McCaskill (D-Mo.) said that Teva Pharmaceuticals (NYSE:TEVA) is “stonewalling” a Senate probe into the the role that opioid manufacturers have in the nation’s opioid crisis. In the senator’s initial inquiries with the generic drugmaker, McCaskill requested an array of documents detailing arrangements between Teva and its customers, as well as internal reviews of pharmacies […]
Teva launches breath-activated asthma aerosol in U.S.
Teva Pharmaceuticals (NYSE:TEVA) has launched its Qvar RediHaler inhalation aerosol in the U.S., marking the first time a breath-actuated inhaled corticosteroid is available for asthma patients as a prophylactic therapy. In contrast to traditional metered-dose inhalers, Teva’s Qvar RediHaler sends medication into the user’s lungs as they inhale. This feature eliminates the need for hand-breath coordination, […]
Teva shares tumble after “challenging” Q4, FY17
Shares in Teva Pharmaceuticals (NYSE:TEVA) fell today after the pharmaceutical company missed sales expectations on Wall Street with its fourth quarter results. The Israel-based company posted a net loss of -$11.6 billion, or -$11.43 per share, on sales of $5.46 billion for the 3 months ended Dec. 31, for a sales loss of -16% compared with […]
Teva inks deal to test drugs with ProBioGen’s artificial lymph node tech
Teva Pharmaceuticals (NYSE:TEVA) has inked a non-exclusive licensing deal to use ProBioGen‘s human artificial lymph node technology in the preclinical testing of the pharma company’s drug candidates. ProBioGen, a contract developer and manufacturer based in Berlin, designed its 3D micro-organoid model for companies to use to predict the reactions that their drugs will provoke in the […]
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