Research & Development News

Several similar patent applications have been filed in Canada, Europe, Japan, China and India.

The company plans to use the funding to further strengthen its core R&D service platforms to significantly expand its existing R&D capabilities and capacity and to adopt new and cutting-edge technology to better serve its partners and customers in adva...

Successful dose and confirmatory study solid platform for phase II/III trial in ALS patients.

The PnuBioVax vaccine contains heat shock proteins and multiple antigens produced by a modified form of S. pneumoniae, leading to a mechanism of action which is expected to be strain-independent.

The collaboration has the potential to progress to Phase II trials in patients who have been diagnosed with either metastatic breast cancer or non-small cell lung cancer.

After demonstrating that nintedanib slows disease progression in idiopathic pulmonary fibrosis, Boehringer Ingelheim is expanding its research with nintedanib into other serious fibrotic lung conditions that arise in association with rare diseases such...

Kanuma is the first approved treatment in the US for patients suffering from LAL-D, a life-threatening and ultra-rare metabolic disorder.

The company intends to make faster-acting insulin aspart available in the prefilled delivery device FlexTouch.

Company's research subsidiary, U3 Pharma, to close.

Water-based “Band-Aid” senses temperatre, lights up, and delivers medicine to the skin.

55 of 59 patients experienced complete remissions in a single-arm study of the largest investigational CART therapy in children and young adults.

GlycoMimetics to initiate myeloma trial in mid-2016.

Supported by Phase III studies in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis.

Collaboration reinforces Propeller Health's leadership in respiratory digital health and creates a joint opportunity to advance treatment of respiratory disease through digital innovation.

Study approach will specifically answer whether treatment with sirukumab can reduce the duration of steroid treatment typical in clinical practice.

Pfizer will be responsible for developing and commercialising any potential therapeutic agents (small molecules or biologics derived from StaR antigens) for each target and will have exclusive global rights to any potential resulting agents.

Acquisition aimed at strengthening ReproCELL’s pharmaceutical industry-targeted drug discovery services.

Company believes that an approval for the intended use of Epi proColon is warranted based on the data that has been submitted to date.

Supported by Phase III studies in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis.

The companies have identified and will advance novel, first-in-class small molecules to treat major unmet needs in neurology and psychiatry.

Idera is eligible to receive approximately $100 million in development and regulatory milestone payments, including a $2.5 million upfront payment.

Fifth approval for Opdivo in 12 months.

Pending EC approval, Biogen would commercialize Benepali in the EU.

Longest follow-up for the Opdivo + Yervoy regimen from study 004 shows 3-year overall survival rate of 68% across Phase I dosing cohorts.

If approved, avelumab could potentially become the first immunotherapy to treat metastatic MCC.

NIH-funded clinical trial marks first major advance in therapy in 40 years.

Transactions are consistent with the evolution of BMS’s strategic focus, including the decision to discontinue its discovery efforts in virology announced in June.

First large-scale study to confirm Ultibro Breezhaler is an effective steroid-free option that both reduces exacerbations and improves lung function in COPD patients with one or more exacerbations in the past year, compared to Seretide.

The collaboration agreement between Concert and Avanir provides Avanir with worldwide rights to develop and commercialize AVP-786 and other deuterium-modified dextromethorphan (d-DM) compounds.

Bimatoprost SR is a biodegradable, intracameral implant providing slow release of bimatoprost and is a differentiated approach to treat glaucoma beyond conventional daily eye drop treatments because it is a non-daily treatment administered by a physici...

Five oral presentations include “Long-Term Response to Anti-VEGF Therapy for DME Can be Predicted After 3 Injections — An Analysis of Protocol I Data”.

FDA approval underscores the important role of targeted medicines to help people with BRAF V600 mutation-positive advanced melanoma.

A novel, potentially disease-modifying treatment for cystic fibrosis for use as monotherapy as well as in combination with other CFTR modulators.

First completed Phase III study of adalimumab biosimilar in the treatment of patients with moderate-to-severe RA.

74% of patients reached their LDL cholesterol goals on 75 mg dose; Of the remaining patients whose dose was adjusted to 150 mg, most achieved their goal.

SD-809 — a much-needed treatment option for the tardive dyskinesia patient population.

If approved, etelcalcetide will be the first calcimimetic agent that can be administered intravenously.

New data show Pradaxa reduced stroke risk and major bleeding compared to warfarin in patients with non-valvular atrial fibrillation.

The company now offeres the first nine antibodies in its Validated Antibody programme which are H3, RNA pol II (S), RNA pol II (S5), H3K9me3, 5mC, AcH3, AcH4, AR and Sin3a

The vaccines division of Sanofi presents at the World Vaccine Congress in Spain.

Patient-reported pain, joint stiffness, fatigue and physical function scores significantly improved with baricitinib compared to adalimumab.

Patients with mild to moderate Alzheimer’s disease and apoe4/4 genotype showed robust and sustained efficacy on cognitive and functional co-primary outcomes over 78 weeks with favorable safety profile.

Vericiguat study in patients with worsening chronic heart failure and reduced ejection fraction.

Overall survival results from CheckMate -025, a landmark Phase 3 study comparing Opdivo versus everolimus in this patient population, serves as basis for application.

First anti-IL5 treatment for adults and adolescents with severe asthma with an eosinophilic phenotype.

Company will use the grant to incorporate Seligo technology into next generation antibiotics and infectious disease therapeutics.

Epigenomics adjusts 2015 outlook after FDA response letter.

Phase I first-in-human study to evaluate GSK’s OX40 agonist GSK3174998 as monotherapy and in combination with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab).

The agreement will leverage the scientific expertise of the two organizations to discover and develop up to five cancer immunotherapies.

Injectable combinations once every 4 or 8 weeks show comparable efficacy versus daily oral combination therapy.

New building to feature collaboration-focused workspace.

Eyela already approved in the EU for neovasular (wet) age-related macular degeneration.

First company to demonstrate the potential of an immune checkpoint inhibitor in the adjuvant treatment for these patients.

Data to support lifitegrast FDA resubmission in Q1 2016; plans on track for potential 2016 launch.

Collaboration will utilize Affinivax’s novel MAPS Vaccine Technology Platform.

Pollutants and contaminants can now be detected at previously undetectable levels.

The E.coli|360-HCP ELISA allows sponsors and biotech companies to postpone the development of a cost-intensive specific HCP assay until a more informed decision on the success of a biologic in development can be made.

If approved by the European Commission, Imlygic would be the first in a class of novel agents known as oncolytic immunotherapies.

AstraZeneca's anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), will be combined with Lilly molecules that target the immune system.

Cosentyx demonstrated rapid onset of action and long-term sustainability in patients with and without prior treatment using anti-tumour-necrosis-factor (anti-TNF) therapy.

Management team completes buy out of specialist ion channel research business from Xention.

Third generic product approved since the resolution of the warning letter at the Hayward facility.

With four programs currently in clinical trials and five more expected to enter the clinic by the end of 2016, Novartis has rapidly built a robust portfolio of programs focused on stimulating the body's immune system to combat cancers.

IDMC concludes that the addition of ganetespib to docetaxel is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall survival compared to docetaxel alone.

Company plans to refile lifitegrast submission in the first quarter of 2016.

Topline results from OPUS-3 Trial expected before year-end.

XEN45 approved in global markets and in in late-stage development in the US.

Eleven granted isunakinra as the international nonproprietary name for EBI-005.

Phase III trial terminated due to insufficient efficacy.

Expansion will power immuno-oncology discovery and research collaborations.

Nearly triple the percentage of patients maintained completely clear skin on BI 655066 after nine months, compared to ustekinumab.

Phase I clinical evaluation of CTP-730 completed.

Horizon will exploit its translational genomics and combination sciences platform to define optimum approaches to treatment and identify cancer patient populations most likely to respond.

Redesigned bi-specific antibodies may offer new hope against secondary breast cancer.

Presentation at the European Committee for Treatment and Research of Multiple Sclerosis

Prize awarded for mapping, at a molecular level, how cells repair damaged DNA and safeguard the genetic information.

Three applications are under review for Daklinza in combination with sofosbuvir with or without ribavirin to treat chronic hepatitis C patients with decompensated cirrhosis, post-liver transplant recurrence of HCV, and coinfection with HIV-1.

Sandoz is seeking approval for all indications included in the reference product's label.

NGF antibody fasinumab currently in Phase II/III osteoarthritis trial.

First New Drug Application for a GLP-1 receptor agonist to include CV outcomes data.

Oxford scientists announce laboratory success using a new linker technique to bond cell-killing agents to cancer-targeting antibodies

The CriPec platform allows for the rational design of custom-made nanomedicines for controlled release of the drug at the desired site of action resulting in an improved efficacy and tolerability.

Clinical trial to assess safety and efficacy of immuno-oncology combination in patients with advanced NSCLC or melanoma.

Elocta is a recombinant factor VIII Fc fusion protein product for the treatment of hemophilia A that, if approved, would be the first hemophilia A treatment with prolonged circulation available in the EU.

The new outstation will provide life science researchers with the company's proprietary DigiWest multiplex protein profiling services, to accelerate lead characterisation, disease mechanism and drug mode-of-action analyses, as well as biomarker identif...

MALT1 could be a promising drug target for some subsets of lymphoma, including diffuse large B cell lymphoma.

If approved, Vesneo will be the first nitric oxide donating prostaglandin receptor agonist available for patients with open angle glaucoma or ocular hypertension.

MIT biological engineers have developed a modular system of proteins that can detect a particular DNA sequence in a cell and then trigger a specific response, such as cell death.

HHS will provide initial funding of approximately $17 million to support preclinical development and antibody manufacturing. This initial funding is designed to support an Investigational New Drug application with the FDA.

Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company's Jardiance (empagliflozin) significantly reduced the risk of the combined endpoint of cardiovascular (CV) death, non-fatal heart attack or non-fatal stroke by 14% when added to standard of...

Findings from a head-to-head trial comparing Victoza (liraglutide) and lixisenatide, both in combination with metformin, demonstrated a significantly greater reduction in HbA1c of -1.83% for liraglutide vs -1.21% for lixisenatide in adults with type 2 ...

Omarigliptin was found to be non-inferior to Merck’s once-daily DPP-4 inhibitor, Januvia (sitagliptin), at reducing patients’ A1C levels from baseline, with similar A1C reductions achieved in both groups.

This is the fourth Breakthrough Therapy Designation granted for Opdivo by the FDA

The company’s sepsis therapy has the potential to be used not only in combination with existing antibiotics, but also to treat patients when conventional therapeutic options are not available.

Finding the long sought-after mediator of mTORC1 activation by leucine opens up opportunities for creating new medicines for metabolic, musculoskeletal, autoimmune and other age-related diseases.