Research & Development News

For the first time, scientists have watched proteins interact with long single-stranded DNA molecules in real time.The new method should yield insights into DNA replication and repair, the researchers say.

Carbohydrates in molecular biology are like dark matter in the universe, according to sialic acid expert Ajit P. Varki of the University of California, San Diego—poorly studied yet crucial to a full understanding of how things actually work.

New data for Lucentis (ranibizumab), the only anti-VEGF therapy licensed across three ocular indications, show that individualized treatment with Lucentis provides sustained improvement in vision with a low number of injections.

Researchers at Emory University have found that a medication that inhibits inflammation may offer new hope for people with difficult-to-treat depression.

Lilly Diabetes announced the release of a new mobile application designed for caregivers and healthcare providers who support people with type 1 diabetes.

Boehringer Ingelheim has announced that the combined treatment experience with Pradaxa? has crossed one million patient-years(1) in the prevention of thromboembolic events in patients after surgery and in patients with non-valvular atrial fibrillation ...

Aquapharm Biodiscovery believes the marine-derived compound AQP-182 could help to tackle multi-drug resistant bacteria.

A new report from Thomson Reuters discusses the economic viability of developing drugs for rare diseases

India's contract research and manufacturing services sector is due to record 41.4 per cent growth.

PhRMA has delivered a robust defence of US pharmaceutical innovation in response to a recent article in the British Medical Journal.

An analytical article in the BMJ has dismissed claims of an innovation crisis in pharmaceutical R&D.

Nodality and Pfizer have announced a new collaborative effort to investigate potential compounds for autoimmune disease.

Novartis sees Africa as one of the next frontiers for clinical development.

AiCuris will present at the International Herpesvirus Workshop in Calgary, Canada, on its two front-running compounds targeting herpes viruses.

Covidien has opened a new $45 million R&D center in Shanghai, China. The center has two core focus areas: design of tailored products and discovery of breakthrough platforms in medical technology.

Tokyo-Tech and Astellas Pharma are teaming up to identify compounds with anti-protozoan activity.

ProMetic has granted NantPro BioSciences rights to its Plasma Protein Purification System and Prion Reduction technologies for the exclusive development and commercialisation of a plasma-derived biopharmaceutical product for the US market.

Takeda anticipates that these applications will be reviewed within the next six months. These NDAs were resubmitted in response to the complete response letter Takeda received from the FDA, dated April 25, 2012.

The company said the quadrivalent seasonal influenza virus-like particle vaccine triggered an immune response against all four strains of the bug after 21 days.

Global biopharmaceutical services provider Parexel has announced an alliance with the KDDF to accelerate global drug development.

The ODYSSEY program will enroll more than 22,000 patients. This includes over ten clinical trials evaluating the effect of SAR236553/REGN727 on the lowering of LDL-C and an 18,000 patient cardiovascular outcomes study.

Clinical trials conducted in developing regions appear to produce just as high-quality data as those performed in developed parts of the world.

A new low-dose treatment for acute pain following surgery has been shown to be effective in Phase 3 trials.

The trial did not meet its primary endpoint of extending the length of time that patients live without their disease getting worse.

The latest Research and Markets report highlights the significant changes that are taking place within pharmaceutical research and development.

The aim of Re-Liver is to reconstitute a standardized and reproducible bioartificial liver organoid (BLO) using healthy human liver as an architectural and biomaterial template.

Gentris and the Shanghai Institutes of Preventative Medicine will work together to accelerate healthcare innovations in the US and China.

Biopharmaceutical companies could significantly cut the cost of clinical trials by reducing the number of non-core procedures they perform.

A new report has highlighted the important role that the biotechnology sector is playing in global health research and development.

Polyphor will apply its MacroFinder drug discovery technology to identify and optimize macrocyclic drug candidates against targets selected by Boehringer.

The Pathway Modulator Technology works through the additional expression of an engineered enzyme in the producer cells.

Novartis has invested in the Explore programme to help fund cutting-edge pharmaceutical research in Quebec.

The results demonstrated positive trends in lung function as measured by FEV1 (forced expiratory volume in one second) and in the secondary outcome measure, rate of pulmonary exacerbations.

Lophius Biosciences has announced the successful realization of two important regulatory milestones.

Antisense Pharma has presented trabedersen complete data from its clinical Phase I/II study in patients with advanced pancreatic cancer, malignant melanoma or colorectal cancer.

In the study, patients receiving teriflunomide 14 mg had a statistically significant reduction in annualized relapse rate and risk of sustained accumulation of disability.

The diabetes-specific R&D center, holding 150 scientists and staff when full, is part of a trend in drug development.

The filing is supported by a comprehensive global Phase 3 clinical development program.

The study was conducted in 278 patients suffering from moderate Alzheimer’s disease, and Lu AE58054 was administered as add-on to donepezil, a commonly used acetylcholinesterase inhibitor for a period of 24 weeks.

A new public-private collaboration aimed at discovering antibiotics has been welcomed by the industry.

The Innovative Medicines Initiative launches a €223.7m programme aimed at tackling antibiotic resistance issue.

Boehringer Ingelheim has announced results from a Phase II study evaluating the investigational compound tiotropium.

The collaboration aims to investigate a targeted therapy for Huntington’s disease.

This grant will support an ambitious scientific collaboration to discover treatments for mitochondrial diseases with high unmet medical need.

The DSTT consortium has attracted new investment which will enable its vital drug discovery work to continue until at least 2016.

A report by consulting firm Cutting Edge Information has underlined the benefits of licensing and co-development deals.

Bristol-Myers Squibb will fund research efforts at Tsinghua University's School of Life Sciences to identify and validate novel targets in oncology and immunoscience.

Novavax is enrolling patients in a second Phase 1 clinical trial of a vaccine that could prevent a potential bird flu pandemic.

Mucosis, in conjunction with the Centre for Human Drug Research, conducted the clinical trial to assess the safety, tolerability, and immunogenicity of nasally administered FluGEM.

Disappointing phase-III trial results have led Roche to discontinue all dalcetrapib studies.

Lundbeck and Otsuka have announced successful results from a Phase 3 clinical trial evaluating the efficacy, safety and tolerability of a once-monthly drug for the treatment of schizophrenia.

Scientists will investigate whether tablets containing curcumin, a compound found in the spice turmeric, can be safely added to the standard treatment for bowel cancer that has spread.

Roche announced that the SUMMACTA study met its primary endpoint. Data from SUMMACTA will be submitted for presentation at an upcoming medical meeting.

A report has found that the US government provides around 45 per cent of total investment in global health R&D.

LifeCodexx has announced the successful completion of the clinical validation study of its noninvasive test method for the detection of fetal trisomy 21 from maternal blood using Next Generation sequencing.

A new collaboration between Novo Nordisk and the Kennedy Institute of Rheumatology could pave the way for new drug candidates, biomarkers and treatment targets for autoimmune inflammatory diseases.

A report by GBI Research predicts significant growth in the global contract research industry and outsourcing to developing countries.

AIC316, a HSV inhibitor with a novel mode of action and much improved half-life, shows superior reduction of shedding events associated with high viral load, which is regarded as clinically relevant for HSV lesion development and transmission.

3D printers could one day be used to produce medicines in a person's own home.

A report by Decision Resources predicts that lesinurad will soon earn a five per cent patient share in the US chronic gout market.

Targacept has been forced to revise the results of an exploratory phase-II clinical study of TC-6987 after discovering an error in its previous statistical analysis.

The US biopharmaceutical sector continues to perform well, with PhRMA members investing almost $50 billion in R&D last year.

Phase-I clinical testing is underway for QGC001, a first-in-class APA inhibitor for the treatment of hypertension.

Synergy Pharmaceuticals has enrolled more than half of the patients for its phase-II/III study of plecanatide for chronic idiopathic constipation.

Cara Therapeutics has announced that phase-I trial results have provided a basis for further clinical development of its oral formulation of CR845.

Trillium Therapeutics provided an update on its lead cancer program - a SIRPaFc fusion protein targeting the CD47 pathway.

Biota is designing phase-III studies after successfully completing a phase-IIb trial with its oral antiviral BTA798 in asthmatics with rhinovirus infection.

GenSpera's lead product G-202 will now be evaluated in a phase-Ib trial following successful dose-escalation studies.

The Cancer Research and Prevention Institute of Texas has announced its latest round of funding to support cancer research and commercialization projects in Texas.

The encyclopedia may allow scientists to use cell lines information to improve cancer clinical trial design and further cancer research.

TC-6987 has shown promise as a treatment for asthma but Targacept will no longer be developing it as a diabetes therapy.

Neurocrine Biosciences has announced that the FDA has responded to the Special Protocol Assessment filed with the FDA on the design of the Phase III program for elagolix in endometriosis.

The new facilities will offer analytical testing, development support and regulatory services to pharmaceutical and biopharmaceutical companies.

Amgen has reported positive results from a phase-Ib study of AMG 145 in patients with high cholesterol despite statin use.

The trial will evaluate the safety and efficacy of MN-221 - a novel, highly selective beta-adrenergic receptor agonist that is designed to be delivered via intravenous infusion.

The company's Fast Trak Training Centers, which are also located in Germany, India, Japan, Singapore, and the US, are equipped with the latest technologies for bioprocessing, in an environment that closely replicates the industrial setting.

Bend Research has announced an initiative to expand its scientific and engineering expertise into biotherapeutics.

The firms have developed an experimental system to study the three-dimensional structure of Mitogen-activated protein kinase kinase.

Argen-X has launched its latest technology for creating human antibody therapeutics.

Merck will provide the California Institute for Biomedical Research $90 million over seven years to advance drug discoveries.

The project will deliver a commercially available kit containing reagents and associated methodologies for bioreactor culture of stem cells on microcarriers.

The Phase 2 study is to assess the efficacy, safety and tolerability of RP5063 in male and female patients with schizophrenia.

QR Pharma announced that The Michael J. Fox Foundation for Parkinson's Research awarded the company $468,000 to conduct research for the development of Posiphen to treat PD.

Based on the data from this study, Zalicus plans to advance Z160 into Phase 2 clinical development for the treatment of neuropathic pain in the second half of 2012.

Medicyte and PRIMACYT have received a grant from the BMBF to develop culturing methods of human hepatocytes for use in cell-based therapies.

BioInvent and Genentech have announced that all patients have completed enrollment in the GLACIER study, a phase IIa study with BI-204 in patients with stable atherosclerotic vascular disease.

FluMist Quadrivalent contains four strains (two type A strains and two type B lineages) to help provide broad protection against circulating influenza A and B.

The 2012 version released Tuesday includes 125 pharmaceutical and biotechnology professionals and their experiences with dozens of small, mid-size, and large CROs offering Phase II/III services.

An international phase II study of the drug showed that the patients survived an average of 15.9 months, compared with nine months on conventional treatment.

The Phase 1 clinical trial will enrol 36 adult volunteers. They will be randomly assigned to receive one of three versions of the vaccine.

Onyx Pharmaceuticals has reached the target enrollment in the ASPIRE trial, a Phase 3 international clinical trial evaluating carfilzomib in combination with lenalidomide (Revlimid?) and low dose dexamethasone in patients with relapsed multiple myeloma...

The collaboration will leverage capabilities across medicinal chemistry, NMDA receptor pharmacology, electrophysiology, computational chemistry and DMPK and in vivo pharmacology.

The identified natural substance inhibits the pumping action to break down the bacteria’s defence mechanisms and the antibiotic treatment could be effective to work.

The two parties will work together to conduct genomic research on lung cancer and liver cancer, two of the most common cancers in Asia.

The world's first clinical trial on a microchip implanted in the body to control the release of drugs has been carried out by US scientists.

The consortium will exploit a recent discovery in nanotechnology to develop a nasal spray formulation of teriparatide that is easy to administer by patients and provides optimal drug plasma levels to enhance efficacy.

Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of orlistat-containing medicines continue to outweigh their risks.

SDI expressed interest in initiating strong working relation with the Indian companies by providing incentives for those who are interested in exploring business ventures within Scotland.

The Inventory provides information on how chemical companies have self-classified chemicals and shows how some have classified the same substance differently.

AiCuris has announced positive results from its placebo-controlled and dose-ranging trial with Letermovir (AIC246).

The FDA's Oncologic Drugs Advisory Committee said the supplemental New Drug Application did not support a favourable benefit-risk profile for acute myeloid leukaemia treatment.

Researchers say using long-acting beta-agonists (LABAs) in fixed-dose combination with inhaled corticosteroid (ICS) appear to reduce asthma attacks as well as or better than corticosteroids alone.

Some of the world's largest pharmaceutical companies have agreed to donate 14 billion doses of medicines to control or eradicate ten neglected tropical diseases by 2020.

Novo Nordisk has announced plans to establish a new centre to conduct type 1 diabetes research in the U.S.

A study says overall pharmaceutical deal-making activity fell 18% in 2011 as pharmaceutical companies cut R&D expenditure and streamlined their research and development activities.

The trial will assess the safety and effectiveness of the drug as a potential treatment for the signs and symptoms of the neurological condition.

The ICMR has invited applications from the Indian scientists affiliated with medical/health institutes in India for collaboration under the two specific programmes.

Adeona Pharmaceuticals announced the initiation of the Phase II clinical trial of Trimesta for the treatment of cognitive dysfunction in multiple sclerosis.

Quintiles has invested in a new company to provide oncology consulting services and new cancer biomarkers.

The data from the initial patients in its ALS Phase I/II human clinical trial treated with its NurOwn? technology did not present any significant side effects and that the NurOwn? treatment has so far proven to be safe.

America’s biopharmaceutical companies are researching 282 medicines to help meet the unique health care needs of children and adolescents.

Kedem says its sublingual formulation with taste masking features makes the drug acceptable and pleasant in taste for the children with chronic dosage requirements.

The institute has developed 30 novel products in the areas of nano-inhalation technology, sublingual injections, treatment of microvasculopathy, gastroenteropathy and emergency medication.

The study showed that single doses of LX4211 in combination with sitagliptin produced lower blood glucose levels after meals (postprandial) as compared to treatment with sitagliptin alone.

BioLeap will use its proprietary technology in computational fragment-based design to identify compounds aimed at biological targets of interest to Kyorin.

This is the fifth milestone achieved against an oncology target within Evotec's collaboration with Boehringer Ingelheim.

Tenofovir is widely used to treat HIV infection. However, the drug causes symptoms that resemble those of vitamin D deficiency, causing bones to lose calcium and reducing bone density.

This phase 2a proof-of-concept trial is designed to assess the safety and efficacy of levotofisopam as a uric acid lowering agent in patients with gout.

Multiple research institutes operating under the umbrella of CNBG will engage with Aeras on a strategy focused on the joint development, manufacturing and distribution of affordable new TB vaccines for use globally.

The goal of Bayer’s CoLaborator-approach is to support start-ups in establishing their research labs, with academic researchers spinning out new firms and venture capital groups being the likely sources of these companies.