Generic Drug News and Research

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Generic Drugs are official nonbrand names by which medicines are known. Generic names usually refer to the chemical name of the drug.

ViroPharma second-quarter net sales increase 33% to $109.0 million

ViroPharma Incorporated reported today its financial results for the second quarter ended June 30, 2010.

28 Jul 2010

Teva second-quarter net sales increase 12% to $3.8 billion

Teva Pharmaceutical Industries Ltd. today reported results for the quarter ended June 30, 2010.

27 Jul 2010

Teva comments on FDA's approval of generic Lovenox injection

Teva Pharmaceutical Industries Ltd. commented today on the U.S. Food and Drug Administration's response to a citizen petition questioning the approval criteria for a generic Lovenox (enoxaparin sodium) injection and its subsequent approval of another generic filer's Abbreviated New Drug Application.

26 Jul 2010

First generic version of Lovenox receives FDA approval for DVT

The U.S. Food and Drug Administration today approved the first generic version of Lovenox (enoxaparin sodium injection), an anti-coagulant drug used to prevent deep vein thrombosis, a potentially deadly blood clotting condition.

23 Jul 2010

News outlets report on medical intellectual property developments, drug access issues

Inter Press Service reports on a recent symposium on access to medicine, "jointly hosted by the WHO, the World Trade Organization and the World Intellectual Property Organisation."

23 Jul 2010

Health experts and Republicans push for biosimilar drug clinical trials

The Hill: On Monday, experts warned during a Capitol Hill discussion hosted by the Congressional Health Care Caucus that "the absence of mandatory clinical trials for biosimilar drugs could compromise their safety and effectiveness." The recently passed health reform law "outlined a pathway for the Food and Drug Administration (FDA) to approve next-generation biopharmaceuticals modeled on original breakthrough drugs.

21 Jul 2010

U.S. District Court upholds validity of Nycomed's Protonix patent

Nycomed announced today that Judge Jose L. Linares of the U.S. District Court for the District of New Jersey has confirmed the jury verdict in favor of Nycomed and Pfizer Inc. The decision upholds the jury verdict issued on April 23, 2010, confirming that the patent is valid and rejecting allegations by the defendants that the patent was invalid as obvious and invalid for double patenting. Against KUDCo, the US generic drug business of the Schwarz Pharma Group, which did not at-risk launch, final Judgment was entered as a result of Judge Jose L. Linares' rulings.

19 Jul 2010

Judge says FTC likely overstepped authority in sharing drugmaker pay-for-delay info

A judge Wednesday criticized the Federal Trade Commission for the "strong possibility" that it "overstepped its bounds and shared confidential information" in a pay-for-delay case between the government and a generic drug company, Reuters reports.

16 Jul 2010

CPhA welcomes announcement of agreement to lower generic drug prices

The Canadian Pharmacists Association today welcomed the announcement of an agreement reached between the Government of British Columbia, the British Columbia Pharmacy Association, and the Canadian Association of Chain Drug Stores to lower generic drug prices and invest in expanded pharmacy services.

12 Jul 2010

First Edition: July 9, 2010

Today's health policy headlines include news about some little-known health reform provisions and how the Obama administration is using technology to help consumers navigate changes resulting from the health overhaul.

9 Jul 2010

Three Rivers Pharmaceuticals receives FDA expanded labeling for INFERGEN

Three Rivers Pharmaceuticals, LLC, today received expanded labeling from the U.S. Food and Drug Administration (FDA) to include daily use of INFERGEN (Consensus Interferon) in combination with ribavirin (RBV) for retreatment of chronic hepatitis C patients. The expanded labeling targets hepatitis C patients who need retreatment.

6 Jul 2010

Intellipharmaceutics provides update on generic version of Effexor XR

Intellipharmaceutics International Inc., today announced the following with regard to its generic drug commercialization activities.

3 Jul 2010

Experts examine corporate websites dedicated to 100 best-selling prescription drugs

Dartmouth Linguistics Professor Lewis Glinert and Jon Schommer, the associate head of the Department of Pharmaceutical Care and Health Systems at the University of Minnesota, have examined the corporate websites dedicated to the 100 best-selling prescription drugs. They found a startling lack of consistency in an industry where advertising standards are regulated by the Food and Drug Administration.

1 Jul 2010

Experts evlauate impact of Medicare Part D program on independent and chain pharmacies

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Medicare Part D) added prescription drug coverage to Medicare beginning in January 2006.

30 Jun 2010

FDA grants approval for first generic version of Effexor XR antidepressant capsules

On June 28, the U.S. Food and Drug Administration approved the first generic version of Effexor XR capsules (venlafaxine hydrochloride) to treat major depressive disorder.

30 Jun 2010

US District Court upholds validity and enforceability of CRESTOR patent

AstraZeneca announced today that Judge Joseph Farnan, Jr., US District Court, District of Delaware, has found that the substance patent protecting CRESTOR (RE37,314 – the '314 patent) is valid and enforceable. In its ruling, the court found that no inequitable conduct was committed by any Shionogi employee. The court also held the '314 patent to be non-obvious and properly reissued.

30 Jun 2010

MGH, Iacocca Foundation complete Phase I BCG clinical trial in type 1 diabetes

Massachusetts General Hospital (MGH) and the Iacocca Foundation announce today the completion of the Phase I BCG clinical trial in type 1 diabetes, as well as the submission of all safety reports to the U.S. Food and Drug Administration (FDA) and the MGH data safety monitoring boards. Plans for the Phase II clinical study, which will continue the investigation of bacillus Calmette-Guerin (BCG) vaccination as a treatment for people with existing type 1 diabetes, are actively underway.

29 Jun 2010

Prescription Solutions introduces Clinical Vantage to improve health and well-being of members

Prescription Solutions, a leading pharmacy benefit management organization and a UnitedHealth Group company, has launched Clinical Vantage, a suite of clinical programs that enables clients to create specialized solutions to meet their particular needs to improve the health and well-being of members.

25 Jun 2010

Walgreen third-quarter sales up 6.1% to record $17.2 billion

Walgreens today announced earnings and sales results for the third quarter of fiscal year 2010.

22 Jun 2010

Also in Global Health News: WHO scraps drug development group; Access to medication in Philippines; Yellow fever vaccine shortage; HIV-positive employee protection

Lancet World Report examines how "[d]isappointment over a long-awaited report on improving drug research and development for neglected diseases" led the WHO to form a new Consultative Expert Working Group (CEWG) to strategize around drug research and development. The formation of the new group comes after the report from the previous working group (EWG) was questioned due to "what some perceived to be a missed opportunity, unclear methods, a lack of transparency and signs of industry interference" and after "suspicions of impropriety" surfaced.

21 Jun 2010