Research & Development News

Unlike TACE, most patients treated with SIR-Spheres Y-90 resin microspheres usually require only a single treatment.

The availability of commercial ready-to-assay cryopreserved cells in a qualified kit will remove the need for developers to employ challenging and time-consuming method development procedures.

Seventeen abstracts to be presented, including new analyses from the Phase III ARISTOTLE and AMPLIFY clinical studies and from real-world databases.

Researchers developed a patch that uses microneedles to deliver anti-PD-1 antibodies locally to the skin tumour.

Application provides additional information to the original MAA submission, including data from the Phase III ORAL global development program in RA.

Will jointly develop a combination therapy of the angiopoietin2 (Ang2) antibody nesvacumab and the vascular endothelial growth factor (VEGF) trap aflibercept, for the treatment of serious eye diseases.

Missed primary efficacy endpoint; fewer events observed in the Brilinta arm but trend did not reach statistical significance.

The application package submitted was not sufficient for approval.

Placon, spun out from Blend Therapeutics, to pursue development of next generation cytotoxic oncology drugs.

In pivotal studies, most patients treated with Taltz achieved significant skin clearance with many achieving virtually clear or completely clear skin at week 12.

FDA requests further characterization of bivalirudin-related substances in the drug product.

Collaboration includes discovery programme for CAR-T cell-based oncology therapies.

New, pivotal Phase III overall survival data from CheckMate -141 for Opdivo in previously treated advanced squamous cell carcinoma of the head and neck, to be presented.

The FDA has confirmed, subject to final minutes of the meeting, the planned two-arm, randomized, double-blind, active comparator design of the confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection, expected to be initiated ...

Vaccine developed by NIH and FDA scientists.

GBI Research says pipeline consists of 29% monoclonal antibodies.

FDA will make a decision on approval by 12 September 2016.

Xalkori is the first and only FDA-approved biomarker-driven therapy for ROS1-positive metastatic NSCLC.

Collaboration will use Siteseeker — a new ‘phenotypic’ screening platform that exploits the dynamics of a live-cell environment to uncover hidden druggable target sites across the entire human genome — to find new therapeutic options.

New scheme supports European Commission priorities.

Innovative drug prototype shown to block damaging activity in human cell lines suggests a promising strategy for future therapeutics.

Application based on data from KEYNOTE-010, which showed superior overall survival for patients taking Keytruda compared to chemotherapy in patients with PD-L1 expression on one percent or more of the cancer cells.

Spiriva Respimat shown effective in the broad range of asthma patients studied who continued to experience symptoms despite taking other asthma maintenance therapies.

First FDA-approved chemotherapy-free treatment option for first-line CLL patients.

Study unlikely to meet primary overall survival endpoint in patients with minimal residual disease.

The safety profile of Victoza in LEADER was generally consistent with previous liraglutide clinical studies.

In a combined analysis of UNCOVER-2 and UNCOVER-3, significant improvement of psoriasis plaques was observed in patients treated with ixekizumab at 1, 2 and 4 weeks.

Rights to commercialize rigosertib in Europe to revert to Onconova.

Approval expands use and offers additional option for women with HR+, HER2- metastatic breast cancer.

GBI Research says the pipeline may significantly alter the clinical and commercial landscape of the disease market over the next decade.

Study will evaluate efficacy, safety and immunogenicity of adalimumab biosimilar candidate MSB11022 compared with Humira.

Concert is using this tablet formulation of CTP-656 in its ongoing multiple ascending dose Phase I clinical trial and intends to use the same formulation in a Phase II clinical trial.

If approved, Alprolix would be among the first therapies in the European Union (EU) to offer people living with hemophilia B prolonged protection against bleeding episodes with prophylactic dosing intervals.

Acticor Biotech is developing an antibody fragment (Fab) considered as a first-in-class anti-thrombotic agent without bleeding risk in the primary treatment of ischemic strokes.

Blueberry Therapeutics is set to create safe, effective “nanomedicines” to treat a number of unmet clinical needs.

Chem-space.com online searchable marketplace features over 15 million compounds.

NIH-funded clinical trial shows Eylea, Avastin, and Lucentis perform similarly when vision loss is mild.

Top-line Phase Ib data in patients with CAD expected in mid-2016.

In advanced progressive, nonfunctional NET, Afinitor is the first approved treatment for patients with lung NET and the first oral therapy for GI NET.

GBI Research report says that despite steady market growth, various unmet needs remain and a cure is yet to be found.

This is the second FDA approval for Gazyva based on a positive Phase III study.

Application seeks to expand Avycaz label to include Phase III clinical data for the treatment of complicated intra-abdominal infections , in combination with metronidazole.

Cobra and CPI will develop in depth scientific and technical understanding to allow a scalable and flexible manufacturing process to be developed to produce, purify and characterise a range of AAV vectors.

The trial successfully achieved its objective.

Results to be presented at future medical meeting, and regulatory submissions planned for 2016

FDA decision anticipated in August 2016.

NIH-funded study finds protective effect strongest in women over age 25.

Results from the FRAME study showed that women receiving subcutaneous injection of romosozumab monthly experienced a 73% reduction in the relative risk of a vertebral fracture through 12 months compared to those receiving placebo.

FDA provides GDUFA goal date of 28 March 28 2017

Alliance to provide drug discovery customers access to industry leading ion channel and transporter technologies.

First-in-class therapy now approved for use in a broader range of women.

PKC412 (midostaurin) significantly improved overall survival of adult patients eligible to receive standard induction and consolidation chemotherapy.

Company due to supply its ANDA product during the second quarter of 2016.

The company is reviewing the letter and will determine next steps.

The decision to stop the study was made after a planned interim analysis of JANUS 1 demonstrated that ruxolitinib plus capecitabine did not show a sufficient level of efficacy to warrant continuation.

First biotech company in Greater China region to receive European approval.

Stiolto Respimat was compared with a European formulation of a combination of a long-acting beta agonist, salmeterol, and an inhaled corticosteroid, fluticasone propionate.

Multi-year R&D collaboration with AbbVie focused on novel medicines for treatment of inflammatory bowel disease.

The Centre for Therapeutic Target Validation welcomes new member Biogen, expanding its efforts to accelerate drug discovery research.

Access to StarDrop will support development of new treatments for neglected diseases via global health programme.

Updated label provides new treatment option for patients with HIV-1 coinfection, advanced cirrhosis, and post-liver transplant HCV recurrence.

Using its established development platform and unique expertise in virology, Microbix intends to develop and launch a range of products to help combat the Zika virus.

The indication sought for Apealea is treatment of epithelial ovarian cancer in combination with carboplatin.

Company achieves key milestones and additional $2.5 million from the Gates Foundation.

Company plans to meet with FDA to determine appropriate path forward.

The initial laboratory space will amount to 5,500 sq. ft, which constitutes nearly 20% increase in Selvita laboratory space, compared to the current state with significant extension possibilities.

The collaboration will use Exaxion's computer-based technology to discover novel antigens.

Agreement further supports Teva’s novel biologics development program.

Annual ‘Drugs to Watch’ study spotlights seven emerging blockbusters poised to enter the market in 2016.

Building on the company's successful history in developing vaccines against similar viruses, most recently the introduction of Dengvaxia against dengue, Sanofi Pasteur is launching a Zika vaccine project.

Andexanet alfa is designed to reverse the anticoagulant activity of Factor Xa inhibitors, including Eliquis (apixaban).

The new research space will add 15,000 sq.ft. to Aragen’s existing laboratories and will double capacity for diverse efficacy studies.

Positive opinion based on reduction in the risk of disease progression or death with Empliciti in combination with standard of care regimen for multiple myeloma demonstrated in ELOQUENT-2 study.

ATM-AVI is an investigational, fixed-dose antibiotic combining aztreonam and avibactam.

Results of global Phase IIb LUX-Lung 7 trial demonstrate afatinib is superior in reducing the risk of lung cancer progression and the risk of treatment failure both by 27% compared to gefitinib.

The drug was also shown to be extremely well tolerated with a safety and adverse event profile similar to that seen for placebo.

Recombinant Fc Receptor proteins from AMSBIO are uniquely suitable for pharmaceutical research.

Resubmission includes positive data from OPUS-3, a Phase III efficacy and safety trial.

Boehringer Ingelheim and Eli Lilly and Company expect to receive a decision from the FDA within the standard review time frame.

The brodalumab BLA is supported by data from the three AMAGINE Phase III pivotal studies.

Opdivo + Yervoy Regimen now indicated for unresectable or metastatic melanoma patients, regardless of BRAF mutational status, based on accelerated approval.

LDC and Roche will jointly advance innovative drug discovery projects.

The addition of Kalbitor and DX-2930 to Shire's portfolio strengthens its leadership position in hereditary angioedema.

AstraZeneca to Conduct Phase IIa Clinical Study of AZD1419.

Baricitinib is for the treatment of moderate-to-severe rheumatoid arthritis.

Tweaking sugar molecules on anti-cancer antibodies improves cell-killing with fewer side effects.

Company has acquired Alphamer immuno-therapeutics platform technology.

Results show Elagolix reduces endometriosis-associated pain compared to placebo.

Collaboration partners to strengthen research in psychiatric diseases.

The research program is designed to accelerate the development of vaccines by decoding the human immune system.

NIAID awards approximately $5 million in funding for 24 research projects.

Venetoclax, an investigational medicine, is a potential new way of treating the most common adult leukemia.

Company generates unique monoclonal antibodies that selectively inhibit the supracellular activation of latent TGF-beta 1 in the immune system.

Development of a biological and computational model for prediction of drug-induced vascular injury for early-stage compounds.

VR315 is a generic, inhaled combination therapy for asthma/COPD delivered using Vectura's proprietary dry powder inhaler and formulation technology.

Final approval of the company's application is subject to the resolution of minor outstanding topics, such as the use of appropriate language in the product labeling.

Sarilumab is an investigational, human monoclonal antibody intended for the treatment of patients with active, moderate-to-severe rheumatoid arthritis

Genomics’ proprietary statistical analysis tools and integrated multi-phenotype database to be used to support R&D at Vertex Pharmaceuticals.

Merck becomes first pharmaceutical company to collaborate with multiple diagnostic providers to support RAS biomarker testing.

The study's Data Monitoring Committee recommended that the study be terminated early due to lack of efficacy.

MannKind is now reviewing its strategic options for Afrezza

The three companies will collaborate to investigate safety, tolerability and preliminary efficacy of avelumab and entinostat in advanced ovarian cancer.

US study sites now enrolling adults in registration-supporting Phase II study.

UCART19 is an allogeneic gene edited CAR T-cell product.

First non-alcohol formulation approved in the US.

Second of two planned trials combining Adcetris and Opdivo under clinical collaboration agreement.

Uptravi will be made available to patients in the US in early January 2016.

sugardown reduces total glycemic index including fructose by up to 28% and insulin by up to 18%.

The presentation reported data from the company's development and validation of filtration methods for the removal of viruses during manufacturing processes of KLH products.

Emergence of novel therapeutics and minimal generic competition in China, Japan and Australia will drive APAC multiple myeloma market growth to 2021, says GBI Research.

Merck-Pfizer Alliance achieves 2015 goal of initiating six pivotal trials with JAVELIN Ovarian 200 and JAVELIN Bladder 100 trials.

FDA designation reinforces potential for BI 1482694 to become a new treatment option for patients with EGFR mutation-positive lung cancer with a T790M mutation.

Bayer is investing USD 335 million in a long-term alliance with CRISPR Therapeutics through new Bayer LifeScience Center unit.

The success of approved products for rare illnesses has opened the door for gene-based treatments of more prevalent diseases, finds Frost & Sullivan.

The FDA has published draft guidance for sponsors of investigational new drug application (IND) studies with recommendations for identifying and evaluating important safety information that must be submitted to FDA and all participating investigators u...

A highly innovative and diverse pipeline of 248 products in active development is set to tackle the ever-encroaching obesity crisis.

Alliance will bring cutting-edge research and technical capability for biologics to China with the aim of addressing unmet patient needs in AstraZeneca's main therapy areas of respiratory, inflammation and autoimmunity; cardiovascular and metabolic dis...

New data demonstrate Supinoxin dose dependently inhibits tumour cell growth in a preclinical model of triple negative breast cancer.