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January 2016
Welcome to the January issue. Our upfront topics range from a cross-country cancer cost comparison, to details of the French cancer trial tragedy. Our feature speculates on the future of the Biopharmaceutical Industry – discussing the role of Immuno-oncology, gene editing and other emerging therapeutic techniques. In best practice, Lisa Allen discusses the approaching deadline for the European Union’s REACH regulation, in NextGen, Miguel Forte discusses the role of vendors and manufacturing organizations to cell therapies, and we Sit Down With Diane Paskiet of West Pharmaceutical Services.
Screening, Identifying, and Quantifying Potential Genotoxic Compounds with High Resolution LC/MS
February 11, 2016
Analysis of chlorhexidine drug substance using an Agilent 6545 Accurate Mass Q-TOF System and MassHunter Mass Profiler Software.
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Thinking Inside – and Outside – the Box
February 9, 2016
Sitting Down With... Diane Paskiet, Director of Scientific Affairs at West Pharmaceutical Services, USA.
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The Rise of Asia’s Biotech Tigers
February 9, 2016
The western world could be considered king of the biotech jungle, but eager biopharma tigers from the east are hungry for a piece of the action – and they are gaining ground. Can single-use technologies help them to catch up even faster? Jinghui Xu believes so.
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Ultra-Engineering UHPLC from Scratch
February 9, 2016
Incremental improvements to ultra-high performance liquid chromatography (UHPLC) have failed to deliver the tangible advances that researchers really want. Sometimes, a full overhaul by re-engineering from the bottom-up is the only way to innovate and move the field forward.
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The Adverse Event Data Advantage
February 9, 2016
A personal experience led us to examine how adverse drug events data can be used to benefit the industry.
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The CMO Serialization Threat
February 9, 2016
The serialization deadlines are coming. It may seem an age away, but preparing for serialization is not as straightforward as you may think. Do you really want to get left behind?
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Are You REACH Ready?
February 9, 2016
The final deadline for the European Union’s REACH regulation is approaching – and the home stretch will be the most challenging, especially for pharma companies that have failed to recognize their role.
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Dosing For Compliance
February 9, 2016
Are current dosage forms really as easy and convenient for patients as pharma manufacturers say they are? Thinking more about real-world usage can help us design more practical drugs that patients are more willing to take.
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Three’s a Charm
February 9, 2016
Nanoparticles help to deliver a three-in-one attack on metastatic melanoma cells
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All Eyes on EMA Approvals
February 9, 2016
From anti-cancer viruses to H3 blocking narcolepsy drugs – we present a year in European drug approvals
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Clinical Trial Tragedy
February 9, 2016
A clinical trial of an FAAH inhibitor in France goes terribly wrong, but whether the compound or manufacturing are to blame remains to be seen
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The (FD)A-Team
February 9, 2016
Are you worried about implementing new manufacturing technology in your plant? Never fear, the FDA’s Emerging Technology Team may be able to lend a helping hand
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Bio-Butterfingers
February 9, 2016
Lipoprotein-nanoplatelets leave researchers hungry to explore drug delivery potential
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Cross-Country Cancer Cost Comparison
February 9, 2016
Oncology medication prices can vary significantly between countries – but by how much and why?
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From Brick Dust to Blockbuster?
February 2, 2016
Many drug candidates are as poorly soluble as “brick dust”, making oral delivery a significant challenge. Fortunately, self-emulsifying lipids – and other innovative solubilizers and polymers – have risen to the challenge of the insolubility dilemma in drug delivery.
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