Pharmaceuticals News and Research

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COU-AA-301 Phase 3 study demonstrates improvement in CRPC survival rate

Results from a pre-specified interim analysis of a randomized, placebo-controlled Phase 3 study, COU-AA-301, demonstrate that patients treated with the investigational agent abiraterone acetate plus low-dose prednisone/prednisolone showed a significant improvement in overall survival compared to patients treated with prednisone/prednisolone plus placebo.

11 Oct 2010

Sales of Merck's telcagepant and CoLucid's lasmiditan in world's major markets to reach $1.3 billion in 2019

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that two first-in-class agents — Merck's telcagepant and CoLucid's lasmiditan — will earn combined sales of approximately $1.3 billion in 2019 in the United States, France, Germany, Italy, Spain, United Kingdom and Japan.

11 Oct 2010

Gelesis presents lead products data at Obesity 2010 Annual Meeting

Gelesis, Inc., a Boston-based company focused on breakthrough treatments for obesity, presented new results at Obesity 2010, the 28th Annual Scientific Meeting of The Obesity Society (San Diego). The new data demonstrated that its lead products (Attiva and Gellica) dramatically reduced food intake in a gold-standard animal model compared to administration of an equal amount of water.

11 Oct 2010

Arable introduces CTMS and EDC software for clinical organizations

Arable Corporation has announced the launch of Arable Perform to bring unique CTMS technologies to the clinical trial industry. Whereas traditional CTMS systems have been costly and require months to implement, Perform brings CTMS and EDC capabilities without the traditionally high start-up costs.

11 Oct 2010

MingSight acquires worldwide rights from Pfizer to develop new chemical entities for human diseases

MingSight Pharmaceuticals announced today that it has acquired the exclusive worldwide rights from Pfizer to develop, manufacture, and commercialize two preclinical stage new chemical entities for the prevention and treatment of human diseases.

11 Oct 2010

AVEO presents tivozanib Phase 2 study results at ESMO Congress

AVEO Pharmaceuticals, Inc. a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that previously reported results from its Phase 2 study evaluating tivozanib for the treatment of advanced renal cell carcinoma (RCC) were presented at the 35th European Society for Medical Oncology (ESMO) Congress in Milan, Italy.

11 Oct 2010

Weikang Bio-Technology reiterates fiscal 2010 revenue guidance, targets growth of 30% to 50% for fiscal 2011

Weikang Bio-Technology Group Co., Inc., a leading developer, manufacturer and marketer of Traditional Chinese Medicine (TCM), Western prescription and OTC pharmaceuticals and other health and nutritional products in the People's Republic of China, today announced that the Company is reiterating its fiscal 2010 revenue guidance of $55 million, net profit of $21 million and earning per share of $0.75.

11 Oct 2010

Valeant announces Alexza's receipt of FDA CRL for AZ-004 NDA

Valeant Pharmaceuticals International, Inc. announced today that Alexza Pharmaceuticals, Inc. has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding Alexza's New Drug Application (NDA) for AZ-004 (Staccato® loxapine) submitted as Adusuve™ Staccato® (loxapine) inhalation aerosol, 5 mg and 10 mg.

11 Oct 2010

BioSante presents update on LibiGel clinical study at NAMS Annual Meeting

BioSante Pharmaceuticals, Inc. presented a LibiGel clinical study update at the 21st Annual Meeting of The North American Menopause Society (NAMS) on October 8, 2010, with more than 1,000 experts and practitioners in menopause and women's health in attendance.

11 Oct 2010

OXiGENE announces ZYBRESTAT Phase 2/3 study results at ESMO Congress

OXiGENE, a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced that an ongoing analysis of positive results reported earlier from a randomized, controlled, Phase 2/3 study of ZYBRESTAT (fosbretabulin, CA4P) were presented today at the 35th European Society of Medical Oncology (ESMO) Congress in Milan, Italy by Julie Ann Sosa, M.D., F.A.C.S., of Yale University.

11 Oct 2010

Afinitor-Sandostatin LAR Depot combination extends median PFS in patients with advanced carcinoid tumors

A Novartis Pharmaceuticals Corporation Phase III study of Afinitor® (everolimus) tablets in combination with Sandostatin® LAR Depot (octreotide acetate for injectable suspension) extended median progression-free survival (PFS), or time without tumor growth, in patients with advanced carcinoid tumors compared to taking octreotide LAR alone.

11 Oct 2010

Promising clinical data of ImmunoGen's lorvotuzumab mertansine to be presented at ESMO conference

ImmunoGen, Inc., a biopharmaceutical company that develops targeted anticancer therapeutics using its Targeted Antibody Payload (TAP) technology, today announced the presentation of encouraging clinical data for the Company's lorvotuzumab mertansine (IMGN901) targeted anticancer compound at the 35th European Society for Medical Oncology (ESMO) Conference being held in Milan, Italy, October 8-12, 2010.

11 Oct 2010

Millennium, Seattle Genetics announce positive top-line results of SGN-35 phase II clinical trial

Seattle Genetics, Inc. and Millennium The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, today announced positive top-line results from a phase II clinical trial of single-agent brentuximab vedotin (SGN-35), an antibody-drug conjugate (ADC) targeted to CD30. The trial was conducted in 58 relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) patients.

11 Oct 2010

FDA issues CRL for AZ-004 NDA application

Alexza Pharmaceuticals, Inc. announced today that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA or Agency) regarding its New Drug Application (NDA) for AZ-004 (Staccato loxapine), submitted as Adusuve Staccato (loxapine) inhalation aerosol, 5 mg and 10 mg.

11 Oct 2010

Auxilium commences dosing in global XIAFLEX phase III program for Peyronie's disease

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced that the first subject has been dosed in the global phase III program of XIAFLEX® for the treatment of Peyronie's disease. Peyronie's disease is the development of scar tissue on the penis that can cause the penis to curve during erection, often interfering with or preventing intercourse and resulting in psychological distress or bother for the patient.

11 Oct 2010

FDA issues CRL to Jazz for JZP-6 NDA for fibromyalgia

Jazz Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has sent the company a complete response letter (CRL) regarding the company's New Drug Application (NDA) for JZP-6 (sodium oxybate) for the treatment of fibromyalgia. The CRL states that the FDA cannot approve the NDA in its present form.

11 Oct 2010

Ipsen announces sale of shares in PregLem Holding to Gedeon Richter

Ipsen today disclosed that it has sold its shares in PregLem Holding SA to Gedeon Richter Plc, as have all PregLem's other shareholders.

11 Oct 2010

BiondVax commences Multimeric-001 flu vaccine Phase IIa clinical study

BiondVax Pharmaceuticals Ltd., an Israeli biopharmaceutical company at the forefront of global efforts towards the development of a Universal Influenza Vaccine, today announced that it has begun to immunize subjects in a Phase IIa clinical trial of the Multimeric-001 Universal Flu Vaccine candidate. The study will evaluate the safety and immunogenicity of the Multimeric-001 vaccine.

11 Oct 2010

FDA warns of harmful stimulant in Slimming Beauty capsules

The U.S. Food and Drug Administration today advised consumers who have Slimming Beauty Bitter Orange Slimming Capsules not to use the product. FDA warns that Slimming Beauty Bitter Orange Slimming Capsules contain the active pharmaceutical ingredient sibutramine, a prescription-only drug which is a stimulant. Sibutramine is not listed on the product label and could harm consumers, especially those with cardiovascular conditions.

11 Oct 2010

Takeda, Envoy enter three-year research alliance to develop schizophrenia drug

Takeda Pharmaceutical Company Limited, a global pharmaceutical company, and Envoy Therapeutics Inc., a recently formed drug discovery company, today announced that they have formed a three-year research alliance aimed at discovering drugs for schizophrenia that will have greater efficacy and safety compared to current therapies.

11 Oct 2010

Pharmaceuticals News and Research

COU-AA-301 Phase 3 study demonstrates improvement in CRPC survival rate

Sales of Merck's telcagepant and CoLucid's lasmiditan in world's major markets to reach $1.3 billion in 2019

Gelesis presents lead products data at Obesity 2010 Annual Meeting

Arable introduces CTMS and EDC software for clinical organizations

MingSight acquires worldwide rights from Pfizer to develop new chemical entities for human diseases

AVEO presents tivozanib Phase 2 study results at ESMO Congress

Weikang Bio-Technology reiterates fiscal 2010 revenue guidance, targets growth of 30% to 50% for fiscal 2011

Valeant announces Alexza's receipt of FDA CRL for AZ-004 NDA

BioSante presents update on LibiGel clinical study at NAMS Annual Meeting

OXiGENE announces ZYBRESTAT Phase 2/3 study results at ESMO Congress

Afinitor-Sandostatin LAR Depot combination extends median PFS in patients with advanced carcinoid tumors

Promising clinical data of ImmunoGen's lorvotuzumab mertansine to be presented at ESMO conference

Millennium, Seattle Genetics announce positive top-line results of SGN-35 phase II clinical trial

FDA issues CRL for AZ-004 NDA application

Auxilium commences dosing in global XIAFLEX phase III program for Peyronie's disease

FDA issues CRL to Jazz for JZP-6 NDA for fibromyalgia

Ipsen announces sale of shares in PregLem Holding to Gedeon Richter

BiondVax commences Multimeric-001 flu vaccine Phase IIa clinical study

FDA warns of harmful stimulant in Slimming Beauty capsules

Takeda, Envoy enter three-year research alliance to develop schizophrenia drug

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