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Watson receives approval of Omeprazole delayed-release capsules

Watson Pharmaceuticals, Inc. has announced today that it has received final approval from the U.S. Food and Drug Administration ("FDA") of its Abbreviated New Drug Application (ANDA) for Omeprazole Delayed-Release Capsules USP in the 10mg, 20mg and 40mg strengths.

2 Jun 2008

BiPar Sciences presents data for novel DNA repair inhibitor

BiPar Sciences, Inc. today announced the results of first-in-human clinical studies of its lead product, BSI-201, in patients with solid tumors.

2 Jun 2008

Genta announces initial trial results for novel drug for bone disease

Genta Incorporated has announced the release of final results from the Company's Phase 1 clinical trial of G4544, a proprietary small molecule that is intended as a treatment for diseases associated with accelerated bone loss. Results showed that the drug was very well-tolerated, and that blood levels were achieved in a range that is known to be clinically bioactive. The data were featured in a poster session at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago on Saturday, May 31, 2008.

2 Jun 2008

Connecticut Attorney General files lawsuit against McKesson over alleged inflation of prescription drug prices

Connecticut Attorney General Richard Blumenthal (D) on Thursday filed a lawsuit in U.S. District Court in Boston over allegations that prescription drug distributor McKesson conspired to inflate the average wholesale prices of hundreds of brand-name medications in violation of federal racketeering and state consumer protection laws, the AP/Hartford Courant reports.

30 May 2008

Appeals courts overturn two verdicts, judgment on award payment in Vioxx lawsuits

State appeals courts in New Jersey and Texas on Thursday reversed two jury verdicts and a judgment on payment of legal fees in lawsuits related to the COX-2 inhibitor Vioxx that would have required Merck to pay about $37 million, Bloomberg/Washington Post reports (Van Voris/Voreacos, Bloomberg/Washington Post, 5/30).

30 May 2008

Thailand's removal of official who supported compulsory licensing 'important' step to 'protecting patients' health,' editorial says

The Thai government's removal last week of Vichai Chokevivat -- "one of the most vocal opponents" of patent protections for drug companies -- from Governmental Pharmaceutical Organization's board is a "small" but "important" step in "restoring Thailand's international reputation and protecting patients' health," a Wall Street Journal Asia editorial says.

30 May 2008

FDA proposes drug label changes to provide more information on risks for women who are pregnant, nursing

FDA on Wednesday proposed changing its labeling system for prescription and over-the-counter drugs to provide more safety information for pregnant and breastfeeding women, the AP/Long Island Newsday reports (AP/Long Island Newsday, 5/28). On average, women in the U.S. take three to five medications when they are pregnant, and more than 90% of women who are breastfeeding take medications during the first week after delivery, USA Today reports.

30 May 2008

Grassley inquiry into fast-tracking of Avastin drug applications could hurt cancer drug development, patients

Sen. Chuck Grassley's (R-Iowa) request that the Government Accountability Office investigate whether FDA acted appropriately in granting "accelerated approval" to a cancer drug "will have a catastrophic effect on America's ability to develop new drugs," Mark Thornton, a former medical officer in FDA's Office of Oncology Drug Products and president of the Sarcoma Foundation of America, writes in a Wall Street Journal opinion piece.

30 May 2008

Brand-name prescription drug companies reached 14 deals with generic manufacturers to delay sale of generics in FY 2007

Brand-name prescription drug makers in fiscal year 2007 reached 14 agreements with generic drug makers to delay market entry of generic medications, according to a report released on Wednesday by the Federal Trade Commission, Reuters reports (Bartz, Reuters, 5/23).

28 May 2008

Bureaucracy has delayed plans for three FDA offices in China

HHS Secretary Mike Leavitt on Friday said that Chinese bureaucracy has delayed plans to establish FDA offices in three cities -- Beijing, Shanghai and Guangzhou -- that would monitor exports of food, medications, medical devices and other consumer products to the U.S., the Associated Press reports.

28 May 2008

Express Scripts reaches $9.5 million settlement with 28 states over allegations of misleading consumers to obtain rebates

Officials from pharmacy benefit manager Express Scripts on Tuesday said the company has agreed to pay $9.5 million to settle lawsuits brought by 28 states and Washington, D.C., alleging it defrauded the states and D.C., the AP/Denver Post reports.

28 May 2008

Health Care Coalition pushes for e-prescribing legislation

The technical standards necessary to establish a national electronic prescribing system already have been adopted by physicians and pharmacy software companies, according to a letter to lawmakers from a coalition of health care providers, insurance companies, academics and pharmacies, CQ HealthBeat reports.

28 May 2008

FDA proposes major revisions to the physician labeling for prescription drugs

The U.S. Food and Drug Administration today proposed major revisions to the physician labeling for prescription drugs (including biological products) to provide better information about the effects of medicines used during pregnancy and breast-feeding.

28 May 2008

Breakthrough by WHO will give poor countries better access to drugs

An agreement has been reached by world health leaders regarding approaches to drug research and development and improving access to medicines.

27 May 2008

Bliss Nipple Cream warning from FDA

The U.S. Food and Drug Administration is warning consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants.

25 May 2008

Pennsylvania State agency seeks to gain control of Medicaid managed care plans' prescription drug benefits

The administration of Pennsylvania Gov. Ed Rendell (D) has proposed shifting control of the prescription drug component of Medicaid managed care plans to the state Department of Public Welfare, the Pittsburgh Post-Gazette reports.

22 May 2008

Pharmaceutical, medical device industries have shifted campaign contributions to Democratic candidates

Pharmaceutical and medical device companies have contributed more to the campaigns of Democratic candidates than Republican candidates in the current election cycle, a "sharp reversal" from previous cycles and "one more sign of the campaign difficulties the GOP could face this November," the AP/Miami Herald reports.

22 May 2008

Merck agrees to pay $58 million to aettle multistate lawsuit that claimed advertisements for Vioxx played down health risks

Merck on Tuesday agreed to a $58 million settlement with 29 states and the District of Columbia to end investigations over allegations that it downplayed cardiovascular risks caused by the COX-2 inhibitor Vioxx in direct-to-consumer advertisements dating back to 1999, the AP/Philadelphia Inquirer reports (Raffaele, AP/Philadelphia Inquirer, 5/21).

21 May 2008

House Committee leaders warn pharmaceutical companies to end use of 'misleading' advertisements

House Energy and Commerce Committee Chair John Dingell (D-Mich.) and Oversight and Investigations Subcommittee Chair Bart Stupak (D-Mich.) in a recent letter warned four pharmaceutical companies to end the use of "misleading and deceptive" direct-to-consumer advertisements for medications, CQ HealthBeat reports.

21 May 2008

Advaxis files investigational new drug application for Lovaxin C

Advaxis Inc. completed its filing of a new investigational new drug ("IND") application with the U.S. Food and Drug Administration ("FDA"). This filing follows the successful completion of a Phase I study overseas.

20 May 2008

Pharmaceutical News

Watson receives approval of Omeprazole delayed-release capsules

BiPar Sciences presents data for novel DNA repair inhibitor

Genta announces initial trial results for novel drug for bone disease

Connecticut Attorney General files lawsuit against McKesson over alleged inflation of prescription drug prices

Appeals courts overturn two verdicts, judgment on award payment in Vioxx lawsuits

Thailand's removal of official who supported compulsory licensing 'important' step to 'protecting patients' health,' editorial says

FDA proposes drug label changes to provide more information on risks for women who are pregnant, nursing

Grassley inquiry into fast-tracking of Avastin drug applications could hurt cancer drug development, patients

Brand-name prescription drug companies reached 14 deals with generic manufacturers to delay sale of generics in FY 2007

Bureaucracy has delayed plans for three FDA offices in China

Express Scripts reaches $9.5 million settlement with 28 states over allegations of misleading consumers to obtain rebates

Health Care Coalition pushes for e-prescribing legislation

FDA proposes major revisions to the physician labeling for prescription drugs

Breakthrough by WHO will give poor countries better access to drugs

Bliss Nipple Cream warning from FDA

Pennsylvania State agency seeks to gain control of Medicaid managed care plans' prescription drug benefits

Pharmaceutical, medical device industries have shifted campaign contributions to Democratic candidates

Merck agrees to pay $58 million to aettle multistate lawsuit that claimed advertisements for Vioxx played down health risks

House Committee leaders warn pharmaceutical companies to end use of 'misleading' advertisements

Advaxis files investigational new drug application for Lovaxin C

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