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 The leading web portal for pharmacy resources, news, education and careers July 23, 2017
Pharmacy Choice - News - Generic Drugs - July 23, 2017

Pharmacy News

 Generic Drugs
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 232     Next >>     Go To Page:

7/15/17 - Rapidly Increasing Cost of Branded Drugs and Aging Populations Drives the Global Authorized Generics Market
Transparency Market Research Report Added "Authorized Generics Market- Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2016- 2024" Albany, NY 07/14/2017 A generic drug is a duplicate copy of original branded drug, which has same dosage form, active pharma ingredients, strength, route of administration, and also same intend
7/15/17 - Roche`s hold on Avastin, Herceptin sales loosens as FDA panel backs Amgen and Mylan biosims [Arab News (Saudi Arabia)]
Roche took a blockbuster double hit Thursday as the FDAs Oncologic Drugs Advisory Committee recommended an Amgen biosimilar to Avastin in the morning, and then a Mylan biosim to Herceptin in the afternoon. The committee voted 17-0 to recommend FDA approval for Amgens ABP 215, an Avastin biosimilar, in each of the approved indications for the refere
7/15/17 - UNE College of Pharmacy's Edward Li Testifies at FDA Advisory Committee on Breast Cancer Treatment Drug
The University of New England issued the following news release:. Edward Li, M.P.H., BCOP, professor in the College of Pharmacy, has testified at the Open Public Hearing portion of the July 13, 2017 Oncologic Drugs Advisory Committee. Biosimilars are a type of biological product that are licensed by the FDA because they are highly similar to an alr
7/15/17 - US FDA PANEL NOD FOR BIOCON BREAST CANCER DRUG BIOSIMILAR
A panel of the United States Food and Drug Administration has unanimously recommended approval for the biosimilar breast-cancer drug of Biocon. The recommendation takes Biocon closer to. Biocon and Mylan now have to get final approval from the US FDA to commercially launch the product.
7/14/17 - Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval for Azacitidine for Injection Vidaza
By a News Reporter-Staff News Editor at Drug Week Breckenridge Pharmaceutical, Inc. announced that FDA has granted final approval of its ANDA Azacitidine for Injection, 100 mg per vial, Single-Dose Vial, a generic version of Vidaza by Celgene Corporation. Breckenridge submitted the ANDA with its development and manufacturing partner Natco Phar
7/14/17 - Canada Generic Drug Market Driven by Changing Demographics and Government Initiatives
The Canada generic drug market has witnessed a significant growth over the past several years, reaching a volume of around 0.46 Billion Units in 2016. Canada currently represents the ninth-largest generic drug market worldwide, accounting for nearly 3% of the total global share. The latest report by IMARC Group titled, "Canada Generic Drug Market:
7/14/17 - DRUG GIANT FALLS OVER FEAR ITS 13.4M CHIEF HAS QUIT [Daily Mail, London]
July 14 Rumours that AstraZeneca chief executive Pascal Soriot is about to jump ship and head to an Israeli rival yesterday led investors to fear the drug maker could become open to another takeover bid. Any uncertainty around Astra's pipeline could once again make it an acquisition target for fellow drug giant Pfizer, which failed in a highly co
7/14/17 - FDA Panel Backs 2 Biosimilars, ALDR Abuzz, MDXG Q2 Revenue Grows 33%
CANONSBURG- Today's Daily Dose brings you news about Alder's stock offering; FDA panel recommendation of 2 biosimilar candidates; Sangamo's investigational drugs SB-318 and SB-913 getting Fast Track designation; Pfizer's upcoming regulatory catalyst related to its rheumatoid arthritis drug; Mallinckrodt's progress in its CONFIRM trial and MiMedx...
7/14/17 - FDA Panel Recommends Approval Of Mylan And Biocon's Biosimilar Trastuzumab
CANONSBURG- Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration Oncologic Drugs Advisory Committee recommended approval of the companies' proposed biosimilar trastuzumab. Data presented to ODAC included results from analytical, nonclinical and clinical studies which demonstrated that our proposed biosimilar trastuzumab i
7/14/17 - Lannett Receives Approval For Cyproheptadine Hydrochloride Syrup, 2 mg/5 mL
Lannett Company, Inc. today announced that it received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Cyproheptadine Hydrochloride Syrup 2 mg/5 mL, the therapeutic equivalent to the reference standard drug, Cyproheptadine Hydrochloride Syrup by Lyne Laboratories, Inc. The product was previously mar
7/14/17 - Mylan Explores the Patient-Centric Road to Biosimilars
SMi Group has announced that Mr Chrys Kokino, Head Biologics Commercial at Mylan has joined the speaker line-up for the 4th annual Biosimilars North America conference in New Jersey. Chrys will present a talk entitled "The Road to Biosimilars: Reaching our destination with the patient in mind." For media enquiries, contact Honey de Gracia at...
7/14/17 - Proposed Policy, Payment, and Quality Provisions Changes to the Medicare Physician Fee Schedule for Calendar Year 2018
Department of Health and Human Services' Centers for Medicare& Medicaid Services issued the following fact sheet:. On July 13, 2017, the Centers for Medicare& Medicaid Services issued a proposed rule that includes proposals to update payment policies, payment rates, and quality provisions for services furnished under the Medicare Physician Fee Sche
7/14/17 - Sens. Klobuchar, Grassley Urge FTC to Release Pay-for-delay Agreements Report
U.S. Senators Amy Klobuchar and Chuck Grassley have urged the Federal Trade Commission to release its report on pay-for-delay agreements. Release of the FY 2015 and 2016 numbers will help Congress understand whether the Court's decision has altered the behavior of drug manufacturers and what legislative reforms are currently needed.
7/13/17 - Amgen And Allergan To Discuss Data Supporting Biologics License Application For ABP 215, A Biosimilar Candidate To Avastin (bevacizumab)
Amgen and Allergan plc. today announced that the Companies will discuss data supporting the ABP 215 Biologics License Application with the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration. ABP 215 is a biosimilar candidate to Avastin and is the first bevacizumab biosimilar candidate to be considered by the FDA.
7/13/17 - Biocom Institute Issues Statement on Passage of FDA Reauthorization Act
"Biocom commends the House of Representatives on passing important legislation to reauthorize the prescription drug, medical device, generic drug, and biosimilar user fee agreements, which are set to expire in September 2017," said Joe Panetta, president and CEO of Biocom. "These agreements are negotiated by the Food and Drug Administration and li
7/13/17 - Brazil Generic Drug Market Driven by Government Initiatives and Public Health System
Brazil generic drug market has grown at a CAGR of 15% during 2010-2016. Some of the factors which have facilitated the market growth include government initiatives, increase in aging-population and growth in the rate of lifestyle diseases. The latest report by IMARC Group titled, "Brazil Generic Drug Market: Industry Trends, Share, Size, Growth, Fo
7/13/17 - Elite Announces New Development and License Agreement with SunGen Pharma LLC [Sudan Tribune]
-Elite Pharmaceuticals, Inc., a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, today announced it has entered into a new Development and License Agreement with SunGen Pharma, LLC to collaborate, develop and commercialize generic pharmaceutical products based upon a unique drug delivery platform used.
7/13/17 - FDA Oncologic Drugs Advisory Committee Unanimously Recommends Approval of Mylan and Biocon's Proposed Biosimilar Trastuzumab
HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, July 13, 2017/ PRNewswire/ Mylan N.V. and Biocon Ltd. today announced that the U.S. Food and Drug Administration Oncologic Drugs Advisory Committee recommended approval of the companies' proposed biosimilar trastuzumab. Biocon CEO and Joint Managing Director Dr. Arun Chandavarkar said: "
7/13/17 - House Energy & Commerce Committee Issues Report on FDA Reauthorization Act
Greg Walden, R- Ore., on July 11. The Food and Drug Administration Reauthorization Act of 2017 enables FDA to continue to collect user fees from regulated industry to supplement Congressional appropriations. Since 1992, pursuant to PDUFA, Congress has authorized FDA to collect fees from regulated industry to supplement Congressional appropriations.
7/13/17 - Klobuchar, Grassley Urge FTC to Release Pay-for-delay Agreements Report
WASHINGTON, D.C.- U.S. Senators Amy Klobuchar and Chuck Grassley have urged the Federal Trade Commission to release its report on pay-for-delay agreements. Release of the FY 2015 and 2016 numbers will help Congress understand whether the Court's decision has altered the behavior of drug manufacturers and what legislative reforms are currently neede
7/13/17 - Mylan/Biocon Herceptin biosimilar faces EU delay [Algeria Press Service]
Herceptin and Avastin represent two out of three big-selling drugs from Roche that are facing cheaper competition for the first time last year, the drugs each generated sales approaching $7 billion. The news from Biocon throws into question whether the company will be able to launch the Herceptin biosimilar in Europe later this year as previously..
7/13/17 - NVS Gets Thumbs Up, Two Biosimilar Candidates To Face FDA Panel, VKTX On Track
CANONSBURG- Today's Daily Dose brings you news about Amicus' stock offering; the regulatory events related to two biosimilar candidates; Asterias' progress with SCiStar trial; Novartis' leukemia drug wining FDA panel endorsement and the near-term clinical trial catalyst of Viking. Alder Biopharmaceuticals Inc. has offered to sell 15 million shares
7/13/17 - PhRMA Issues Statement on House Passage of PDUFA VI Reauthorization
The Pharmaceutical Research and Manufacturers of America issued the following statement by President and CEO Stephen J. Ubl:. "Timely reauthorization of the Prescription Drug, Biosimilar and Generic Drug User Fee Acts is crucial to patients in need of life-saving treatments and enhancing the competitive market in biopharmaceutical innovation.
7/13/17 - Rep. Green Legislation Passes House of Representatives
As the Ranking Member of the Energy and Commerce Subcommittee on Health, Congressman Green has worked on a bipartisan basis to pass a package of user fee agreements that will reauthorize key FDA capabilities to review and evaluate medical devices, brand and generic drugs, and biosimilar products. Although the current five-year FDA user fee agreemen
7/13/17 - Sex, drugs, and sharing trade secrets [Philly.com]
That's the allegation by Teva Pharmaceuticals USA against a former top executive in Horsham who is accused of sharing trade secrets and confidential business information with her boyfriend, the president and CEO of a rival generic-drug company, Apotex Inc.. Barinder Sandhu was Teva's senior director of regulatory affairs for U.S. generics between 2
Articles(s): 1 - 25 of 232     Next >>     Go To Page:


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