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Agile completes enrollment in AG200-15 Phase 3 contraceptive patch study

Agile Therapeutics, Inc., a pharmaceutical development company specializing in women's healthcare products, today announced the Company has completed patient enrollment in its pivotal, Phase 3 NEW CHOICE Study of AG200-15, Agile's lead contraceptive patch. Agile's NEW CHOICE Study enrolled 1500 women at over 100 sites throughout the U.S. The study is comparing the efficacy and tolerability of AG200-15 to a low-dose, oral contraceptive.

4 Oct 2010

Pharmatek adds roller compaction to GMP manufacturing facilities

Pharmatek Laboratories, Inc., a premier contract development and manufacturing organization supporting the pharmaceutical industry, announced that it has added roller compaction to its solid oral dosage form manufacturing capabilities. The company has purchased two roller compactors, a pilot-scale Vector TFC-220 roller compactor with a rate of 20 kg/hour, and a Vector TFC-LAB Micro lab-scale roller compactor with a rate of 1 kg/hour. Both machines have been integrated into Pharmatek's GMP facility and are ready for GMP manufacturing.

4 Oct 2010

Merck's boceprevir Phase III studies for HCV to be presented at 61st AASLD

Merck today announced that final results from two pivotal Phase III studies of boceprevir, its investigational oral hepatitis C protease inhibitor, will be presented in oral plenary sessions at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place from Oct. 29 through Nov. 2 in Boston. Results for boceprevir in response-guided therapy strategies, which evaluated treatment durations shorter than current standard therapy, will be presented during the meeting.

4 Oct 2010

AVEO Pharmaceuticals to present tivozanib Phase 2 study results at IKCS Symposium

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) will be presented at the Ninth International Kidney Cancer Symposium (IKCS) in Chicago, Illinois, October 1-2, 2010.

4 Oct 2010

WHO says polio outbreak in Angola must be stopped to avoid 'international consequences'

A polio outbreak in Angola, which started in 2007, could have "international consequences" if it is not stopped, Sona Bari, the WHO's spokesperson on polio eradication, said on Friday, Reuters reports.

4 Oct 2010

Array BioPharma to present positive interim results of Phase 1 ARRY-380 trial at ASCO Symposium

Array BioPharma Inc. today announced positive interim results of its novel, oral HER2 (ErbB2) inhibitor, ARRY-380, in a Phase 1 trial in patients with advanced cancer.

4 Oct 2010

Noven acquires global rights to Daytrana from Shire affiliates

Noven Pharmaceuticals, Inc. today announced that it has completed the acquisition of global rights to Daytrana® (methylphenidate transdermal system) from affiliates of Shire plc.

1 Oct 2010

Collagen Matrix's new Collagen Dental Membrane granted FDA 510(k) clearance

Collagen Matrix, Inc., the leader in collagen- and mineral-based matrix engineering, announced today that it has received FDA's 510(k) clearance of a new Collagen Dental Membrane derived from porcine dermis indicated for use in oral surgical procedures involving guided tissue and bone regeneration.

1 Oct 2010

Global phase IV study confirms efficacy of erlotinib in treatment of non-small cell lung cancer

Featured in the October edition of the Journal of Thoracic Oncology (JTO), data from The Tarceva Lung Cancer Survival Treatment (TRUST) confirms the safety and efficacy profile of erlotinib, a highly potent oral active, reversible inhibitor of epidermal growth factor receptor (EGFR) tyrosine-kinase (TK) activity in a large heterogeneous non-small cell lung cancer (NSCLC) population.

1 Oct 2010

Achillion initiates ACH-1625 Phase II dosing for HCV infection

Achillion Pharmaceuticals, Inc., a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced that the Company has initiated patient dosing in a Phase II clinical trial of ACH-1625 for the treatment of hepatitis C virus (HCV) infection. ACH-1625 is a potent small molecule inhibitor of HCV protease, an enzyme necessary for viral replication. The drug candidate was discovered and is being advanced by Achillion.

1 Oct 2010

FDA takes action against unapproved single-ingredient oral colchicine

The U.S. Food and Drug Administration took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial Mediterranean Fever (FMF).

1 Oct 2010

South Asian ethnicity is a risk factor for cardiovascular events after renal transplantation

Ethnicity is a contributing risk factor of cardiovascular problems in kidney recipients of South Asian origin post-transplant, according to a study appearing in an upcoming issue of the Clinical Journal of the American Society Nephrology (CJASN).

1 Oct 2010

Study demonstrates rufinamide therapy is effective in reducing partial seizure frequency

Researchers from the Arkansas Epilepsy Program found treatment with rufinamide results in a significant reduction in seizure frequency compared with placebo, for patients with uncontrolled partial-onset seizures (POS).

1 Oct 2010

NIH awards Polymedix $986,000 to develop defensin mimetic antimicrobial compounds for oral candidiasis

PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has received a Phase 2 grant in the amount of $986,000 from the National Institute of Health (NIH) to support the development of defensin mimetic antimicrobial compounds for the treatment of oral candidiasis. This grant will fund this research project through August 31, 2012. This award represents the 14th grant or research contract received to date by PolyMedix.

30 Sep 2010

Prix Galien USA committee honors life saving innovations

The Prix Galien USA committee honored innovations that are saving lives last night during the Prix Galien Awards Gala. The Pro Bono Humanum Award, the Prix Galien USA 2010 and the Prix Galien International were presented and related accomplishments celebrated.

30 Sep 2010

Repligen Corporation completes patient enrollment in RG2417 Phase 2b clinical trial

Repligen Corporation reported today that it has completed enrollment of patients in its Phase 2b clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar depression.

30 Sep 2010

sanofi-aventis announces top-line results from lixisenatide Phase III GETGOAL-L-ASIA trial for Type-2 Diabetes

Zealand Pharma A/S, the biopharmaceutical company dedicated to the discovery and development of innovative peptide-based drugs, is pleased to note that its partner, sanofi-aventis, has today announced positive top-line results of the Phase III GETGOAL-L-ASIA trial which assessed the efficacy and safety of lixisenatide, a once-daily GLP-1 receptor agonist discovered by Zealand Pharma, in combination with basal insulin.

30 Sep 2010

FDA grants Type B meeting to review Phase III pivotal efficacy protocols for Androxal

Repros Therapeutics Inc. today announced that the Company has been granted a Type B meeting to be held on November 8, 2010 with the Division of Reproductive and Urologic Products to review the Company's Phase III pivotal efficacy protocols for Androxal in the treatment of secondary hypogonadism. Androxal is an oral drug that normalizes both testosterone and sperm levels.

30 Sep 2010

UIC develops new technique to anchor teeth back in jaw using stem cells

A new approach to anchor teeth back in the jaw using stem cells has been developed and successfully tested in the laboratory for the first time by researchers at the University of Illinois at Chicago.

30 Sep 2010

Access Pharmaceuticals reports significant progress in Cobalamin-targeted drug-delivery program for siRNA therapies

ACCESS PHARMACEUTICALS, INC., a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced today that it has made significant progress with its proprietary Cobalamin-targeted drug-delivery program for siRNA therapies.

30 Sep 2010

Oral News and Research

Agile completes enrollment in AG200-15 Phase 3 contraceptive patch study

Pharmatek adds roller compaction to GMP manufacturing facilities

Merck's boceprevir Phase III studies for HCV to be presented at 61st AASLD

AVEO Pharmaceuticals to present tivozanib Phase 2 study results at IKCS Symposium

WHO says polio outbreak in Angola must be stopped to avoid 'international consequences'

Array BioPharma to present positive interim results of Phase 1 ARRY-380 trial at ASCO Symposium

Noven acquires global rights to Daytrana from Shire affiliates

Collagen Matrix's new Collagen Dental Membrane granted FDA 510(k) clearance

Global phase IV study confirms efficacy of erlotinib in treatment of non-small cell lung cancer

Achillion initiates ACH-1625 Phase II dosing for HCV infection

FDA takes action against unapproved single-ingredient oral colchicine

South Asian ethnicity is a risk factor for cardiovascular events after renal transplantation

Study demonstrates rufinamide therapy is effective in reducing partial seizure frequency

NIH awards Polymedix $986,000 to develop defensin mimetic antimicrobial compounds for oral candidiasis

Prix Galien USA committee honors life saving innovations

Repligen Corporation completes patient enrollment in RG2417 Phase 2b clinical trial

sanofi-aventis announces top-line results from lixisenatide Phase III GETGOAL-L-ASIA trial for Type-2 Diabetes

FDA grants Type B meeting to review Phase III pivotal efficacy protocols for Androxal

UIC develops new technique to anchor teeth back in jaw using stem cells

Access Pharmaceuticals reports significant progress in Cobalamin-targeted drug-delivery program for siRNA therapies

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