Research & Development News

The results were not significantly different from that observed with placebo, and hence Alkermes has determined not to pursue further development of ALKS 33 in this treatment area.

Synta Pharmaceuticals reports positive results from a Phase II single-agent clinical trial of ganetespib, a potent, synthetic, small-molecule inhibitor.

The study will evaluate the safety profile and effects of the drug on brain glucose use in patients aged 55-85 with mild Alzheimer's disease.

The trial successfully demonstrated the safety of an IV infusion of Methamphetamine and produced the IV infusion pharmacokinetics needed to initiate Phase IIa clinical studies in stroke patients.

A new research reports a high prevalence of vitamin D insufficiency and deficiency among patients with psoriatic arthritis.

The study will evaluate the safety, tolerability and pharmacokinetics of single or multiple doses of BL-1021 in healthy volunteers.

The study enrolled 501 subjects and demonstrated a reduction in endpoint mean pain score compared to a placebo.

A study has produced a synthetic tissue, a hydrogel, which mimics the properties of mucosal tissues, such as those found in the mouth and stomach, to assess how medicines will react in the body.

Nuvilex announced successful results for the treatment of breast cancer from preclinical studies.

Enzo Biochem reported its discovery of new class of proteins to inhibit the Wnt signalling pathway.

The study evaluated 190 patients and showed talactoferrin reduced mortality and was well-tolerated in patients with severe sepsis.

Scientists believe the new technique will help under-used antibiotic drugs like colistin to be used to fight against the spread of life-threatening bacterial infections.

Sanofi signs a research collaboration with Rib-X Pharmaceuticals to develop novel antibiotics.

Amgen and UCB are working with NASA Ames Research Center to conduct a preclinical test of a sclerostin antibody in an experiment aboard space shuttle Atlantis.

The trial enrolled 19 patients and showed ataluren induced improvements in chloride channel activity, cystic fibrosis-related cough and positive trends in lung function.

The companies will test Pharmasset's PSI-7977, a nucleotide polymerase inhibitor, along with TMC435, Tibotec’s protease inhibitor.

The study said the risk increased by 72 percent for healthy, middle-aged smokers. FDA officials responded by saying that more analysis was needed before the agency would change its position.

Almac’s Diagnostics unit will be the central service lab to perform the analytic phase and results delivery to clinicians of Exonhit's AclarusDx diagnostic test.

The trial will evaluate the safety and efficacy of Synavive as a treatment for the signs and symptoms of rheumatoid arthritis in about 250 subjects.

Genentech has announced successful clinical results from the two Phase III trials of Lucentis against diabetic macular oedema.

The vaccine, known as SCIB2, stimulates immune responses to the lung cancer antigen NY-ESO-1 and may also have potential utility in oesophageal, liver, gastric, prostate, ovarian and bladder cancers.

The researchers believe the vaccine could be used as part of a combination therapy to recent-onset type 1 diabetes patients.

The study included 150 patients and demonstrated improvements in signs and symptoms with its low and high doses of MIM-D3.

Bayer HealthCare works with the Ludwig Boltzmann Institute (LBI) for Lung Vascular Research in the research area of lung vascular diseases.

The studies demonstrated the drug's safety and its ability to cross the blood-brain barrier, proving it effective against the disease in its first two stages.

The study results found that all doses of the drug showed glycosylated haemoglobin reductions at week 12 versus placebo.

Anacor Pharmaceuticals reports positive results from a mid-stage trial of a drug candidate designed to treat the skin condition psoriasis.

Under the terms of the collaboration, Sanofi will provide 80,000 chemical compounds to Weill Cornell, where the compounds will be screened to assess their ability to inhibit growth of Mycobacterium tuberculosis.

A new survey says Indian companies will need to start doing more collaborative work to catch up with trend setters in Eastern Europe.

The open-label and multicentre trial enrolled 16 patients and showed the efficacy of the brain cancer drug.

ALT-803 has demonstrated anti-tumor activities in various preclinical cancer models and could potentially make a life-changing difference for patients with solid and hematological tumors.

The parties will integrate their expertise to identify active compounds against high-value therapeutic targets.

The Institute will serve as the single entry point for academic collaborations in France across multiple disease areas and scientific disciplines.

The study demonstrated the efficacy and safety of the drug in patients with mesalazine-refractory ulcerative colitis.

BMS and AstraZeneca reported positive data from a Phase III clinical study evaluating their investigational sodium-glucose co-transporter-2 (SGLT2) inhibitor dapagliflozin, combined with metformin, for the treatment of type 2 diabetes.

Recent findings showed when combined with standard anti-leukemia agents, the biological activity of a drug candidate showed synergistic anti-leukemia effects.

Beyond providing a platform to develop new drugs, the genomic test will also bring significant economic benefit to the UK, as it will be commercially available to a global market.

The ?5.9m grant will help the company fund a two-year research project.

The study is the first systematic investigation into the long term health impacts of 'anticholinergic activity'.

Porsolt and JSW announced that they have signed a strategic collaboration agreement to co-market complementary contract research services.

The study found a significant improvement in lung function and a reduction in disease flare-ups in those receiving the treatment.

CorMedix announced its completion of patient enrollment in its Phase II contrast-induced acute injury study with its oral drug candidate CRMD001.

CytRx announced the preliminary results from its Phase II trial of cancer-inhibitor candidate bafetinib.

The findings indicated the drug benifitted patients for whom standard second-line induction therapy is not an option or has failed to produce a robust response prior to autologous stem cell transplant.

Symphogen has reported the preliminary results from a Phase II clinical trial of rozrolimupab in RhD positive, non-splenectomised adults with immune thrombocytopenia.

The first part of the study demonstrated the safety and tolerability of the combination regimen with no serious side effects.

Drug developer Abbott has reported interim efficacy and safety results from a Phase III study of levodopa-carbidopa intestinal gel.

The vaccine, which could be the first vaccine for dengue fever, is on track to be available in 2014. It is being tested in 15 countries and initial results are expected at the end of next year.

Researchers have completed a Phase I study with atropine sulphate delivered from a MicroDose proprietary dry powder inhaler to combat the effects of nerve agent poisoning.

The decision to terminate was based on the observation that V710 was unlikely to demonstrate a statistically significant clinical benefit.

This collaboration provides Merck with access to diverse developmental and commercial diagnostic technologies.

The Foundation's activities will focus on persuading opinion leaders, policymakers inside and outside government, and other decision makers of the benefits and safety of vaccines and the merits of increased investment in vaccine research.

The pilot project, initiated following review from the U.S. FDA, uses mobile phone and web-based technology to collect necessary data for the trial without clinic visits.

Synta Pharmaceuticals has announced successful clinical responses from the Phase II trial of ganetespib in patients with advanced non-small cell lung cancer.

The drug showed reduction of exacerbations and improvements in lung function. The study also demonstrated the safety and efficacy of the drug candidate for COPD.

The Phase III trial is designed to examine the efficacy, safety and tolerability of the drug versus a placebo.

The study continues to show that the vaccine increases the usual time until relapse for follicular lymphoma by about 14 months.

BioSante Pharmaceutical said the ability to top enrolment as per the sample size analysis indicates a 90% predictive probability of success of the LibiGel Phase III clinical development programme.

The trial was conducted at five centres in the US, and evaluated the safety and immunogenicity of DPX-0907 vaccine in patients with advanced stage breast, ovarian or prostate cancer.

The primary endpoint of the study is to determine the percentage of patients that achieve a Clinical Benefit Response.

The Phase II trial included 113 patients demonstrated that 57% of patients taking cixutumumab experienced stable disease.

The primary endpoint of the study is to determine the percentage of patients that achieve a Clinical Benefit Response.

Under the terms of the agreement, AstraZeneca has worldwide commercial rights to product candidates emerging from the collaboration.

The results demonstrated that treatment with gene therapy agent showed the clinically meaningful improvement and durability over the long-term.

Basilea Pharmaceutica reported positive top-line results from the Phase I study of its antibiotic BAL30072.

In the framework of this agreement, Sanofi will initially bring molecules from its libraries into the partnership, while DNDi and Sanofi collaborate in research activities on innovative molecular scaffolds.

Novartis recently announced positive data from two late stage trials of its pipeline candidate ACZ885 for the treatment of patients suffering from severe gouty arthritis.

The clinical phase I study investigated the safety, tolerability and pharmacokinetics of single ascending doses of BAL30072 in healthy volunteers.

KemPharm announced positive results from a Phase 1 clinical trial of its most advanced opioid-based drug candidate, KP201, a novel hydrocodone prodrug for treating pain.

The Phase III study included 2,492 patients and showed Tribenzor was safe and effective in patients with hypertension.

The increase is more pronounced in people who are diabetic, and in whom the control of blood sugar levels is particularly important.

Medivir announces positive 48-week interim data from TMC435 hepatitis C Phase IIb study.

The study showed that the drug increased the number of specific T-cells responsible for the maintenance of long-term immunologic memory.

The Phase III study showed the drug increased bone metastasis-free survival for more than four months, delayed the time to first bone metastasis and reduced risk by 15% compared with the placebo.

The study aims to understand how methotrexate is being absorbed, retained, and metabolized by a patient.

A gene allele that increases the risk of Alzheimer's disease starts to damage the brain 50 years before symptoms of the disease appear, a new study says.

Researchers have announced that anti-retroviral drugs have cut deaths caused by HIV by more than 60% in China.

NovaBay Pharmaceuticals announced the results of a phase II clinical study for the treatment of adenoviral conjunctivitis.

AstraZeneca said the results may have a positive effect on progression-free survival in women with serous ovarian cancer, and may be a therapeutic option for the aggressive form of cancer.

The UK’s Technology Strategy Board and the Medical Research Council are jointly investing ?3.7m in seven major research projects for personalised medicine.

Takeda and H Lundbeck announced the initiation of a phase III clinical trial in Japan for Lu AA21004 in patients with major depressive disorder.

The current study focused on an inherited genetic deficiency that prevents the production of coenzyme Q, a critical antioxidant and component of the energy-generating respiratory chain.

This trial assessed progression-free survival as a primary endpoint in 113 patients with advanced or metastatic soft tissue sarcoma and Ewing family of tumors who were treated with cixutumumab.

A network of clinical trial centres will launch in the UK to improve survival rates among patients suffering from blood cancers.

The data from the Symbicort study supports the understanding of the product's efficacy and safety in African-American patients, who are more prone to asthma.

The study included 189 patients and showed that 94.7% of patients treated with Exparel were satisfied with their post-surgical analgesia.

Abbott has submitted applications to both the US Food and Drug Administration and the European Medicines Agency seeking approval to market Humira.

The Manchester Collaborative Centre for Inflammation Research will bring together scientists from the pharmaceutical industry and academia to work on inflammation research and translational medicine.

The European Commission has selected two research projects in a shortlist of six that will compete for two EU funding agreements, each worth €1bn.

The CAMbrella project aims to develop a European research plan boosting the utility of alternative medicine, and to help to develop regulation.

Under the agreement, Halozyme may receive as much as $83 million, with $9 million upfront and potential future milestone payments of $74 million based on clinical and regulatory targets, plus a 10% royalty on future sales.

The study demonstrated the effect of weekly injections of Nexvax2 over three weeks, in coeliac patients on a strict gluten-free diet.

The results showed that 45% of patients in the Velcade arm achieved a complete response or near complete response, compared to 35% of patients in the control group.

The study analysis included 494 adult patients with UC who had not responded well to conventional therapy.

Pfizer has published clinical trial data that supports the effectiveness of its drug Pristiq for the treatment of hot flashes in postmenopausal women.

Pfizer announced that its Phase 3 immunogenicity and safety trials of Prevnar 13 in adults aged 50 years and older have met all study endpoints.

The Swedish firm will collaborate with a research group to deliver novel therapies aimed at overcoming drug resistance and relapse in cancer.

The collaboration between the Center for World Health and Medicine and the Institute for OneWorld Health aims to develop safe and effective anti-secretory drugs.

The Phase I clinical study in healthy volunteers showed that AM152 is safe and well-tolerated at doses that are expected to provide a full range of receptor coverage in humans.

A study shows DNA from Helicobacter pylori, a common stomach bacteria, minimizes the effects of colitis.

The research group analysed blood samples of people with HIV and found their virus had evolved to evade or ‘escape’ the ADCC antibodies against HIV they are making to try to control their virus.

Lopinavir, a widely used HIV drug, could be used to prevent cervical cancer, scientists have found.

SARcode Corporation presented study results for their lead investigational molecule, SAR 1118.

Initial findings of the analysis of 78,000 Medicare patients indicated that there was an 11% greater chance of death and 57% higher chance of stroke among those taking Avastin compared to those taking Lucentis.

This study will evaluate the safety and pharmacology of SelG1 prior to advancement into a Phase II trial in patients with sickle cell disease.

A three-party collaboration deal has been achieved among the Yale School of Medicine, Pfizer, Inc. and Icagen, Inc. to investigate potential new pain compounds.

The drug candidate is currently undergoing Phase II trial in patients with acute bacterial skin and skin structure infections that are caused by Staphylococcus bacteria.

Further studies need to be carried out in order to allow it to be sold as a prescription drug on the German market.

Thai researchers from Mahidol University gave their focus on a new drug-delivery system to treat brain cancer patients.

MonoSol Rx and KemPharm have partnered to jointly develop KemPharm's KP106 for ADHD patients.

A Phase II clinical trial has demonstrated positive effects of selumetinib in people with advanced biliary cancer.

The expansion of the trial to two new European countries will raise the total number of centers to over 40 and will help accelerate patient recruitment.

The goal of the study is to identify and validate biomarkers that correlate with vaccine-induced protective immunity against malaria infection.

In the absence of anti-inflammatory drugs, 54% of patients responded to the antidepressant, whereas only 40% of patients responded in the presence of anti-inflammatory agents.

Results showed that during a mean follow-up of 38 months, 39 (26 percent) of patients had at least one VBT, and upon retesting, 38 percent of these patients did not have a VBT and 10 (38 percent) had no evidence of genotypic resistance.

Understanding the role of protein molecules is vital for health research and finding cures and medicines for diseases.

Biovista announced that it has entered into a research collaboration agreement with Novartis.

Japan Tobacco and Torii Pharmaceutical have started the Phase III clinical trial of ferric citrate in Japan to treat patients with hyperphosphatemia.

Researchers found a new way to deal with cystic fibrosis infections.

Pain Therapeutics is out to develop a more abuse-resistant drug that includes oxycodone, a very effective painkiller which has proven to be very easy to abuse in the past.