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Pharma and biotech companies to assess new FDA REMS guidance

Yesterday, the FDA issued very important draft guidance for pharmaceutical and biotechnology companies for formatting, assessing and modifying Risk Evaluation & Mitigation Strategies (REMS) to ensure the safe use of pharmaceutical products.

5 Oct 2009

Diagnocure signs agreement with Lab21 for marketing its Previstage test

DiagnoCure Inc., a life sciences company commercializing high-value cancer diagnostic tests and delivering laboratory services, announced that it signed an exclusive agreement with a new partner, Lab21, a global provider of diagnostic products and services, for the promotion, marketing and selling of its Previstage(TM) GCC Colorectal Cancer Staging Test in the United Kingdom and Ireland.

5 Oct 2009

comScore study results of changes in search engine marketing in the pharmaceutical industry

comScore, Inc., a leader in measuring the digital world, today released the results of a study of changes in search engine marketing in the pharmaceutical industry as a result of the FDA warning letters distributed in March 2009.

5 Oct 2009

The Lewin Group issues recommendations to overcome barriers obstructing the lupus drug development

Today, The Lewin Group, a national health care consulting firm, issued recommendations on ways to overcome the barriers that have obstructed lupus drug development resulting in no new drug approval for this disease in more than 50 years - since the Eisenhower Administration.

From CSL Ltd 5 Oct 2009

The EURORDIS and NORD rare disease organizations form a partnership

The leading advocacy groups for Americans and Europeans with rare diseases -- the National Organization for Rare Disorders (NORD) and the European Organization for Rare Diseases (EURORDIS) -- have signed a Memorandum of Understanding to join forces on several key strategic initiatives on behalf of rare disease patients and their families.

3 Oct 2009

$APP Pharmaceutical continues support of FDA's USP standards for unfractionated heparin$

APP Pharmaceutical continues support of FDA's USP standards for unfractionated heparin

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ:APCVZ), and the leading supplier of heparin sodium to the U.S. market, announced today its continued support of the US Food & Drug Administration (FDA) and medical community for the October 1, 2009 implementation of the new United States Pharmacopeia (USP) monograph change for unfractionated heparin.

3 Oct 2009

Pharmatek to install the Xcelodose automated encapsulator system in San Diego

Pharmatek Laboratories, Inc., a premier contract development and manufacturing organization supporting the pharmaceutical industry, announced that it is the first CRO on the West Coast to acquire the Xcelodose system, enhancing the company's preclinical and early phase clinical GMP supply capabilities.

3 Oct 2009

Caraco closes Asset Purchase Agreement with Forest as part of ANDA patent litigation settlement

Caraco Pharmaceutical Laboratories, Ltd. announced that, as part of the previously announced settlement of the legal proceedings related to Lexapro (escitalopram oxalate) tablets, it closed an Asset Purchase Agreement ("APA") transaction with Forest Laboratories, Inc. ("Forest") to acquire several products from Forest's Inwood line of business.

3 Oct 2009

HCRI commences patient enrollment in dual antiplatelet therapy study

The Harvard Clinical Research Institute (HCRI) announced today that the first patients have been enrolled in the DAPT Study, marking the official initiation of the four-year clinical trial to investigate the duration of dual antiplatelet therapy (DAPT, the combination of aspirin and a thienopyridine/antiplatelet medication to reduce the risk of blood clots) following drug-eluting stent implantations.

3 Oct 2009

Retinoic acid may provide relief for ulcerative colitis

Here's another reason why you should take your vitamins. A new research report appearing in the October 2009 print issue of the Journal of Leukocyte Biology (http://www.jleukbio.org) suggests that retinoic acid, the oxidized form of vitamin A, could be a beneficial treatment for people suffering from ulcerative colitis and other irritable bowel diseases.

3 Oct 2009

Electronic medical records: A valuable asset to healthcare industry

Hundreds of billions of gigabytes of health information are now being collected in electronic medical records, and three-quarters (76%) of more than 700 healthcare executives recently surveyed by PricewaterhouseCoopers LLP agree that the secondary use of this information will be their organization's greatest asset over the next five years.

3 Oct 2009

TMS Health expands its Boca Raton Headquarters

TMS Health, the largest provider of outbound and inbound Teleservices to the U.S. Pharmaceutical Industry, is expanding its Boca Raton headquarters.

3 Oct 2009

TNF-alpha inhibitor drug class sales to increase up to $1.1 billion in 2018

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, in addition to sales of Centocor Ortho Biotech/Schering-Plough/Mitsubishi Tanabe Pharma's Remicade, the two emerging TNF-alpha inhibitors Abbott/Eisai's Humira and Centocor Ortho Biotech/Schering-Plough/Mitsubishi Tanabe Pharma/Janssen's Simponi will drive sales of the TNF-alpha inhibitor drug class to nearly triple by 2018 for the treatment of ulcerative colitis.

3 Oct 2009

RXi receives USPTO notices of allowance for certain siRNA sequence-specific patent applications

RXi Pharmaceuticals Corporation, a biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi), today announced that Notices of Allowance were recently issued by the United States Patent Office (USPTO) on patent applications filed by Thermo Fisher Scientific Inc. and licensed to RXi Pharmaceuticals encompassing small interfering RNA (siRNA) sequences targeting superoxide dismutase (SOD1), Amyloid beta (A4) precursor protein (APP), interleukin-1 receptor-associated kinase 4 (IRAK4), hepatocyte growth factor receptor (MET protooncogene) and cyclin-dependent kinase (cdk) inhibitor p27 (also known as Kip1, CDKN1B).

From Thermo Fisher Scientific Inc. 3 Oct 2009

Quest PharmaTech acquires immunotherapeutic antibody products from Paladin Labs

Quest PharmaTech Inc. ("Quest" or the "Company"), a pharmaceutical company developing and commercializing products for the treatment of cancer, today announced that it has acquired a pipeline of late-stage immunotherapy product candidates from Paladin Labs Inc. ("Paladin").

3 Oct 2009

Chinese government places second purchase order for Sinovac Biotech's H1N1 vaccine

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today that Sinovac has received its second purchase order for its H1N1 vaccine, PANFLU.1, from the Ministry of Industry and Information Technology of the People's Republic of China for the national stockpiling plan.

3 Oct 2009

Sagent announces launch of vinorelbine injection

Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced that it has launched vinorelbine injection, USP, an anti-mitotic chemotherapy drug. According to IMS, 2008 sales of vinorelbine injection, USP in the United States approximated $17 million. Sagent will begin marketing and shipping vinorelbine injection immediately.

3 Oct 2009

New strategic research service for the oncology market launched by Health Strategies Group

Health Strategies Group, a leading provider of market intelligence to the pharmaceutical and biotechnology industries, has just launched Oncology Performance Edge, a new strategic research service that helps marketing and sales executives in the oncology field improve brand performance by understanding how best to invest their resources.

3 Oct 2009

DelSite's assests acquired by Nanotherapeutics

Nanotherapeutics, Inc., a privately held specialty biopharmaceutical company, announced today that it had acquired certain assets from DelSite (formerly Carrington Laboratories, Inc.) out of Chapter 7 bankruptcy proceedings in the U.S. Bankruptcy Court for the Northern District of Texas, Dallas Division.

3 Oct 2009

Lawmakers get contributions from industry groups and associated lobbyists

A study by the Center for Responsive Politics and the Sunlight Foundation has found that key lawmakers have received significant contributes not only from major health industry companies - who often lead in contributions to members of Congress - but also from their lobbyists, who have contributed from their personal resources, The Washington Post reports.

3 Oct 2009