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FDA approves Tesaro’s Zejula for recurrent ovarian cancer
By PBR Staff Writer
Tesaro has secured approval from the US Food and Drug Administration (FDA) for Zejula (niraparib) for women with recurrent ovarian cancer.
News
University of Dundee secures grant to discover new antibacterial drugs
University of Dundee in the UK has been awarded almost £1m to boost efforts to identify new new antibiotics to tackle bacterial infections.
Drug Research > Drug Discovery & Development > News
Summit to extend PhaseOut DMD trial for ezutromid
Summit Therapeutics has announced that, subject to regulatory approval, it will go ahead with the planned extension phase of PhaseOut DMD, a Phase 2 clinical trial studying the utrophin modulator ezutromid.
Contract Research & Services > Clinical Trials > News
Allergan, Paratek’s acne drug succeeds in two phase 3 trials
By PBR Staff Writer
Allergan and Paratek Pharmaceuticals’ acne drug sarecycline has met its primary efficacy endpoints in two phase 3 trials.
Contract Research & Services > Clinical Trials > News
NSF- A Final Word on KPIs – A Case Study From a Site Quality Head
Leadership had mixed views of KPIs. Many did not distinguish between leading and lagging, and none focused on behavior first, measure second. We set out to address these issues.
NSF asks a Production Director for their views on moving forward with KPIs
| By NSF Health Sciences Pharma Biotech PBR
KPIs and the Production Director: Select Fewer, More Significant KPIs and Set Goals for Your Metrics
White Papers
NSF determines what KPIs mean for Employees
| By NSF Health Sciences Pharma Biotech PBR
KPIs and Employees: Involve Us Upfront and Let Us Help Define Relevant Measures
White Papers
NSF asks ex-MHRA Inspector about the Importance of KPIs and gets Interesting Results
| By NSF Health Sciences Pharma Biotech PBR
KPIs and the Regulator: I’m Looking for Quality Metrics, Management Review and Continual Improvement.
White Papers
Ignyta to explore strategic options for cancer candidate taladegib
Ignyta is exploring strategic options for taladegib and has entered into an amended and restated license, development and commercialization agreement with Eli Lilly and Company for the taladegib oncology program.
Drug Research > Drug Discovery & Development > News
PureTech signs licensing and equity deal with Novartis to advance clinical stage mTORC1 programs
PureTech Health has signed a licensing and equity agreement with Novartis to advance two clinical-stage programs targeting the mechanistic target of rapamycin complex 1 (mTORC1) pathway.
Contract Research & Services > Contract Services > News
Xenon’s acne drug XEN801 fails in phase 2 trial
By PBR Staff Writer
A phase 2 trial of Xenon Pharmaceuticals’ acne drug XEN801 has failed to meet its efficacy endpoints in patients having moderate to severe acne.
Contract Research & Services > Clinical Trials > News
Genentech's Rituxan gets FDA breakthrough therapy status to treat pemphigus vulgaris
By PBR Staff Writer
Roche’s subsidiary Genentech has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its Rituxan (rituximab) to treat pemphigus vulgaris.
Regulatory Affairs > News

PBR Supplier Recommendations

WeylChem Group - We Live Know-How
The WeylChem group of companies is an international fine chemicals group, part of International Chemical Investors Group, ICIG. The WeylChem group is a specialised service provider to the agrochemical, pharmaceutical, polymer and specialty chemicals industries, offering custom-, toll-manufacturing and processing services as well as advanced intermediates, reagents and performance products.... Production & Manufacturing > Fine & Speciality Chemicals > Suppliers
SHL Healthcare - Developer and Manufacturer for Equipment Solutions
SHL Healthcare develops and manufactures equipment solutions for home, hospital and long-term care use with a focus on patient comfort and functionality. Our broad range of products include medical slings, rehabilitation beds, pressure mattress systems, lifting equipment, medical soft goods and a variety of related accessories. ... Suppliers
SHL Group - Pen Injectors, Autoinjectors and Inhaler Systems
SHL is a privately-owned developer, designer and manufacturer of advanced drug delivery devices.... Regulatory Affairs > Suppliers
NSF Health Sciences Pharma Biotech
NSF International’s pharma biotech services include world-class regulatory and compliance consulting, auditing, residential and on-site pharmaceutical training and clinical testing on a global basis. ... Suppliers
CRFweb... from Clindox, Suppliers of Clinical Trial Software
CRFweb is the groundbreaking eCRF application brought to you by Clindox. It sets new standards in web-based, clinical trial software. The combination of a comprehensive feature set, incredibly quick set-up time, simplicity of use and flexible pricing means no trial is too large or too small to be practical. The whole process is genuinely DIY, allowing trial managers to really take control of their trial. ... Contract Research & Services > Clinical Trials > Suppliers
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PBR White Paper Recommendations

NSF - Site Director: KPIs Should Look Forward as well as Measure Results By NSF Health Sciences Pharma Biotech PBR
A Site Director expresses his views on how to use KPIs most productively. ... White Papers NSF asks a Production Director for their views on moving forward with KPIs By NSF Health Sciences Pharma Biotech PBR
KPIs and the Production Director: Select Fewer, More Significant KPIs and Set Goals for Your Metrics... White Papers NSF determines what KPIs mean for Employees By NSF Health Sciences Pharma Biotech PBR
KPIs and Employees: Involve Us Upfront and Let Us Help Define Relevant Measures... White Papers NSF asks ex-MHRA Inspector about the Importance of KPIs and gets Interesting Results By NSF Health Sciences Pharma Biotech PBR
KPIs and the Regulator: I’m Looking for Quality Metrics, Management Review and Continual Improvement.... White Papers Tech Talk: CHANGING GMP BEHAVIORS with NSF By NSF Health Sciences Pharma Biotech PBR
Most people are content sticking with what they know and their tried and tested habits. It’s easy. To get people to think and act differently (a painful process for most), you have to provide them with the motivation.... White Papers See more
1-15 of 55233 results