Pharmaceuticals News and Research

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FDA completes review of compounded hydroxyprogesterone caproate products and APIs

FDA (or the Agency) approved Makena (hydroxyprogesterone caproate) in February 2011 for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth. Beginning many years before Makena was approved, a version of the active ingredient of Makena has been available to patients whose physicians requested the drug from a pharmacist who compounded the drug.

18 Jun 2012

GAO: Medicaid anti-fraud audit program falls short on cost-benefit analysis

Private contractors received $102 million to review Medicaid fraud data, yet had only found about $20 million in overpayments since 2008, according to a new report by the federal government.

16 Jun 2012

Research roundup: Best health care for homeless, new business model for pharma

The cost and coordination of health care for homeless individuals can be a challenge for states. But as this brief describes, establishing supportive housing - which provides social services, usually on site - "can help improve health, increase survival rates, foster mental health recovery, and reduce alcohol and drug use."

16 Jun 2012

St. Michael's to investigate new treatments for prevention of brain injury complications

St. Michael's Hospital has been awarded up to $700,000 from the Federal Economic Development Agency of Southern Ontario to investigate new treatments to prevent complications following certain brain injuries.

16 Jun 2012

Otsuka, Bristol-Myers Squibb announce six-year data from SPRYCEL Phase 3 trial on CP-CML

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Europe Ltd., today announced six-year follow-up results from a Phase 3 randomised, open-label, dose-optimisation study of SPRYCEL (dasatinib) in Philadelphia chromosome-positive (Ph+) chronic-phase chronic myeloid leukaemia (CP-CML) adult patients resistant or intolerant to Glivec (imatinib).

16 Jun 2012

Health Canada approves Sunovion’s LATUDA NDA to treat schizophrenia

Sunovion Pharmaceuticals Canada Inc. today announced that the New Drug Submission (NDS) for LATUDA (lurasidone HCl), for the treatment of adult patients with acute schizophrenia has been approved by Health Canada.

16 Jun 2012

OSU unveils new online course for pharmacists

Oregon State University (OSU) has unveiled an online course for pharmacists, designed to improve their management and human resource abilities while providing a valuable continuing education opportunity.

16 Jun 2012

New approach to drug design may yield more effective and less toxic cancer medicines

A new approach to drug design, pioneered by a group of researchers at the University of California, San Francisco (UCSF) and Mt. Sinai, New York, promises to help identify future drugs to fight cancer and other diseases that will be more effective and have fewer side effects.

16 Jun 2012

Civitas commences CVT-301 Phase 2a trial in Parkinson's disease

Civitas Therapeutics, Inc., a privately-held pharmaceutical company developing transformative therapeutics using the ARCUS respiratory delivery platform, announced today the initiation of a Phase 2a clinical trial in Parkinson's disease patients evaluating CVT-301, an inhaled formulation of levodopa (L-dopa), for the rapid relief from motor fluctuations.

16 Jun 2012

NextGen commercializes new assay for identification of biomarkers in brain disorders

NextGen Group Plc, the AIM listed company developing its own diagnostics product pipeline and providing diagnostic biomarker development services, announces the commercialisation of a new assay for the identification of diagnostic biomarkers in brain disorders in animal models.

15 Jun 2012

Research examines link between metabolic syndrome and cognitive disorders

No effective treatments are currently available for the prevention or cure of Alzheimer's disease (AD), the most frequent form of dementia in the elderly. The most recognized risk factors, advancing age and having the apolipoprotein E Ɛ4 gene, cannot be modified or treated. Increasingly, scientists are looking toward other risk factors to identify preventive and therapeutic strategies.

15 Jun 2012

Nouveau Life explores line of specialty supplements for seniors

Nouveau Life Pharmaceuticals, Inc., a provider of quality all-natural dietary supplements, announced today that the Company is exploring a line of specialty supplements for seniors.

15 Jun 2012

ISCO develops new TTF-based stem cell technology

International Stem Cell Corporation announced that scientists in its wholly-owned subsidiary, Lifeline Cell Technology (LCT), have developed a technology to modify human stem cells by using engineered proteins, called "transducible transcription factors" or "TTFs."

15 Jun 2012

Impel NeuroPharma announces important POD technology milestones

Impel NeuroPharma, a medical device company developing a novel drug delivery device that enables drugs to bypass the blood-brain barrier (BBB) using direct nose-to-brain delivery, today announced a set of important milestones in its drive to commercialize its POD technology.

15 Jun 2012

Positive top-line results from Teva’s GALA Phase III trial on RRMS

Teva Pharmaceutical Industries Ltd. today announced positive top-line results from the GALA (Glatiramer Acetate Low-Frequency Administration) Phase III clinical trial assessing the efficacy, safety and tolerability of 40 mg/1 ml glatiramer acetate injection (GA) administered subcutaneously three times a week compared to placebo in relapsing-remitting multiple sclerosis (RRMS) patients.

15 Jun 2012

Third Rock Ventures announces formation of Global Blood Therapeutics

Third Rock Ventures, LLC today announced the formation of Global Blood Therapeutics, Inc. and its $40.7 million Series A financing of the company.

15 Jun 2012

Quest receives FDA clearance to initiate oregovomab Phase II trial in ovarian cancer

Quest PharmaTech Inc., a pharmaceutical company developing and commercializing products for the treatment of cancer, announces that it has received clearance from the United States Food and Drug Administration to initiate U.S. sites for an ongoing international Phase II clinical trial for oregovomab in advanced ovarian cancer patients.

15 Jun 2012

Hay fever vaccine shows efficacy in phase IIa trial

A novel vaccine for grass pollen allergy has shown significant improvements for patients in a Phase IIa trial. The vaccine BM32 is based on an innovative recombinant peptide carrier technology that allows for fewer injections and shows fewer side effects compared with other immunotherapy treatments for allergy sufferers. BM32 has been developed by Biomay AG, an Austrian biopharmaceutical company specialized in the discovery and development of innovative allergy therapeutics. The company has already initiated a Phase IIb trial for BM32 with 180 allergic patients.

14 Jun 2012

Study examines constitutionality of pharmaceutical gift laws

We've all seen them in the waiting room of the doctor's office-pens, notepads, magnets, and clipboards adorned with the logos of brand-name drugs. These freebies may seem inconsequential, but a large and compelling body of evidence shows that even these small gifts may influence which drug a doctor prescribes.

14 Jun 2012

Osteoporosis self-reports unreliable measure for case defintions

Self-reports of incident osteoporosis in middle-aged and older women should not be relied on for a case definition, suggest study findings showing poor-to-moderate validity for this measure.

14 Jun 2012