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 The leading web portal for pharmacy resources, news, education and careers September 18, 2014
Pharmacy Choice - News - Generic Drugs - September 18, 2014

Pharmacy News

 Generic Drugs
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 52     Next >>     Go To Page:

9/18/14 - Abu Dhabi lays foundation to make anti-cancer generic drugs [Khaleej Times (United Arab Emirates)]
Life Pharma, which is part of Abu Dhabi based VPS Healthcare group, is setting up the plant at Abu Dhabi's Khalifa Industrial Zone.. Life Pharma, which is part of Abu Dhabi based VPS Healthcare group, is setting up the plant at Abu Dhabi's Khalifa Industrial Zone. The project's first two phases would be ready in 18- months, after which production w
9/18/14 - Bharat Book Bureau: Biosimilars - Biosimilars on the cusp of a new era
The biosimilars market is undergoing rapid change with developments such as the recent approvals of infliximab and trastuzumab heralding a new era. In order to keep up with the pace of change in the marketplace, regulatory agencies have been developing updated guidance around the development and approval of biosimilars, but there is still a lack of
9/18/14 - EPIRUS Biopharmaceuticals' Remicade Biosimilar Gets Final Approvals in India [Health & Beauty Close - Up]
EPIRUS Biopharmaceuticals said that it has received final marketing and manufacturing approvals for its Remicade biosimilar, BOW015, from the Drug Controller General of India. "We believe that the data supporting BOW015's clinical comparability to Remicade, presented earlier this year at the EULAR meeting in Paris, combined with EPIRUS' focus on e
9/18/14 - Gilead Inks Generic Licensing Pacts to Increase Access to Hepatitis C Treatments in Developing Countries [Health & Beauty Close - Up]
Gilead Sciences said the company has signed non-exclusive licensing agreements with seven India- based generic pharmaceutical manufacturers to expand access to its chronic hepatitis C medicines in developing countries. In its release, the Company said that the agreements allow the companies- Cadila Healthcare, Cipla, Hetero Labs, Mylan Laboratories
9/18/14 - India,United States : EPIRUS gets approval for its first biosimilar drug distribution called REMICADE [TendersInfo (India)]
The drug company formed out of a merger with Zalicus, Epirus Biopharmaceuticals is announcing its first-ever drug approval. The US Food and Drug Administration is formulating its guidelines for what can be called a biosimilar, other countries, including Europe and India, have moved ahead and are already approving such drugs. It will be manufactured
9/17/14 - Analyzing the Generic Drugs Sector of the US Pharmaceutical Industry - 2014
Dublin- Research and Markets has announced the addition of the "Analyzing the Generic Drugs Sector of the US Pharmaceutical Industry- 2014" report to their offering. This research presents Analyzing the Generic Drugs Sector of the US Pharmaceutical Industry- a comprehensive coverage of the generic drugs market in the United States. Strategies for s
9/17/14 - Draft Guidance for Industry on Abbreviated New Drug Application SubmissionsRefuse To Receive for Lack of Proper Justification of Impurity Limits;...
This draft guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications and related submissions for which the applicant is seeking approval of a new strength of the drug product. The draft guidance highlights deficiencies about impurity information that may cause FDA to refuse to receive an ANDA.
9/17/14 - Gilead Announces Generic Licensing Agreements to Increase Access to Hepatitis C Treatments in Developing Countries
Release date- 16092014- NEW DELHI- Gilead Sciences, Inc. today announced that the company has signed non-exclusive licensing agreements with seven India- based generic pharmaceutical manufacturers to expand access to its chronic hepatitis C medicines in developing countries. The agreements allow the companies- Cadila Healthcare Ltd., Cipla Ltd., He
9/17/14 - Guidance for Industry on Abbreviated New Drug Application SubmissionsRefuse-to-Receive Standards; Availability
This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications and related submissions. The guidance represents the FDA's current thinking regarding the types of serious deficiencies that may cause FDA to refuse-to-receive the submission. ADDRESSES: Submit written requests for single copies of this...
9/17/14 - In AJMC, Oster & Fendrick Challenge Designation of High-Value Generic Drugs as "Non-Preferred" Based on Cost, Not Evidence
An informal survey of plans reported today in The American Journal of Managed Care found that even staples like metformin, the standard first-line therapy for type 2 diabetes, are not off-limits from "non-preferred" status and higher co-pays for consumers. These findings are outlined in an editorial published today by Gerry Oster, PhD, a medical ec
9/17/14 - Research and Markets: Analyzing the Generic Drugs Sector of the US Pharmaceutical Industry - 2014
Research and Markets has announced the addition of the "Analyzing the Generic Drugs Sector of the US Pharmaceutical Industry- 2014" report to their offering. This research presents Analyzing the Generic Drugs Sector of the US Pharmaceutical Industry- a comprehensive coverage of the generic drugs market in the United States. Strategies for survival
9/17/14 - Statement from Ralph G. Neas, President and CEO, GPhA, Regarding the FDA's Public Hearing on GDUFA
Generic Pharmaceutical Association issued the following news release:. The generic industry works closely with FDA to improve access to generic drugs. GDUFA is a historic achievement for both FDA and the generic pharmaceutical industry.
9/16/14 - A.G. Schneiderman Files Groundbreaking Lawsuit to Block Pharmaceutical Manufacturer from Manipulating Alzheimer's Patients
Attorney General Eric T. Schneiderman today announced an antitrust lawsuit seeking to prevent pharmaceutical manufacturer Actavis plc and its New-York based subsidiary Forest Laboratories from forcing Alzheimer's patients to switch medications as part of an anti-competitive strategy designed to maintain high drug prices. Actavis has announced a...
9/16/14 - Gilead Expands Access To Hepatitis C Drugs In Developing Countries
FOSTER CITY- Gilead Sciences Inc Monday signed non-exclusive licensing agreements with seven India- based generic drug makers to expand access to its chronic hepatitis C medicines in developing countries. The agreements allow the companies- Cadila Healthcare, Cipla, Hetero Labs, Mylan Laboratories, Ranbaxy Laboratories, Sequent Scientific, and Stri
9/16/14 - Gilead strikes deal on cheaper version of hepatitis C drug [The Philadelphia Inquirer]
Sept. 16 The shifting global pharmaceutical industry shifted a bit more Monday when Gilead Sciences said it struck a deal with seven India- based generic drugmakers, including a subsidiary of Pittsburgh- based Mylan Inc., to make and sell cheaper versions of Gilead's $1,000- per-pill hepatitis C medication, Sovaldi, in 91 developing nations.
9/16/14 - Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 49025) - Hearing
EVENT: Health and Human Services Department; Food and Drug Administration holds a hearing to solicit public comment on topics related to implementation of the Generic Drug User Fee Amendments of 2012, and the GDUFA Commitment Letter that accompanies the legislation. LOCATION: College Park Marriott Hotel and Conference Center, 3501 University Boulev
9/16/14 - Hetero Enters License Agreement With Gilead Sciences Inc., USA to Produce Generic Sofosbuvir for Treatment of Chronic Hepatitis C
Under the said agreement, Hetero is entitled to manufacture and market sofosbuvir and ledipasvir/sofosbuvir in the territories of India, Asia Pacific, Sub-Saharan Africa and other Least Developed Countries. BPS Reddy, Hetero Group's Chairman commented that, " Hetero is pleased to partner with Gilead on their initiative to bring these life saving me
9/16/14 - Lannett Reports FDA Approval of Oxycodone Hydrochloride Oral Solution [Health & Beauty Close - Up]
Lannett Company has received approval from the U.S. Food and Drug Administration of its abbreviated new drug application for oxycodone hydrochloride oral solution USP, 100 mg per 5 mL. "Oxycodone Hydrochloride Oral Solution USP, 100 mg per 5 mL, is an important and long awaited addition to our pain management franchise and represents our fourth pr
9/16/14 - Mylan Commences Phase III Clinical Trials for its Generic Version of Advair Diskus and Insulin Analog to Lantus
Mylan Inc., one of the world's leading global pharmaceutical companies, today announced it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's Advair Diskus and its insulin analog to Sanofi's Lantus . In October 2014, Mylan will commence a Phase III clinical trial to evaluate the equivalence of its product to
9/16/14 - Research and Markets Adds Report: Biosimilars - Biosimilars on the Cusp of a New Era [Manufacturing Close - Up]
Research and Markets has added "Biosimilars- Biosimilars on the Cusp of a New Era" report to its offerings. In a release, Research and Markets noted that report highlights include:. In order to keep up with the pace of change in the marketplace, regulatory agencies have been developing updated guidance around the development and approval of biosimi
9/16/14 - Simulations Plus Wins Cooperative Agreement with FDA [Global Data Point]
Michael Bolger, chief scientist at Simulations Plus and principal investigator for the cooperative agreement, stated: "We are very pleased to have this opportunity to work with the FDA on this project. Under the cooperative agreement, the FDA's purpose is to support and stimulate Simulations Plus' activities in the development of the improved ocula
9/16/14 - STRIDES ARCOLAB PROMOTER BAGS DEALS FROM GILEAD
Arun Kumar, the reclusive promoter of Strides Arcolab of Bangalore and SeQuent Scientific, has signed two deals with global pharmaceutical major Gilead Sciences. Gilead has signed non-exclusive licensing agreement with seven Indian generic pharmaceutical manufacturers to expand access to its chronic hepatitis C medicines in developing countries.
9/16/14 - The Rheumatoid Arthritis Drug Market Will Grow to $18.2 Billion in 2023, Driven by the Uptake of Oral Jak Inhibitors and Non TNF-alpha Biologics
Decision Resources Group finds that the rheumatoid arthritis disease-modifying antirheumatic drug market will increase from $14 billion in 2013 to over $18.2 billion in 2023 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. In particular, the growth of the Jak inhibitor drug class, driven by the anticipated approv
9/15/14 - APNewsBreak: NY bid to halt Alzheimer's drug swap
ALBANY, N.Y. New York's attorney general filed a federal lawsuit Monday seeking to stop a manufacturer from discontinuing its drug widely used to treat Alzheimer's patients, arguing the company is illegally driving patients to its newer patented drug to avoid losses from cheaper generic alternatives coming out next year. Attorney General Eric...
9/15/14 - EPIRUS Remicade Biosimilar Receives Final Approvals in India
EPIRUS Biopharmaceuticals, Inc., a Boston- based biopharmaceutical company focused on the global development and commercialization of biosimilar monoclonal antibodies, announced today that it has received final marketing and manufacturing approvals for its Remicade biosimilar, BOW015, from the Drug Controller General of India.
Articles(s): 1 - 25 of 52     Next >>     Go To Page:


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