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Medivation, Astellas to initiate Phase III trial of prostate cancer drug enzalutamide
By PBR Staff Writer
Medivation and Astellas are planning to begin a Phase III clinical trial of enzalutamide in men with high-risk, hormone-sensitive, non-metastatic prostate cancer.
Contract Research & Services > Clinical Trials > News
Affinivax launches new conjugate vaccine for Ggobal impact on infectious diseases
Affinivax, a biotechnology company dedicated to developing novel vaccines, has announced its launch with a $4m investment from the Bill & Melinda Gates Foundation.
Production & Manufacturing > Manufacturing > News
ASLAN selects Medidata as enterprise-wide technology platform to improve clinical development
Medidata, the leading global provider of cloud-based solutions for clinical research in life sciences, has signed an enterprise agreement with ASLAN Pharmaceuticals, an oncology-focused biotechnology company.
Automation > IT & Software > News
Tribute Pharmaceuticals secures uracyst patent in Europe
Tribute Pharmaceuticals Canada has received a patent approval from the European Patent Office (EPO) for intellectual property central to one of the Company's lead products, Uracyst/Uropol (a sterile sodium chondroitin sulfate solution, 2%), for the treatment of interstitial cystitis by instillation into the bladder of a patient.
Production & Manufacturing > Process & Production > News
Levolta receives US patent for new investigational therapy for controlling osteoarthritis
Levolta Pharmaceuticals an emerging leader in developmental osteoarthritis (OA) therapy, has announced that the US Patent and Trademark Office has awarded the company a patent for its novel VOLT01, a derivative of zoledronic acid (ZA), a proposed commercial product that has shown promise as a disease-modifying drug in clinical trials.
Production & Manufacturing > Process & Production > News
Cirrus Pharmaceuticals to invest in cGMP manufacturing suite in US
Cirrus Pharmaceuticals, a Kemwell company, which is a 100% services oriented company providing pharmaceutical contract development and manufacturing services, has announced that it will be investing in a flexible cGMP suite in its facility in RTP, North Carolina.
Production & Manufacturing > Manufacturing > News
AstraZeneca's XIGDUO XR combination diabetes drug gets FDA approval
By PBR Staff Writer
British drugmaker AstraZeneca has received approval from the US Food and Drug Administration for its once-daily XIGDUO XR drug to treat adults with type 2 diabetes.
Production & Manufacturing > Manufacturing > News
Onxeo reports positive preliminary results from Validive Phase II trial for oral mucositis
By PBR Staff Writer
French biopharmaceutical firm Onxeo has reported positive preliminary top-line results from its Phase II clinical trial of Validive (mucoadhesive buccal tablet MBT clonidine Lauriad) to prevent severe oral mucositis (OM).
Automation > IT & Software > News
Auspex begins Phase III AIM-TD trial of SD-809 in patients with tardive dyskinesia
By PBR Staff Writer
Auspex Pharmaceuticals has started patient enrollment in a multi-center Phase III clinical trial of its investigational drug SD-809 (deutetrabenazine) to treat people with tardive dyskinesia, a debilitating and often irreversible movement disorder.
Contract Research & Services > Clinical Trials > News
GlaxoSmithKline introduces Incruse Ellipta in UK for COPD patients
By PBR Staff Writer
GlaxoSmithKline (GSK) has launched a new once-daily bronchodilator treatment, Incruse Ellipta (umeclidinium) in the UK, to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Production & Manufacturing > Manufacturing > News
Bristol-Myers Squibb expands manufacturing agreement with Lonza
By PBR Staff Writer
Bristol-Myers Squibb (BMS) has expanded its existing multi-year biologics manufacturing agreement with Swiss chemicals and biotechnology firm Lonza.
Production & Manufacturing > Manufacturing > News
RetroSense gets FDA orphan drug status for RST-001 to treat retinitis pigmentosa
By PBR Staff Writer
US-based RetroSense Therapeutics has received orphan drug designation from the Food and Drug Administration (FDA) for its lead product RST-001 to treat retinitis pigmentosa (RP), a genetic condition which leads to the progressive degeneration of rod and cone photoreceptors.
Regulatory Affairs > News
FDA grants accelerated approval for Pfizer' meningococcal B vaccine Trumenba
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted accelerated approval for Pfizer's Trumenba (meningococcal group B vaccine) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals aged 10-25 years.
Regulatory Affairs > News
Kamada's Glassia gets FDA orphan drug status for GVHD treatment
By PBR Staff Writer
Irish firm Kamada has received orphan drug designation from the US Food and Drug Administration’s (FDA) Office of Orphan Products Development for its human Alpha-1 Antitrypsin (AAT) Glassia, to treat immunologically-based graft versus host disease (GVHD).
Production & Manufacturing > Process & Production > News
MEI Pharma begins dosing in ME-344 Phase Ib trial for small cell lung and ovarian cancers
By PBR Staff Writer
US-based MEI Pharma has dosed the first patient in a cohort-expansion stage of its Phase Ib clinical trial of ME-344 in combination with topotecan to treat patients with small cell lung or ovarian cancer who failed initial therapy.
Drug Research > Drug Discovery & Development > News

PBR Supplier Recommendations

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
3R PHARMA CONSULTING - Reducing Regulatory Risk
3R PHARMA CONSULTING provides cost-effective, timely solutions to registration filings and challenges in pharmaceutical development strategies across Europe, the US and the rest of world. ... Regulatory Affairs > Suppliers
FeF Chemicals - Insulin Human and Benzalkonium Chloride Products
FeF Chemicals is a Novo Nordisk company that specialises in the supply of ingredients for the biopharmaceutical and pharmaceutical industries, such as insulin human for cell culture media and cGMP manufactured quaternary ammonium compounds (usually referred to as quats) such as benzalkonium chloride, cetrimide and cetrimonium bromide.... Production & Manufacturing > Manufacturing > Suppliers
Fujifilm Diosynth Biotechnologies - Biopharmaceutical Process Development and Manufacturing Services
We are one of the world’s leading suppliers of contract process development and manufacturing services for the biopharmaceutical industry. Created in April 2011, Fujifilm Diosynth Biotechnologies has more than 900 employees, operating from two sites in Billingham, UK, and the Research Triangle Park in North Carolina, US.... Production & Manufacturing > Manufacturing > Suppliers
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PBR White Paper Recommendations

Sign up to NNIT’s Newsletter By NNIT
Sign up to NNIT’s newsletter and receive inspiration on how IT can create value for life sciences companies. You'll get articles, whitepapers, cases and invitations to webinars. Sign up here: http://www.nnit.com/pages/news.aspx#/ ... White Papers Exosomes and Microvesicles: Characterisation by Nanoparticle Tracking Analysis By Malvern Instruments
While the principles underpinning the Nanoparticle Tracking Analysis (NTA) technique have been described in an earlier white paper, it must be reiterated that the use of high intensity laser beams combined with a low-background optical configuration allows particles of deeply sub-micron dimensions to be visualised, the lower range of particle sizes measureable depending on particle refractive index.... White Papers Viruses and Viral Vaccines: Characterisation by Nanoparticle Tracking Analysis By Malvern Instruments
NTA utilises the properties of both light scattering and Brownian motion in order to obtain the particle size distribution of samples in liquid suspension. A laser beam is passed through the sample chamber, and the particles in suspension in the path of this beam scatter light in such a manner that they can easily be visualised via a 20x magnification microscope onto which is mounted a camera. The camera, which operates at approximately 30 frames per second (fps), captures a video file of the particles moving under Brownian motion within the field of view of approximately 100μm x 80 μm x 10 μm (Figure 1).... White Papers How can Nanoparticle Tracking Analysis Assist in the Production of Nanoparticles By Malvern Instruments
This white paper highlights the growth in the use of the technique of Nanoparticle Tracking Analysis as applied to nanoparticles and nanomaterials production and analysis, from the very first reports on nanoscale silver and gold (Lundahl et al. (2008) and Marsh et al. (2008), respectively).... White Papers Ophthalmic Study Endpoints By Cromsource
Ophthalmic studies rely on complex tests and assessments to meet clinical study endpoints. Each test may be time-consuming to administer, assess, and interpret. Consequently, it is important not to overcrowd a study with unnecessary assessments. Choosing endpoints that are clinically relevant is increasingly important in bringing new therapies to market more quickly.This paper provides a brief overview of some common endpoints in ophthalmology research, and issues to take into account when considering endpoints for ophthalmic studies.... Contract Research & Services > Contract Research > White Papers See more
1-15 of 50176 results