Pharmaceuticals News and Research

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AclarusDx Alzheimer’s test now available as RUO product

ExonHit Therapeutics is pleased to announce that AclarusDx™ Alzheimer’s test (formerly known as EHT Dx21), its blood-based test for the detection of Alzheimer’s disease (AD), is now available as a Research Use Only (RUO) product for pharmaceutical companies and leading academic centers conducting clinical trials in Alzheimer’s disease.

3 Dec 2009

European Phase III clinical trial of budesonide MMX completes patient enrollment

Santarus, Inc., a specialty biopharmaceutical company, today announced that its collaboration partner, Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals SpA (SIX: COPN), has completed enrollment of 514 patients in the European Phase III clinical trial to evaluate budesonide MMX® administered over eight weeks for the induction of remission of mild or moderate active ulcerative colitis.

3 Dec 2009

Watson Pharmaceuticals obtains FTC approval to acquire Arrow Group

Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that the Federal Trade Commission (FTC) has accepted a proposed consent order for public comment relating to Watson's pending acquisition of privately held Arrow Group and has granted early termination of the Hart Scott Rodino waiting period, thereby permitting the parties to close the transaction.

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

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

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

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

Senators consider women's insurance amendment, Medicare funding issues, with votes likely today

The New York Times: "In a day of desultory debate on sweeping health care legislation, senators appealed to two potent political constituencies ... with Democrats seeking additional medical benefits for women and Republicans vowing to preserve and protect Medicare for older Americans. The Democrats' first amendment, offered by Senator Barbara A. Mikulski of Maryland, would require insurers to cover more screenings and preventive care for women, with no co-payments."

2 Dec 2009

Patient enrollment complete in Peregrine Pharmaceuticals' Cotara trial

Peregrine Pharmaceuticals, Inc. today reported completion of patient enrollment in a dose confirmation and dosimetry trial of Cotara® in patients with relapsed glioblastoma multiforme (GBM), the deadliest form of brain cancer. Cotara is a targeted monoclonal antibody linked to a radioisotope being developed as a potential new treatment for GBM.

2 Dec 2009

Over twenty new drug metabolism assays launched by Absorption Systems

Absorption Systems, a leader in drug safety and ADMET (absorption, distribution, metabolism, excretion and toxicity) testing, today announced the introduction of a more complete series of drug metabolism assays designed to support the pharmaceutical R&D process, from early-stage discovery through late-stage clinical development.

2 Dec 2009

American Scientific Resources commences production of its FDA approved home needle destruction device

American Scientific Resources, Inc., announces that the Disintegrator Plus(TM), the world's only FDA approved home needle destruction device (NDD), is in its first production run for ASR.

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

FDA grants Fast Track designation for AEterna Zentaris' perifosine

AEterna Zentaris Inc., a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company's PI3K/Akt pathway inhibitor compound, perifosine (KRX-0401), for the treatment of relapsed/refractory multiple myeloma.

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

TARIS Biomedical completes Phase 1 study of its intravesical drug-device convergence system

TARIS Biomedical, a specialty pharmaceutical company pioneering the field of drug-device convergence for targeted therapies, announced today the successful completion of a Phase 1 clinical study of its intravesical drug-device convergence system designed to provide sustained-release of drug directly to the bladder.

2 Dec 2009

Accera Pharmaceuticals to implement the Veeva CRM suite of multi-tenant SaaS applications

Less than 9 months after implementing a new CRM application, Accera Pharmaceuticals began searching for a replacement. The commercial-stage biotechnology company, which launched Axona™ (a prescription-only medical food for the clinical dietary management of the metabolic processes associated with mild-to-moderate Alzheimer's disease) around the same time as it implemented its current system, had quickly outgrown the generic CRM tool.

2 Dec 2009

Jiangsu Yanshen Biological Technology Stock suspends production of all products

Simcere Pharmaceutical Group ("Simcere" or the "Company"), a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, today reported that its subsidiary Jiangsu Yanshen Biological Technology Stock Co., Ltd. ("Jiangsu Yanshen") has suspended production of all its products in order to conduct an internal inspection and improve its quality control systems.

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

University of Texas M.D. Anderson Cancer Center and Stemline Therapeutics enter into research collaboration

Stemline Therapeutics, Inc., a private clinical stage biopharmaceutical company and leading developer of oncology compounds directed to cancer stem cells, today announced that The University of Texas M.D. Anderson Cancer Center (Houston, TX) and Stemline have entered into a research collaboration.

2 Dec 2009

Pharmaceuticals News and Research

AclarusDx Alzheimer’s test now available as RUO product

European Phase III clinical trial of budesonide MMX completes patient enrollment

Watson Pharmaceuticals obtains FTC approval to acquire Arrow Group

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

Impax Laboratories acquires ANDA from Watson Pharmaceuticals and Cobalt Laboratories

Aspen Brook Consulting announces 2010 Bioprocess Management Summit

Javelin Pharmaceuticals submits an NDA for Dyloject Injection

Senators consider women's insurance amendment, Medicare funding issues, with votes likely today

Patient enrollment complete in Peregrine Pharmaceuticals' Cotara trial

Over twenty new drug metabolism assays launched by Absorption Systems

American Scientific Resources commences production of its FDA approved home needle destruction device

FDA approves revised clinical trial protocol for CytRx' arimoclomol

FDA grants Fast Track designation for AEterna Zentaris' perifosine

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

Shire settles ADDERALL XR authorized generic version supply litigation

TARIS Biomedical completes Phase 1 study of its intravesical drug-device convergence system

Accera Pharmaceuticals to implement the Veeva CRM suite of multi-tenant SaaS applications

Jiangsu Yanshen Biological Technology Stock suspends production of all products

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

University of Texas M.D. Anderson Cancer Center and Stemline Therapeutics enter into research collaboration

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