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Alexza Pharmaceuticals to meet with FDA to discuss CRL regarding its NDA for AZ-004

Alexza Pharmaceuticals, Inc. announced today that the Company has scheduled an End-of Review meeting with the U.S. Food and Drug Administration in December to discuss the Complete Response Letter regarding the Company's New Drug Application for AZ-004 (Staccato loxapine).

8 Dec 2010

FDA Advisory Committee votes in favor of Orexigen's Contrave for treatment of obesity

Orexigen® Therapeutics, Inc. and Takeda Pharmaceutical Company Limited announced today that the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 7 that the available data adequately demonstrate that the potential benefits of Contrave® (naltrexone sustained release (SR)/bupropion SR) outweigh the potential risks when used long-term in a population of overweight and obese individuals and support approval.

8 Dec 2010

Contrave, new weight loss pill gets FDA panel nod

A Food and Drug Administration (FDA) panel yesterday recommended the approval of Orexigen Therapeutics’ weight loss drug Contrave. This is the first time a weight loss drug has received the nod. The vote went 13 to 7 for Contrave’s approval and 11 to 8, with an abstention that additional studies be conducted on heart risks. Although experts agree to risks they believe the benefits outweigh the risks. Although the FDA is not compelled to go with the panel’s recommendation, it more often than not does. The FDA will deliver its verdict by Jan. 31 2011.

7 Dec 2010

$Seattle Genetics and Millennium announce positive data from SGN-35 Phase II trial in relapsed or refractory ALCL$

Seattle Genetics and Millennium announce positive data from SGN-35 Phase II trial in relapsed or refractory ALCL

Seattle Genetics, Inc. and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, today announced positive data from a phase II clinical trial of single-agent brentuximab vedotin (SGN-35) in relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). Brentuximab vedotin is an antibody-drug conjugate (ADC) targeted to CD30, a defining marker of ALCL. The data were presented today during an oral session at the 52nd American Society of Hematology (ASH) Annual Meeting in Orlando, FL.

7 Dec 2010

China Biologic receives license to commence commercial plasma collection at Yishui station

China Biologic Products, Inc., one of the leading plasma-based biopharmaceutical companies in the People's Republic of China, operating through its indirect majority-owned subsidiaries, Shandong Taibang Biological Products Co., Ltd. and Guiyang Dalin Biologic Technologies Co., Ltd., and its equity investment in Xi'an Huitian Blood Products Co., Ltd., today announced that it has received a plasma collection license from the Shandong Province Health Department for its newly built plasma collection station in Yishui county, Shandong province.

7 Dec 2010

Zogenix, Desitin receive MAA approval for SUMAVEL DosePro needle-free delivery system in Denmark

Aradigm Corporation today announced that Zogenix, Inc. and Desitin Pharmaceuticals GmbH ("Desitin") were granted approval of the Marketing Authorization Application ("MAA") for SUMAVEL® DosePro™ (sumatriptan injection) needle-free delivery system by the Danish Medicines Agency of Denmark.

7 Dec 2010

$Onyx Pharmaceuticals reports positive Phase 2b 003-A1 study results of carfilzomib for refractory multiple myeloma$

Onyx Pharmaceuticals reports positive Phase 2b 003-A1 study results of carfilzomib for refractory multiple myeloma

Onyx Pharmaceuticals, Inc. today announced positive complete results from the Phase 2b 003-A1 study of single-agent carfilzomib, a next generation proteasome inhibitor, in patients with relapsed and refractory multiple myeloma.

7 Dec 2010

Matrix's NDA for Abacavir Sulfate receives tentative FDA approval under PEPFAR

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Abacavir Sulfate Tablets, 60 mg. The NDA is based on the reference listed drug Ziagen® by ViiV Healthcare.

7 Dec 2010

Watson, Natco confirm development agreement for generic Revlimid

Watson Pharmaceuticals, Inc. and Natco Pharma Limited today confirmed an exclusive, U.S. development and license agreement, to develop and commercialize lenalidomide 5, 10, 15 and 25 mg tablets. The companies also confirmed that Natco has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its lenalidomide 5, 10, 15 and 25 mg product. Natco's lenalidomide tablets are generic versions of Celgene's Revlimid ® Tablets.

7 Dec 2010

Consolidation treatment with Y-90 epratuzumab after R-CHOP improves remission in DLBCL lymphoma

Immunomedics, Inc., a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today reported that consolidation treatment with fractionated yttrium-90 (Y-90) labeled epratuzumab, after induction therapy with rituximab and CHOP (R-CHOP) chemotherapy, improved remission status of adult patients with diffuse large B-cell lymphoma (DLBCL), a form of aggressive lymphoma.

7 Dec 2010

Breast cancer patients taking tamoxifen anxious to have CYP2D6 genetic test

While the medical community continues to debate the benefits of CYP2D6 genetic testing for women on the breast cancer treatment tamoxifen, patients using the medication are anxious to have the tests. According to a new survey of more than 700 women with breast cancer currently taking tamoxifen, almost 80 percent of respondents would choose to have a genetic test that determines CYP2D6 genotype, yet only 14 percent of these women have been tested. CYP2D6 is an enzyme that influences how well the body processes tamoxifen into its more active form.

7 Dec 2010

Interim results from Cytheris CYT107 Phase I clinical trial in TCD bone marrow transplant patients

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced interim results from a Phase I clinical trial of its investigational drug candidate, recombinant human Interleukin-7 (CYT107), in the treatment of post-transplant patients with T-cell depleted (TCD) bone marrow or peripheral blood stem cell transplants.

7 Dec 2010

Epratuzumab-rituximab combination therapy effective against previously untreated follicular lymphoma

Immunomedics, Inc., a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that combination therapy with epratuzumab and rituximab was effective, with durable complete responses in one-third of evaluable patients, and was very well tolerated by patients with previously untreated follicular lymphoma (FL).

7 Dec 2010

Selcia's radiochemistry facility granted GMP certificate

Selcia Limited, a leading independent provider of Carbon-14 (C-14) radiolabelling services, is pleased to announce that its radiochemistry facility has been granted a Good Manufacturing Practice (GMP) certificate for the preparationand C-14 labellingofActive Pharmaceutical Ingredients (APIs)for clinical trials following a successful inspection by the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

7 Dec 2010

Lytix Biopharma, KAEL-GemVax initiate treatment in LTX-315/GV1001 combination anti-cancer vaccine trial

The Norwegian biopharmaceutical company Lytix Biopharma and the Korean biotechnology company KAEL-GemVax announced today the successful first treatment in the study of a combination of LTX-315 and GV1001 as anti-cancer vaccine therapy.

7 Dec 2010

IMO-4200 dual agonist increases antitumor activity in lymphoma models: Study

Idera Pharmaceuticals, Inc. today presented data showing that IMO-4200, a dual agonist of Toll-like receptor (TLR) 7 and TLR8, in combination with approved cancer treatments, rituximab or bortezomib, significantly increased antitumor activity in several preclinical lymphoma models. The presentation, entitled "Antitumor Activity of an RNA-Based Agonist of TLR7 and 8 in Preclinical Models of Hematological Malignancies," was made at the 52nd Annual Meeting of the American Society for Hematology in Orlando, Florida by Idera scientists.

7 Dec 2010

ADHD drug market will decrease from $5 billion in 2009 to $4.1 billion in 2019: Report

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the attention-deficit/hyperactivity disorder (ADHD) drug market in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan will fluctuate modestly over the next decade, decreasing from $5 billion in 2009 to a trough in 2013 before climbing to $4.1 billion in 2019.

7 Dec 2010

Positive results from PROCHIEVE 8% vaginal progesterone gel Phase III trial to reduce preterm birth risk

Columbia Laboratories, Inc. and Watson Pharmaceuticals, Inc. today announced positive top-line results from the PREGNANT Study, a large, global Phase III clinical trial evaluating PROCHIEVE® 8% vaginal progesterone gel to reduce the risk of preterm birth in women with a short cervical length as measured by transvaginal ultrasound at mid-pregnancy.

7 Dec 2010

Cylene Pharmaceuticals to present data on CK2 inhibitor at ASH Annual Meeting

Cylene Pharmaceuticals, Inc. has been selected to present data describing the activity of their first-in-class CK2 inhibitor at the 52nd Annual Meeting of the American Society of Hematology, to be held on December 4-7 in Orlando, FL, the company announced today. Kenna Anderes, VP Cancer Biology at Cylene, will discuss research on targeting CK2, a protein kinase that is essential for the progression of multiple myeloma but that has not been previously exploited as an anticancer target.

7 Dec 2010

Pfizer CEO unexpectedly retires

As the chairman of the trade group Pharmaceutical Research and Manufacturers of America, Kindler was instrumental in lining up drugmaker support for this year's health care overhaul in a deal that ultimately will bring those companies more customers and sales. The industry had helped defeat the Clinton adminstration's attempt to reform health care in 1994

7 Dec 2010

Pharmaceuticals News and Research

Alexza Pharmaceuticals to meet with FDA to discuss CRL regarding its NDA for AZ-004

FDA Advisory Committee votes in favor of Orexigen's Contrave for treatment of obesity

Contrave, new weight loss pill gets FDA panel nod

Seattle Genetics and Millennium announce positive data from SGN-35 Phase II trial in relapsed or refractory ALCL

China Biologic receives license to commence commercial plasma collection at Yishui station

Zogenix, Desitin receive MAA approval for SUMAVEL DosePro needle-free delivery system in Denmark

Onyx Pharmaceuticals reports positive Phase 2b 003-A1 study results of carfilzomib for refractory multiple myeloma

Matrix's NDA for Abacavir Sulfate receives tentative FDA approval under PEPFAR

Watson, Natco confirm development agreement for generic Revlimid

Consolidation treatment with Y-90 epratuzumab after R-CHOP improves remission in DLBCL lymphoma

Breast cancer patients taking tamoxifen anxious to have CYP2D6 genetic test

Interim results from Cytheris CYT107 Phase I clinical trial in TCD bone marrow transplant patients

Epratuzumab-rituximab combination therapy effective against previously untreated follicular lymphoma

Selcia's radiochemistry facility granted GMP certificate

Lytix Biopharma, KAEL-GemVax initiate treatment in LTX-315/GV1001 combination anti-cancer vaccine trial

IMO-4200 dual agonist increases antitumor activity in lymphoma models: Study

ADHD drug market will decrease from $5 billion in 2009 to $4.1 billion in 2019: Report

Positive results from PROCHIEVE 8% vaginal progesterone gel Phase III trial to reduce preterm birth risk

Cylene Pharmaceuticals to present data on CK2 inhibitor at ASH Annual Meeting

Pfizer CEO unexpectedly retires

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