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FDA critics say controversy about diabetes drug points to need for agency changes

Reuters: "The controversy surrounding a GlaxoSmithKline Plc diabetes drug points to a need for changes in the way the U.S. Food and Drug Administration handles safety issues, agency critics told lawmakers on Wednesday.

30 Apr 2010

Johnson & Johnson subsidiaries agree to pay over $81M to resolve Topamax illegal promotion allegations

American pharmaceutical manufacturers Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals Inc., both subsidiaries of Johnson & Johnson, have agreed to pay more than $81 million to resolve criminal and civil liability arising from the illegal promotion of the epilepsy drug Topamax, the Justice Department announced today.

30 Apr 2010

Lotus Pharmaceuticals receives Chinese SFDA approval to commence Laevo-Bambuterol clinical trials

Lotus Pharmaceuticals, Inc., a growing developer, manufacturer and seller of medicine and drugs in the People's Republic of China today reported that its innovative asthma drug Laevo-Bambuterol has received approval from China's State Food & Drug Administration's (SFDA) to commence clinical trials (No.2010L01309 and 2010L01399).

30 Apr 2010

Mylan first-quarter total revenues increase 7% to $1.29 billion

Mylan Inc. today announced its financial results for the three months ended March 31, 2010.

30 Apr 2010

IPS examines how Uganda's anti-counterfeit bill could impact access to generic drugs

Inter Press Service examines Uganda's "controversial Counterfeit Goods Bill," which some say will limit the public's access to "life-saving generic medicines."

30 Apr 2010

Impax initiates challenge of patent listed by Shionogi Pharma concerning Fenoglide

Impax Laboratories, Inc. today confirms that it has initiated a challenge of a patent listed by Shionogi Pharma, Inc. in connection with its Fenoglide® (fenofibrate) tablets, 40 and 120 mg.

30 Apr 2010

Provenge cellular immunotherapy for men with advanced prostate cancer receives FDA approval

The U.S. Food and Drug Administration today approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease.

30 Apr 2010

SCOLR Pharma first-quarter total revenues decrease 3%

SCOLR Pharma, Inc. today reported financial results for the first three months ended March 31, 2010.

30 Apr 2010

Depomed attributes 56% increase in first-quarter revenue to $5.8M increase in Glumetza product sales

Depomed, Inc. today reported financial results for the first quarter ended March 31, 2010.

30 Apr 2010

FDA approves Provenge prostate cancer vaccine

Cancer may now be fought with a vaccine. The FDA has finally approved an immune boosting vaccine which is said to extend survival of patients at an advanced stage of prostate cancer by four months. This is twice as long as what could be expected with regular chemotherapy. There is also an increase of three years survival after detection in initial stage by 38% thanks to the vaccine.

30 Apr 2010

FDA grants Bavarian Nordic Fast Track designation for PROSTVAC

Bavarian Nordic A/S announced today that PROSTVAC™ has been granted Fast Track designation by the U.S. Food & Drug Administration (FDA) for its proposed use in the treatment of men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).

29 Apr 2010

Investment report on Somaxon Pharmaceuticals from MicroStockProfit.com

MicroStockProfit.com announces an investment report featuring Somaxon Pharmaceuticals Inc. The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.

29 Apr 2010

Labopharm, Gruppo Angelini sign agreement to commercialize OLEPTRO in the U.S.

Labopharm Inc. and Gruppo Angelini today announced they have entered into an agreement to establish a joint venture in the United States for the commercialization of OLEPTRO, a novel once-daily formulation of the antidepressant trazodone approved by the U.S. Food and Drug Administration on February 3, 2010.

29 Apr 2010

Celgene's first-quarter non-GAAP total revenue up 31% to $789 million

Celgene Corporation announced non-GAAP net income of $294.6 million, or non-GAAP diluted earnings per share of $0.63 for the quarter ended March 31, 2010. Non-GAAP net income for the first quarter of 2009 was $205.1 million or non-GAAP diluted earnings per share of $0.44. Based on U.S. GAAP, Celgene reported net income of $234.4 million, or diluted earnings per share of $0.50 for the quarter ended March 31, 2010. GAAP net income for the first quarter of 2009 was $162.9 million, or diluted earnings per share of $0.35.

29 Apr 2010

Jiangsu Yanshen receives SFDA disciplinary notice for substandard quality human use rabies vaccine

Simcere Pharmaceutical Group, a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, today announced that Jiangsu Yanshen Biological Technology Stock Co., Ltd. has received disciplinary notice from China's State Food and Drug Administration regarding its production of substandard quality human use rabies vaccine.

29 Apr 2010

Human Genome Sciences reports net loss of $47.9M for first-quarter 2010

Human Genome Sciences, Inc. today announced financial results for the quarter ended March 31, 2010, and provided highlights of recent key developments.

29 Apr 2010

Obese children metabolize caffeine and dextromethorphan at different rates than healthy weight children

Researchers from the University of Minnesota College of Pharmacy have provided the first evidence-based data on changes in drug metabolism in obese children as compared to healthy weight children.

29 Apr 2010

Oncos Therapeutics completes $5.5M investment from HealthCap

Oncos Therapeutics, a biotech company developing new cancer therapeutics based on its next generation oncolytic viruses, completed a - 4 million ($ 5.5 million) investment from HealthCap. With committed capital exceeding - 800 million, HealthCap is one of the largest specialized providers of venture capital within life sciences in Europe.

29 Apr 2010

Gilead announces bioequivalence of Truvada in combination with Tibotec Pharmaceuticals' TMC278 NNRTI

Gilead Sciences, Inc. announced today it has obtained data supporting bioequivalence of a formulation of the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride, 25 mg).

29 Apr 2010

Bristol-Myers Squibb to present on belatacept at American Transplant Congress

Bristol-Myers Squibb Company announced today that belatacept, an investigational selective T cell co-stimulation blocker being studied for use in solid organ transplantation, will be the subject of eight clinical presentations related to kidney transplantation at the American Transplant Congress, being held May 1 - 5 in San Diego.

29 Apr 2010

Pharmaceutical News

FDA critics say controversy about diabetes drug points to need for agency changes

Johnson & Johnson subsidiaries agree to pay over $81M to resolve Topamax illegal promotion allegations

Lotus Pharmaceuticals receives Chinese SFDA approval to commence Laevo-Bambuterol clinical trials

Mylan first-quarter total revenues increase 7% to $1.29 billion

IPS examines how Uganda's anti-counterfeit bill could impact access to generic drugs

Impax initiates challenge of patent listed by Shionogi Pharma concerning Fenoglide

Provenge cellular immunotherapy for men with advanced prostate cancer receives FDA approval

SCOLR Pharma first-quarter total revenues decrease 3%

Depomed attributes 56% increase in first-quarter revenue to $5.8M increase in Glumetza product sales

FDA approves Provenge prostate cancer vaccine

FDA grants Bavarian Nordic Fast Track designation for PROSTVAC

Investment report on Somaxon Pharmaceuticals from MicroStockProfit.com

Labopharm, Gruppo Angelini sign agreement to commercialize OLEPTRO in the U.S.

Celgene's first-quarter non-GAAP total revenue up 31% to $789 million

Jiangsu Yanshen receives SFDA disciplinary notice for substandard quality human use rabies vaccine

Human Genome Sciences reports net loss of $47.9M for first-quarter 2010

Obese children metabolize caffeine and dextromethorphan at different rates than healthy weight children

Oncos Therapeutics completes $5.5M investment from HealthCap

Gilead announces bioequivalence of Truvada in combination with Tibotec Pharmaceuticals' TMC278 NNRTI

Bristol-Myers Squibb to present on belatacept at American Transplant Congress

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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