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PharmTech Europe
28 August 2018

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Top Stories

UK Outlines Potential Pharma Changes Post-Brexit

Guidances for regulatory changes, batch testing, and reporting address situations resulting from “no-deal” Brexit scenario.
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DHSC Directs Pharma to Stockpile Medicines

As a contingency against border delays resulting from a “no-deal” Brexit, the Department of Health and Social Care (DHSC) directs pharma companies to stock extra medicines.
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Check out the PharmTech Europe Supplement on APIs, Excipients, and Manufacturing, includes the CPhI Worldwide Planning Guide.

August Supplement 2018
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Industry News

Experts Reveal Ebola Vaccine Status and Potential

Experts from the Partnership for Research on Ebola VACcination report on progress and uncertainties regarding a safe and effective Ebola vaccine.
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Zika Vaccine Clinical Trial Begins

The National Institute of Allergy and Infectious Diseases began a first-in-human trial of an experimental live, attenuated Zika virus vaccine.
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More Industry News

Regulatory News

Repeat Quality Deviations Found at India Facility

FDA sent a warning letter to Apotex Research Private Limited after investigators found current good manufacturing practice violations.
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FDA Approves First Drug for Rare Eye Disease

Dompé Farmaceutici‘s Oxervate (cenegermin), a topical eye drop, is the first treatment approved by the agency for neurotrophic keratitis, a rare disease affecting the cornea.
/ read more /


More Regulatory News

Bio/Pharma News

King Bio Recalls Products Due to Microbial Contamination

King Bio is recalling several of its kids and infant products due to possible microbial contamination.
/ read more /


Astellas Acquires Gene Therapy Company Quethera

The acquisition will strengthen Astellas Pharma’s position in ophthalmology.
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More Bio/Pharma News

Supplier News

Catalent Acquires Juniper Pharmaceuticals

The acquisition of Juniper expands and strengthens Catalent’s offerings in formulation development, bioavailability solutions, and clinical-scale oral dose manufacturing.
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Swedish Government and GE Healthcare Open an Innovation Center for Life Sciences

The new Testa Center in Uppsala, Sweden is a collaborative test bed offering biotechnology equipment from GE Healthcare for process development.
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More Supplier News

FEATURED TOPICS

ANALYTICS

Outsourcing Glycan Analysis

Industry experts discuss the challenges of performing glycan analysis and how companies can gain specific expertise from outsourcing partners.
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US REGULATORY WATCH

FDA Seeks to Revive Quality Metrics Initiative

The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.
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DOSAGE FORMS

Evaluation of Physical Characteristics of Dexlansoprazole Orally Disintegrating Tablets

This article describes the approaches used during the development of a dexlansoprazole delayed-release orally disintegrating tablet (ODT) to evaluate tablet size and texture as they relate to disintegration rate and patient experience; in addition, the resistance to alcohol was also characterized.
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SUPPLY CHAIN

Reducing the Risk of Pharma Air Transport

Air transport continues to be the most secure way to ship valuable therapies, but it is also the riskiest. Standards are helping to improve service quality.
/ read more /


Events

SMi's 9th Annual Biosimilars & Biobetters Conference

London, United Kingdom

26–27 September 2018

CPhI 2018

Madrid, Spain

9–11 October 2018

Cell & Gene Therapy 2018

London, United Kingdom

10–11 October 2018

PDA Europe Pharmaceutical Microbiology

Berlin, Germany

15–16 October 2018


more events

eBOOKS

Biologics and Sterile Drug Manufacturing 2018

This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics.

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