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New Jersey Superior Court links Roche's Accutane to IBD

In another major courtroom verdict linking powerful acne medication Accutane with long-term inflammatory bowel disease (IBD), a nine-person New Jersey jury has found that pharmaceutical maker Hoffman-La Roche Inc. failed to provide an adequate warning of the possible condition to Andrew McCarrell's prescribing physician, which then led to his development of chronic IBD. Mr. McCarrell, who was 23 at the time he took Accutane, developed a severe case of IBD and thereafter had his colon removed. The jury awarded compensatory damages of $25.16 million to Andy, now in his thirties.

19 Feb 2010

DSM Pharmaceutical Products wins Profiles in Sustainability award

DSM Pharmaceutical Products, based in Parsippany, NJ, today announced that it has received a Profiles in Sustainability award from United Business Media and ICIS Chemical Business. United Business Media Limited is a leading global business media company and parent of InformexUSA, where the award was announced today in San Francisco.

19 Feb 2010

Proven strategies mastered by best-in-class biopharma companies

Companies invest hundreds of millions – and occasionally billions – of dollars overall in developing new drugs and face countless hurdles in bringing these new products to market. To make good on these vast investments, successful companies must maximize product uptake across all customer groups: not only among patients and physicians, but also among government and private payers to win formulary access and improve product placement.

19 Feb 2010

FDA approves 53 new cancer indications between July 2005 and end of 2007

The U.S. Food and Drug Administration's Office of Oncology Drug Products approved more than 50 new indications for the use of oncology and hematology drugs and biologics between July 2005, when the office began reviewing marketing applications, and the end of 2007, according to a new agency study.

19 Feb 2010

UBC researcher finds improved uptake of highly active antiretroviral therapy

A comprehensive population-based study, conducted by the BC Centre for Excellence in HIV/AIDS (BC-CfE) and presented at the 17th Conference on Retroviruses and Opportunistic Infections in San Francisco, shows that expanded highly active antiretroviral therapy (HAART) coverage was associated with a 50% decrease in new yearly HIV infections among injection drug users.

19 Feb 2010

Novartis' Tasigna capsules granted priority review by FDA for treatment of adult patients with Ph+ CML

Novartis announced today that Tasigna® (nilotinib) 200 mg capsules has been granted priority review by the US Food and Drug Administration for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

19 Feb 2010

Researchers develop technology to preserve vaccines in tropical temperatures

A team of British researchers have developed a simple, low-cost method to preserve vaccines in tropical climates, which they say could help to revolutionalize vaccination campaigns in developing countries, Reuters reports.

19 Feb 2010

Pharmaceutical and biotechnology companies working on nearly 200 new medicines to treat diabetes

A Stratton Spotlight article recently highlighted a Centers for Disease Control and Prevention (CDC) survey that showed a dramatic rise in the number of diabetes cases during the last 10 years and noted that pharmaceutical research and biotechnology companies are working on nearly 200 new medicines to treat this debilitating disease.

19 Feb 2010

GSK decides to remove potentially hazardous zinc from denture adhesive products

GlaxoSmithKline, the maker of popular denture adhesives Poligrip and Super Poligrip, announced today that it will remove zinc from all of its denture adhesive products. The pharmaceutical giant has added the potentially hazardous mineral to its adhesives for decades, despite overwhelming evidence that consuming large quantities of zinc over an extended period of time can cause serious neurological damage.

19 Feb 2010

VARI researchers find ways to reverse resistance to sunitinib: Patients with ccRCC show positive response

Van Andel Research Institute researchers have found a way to reverse resistance to sunitinib, a treatment that is currently the first line of defense against clear cell renal cell carcinoma (ccRCC), a deadly form of kidney cancer. Most patients who show a positive response to sunitinib develop a resistance to the drug after one year of treatment.

19 Feb 2010

Valensa International enters into license agreement with Biova for BiovaFlex ingredient

Valensa International (Eustis, FL USA) announced today that it has entered into a license agreement with Biova, LLC (Johnston, Iowa USA) that will allow Valensa to include the patented BiovaFlex(TM) water-soluble egg shell membrane ingredient in a proprietary new series of formulated joint health products.

19 Feb 2010

Report examines how medical technology changes state of health care

Federal researchers Wednesday released a report that examines how medical technology is changing the state of health care.

19 Feb 2010

FDA's proposed label changes for LABA asthma medications: GSK reviews

GlaxoSmithKline is reviewing label changes proposed today by the US Food and Drug Administration (FDA) for asthma medications containing long-acting beta-agonists (LABAs), such as GSK's Advair (salmeterol / fluticasone propionate). GSK and makers of the other affected medicines containing LABAs have 30 days to agree with the proposed changes or state why they are not warranted.

19 Feb 2010

Asthma: LABAs should not be used alone

The U.S. Food and Drug Administration today announced that drugs in the class of long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma in children or adults. Manufacturers will be required to include this warning in the product labels of these drugs, along with taking other steps to reduce the overall use of these medications.

19 Feb 2010

FDA accepts filing of Jazz Pharmaceuticals' NDA for sodium oxybate

Jazz Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has accepted for filing the New Drug Application (NDA) for JZP-6 (sodium oxybate) for the treatment of fibromyalgia.

19 Feb 2010

Lower dose of avosentan drug may provide more favorable results in diabetes patients

The drug avosentan substantially reduces urinary protein loss in people with type 2 diabetes and kidney disease, but the drug causes serious side effects, according to a study appearing in an upcoming issue of the Journal of the American Society Nephrology (JASN).

18 Feb 2010

FDA approves Rituxan-FC combination therapy for CLL

Genentech, Inc., a wholly owned member of the Roche Group, and Biogen Idec announced today the U.S. Food and Drug Administration (FDA) approved Rituxan® (rituximab) in combination with fludarabine and cyclophosphamide (FC) for people with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia (CLL).

18 Feb 2010

GeoVax Labs presents results of preclinical study on prototype HIV/AIDS vaccine at CROI

GeoVax Labs, Inc., an Atlanta-based, biopharmaceutical company developing vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus), today announced that it presented the results of a preclinical study on a prototype HIV/AIDS vaccine at the Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco.

18 Feb 2010

Rituxan, intended for patients with CLL receives FDA approval

The U.S. Food and Drug Administration today approved Rituxan (rituximab) to treat certain patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow cancer.

18 Feb 2010

OPKO Health acquires Pharmacos Exakta

OPKO Health, Inc. today announced that it has completed the acquisition of Pharmacos Exakta, S.A. de C.V. (“Pharmacos Exakta”), a privately-owned Mexican pharmaceutical company engaged in the manufacture, marketing and distribution of ophthalmic and other pharmaceutical products for government and private markets since 1957. OPKO acquired Pharmacos Exakta, including a manufacturing facility owned by an affiliate, for cash and shares of OPKO Common Stock.

18 Feb 2010