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Appeals court decisions in Vioxx lawsuits indicate 'sanity still exists' in legal system, editorial states

State appeals courts in New Jersey and Texas last week "delivered a one-two punch to the liability suits against Merck for its Vioxx painkiller," an indication that "some sanity still exists in the tort system -- at least at the appellate level," according to a Wall Street Journal editorial.

2 Jun 2008

Journal of Pharmaceutical Innovation publishes groundbreaking scientific papers

The first scientific papers outlining the progress made on the Product Quality Lifecycle Implementation (PQLI) initiative are being published in the June 2008 issue of the Journal of Pharmaceutical Innovation (JPI).

2 Jun 2008

New breast cancer drug combo shrinks aggressive tumours

An international trial of a new breast cancer drug has shown the drug is able to shrink tumours caused by one of the most aggressive forms of the disease.

2 Jun 2008

Peregrine Pharmaceuticals updates on Bavituximab breast cancer study

Peregrine Pharmaceuticals, Inc. has announced that results from a Phase I clinical trial of its lead anti-phosphatidylserine (anti-PS) antibody bavituximab in combination with chemotherapy in patients with advanced cancer were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting.

2 Jun 2008

Mylan acquires generics businesses of Merck KGaA

Mylan Inc. today announced that it has acquired Merck KGaA's Central & Eastern Europe (CEE) generics businesses, which include operations in Poland, Hungary, Slovakia, Slovenia and the Czech Republic.

2 Jun 2008

Oncolytics Biotech announces results for intravenous Reolysin in patients with sarcomas metastatic to the lung

Oncolytics Biotech Inc. has announced that interim results of a Phase II study of intravenous Reolysin in patients with sarcomas metastatic to the lung were presented yesterday at the American Society of Clinical Oncology (ASCO) annual meeting.

2 Jun 2008

Medarex announces preliminary data for investigational anti-PD-1 antibody

Medarex, Inc. has announced preliminary data from an ongoing Phase 1 study of MDX-1106 (ONO-4538: development code of Ono Pharmaceutical Co., Ltd.), a fully human anti-PD-1 antibody.

2 Jun 2008

IDM Pharma presents new data on IDM-2101 in non-small cell lung cancer

IDM Pharma, Inc. today announced follow-up results from the Phase 2 study of IDM-2101 showing that the product candidate was well tolerated, induced broadly specific cytotoxic T lymphocyte (CTL) responses, and showed a positive survival trend in HLA-A2 positive patients with non-small cell lung cancer (NSCLC) who were treated with IDM-2101, compared to a parallel external control group of HLA-A2 negative non-treated patients.

2 Jun 2008

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

Pharmaceutical News

Appeals court decisions in Vioxx lawsuits indicate 'sanity still exists' in legal system, editorial states

Journal of Pharmaceutical Innovation publishes groundbreaking scientific papers

New breast cancer drug combo shrinks aggressive tumours

Peregrine Pharmaceuticals updates on Bavituximab breast cancer study

Mylan acquires generics businesses of Merck KGaA

Oncolytics Biotech announces results for intravenous Reolysin in patients with sarcomas metastatic to the lung

Medarex announces preliminary data for investigational anti-PD-1 antibody

IDM Pharma presents new data on IDM-2101 in non-small cell lung cancer

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

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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