Pharmaceuticals News and Research

RSS

Provectus reports on end-of-Phase 2 meeting with FDA on licensure of PV-10 for metastatic melanoma

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, announced today that it has held an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to seek consensus on clinical program scope and endpoints for licensure of PV-10 for metastatic melanoma. The meeting was held at the Agency's White Oak Campus in Silver Spring, MD.

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

BD second-quarter revenues up 7.0% to $1.845 billion

BD (Becton, Dickinson and Company) today reported quarterly revenues of $1.845 billion for the second fiscal quarter ended March 31, 2010, representing an increase of 7.0 percent from the prior-year period, or 6.6 percent on a foreign currency-neutral basis.

From BD (Becton, Dickinson and Company) 29 Apr 2010

AVEO Pharmaceuticals reports net loss of $14.4 million for first-quarter 2010

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced financial results for the quarter ended March 31, 2010, provided an update on progress towards achievement of 2010 goals as well as 2010 financial guidance.

29 Apr 2010

New MDC tool provides alternative choices to user's current prescription drugs

Healthcare reform legislation has enacted changes that will significantly affect the Medicare Part D prescription drug program. The most immediate impact of the reform aims to close the "donut hole", a component of the benefit design in which seniors must pay the full cost for their drugs themselves.

29 Apr 2010

Incorporation of NexACT technology helps reduce dose of Å6 compound for ovarian cancer treatment

NexMed, Inc., a specialty CRO with a pipeline of products based on the NexACT® technology, today announced that results from a pre-clinical study showed significant improvement in the delivery and half life of Å6, a proprietary peptide treatment for ovarian cancer currently in Phase 2 development by Angstrom Pharmaceuticals. Specifically, the incorporation of NexACT® enabled the dose of Å6 to be cut by half, or from twice per day to once per day delivered subcutaneously, while achieving the same level of efficacy in the mouse lung metastasis model.

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

Survey: Americans worry about getting health coverage, but leading Democrat optimistic of turnaround

Reuters: A new survey published Wednesday suggests that "Americans are steadily losing confidence in their ability to get healthcare and pay for it, despite the passage of healthcare reform legislation."

29 Apr 2010

Panel finds insufficient evidence to support preventive measures for cognitive decline, Alzheimer's disease

Many preventive measures for cognitive decline and for preventing Alzheimer's disease-mental stimulation, exercise, and a variety of dietary supplements-have been studied over the years. However, an independent panel convened this week by the National Institutes of Health determined that the value of these strategies for delaying the onset and/or reducing the severity of decline or disease hasn't been demonstrated in rigorous studies.

29 Apr 2010

Astrazeneca settles drug marketing lawsuit, plea deal rejected for possibly defective heart device maker

The New York Times: AstraZeneca has settled a case and agreed to pay $520 million after federal investigations into its marketing practices for a schizophrenia drug, Seroquel. The announcement came Tuesday from Attorney General Eric Holder. Government officials, including Health and Human Services Secretary Kathleen Sebelius, said the company paid illegal kickbacks to doctors to promote drugs for unapproved uses by children, the elderly, veterans and prisoners, which is illegal under federal law.

29 Apr 2010

Pain Therapeutics reports net loss of $1.0 million for first-quarter 2010

Pain Therapeutics, Inc., a biopharmaceutical company, today reported first quarter 2010 financial results. Net loss for Q1 2010 was $1.0 million, or $0.02 per share, compared to a net loss of $1.8 million, or $0.04 per share, for Q1 2009.

29 Apr 2010

OSI Pharmaceuticals announces European Commission's approval of Tarceva for NSCLC

OSI Pharmaceuticals, Inc. announced today that its international partner for Tarceva® (erlotinib), Roche, received approval from the European Commission for Tarceva as a monotherapy maintenance treatment in patients with advanced non-small cell lung cancer (NSCLC) whose disease remains largely unchanged (stable disease) after platinum-based initial chemotherapy.

29 Apr 2010

Watson Laboratories sued in connection with filing of ANDA for generic version of Rapamune tablets

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, has been sued by Pfizer Inc. and Wyeth Pharmaceuticals Inc. in connection with the filing of Watson's Abbreviated New Drug Application for sirolimus tablets in the 1 mg and 2 mg strengths.

29 Apr 2010

Roche announces results of phase III T-emerge 3 study of taspoglutide in diabetics

Ipsen, a global biopharmaceutical group, today announced that its partner Roche has disclosed results of the phase III T-emerge 3 study in patients with diabetes with taspoglutide, the first once weekly glucagon-like peptide-1 (GLP-1) analogue based on a human sequence. Taspoglutide originating from Ipsen's research is developed by Roche.

29 Apr 2010

NIDCR awards Selenium $912,943 grant for development of antimicrobial dental devices and water lines

The National Institute of Dental and Craniofacial Research (NIDCR), one of the National Institutes of Health (NIH), has issued a two-year $912,943 grant to biopharmaceutical company Selenium, Ltd. to support the development of antimicrobial dental devices and water lines. In the two-part grant the NIH has approved $492,972 for year one and $419,971 for year two dependent on achieving year one objectives.

29 Apr 2010

Adamas Pharmaceuticals presents study results of TCAD therapy in immunocompromised influenza A patients

Adamas Pharmaceuticals, Inc., a privately held company, announced today the results from the first clinical study evaluating triple combination antiviral drug (TCAD) therapy for the treatment of influenza A in immunocompromised patients. Data from this Phase 1b study were presented by clinical investigator Dr. Janet Englund in a clinical symposium at the 23rd International Conference on Antiviral Research (ICAR) in San Francisco.

29 Apr 2010

Salix Pharmaceuticals receives FDA complete response letter for GIAZO Tablets NDA

Salix Pharmaceuticals, Ltd. today announced the Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for GIAZO™ (balsalazide disodium) Tablets 1.1 g. for the treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older.

29 Apr 2010

Lycera to advance discovery, development efforts with second tranche of $11 million Series A financing

Lycera Corporation, a biopharmaceutical company pioneering an innovative approach to developing novel oral medicines to treat autoimmune diseases, today announced that the company has made important progress, triggering a second tranche of $11 million in its Series A financing. Proceeds from the second tranche will be used to continue to advance Lycera's discovery and development efforts and further support the growth of the company.

29 Apr 2010

Ceregene continues enrollment in new Phase 1/2 clinical study of CERE-120 for Parkinson's disease

Ceregene, Inc., a biopharmaceutical company, announced today that enrollment is proceeding in a new Phase 1/2 clinical study evaluating CERE-120, a gene therapy product which delivers the neurotrophic factor neurturin, to dying neurons in Parkinson's disease patients. This new clinical study follows a completed Phase 2 trial and builds on experience gained in that trial, by enhancing the dosing regimen and optimizing the duration of patient follow up.

29 Apr 2010

Mylan Pharmaceuticals' ANDA for generic version of Flomax receives FDA approval

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Tamsulosin Hydrochloride Capsules USP, 0.4 mg, the generic version of Boehringer Ingelheim's benign prostatic hyperplasia treatment, Flomax.

29 Apr 2010

Pharmaceuticals News and Research

Provectus reports on end-of-Phase 2 meeting with FDA on licensure of PV-10 for metastatic melanoma

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

BD second-quarter revenues up 7.0% to $1.845 billion

AVEO Pharmaceuticals reports net loss of $14.4 million for first-quarter 2010

New MDC tool provides alternative choices to user's current prescription drugs

Incorporation of NexACT technology helps reduce dose of Å6 compound for ovarian cancer treatment

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

Survey: Americans worry about getting health coverage, but leading Democrat optimistic of turnaround

Panel finds insufficient evidence to support preventive measures for cognitive decline, Alzheimer's disease

Astrazeneca settles drug marketing lawsuit, plea deal rejected for possibly defective heart device maker

Pain Therapeutics reports net loss of $1.0 million for first-quarter 2010

OSI Pharmaceuticals announces European Commission's approval of Tarceva for NSCLC

Watson Laboratories sued in connection with filing of ANDA for generic version of Rapamune tablets

Roche announces results of phase III T-emerge 3 study of taspoglutide in diabetics

NIDCR awards Selenium $912,943 grant for development of antimicrobial dental devices and water lines

Adamas Pharmaceuticals presents study results of TCAD therapy in immunocompromised influenza A patients

Salix Pharmaceuticals receives FDA complete response letter for GIAZO Tablets NDA

Lycera to advance discovery, development efforts with second tranche of $11 million Series A financing

Ceregene continues enrollment in new Phase 1/2 clinical study of CERE-120 for Parkinson's disease

Mylan Pharmaceuticals' ANDA for generic version of Flomax receives FDA approval

Drug Discovery - Second Edition eBook

Discover how SciY empowers scientists

Why use light scattering to analyze proteins and viral vectors?

Changing the landscape of R&D to build clinical success from the ground up

Latest Life Science News