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Novartis launches new OTC children's liquid acetaminophen product

Novartis announces the introduction of Triaminic™ Fever Reducer Pain Reliever, the only branded over-the-counter children's liquid acetaminophen product currently available nationwide in the US. Triaminic® now offers parents a product that combines the pain relieving and fever-reducing power of acetaminophen with the brand that has been trusted by pediatricians and parents for more than 50 years.

27 Jul 2010

Pilot program to confront major eDiscovery challenges in life sciences

eDiscovery for Pharma, Biotech and Medical Device Industries will be the key meeting of the year for eDiscovery experts in the life science space. This event will bring together leading eDiscovery experts to confront the major eDiscovery challenges specific to pharmaceutical, biotech, and medical device industries.Attendees will learn best eDiscovery practices to help prepare organizations for FDA inquiries, patent litigation, HIPAA compliance and data security issues; plus CLE credits are available.

27 Jul 2010

AHF denies BMS sales reprepresentatives access to healthcare centers

Today AIDS Healthcare Foundation (AHF) announced that it has banned pharmaceutical sales representatives from Bristol-Myers Squibb (BMS) from calling on AHF's medical providers and staff in its sixteen U.S. healthcare centers. The decision is based on BMS' refusal to lower the price of its key AIDS drug Reyataz for cash-strapped AIDS Drug Assistance Programs.

27 Jul 2010

NIH issues SBIR grant to Titan Pharmaceutical for PD treatment development

Titan Pharmaceuticals, Inc. today announced that the National Institutes of Health has awarded the company a grant under the Small Business Innovation Research program supporting the development of a long-term, non-fluctuating dopamine agonist treatment for Parkinson's disease. The first year award in the amount of $300,000 will be available to Titan starting August 1, 2010, and an additional $195,000 for the second year starting August 1, 2011 has been recommended subject to availability of funds and satisfactory progress of the project. The grant will be administered by the National Institute of Neurological Disorders and Stroke.

27 Jul 2010

Scientists develop obesity drug without neurological side effects

The drug rimonabant was developed as a treatment for obesity and its myriad of serious health consequences. Despite having its desired effects on weight, which it decreased, and on levels of glucose and fats in the blood, rimonabant was never approved for use in the US because of serious neurological side effects including depression and anxiety. Now, a team of researchers, led by George Kunos, at the National Institutes of Health, Bethesda, and Alexandros Makriyannis, at Northeastern University, Boston, have developed a drug that has the same positive effects in mice on levels of glucose and fats in the blood as rimonabant but none of the neurological side effects.

27 Jul 2010

Epilepsy drugs analyzed for causing increased risk of suicide in patients

While the Food and Drug Administration requires a warning of an increased risk of suicide for all epilepsy drugs, a new study shows that only certain drugs may increase the risk. The study is published in the July 27, 2010, issue of Neurology, the medical journal of the American Academy of Neurology. Newer drugs with a higher risk of causing depression than other epilepsy drugs, such as levetiracetam, topiramate and vigabatrin, were found to increase the risk of self-harm or suicidal behavior among people with epilepsy.

27 Jul 2010

New drug for type 2 diabetes, Effect of insulin on bones

In a groundbreaking finding, a new medicine Galvus (vildagliptin) has been created for people with type 2 diabetes that would lower blood glucose levels without the side effects of other medications.

26 Jul 2010

CMSI signs Letter of Intent with Green Medicals to acquire equity interest in 8 medical marijuana dispensaries

Cannabis Medical Solutions Inc., a leading company specializing in both brick-and-mortar and online merchant payment solutions and financial security products for medical marijuana dispensaries and high-risk merchant accounts, today announced that the Company has signed a Letter of Intent with Green Medicals LLC to acquire equity interest in up to eight (8) medical marijuana dispensaries within the state of Colorado.

26 Jul 2010

FDA approves Perrigo's OTC Cetirizine Cherry Syrup

Perrigo Company today announced that it has received final approval from the U.S. Food and Drug Administration to manufacture and market over-the-counter (OTC) Cetirizine Cherry Syrup, 1mg/ml. Shipments will begin in the Company's fiscal first quarter 2011. Cherry joins the currently available grape flavor cetirizine syrup in Perrigo's product portfolio, giving patients a choice of store brand flavors.

26 Jul 2010

Tibotec submits NDA for TMC278 anti-HIV compound to FDA

Tibotec Pharmaceuticals today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TMC278 (rilpivirine), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), being studied for once-daily use with other antiretroviral agents in treatment-naive HIV-1-infected adults. If approved, TMC278 will be the third anti-HIV compound to be introduced by Tibotec Pharmaceuticals.

26 Jul 2010

FDA grants Biovest's BiovaxID vaccine Orphan Drug Designation for mantle cell lymphoma

Biovest International, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BiovaxID®, Biovest's personalized cancer vaccine, for a second lymphoma indication: mantle cell lymphoma. Mantle cell lymphoma is an aggressive and lethal B-cell blood cancer for which there is no current consensus standard-of-care.

26 Jul 2010

Orthovita's PMA supplement for new collagen processing facility receives FDA approval

Orthovita, Inc., an orthobiologics and biosurgery company, reported today that the U.S. Food and Drug Administration (FDA) approved Orthovita's PMA supplement for a new collagen processing facility in Malvern, Pennsylvania. Orthovita will use the new facility to process the highly purified form of collagen used in its VITAGEL™ Surgical Hemostat product. VITAGEL is a composite liquid hemostat used in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

26 Jul 2010

Nano-patch to replace needles for vaccination soon: Study

Those who fear needles have good news awaiting them. Australian researchers have developed a new method of vaccine delivery using needle-free nano-patches. These could also be mailed to people during pandemics. This breakthrough is published in the latest edition of the journal Small.

26 Jul 2010

Boehringer Ingelheim announces European CHMP Positive Opinion for TWYNSTA

Boehringer Ingelheim announced today that the European Committee for Medicinal Products for Human Use (CHMP) adopted a Positive Opinion for the approval of TWYNSTA®. It will be indicated in adults whose blood pressure is not adequately controlled on amlodipine and is also indicated as replacement therapy in adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of TWYNSTA containing the same component doses.

26 Jul 2010

NovImmune, Genentech sign exclusive licensing agreement for anti-IL-17 antibody

NovImmune, an antibody-focused research and development biotech company, announced today that it successfully entered into an exclusive licensing agreement with Genentech Inc. a member of the Roche Group for a proprietary anti-IL-17 fully human monoclonal antibody, and access to back-up antibodies.

26 Jul 2010

Teva comments on FDA's approval of generic Lovenox injection

Teva Pharmaceutical Industries Ltd. commented today on the U.S. Food and Drug Administration's response to a citizen petition questioning the approval criteria for a generic Lovenox (enoxaparin sodium) injection and its subsequent approval of another generic filer's Abbreviated New Drug Application.

26 Jul 2010

Neu5Gc in drugs provokes strong immune response

Researchers at the University of California, San Diego School of Medicine have discovered that a kind of sugar molecule common to chimpanzees, gorillas and other mammals but not found in humans provokes a strong immune response in some people, likely worsening conditions in which chronic inflammation is a major issue.

26 Jul 2010

VA to allow patients to use medical marijuana

The Department of Veterans Affairs will formally allow patients treated at its hospitals and clinics to use medical marijuana in states where it is legal, a policy clarification that veterans have sought for several years. A department directive, expected to take effect next week, resolves the conflict in veterans facilities between federal law, which outlaws marijuana, and the 14 states that allow medicinal use of the drug, effectively deferring to the states. ...Under department rules, veterans can be denied pain medications if they are found to be using illegal drugs.

26 Jul 2010

FDA approves Aricept 23 mg tablet for Alzheimer's disease

Eisai Inc. and Pfizer Inc announced today that the U.S. Food and Drug Administration (FDA) approved a new once-daily, higher-dose Aricept 23 mg tablet for the treatment of moderate-to-severe Alzheimer's disease (AD). Aricept 23 mg tablet offers another dosing option for patients with moderate-to-severe AD, for whom few treatments are available

26 Jul 2010

FDA grants marketing approval of ANDA for enoxaparin sodium for injection

Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the U.S. Food and Drug Administration has granted marketing approval of the Abbreviated New Drug Application for enoxaparin sodium for injection filed by Sandoz. Developed under a collaboration agreement between Momenta and Sandoz, this product has been designated therapeutically equivalent to the reference-listed drug, Lovenox, which is marketed by Sanofi-Aventis.

26 Jul 2010