Research & Development News

Application seeks to expand Vraylar label to include Phase III clinical data for the maintenance treatment of schizophrenia.

Cosentyx has shown superior and sustained results versus both Stelara and Enbrel, delivering long-lasting clear or almost clear skin.

Vertex to develop CTP-656 for potential use in future combination regimens aimed at treating the underlying cause of CF.

Provides hope for patients with severe asthma, who currently have very limited treatment options.

Comprehensive development program show potential of GP2017 to treat inflammatory diseases, such as rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis.

MEDI8897 has been engineered to have a long half-life so that only one dose would be needed for the entire RSV season.

More patients now able to receive a standard-of-care treatment with Erbitux plus Folfiri or Folfox.

Affinivax’s MAPS vaccine technology overcomes the limitations of current conjugate vaccine technology, creating a MAPS pneumococcal vaccine that enables broader protection.

Second Biologics License Application accepted by the FDA for avelumab.

If approved, Natpar would be the first licensed recombinant parathyroid hormone in Europe for the management of chronic hypoparathyroidism, the only endocrine-deficiency disorder with no hormone treatment.

Compared with warfarin, Pradaxa was associated with a 26% reduced risk of stroke and a 20% reduced risk of major bleeding.

Tool explores the time course of drug exposure, biomarker response and outcome.

Antibody levels maintained against multiple targets 6 months post vaccination.

Experimental vaccine targets mosquito saliva.

Aids R&D initiatives to advance precision medicine.

Modified baker’s yeasts cause an immune response and the production of lymphocyte killers, which detect and eliminate cancerous cells.

New kit enables covalent conjugation of antibodies and proteins to magnetic particles.

Trial data further supports the existing clinical profile of CT-P13 in inflammatory bowel disease.

Study showed that people whose disease expressed PD-L1 and were treated with Tecentriq plus Avastin had a 36% reduction in the risk of their disease worsening

Steroid-free Spiriva Respimat now approved as asthma treatment for age 6 and older.

More than 50% of patients in three clinical studies who used Siliq achieved total skin clearance within a year.

Baricitinib, marketed as Olumiant, is the first JAK inhibitor approved to treat RA in the EU.

The presentations highlight Alzheon’s ‘precision medicine’ approach to drug development for Alzheimer’s disease.

If approved, this treatment could be the first two-drug regimen for HIV.

Foresee technology can help to develop stable, formulated peptides in solution for controlled-release therapy for 3- and 6-month durations of action after a single injection.

NIH-funded research suggests zebrafish models may be efficient resource for identifying drugs for clinical use.

JZP-110 is a selective dopamine and norepinephrine reuptake inhibitor.

Boehringer Ingelheim to conduct trial in collaboration with a subsidiary of Merck (MSD).

NIH-funded preclinical study suggests a possible treatment for Alzheimer’s disease and other neurodegenerative disorders.

By the end of 2017, company plans to increase to 230 process chemists and 70 analytical chemists.

Landmark Repatha cardiovascular outcomes study meets primary and key secondary endpoint.

Keytruda also receives Breakthrough Therapy Designation for second-line treatment.

Opdivo has now been approved in six tumour types in just over 2 years.

First anti-PD-1 therapy approved in Europe for previously untreated patients with metastatic NSCLC.

Decision marks the third TSC-related indication for Votubia in the EU.

New clinical data for Avycaz demonstrates efficacy in cUTI patients including those with infections due to resistant Gram-negative pathogens.

Amgen receives positive CHMP opinion for biosimilar adalimumab.

Actelion R&D unit to spin out into standalone company based and listed in Switzerland.

Combination studied as treatment for patients with advanced clear cell renal cell carcinoma.

AnestaGel uses a novel approach to delivering sustained-released analgesics into the target tissue via the Matrix, which is a tunable, biocompatible, and pH neutral platform.

Clinical trial is the first of its kind to treat IBS symptoms by cannabinoid-containing chewing gum.

Disease prevalence can be monitored with a precision never before possible.

Provides the company with increased control over discovery research, antibody generation, medicinal chemistry and bioconjugation for generating antibody drug conjugates.

VR647 is a drug/device combination, using the AKITA JET smart nebuliser, for the delivery of nebulised budesonide.

Feasibility study to examine three different oral formulations engineered with Enteris’ Peptelligence platform.

Extends multi-year agreement in drug discovery with focus on cardiovascular and central nervous system disorders, immunology, infectious diseases and oncology.

The molecule, which is a PPMO, will likely be ready for testing in humans in about 3 years.

Topline results from the Phase II trial are expected by year-end 2017.

Sofosbuvir/Velpatasvir/Voxilaprevir cranted an accelerated assessment by the EMA.

Once-daily treatment reduces persistent facial erythema associated with rosacea through 12 hours.

Opdivo demonstrated a 37% reduction in the risk of death compared to placebo.

Therapies targeted at this novel mechanism have the potential for disease-modification because they will address the genetic root cause of AD.

Opiorphin represents a new class of potent and safe painkiller.

leon nanodrugs' MJR technology offers reformulation options that address API solubility issues.

WHF therapy can be directly applied on a wound to stimulate the natural human wound healing process.

All programs (two promising clinical-stage programs targeting DNA damage and repair, and two novel pre-clinical programs) have first-in-class and best-in-class potential.

RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation.

New study to evaluate combination of Lartruvo and Keytruda.

KumaMax could provide hope celiac patients who try, but are unable to completely avoid gluten exposure in their diets,

JOTROL is being developed to remedy resveratrol’s poor bioavailability and dose limiting gastrointestinal side effects.

Phase Ib/II studies to explore a novel immuno-oncology combination in hematological and solid tumours with high unmet medical need.

Noxxon continues transition to clinical oncology company.

The company's long-acting therapeutic peptides are designed to allow the efficient delivery of the active element to intracellular targets.

Resunab is designed to resolve inflammation thus having the potential to provide significant clinical benefit to CF patients, importantly without immunosuppression.

Reported research continues to demonstrate the anti-cancer properties of cannabinoids.

The participating NIPTE team will primarily focus on biopharmaceutical formulations and product development, and FDA regulatory science.

Study is exploring potential benefits of combining a cancer vaccine and PD-1 checkpoint inhibitor.

Ocrevus is the first and only investigational medicine to show superior efficacy versus comparators in both relapsing and primary progressive multiple sclerosis in clinical studies.

New FDA-approved indications for Adynovate provides more hemophilia A patients access to proven prophylaxis with a simple, twice-weekly dosing schedule.

Six patients have been identified with hepatotoxicity, including several cases of veno-occlusive disease, with four fatal events.

Published study results showed an overall response rate of 69.6% for MYL-1401O compared to 64% for branded trastuzumab.

Computationally intelligent drug discovery platform receives two Fierce Innovation awards for Biotech Innovation and Best New Product.

Spinraza improved motor function in SMA patients.

Development and licence agreement is for pMDI inhaled triple therapy (VR2076) for asthma and COPD.

Abdominal pain improved 56% with CR1 300 mcg relative to placebo in Phase IIb trial.

Extension is the result of the submission of additional data regarding the commercial manufacturing process of the biologic.

First and only PARP inhibitor in the US indicated t.o treat advanced ovarian cancer patients who have been treated with two or more chemotherapies and who have deleterious germline or somatic BRCA mutations.

Ionis earns $25 million milestone payment.

AB-SA01 meets primary endpoints of safety and tolerability and reduces S. aureus bacterial load in all patients.

Labeling revisions also include updates to corresponding warning and addition of clinical data on superior efficacy of Chantix compared with bupropion or nicotine patch.

The project aims to create a step-change in the capabilities of current bioproduction methods, meeting unmet needs in the field of viral vector production.

Catalent Biologics will employ its proprietary GPEx cell line technology and ambr workstation to develop, optimize the process for expression, and manufacture antibodies for further investigation by MVI and its partners.

Phase IV study demonstrates a lack of improvement in progression-free survival in patients with chemotherapy-naïve metastatic CRPC whose prostate-specific antigen has previously progressed on Xtandi.

New shareholder, Axxamof Milan, Italy, will transfer certain therapeutic assets to the R&D programs of Acousia.

"MEDI1814 has a unique mechanism among antibodies in clinical development and could provide a distinct approach to treating Alzheimer's disease."

Collaboration will explore the potential of novel applications of Albumedix’s albumin-based drug delivery platform, Veltis.

The CDMO’s initiatives include laboratory research for the preparation of APIs, with a particular focus on chiral molecules and emphasis on the principles of sustainable development and ‘green chemistry’.

If approved, the product could provide blood cancer patients with access to potentially life-saving medicine.

UCL pioneers the engineering of novel nanoscale drug delivery vehicles, which can be tuned to release a range of cargos.

The only oral T2D medicine to provide a life-saving cardiovascular benefit.

Represents a potentially novel disease-modifying therapeutic option.

T2DM therapies are capable of modifying the activity of insulin in the brain.

Partnership combines MolPort’s 6.3 Million HTS Compounds with StarDrop’s data analysis and compound design capabilities.

If approved by the FDA, avelumab could be the first treatment indicated for patients with metastatic Merkel cell carcinoma.

No clinically meaningful differences between biosimilar etanercept and the originator product in safety and efficacy over 52 weeks.

Opdivo is now the first and only PD-1 inhibitor approved for a hematologic malignancy in the European Union.

Lilly's solanezumab fails to meet primary endpoint of Phase III study.

Chase acquisition adds a new Phase III ready program for Alzheimer's disease to Allergan portfolio.

Studies suggest calcilytics may represent effective future asthma therapeutics.

Grant will be used to tackle one of the biggest bioproduction problems currently facing the industry

Deal followed results of Phase II SUSTAIN study of SelG1 in reduction of vaso-occlusive pain crises, a major complication of SCD with limited treatment options.

ITCA 650 is the first investigational drug to use Intarcia's disruptive Medici Drug Delivery System to deliver chronic medicines just once or twice yearly.

Second Phase III study confirms results from previous studies.

BI 695502 met all the pre-defined primary and secondary endpoints in the INVICTAN-1 study.

CSL112 is being developed to reduce the high incidence of early recurrent cardiovascular events.

Nearly two-thirds of patients experienced plaque regression with Repatha on top of optimized statin therapy.

Data in Japan, China and South Korea will form basis of new regulatory submissions for Benlysta.

Is the only oral type 2 diabetes medicine shown to reduce the risk of cardiovascular death.

Treatment proven in a Phase III trial to significantly extend overall survival for patients with recurrent or metastatic squamous cell head and neck cancer.

The first study initiated as part of this agreement is a Phase III registrational trial evaluating Kyprolis in combination with Darzalex and dexamethasone compared to Kyprolis and dexamethasone alone.

Screening method provides a potential new approach to repurpose known drugs and compounds.

Research has shown that boosting immunity in the nose and lungs may be the best way of increasing defence against RSV.

Biologics and monoclonal antibodies to become a bigger presence within the small-molecule-dominated landscape.

These shark antibodies are considered to have immediate and highly disease-specific potential for the diagnosis and treatment of Alzheimer’s disease.

First of five planned clinical trials to test ZPIV vaccine.

Biogen is preparing for the potential launch of Spinraza in the US possibly as early as the end of 2016.

New research has raised the possibility of minimising the side effects of treatment for patients with autoimmune diseases, such as multiple sclerosis and inflammatory bowel disease.

First early access scheme for breakthrough immunotherapy in blood cancer.

Filing includes analytical, functional and pre-clinical data, and results from the pharmacokinetics and confirmatory efficacy/safety global clinical trial in Type 2 diabetes patients comparing Mylan's and Biocon's Insulin glargine with Lantus.