Research & Development News

The study showed that CVT-301 is safe and easily absorbed into the bloodstream, via the lungs, at levels that are likely to produce a therapeutic outcome.

A delegation of New Zealand life sciences companies are joining the throngs of international therapeutics, medical device and health IT companies in San Francisco.

INSYS Therapeutics has announced the FDA approval of its branded breakthrough cancer pain medication.

Antiretrovirals have been proven to prolong the lives of HIV sufferers significantly, but a lack of production in Africa and high import prices have slowed their distribution.

The US FDA has approved total 2,244 ANDAs during last five years from 2007 to 2011, of which Indian companies received final approval for 694 ANDAs.

Pharmacopoeia monographs would serve not just for consumers but is important for physicians and pharmacists.

Emergent announced the initiation of patient dosing in the Phase 2 study of TRU-016 in combination with bendamustine for patients with relapsed CLL.

Scientists report on an approach to treating inflammatory bowel diseases that uses small synthetic molecules to trigger the production of antibodies against two metalloproteinases.

Approximately 170 patients will be randomized to receive one of two dose levels of gevokizumab or placebo administered subcutaneously over a three-month period.

Anacor Pharmaceuticals has completed the enrollment of approximately 600 patients in the second of its two Phase 3 trials of tavaborole.

Having been encouraged by successful experiments on the mice, the researchers had applied for a patent of the compound and are now preparing to test the compound on human beings.

The FDA has granted University of Western Ontario researchers approval to start human trials of their HIV vaccine.

The Esprit drug eluting BVS is designed specifically for use in peripheral arteries and is made of polylactide, the same proven biocompatible material used in the company's Absorb drug eluting BVS for coronary artery disease.

The current financing is intended to help with a Phase II placebo-controlled multicenter trial of Xen2174 in a post bunionectomy surgical patient population.

By identifying targets that prevent or reverse Tau dysfunction, BMS and Gladstone hope to identify novel therapeutic strategies to modify the course of the disease.

Upon completion of the FDA's review of the IND, Oncothyreon expects to initiate a Phase 1 trial of ONT-10.

The pact signals a further push from the pharmaceutical company into the rare diseases area following previous collaborations to fight Duchenne muscular dystrophy.

Lipids may become an important new class of adjuvants not only because of their intrinsic properties but also because of their capacity to activate NKT cells.

Olesoxime did not demonstrate significant benefit on the primary endpoint of survival after 18 months of treatment over that of riluzole.

Receptos will use its proprietary technology platform to produce high resolution protein crystal structures of the discovery target and drive Ono's structure-based drug design efforts.

The Phase I study is a single-centre, randomised, placebo-controlled trial that will investigate the safety, tolerability and PK profile of ALX-0171 in healthy volunteers.

In experimental models, the researchers found that by using new drugs that block this master switch they prevented blood vessel growth and stopped the growth of cancers.

The SME-driven project, coordinated by CYTOO, aims to combine HT applications of RNAi with an emerging new technology for normalizing cultured cells’ behaviour by growing them on adhesive micropatterns.

The encouraging preclinical results underline perifosine's potential in combination therapy with anti-cancer agents.

The anti-IL-17 antibody was generated at NovImmune and licensed to Genentech in July 2010. The initiation of the Phase I clinical trial triggers a milestone payment from Genentech of an undisclosed amount.

The vaccine is the first therapeutic cancer vaccine in clinical development that does not target the cancer cells directly, but rather the tumor stroma, a structure that is required by solid tumors for their growth.

The collaboration seeks to identify glycans, the complex carbohydrate component of glycoproteins, which can play a role in health and disease.

The new Alzheimer's antibodies only latched on to the harmful clumped proteins and not the harmless monomers or single peptides that are not associated with disease.

A combination of two inhaled respiratory drug molecules in a pre-determined ratio within Multi-component Particles (MCP) can significantly improve co-localisation of the active drug components in the lung.

Roche and three Swiss institutions will jointly establish an external academic translational research center.

The ISARIC is a global collaboration of more than 20 hospital-based clinical research networks.

Sweden-based Beactica has entered into a deal with Almac Discovery, a division of the Almac Group, for drug discovery.

Pearl Therapeutics announced positive top-line results from a randomized, double-blind, Phase 2b, dose-ranging study of glycopyrrolate.

The facility will undertake the development of drugs designed to treat challenging cancers through advances in synthetic organic chemistry.

Synta has announced the publication in Molecular Cancer Therapeutics of ganetespib results.

APD209 comprises a new and patent protected use for an oral combination of two currently marketed drugs and has been designed to increase appetite, muscle mass and muscle function.

Zalicus plans to run Phase 1 human pharmacokinetic and safety studies during the remainder of 2011 and into early 2012.

As part of the collaboration with AstraZeneca, the Medical Research Council is inviting research proposals from across the UK academic community to use the compounds in new areas.

The company will continue testing REOLYSIN with various chemotherapeutic agents across multiple trials to further understand its potential in the treatment of pancreatic cancer.

At present, there is no homoeopathic college in Sri Lanka, and it has one hospital with no adequate staff. The Sri Lankan government is planning to open nine hospitals, one referral besides importing homoeopathic drugs from abroad.

India has been opted as the hub for lung cancer trials as Roche has set up clinical trial sites here as part of its global study for treatment of a particular variant of lung cancer.

The clinical trial is the first to test the vaccine in humans following pre-clinical studies in latently infected animals.

This Phase 2b study enrolled 51 patients at 11 medical centers throughout the United States.

Of the 88 medicines and vaccines in development, 49 are antivirals and 27 are vaccines. All of the medicines are either in clinical trials or awaiting review by the FDA.

The number of animals used at Novo Nordisk has fallen from more than 13,000 a year in the 1990s to just 772 in 2010.

The two institutions will pursue joint investigations in regenerative medicine, individualized medicine, metabolism, neurosciences, and aging research.

Roche gains an exclusive worldwide license to PTC's SMA programme, which includes three compounds currently in preclinical development, as well as potential back-up compounds.

Exelixis and the NCI will carry out a number of clinical trials to evaluate the safety and efficacy of cabozantinib in several cancers, in comparison with other VEGFR2 inhibitors.

Researchers have identified a novel anticancer drug that fights tumours by effectively making them poison themselves.

A clinical phase I/II trial will be initiated within the next few months on 12 patients with metastatic renal cancer.

Scientists use chiral technology to attack a specific disease and paves the way towards a more targeted approach to killing pathogens.

The funding will allow IDRI to continue its early phase drug discovery efforts focused on identifying new and better therapies against tuberculosis.

About 30 healthy adult volunteers will be enrolled in the single-dose, open-label, randomised and three-way crossover study.

The programme plans to test up to 9,000 tumour samples to identify genetic markers in cancers including breast, bowel, lung, prostate, ovarian, and melanoma.

The company anticipates hiring a significant number of scientists for the two research units, including biologists, chemists and individuals with other areas of research expertise.

The study included 22 patients and evaluated the safety and efficacy of the combination therapy.

A research project aims to find out ideal variety of karela to cure diabetes.

This is the second new class of antimalarials discovered by the same group in the last two years and holds promise as a next-generation treatment for malaria.

Shire and Shionogi will co-develop and co-market Shire’s ADHD medicines in Japan.

Cenix will conduct target validation to prioritize novel therapeutic drug target candidates, thereby accelerating and enriching the SYGNIS drug development pipeline.

GSK announces topline results from the first of eight Phase III studies of albiglutide to complete in type 2 diabetes.

The Phase III programme involves approximately 3,500 patients with moderate to severe COPD and consists of two large pivotal studies.

Japan's Takeda Pharmaceutical has launched its phase II clinical trials of quadrivalent vaccine TAK-361S.

Gilead will be responsible for the formulation, manufacturing, registration, distribution, and commercialization worldwide. Tibotec will have the right to co-detail the single-tablet regimen in certain major markets.

In the study, patients randomised to apixaban received daily injections of enoxaparin placebo for a minimum of 6 days and patients randomised to enoxaparin received apixaban placebo tablets for 30 days.

Concert Pharmaceuticals and TRND will jointly work to advance Concert's deuterium-modified praziquantel program as a potential treatment for schistosomiasis.

IDF estimates the number of people living with diabetes is expected to rise from 366 million in 2011 to 552 million by 2030, if no urgent action is taken.

Anacor has completed enrollment of approximately 600 patients in the first of two Phase 3 trials for Tavaborole for the treatment of onychomycosis.

Under the terms of the license agreements, CureVac may receive an upfront payment from Sanofi Pasteur for each pathogen, research funding and payments for achieving several clinical, regulatory and commercial milestones.

This fund will invest in technologies and life-sciences companies to enhance our platform capabilities and to help great minds realize the potential of their technologies and intellectual property,' said WuXi in its latest quarterly report.

The novel therapeutics will specifically target tumour cells and are expected to be more effective and safer than traditional cancer treatments.

Abbott has announced the results from Premier and DE019 Phase III studies.

The Phase IIa study is designed to assess the extent to which this hypothesis holds true in type II diabetics. It will be a single-centre study, conducted in Germany.

ORCA Therapeutics BV has received an innovation credit of up to € 5 million to support development of its compound ORCA-010.

Epistem plc announces a partnership with Dr Matthew Hardman at The University of Manchester in which novel preclinical models for cutaneous wound healing.

The programme will support high quality research networks working on collaborative projects and will provide a mechanism for future extended projects of Euro-Indian cooperation.

Results of Period two showed that the percentage of patients who maintained LDA or achieved clinical remission at week 88 was significantly higher in patients receiving ENBREL plus MTX than those on MTX alone.

Experts in eye diseases from Europe, Australia, Japan and the US had a workshop to review regulatory and scientific challenges in developing medicines for eye disorders.

The study will evaluate the safety, tolerability, and efficacy of AVP-923 for the treatment of central neuropathic pain in patients with multiple sclerosis.

VGX-100 is a human antibody that acts against the human VEGF-C protein. The Phase I study will investigate VGX-100 in patients with a variety of late-stage cancers.

Through the establishment of its new vaccine research unit, Daiichi Sankyo aims to enhance and broaden exploratory research for vaccines to prevent infectious diseases.

Domainex Ltd. has been awarded a ?250,000 grant by UK’s national innovation agency to help support the development of a new drug for the treatment of several common cancers.

InVitria’s media would fill an unmet need, as most current commercial vaccines are manufactured using fetal bovine serum or other animal-derived media components.

With this approval, Roche now offers a full selection of hepatitis tests in its immunoassay portfolio.

KemPharm announces to initiate the development of KP511, the second product in the company's pain therapy range.

Biogen Idec announced its BG-12 for the treatment of multiple sclerosis significantly reduced relapse rates in people with relapsing-remitting MS, in a Phase III trial.

The study assessed the pharmacokinetics, safety and tolerability of BAL30072 in healthy volunteers, following multiple ascending doses of intravenous infusions.

The NIAID award covers development, manufacturing, and clinical activities to position TP-271 for further development against certain biothreat agents.

AP301 is being developed for the prevention and treatment of oedematous respiratory failure in patients suffering from lung infection, lung injury and lung transplantation.

The primary aims of the study are to determine the safety and efficacy of two doses of Menerba compared to placebo after 12 weeks of treatment.

Allon Therapeutics has announced its completion of the enrollment objective of 300 patients in the phase 2/3 pivotal clinical trial evaluating the neuroprotective drug candidate Davunetide.

The company is to release new results from the SEL24 program, a group of specific inhibitors of Pim-1 kinase, as well as the first data from SEL120 program, a potentially first in class kinase inhibitor.

The results show that AIN457 could potentially bring about a considerable improvement in the lives of patients with moderate-to-severe plaque psoriasis by producing a rapid response and substantial relief of symptoms.

The two California-based firms entered into a collaborative relationship to leverage Freeslate solutions in addressing aggregation and particulation in protein drug products.

The collaboration combines Lena’s proprietary nano-particle engineering technology with Encap’s liquid filled hard capsule technology.

XmAb5871 uses a novel dual-targeted approach to potently suppress autoimmune disorders that may avoid some of the side effects seen with other therapeutic antibodies that modulate immune response.

Researchers in the UK have discovered a new way for the creation of perfect drug combinations, which would prevent inflammation.

The double-blind randomised 24-week safety and efficacy Phase 3 study will enroll approximately 450 patients with type 2 diabetes who are not adequately controlled on diet and exercise.

The 2011 'EU Industrial R&D Investment Scoreboard' shows that R&D investment by top EU companies recovered strongly in 2010.

The randomised double-blind placebo-controlled trial will evaluate the safety and tolerability of CCX168 in patients with ANCA-associated renal vasculitis.

Kissei Pharmaceutical is to fund $2.5m to support further clinical development of MediciNova's MN-221 to treat acute exacerbations of asthma or chronic obstructive pulmonary disease.

Metabolon has licensed its proprietary metabolomics platform technology to SJTU to enable a world class biochemical profiling laboratory at the university.

The National Institutes of Health funds the University of California San Francisco to discover and optimise oxaboroles as antimalarial drugs.

The Phase I study is to evaluate the safety, tolerability and pharmacokinetic profile of INK1117 in patients with advanced solid malignancies.

Under the terms of the collaboration agreement, Eisai will be provided with novel neurological drug discovery targets discovered by the university's network of scientists.

Danish pharmaceutical company Lundbeck has established a new research facility in China to get more research opportunities offered in the region.

In the double-blind, randomised and placebo-controlled study, Aimspro was found to be a safe and well-tolerated medication when administered to systemic sclerosis patients at a late-stage of the disease.

It is suggested that heart disease manifests differently in women, affecting the microvasculature (small blood vessels) instead of the macrovasculature (major blood vessels) as it does in men.

The award will fund the preclinical and clinical development of a new class of bridged bicyclic antibiotics to be used as medical countermeasures against multiple biodefense Category A and B bacteria.

Dr Robert Beckman from Daiichi Sankyo talks about the challenges in incorporating predictive biomarkers into oncology drug development to achieve patient stratification.

The primary objective of the trial is to determine the hematologic improvement-erythroid response rate as determined by clinically significant transfusion reduction or independence.

Canada's Critical Outcome Technologies said a composition of matter patent has been granted for the company's oncology drug candidate.

A study demonstrates that two to seven months of treatment with gantenerumab led to dose-dependent amyloid reduction in the brains of patients with Alzheimer's disease.

Patients receiving BIT225 in combination with interferon and ribavirin showed better reductions in hepatitis C virus levels than patients receiving standard of care treatment alone.

The database aims to improve the availability of information on the use of medicines in children, enabling healthcare professionals and investigators to be aware of the results studies that have been conducted on children in the past.

PAREXEL Academy and the National University of Singapore will jointly offer an academic program in Singapore for clinical development professionals.

Two French pharmaceutical companies sign a licensing and research agreement for deubiquitinating enzymes in several therapeutic areas.

The Phase 2b study will evaluate the efficacy of AZD3480 head-to-head with donepezil, the marketed medication most often prescribed for Alzheimer's disease.

The study is expected to enroll approximately 60 patients who will be monitored for 60 days following their last injection.

In a Phase I clinical study, Novavax RSV vaccine candidate demonstrated high antibody response, a significant dose-response pattern, high rates of seroconversion at all doses.