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PharmTech Europe
07 May 2019

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Top Stories

EMA Recommends 13 Drugs for Approval

The agency recommended marketing authorization for two orphan drugs and treatments for opioid dependence, HIV, cancer, and more.
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NHS England Strikes Deal with Three Pharma Companies to Eliminate Hepatitis C

NHS England and three pharma companies have agreed to work together to find and cure tens of thousands more people with hepatitis C, potentially leading to Britain becoming the first country to eliminate the virus.
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Industry News

AstraZeneca, BenevolentAI Partner on AI for Drug Discovery

The companies will join forces to use artificial intelligence (AI) and machine learning to discover and develop new treatments for two chronic diseases.
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General Pharmaceutical Council Introduces Further Safeguards for Online Medicines Purchases

The UK's General Pharmaceutical Council (GPhC) has strengthened its guidance for online pharmacies to further safeguard patients when purchasing medicines.
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Regulatory News

EMA Updates Prescribing Information of Breast Cancer Medicine while Data are Re-Analyzed

EMA has revealed that it is updating the prescribing information of Tyverb (lapatinib) as a result of the detection of errors in study results.
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CHMP Recommends Implant for Opioid Dependence

The CHMP has recommended that Sixmo (buprenorphine) be granted a marketing authorization in the EU as a substitution treatment for opioid dependence.
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Bio/Pharma News

Intertek Expands Pharma Services Facility

Intertek has announced the expansion of its pharmaceutical services laboratory in Melbourn, near Cambridge, UK, through the acquisition of a new 20,000 sq. ft facility.
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Kite to Expand Cell Therapy Manufacturing

A new facility in Frederick County, MD, will expand the company's cell therapy manufacturing capabilities.
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More Bio/Pharma News

Supplier News

Integrated First-in-Human Service Package for Poorly Soluble Small Molecules

Lonza's SimpliFiH Services addresses bioavailability challenges with drug substance, solid-state characterization, and drug product for first-in-human studies.
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Sharp to Expand US Packaging Capacity and Capabilities

Contract packaging and clinical supply service company Sharp invested $21 million to expand its packaging capacity and capabilities in Pennsylvania.
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FEATURED TOPICS

FORMULATION

Particles on Best Behavior

Characterizing particles and understanding bulk powder behavior is critical to get the best pharma product.
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MANUFACTURING

OSD Continuous Manufacturing Strategies

In OSD continuous manufacturing, flexible batch sizes can optimize supply, but equipment and processing challenges are still being addressed.
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PEER-REVIEWED RESEARCH

Degradation Pathways: A Case Study with Pegylated L-Asparaginase

It is important to address manufacturing problems associated with the shorter shelf-life of pegylated L-asparaginase (pegaspargase) upon long-term storage in the form of a solution.
/ read more /

QUALITY SYSTEMS

Channeling Customer Complaints into Quality

A robust customer complaint handling system is an integral part of a quality management system, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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PRODUCT PROFILE

Shimadzu

C2MAP automated pretreatment module
Complete LC/MS solution for cell culture analysis

Shimadzu's C2MAP-2000 automated pretreatment module is for pretreating of culture media samples by adding reagents such as a deproteinizing agent or internal standard substance, filtering of precipitated proteins, and diluting of samples.
/ Read more/


Events

RAPS Regulatory Conference Europe 2019

Brussels, Belgium

13–14 May 2019

Injectable Drug Delivery 2019

London, UK

15–16 May 2019

Advanced Therapy Medicinal Products Conference

Vilnius, Lithuania

4 June 2019


more events

eBOOKS

Laboratory Best Practices 2018 eBook

The editors explore new tools for bio/pharma lab studies—such as robotics, augmented reality, and advanced instrumentation—as well as best practices for method development, multiple attribute monitoring, lab mixers, and raw material testing.

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