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PharmTech Europe
5 September 2017

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Top Stories

FDA Approves Novartis' CAR-T Drug, First Gene Therapy Approval in US

FDA approves Novartis' CAR-T therapy, marking the first time a cell therapy based on gene transfer has been approved in the United States for any indication.
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AstraZeneca and Takeda to Partner for PD Treatment

AstraZeneca and Takeda will partner to develop and commercialize MEDI1341, an alpha-synuclein antibody currently in development as a potential treatment for Parkinson's disease.
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What Country Ranks Highest in Pharma Manufacturing?
CPhI survey seeks industry input to rank top-performing nations on pharma manufacturing and business factors.

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Industry News

Hospira Recalls One Lot of Injectable Vancomycin Hydrochloride

Hospira, a Pfizer company, is voluntarily recalling one lot of vancomycin hydrochloride for injection, USP, 750 mg/vial because of glass within a single vial.
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CPI Joins Consortium for Automated Continuous Biologics Purification

With £4.5 million (US$5.8 million) in funding, the consortium is tasked with developing a new automated continuous biologics purification unit to make biologic drug manufacturing more efficient.
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Regulatory News

FDA Seizes Military Vaccine Used in Unauthorized Stem-Cell Treatments

FDA halts unproved stem-cell cancer treatments administered to California patients, which was derived from a commercially unavailable military-grade vaccine.
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EMA Increases Support for SMEs

EMA recognizes the need to provide more assistance and guidance to SMEs developing new medicines and applying for marketing authorizations.
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Bio/Pharma News

Sanofi Closes Acquisition of Protein Sciences

The acquisition of Protein Sciences, a vaccines biotechnology company, strengthens Sanofi's influenza vaccines portfolio.
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Xellia Completes Budapest Facility Expansion

Xellia Pharmaceuticals completed the expansion of its laboratory services building at its Budapest manufacturing site.
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More Bio/Pharma News

Supplier News

Cambrex Invests in Analytical Laboratory Expansion

Cambrex will expand its High Point, NC, facility with a $3.2-million, 11,000-square feet analytical laboratory.
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Corden Pharma Facility in Italy is Cleared by FDA

An FDA evaluation concluded that Corden Pharma Latina's corrective actions addressed the concerns in an FDA warning letter.
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FEATURED TOPICS

40th ANNIVERSARY

Biologics Advance the Pharma Industry

Advancements in cell culture and protein technology have opened the door for new therapies.
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MANUFACTURING

A Continuous Improvement Metric for Pharmaceutical Manufacturing

Statistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.
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OUTSOURCING

CDMOs: New Administration, New Frontier

Despite some progress, the industry is still in a wait-and-see mode regarding the administration, Congress, and FDA.
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STANDARDS & REGULATIONS

Data Integrity Expectations of EU GMP Inspectors

The author reviews key technological expectations of EU GMP inspectors on the integrity of e-records.
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Product Profile

LCMS-8060 triple quadrupole mass spectrometer

Shimadzu's LCMS-8060 is designed to push the limits of LC/MS/MS quantitation for applications requiring the highest sensitivity and robustness while delivering a meaningful solution for routine LC/MS/MS analyses.
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Event Profile

CPhI Worldwide 2017

Date: 24-26 October 2017
Venue: Messe Frankfurt, Germany
CPhI Worldwide, together with co-located events ICSE, InnoPack, P-MEC and FDF, hosts more than 42,000 visiting pharma professionals over three days. 2,500+ exhibitors from 153 countries gather at the event to network and take advantage of more than 150 free industry seminars. The exhibition covers every sector of the pharmaceutical market under one roof.
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UPCOMING WEBCASTS

Using Health-Based Exposure Limits (HBELs) to Assess Risk
Live Webcast: Wednesday, September 6 at 11:00am EDT
Register now


Formulation Selection and in-vitro Screening for Oral Bioavailability Enhancement
Live Webcast: Tuesday, September 12 at 11:00am EDT
Register now


No-Fuss Continued Process Verification: Automating Process and Product Monitoring
Live Webcast: Thursday, September 14 at 11:00am EDT
Register now


ON DEMAND WEBCAST

Choosing the Best Biomanufacturing Strategy: The Value of a Multi-Pronged Approach
On Demand
Learn more


Events

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

Ennigerloh, Germany

19–21 September 2017


more events

Reference Library

Pharmaceutical Technology presents its Process Analytical Technology resource guide combo

A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.
/ Click here /


More Reference BookS

eBOOKS

Biologics and Sterile Manufacturing

New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics.

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