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Second round of revised quality standards for blood thinner heparin released

Further helping to secure public health, a second round of revised quality standards for the widely used blood thinner heparin became effective today, the U.S. Pharmacopeial (USP) Convention announced. Working closely with the Food and Drug Administration (FDA), the pharmaceutical industry, and other regulatory and scientific bodies, USP started initial revisions in 2008 after adverse reactions and deaths resulted from heparin intentionally adulterated with over-sulfated chondroitin sulfate (OSCS).

5 Oct 2009

Phase I clinical trial results to test the safety and immunogenicity of VGX-3100 released

Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, announced today interim safety and immunogenicity data from its therapeutic cervical cancer vaccine (VGX-3100) trial. VGX-3100 is a DNA vaccine targeting the E6 and E7 proteins of human papillomavirus (HPV) types 16 and 18 and is delivered via in vivo electroporation.

5 Oct 2009

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Yesterday, the FDA issued very important draft guidance for pharmaceutical and biotechnology companies for formatting, assessing and modifying Risk Evaluation & Mitigation Strategies (REMS) to ensure the safe use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

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

Workshop to revise and update Pharmacy Benefit Management and Drug Therapy Management

URAC, the nation's leading health care accreditation and education organization, will introduce new performance measures and reporting standards to its Pharmacy Benefit Management (PBM) and Drug Therapy Management (DTM) Accreditation programs at a workshop focused on the latest revisions and updates to the standards.

5 Oct 2009

Researchers engineer antidotes for blood-thinner aptamers

Imagine a surgical patient on a blood-thinning drug who starts bleeding more than expected, and an antidote that works immediately - because the blood thinner and antidote were designed to work together. Researchers at Duke University Medical Center have engineered a way to do this for an entire, versatile class of drugs called aptamers and published their findings in Nature Medicine.

4 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

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

HSPH's survey on H1N1 vaccines

In a new survey, Harvard School of Public Health (HSPH) researchers found that just 40% of adults are "absolutely certain" they will get the H1N1 vaccine for themselves, and 51% of parents are "absolutely certain" that they will get the vaccine for their children. The survey examined the reasoning among those who said they would not get the vaccine or might not. This is the latest in a series of surveys of public views concerning the H1N1 flu outbreak undertaken by the Harvard Opinion Research Program at HSPH. The polling was done September 14-20, 2009.

3 Oct 2009

Report on the worldwide market for anti-infectives

Drug resistance is a key public health problem and also a problem for makers of branded antibacterial products, according to the findings of a new report. Traditional antibiotics: quinolones, cephalosporins, and penicillins, have seen their market share erode due to loss of effectiveness, while at the same time they are facing heavy generic competition.

3 Oct 2009

Publix Pharmacies offers to compound Tamiflu into an oral suspension for no additional charge

In response to the shortage of Tamiflu in liquid form, all 795 Publix Pharmacies will offer to compound Tamiflu into an oral suspension.

3 Oct 2009

Misuse of aspirin might have caused high death rate during 1918-1919 influenza pandemic

The devastation of the 1918-1919 influenza pandemic is well known, but a new article suggests a surprising factor in the high death toll: the misuse of aspirin. Appearing in the November 1 issue of Clinical Infectious Diseases and available online now, the article sounds a cautionary note as present day concerns about the novel H1N1 virus run high.

3 Oct 2009

New study shows that NovoMix 30 is effective for type 2 diabetes patients who are to start on insulin

Data from a new study presented today at the annual meeting of the European Association for the Study of Diabetes (EASD) shows that type 2 diabetes patients starting insulin treatment with once-daily injection of NovoMix® 30 (biphasic insulin aspart) achieve a significantly greater HbA1c reduction compared to patients starting with a daily injection of insulin glargine.

3 Oct 2009

Bradycardia more likely in patients taking cholinesterase inhibitors

People taking one of several drugs commonly prescribed to treat Alzheimer's disease are more likely to be hospitalized for a potentially serious condition called bradycardia than patients not taking these medications.

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

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

Vaccinate children with H1N1 flu vaccine to control swine flu: UAB

The optimal way to control swine flu, the new H1N1 virus that emerged as a global threat in 2009, is to vaccinate children with the planned H1N1 flu vaccine, says the co-director of the University of Alabama at Birmingham (UAB) Division of Pediatric Infectious Diseases.

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

Pharmaceutical News

Second round of revised quality standards for blood thinner heparin released

Phase I clinical trial results to test the safety and immunogenicity of VGX-3100 released

Pharma and biotech companies to assess new FDA REMS guidance

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

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

Workshop to revise and update Pharmacy Benefit Management and Drug Therapy Management

Researchers engineer antidotes for blood-thinner aptamers

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

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

HSPH's survey on H1N1 vaccines

Report on the worldwide market for anti-infectives

Publix Pharmacies offers to compound Tamiflu into an oral suspension for no additional charge

Misuse of aspirin might have caused high death rate during 1918-1919 influenza pandemic

New study shows that NovoMix 30 is effective for type 2 diabetes patients who are to start on insulin

Bradycardia more likely in patients taking cholinesterase inhibitors

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

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

Sagent announces launch of vinorelbine injection

Vaccinate children with H1N1 flu vaccine to control swine flu: UAB

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

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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