Pharma Industry Animation Marketing

Pharmaceutical Companies Seek Clarity On Evidence Needed For Drug Label Change
With the discovery of a growing number of predictive biomarkers for existing drugs, the question of when and how to add pharmacogenetic information to drug labels has taken on greater urgency. On December 16 the Oncologic Drug Advisory Committee (ODAC) of the Food and Drug Administration (FDA) met in Gaithersburg, MD with representatives from pharmaceutical companies Amgen and Imclone.

DNA Nanotubes May Soon Find Their Way Into A New Generation Of Ultra-Tiny Electronic And Biomedical Innovations
Arizona State University researchers Hao Yan and Yan Liu imagine and assemble intricate structures on a scale almost unfathomably small. Their medium is the double-helical DNA molecule, a versatile building material offering near limitless construction potential.

American Medical Student Association Applauds Pharmaceutical Industry For Voluntary Ban; Continues To Call For Federal Regulation
The American Medical Student Association (AMSA), the nation's oldest and largest, independent association for physicians-in-training, applauds the pharmaceutical industry for implementing a voluntary ban on gifts to physicians, which began on January 1, 2009. Enacted by the Pharmaceutical Research and Manufacturers of America (PhRMA), the ban will prohibit pens, coffee mugs and other branded gifts.

FDA Approves Most Comprehensive System To Test Donated Blood For HIV, Hepatitis B & Hepatitis C
The United States Food & Drug Administration (FDA) approved a new nucleic acid test from Roche to screen donated blood for HIV-1 Group M RNA, hepatitis C RNA and hepatitis B DNA in a single, automated assay. The test, called the cobas TaqScreen MPX Test for use on the cobas s 201 system, is a qualitative in vitro test for comprehensive single-assay detection of HIV-1 Group M RNA, HIV-1 Group O RNA, HIV-2 RNA, hepatitis C Virus RNA and hepatitis B Virus DNA in human plasma.

Bionovo Publishes Discoveries In Predictable Tissue Selectivity For Selective Estrogen Receptor Modulators Platform
Bionovo, Inc. (Nasdaq: BNVI) announced results describing predictable estrogen regulatory elements that can be used to identify estrogenic drugs that are safer. The data, published in Molecular and Cellular Endocrinology, showed that the new regulatory elements can distinguish the estrogenic pharmacological activity exerted by different compounds and allow for more accurate prediction of specific tissue effect.

Schering-Plough Announces European Submission Of Fertility Medicine Corifollitropin Alfa
Schering-Plough Corp., (NYSE: SGP), a leading provider of fertility treatments, announced today that the European Medicines Agency (EMEA) has validated (accepted for review) its Marketing Authorization Application (MAA) for corifollitropin alfa, the company's experimental, sustained follicle stimulant (SFS). This application will follow the Centralized Procedure.

FDA Issues Complete Response Letter To Ipsen For Dysport® Biologics License Application For Treatment Of Cervical Dystonia
Ipsen (Paris:IPN) today announced that the US Food and Drug Administration (FDA) issued a Complete Response Letter for its Biologics License Application (BLA) for its Botulinum toxin Type A, Dysport®. The application, submitted by the Group in late 2007, seeks approval to market Dysport® for the treatment of cervical dystonia. The Group is now actively preparing to launch the product, once approved by the FDA, and as soon as reimbursement coverage is adequate.

Cleveland BioLabs Reports Advances In Curaxin Anticancer Program
Cleveland BioLabs, Inc. (NASDAQ: CBLI) announced several advances in the development of Curaxins, the leading class of drug candidates in the Company's anticancer drug discovery program. Curaxins are synthetic small molecules designed to simultaneously target major stress response pathways that are frequently deregulated in cancer.

Pegloticase BLA Filing Accepted For Priority Review By FDA
Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's Biologics License Application (BLA) for pegloticase, a novel biological drug for treatment-failure gout (TFG) patients. The FDA also granted the Company's BLA with a priority review status which accelerates the review period to six months.

Pfizer Tops Annual "Most Effective" Sales Force Ranking, According To Study By GfK Market Measures
For the fifth year in a row, Pfizer has claimed the top spot as the industry's "most effective" sales force, as ranked by GfK Market Measures in a study with more than 800 physicians across 12 specialties.

Dynavax Announces Termination Of Partnership With Merck For HEPLISAVâ„¢ Hepatitis B Vaccine - All Rights Revert To Dynavax
Dynavax Technologies Corporation (Nasdaq:DVAX) today announced the termination of a global license and development collaboration agreement with Merck & Co., Inc. for HEPLISAVTM, a Phase 3 hepatitis B virus (HBV) vaccine. All rights to develop and commercialize HEPLISAV revert to Dynavax.

Teva Announces Tentative Approval Of Generic Seroquel® Tablets
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of AstraZeneca's antipsychotic agent Seroquel® (Quetiapine Fumarate) Tablets, Eq. 25 mg base, 50 mg base, 100 mg base, 150 mg base, 200 mg base, 300 mg base and 400 mg base. The brand product had annual sales of approximately $3.

New Report Highlights Dramatic Change In U.S. Drug Spending Trends, Policy Implications
A major reduction in real prescription drug spending growth has created a "turning point" in healthcare with several policy implications, according to a study published this month by the journal Health Affairs as a Web Exclusive. The report, "Prescription Drug Spending Trends in the United States: Looking Beyond the Turning Point," uses IMS Health (NYSE: RX) information adjusted for inflation to document that U.S.

New Paradigm For Medicinal Chemistry Offered By International Public-Private Partnership
The Wellcome Trust has announced a £4.1 million investment in a new initiative to generate small molecule inhibitors - "chemical probes" - for 25 proteins involved in epigenetic signalling, and to release these probes into the public domain with no restriction on use. Early stage information sharing on chemical probes is highly unusual and breaks with the tradition of keeping such data confidential.

NicOx Announces Results For TPI 1020 In COPD
NicOx S.A. (NYSE Euronext Paris: COX) announced the results of a phase 2a study for TPI 1020, conducted in 62 patients with Chronic Obstructive Pulmonary Disease (COPD) by its partner Topigen Pharmaceuticals Inc. TPI 1020 showed good overall safety and tolerability, although its activity profile was not significantly different from budesonide, a conventional corticosteroid commonly used in respiratory disorders.