Research & Development News

Approval makes Xolair the only biologic for children ages six and up with uncontrolled allergic asthma.

Head-to-head Phase III trial demonstrated superiority of Kyprolis and dexamethasone over Velcade and dexamethasone in patients with relapsed multiple myeloma.

Collaboration combines Merck’s leadership in immuno-oncology with Moderna’s pioneering mRNA vaccine technology and rapid cycle time, small-batch GMP manufacturing capabilities.

The partnership covers potential new medicines for atopic dermatitis and psoriasis.

Companies will evaluate the combination of Opdivo and enadenotucirev to treat a range of tumour types in late-stage cancer patients.

Positive results in a double-blind controlled study in the knee.

Should the MenABCWY vaccine perform well in upcoming Phase III studies, it has the potential to become market leader, says GlobalData.

Endocrinologic and Metabolic Drugs Advisory Committee votes in favour of cardiovascular mortality benefit for JARDIANCE for adults with type 2 diabetes.

The new drug is safe for intravenous injection and can dissolve clots up to 4000 times more efficiently than ordinary enzyme-based drugs.

Promising preclinical studies suggest human vaccine will likely be feasible.

New targets need to be identified and converted into improved therapeutic options, particularly in order to develop therapies more aligned with the underlying disease pathophysiology, says GBI Research.

Agreement is the latest in a series of acquisitions and strategic collaborations that have bolstered Novartis' deep and diverse immuno-oncology pipeline.

Ofev is effective in slowing disease progression in both diagnostic subgroups which confirms the efficacy of OFEV across a range of IPF patients.

This milestone marks the sixth Breakthrough Therapy Designation for Opdivo.

Clinical-grade cell line will enable development of new therapies and accelerate early-stage clinical research.

Label now includes Phase III clinical data evaluating the safety and efficacy of Avycaz (in combination with metronidazole) in patients with complicated intra-abdominal infections.

Project will deliver second cell line for manufacture of immuno-oncology antibody ADC-1015 following ADC-1013 success.

A new analysis published in JAMA Cardiology is the first to quantify the possible impact of Entresto's potential benefit in reducing death.

Of the three major indications within hematological cancer, namely leukemia, lymphoma and myeloma, leukemia has the largest pipeline, with 798 products in active development.

Ongoing quality control analysis has revealed that the stored drug product is no longer within the original specification.

Move approves the use of contract manufacturing organisations.

Trial to test the first new cough drug in 50 years.

Results show that cysteamine reverses resistance to clinically important antibiotic classes such as aminoglycosides, fluoroquinolones, macrolides, folate pathway inhibitors and beta-lactams.

Key outcome of the strategic review is a commitment to commercializing brigatinib in the US, subject to approval by the FDA.

This represents one of the fastest ever approvals by NICE – UK patients will be the first to benefit across Europe.

“As a result of applying the wrong appraisal process, approximately 2,700 people in England who could benefit from Orkambi are being forced to continue waiting for access.”

Vast majority of Zika vaccine products are currently in early preclinical trials, indicating that it will take many years until one of them receives market approval, says GlobalData.

KAF156 belongs to a novel class of antimalarials that act against both the blood and liver stages of the parasite's lifecycle.

The launch of Roche’s recently-approved PD-1 immune checkpoint inhibitor Tecentriq will usher in a dramatic change in the treatment paradigm of metastatic bladder cancer, says GlbalData.

'Imperatives for pharmaceutical companies include reducing product development costs, maximizing the annual product revenue, and optimizing the life cycle of a drug,' says GBI Research.

Data from ongoing Phase Ib clinical study presented at 21st Congress of the European Hematology Association in Copenhagen.

Patients showed modified immunological responses to grass pollen, indicating inhibition of disease progression.

Afferent Pharmaceuticals is a leader in the development of therapeutic candidates targeting the P2X3 receptor for the treatment of common, poorly-managed, neurogenic conditions.

Data from the registry will be made accessible to all researchers, with grant applications available for high-priority projects.

The therapeutic Tat vaccine against HIV/AIDS can effectively improve the response to antiretroviral drugs in people living with HIV.

New survival results also reported from study group with previously treated advanced bladder cancer.

Phase II study evaluating the combination of RG-101 and GSK's long-acting parenteral formulation of GSK2878175 as a potential single-visit cure to begin Q4 2016

Their proprietary family of 2 Amino-Imadazole compounds renders bacteria incapable of mounting any kind of defense against antibiotics or other threats.

Interim data from the first four patients treated in this study showed that evinacumab added to current lipid-lowering therapy reduced low-density lipoprotein cholesterol levels by an additional 55% at week 4 compared to baseline.

$142 million will be awarded over 5 years to the Mayo Clinic to establish the world’s largest research-cohort biobank for the PMI Cohort Program, a longitudinal research study which aims to enroll 1 million or more US participants to advance precision ...

Results from the SUSTAIN 4 trial were presented at the American Association of Clinical Endocrinologists 25th Annual Scientific and Clinical Congress (AACE) in Orlando, US.

Adoption of digital transformation to drive patient outcomes may improve competitive position for pharma R&D organizations.

Single molecule TRP ion channel agonist in randomized, blinded, controlled, cross-over study.

The paper describes a innovative synthetic chemistry platform that enables access to novel macrolide antibiotics.

Both plecanatide 3 mg and 6 mg doses met the primary endpoint.

HuScreen will initially focus on popular indications such as colorectal, gastric, lung (small and non-small cell type), ovarian and breast cancer.

First and only anti-PDL1 cancer immunotherapy approved by the FDA.

Independent Data Monitoring Committee recommends stopping the trial early as it met the primary endpoint, significantly extending progression-free survival (PFS) compared to letrozole alone, at pre-planned interim analysis.

Benralizumab first AstraZeneca respiratory biologic to complete Phase III.

A new analysis of Phase III INPULSIS trials reinforces OFEV's slowing of disease progression in a composite endpoint involving lung function decline (FVC decrease >10%) and death.

Includes 3-year overall survival data in melanoma and updated overall survival data in non-small cell lung cancer, as well as updated findings in head and neck cancer.

Ultibro Breezhaler also significantly reduced the rate and prolonged the time to the first moderate or severe exacerbation, compared with Seretide.

Significant unmet needs within veterinary care are driving veterinarians to treat animals such as dogs, cats and horses by prescribing drugs intended for human use.

First and only immunostimulatory antibody approved in the European Union for multiple myeloma.

The novel approach builds on ground-breaking research results from Prof. Moritz Rossner and his team at the Max Planck Institute of Experimental Medicine in Göttingen.

Approval allows for the marketing of the Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen in all 28 Member States of the EU.

Expanding capabilities in formulation development to include specialist pre-formulation, formulation prototyping and formulation development services.

Lilly has received additional designations for olaratumab from the FDA, including Breakthrough Therapy, Fast Track and Orphan Drug, for this indication.

Discovery provides proof of principle for safe, targeted delivery of drugs to the placenta to improve pregnancy outcomes.

Phase I to Begin Second Quarter of 2016.

Through this agreement, Sun Pharma commits development of Cissampelos pariera (Cipa), a botanical drug in collaboration with ICGEB.

The proceeds will be used to further the development of GB-102, Graybug Vision’s lead drug for wet AMD, through Phase II clinical trials and to initiate a clinical program for the company’s proprietary glaucoma compound.

The first drug approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

Dr Shilin Chen Recognized for Herbal Genomics Research.

Positive benefit-risk profile of Zinbryta supported by large head-to-head Phase III DECIDE study.

Subject to approvals, Ilaris will likely be first FDA-approved treatment for TRAPS and HIDS/MKD, and an important alternative treatment for patients with FMF.

New gene discovery could mean more personalised cancer care.

Authors conclude no significant increase in serious neuropsychiatric adverse events with Chantix/Champix relative to placebo or nicotine patch.

Designation signals the urgent need for new treatment approaches in recurrent or metastatic squamous cell carcinoma of the head and neck after platinum based therapy.

Everolimus is the first adjunctive therapy shown in a prospective randomized Phase III study to achieve clinically significant seizure control in TSC patients.

Data presented at AACR Annual Meeting from CIVO platform.

Neuraminidase, which is not currently the main target antigen in traditional flu vaccines, enables newly formed flu viruses to exit the host cell and cause further viral replication in the body.

The trials are targeted to begin within the next 12 months and are planned to enroll people with chronic heart failure both with and without type 2 diabetes.

Phase III data for nivolumab in head and neck cancer show biggest increase in survival for 20 years.

Broad spectrum of technological advances for cancer research on display at AACR 2016.

Innovative research demonstrates Seattle Genetics’ leadership in empowered antibodies.

Data from these additional Phase III studies were presented at The International Liver Congress 2016.

New formulation, in adherence with approved indications, intended for children, adolescents and adults with difficulty swallowing or opening capsules.

The agreement provides Takeda access to Presage’s proprietary CIVO technology platform to enable identification of novel oncology drug combinations in solid tumours.

Terminating the EEC allows AmpliPhi to take advantage of the rapid advancements being made in the field of synthetic biology.

APD371 is a highly selective and potent agonist of the cannabinoid 2 receptor with potential utility in the treatment of pain.

The first BCL-2 inhibitor in relapsed/refractory chronic lymphocytic leukemia patients with 17p deletion.

Recent discoveries about the eye’s involvement in Parkinson’s offer new hope to the millions of people who suffer from the disease.

Encouraging new data relevant to escalating Gram-negative infection crisis presented at 26th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).

Adds selective muscarinic agonists discovered and developed by Heptares to Allergan's leading CNS pipeline.

Phase II/III trial of AZD3293, an oral potent small molecule BACE inhibitor, will continue to Phase III after positive interim safety data.

Two formulations approved: once-daily tablet and oral suspension formulation designed for younger children who may not be able to swallow tablets.

The event content will include API and formulation development, clinical study design and regulatory requirements.

New tablet attaches to the lining of the GI tract, resists being pulled away.

The parties created IPS-MRCT Joint Centre for Therapeutic Antibodies to combine their expertise in research and development, intellectual property (IP) protection and management, and commercial acumen for more precise and efficient technology transfer.

First-line study evaluating avelumab in combination with Inlyta (axitinib) compared with Sutent (sunitinib malate) monotherapy in renal cell carcinoma.

In spite of similar approval numbers, the US continue to outpace Europe.

Dupilumab is first systemic therapy to show positive Phase III results in patients with moderate-to-severe atopic dermatitis, a serious, chronic inflammatory skin disease marked by widespread rash, itching and associated psychosocial comorbidities.

The medicine is a stem cell gene therapy created for an individual patient from their own cells which is intended to correct the root cause of the disease.

RedHill Biopharma's interim results from Phase IIa proof-of-concept study supporting therapeutic potential of RHB-104 in multiple sclerosis

If approved, Trevica will be the first treatment for schizophrenia to be administered four times a year and will provide the longest dosing interval available for an antipsychotic medication in the EU.

Flixabi to be the second anti-TNF biosimilar commercialized and manufactured by Biogen in the EU.

Pivotal RA-BEACON study published in New England Journal of Medicine.

Opdivo has potential to become first PD-1 inhibitor approved in a hematological malignancy in European Union.

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.