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Lilly's Trulicity solution for injection gets European approval to treat type 2 diabetes
By PBR Staff Writer
Eli Lilly and Company has received marketing authorization from the European Commission for Trulicity (dulaglutide) solution for injection to improve glycaemic control in adults with type 2 diabetes.
Drug Research > Drug Delivery > News
Synthon doses first patient in Phase I trial of cancer drug SYD985
By PBR Staff Writer
Synthon Biopharmaceuticals (Synthon) has started dosing patients with its investigational anti-HER2 antibody-drug conjugate (ADC), SYD985, in a Phase I trial to treat metastatic solid tumors.
Automation > IT & Software > News
Oxford and Menarini begins first-in-human trial of leukemia drug OBT357
By PBR Staff Writer
Oxford BioTherapeutics and Menarini Group have started the first-in-human clinical trial of OBT357 (MEN1112), a new improved antibody to treat acute myeloid leukemia (AML).
Drug Research > Drug Discovery & Development > News
Alexion's Soliris secures orphan drug designation (ODD) in Japan to treat neuromyelitis optica
By PBR Staff Writer
Alexion Pharmaceuticals has received orphan drug designation (ODD) from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Soliris (eculizumab) to treat patients with neuromyelitis optica (NMO), a life-threatening, ultra-rare neurologic disorder.
Regulatory Affairs > News
EMA committee grants orphan designation for Apitope's ATX-F8-117 to treat haemophilia A
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has granted orphan medicinal product designation to Apitope's ATX-F8-117 to treat patients with haemophilia A.
Regulatory Affairs > News
Mylan confirms first-to-file patent challenge relating to BREVIBLOC
Mylan confirmed that it and several subsidiaries have been sued by Baxter International, Baxter Healthcare Corporation and Baxter Healthcare S.A., in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Esmolol HCl in Sodium Chloride Injection, 10mg/ml (250 ml) and 20 mg/ml (100 ml).
Production & Manufacturing > Process & Production > News
Paragon wins NIH contract to design and scale-up manufacturing of rhE-Selectin protein
Paragon Bioservices has been awarded a contract from the National Institutes of Health (NIH) National Institute of Neurological Disorders and Stroke to design and establish a scale-up manufacturing process for the cGMP production of the recombinant human rhE-selectin protein.
Contract Research & Services > Contract Services > News
Valeant gets FDA approval for ONEXTON gel to treat acne vulgaris
Valeant Pharmaceuticals International has received approval from the Food and Drug Administration (FDA) for ONEXTON Gel (clindamycin phosphate and benzoyl peroxide), 1.2%/3.75%, for the once-daily treatment of comedonal (non-inflammatory) and inflammatory acne in patients 12 and older.
Regulatory Affairs > News
Trimel announces issuance of additional patent covering NATESTO
Trimel Pharmaceuticals announced that its technology partner Mattern Pharma AG has been granted an additional United States Patent in respect of NATESTO and its proprietary nasal gel technology.
Automation > IT & Software > News
New Malvern Application Note Shows Value of Nanoparticle Tracking Analysis in Exosome Studies
Malvern Instruments has published a new application note that examines the use of the company’s NanoSight Nanoparticle Tracking Analysis (NTA) technology in the study of extracellular vesicles, in this case exosomes, where ensuring the stability of sample preparations is an essential precursor to more detailed research work.
Press Releases
Inergetics' advisory board meets to discuss launch preparations for new CBD-Based supplement line
Inergetics, a world-class developer of nutritional supplements, announced that it had held a meeting of its Scientific/Medical Advisory Board to discuss product development and other preparations for the launch of its new CBD-based product line.
Production & Manufacturing > OTC > News
Amgen and AstraZeneca report positive Phase III trial results of plaque psoriasis drug brodalumab
By PBR Staff Writer
Amgen and AstraZeneca have reported positive results from its multi-arm Phase III AMAGINE-2 trial of brodalumab to treat patients with moderate-to-severe plaque psoriasis.
Drug Research > Drug Delivery > News
FDA extends review period for Novartis’ multiple myeloma investigational compound LBH589
By PBR Staff Writer
The US Food and Drug Administration (FDA) has extended the priority review period by up to three months for Novartis' new drug application (NDA) of LBH589 (panobinostat), a potent pan-deacetylase (pan-DAC) inhibitor, in combination with bortezomib and dexamethasone for patients with previously treated multiple myeloma.
Regulatory Affairs > News
Amgen terminates all company-sponsored trials of rilotumumab in advanced gastric cancer
By PBR Staff Writer
Amgen has terminated all of the company-sponsored clinical trials of rilotumumab, an investigational fully-human monoclonal antibody, in advanced gastric cancer including the Phase III RILOMET-1 and RILOMET-2 trials.
Contract Research & Services > Clinical Trials > News
Perrigo launches generic version of Astellas' Protopic ointment 0.1% and 0.03%
Perrigo Company has agreed to market the authorized generic version of Astellas U.S. LLC's' Protopic Ointment 0.1% and 0.03%. Shipments to our pharmacy customers have commenced.
Production & Manufacturing > OTC > News

PBR Supplier Recommendations

Merge eClinical - Where Smart Research Goes to Work
Merge eClinical develops and markets smart software that streamlines the clinical research process. Our company is built on the belief that every study – no matter its size, location or research setting – deserves the benefits offered by information technology to improve safety, quality and study outcomes. eClinicalOS™ (eCOS) is a single, scalable cloud-based platform that lets clinical research professionals design, launch and manage trials with more control, convenience and confidence than ever before. Eight of the top ten CROs and eight of the top ten pharmaceutical companies in the world use eCOS, and at least one new study using eCOS is deployed every day. ... Suppliers
Hybrigenics Services - Protein Interactions Expert
Who else knows your protein better than you? Who else knows proteins interactions better than us?... Contract Research & Services > Contract Research > Suppliers
Munters - Your Perfect Climate
Munters is the global leader in energy efficient climate control. Munters provide temperature and humidity climate solutions to assist manufacture and storage of products and create comfortable indoor environments. The company was established over 65 years ago and with over 3,000 employees in 30 offices worldwide.... Suppliers
Molnár-Institute - DryLab HPLC Method Development Software
Founded in 1981, Molnár-Institute focuses on strategies for improving the efficiency and success of modern HPLC. Our state-of-the-art HPLC modelling software, DryLab supports chromatographers worldwide in method development, optimisation, troubleshooting, robustness testing, and training.... Production & Manufacturing > Manufacturing > Suppliers
Mexichem Fluor - Pure Quality
Mexichem Fluor is the world leader in medical propellants and we have many years of experience operating to the highest current Good Manufacturing Practice (cGMP) standards. Our detailed understanding of the needs, standards and regulatory requirements of the pharmaceutical sector, coupled with our expertise in fluorine chemistry, makes us unique in our industry.... Production & Manufacturing > Fine & Speciality Chemicals > Suppliers
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PBR White Paper Recommendations

Early Phase Clinical Research in Italy By Cromsource
In recent years, the legislation in Italy which governs clinical research activity has undergone important changes. These revisions also affected the conduct of early phase clinical research, including Phase 1. Specifically, legislation introduced in 1998, 2001, 2003, 2007 and 2012 introduced changes which are relevant to the conduct of Phase I studies in Italy.... Contract Research & Services > Contract Research > White Papers Catch a Wave and You’re Sitting on Top of the World:How Information Technology is Leveling the Playing Field By Merge eClinical
Some 50 years ago, The Beach Boys offered up this observation: “Catch a wave and you’re sitting on top of the world.” They may have been singing about the virtues of surfing, but the refrain is applicable to a lot more than just hanging 10. It is no surprise that since 2000, there’s been a tidal wave of information technology advancements that’s been gathering size, speed and intensity. This wave has fundamentally reshaped how, when and where we communicate and conduct business.... White Papers Achieving Cost and Process Efficiencies with Online Endpoint Coordination and Adjudication By Merge eClinical
Clinical trials increasingly rely on endpoint adjudication to better assess patient events and provide standardised endpoint classifications. The increased trend toward the use of endpoint adjudication in a wider variety of clinical trials is being driven by regulatory, clinical, business and technology trends:... White Papers ML Plus Brochure By Munters
Introducing the ML Plus systems that is specifically designed to control both temperature and relative humidity in demanding production processes.... White Papers Pharma Application Brochure By Munters
This whitepaper gives you a brief overview on the advantages of implementing Munters dehumidification solution into all steps of the manufacturing process. From storing and transportation of raw materials, through all production processes and until the final product is stored before distribution.... White Papers See more
1-15 of 50412 results