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 The leading web portal for pharmacy resources, news, education and careers December 15, 2018
Pharmacy Choice - News - Generic Drugs - December 15, 2018

Pharmacy News

 Generic Drugs
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 89     Next >>     Go To Page:

12/15/18 - Bevacizumab Biosimilar, IBI305, Meets Primary End Points in 2 Clinical Trials [T-break Tech (Middle East)]
"Lung cancer is the highest incidence cancer in China, and bevacizumab is an important treatment for non-small lung cancer patients. The launch of a high-quality bevacizumab biosimilar will improve drug accessibility and benefit more patients, "said Li Zhang, MD, from the cancer hospital of Sun Yat-Sen University, in a statement announcing the posi
12/15/18 - Innovent reports positive results from two trials of IBI305 [Syrian Arab News Agency]
Innovent Biologics has reported positive results from two clinical trials of IBI305 after meeting the pre-defined primary endpoints of both studies. China- based Innovents IBI305 is a biosimilar of bevacizumab, which is a recombinant humanised anti-vascular endothelial growth factor monoclonal antibody developed for use as injection.
12/15/18 - On Senate Floor, Portman Highlights How PSI Investigative Report Resulted in Lower Prices for Opioid Overdose Reversal Drug
Last night, U.S. Senator Rob Portman delivered remarks on the Senate floor about the bipartisan Permanent Subcommittee on Investigations report, which was highlighted on 60 Minutes, that found the drug manufacturer kaleo increased the price of its opioid overdose reversal drug by more than 600 percent to "capitalize on the opportunity" of "opioid o
12/15/18 - Pfizer Receives Positive CHMP Opinion for Oncology Biosimilar, ZIRABEV
Pfizer Inc. today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion, recommending marketing authorization for ZIRABEV (TM), a potential biosimilar to Avastin. 1 ZIRABEV is a monoclonal antibody for the treatment of metastatic carcinoma of the colon or rectum, metastatic
12/15/18 - R Supply, Installation, Testing And Commissioning Of 4 No.s - Visi Coolers & Its Accessories For Hll Generic Drug Stores At Various Locations In Gujarat [TendersInfo (India)]
Tenders are invited for Supply, Installation, Testing and Commissioning of 4 no.s- Visi Coolers& its accessories for HLL Generic Drug Stores at various locations in Gujarat EMD value: INR 5000 Opening date: 20 Dec 2018 Major organization: HLL LIFECARE LIMITED Address: hll bahwan poojapura Country: India Url: www.lifecarehll.com Tender notice number
12/15/18 - Ridgefield pharma continues chase of blockbuster drug alone [The Hour, Norwalk, Conn.]
Boehringer Ingelheim Pharmaceuticals intends to find out and the Ridgefield giant is not following the script of its competitors. "Boehringer Ingelheim believes the introduction of high-quality, lower-cost biosimilars is critical for both patients and the sustainability of the system," stated Susan Holz, a Boehringer Ingelheim spokesperson in...
12/14/18 - Amneal Pharmaceuticals Inc (NYSE:AMRX) gets downgraded to Equal Weight by Morgan Stanley with a price target of $18.00
Analyst Ratings For Amneal Pharmaceuticals Inc (NYSE:AMRX) Today, Amneal Pharmaceuticals Inc (NYSE:AMRX) stock was downgraded by Morgan Stanley from Overweight to Equal Weight with a price target of $18.00. There are 6 Hold Ratings, 3 Buy Ratings, no Strong Buy Ratings, no Sell Ratings on the stock. The current consensus rating on Amneal Pharmaceut
12/14/18 - Celltrion and Teva Announce FDA Approval of HERZUMA (trastuzumab-pkrb), a Biosimilar to HERCEPTIN, for the Treatment of HER2-Overexpressing Breast Cancer for Certain Indications
INCHEON, South Korea& JERUSALEM Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration has approved HERZUMA , a HER2/neu receptor antagonist biosimilar to HERCEPTIN 1 for the following indications:. Biosimilars are of growing importance to the oncology community and the approva
12/14/18 - Federal Register Extracts
Agency: " Food and Drug Administration, HHS." SUMMARY: The Food and Drug Administration is announcing the withdrawal of the proposed rule on "Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products" that published in the Federal Register of November 13, 2013. FDA is taking this action in light of concerns exp
12/14/18 - Global Biosimilar Monoclonal Antibiotics Market to Witness a Perspective CAGR of 35.70% by 2026
New York, NY 12/14/2018 The global Biosimilar Monoclonal Antibiotics Market was assessed at US$ 1,516.9 Mn in 2016, growing at a CAGR of 35.70% during the forecast period 2017-2026 according to the market research report, "Global Biosimilar Monoclonal Antibiotics Market" Size, Share, Growth, Trends, Opportunity, Risks& Forecast, 2017-2026.
12/14/18 - House Judiciary Subcommittee Issues Testimony From Justice Department on Oversight of Antitrust Enforcement Agencies
The House Judiciary subcommittee on Regulatory Reform, Commercial and Antitrust Law, issued the following testimony by Makan Delrahim, assistant attorney general for the Antitrust Division of the Department of Justice, at a hearing entitled "Oversight of the Antitrust Enforcement Agencies":. "Chairman Marino, Ranking Member Cicilline, and distingu
12/14/18 - House Passes Welch Legislation Closing Drug Company Loophole
Peter Welch, D- Vermont, issued the following news release:. Peter Welch that closes a loophole in the federal Medicaid program exploited by drug companies to minimize drug discounts required for participation in the program. Kurt Schrader, introduced the Medicaid Drug Rebate Accountability Act after a report by the Inspector General for the Depart
12/14/18 - In Victory for WLF, FDA Abandons Controversial Proposed Rule on Generic Drug Labeling
The Washington Legal Foundation issued the following news release:. FDA's decision marked a major victory for Washington Legal Foundation, which repeatedly urged FDA to abandon the rule. FDA's proposal would have permitted generic companies to revise their labels unilaterally while they awaited word on whether FDA approved the change.
12/14/18 - Pfizer Receives Positive CHMP Opinion for Oncology Biosimilar, ZIRABEV? (bevacizumab)
Pfizer Inc. today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion, recommending marketing authorization for ZIRABEV?, a potential biosimilar to Avastin. 1 ZIRABEV is a monoclonal antibody for the treatment of metastatic carcinoma of the colon or rectum, metastatic b
12/14/18 - Public Citizen Issues Statement on Generic Drug Labeling
Public Citizen issued the following statement by Sidney Wolfe, founder and senior adviser of Health Research Group:. Today, the U. S. Food and Drug Administration announced that it will withdraw a 2013 proposed rule, prompted by a 2011 Public Citizen petition, which would have allowed generic drug makers to immediately update safety labels describi
12/14/18 - Withdrawal of Proposed Rule on Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
Agency: " Food and Drug Administration, HHS." SUMMARY: The Food and Drug Administration is announcing the withdrawal of the proposed rule on "Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products" that published in the Federal Register of November 13, 2013. FDA is taking this action in light of concerns exp
12/13/18 - AHIP Commends Administration for Encouraging More Competition to Lower Prices for Biologics
America's Health Insurance Plans issued the following statement:. Matt Eyles, president and CEO of America's Health Insurance Plans, issued this statement following the Food and Drug Administration's release of guidance documents on the development of biosimilar and interchangeable products and on the transition of products like insulin from its...
12/13/18 - Allied Pharma, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications
Agency: " Food and Drug Administration, HHS." FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945, Trang.Tran@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The applicants listed in the table have informe
12/13/18 - Biosimilars Market Shows Stunning Growth at 26% CAGR with Upcoming Business Opportunities Till 2023: Market Research Future published a research report on Global Biosimilars Market. Report presents an in-depth assessment of the market which has key t
Pune, India 12/13/2018 Key Players for Global Biosimilars Market. The key players in the global biosimilars market include Accord Healthcare, Amgen Inc., Astra Zeneca, Biocon Ltd., Celltrion, Inc., Dr. Reddy's Laboratories Ltd., Eli Lilly, F. Hoffmann-La Roche Ltd., Novartis, Pfizer Inc., Samsung Bioepis, Sandoz International GmbH, and Teva P
12/13/18 - European Medicines Agency Accepts Extension Marketing Authorisation Application for Review of Celltrion's Remsima SC, the Subcutaneous Version of Remsima
By a News Reporter-Staff News Editor at Pharma Business Week Celltrion, Inc. announced that the European Medicines Agency has accepted for review of the Extension Marketing Authorisation Application for' Remsima SC', the subcutaneous version of Remsima , the autoimmune disease therapeutic antibody biosimilar of infliximab. In a bid to secure...
12/13/18 - FDA Commissioner Gottlieb Issues Statement on Maintaining Efficiency of Generic Development
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following joint statement by Commissioner Scott Gottlieb and Janet Woodcock, director of FDA' s Center for Drug Evaluation and Research on the efforts to modernize generic drug labels while maintaining the efficiency of generic development:. "Protecting patie
12/13/18 - FDA rolls out expectations for a looming regulatory shift for insulin and other biologics [T-break Tech (Middle East)]
While highlighting the need to bring down the price of insulin, FDA Commissioner Scott Gottlieb explained at the CMS/ FDA Summit in Washington DC on Tuesday that the goal of the guidances and new policies is two-fold: to minimize sponsors ability to game the exclusivity provisions and forestall biosimilar entry, and to make sure that when drugs tra
12/13/18 - Global Biosimilar Monoclonal Antibodies Market (2018-2024): Rising Demand for Biosimilar Drugs Owing to their Cost Effectiveness
The "Biosimilar Monoclonal Antibodies Market: Global Industry Analysis, Trends, Market Size and Forecasts up to 2024" report has been added to ResearchAndMarkets.com' s offering. The report predicts the global biosimilar monoclonal antibodies market to grow with a CAGR of 55.2% over the forecast period of 2018-2024.. The study on biosimilar monoclo
12/13/18 - Global Biosimilar Monoclonal Antibodies Market (2018-2024): Rising Demand for Biosimilar Drugs Owing to their Cost Effectiveness - ResearchAndMarkets.com
The "Biosimilar Monoclonal Antibodies Market: Global Industry Analysis, Trends, Market Size and Forecasts up to 2024" report has been added to ResearchAndMarkets.com' s offering. The report predicts the global biosimilar monoclonal antibodies market to grow with a CAGR of 55.2% over the forecast period of 2018-2024. The study on biosimilar monoclon
12/13/18 - Global biosimilar monoclonal antibodies market is expected to grow with a CAGR of 55.2% over the forecast period of 2018-2024
The report on global biosimilar monoclonal antibodies market provides qualitative and quantitative analysis for the period of 2016 to 2024. Read the full report: https://www.reportlinker.com/p05627413 The report predicts the global biosimilar monoclonal antibodies market to grow with a CAGR of 55.2% over the forecast period of 2018-2024. The stud
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