US FDA eases Teva headache with Ajovy approval

US FDA eases Teva headache with Ajovy approval

Earlier this week, the US Food and Drug Administration (FDA) approved Teva Pharmaceuticals’ Ajovy (fremanezumab-vfrm) injection – the first calcitonin gene-related peptide (CGRP) treatment with quarterly and monthly dosing options. Ajovy is indicated for the preventive treatment of migraine in adults. The monoclonal antibody works by binding to the CGRP ligand and blocking its binding […]

Data Integrity a Top Concern for Manufacturers, FDA Says

Data Integrity a Top Concern for Manufacturers, FDA Says

Posted 18 September 2018 | By Zachary Brennan  When a pharmaceutical or active pharmaceutical ingredient manufacturer has data integrity issues, that’s likely the tip of the iceberg, Sarah Barkow, of FDA’s Office of Manufacturing Quality, told attendees of the Pharma and Biopharma Outsourcing Association’s annual conference in Rockville, MD. “You need to worry about [data […]

Global Active Pharmaceutical Ingredient Market (2018-2025) Size|Growth|Share|Demand Analysis and Outlook By Key …

Global Active Pharmaceutical Ingredient Market (2018-2025) Size|Growth|Share|Demand Analysis and Outlook By Key …

Global Active Pharmaceutical Ingredient Market 2018-2025 – Sales, Supply & Demand Analysis and Outlook By Key Players, Types and Applications. A modernized industry Analysis Report 2018 has been published by MarketDesk.us Titled “Global Active Pharmaceutical Ingredient Market Report 2018” which presents an outlook for the up-to-date market cost in addition to the expected forecast which […]

Celltrion clears manufacturing issues raised by FDA

Celltrion clears manufacturing issues raised by FDA

[THE INVESTOR] Celltrion said Sept. 16 that the US Food and Drug Administration has given its OK to the Korean biopharmaceutical firm’s manufacturing facility after re-inspection, clearing a year-long problem that hampered the approval of its biosimilar products. The FDA classified the firm’s production site in Incheon as “voluntary action indicated,” in an Establishment Inspection Report, […]

Global Active Pharma Ingredient Market 2018-2025 Novartis, Pfizer, Teva

Global Active Pharma Ingredient Market 2018-2025 Novartis, Pfizer, Teva

The Global Active Pharma Ingredient Market Report 2018 published by 9Dimen Research Store is a complete study of the business sectors, 2012-2018. It analyses the important factors of the Active Pharma Ingredient market based on present industry, Active Pharma Ingredient market demands, business strategies utilized by Active Pharma Ingredient market players and the future prospects […]

Global Active Pharmaceutical Ingredient Market Share 2018- Dr. ReddyÂ's Laboratories, Roche, Bayer, TEVA, Johnson …

Global Active Pharmaceutical Ingredient Market Share 2018- Dr. ReddyÂ's Laboratories, Roche, Bayer, TEVA, Johnson …

A recent report on Global Active Pharmaceutical Ingredient Market 2018 assessed a decisive analysis on the active pharmaceutical ingredient industry on worldwide and regional level. It explains what are active pharmaceutical ingredient marketing strategies of leading companies and their expenses. Together with media supply, it highlights active pharmaceutical ingredient marketing, sales, and business planning. It […]

Will Ajovy lead Teva's turnaround?

Will Ajovy lead Teva's turnaround?

U.S. approval of Teva Pharmaceutical’s migraine drug Ajovy on Friday removed a major uncertainty facing investors, spurring a 5% jump in the Israeli drugmaker’s stock price when market trading resumed Monday.  Ajovy, a preventive treatment that targets a protein known as CGRP, is seen as a crucial driver of growth for Teva and a potential […]

Cocktail drugs ban good for health

Cocktail drugs ban good for health

The government has done well to ban the manufacture, sale and distribution of 328 fixed dose combination (FDC) drugs which have for long been considered a health hazard. The ban has come into immediate effect and covers drug cocktails for treating cold and cough, antibiotics, painkillers, anti-depressants, diabetic drugs, etc., sold under some 6,000 different […]

Teva Analysts Say Migraine Drug Approval Gives Needed Relief

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Second Impurity Identified in Recalled Valsartan Products

Second Impurity Identified in Recalled Valsartan Products

N-Nitrosodiethylamine is a known animal and suspected human carcinogen An additional impurity, N-Nitrosodiethylamine (NDEA), has been identified in some of the recalled valsartan products (160mg [lot BV47D001] and 320mg [lots BV48D001 and BV48D002]) from Torrent Pharmaceuticals. NDEA is a known animal and suspected human carcinogen. The FDA began testing valsartan for NDEA after learning that […]

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