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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

Einstein scientists awarded $4.1M to test microbicide Carraguard against HPV

The National Cancer Institute has awarded Albert Einstein College of Medicine of Yeshiva University $4.1 million to test the microbicide Carraguard- against the human papillomavirus, which causes cervical cancer. The research will evaluate the efficacy of Carraguard- - a clear gel made from the seaweed derivative carrageenan - in preventing new HPV infections in women.

26 Jul 2010

First generic version of Lovenox receives FDA approval for DVT

The U.S. Food and Drug Administration today approved the first generic version of Lovenox (enoxaparin sodium injection), an anti-coagulant drug used to prevent deep vein thrombosis, a potentially deadly blood clotting condition.

23 Jul 2010

China Sky One Medical receives SFDA approval for producing Ciclopirox Olamine Vaginal Suppositories

China Sky One Medical, Inc., a leading fully integrated pharmaceutical company in the People's Republic of China, today announced that the Company has obtained approval from the State Food and Drug Administration in China for the production of Ciclopirox Olamine Vaginal Suppositories.

23 Jul 2010

Taiho Pharmaceutical receives approval to market ABRAXANE IV Infusion 100 mg in Japan

Abraxis BioScience, Inc., a fully integrated, global biotechnology company, today announced that Taiho Pharmaceutical Co., Ltd. has received approval from the Ministry of Health, Labor and Welfare to market ABRAXANE IV Infusion 100 mg, Paclitaxel Injection (Suspension with Albumin), for use in the treatment of breast cancer. The New Drug Application (J-NDA) for ABRAXANE was filed with the Ministry of Health, Labor and Welfare in 2008.

23 Jul 2010

Preclinical data of new acamprosate prodrug to be presented at International Fragile X Conference

XenoPort, Inc. announced today that it has discovered a novel prodrug that has the potential to improve significantly the blood concentration of acamprosate compared with the currently approved formulation of acamprosate. Preclinical data on this new product candidate will be presented tomorrow at the National Fragile X Foundation's 12th International Fragile X Conference in Detroit, Michigan.

23 Jul 2010

Titan anticipates second-quarter Fanapt royalty payment of $55,000

Titan Pharmaceuticals, Inc. today reported that the company expects to receive a royalty payment of approximately $55,000 on second quarter 2010 sales of Fanapt (iloperidone) of approximately $693,000. This reflects a significant decrease from first quarter sales which, as is customary, included substantial initial product stocking in the distribution channels.

23 Jul 2010

Expert to speak on challenges, issues in development, implementation of REMS

At two Food and Drug Administration meetings, Sidney H. Schnoll, MD, PhD, Vice President, Pharmaceutical Risk Management Services of PinneyAssociates, will discuss the need for predictability, feasibility and transparency to ensure that Risk Evaluation and Mitigation Strategies benefit patient safety and public health.

23 Jul 2010

News outlets report on medical intellectual property developments, drug access issues

Inter Press Service reports on a recent symposium on access to medicine, "jointly hosted by the WHO, the World Trade Organization and the World Intellectual Property Organisation."

23 Jul 2010