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 The leading web portal for pharmacy resources, news, education and careers May 6, 2015
Pharmacy Choice - News - Generic Drugs - May 6, 2015

Pharmacy News

 Generic Drugs
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Articles(s): 1 - 25 of 58     Next >>     Go To Page:

5/5/15 - ANI PHARMACEUTICALS INC - 10-Q - Management's Discussion and Analysis of Financial Condition and Results of Operations
Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many important factors, including those set forth under "Risk Factors" in our annual report on Form 10- K for the year ended December 31, 2014. EXECUTIVE OVERVIEW ANI Pharmaceuticals, Inc. and its wholly-owned, consolidated subsidiary,
5/5/15 - Approval of the First Biosimilar in the US Opens the Doors of a Lucrative Market
The move is being hailed by biosimilar manufacturers and is expected to fuel numerous submissions in the coming days, says RNCOS.Noida, UP 05/05/2015 The much awaited biosimilars have finally entered the US pharmaceutical market with the FDA approval of Sandoz's Zarxio, a G-CSF. A new research study conducted by RNCOS, "Global Biosimila
5/5/15 - Biosimilars Market - Global Industry Analysis, Growth and Forecast 2014 - 2020
Transparency Market Research Report Added "Biosimilars Market" to its database.Albany, NY 05/05/2015 The global market for biosimilars is getting a strong impetus due to the growing pressure to cut medical and healthcare expenses. Biosimilars are available at rates lower by 10%-30% in comparison to their parent products. The rising global ger
5/5/15 - FDA grants tentative approval for Amerigen's generic Toviaz [Arab News (Saudi Arabia)]
The US Food and Drug Administration has granted tentative approval for Amerigen Pharmaceuticals' abbreviated new drug application for a generic version of Toviaz. According to IMS Health, US sales of Toviaz were about $215 m for the 12 months ended 31 December 2014. According to Amerigen, it is challenging certain patents listed in the Orange Book
5/5/15 - Generic Drug Companies in Asia Focus More on Market Expansion and Quality, Less on Patent Cliff, Finds Frost & Sullivan
By a News Reporter-Staff News Editor at China Weekly News Fewer blockbusters drugs are expected to go off-patent post 2015, resulting in a scarcity of opportunities for generic companies in Asia. New analysis from Frost& Sullivan, Patent Cliff and the Future of Generics in Asia, finds that the generics market is expected to grow at a compound ann
5/5/15 - MOMENTA PHARMACEUTICALS INC - 10-Q - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and notes thereto appearing elsewhere in this Quarterly Report on Form 10- Q and the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10- K
5/5/15 - Mylan Confirms First-to-File Patent Challenge Relating to Minivelle
POTTERS BAR, England and PITTSBURGH, May 5, 2015/ PRNewswire/ Mylan N.V. today confirmed that it and its subsidiaries Mylan Pharmaceuticals Inc. and Mylan Technologies Inc. have been sued by Noven Pharmaceuticals Inc. and Hisamitsu Pharmaceutical Co., Inc., in connection with the filing of an Abbreviated New Drug Application with the U.S. Food an
5/5/15 - Mylan Launches Generic Seasonale Tablets
POTTERS BAR, England and PITTSBURGH, May 5, 2015/ PRNewswire/ Mylan N.V. today announced the U.S. launch of Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0. 03 mg, which is the generic version of Teva's Seasonale Tablets. Mylan's partner Famy Care Ltd. received final approval from the U.S. Food and Drug Administration for its Abbre
5/5/15 - Mylan Profit Tops Estimates, Sales Misses
CANONSBURG- Dutch generic drug maker Mylan N.V., on Tuesday reported a plunge in first-quarter profit, hurt by acquisition costs and a stronger dollar. Mylan is in the midst of a three-way takeover battle and reiterated its commitment to acquire Irish rival Perrigo. The company posted first-quarter net earnings to shareholders of $56.6 million or $
5/5/15 - New Forum Launches to Expand Access to Biosimilar Medicines, Improve Healthcare
A coalition of 11 leading companies involved in the development and manufacturing of biopharmaceuticals and "biosimilar" medicines today announced the formation of the Biosimilars Forum the first nonprofit organization solely dedicated to expanding patient access to biosimilars in the United States. The founding members of the Biosimilars Foru
5/5/15 - VANC Pharmaceuticals Announces Health Canada Approval for 5 New Generic Molecules and Provides Commercialization Update [Global Data Point]
VANC will start manufacturing of these products once Notice of Compliance is received from Health Canada, which is anticipated in the next few weeks. The NOC from Health Canada provides the authorization for VANC to market and sell the generic molecules in Canada. "We are excited to continue growing our portfolio of generic drugs as we work toward
5/5/15 - VANDA PHARMACEUTICALS INC. FILES (8-K) Disclosing Other Events
On May 5, 2015, Vanda Pharmaceuticals Inc. announced that it has filed a lawsuit in the U.S. District Court of Delaware against Inventia Healthcare Pvt. Ltd. for patent infringement. The lawsuit was filed as a result of Inventia submitting an Abbreviated New Drug Application to the U.S. Food and Drug Administration in which Inventia is seeking appr
5/4/15 - Findings from J.H. DeVries and Colleagues Update Understanding of Diabetes, Obesity and Metabolism (Biosimilar insulins: a European perspective)
According to news reporting out of Dusseldorf, Germany, by NewsRx editors, research stated, "Biosimilar insulins are likely to enter clinical practice in Europe in the near future." According to the news editors, the research concluded: "It also summarizes the current biosimilars approved in Europe and the key clinical issues associated with the us
5/4/15 - Gene Techno Science Enters into Co-Development Agreement with Sanwa Kagaku Kenkyusho
Gene Techno Science Co., Ltd., a biotechnology company, has entered into a co-development agreement with Sanwa Kagaku Kenkyusho Co., Ltd., a pharmaceutical and healthcare company and subsidiary of Suzuken Co., Ltd., to develop darbepoetin alfa biosimilars. Under the agreement, Sanwa Kagaku Kenkyusho will apply for marketing approval and sell the Da
5/4/15 - Governor to receive Ala. lawmakers bill reversing state SC's 'innovator liability' decision [National Iraqi News Agency (Iraq)]
A bill has been passed by Alabama lawmakers who would turn over a state Supreme Court ruling that held a brand-name drug manufacturer can be liable for physical injuries caused by a generic drug product that it neither made nor sold. Lawmakers crafted the bill after the Alabama Supreme Court issued its ruling in Weeks v. A month later, Pfizer, alon
5/4/15 - Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 22204) - Meeting
EVENT: Health and Human Services Department; Food and Drug Administration holds a meeting on the Generic Drug User Fee Amendments of 2012.. LOCATION: FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31 Conference Center, the Great Room, Room 1503, Silver Spring, Md.. CONTACT: Connie Wisner, 240-402-7946, Connie.Wisner@fda.hhs.gov.
5/4/15 - Hospira Statement On FDA's Final Biosimilar Guidance Documents [Global Data Point]
According to the FDA, the guidance documents Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product; and Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and...
5/4/15 - Inclining Healthcare Expenditure Prompting Generics Growth
Revision of Affordable Act during 2013, higher registrations through Medicaid& Medicare as well as Investment by private insurance players to drive investment in US Generics industry, says RNCOS.Noida, UP 05/04/2015 According to a new research report by RNCOS entitled, "US Generic Drug Market Outlook 2018", the United States devotes hig
5/4/15 - Momenta Pharmaceuticals Reports First Quarter 2015 Financial Results [Global Data Point]
"The recent FDA approval of the ANDA for Glatopa?, the first generic version of daily COPAXONE 20 mg, was another proud moment for our Company," said Craig Wheeler, President and CEO, Momenta Pharmaceuticals. The Company earned a $10.0 million milestone for the sole approval under its collaboration agreement with Sandoz.? On January 20, 2015, t
5/4/15 - RNCOS - Business Consultancy Services: Approval of the First Biosimilar in the US Opens the Doors of a Lucrative Market
The much awaited biosimilars have finally entered the US pharmaceutical market with the FDA approval of Sandoz's Zarxio, a G-CSF. A new research study conducted by RNCOS, "Global Biosimilar Market Outlook 2020", reveals that the market, which was worth US$ 1.89 Billion in 2014, is expected to reach US$ 25.5 Billion by 2020, growing at an impressive
5/4/15 - US Generic Drug Market Outlook 2018
The US is the largest pharmaceutical market in the world. Driven by the factors such as large healthcare spending, high per-capita income, and strong research& development investments, the pharmaceutical market in the US has witnessed an upward surge over the past few years. Besides, factors such as surging drug prices, lack of FDA support, long
5/4/15 - VANC Pharmaceuticals Announces Health Canada Approval for 5 New Generic Molecules and Provides Commercialization Update
VANC Pharmaceuticals Inc. is pleased to announce that it has received Drug Identification Numbers from Health Canada for 5 new generic molecules as an initial notice of consent for new drug submissions. VANC will start manufacturing of these products once Notice of Compliance is received from Health Canada, which is anticipated in the next few week
5/2/15 - Alabama lawmakers passed bill overturns Supreme Court's verdict to governor [National Iraqi News Agency (Iraq)]
Alabama lawmakers passed a law to reverse a controversial state Supreme Court decision that held brand-name drug companies responsible for injuries caused by generic versions manufactured elsewhere. In 2013, the state Supreme Court ruled in favor of Danny Weeks, who sued Pfizer, Wyeth and Schwarz Pharma after he developed symptoms of a movement dis
5/2/15 - Coherus BioSciences to Present at Deutsche Bank Health Care Conference on May 7 [Jerusalem Post (Israel)]
-Coherus BioSciences, Inc., a leading pure-play, global biosimilars company with late-stage clinical products, today announced that it will present at the Deutsche Bank 40th Annual Health Care Conference on Thursday, May 7 at 1:30 pm ET in Boston. Coherus possesses late stage clinical products and commercialization partnerships with multinational..
5/2/15 - With biosimilar drug development on the rise, researchers explore efficacy
By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week In the emerging biosimilar market, biosimilar antibodies are being developed to treat conditions currently addressed by their original, targeted biological therapy. Only a few biosimilars are approved by the EMA, and just one has been approved by the FDA. The article focuses
Articles(s): 1 - 25 of 58     Next >>     Go To Page:


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