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PharmTech Europe
13 June 2017

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Top Stories

EMA Faces Brexit Challenges

The impact of Brexit on the European drug approval regulatory framework presents challenges for EMA.
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Drug Spending Not Driving Rising Health Care Costs

New reports indicate that drug prices are slowing compared to other healthcare costs.
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Podcast

Finn Bauer talks about Parteck SRP 80, an excipient for direct compression of matrix-based, sustained-release tablets. Parteck SRP 80 won the Excellence in Excipients Award at the 2016 CPhI Pharma Awards.

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Industry News

AstraZeneca Recalls Samples of Brilinta

The company voluntarily recalled one lot of Brilinta 90 mg professional samples because it contained another medicine.
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Ohio Sues Five Opioid Manufacturers

The state is alleging that misleading marketing practices contributed to the opioid epidemic in Ohio.
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More Industry News
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Regulatory News

EMA Issues Brexit Guidance

The agency released guidance for industry regarding the United Kingdom’s withdrawal from the European Union.
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FDA Warns Utah Company for Repeated Quality Failures

Yusef Manufacturing Laboratories, LLC received an FDA warning letter citing CGMP violations at its Clearfield, UT facility.
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More Regulatory News

Bio/Pharma News

Takeda Constructs High-Containment Facility in Ireland

Takeda will build a new production facility at its existing Grange Castle site in Ireland.
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Valeant to Sell iNova Pharmaceuticals for $930 Million

Proceeds from the sale will be used to repay the company’s term loan debt under its Senior Secured Credit Facility.
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More Bio/Pharma News

Supplier News

AMRI to be Acquired by The Carlyle Group

The company will be acquired for $21.75 per share in cash.
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Acasti Pharma and CordenPharma Announce Large-Scale Production of CaPre with Continuous Manufacturing

A continuous process for purifying raw krill oil for production of omega-3 phospholipid was designed and implemented.
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More Supplier News

FEATURED TOPICS

API SYNTHESIS & MANUFACTURING

Accessing Cannabinoids Using Biocatalysis

Efficient synthesis of complex cannabinoids is possible while avoiding marijuana cultivation.
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PEER-REVIEWED RESEARCH

A Forensic Microscopy Approach for Identifying Subvisible Particulates in a Sterile Ophthalmic Solution

The authors describe a forensic microscopy approach to characterize particles that were visually observed during stressed stability testing of an ophthalmic solution formulation.
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FORMULATION

Particle Size Reduction for Investigational New Drugs

Modern air jet milling can be used to investigate the feasibility of micronization as a solubilization approach in formulation development.
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SUPPLY CHAIN

Synchronizing Anticounterfeiting Efforts

Serialization and complementary authentication technologies are needed in order to meet DSCSA and FMD regulations.
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Product Profiles

Abbvie

AbbVie's Contract Manufacturing Business has been serving our partners globally for more than 35 years.
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Aptar Pharma

Aptar Pharma’s Electronic Lockout Device Approved by EMA
Aptar Pharma’s e-Lockout device is the first and only fully integrated electronic nasal drug delivery device to be approved by a US or European regulatory authority.
/ Read more/

Patheon

Patheon OneSource™
Patheon OneSource™ helps small and emerging pharmaceutical companies lower risk and drive more predictable outcomes by integrating drug substance and drug product development decisions within a single CDMO.
/ Read more/

Starna Scientific Ltd

Solving Instrument Qualification problems in the Deep UV
Deep UV (<200 nm) qualification problems for UV spectrophotometers can be solved using a unique Certified Reference Material from Starna to provide reliable qualification data.
/ Read more/


ON DEMAND WEBCAST

Best Practices for Extractables and Leachables Testing for Primary Drug Product Packaging
On Demand
Learn more


Events

1st Seminar on Formulation Designs for Challenging Needs

London, United Kingdom

22 June 2017

Advanced Therapy Medicinal Products

Valencia, Spain

27–28 June 2017

Excipientfest Asia

Beijing, China

13–14 July 2017

Workshop on Continuous Pharmaceutical Manufacturing: From Powder to the Coated Tablet

Ennigerloh, Germany

19–21 September 2017


more events

Reference Library

Pharmaceutical Technology Solid Dosage Combo

Increase your knowledge of solid dosage technology and solid dose tablet manufacturing processes. These comprehensive pharmacology reference guides cover a variety of solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Drug delivery system manufacturing professionals can use the solid dosage manufacturing books to stay current with compressed tablet manufacturing processes, solid dosage processing equipment, tablet-pressing processes, and pharmaceutical industry trends in oral solid dosage manufacturing and solid dosage form development.
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More Reference BookS

eBOOKS

Quality Throughout the Supply Chain

Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain.

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