Research & Development News

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.

Bococizumab deemed unlikely to provide value to patients, physicians, or shareholders.

Trial showed LEE011 plus letrozole reduced the risk of progression or death by 44% over letrozole alone.

Access for Canadian women remains in jeopardy despite mounting evidence of significant clinical benefits of Lynparza.

If approved, avelumab, an investigational anti-PD-L1 IgG1, could be the first treatment indicated for patients with metastatic Merkel cell carcinoma.

Collaboration provides a comprehensive platform for data management, analysis and compound design in drug discovery.

New studies support flexible dosing and co-administration with flu vaccine.

Acquisition expands Allergan's gastroenterology pipeline.

The three research organizations have a history of flavivirus vaccine collaboration.

NIH-funded study suggests patch is safe, convenient mode of treatment.

Phase III study established equivalence in efficacy and similar safety profile between BI 695501 and Humira (adalimumab) in patients with active rheumatoid arthritis.

Programs include a systematic approach to drug repurposing and data-driven, proactive chronic disease management - both fueled by the IBM Watson Health Cloud.

Results demonstrate encouraging response rate in an expanded population of heavily pre-treated classical Hodgkin lymphoma patients.

New treatment elicits two-pronged immune response that destroys tumors in mice.

Data demonstrate improvement in radiographic progression-free survival in patients with metastatic castration-resistant prostate cancer who were treated with enzalutamide compared to patients who were treated with bicalutamide.

Keytruda is the first immunotherapy to show improved overall survival compared with chemotherapy in urothelial cancer.

Top-line results across more than 1,250 moderate to very severe COPD patients confirmed that both Phase III studies met their primary efficacy endpoint.

Collaboration will focus on the discovery, non-clinical development and manufacturing of novel ADC products against undisclosed targets.

The subscription deal, which is valued at a minimum of £500,000, provides partner access to Horizon's engineered cell lines.

First and only anti-PDL1 cancer immunotherapy approved by the FDA for metastatic non-small cell lung cancer.

Brain cells that provide structural support also influence feeding behavior, study shows.

New database provides access to oncology studies in an effort to speed medicines to patients.

Includes an oral presentation looking at the effect of prior treatment with tumour necrosis factor inhibitors on efficacy endpoints.

TNT009 is currently in clinical development for the treatment of autoimmune hemolytic anemia, including Cold Agglutinin Disease (CAD), a form of autoimmune hemolytic anemia.

Trial shows rigorous clinical research feasible during a public health emergency.

Company's continued expansion allows it to further improve the transition of drug candidates from the discovery medicinal chemistry space through to formal regulatory based drug product development.

The studies have the potential to reveal novel insights for previously unknown autophagy signalling components, which could suggest rapid and innovative starting points for new drug treatments.

Application seeks to expand Avycaz label to include Phase III clinical data for the treatment of complicated urinary tract infections.

Grant established by Merck recognizes pioneering research in personalized treatment of solid tumours.

Data were presented at the 2016 European Society for Medical Oncology Congress.

Funding will allow the company to advance its research projects and move closer towards its goal of evaluating the efficacy of muco-regulatory drugs in patients.

MEDI2070 is in development as a next-generation IL-23-only targeted therapy for Crohn's disease and ulcerative colitis.

Cosentyx significantly superior to Stelara in delivering long-lasting skin clearance in psoriasis over 52 weeks.

NIH-funded mouse study identifies a key player in the progression of the disorder.

The company will exhibit and demonstrate a range of instruments and consumables from the liquid handling portfolio, including: pipettes & tips, manual and electronic dispensers and automated pipetting systems.

The introduction of a single vial presentation was part of commitments required by the FDA when it approved Egrifta (Tesamorelin for Injection).

Submission of Marketing Authorization Application to the EMA planned in the coming weeks.

Funds will be used for Phase II development and manufacturing.

Ilaris is the first and only US FDA-approved biologic treatment for patients with TRAPS, HIDS/MKD and FMF disease.

Freeze-dried cellular components can be rehydrated to churn out useful proteins.

Results published in the New England Journal of Medicine demonstrate that KAF156 shows activity against blood and liver stages of malaria parasites, including artemisinin-resistant parasites.

Extends the current indications for Opdivo to include the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.

Combination provides an enterprise platform for comprehensive data management, analysis and compound design in drug discovery.

New 24-page guide that brings together applications, protocols, results and citations for researchers.

Gene-regulating RNA molecules could help treat early-stage breast cancer tumours before they spread.

Current R&D strategies in osteoarthritis are characterized by a trend towards developing new analgesics with novel MOAs, and drugs with disease-modifying effects.

Approval given to EXONDYS 51 (eteplirsen) as a once weekly intravenous infusion of 30 mg/kg for the treatment of DMD in patients who have a confirmed mutation in the DMD gene that is amenable to exon 51 skipping.

This was the first clinical trial to combine these two different anti-diabetes medicines, a GLP-1 receptor agonist and an SGLT-2 inhibitor, as an addition to standard-of-care therapy to evaluate potential benefits for patients with type 2 diabetes with...

Company expects to start submitting regulatory applications for the candidate vaccine for the prevention of shingles in people 50 years and above later this year.

MIT chemists have now shown they can package three or more drugs into a novel type of nanoparticle, allowing them to design custom combination therapies for cancer.

The data support the company's phage cocktails products' great potential as effective therapies to treat antibiotic resistant and difficult-to-treat infections.

This agreement allows any organisation, through CPI or NIBRT, to access Horizon’s biomanufacturing cell lines for research purposes.

Patent covers East Indian sandalwood oil-containing compositions that can be used to treat a variety of cancers.

Designation also includes the associated interstitial lung disease.

Benralizumab Phase III trials met primary and key secondary endpoints.

Company's immuno-oncology and histology services have allowed clients' go/no-go decisions to be made earlier in the drug development process and ultimately reduce clinical attrition.

The Aerobika device demonstrated a clinically-significant reduction in exacerbations in as little as 30 days of treatment, when used as an add-on to usual COPD medications.

Ultibro Breezhaler reduced rate of all COPD exacerbations across different patient sub-groups vs Seretide in new analyses from FLAME study.

Tiotropium+olodaterol Respimat along with exercise training and behavior modification significantly increased exercise capacity compared to placebo.

Increased risk of stroke fails to support further development.

Company also provides update on new interim analysis from Phase Ib study.

New study shows that rate of patient persistence using Sandoz AirFluSal Forspiro is twice as high as for reference product Seretide Diskus.

Results provide compelling support for the hypothesis that amyloid build-up is a key factor in driving cognitive decline in Alzheimer's disease.

Consistently reduced low-density lipoprotein cholesterol in patients across cardiovascular risk subgroups or with familial hypercholesterolemia.

Study to evaluate the effect of CERC-501 on stress-related smoking lapse.

Companies will collaborate to develop and commercialize four generic products - two CNS stimulants and two beta blockers.

Patent expected to be valid until 2032, once granted.

The Phase III EXPAND study of BAF312 (siponimod) in secondary progressive multiple sclerosis met its primary endpoint of reducing the risk of three-month confirmed disability progression versus placebo

Biothera’s Imprime PGG and Merck’s anti-PD-1 inhibitor Keytruda (pembrolizumab) to be evaluated in combination for patients with either advanced melanoma or metastatic triple negative breast cancer.

Nineteen abstracts to be presented, including new post-hoc sub-analyses from the ARISTOTLE Phase III trial and multiple retrospective real-world data analyses from ACROPOLIS.

AZD3293 is an investigational treatment for early Alzheimer's disease

Cytokine and cytokine receptors, as well as protein kinases, largely dominate.

RE-VECTO will provide insights into the diverse types of situations in which reversal of an anticoagulant is performed in clinical practice.

Trial will look to explore the benefit of combining CV301 with Opdivo in patients with previously treated non-small cell lung cancer.

New enzyme-mapping advance could help drug development.

Collaboration will use HuTARG - a first-in-class protein engineering platform.

Preparations underway for the first human trials involving patients with antibiotic resistant lung infections.

Following interim analysis, a DMC recommends the study to continue without modification.

Partnership facilitates efforts by researchers from academia to discover novel compounds with the potential to become new patient treatments.

Animal studies fully underway to evaluate the safety and effectiveness of cannabis strains.

SkinJect Microneedle Patch to deliver drug to treat and immunize skin cancer patients.

Through this partnership, the academic institutions in the Consortium will have access to Charles River’s early discovery and drug development resources and services to accelerate their early-stage drug development processes.

New treatment option for patients with with disease progression on or after platinum-containing chemotherapy.

Opdivo did not meet trial primary endpoint of progression-free survival in patients expressing PD-L1 ≥ 5%.

Companies to pursue "off-the-shelf" cellular therapies in oncology.

The partnership created a fucose knockout GPEx cell line expressing high levels of an anti-HER2 antibody.

The data support Selecta’s lead clinical program, showing Selecta’s SVP-Rapamycin (SEL-110) induces antigen-specific immune tolerance and prevents the formation of anti-drug antibodies to biologic drugs, including pegsiticase (for gout) and adalimumab ...

Sarilumab is an investigational human monoclonal antibody directed against the IL-6 receptor that is intended for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

If approved, SUN-101/eFlow will be the first nebulized long-acting muscarinic antagonist (LAMA) for the long-term, maintenance treatment of airflow obstruction in patients with COPD.

AptaTRACE is the first algorithm that uses the full scope of sequencing data from a large number of selection rounds to capture sequence and structure features of aptamers that bind to the target.

Designation is for an investigational treatment of adults who have nonalcoholic steatohepatitis (NASH) with liver fibrosis.

Analysis shows a correlation between tau tangles and cognitive decline in patients living with Alzheimer's disease.

The human cell culture specialists join experts in ion channel research to study human iPSC-derived cardiomyocytes for drug discovery applications.

The research will evaluate Opdivo and live attenuated double–deleted Listerial monocytogenes cancer immunotherapy

Data from a Phase III study indicate overall survival showed no benefit of Revlimid.

Pharmacokinetic and safety data from Phase Ib studies with ALZ-801, an optimized prodrug of tramiprosate, presented at the Alzheimer's Association International Conference.

Significant step towards bringing the only licensed prescription medication for IBS-D to patients in 28 countries of the EU.

Collaboration will explore the safety and potential enhanced efficacy of combining checkpoint inhibitors with a cancer stem cell-targeting antibody drug conjugate in SCLC.

The financing will be used to expand the company's leading precision medicine decision support solutions in oncology.

The charity will now also be able to pursue exciting novel research and development collaborations with new partners.

Study to evaluate potential of novel combination therapy for hormone-receptor-positive, human epidermal growth factor receptor 2-negative (HR+, HER2-) metastatic breast cancer (mBC).

The collaboration will evaluate the use of Avacta’s Affimer technology in combination with Glythera’s PermaLink conjugation chemistry.

Epclusa is the first and only all-oral, single tablet regimen for all genotypes (1-6) of chronic hepatitis C virus infection and is Gilead’s third Sofosbuvir-based treatment.