Pharmaceuticals News and Research

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Mount Sinai School of Medicine, Alnylam collaborate to develop microRNA-based attenuated influenza viruses

Mount Sinai School of Medicine has completed an exclusive option agreement with Alnylam Pharmaceuticals, Inc. a leading RNAi therapeutics company, for intellectual property related to RNAi applications in vaccine development. These new applications of RNAi technology define opportunities for the advancement of novel vaccines in infectious disease.

18 Jun 2010

Drug makers face tightened regulations by FDA and less clout at medical meetings

The Washington Post: "The Food and Drug Administration this week began posting online the results of safety evaluations of recently approved drugs and vaccines. The action follows a law enacted in 2007 that requires the agency to provide more safety information to consumers and health professionals. The evaluations must be conducted 18 months after a new drug comes on the market.

18 Jun 2010

HRA Pharma announces FDA Advisory Committee approval for ulipristal acetate as emergency contraceptive

HRA Pharma announced today that the U.S. Food and Drug Administration's (FDA) Advisory Committee for Reproductive Health Drugs voted 11 to 0 that the company's application provided sufficient information to conclude that ulipristal acetate is effective and safe for use as an emergency contraceptive.

18 Jun 2010

Fraudulent Tamiflu sold over Internet, FDA warns

The U.S. Food and Drug Administration today warned consumers about a potentially harmful product represented as "Generic Tamiflu" sold over the Internet. FDA tests revealed that the fraudulent product does not contain Tamiflu's active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin.

18 Jun 2010

First patient dosed in AR-42 Phase I/IIa clinical study at OSUCCC-James in adult patients with blood cancer

Arno Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing oncology therapeutics, today announced the dosing of the first patient in an investigator sponsored Phase I/IIa clinical study of AR-42 (formerly OSU-HDAC42) at The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC-James) in adult patients with relapsed or refractory multiple myeloma (MM), chronic lymphocytic leukemia (CLL) or lymphoma.

18 Jun 2010

FDA approves new indication for Tasigna in treatment of rare blood cancer

The U.S. Food and Drug Administration today approved a new indication for Tasigna (nilotinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

18 Jun 2010

Ricerca announces services under U.S. DEA license

Ricerca Biosciences, an industry-leading, integrated preclinical contract research organization (CRO) providing services to the chemical and biopharmaceutical industries, is pleased to announce services it can now provide under its United States Drug Enforcement Administration (DEA) license.

18 Jun 2010

Phylogeny, Neoprobe announce collaboration to develop head and neck cancer detection technology

Phylogeny, the in situ company, and Neoprobe, a diversified developer of innovative biomedical surgical oncology products, announce their collaboration to develop head and neck cancer detection technology.

18 Jun 2010

FDA assigns PDUFA action date for Orexigen's Contrave NDA review

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date of January 31, 2011 for the review of the Contrave® (naltrexone sustained release (SR)/bupropion SR) New Drug Application (NDA).

17 Jun 2010

Kaplan EduNeering, DIA announce strategic alliance to create online educational offerings

Kaplan EduNeering, a leading provider of compliance and knowledge management solutions, and the Drug Information Association (DIA), a global professional member association, announced a new strategic alliance to create online educational offerings for biotechnology, pharmaceutical, academic, and regulatory professionals around the world.

17 Jun 2010

China Yongxin Pharmaceuticals expands chain of drugstores to 103

China Yongxin Pharmaceuticals Inc., one of the leading health products distribution and retail sales companies in China, today announced the opening of three new chain drugstores in Changchun City. These new openings bring the Company's total number of stores to 24 in Changchun City, and 103 throughout Northeastern China, exceeding the Company's previously projected rate of growth in terms of number of locations.

17 Jun 2010

Neptune Technologies & Bioressources not to proceed with private placement

Neptune Technologies & Bioressources Inc. announces that, due to market conditions, it will not be proceeding with the private placement as announced in a news release dated May 4, 2010.

17 Jun 2010

Amerinet joins Unibased to provide financial performance improvement solutions

Amerinet Inc., a leading national healthcare group purchasing organization, today announced Unibased Systems Architecture has joined the Amerinet Alliance for Financial Efficiency, a partnership of market-leading companies providing best-of-class revenue cycle and financial performance improvement solutions that support healthcare facilities of all sizes.

17 Jun 2010

Teva exercises option to invest additional $11.9M in Andromeda Biotech

Andromeda Biotech Ltd. announces that Teva Pharmaceutical Industries Ltd. decided to exercise its option to invest in Andromeda Biotech Ltd. at a company per-money valuation of 170 million US dollars.

17 Jun 2010

Kun Run Biotechnology obtains China SFDA manufacturing approval for Entecavir

Kun Run Biotechnology, Inc., a leading bio-pharmaceutical company in China focusing on manufacturing and sales of peptide-based and small molecule drugs, today announced that they have obtained the manufacturing approval for Entecavir from the China State Food and Drug Administration (SFDA).

17 Jun 2010

Scientific American publishes article on "rebirth" of DNA vaccines

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that Scientific American magazine has published in its July issue an article entitled "DNA Drugs Come of Age." The article was co-authored by Dr. David Weiner, Chairman, Scientific Advisory Board, Inovio Pharmaceuticals, and Professor, Department of Pathology & Laboratory Medicine, at the University of Pennsylvania and Dr. Matthew Morrow, a post-doctorate research fellow at University of Pennsylvania.

17 Jun 2010

Bayer, OncoMed collaborate to develop anti-cancer stem cell therapeutics to target Wnt signaling pathway

Bayer Schering Pharma AG and OncoMed Pharmaceuticals, Inc., today announced a global strategic alliance to discover, develop and commercialize novel anti-cancer stem cell therapeutics targeting the Wnt signaling pathway.

17 Jun 2010

USFDA approves Sun Pharma's generic Keppra Injection ANDA

Sun Pharma announced that USFDA has granted an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Keppra® Injection, levetiracetam injection.

17 Jun 2010

Deuterium depletion symposium focusses on oncotherapy, anticancer, diabetes, anti-aging research

1st International Symposium on Deuterium Depletion was held on 13-14 May 2010 in Budapest, Hungary. The conference programme focused on the advances in the research and clinical application of deuterium depletion, its present and future role in anticancer research and oncotherapy, diabetes research and anti-aging.

17 Jun 2010

Research studies may lead to future development of cell transplant therapy for ALS

The University of California, San Diego, The Salk Institute for Biological Studies and Life Technologies Corporation today announced the initiation of studies which may lead to the future development of cell transplant therapy for amyotrophic lateral sclerosis, also known as Lou Gehrig's disease. Currently, there is only one FDA-approved pharmaceutical addressing this lethal disease, which affects approximately 30,000 people in the United States.

17 Jun 2010

Pharmaceuticals News and Research

Mount Sinai School of Medicine, Alnylam collaborate to develop microRNA-based attenuated influenza viruses

Drug makers face tightened regulations by FDA and less clout at medical meetings

HRA Pharma announces FDA Advisory Committee approval for ulipristal acetate as emergency contraceptive

Fraudulent Tamiflu sold over Internet, FDA warns

First patient dosed in AR-42 Phase I/IIa clinical study at OSUCCC-James in adult patients with blood cancer

FDA approves new indication for Tasigna in treatment of rare blood cancer

Ricerca announces services under U.S. DEA license

Phylogeny, Neoprobe announce collaboration to develop head and neck cancer detection technology

FDA assigns PDUFA action date for Orexigen's Contrave NDA review

Kaplan EduNeering, DIA announce strategic alliance to create online educational offerings

China Yongxin Pharmaceuticals expands chain of drugstores to 103

Neptune Technologies & Bioressources not to proceed with private placement

Amerinet joins Unibased to provide financial performance improvement solutions

Teva exercises option to invest additional $11.9M in Andromeda Biotech

Kun Run Biotechnology obtains China SFDA manufacturing approval for Entecavir

Scientific American publishes article on "rebirth" of DNA vaccines

Bayer, OncoMed collaborate to develop anti-cancer stem cell therapeutics to target Wnt signaling pathway

USFDA approves Sun Pharma's generic Keppra Injection ANDA

Deuterium depletion symposium focusses on oncotherapy, anticancer, diabetes, anti-aging research

Research studies may lead to future development of cell transplant therapy for ALS

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