NASHIK: The allegations by doctors and chemists that the bio-availability of generic drugs was doubtful were termed as baseless by the state commissioner of the Food and Drug Administration, Mahesh Zagade. Bio-availability is the amount of the drug that reaches the targeted organ when administered. The commissioner was in Nashik to attend a program
The regulator claims Alpharma, Genetics UK and Norton Healthcare were paid by GSK to delay production of cheaper copycat versions of the drug which could have saved the NHS millions. If the OFT proves its case, it could hit GSK with a fine worth 30% of its UK turnover during 2001-04, which averaged pounds 1.4 bn per year. In January 2013, the US Fe
The regulator claims Alpharma, Genetics UK and Norton Healthcare were paid by GSK to delay production of cheaper copycat versions of the drug which could have saved the NHS millions. If the OFT proves its case, it could hit GSK with a fine worth 30% of its UK turnover during 2001-04, which averaged pounds 1.4 bn per year. In January 2013, the US Fe
By a News Reporter-Staff News Editor at Health& Medicine Week- Actavis, Inc. confirmed that the United States District Court for the District of New Jersey has granted a motion by AstraZeneca seeking a temporary restraining order to prevent Actavis from further distribution of its generic version of AstraZeneca's Pulmicort RESPULES 0.25, 0.5 mg p
TRENTON, N.J. Biotech drugmaker Amgen Inc. will focus on recent results on a key experimental melanoma drug, testing of other drugs and revenue from its top-selling drugs when it reports first-quarter results after the stock market closes Tuesday. Amgen executives are expected to lay out plans to release detailed results on TVEC, short for the...
The European Federation of Pharmaceutical Industries and Associations issued the following news release:. The European Federation of Pharmaceutical Industries& Associations, its specialised group the European Biopharmaceutical Enterprises and the European Association for Bioindustries welcome the consensus information document on biosimilars...
Generic Pharmaceutical Association issued the following news release:. The BPC proposal calls for stronger incentives for Medicare low-income subsidy beneficiaries to use lower-cost drugs, along with incentives for Part D plans to provide generic alternatives. The Medicare low-income subsidy population can benefit similarly, saving billions by...
"For too long, drug abusers have been able to crush or dissolve opioid drug products like OxyContin and defeat the time-release mechanisms for snorting or injecting the drugs," said Upton, who met with law enforcement leaders attending a meeting of the Michigan Association of Chiefs of Police, Fifth District, as well as other state and local offici
Hyderabad: Drug firm Lupin is gearing up for a commercial launch of Bayer's oral contraceptive Yaz in the US market after patent holder lost the case to generic drug makers in higher court. The Indian pharma company is currently awaiting the US Food and Drug Administration approval for the tablets containing drospirenone and ethinyl estradiol.
By a News Reporter-Staff News Editor at Health& Medicine Week The Lupus Foundation of Florida applauds the Health Policy committee of the Florida Senate for the passage of Senate Bill 732 out of committee. "As a patient advocate, I overwhelmingly support this bill, which sets guidelines for safely introducing biosimilar drugs into the Florida ph
Dublin- Research and Markets has announced the addition of the "Healthcare, Regulatory and Reimbursement Landscape- Portugal" report to their offering. Blockbuster drugs such as Amgen's Neupogen, AstraZeneca's Nexium, Bristol-Myers Squibb's Abilify, and Pfizer's Celebrex are all due to lose their patents in the next two years, opening the market to
Research and Markets has announced the addition of the " Russia Generics and Biosimilars" report to their offering. The Generics market in Russia is dominated by foreign manufacturers in terms of value, despite high volume sales of local products. Despite high volume uptake, generics still only account for a small proportion of the total market val
Research and Markets has announced the addition of the "The Politics of Pharma: Washington, States, and the Court's Impact on the Industry" report to their offering. Post-election, another bi-partisan congressional group is pushing for the FDA to impose stricter regulations on certain painkillers. Meanwhile, the Administration's prioritization of g
Dublin- Research and Markets has announced the addition of the Russia Generics and Biosimilars report to their offering. The Generics market in Russia is dominated by foreign manufacturers in terms of value, despite high volume sales of local products. Despite high volume uptake, generics still only account for a small proportion of the total marke
Research and Markets has announced the addition of the "The Politics of Pharma: Washington, States, and the Court's Impact on the Industry" report to their offering. The November elections kept the face of Washington the same, with the re-election of President Obama, Democratic control of the Senate and Republican control of the House. Post-electio
MUMBAI: Cipla has announced the launch of the first biosimilar of' etanercept' in India under the brand' Etacept' for the treatment of rheumatic disorders. Formed through a partnership alliance, the drug is manufactured by a China- based company Shanghai CP Guojian Pharmaceutical Co, which will be marketed by Cipla. The introduction of Etacept now
Research and Markets has announced the addition of the "Comparison of Biopharmaceutical Industry between China and India 2013" report to their offering. The report, Comparison of Biopharmaceutical Industry between China and India, has revealed the relative competencies of the biopharmaceutical industry in these two countries, including their curren
The FDA also said this week it will not accept or approve generic versions of the drug. The FDA approved the original formulation of OxyContin in 1995, but the product was abused by addicts who discovered crushing or dissolving the pill caused the drug to be released more rapidly in the bloodstream. "The development of abuse-deterrent opioid analg
The report' Generic Pharmaceuticals- Industry Report' analysis is the most definitive and accurate study of the generic pharmaceuticals sector in 2013. The report is split into two sections and uses both a written and graphical analysis- analysing the 200 largest Generic Pharmaceuticals companies. The Generic Pharmaceuticals report contains the...
Chairman Upton, Ranking Member Waxman, and Members of the Committee, thank you for the invitation to discuss the President's FY 2014 Budget for the Department of Health and Human Services. The Budget totals $967.3 billion in outlays and proposes $80.1 billion in discretionary budget authority. Marketplaces will be operational in 2014; open enrollme
BURLINGTON, Mass., April 18, 2013/ PRNewswire/ Decision Resources Group is pleased to announce a distinguished lineup of speakers who will be joining its well-regarded Competitive Landscape Seminar Series focusing on Biologics and Biosimilars on May 2, 2013 at the Hotel Solamar in San Diego, CA. The panel discussion will focus on the key issues a
Research and Markets has announced the addition of the "Comparison of Biopharmaceutical Industry between China and India 2013" report to their offering. The report, Comparison of Biopharmaceutical Industry between China and India, has revealed the relative competencies of the biopharmaceutical industry in these two countries, including their curren
Richard W. Schulte, a partner with the experienced drug injury firm of Wright& Schulte LLC, continues his fight on behalf of victims of generic drug injuries, the Firm reports. On March 14th, the Sixth Circuit Court of Appeals ruled that a woman being represented by Richard Schulte could proceed with her state failure to warn claim against Pliva, I
And I would like to thank the Subcommittee for its past investments in FDA, which have helped us meet the demands of our broad and increasingly complex mission. I. FDA plays a vital role in the health of our citizens and our regulated industries. Congress has given FDA responsibility for a vast range of products that are central to the health and w
A Food and Drug Administration Advisory committee will convene on May 2nd to vote for or against recommending tivozanib for approval. Sorafenib is marketed by Onyx Pharmaceuticals under the trade name of Nexavar global Nexavar net sales topped over $1 billion in 2011.. Tivozanib should receive a positive recommendation from the FDA Adcomm, so I w