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FDA issues complete response letter regarding the NDA for carisbamate

The U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for carisbamate, an anti-epileptic drug in development, announced Ortho-McNeil-Janssen Pharmaceuticals, Inc.

23 Aug 2009

Adamas Pharmaceuticals forges agreement with U.S. Naval Health Research Center for evaluating triple combination antiviral drug

Adamas Pharmaceuticals, Inc., a privately held company, announced today that it has entered into a Cooperative Research and Development Agreement (CRADA) with the United States Naval Health Research Center for preclinical studies evaluating Adamas' triple combination antiviral drug (TCAD) therapy for influenza A, including novel influenza A/H1N1. TCAD therapy includes Adamas' investigational proprietary fixed-dose oral combination drug, to be administered adjunctively with a neuraminidase inhibitor, including Tamiflu (oseltamivir phosphate, Roche).

22 Aug 2009

Cortex Pharmaceuticals receives delisting notification from NYSE Amex

Cortex Pharmaceuticals, Inc. (NYSE Amex (COR)) reported that it has received a delisting notification from the NYSE Amex LLC indicating that it has not accepted the Company’s plan to regain compliance with the Exchange’s continued listing standards, as submitted by the Company in June.

21 Aug 2009

FDA approves Epocal's new glucose test on the epoc Blood Analysis System

Epocal, Inc., a leading edge provider of point of care technology, announced today that it has received U.S. Food and Drug Administration (FDA) clearance to market its new glucose test on the epoc Blood Analysis System.

21 Aug 2009

Nutra Pharma launches Cobroxin for chronic pain relief

Nutra Pharma Corp. (OTCBB: NPHC), a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), has announced today that it has launched an over-the-counter (OTC) pain reliever, Cobroxin, for the treatment of Stage 2 (moderate to severe) chronic pain.

21 Aug 2009

Takeda Canada reacquires commercial rights for an oral type 2 diabetic treatment drug

Takeda Canada, Inc. announced that it has reacquired the Canadian commercial rights to ACTOS(R) (pioglitazone HCl), an oral treatment for type 2 diabetes, from Eli Lilly Canada Inc. Takeda, the discoverer of ACTOS, licensed the drug to Lilly as part of a worldwide agreement in 1999.

21 Aug 2009

Syntagon to deliver presentation on controlling genotoxic impurities

Leading contract research organisation, Syntagon, is to deliver a presentation on controlling genotoxic impurities at one of the Pharma industry’s highest profile events, CPhI Worldwide, being held this October in Madrid, Spain.

21 Aug 2009

Medicago and Ajanta Pharma forge MoU to commercialize seasonal influenza VLP-based vaccines in India

Medicago Inc., a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced that it has signed a Memorandum of Understanding ("MOU") with Ajanta Pharma Limited ("Ajanta") to discuss and negotiate an agreement to commercialize Medicago's pandemic and seasonal influenza VLP-based vaccines in India and other territories.

21 Aug 2009

New antimalarial drug discovery project funded by European Commission

The European Commission is funding a two year, -500,000 project to co-ordinate European and international research into the development of new drugs to treat malaria.

21 Aug 2009

Newspapers examine debate over affordable drugs in developing countries

The Los Angeles Times examines how "activists in Washington, and Thailand and other developing countries are accusing the Obama administration of endangering access to affordable drugs to fight AIDS and other epidemic diseases."

21 Aug 2009

U.S District Court grants preliminary approval for the settlement of Sampson v. Robinson case

Bristol-Myers Squibb Company (NYSE:BMY) announced today that the United States District Court for the Southern District of New York has granted preliminary approval of settlement of Sampson v. Robinson, et al., Case No. 1:07-CV-06890 (on appeal: Case No. 08-5475), a shareholder action pursued derivatively on behalf of Bristol-Myers Squibb. The action concerned allegations relating to the efforts to settle the Plavix patent litigation in 2006. The proposed settlement is subject to final Court approval. The Court has set a final approval hearing for December 8, 2009 at 2 p.m. in the courtroom of the Honorable Paul A. Crotty, United States District Judge.

21 Aug 2009

Health Canada approves Anika Therapeutics' MONOVISC drug

Anika Therapeutics, Inc. (Nasdaq: ANIK), a leader in products for tissue protection, healing and repair based on hyaluronic acid (HA) technology, today announced that it has received Health Canada approval for MONOVISC™, its single injection viscosupplement approved for the treatment of osteoarthritis of the knee. Anika expects to launch MONOVISC this month through its long-term ORTHOVISC® distribution partner in Canada, Rivex Pharma Inc., the specialty drug distribution division of Aurora, Ontario-based Helix BioPharma Corp. (TSX: HBP). MONOVISC has been broadly available in the European Union since the second quarter of 2008.

21 Aug 2009

Influenza A H1N1 Real Time RT-PCR tests detect RNA of H1N1 influenza virus

Focus Diagnostics, the infectious disease diagnostics business of Quest Diagnostics Incorporated, today announced that its Influenza A H1N1 (2009) Real Time RT-PCR test is now available as a test kit for use by "high complexity" clinical laboratories in the U.S.

21 Aug 2009

AMDL Diagnostics to focus on in vitro diagnostic cancer tests

AMDL Inc. (NYSE Alternext US: ADL), a US-based pharmaceutical company with major operations in China, announced the inauguration of AMDL Diagnostics Inc. (ADI), a new wholly-owned subsidiary that will focus on the research, development, manufacture and international sales of Onko-Sure(TM)-- AMDL's proprietary, regulatory approved in vitro diagnostic (IVD) cancer test.

21 Aug 2009

Federal guidelines for seasonal and swine flu vaccines questioned

With the seasonal flu season approaching and uncertainty over whether swine flu will become more severe, new research published by Yale School of Public Health has found that more people are likely to avoid illness if vaccines are given out first to those most likely to transmit viruses, rather than to those at highest risk for complications.

20 Aug 2009

Adverse cardiovascular events during treatment with pioglitazone and rosiglitazone: Population-based cohort study

Rosiglitazone, a drug used to treat type 2 diabetes, is associated with an increased risk of heart failure and death among older patients compared to a similar drug (pioglitazone), concludes a study published on bmj.com today.

20 Aug 2009

Consumer groups urge transparency in health care reform for pharmacy benefit managers

Three top consumer groups are urging Congress to include in health care reform legislation transparency requirements for pharmacy benefit managers (PBMs) participating in any new federally sponsored health plans in a public health care exchange. The Consumer Federation of America (CFA), U.S. Public Interest Research Group (PIRG), and the National Legislative Association on Prescription Drug Prices (NLARx) have sent a joint letter to House Speaker Nancy Pelosi (D-CA) supporting the provision, authored by Rep. Anthony Weiner (D-NY) and included in the House Energy and Commerce Committee’s America’s Affordable Health Choices Act of 2009 (H.R. 3200).

20 Aug 2009

Cambodia's maternal mortality; drugs in Uganda; cholera risk in Zimbabwe; HIV laws in Niger

A lack of outreach by public health officials and rural villagers' preference for traditional midwives have hindered efforts to reduce maternal morality in Cambodia, government officials said recently at regional conference, the Phnom Penh Post reports.

20 Aug 2009

Chemical components of elderberry, cinnamon and green tea extracts block HIV viruses from infecting cells

The development of new antiviral drugs has had a tremendous impact on the quality of life and life expectancy of HIV-positive and AIDS patients, as the drugs effectively disrupt the replication cycle of the HIV virus. Yet the regular use of those drugs - such as zidovudine (also known as azidothymidine or AZT), protease inhibitors, and highly active antiretroviral therapy (HAART) involving multidrug therapies - has led to resistant HIV strains.

20 Aug 2009

Advaxis awarded $210,000 for development of a dual antigen vaccine

Advaxis, Incorporated (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Lm) vaccine company, has been awarded a $210,000 grant from the US National Institute of Health (NIH) to develop a single bioengineered Lm vaccine to deliver two different antigen-adjuvant proteins.

20 Aug 2009

Pharmaceutical News

FDA issues complete response letter regarding the NDA for carisbamate

Adamas Pharmaceuticals forges agreement with U.S. Naval Health Research Center for evaluating triple combination antiviral drug

Cortex Pharmaceuticals receives delisting notification from NYSE Amex

FDA approves Epocal's new glucose test on the epoc Blood Analysis System

Nutra Pharma launches Cobroxin for chronic pain relief

Takeda Canada reacquires commercial rights for an oral type 2 diabetic treatment drug

Syntagon to deliver presentation on controlling genotoxic impurities

Medicago and Ajanta Pharma forge MoU to commercialize seasonal influenza VLP-based vaccines in India

New antimalarial drug discovery project funded by European Commission

Newspapers examine debate over affordable drugs in developing countries

U.S District Court grants preliminary approval for the settlement of Sampson v. Robinson case

Health Canada approves Anika Therapeutics' MONOVISC drug

Influenza A H1N1 Real Time RT-PCR tests detect RNA of H1N1 influenza virus

AMDL Diagnostics to focus on in vitro diagnostic cancer tests

Federal guidelines for seasonal and swine flu vaccines questioned

Adverse cardiovascular events during treatment with pioglitazone and rosiglitazone: Population-based cohort study

Consumer groups urge transparency in health care reform for pharmacy benefit managers

Cambodia's maternal mortality; drugs in Uganda; cholera risk in Zimbabwe; HIV laws in Niger

Chemical components of elderberry, cinnamon and green tea extracts block HIV viruses from infecting cells

Advaxis awarded $210,000 for development of a dual antigen vaccine

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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