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Ethicon submits BLA to FDA for Fibrin Pad

Ethicon, Inc., a worldwide leader in surgical care, announced today that the company has submitted a Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the Fibrin Pad, a novel product candidate that combines Ethicon's biomaterials and plasma-derived biologics (Human Fibrinogen and Human Thrombin), to aid in stopping soft tissue bleeding during surgery.

19 Nov 2010

FDA approves IDE application for Home Hemodialysis system

Baxter International Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application for a Home Hemodialysis (HD) system in development through a collaboration between DEKA Research and Development Corp., HHD LLC, and Baxter.

From Baxter International Inc. 19 Nov 2010

FDA approves new drug application for NEXTERONE Premixed Injection

Prism Pharmaceuticals, Inc. announced today that the U.S. Food & Drug Administration has approved the supplemental new drug application for NEXTERONE (amiodarone HCl) Premixed Injection, the first and only premixed intravenous (IV) bag formulation of the antiarrhythmic agent amiodarone IV.

19 Nov 2010

Expert panel to endorse newly approved therapeutic vaccine for advanced prostate cancer

Provenge is one step closer to being covered by Medicare. An expert panel voted Wednesday to endorse the newly approved therapeutic vaccine for men with advanced prostate cancer.

19 Nov 2010

New findings show promising treatment for MS

Successfully treating and reversing the effects of multiple sclerosis, or MS, may one day be possible using a drug originally developed to treat chronic pain, according to Distinguished Professor Linda Watkins of the University of Colorado at Boulder.

19 Nov 2010

Eisai signs statement of intent with WHO to supply medicine for treatment of lymphatic filariasis

Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito) announced today that it has signed a statement of intent with the World Health Organization to supply free of charge a primary medicine for the treatment of lymphatic filariasis.

19 Nov 2010

Call for more transparency and improvements to drug safety in Canada

A commissioned discussion paper released today by the Health Council of Canada, Keeping an Eye on Prescription Drugs, Keeping Canadians Safe, underscores the many limitations to how drug safety and effectiveness is monitored and reported in Canada. The report provides clear recommendations for changes to the current system to ensure Canadians are safe from undue pharmaceutical harm.

18 Nov 2010

Multiple epidemiological parameters drive increase in drug-treatment opportunities for pancreatic cancer: Decision Resources

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds significant trends in multiple epidemiological parameters to be driving the increase in drug-treatment opportunities for pancreatic cancer over the period 2009 to 2024, including population aging, increasing risk of recurrence following resection and modest improvements in survival.

18 Nov 2010

PAREXEL reaches milestone in early phase studies

PAREXEL International Corporation, a leading global biopharmaceutical services provider, today announced that it reached a milestone of completing 200 early phase studies in patient populations during the past three years.

From Parexel 18 Nov 2010

CDC data: Adults remain unvaccinated against preventable infectious illnesses

New data from the Centers for Disease Control and Prevention (CDC) show that adults remain largely unvaccinated against preventable infectious illnesses.

18 Nov 2010

Multiple sclerosis drug shows promise to counteract effects of botulinum neurotoxin

Scientists are reporting that variants of a drug already approved for treating multiple sclerosis show promise as a long sought treatment for victims of bioterrorist attack with botulinum neurotoxin which is 10,000 times deadlier than cyanide and the most poisonous substance known to man.

18 Nov 2010

FIP's PSWC and AAPS Annual Meeting to highlight targeted inhalable dry powder HPV vaccine

New research being presented at the 2010 FIP Pharmaceutical Sciences World Congress in association with the American Association of Pharmaceutical Scientists Annual Meeting and Exposition will highlight a targeted inhalable dry powder vaccine that may prove preferable in terms of needle avoidance and expected lower cost than the current commercial human papillomavirus (HPV) vaccine used throughout the world.

18 Nov 2010

Sun Pharma receives FDA approval for generic Tiazac ANDA

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of once-a-day Tiazac® extended release capsules.

18 Nov 2010

New anti-cancer drug targeting vitamin D receptor reduces PSA level in HRPC

A new anti-cancer drug aimed at vitamin D receptors on cancer cells has prompted encouraging responses in the levels of PSA (prostate specific antigen) in men with prostate cancer that has become resistant to hormonal therapies.

18 Nov 2010

FDA approves Sun Pharma's generic Clarinex ANDA

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted it an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Schering Plough's Clarinex® tablets, 5 mg.

18 Nov 2010

EMA reviews CTI's Pixuvri Marketing Authorization Application for NHL

Cell Therapeutics, Inc. announced today that CTI's Marketing Authorization Application seeking approval for Pixuvri (pixantrone dimaleate) for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin's lymphoma was validated and accepted for review by the European Medicines Agency.

18 Nov 2010

Merck announces FDA Advisory Committee approval of GARDASIL for anal cancer and AIN treatment

Merck announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee has advised that the data presented support an indication for GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer and anal intraepithelial neoplasia (AIN) in both males and females 9 through 26 years of age.

18 Nov 2010

Statins activate bacterial-killing properties of white blood cells

Widely prescribed for their cholesterol-lowering properties, recent clinical research indicates that statins can produce a second, significant health benefit: lowering the risk of severe bacterial infections such as pneumonia and sepsis.

18 Nov 2010

FDA grants three years of marketing exclusivity to ISTA's BROMDAY

ISTA Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has granted the Company three years of marketing exclusivity for BROMDAY (bromfenac ophthalmic solution) 0.09%, as provided under the Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman Act.

18 Nov 2010

New pharmacogenetic test enables a personalized medicine approach

Luminex Corporation, today announced that it has commercially launched its first pharmacogenetic test, the xTAG CYP2D6 Kit, which recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

From Luminex 17 Nov 2010

Pharmaceutical News

Ethicon submits BLA to FDA for Fibrin Pad

FDA approves IDE application for Home Hemodialysis system

FDA approves new drug application for NEXTERONE Premixed Injection

Expert panel to endorse newly approved therapeutic vaccine for advanced prostate cancer

New findings show promising treatment for MS

Eisai signs statement of intent with WHO to supply medicine for treatment of lymphatic filariasis

Call for more transparency and improvements to drug safety in Canada

Multiple epidemiological parameters drive increase in drug-treatment opportunities for pancreatic cancer: Decision Resources

PAREXEL reaches milestone in early phase studies

CDC data: Adults remain unvaccinated against preventable infectious illnesses

Multiple sclerosis drug shows promise to counteract effects of botulinum neurotoxin

FIP's PSWC and AAPS Annual Meeting to highlight targeted inhalable dry powder HPV vaccine

Sun Pharma receives FDA approval for generic Tiazac ANDA

New anti-cancer drug targeting vitamin D receptor reduces PSA level in HRPC

FDA approves Sun Pharma's generic Clarinex ANDA

EMA reviews CTI's Pixuvri Marketing Authorization Application for NHL

Merck announces FDA Advisory Committee approval of GARDASIL for anal cancer and AIN treatment

Statins activate bacterial-killing properties of white blood cells

FDA grants three years of marketing exclusivity to ISTA's BROMDAY

New pharmacogenetic test enables a personalized medicine approach

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

How GLP‑1 Agonists Are Shaping the Future of Obesity Treatment With Dr Bryony Henderson

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