Pharmaceuticals News and Research

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Shire announces study results of Vyvanse Capsules CII for treatment of ADHD in adolescents

Shire plc, the global specialty biopharmaceutical company, today announced the results of a study evaluating the safety and efficacy of Vyvanse (lisdexamfetamine dimesylate) Capsules CII for the treatment of Attention Deficit Hyperactivity Disorder in adolescents aged 13 to 17 years.

26 May 2010

Positive results reported from Phase IIa clinical trial of intranasal oxytocin for CDH

Trigemina, Inc., a Mountain View based privately-held biopharmaceutical company, reports positive results from a time-based interim analysis of its Phase IIa clinical trial in Chronic Daily Headache. The trial is a collaborative effort between Trigemina and Dr. Egilius Spierings of MedVadis Research Corporation located outside of Boston. The study compares intranasal oxytocin with placebo in patients suffering from CDH.

26 May 2010

Academic researchers say tour yielded 23 percent increase in patients who got best, cheapest drugs

Reuters reports that 150 academic researchers touring the U.S. to make recommendations on diuretics and best and cheapest practices for blood pressure medicine have reported a 23 percent increase in patients who get the recommended drugs, "twice the increase in the U.S. over the same period."

26 May 2010

Vertex reports 75% patients with HCV achieve viral cure with 12-week telaprevir-based combination regimen

Vertex Pharmaceuticals Incorporated today announced that 75% of people chronically infected with genotype 1 hepatitis C virus (HCV) who had not previously been treated achieved a sustained viral response (SVR or viral cure) after receiving a 12-week telaprevir-based combination regimen, followed by treatment with pegylated-interferon and ribavirin alone, in the Phase 3 ADVANCE trial.

26 May 2010

AMRI to reduce US workforce by 10%

AMRI today announced that it is repositioning itself to meet a continued shift in demand from customers for services in Asia and Europe. Overall for 2009 and 2010, the company anticipates investing in excess of $30 million on international facility and capability expansions and estimates its non-US workforce will increase by approximately 180 positions in order to meet known and anticipated customer demand.

26 May 2010

Immunomedics announces receipt of $5M from Nycomed for reaching clinical milestone

Immunomedics, Inc., a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced the receipt of $5 million from Nycomed for reaching a clinical milestone under the license and collaboration agreement, entered into on July 11, 2008.

26 May 2010

Genzyme's suit stays final FDA approval of Watson's generic Renvela ANDA

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market sevelamer carbonate 800mg tablets. Watson's sevelamer carbonate tablet is the generic version of Genzyme's Renvela®. Renvela ® is a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease who are on dialysis.

26 May 2010

Mylan Pharmaceuticals introduces Temazepam Capsules USP, 7.5 mg

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Temazepam Capsules USP, 7.5 mg.

25 May 2010

Rockwell Medical's SFP Phase IIb data accepted for presentation at XLVII ERA-EDTA Congress

Rockwell Medical, a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia, announced today that Phase IIb data for its lead drug candidate Soluble Ferric Pyrophosphate (SFP) have been accepted for presentation at the XLVII European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) Congress, organized in collaboration with the Deutsche Gesellschaft fur Nephrologie (DGfN) in Munich, Germany, June 25-28, 2010.

25 May 2010

La Jolla Pharmaceutical announces $16.3 million private placement

La Jolla Pharmaceutical Company announced today that the Company has entered into definitive agreements with institutional investors and affiliates for a private placement of common stock, convertible preferred stock and warrants to purchase convertible preferred stock totaling up to $16.3 million in gross proceeds.

25 May 2010

Experts question 'doc fix' as Reid threatens weekend work on bill with COBRA, Medicare provisions

Politico: Experts are questioning the virtues of the three-year Medicare "doc fix" that would stave off cuts to Medicare doctors' pay but set up a larger fight down the road. ... In health policy circles, the 'doc fix' has become emblematic of Washington's worst habits: a potentially solvable policy problem run amok for about a decade now, bogged down in pure politics and accounting gimmicks. The 'doc fix,' a last-minute infusion of funds to head off a looming doctor pay cut under Medicare, hits the floor this week via the tax extenders bill ..."

25 May 2010

Valocor Therapeutics acquires, licenses dermatology therapeutic programs from QLT

Valocor Therapeutics, Inc., a newly formed company focused on the development of innovative therapies for the treatment of dermatologic conditions, today announced the acquisition and license of certain dermatology therapeutic programs from QLT Inc.. This transaction was facilitated by a seed financing for Valocor led by the Working Opportunity Fund, which is managed by GrowthWorks Capital Ltd.

25 May 2010

CoDa Therapeutics reports positive results from Phase 2 study of NEXAGON for chronic venous leg ulcers

CoDa Therapeutics, Inc., a biopharmaceutical company focused on the development and commercialization of therapeutics for wound care and tissue repair, today announced positive results from its Phase 2 NOVEL Study of NEXAGON® in patients with chronic venous leg ulcers. NEXAGON® is a topically applied, novel therapeutic candidate, with the potential to revolutionize the wound healing treatment paradigm by leveraging a new mechanism and target involved in the healing process.

25 May 2010

Spectrum Pharmaceuticals to present clinical data on belinostat at ASCO 2010

Spectrum Pharmaceuticals, Inc., a commercial stage biotechnology company with a primary focus in hematology and oncology, today announced that clinical data on belinostat will be presented at the 2010 Annual Meeting of the American Society of Clinical Oncology, to be held June 4-8, 2010 at the McCormick Place Convention Center in Chicago, Illinois.

25 May 2010

DMC recommends ARIAD continue Phase 3 trial of oral ridaforolimus for metastatic sarcomas to final analysis

ARIAD Pharmaceuticals, Inc. today announced that the independent Data Monitoring Committee (DMC) of the Phase 3 SUCCEED trial has completed the second interim efficacy analysis as specified in the study protocol and has recommended that the randomized, placebo-controlled trial of oral ridaforolimus in patients with metastatic sarcomas continue to its final analysis, without modification to the study protocol.

25 May 2010

Clovis Oncology, Avila Therapeutics announce development agreement for NSCLC EMSI program

Clovis Oncology, Inc., a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents, and Avila Therapeutics, Inc., a biotechnology company designing targeted covalent drugs, announced today an agreement for the development and commercialization of Avila's epidermal growth factor receptor (EGFR) mutant-selective inhibitor (EMSI) program, currently in pre-clinical development for the treatment of non-small cell lung cancer (NSCLC).

25 May 2010

Yissum introduces Dralgo platform to accelerate discovery of promising drug candidates

Drug discovery and development is a highly risky process, with only one in 10,000 initial candidate compounds reaching the market. When taking into account the aborted candidates, the cost of developing one successful drug may even reach $1 billion, and the development process may take as long as 15-20 years.

25 May 2010

ImmunoGen to present clinical data on IMGN388 solid tumor compound at 2010 ASCO

ImmunoGen, Inc., a biopharmaceutical company that develops targeted anticancer therapeutics, announced today that there will be several clinical data presentations for compounds utilizing the Company's Targeted Antibody Payload (TAP) technology at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO) being held in Chicago on June 4-8, 2010.

25 May 2010

NovaBay Pharmaceuticals completes enrollment in Phase 2a trial of NVC-422 for treatment of impetigo

NovaBay Pharmaceuticals, Inc., a clinical stage biotechnology company developing first-in-class, anti-infective compounds for the treatment and prevention of antibiotic-resistant infections, today announced the completion of enrollment in a Phase 2a proof-of-concept trial for the treatment of impetigo.

25 May 2010

AlphaMed Press earns CEO Cancer Gold Standard accreditation

AlphaMed Press has received CEO Cancer Gold Standard™ accreditation, recognizing the organization's commitment to taking concrete actions to reduce the cancer risk of its employees and their families through screenings, early detection, and healthy changes in lifestyle and in the workplace.

25 May 2010

Pharmaceuticals News and Research

Shire announces study results of Vyvanse Capsules CII for treatment of ADHD in adolescents

Positive results reported from Phase IIa clinical trial of intranasal oxytocin for CDH

Academic researchers say tour yielded 23 percent increase in patients who got best, cheapest drugs

Vertex reports 75% patients with HCV achieve viral cure with 12-week telaprevir-based combination regimen

AMRI to reduce US workforce by 10%

Immunomedics announces receipt of $5M from Nycomed for reaching clinical milestone

Genzyme's suit stays final FDA approval of Watson's generic Renvela ANDA

Mylan Pharmaceuticals introduces Temazepam Capsules USP, 7.5 mg

Rockwell Medical's SFP Phase IIb data accepted for presentation at XLVII ERA-EDTA Congress

La Jolla Pharmaceutical announces $16.3 million private placement

Experts question 'doc fix' as Reid threatens weekend work on bill with COBRA, Medicare provisions

Valocor Therapeutics acquires, licenses dermatology therapeutic programs from QLT

CoDa Therapeutics reports positive results from Phase 2 study of NEXAGON for chronic venous leg ulcers

Spectrum Pharmaceuticals to present clinical data on belinostat at ASCO 2010

DMC recommends ARIAD continue Phase 3 trial of oral ridaforolimus for metastatic sarcomas to final analysis

Clovis Oncology, Avila Therapeutics announce development agreement for NSCLC EMSI program

Yissum introduces Dralgo platform to accelerate discovery of promising drug candidates

ImmunoGen to present clinical data on IMGN388 solid tumor compound at 2010 ASCO

NovaBay Pharmaceuticals completes enrollment in Phase 2a trial of NVC-422 for treatment of impetigo

AlphaMed Press earns CEO Cancer Gold Standard accreditation

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