Pharmacology

Oxford BioMedica plc, a gene-based biopharmaceutical company, and Cardiff University announced a Phase II trial to assess the safety and immunological activity of TroVax(R), a therapeutic vaccine for patients with inoperable metastatic colorectal cancer (CRC). The study will be funded by Cardiff University, with some funding awarded by Cancer Research Wales, and Oxford BioMedica will provide TroVax(R). The trial is supported by the Experimental Cancer Medicine Centre (ECMC), Cardiff.
Colorectal cancer is the second most common cause of cancer mortality in the UK with an estimated 16,…

Science 2.0 fave Dr. Neil deGrasse Tyson recently sent a funny thing across his Twitter feed:
Q: What do you call Alternative Medicine that survives double-blind laboratory tests? A: Regular Medicine.
And that's the crux of the issue, isn't it? There's no Big Pharm conspiracy against homeopathy, for example. What multi-national conglomerate wouldn't love to slosh some magic water in a bottle and sell it for 10 bucks or more? It just doesn't work.
Yet con artists have cleverly used 'alternative' medicine to appeal to people with a faux independent mindset; too smart and progressive…

A new study has assessed the effectiveness of two somatostatin vaccinations, JH17 and JH18, in reducing weight gain and increasing weight loss in mice.
Somatostatin is a peptide hormone which inhibits the action of growth hormone (GH) and insulin-like growth factor (IGF-1), both of which increase metabolism and result in weight loss. Vaccination with modified somatostatin caused the body to generate antibodies to somatostatin, effectively removing this inhibition without directly interfering with the growth hormones and subsequently increasing energy expenditure and weight loss.
Keith Haffer…

Mundipharma today announced the positive European Commission (EC) decision for flutiform(R) (fluticasone propionate/formoterol fumarate), a new combination therapy for the maintenance treatment of asthma, in Europe. This decision is binding on all 21 Concerned Member States involved in the decentralized procedure (DCP) and the first national approvals of flutiform are expected across a number of countries by the end of 2012.
The combination of fluticasone propionate (fluticasone), an inhaled corticosteroid (ICS), and formoterol fumarate (formoterol), a long-acting beta2-agonist (LABA)…

A phase II interferon-free combination study with TMC435 and daclatasvir will evaluate treatment-naive or previous null responder patients with HCV genotype 1a and 1b - The study will include approx. 180 patients and will evaluate a combination of TMC435 and daclatasvir, with or without Ribavirin, in four different cohorts for 12 or 24 weeks of treatment
Medivir AB announced that a phase II combination study with the investigational compound TMC435 and Bristol-Myers Squibb's investigational compound daclatasvir will start in July.
TMC435, a once daily potent NS3/4A…

In a head-to-head trial between VPRIV and Cerezyme(R) (imiglucerase), only patients treated with VPRIV experienced statistically significant improvement in lumbar spine bone mineral density at 9 months
Shire plc today presented new data that show VPRIV(R) (velaglucerase alfa for injection), the company's enzyme replacement therapy for type 1 Gaucher disease, significantly improved selected markers of Gaucher-related bone disease in patients. These data were presented at the European Working Group on Gaucher Disease (EWGGD) meeting held in Paris, France.
The data…

Janssen-Cilag International NV (Janssen) announced today that the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending approval of subcutaneous (under the skin) administration of VELCADE(R) (bortezomib). VELCADE(R) is indicated for the treatment of multiple myeloma, a type of blood cancer. Subcutaneous bortezomib has fewer side effects and offers greater convenience for patients, with similar efficacy compared to intravenous bortezomib. VELCADE(R) plays a central role in effectively managing multiple myeloma…

Abbott announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for HUMIRA (adalimumab) in adults with severe axial spondyloarthritis (axSpA) who have no X-ray evidence of structural damage. Upon final decision from the European Commission, HUMIRA will be the first and only approved medication available for non-radiographic axSpA patients (nr-axSpA).
AxSpA, which includes ankylosing spondylitis (AS) and nr-axSpA, can be a debilitating condition that primarily presents with chronic back pain and stiffness, and can also be accompanied by…

Takeda Pharmaceutical Company Limited and AMAG Pharmaceuticals, Inc. today announced the granting of marketing authorization by the European Commission (EC) for ferumoxytol, a new intravenous (IV) iron therapy to treat iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD). The marketing authorization follows a positive opinion issued on April 19, 2012, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Across the three pivotal Phase III safety and efficacy studies, 1,726 subjects were exposed to ferumoxytol,…

Takeda Pharmaceutical Company Limited and NPS Pharmaceuticals, Inc. , jointly announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product teduglutide (Revestive in Europe) as a once-daily treatment for adult patients with short bowel syndrome (SBS).
SBS is a rare but debilitating disease characterized by the body's severely impaired ability to absorb nutrients and fluids through the gastrointestinal tract in people who…