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Health experts and Republicans push for biosimilar drug clinical trials

The Hill: On Monday, experts warned during a Capitol Hill discussion hosted by the Congressional Health Care Caucus that "the absence of mandatory clinical trials for biosimilar drugs could compromise their safety and effectiveness." The recently passed health reform law "outlined a pathway for the Food and Drug Administration (FDA) to approve next-generation biopharmaceuticals modeled on original breakthrough drugs.

21 Jul 2010

Lannett's ANDA for Phentermine Hydrochloride Blue/White Seed Capsules receives FDA approval

Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Phentermine Hydrochloride Blue/White Seed Capsules USP, 30 mg, the generic equivalent of Sandoz, Inc.'s Reference Listed Drug (RLD) Phentermine Hydrochloride Capsules USP, 30 mg.

21 Jul 2010

Genentech disappointed with FDA ODAC's recommendation against Avastin

Genentech, Inc., a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to one that use of Avastin® (bevacizumab) in combination with paclitaxel for previously untreated (first-line) advanced HER2-negative breast cancer be removed from Avastin's U.S. label.

21 Jul 2010

Sinobiopharma, Xianfeng enter agreement to manufacture, co-market Clindamycin and L-alanyl-L-glutamine

Sinobiopharma, Inc. is pleased to announce that it has signed an agreement with Anhui Xianfeng Pharmaceuticals Co., Ltd to manufacture and co-market Clindamycin, an antibiotic, and L-alanyl-L-glutamine, a parenteral nutrition.

21 Jul 2010

Gilead Sciences second-quarter total revenues increase 17% to $1.93 billion

Gilead Sciences, Inc. announced today its results of operations for the quarter ended June 30, 2010. Total revenues for the second quarter of 2010 were $1.93 billion, up 17 percent compared to total revenues of $1.65 billion for the second quarter of 2009. Net income for the second quarter of 2010 was $712.1 million, or $0.79 per diluted share, compared to net income for the second quarter of 2009 of $571.4 million, or $0.61 per diluted share.

21 Jul 2010

Natural, needle-free vaccination against malaria

If mice are administered an antibiotic for three days and are simultaneously infected with malaria, no parasites appear in the blood and life-threatening disease is averted. In addition, the animals treated in this manner also develop robust, long-term immunity against subsequent infections. This discovery was made by the team headed by Dr. Steffen Borrmann from the Department of Infectious Diseases at Heidelberg University Hospital in cooperation with Dr. Kai Matuschewski of the Max Planck Institute for Infection Biology in Berlin. The scientists think that safe and affordable prophylaxis with antibiotics in residents of areas with high malaria transmission has the potential to be used as a natural "needle-free" vaccination against malaria.

21 Jul 2010

FDA accepts MannKind's resubmission of AFREZZA NDA, sets PDUFA action date

MannKind Corporation today announced that it has submitted, and the U.S. Food and Drug Administration has accepted, MannKind's resubmission of its New Drug Application for AFREZZA™ (insulin human [rDNA origin]) and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding Prescription Drug User Fee Act action date of December 29, 2010.

21 Jul 2010

New & improved rotavirus vaccine to be trialed in Melbourne

Now a vaccine is being developed against rotavirus in Melbourne. At present Australian children were given rotavirus vaccine at the age of six to eight weeks since 2007. This new vaccine will be applicable to infants from birth.

20 Jul 2010

New development in flu prevention & treatment

In a groundbreaking development, scientists at the Australian National University in Canberra have found the key to the mutation of the flu virus. This may allow the manufacturing of a life-long vaccine stopping the need for repeated vaccinations. The scientists reveal that they have found a protein in the virus that changes or mutates in order to develop resistance in the virus.

20 Jul 2010

Access selects BioScrip as exclusive distribution and service partner for MuGard

ACCESS PHARMACEUTICALS, INC., a biopharmaceutical company specializing in products for cancer and supportive care, announced today it has signed an exclusive specialty distribution agreement with BioScrip for its lead product, MuGard -- an FDA-approved, ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of radiotherapy and/or chemotherapy.

20 Jul 2010

Winston Laboratories receives NOC for CIVANEX

Winston Laboratories, Inc., a wholly-owned subsidiary of Winston Pharmaceuticals, Inc., a pharmaceutical company focused on developing and commercializing novel pain management therapies, announced that it has received Notice of Compliance from the Therapeutics Drug Directorate, Health Canada for its New Drug Submission for CIVANEX (zucapsaicin cream 0.075%) for the treatment of the signs and symptoms of osteoarthritis.

20 Jul 2010

Inergetics receives CPR to market Resurgex Select product as nutritional supplement

Inergetics, Inc., a leader in targeted product development for the Clinical Nutrition and Sports Supplement Markets, today announced that the Company has received a Certificate of Product Registration from the FDA Philippines, certifying that its Resurgex Select product can now be marketed as a nutritional supplement for cancer patients and other immune-compromised individuals throughout the country.

20 Jul 2010

Fero Industries provides comments concerning FDA advisory panel recommendation on diabetes drug Avandia

Fero Industries, Inc. is pleased to provide these comments regarding the recent Food and Drug Administration advisory panel recommendation concerning the GlaxoSmithKline PLC diabetes drug Avandia. The FDA advisory panel has recommended that the agency keep diabetes drug Avandia on the U.S. market despite data clearly showing an increased risk of a heart attack and that GSK covered up their own research that first identified the problem.

20 Jul 2010

Biogen Idec second-quarter revenues increase 11% to $1.2 billion

Biogen Idec Inc., a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today announced its second quarter 2010 results.

20 Jul 2010

European marine and algae oil omega-3 ingredient market to grow at 10% CAGR to reach $525.6M in 2013

The flood of scientific evidence on omega-3 eicosapentaenoic acid/docosahexaenoic acid (EPA/DHA) has significantly buoyed the credibility of polyunsaturated fatty acids (PUFAs) as vital functional ingredients. Heightened consumer awareness has had a telling effect on the healthy growth charts of the marine and algae oil omega-3 ingredients market.

20 Jul 2010

NanoViricides presents study results of nanoviricides anti-Ebola agents

NanoViricides, Inc. reports that the results of the evaluation of several of its nanoviricides anti-Ebola agents were presented July 17th at the Annual Meeting of the American Society for Virology, July 17-21, at Montana State University, Bozeman, MT. Dr. Corinne Scully delivered the presentation, which was entitled "Polymeric Micelle Nanomaterials as Antiviral Compounds For Ebola Virus Infection."

20 Jul 2010

Dyax launches newly enhanced product website featuring comprehensive financial assistance program

Dyax Corp. today announced that it has launched its newly enhanced product website, www.KALBITOR.com, featuring its comprehensive financial assistance program. KALBITOR (ecallantide) is approved for the treatment of acute attacks of hereditary angioedema in patients 16 years of age and older.

20 Jul 2010

New report compares efficacy of Plavix, Effient in treating patients with ACS

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, for the treatment of acute coronary syndrome, 56 percent of surveyed interventional cardiologists who prescribe Bristol-Myers Squibb/Sanofi-Aventis' Plavix in high doses, consider it to be comparable in efficacy to Daiichi Sankyo/Eli Lilly's recently-launched Effient.

20 Jul 2010

MDMA (Ecstasy) holds promise for chronic treatment-resistant PTSD

MDMA (-3,4-methylenedioxymethamphetamine, also known as Ecstasy), may one day offer hope for individuals with posttraumatic stress disorder (PTSD), even people for whom other treatments have failed. Clinical trial results out today in the Journal of Psychopharmacology, published by SAGE, suggests that MDMA can be administered to subjects with PTSD without evidence of harm and could offer sufferers a vital window with reduced fear responses where psychotherapy can take effect.

20 Jul 2010

Parkinson's medication produces serious side effects in the form of involuntary, jerky movements: Research

One in every 100 elderly people suffers from Parkinson's disease, a disease of the nervous system with symptoms including stiffness and shaking. The standard medication used to treat Parkinson's is Levodopa, a drug that initially has major benefits but can later also produce serious side effects in the form of involuntary, jerky movements. A research group at Lund University has now found a way to study what it is in the brain that causes these side effects.

20 Jul 2010

Pharmaceutical News

Health experts and Republicans push for biosimilar drug clinical trials

Lannett's ANDA for Phentermine Hydrochloride Blue/White Seed Capsules receives FDA approval

Genentech disappointed with FDA ODAC's recommendation against Avastin

Sinobiopharma, Xianfeng enter agreement to manufacture, co-market Clindamycin and L-alanyl-L-glutamine

Gilead Sciences second-quarter total revenues increase 17% to $1.93 billion

Natural, needle-free vaccination against malaria

FDA accepts MannKind's resubmission of AFREZZA NDA, sets PDUFA action date

New & improved rotavirus vaccine to be trialed in Melbourne

New development in flu prevention & treatment

Access selects BioScrip as exclusive distribution and service partner for MuGard

Winston Laboratories receives NOC for CIVANEX

Inergetics receives CPR to market Resurgex Select product as nutritional supplement

Fero Industries provides comments concerning FDA advisory panel recommendation on diabetes drug Avandia

Biogen Idec second-quarter revenues increase 11% to $1.2 billion

European marine and algae oil omega-3 ingredient market to grow at 10% CAGR to reach $525.6M in 2013

NanoViricides presents study results of nanoviricides anti-Ebola agents

Dyax launches newly enhanced product website featuring comprehensive financial assistance program

New report compares efficacy of Plavix, Effient in treating patients with ACS

MDMA (Ecstasy) holds promise for chronic treatment-resistant PTSD

Parkinson's medication produces serious side effects in the form of involuntary, jerky movements: Research

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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