Research & Development News

The digital models will include a patient’s genetic and physiological make-up, using computing, IT storage, networking and modelling technologies.

Alkermes has announced the initiation of a Phase 2b study of ALKS 37, an orally active, peripherally restricted opioid antagonist for the treatment of opioid-induced constipation.

The trial showed that radium-223 chloride improved overall survival in 44% of patients with castration-resistant prostate cancer and symptomatic bone metastases.

The study examined the relationship between asthma and glycemic control in a racially and ethnically diverse group of 1,994 children and young adults aged 3 through 21 years with diabetes from across the United States.

The Phase II study showed that people who received trastuzumab emtansine experienced a 41 percent reduction in the risk of their disease worsening or death and lived a median of five months longer without their disease worsening.

The Phase I study will enrol up to 40 healthy adult volunteers to assess the safety profile of a single intravenous administration of TCN-032 compared to placebo.

Selvita has signed an agreement with Germany-based Evestra to deliver a range of drug metabolism, pharmacokinetic and physicochemical studies.

Boehringer Ingelheim has announced the enrolment of its first patient for a new phase III trial of an investigational chronic obstructive pulmonary disease therapy.

This is the first such ESC trial in Europe, which hopes to offer a glimpse of whether an injection of healthy retinal cells can arrest or even reverse the disease.

The trial has been designed to evaluate three once-daily doses of INX-189 (25mg, 50mg and 100mg) administered in combination with pegylated interferon and ribavirin for 12 weeks.

A new method that prevents HIV from weakening a patient's immune system have been discovered by a research team.

Novartis' ACZ885 shows positive results in a Phase III trial involving patients with systemic juvenile idiopathic arthritis.

AB Science is to commence its Phase III study of masitinib in severe persistent asthma.

Under the agreement, Ono will receives exclusive rights to all indications for injectable formulations of KAI-4169 in Japan, while KAI retains marketing rights in all other regions of the world.

The study will involve up to 225 patients, and will evaluate the safety and efficacy of weekly injections of CJC-1134-PC for a period of 17 weeks.

Under the agreement HQL will use its proprietary computational platform for screening chemical libraries that cover diverse chemotypes.

Acceleron starts a Phase I clinical study of ACE-536, the company's fourth internally discovered, developed and manufactured drug to enter human clinical trials in the past five years.

The Japanese pharma has initiated 3 phase III clinical trials, including a multi-center, double-blind controlled trial which will evaluate the efficacy and safety of TAK-875.

The decision follows reports of two serious adverse events in patients recruited in separate studies.

Pfizer has moved its research unit for cardiovascular and endocrine disease from Groton to Cambridge, Massachusetts.

The randomised, double-blind, placebo-controlled and parallel-group Phase II trial aims to evaluate the safety and efficacy of DRL-17822 in patients with type-II dyslipidemia.

The Crestor study involved around 1,300 patients and demonstrated that the tolerability and efficacy were in line with previous studies and approved product labelling.

The amended agreement provides an option for GSK to expand its rights around the bacterial enzyme target LeuRS in return for a milestone payment ranging from $5.5 million to $6.5 million.

In the trial, a maximum of 82 patients are expected to be treated with different doses of the HuCAL-derived antibody MOR202.

MuDelta, an investigational oral agent for the treatment of diarrhea-predominant irritable bowel syndrome, met its primary objectives of establishing tolerability, safety and efficacy in a 12-week study.

Researchers have found a promising new therapeutic target that could lead to better drugs to treat post-traumatic stress disorder.

The primary goal of the study was to evaluate the safety and tolerability of two doses of Menerba, higher than those previously tested during Phase II studies, after four weeks of treatment.

The R&D facility in Beijing will have its main focus on individualized treatments for cancer and other diseases.

The Phase IIb clinical trial is to evaluate the efficacy and safety of KUR-211 used as an adjunct to standard of care in patients with diabetic foot ulcers.

On average, patients were exposed to the study drug for more than 14 months, with a maximum exposure of 24.6 months. Macitentan was generally well tolerated in the patient population.

Adamis Pharmaceuticals announced that it enrolled the first patient in its Phase I/IIa clinical prostate study. In the study, patients will be assessed for toxicity, biochemical, radiographic and clinical responses.

The study involved 389 people who received either 8mg or 12mg of perampanel or placebo once-daily for 19 weeks in addition to regular treatment.

JX-594 attacked tumours in 23 patients as part of a small trial. Healthy tissue in the patients' bodies was left unharmed.

Researchers believe they have a way to help scientists come up with better ways of treating seasonal flu caused by the influenza B strain.

The primary efficacy endpoints include a measure of difference in the change in lean body mass and muscle strength in patients with weight loss associated with non-small cell lung cancer.

Alimentary Health and Norgine will both evaluate proprietary probiotic technology for development as a medicinal product for the treatment or management of gastrointestinal conditions.

The safety and efficacy of TAK-385 in subjects with endometriosis and uterine fibroids will be evaluated in two individual phase 2, double-blind, comparative studies.

Researchers believe that control of the complement abnormalities will be confirmed with further clinical testing in children with earlier stage disease, and that CDX-1135 may be able to restore kidney function and provide long-term disease control.

The IOM determined that the vaccines weren't tied to an increased risk of autism or type 1 diabetes.

The first Phase I/II clinical study aims to evaluate the tolerability and efficacy of somatic cell therapeutics for the treatment of peripheral arterial occlusive disease.

The study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy subjects and subjects who suffer from primary insomnia.

Included in the investment is four new biomedical research units, specialising in research into the treatment of dementia, and further research into cancer, diabetes and heart disease.

Successful data will support an expanded indication for Folotyn in the US in this patient population and to convert the current accelerated approval for relapsed and refractory PTCL to a full approval.

The company will recruit around 88 subjects in the trials in patients with relapsed indolent B-cell lymphoma and those who have failed prior treatments.

Argenta, a service division of Galapagos, has extended drug discovery agreement with Genentech which led the contract value to ?21.5m.

The study will evaluate the efficacy and safety of Eteplirsen in Duchenne muscular dystrophy patients over 24 weeks of dosing.

Normally, SIRT3 sets off a complex chain of events to transform fat into energy at the cellular level. But deleting the SIRT3 gene disrupted this chain, and fat deposits weren't broken down as they should have been.

Scientists are using computer programs that analyze drug data and genetic information to discover new uses for medicines already on the market.

Aeras and the Oxford-Emergent Tuberculosis Consortium have announced the start of a Phase IIb proof-of-concept efficacy trial of a new TB vaccine.

The technology selectively induces apoptosis in cells containing viral dsRNA, rapidly killing infected cells without harming uninfected cells.

Adolor Corporation has received positive results from two Phase II studies of ADL5945 in chronic non-cancer pain patients with opioid-induced constipation.

Scientists from India and Australia will start joint research for vaccines & medical diagnostics, stem cells, transgenic crops and marker assisted breeding and bioenergy.

German biopharma Scil Proteins signed a collaboration with the Martin Luther University Halle-Wittenberg to develop therapies for gastrointestinal tumours.

LX1031 was well tolerated in the study and showed improvements in a global assessment of adequate relief from IBS pain and discomfort and in stool consistency.

The collaboration is for the development of a novel malaria vaccine, which combines WRAIR's malaria antigen CelTOS with IDRI's potent GLA-SE adjuvant.

Qiagen and Pfizer partner to develop companion diagnostic for novel compound in global clinical trials for lung cancer.

The Company expects to complete patient enrollment in August and for the last patient to complete the study in September, with preliminary data from the study scheduled to be available in October 2011.

Impax aims to submit an NDA for IPX066 to FDA by the end of 2011. GSK expects to file a marketing authorization application for IPX066 in the EU during 2012.

Pulmatrix raised $14 million to progress its lead inhaled cationic airway lining modulator drug candidate.

Pharmacyclics Inc. will cooperate with the National Cancer Institute to develop PCI-32765, a small molecule inhibitor of Bruton's tyrosine kinase for the treatment of blood cancers.

Scientists assume that the genes behind high cholesterol in Chinese patients may be different from those responsible for the same problems in Western populations.

A vaccine created with an old tuberculosis remedy stimulates white blood cells to produce cytokines, which identify cancer cells as foreign to the body.

The Phase 11b trial will test the vaccine in around 1400 adults aged 18-50 who are infected with HIV.

Biogen Idec and Abbott Laboratories reported encouraging results from a second phase two clinical trial of drug daclizumab.

Researchers have identified 29 new genetic variants implicated in susceptibility to multiple sclerosis.

Intercept Pharmaceuticals and Les Laboratoires Servier announced that they have signed an agreement for the discovery and development of novel TGR5 agonists for the treatment of type 2 diabetes.

The companies that participated in the survey expect their r&d investment inside the EU to grow 3% a year over the next three years.

HP802-247 achieved statistical significance, compared with control plus standard care, in both the primary and secondary endpoints.

Data from the study in juveniles confirmed therapy using ENB-0040 led to significant improvements in rickets in treated patients.

Dyax announced treatment of the first patient in a Phase II trial evaluating the efficacy and safety of a therapy for acute treatment of angiotensin converting enzyme inhibitor-induced angioedema.

Lexicon Pharmaceuticals announced positive, top-line proof-of-concept data from its Phase 2 study in carcinoid syndrome with LX1032, telotristat etiprate.

The study will enrol approximately 450 patients, and is designed to compare the efficacy and safety of masitinib at 3mg/kg/day and 6mg/kg/day to methotrexate in the treatment of patients with active rheumatoid arthritis.

Swedish pharmaceutical company Sobi has recruited first patient in Kiobrina Phase III trial.

Criterium, a full-service, global CRO, has been selected to manage the operational aspects of Phase Ib/IIa trial of SNS01-T, a lead therapeutic candidate for the treatment of multiple myeloma.

In the study, Protagen's biomarker portfolio will be used for the rapid identification of auto-antibody signatures in the serum of systemic lupus erythematosus patients.

The firms say the decision to discontinue the program is based on a commercial reassessment, which included the evaluation of a revised development plan.

The trial is the first of two planned multicentre, global, double-blind, randomised Phase 3 studies to compare the safety and efficacy of CXA-201.

The U.S. Health and Human Services Department announced the awarding of research funding to two companies to develop treatments against acute radiation syndrome.

The International Vaccine Institute and Inviragen announce a collaboration to accelerate development of a dengue vaccine.

Researchers have found a better way to classify different types of stomach cancers, which can help customize treatments for patients.

Study centers across the U.S. are recruiting patients for a clinical study to examine whether an investigational drug is safe and effective in treating opioid-induced constipation.

Researchers found combined tamoxifen with dasatinib reversed chemotherapy resistance caused by fibroblasts in the surrounding tissue.

Lexicon now plans to move LX1033 forward into a Phase II study in patients with diarrhoea-predominant irritable bowel syndrome.

The oncology company plans to complete the required pre-clinical studies of NV-344 to submit an Investigational New Drug application to the US FDA by the first quarter of 2012.

Axxam Spa and Polyphor Ltd announce a joint discovery research project for the generation of GLP-1R modulators.

Based on the study data, Ceridia plans to conduct bio-equivalence and bioavailability trials, which will include anti-inflammatory, anti-infective and oncology drugs.

Researchers have discovered an antibody that is effective at fighting at all types of the influenza A virus.

The stem cells from the bone marrow of 13 people with MS will make their way to the brain, where it is hoped they will repair the damage caused by MS.

Baxter International reports new data from a series of studies during the 23rd annual congress of the ISTH in Kyoto.

In the study, the primary efficacy parameter is the per cent 'off time' during waking hours based on the patients' Parkinson's disease diaries.

R&D efforts are a mission critical activity for biotech companies, but according to a new report, company performance is not always directly linked to the level of R&D efforts undertaken.

Glenmark Pharmaceuticals said it has completed the Phase I trial of its new chronic pain drug candidate GRC 15300.

The study assessed eteplirsen's safety, tolerability, pharmacokinetic profile and ability to restore dystrophin expression.

Liver specialists and researchers globally are working on new treatment options including a combination drug that would ensure complete eradication of hepatitis virus.

The multilateral coordination board for International Space Station partner agencies has discussed the use of the facility for biotechnological research.

Repligen announces initiation of RG1068 pilot study to improve detection and characterisation of pancreatic cancer.

Studies found administering Cryab to animals 12 hours after stroke induction led to significantly reduced stroke volume and lower levels of inflammatory cytokines.

The approval follows a systematic literature review of published scientific articles that describe the efficacy and safety of the injection compared to a blue dye used in lymph node localisation by Pharmalucence.

Sanofi Pasteur and Leukocare will cooperate to evaluate Leukocare’s Stabilizing and Protecting Solutions platform for improving the shelf-life of certain vaccine formulations.

The aim of this study was to focus on the role of meteorological variables on the rate of ischemic events in a geographical area that would be representative of an east coast city population.

The Phase IIb/III trial will evaluate treatment with ganetespib and docetaxel compared with docetaxel alone.

The current regulations governing human subject research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site.

The mass production of medicines in genetically modified plants could reduce costs and improve access to drugs in developing countries where diseases such as HIV are a huge problem.

The Phase I study assessed the pharmacokinetics, safety and tolerability of cenicriviroc and tenofovir disoproxil fumarate when co-administered in healthy adults.

The study demonstrated the safety and tolerability of Levomilnacipran in patients with major depressive disorder.

The study showed pertuzumab combined with Herceptin (trastuzumab) and docetaxel chemotherapy improved progression-free survival rate compared to Herceptin and docetaxel in people with metastatic breast cancer.

In a five-country survey, respondents expressed strong support for increasing government spending for research on new treatments for Alzheimer's disease.

A new therapy based on nanotechnology could improve chemotherapy for cancer patients without side effects.

BioMarin Pharmaceutical has initiated a Phase I trial of a once-daily, oral poly-ADP-ribose polymerase inhibitor for advanced haematological malignancies.

OncoVista Innovative Therapies, Inc. reported that it has initiated an additional safety study of OVI-117 in a 2nd animal species.

The trial will enrol 48 paediatric and adult patients who have undergone haematopoietic stem cell transplantation.

The scientists believe their approach could provide an affordable and durable method for reducing the continuing worldwide epidemic of HIV.

SARcode Bioscience raised $44 million to support Phase III development of its topical drug SAR 1118 for the treatment of dry eye syndrome.

Abbott is investigating a new powder formulation of Norvir as well as a co-formulation of three HIV medicines - lopinavir, ritonavir and 3TC (lamivudine).

The trial enrolled 32 healthy volunteers in four cohorts of eight participants each. The drug showed dose-proportional pharmacokinetic exposure over the tested dose range.

Sanofi-Aventis and Regeneron Pharmaceuticals Inc said their experimental drug Sarilumab showed signs of improvement in rheumatoid arthritis patients in a mid-stage trial.

Studies conducted in some African countries have shown some AIDs drugs can prevent the spread of HIV to uninfected individuals.

Advaxis has concluded patient recruitment in first low dose cohort in a Phase II trial.

The company expects to file for U.S. and E.U. approval of alemtuzumab in MS in early 2012.

Researchers have identified the genetic mutations responsible for the new strain's extreme resistance to all cephalosporin-class antibiotics.