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AstraZeneca and Targacept enter into agreement to develop and commercialize TC-5214

AstraZeneca and Targacept, Inc. today announced a collaboration and license agreement for the global development and commercialization of TC-5214, Targacept’s late-stage investigational product for major depressive disorder (MDD).

3 Dec 2009

Roche ships additional quantities of Tamiflu oral suspension

Roche announced today that it has begun shipping additional quantities of Tamiflu® (oseltamivir phosphate) oral suspension (liquid).

3 Dec 2009

Researchers to publish a paper on the availability of 'Spice' drugs online

A paper to be published this month by University of Hertfordshire researchers about the availability of 'Spice' drugs online will raise new concerns about its mood altering effects.

3 Dec 2009

Cephalon's lawsuit against Teva Pharmaceuticals for patent infringement of NUVIGIL tablets

Cephalon, Inc. today announced that it has filed a lawsuit in U.S. District Court in Delaware against Teva Pharmaceuticals USA, Inc. for infringement of U.S. Patent Nos. 7,132,570 (the "'570 Patent"), 7,297,346 (the "'346 Patent") and RE37,516 (the "'516 Patent") for the Cephalon product NUVIGIL® (armodafinil) Tablets [C-IV].

3 Dec 2009

FDA grants Fast Track designation for Keryx Biopharmaceuticals' KRX-0401

Keryx Biopharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway, for the treatment of relapsed/refractory multiple myeloma.

3 Dec 2009

Beta 2 adrenergic agonist drugs linked to autism-spectrum disorders

Commonly prescribed beta 2 adrenergic agonist drugs for the treatment of asthma in pregnant women as well as pre-term labor may increase the incidence of autism-spectrum disorders, psychiatric pathology, cognitive problems and poor school performance in their children, according to a new study published in the December 2009 issue of the American Journal of Obstetrics & Gynecology.

3 Dec 2009

The Hill examines push to get more U.S. funding for malaria medicines

The Hill examines Medicines for Malaria Venture's (MMV) efforts to get more U.S. funding for its work. According to the newspaper, the group is "asking USAID and Congress to redirect more money beginning next year to drug research and development from a pot of funds used to cover the range of efforts to treat and prevent malaria, such as providing mosquito nets."

3 Dec 2009

U.S. H1N1 cases decreasing, CDC says; HHS to review approach to health-threat preparedness

The number of H1N1 (swine flu) cases in the U.S. appears to be decreasing, the CDC said Tuesday, CQ HealthBeat reports. "Flu was widespread in 32 states by the end of the week of Nov. 21, a decrease from 43 states in the prior week and 46 states earlier this fall, according to the CDC," the news service writes. "

3 Dec 2009

Impax Laboratories acquires ANDA from Watson Pharmaceuticals and Cobalt Laboratories

Impax Laboratories, Inc. today announced it acquired Abbreviated New Drug Applications (ANDA) from Watson Pharmaceuticals and Cobalt Laboratories, a subsidiary of Arrow Group.

2 Dec 2009

Repeated use of ecstasy drug increases the risk of developing sleep apnea

Repeated use of the drug popularly known as "ecstasy" significantly raises the risk of developing sleep apnea in otherwise healthy young adults with no other known risk factors for the sleep disturbance, a new study by Johns Hopkins scientists suggests.

2 Dec 2009

Kalbitor drug approved by FDA

The U.S. Food and Drug Administration approved Kalbitor (ecallantide) on Dec. 1 to treat sudden and potentially life-threatening fluid buildup that can occur in people with a rare genetic condition known as hereditary angioedema (HAE).

2 Dec 2009

Aspen Brook Consulting announces 2010 Bioprocess Management Summit

Aspen Brook Consulting, Inc., announces the 2010 Bioprocess Management Summit. This event, occurring February 24th-26th, 2010 at The Canyons Hotel and Conference Center in Park City UT, has been designed as a forum where members of the bioprocess community gather annually to share their knowledge and experience in an effort to address challenges facing the biopharmaceutical industry.

2 Dec 2009

Champions Biotechnology and Ramot establish licensing agreement

Champions Biotechnology, Inc., a U.S. Oncology drug development company with a predictive preclinical platform aimed at accelerating the development and enhancing the value of oncology drugs, has established an exclusive licensing agreement with Ramot at Tel Aviv University Ltd., Tel Aviv University's wholly owned technology transfer company.

2 Dec 2009

Javelin Pharmaceuticals submits an NDA for Dyloject Injection

Javelin Pharmaceuticals, Inc., a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its investigational product candidate, Dyloject™ (diclofenac sodium) Injection, for the management of acute moderate-to-severe pain in adults.

2 Dec 2009

Women at high risk of developing breast cancer reluctant to take tamoxifen for prevention

Even when women at high-risk of breast cancer are well-informed about the risks and benefits of using the drug tamoxifen for prevention, only 6 percent said they were likely to take it.

2 Dec 2009

FDA approves revised clinical trial protocol for CytRx' arimoclomol

CytRx Corporation, a biopharmaceutical company, is permitted to re-enter the clinic with its orally administered molecular chaperone drug candidate arimoclomol as a therapeutic treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease), following the U.S. Food and Drug Administration’s (FDA) acceptance of a revised clinical trial protocol.

2 Dec 2009

Generic erosion to decrease branded atypical antipsychotics schizophrenia drug market to $5.2B

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that generic erosion of several established branded atypical antipsychotics will cause the schizophrenia drug market to decrease from $6.3 billion in 2008 to $5.2 billion in 2013 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

2 Dec 2009

Shire settles ADDERALL XR authorized generic version supply litigation

Shire plc, the global specialty biopharmaceutical company, announces that it has settled the litigation with Teva Pharmaceuticals USA, Inc. ("Teva") over Shire's supply to Teva of an authorized generic version of ADDERALL XR. Shire has been supplying Teva with authorized generic ADDERALL XR since April 1, 2009.

2 Dec 2009

Sinovac Biotech receives fourth purchase order for its H1N1 vaccine from Chinese government

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today that it has received its fourth purchase order for its H1N1 vaccine, PANFLU.1(TM), from China's Ministry of Industry and Information Technology for the national purchase plan.

2 Dec 2009

Beta 2 adrenergic agonist drugs can increase risk of autism-spectrum disorders in developing fetus

2 Dec 2009

Pharmaceutical News

AstraZeneca and Targacept enter into agreement to develop and commercialize TC-5214

Roche ships additional quantities of Tamiflu oral suspension

Researchers to publish a paper on the availability of 'Spice' drugs online

Cephalon's lawsuit against Teva Pharmaceuticals for patent infringement of NUVIGIL tablets

FDA grants Fast Track designation for Keryx Biopharmaceuticals' KRX-0401

Beta 2 adrenergic agonist drugs linked to autism-spectrum disorders

The Hill examines push to get more U.S. funding for malaria medicines

U.S. H1N1 cases decreasing, CDC says; HHS to review approach to health-threat preparedness

Impax Laboratories acquires ANDA from Watson Pharmaceuticals and Cobalt Laboratories

Repeated use of ecstasy drug increases the risk of developing sleep apnea

Kalbitor drug approved by FDA

Aspen Brook Consulting announces 2010 Bioprocess Management Summit

Champions Biotechnology and Ramot establish licensing agreement

Javelin Pharmaceuticals submits an NDA for Dyloject Injection

Women at high risk of developing breast cancer reluctant to take tamoxifen for prevention

FDA approves revised clinical trial protocol for CytRx' arimoclomol

Generic erosion to decrease branded atypical antipsychotics schizophrenia drug market to $5.2B

Shire settles ADDERALL XR authorized generic version supply litigation

Sinovac Biotech receives fourth purchase order for its H1N1 vaccine from Chinese government

Beta 2 adrenergic agonist drugs can increase risk of autism-spectrum disorders in developing fetus

Achieving and maintaining ISO 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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