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PharmTech Europe

8 November 2016

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Top Stories

Pfizer China Receives Approval for Prevenar 13

CFDA granted Pfizer China approval for the company's Prevenar 13 vaccine.
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NICE Recommends Eribulin

NICE recommended eribulin for the treatment of patients with breast cancer, reversing its 2012 decision.
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Industry News

Interpharm Praha A.S Receives FDA Warning Letter

The Czech Republic drug manufacturer was cited for data integrity and quality issues.
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Newly Discovered Protein May Hold Key to Better Drugs for Neglected Diseases

Researchers in the University of Dundee have discovered a new method of activating drugs to combat visceral leishmaniasis. The discovery could lead to better treatments for neglected tropical diseases.
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EXPERT INTERVIEW

Angelo Stracquatanio, co-founder of Apprentice Field Suite, spoke with Pharmaceutical Technology about smart glasses and their use in pharmaceutical manufacturing.

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Regulatory News

TraceLink Launches Early Access Program for Life Sciences Cloud

TraceLink launched the EU-hosted early access program to reduce the time, cost, and risk of achieving regulatory compliance for global requirements.
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FDA Advises Limited Clinical Testing for Biosimilars

The biosimilar pathway permits licensure based on less than full clinical data.
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Bio/Pharma News

Bellicum Collaborates on CAR-T Therapies

Bellicum and Ospedale Pediatrico Bambino Gesù will collaborate on preclinical and clinical development of CAR-T and TCR therapeutics.
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Astellas to Acquire Ganymed

Astellas will acquire Ganymed and its portfolio of ideal monoclonal antibody candidates.
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More Bio/Pharma News

Supplier News

Recipharm Adds New Lab to Italian API Facility

Recipharm is investing more than EUR1.2 million to enhance its small-scale GMP API development and manufacturing capabilities in Paderno Dugnano, Italy.
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Lonza Holds Grand Opening of New Drug Product Services Labs

The new facility will focus on formulation development, drug product analytical development, and quality control.
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FEATURED TOPICS

ASEPTIC/STERILE PROCESSING

Defining Risk Assessment of Aseptic Processes

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.
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STANDARDS & REGULATION

Pharmacovigilance of Biologics Under Scrutiny

Regulators are tightening up on post-marketing monitoring of biological medicines to detect deficiencies caused by manufacturing problems, particularly those stemming from post-authorization changes in the manufacturing process.
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VIEWPOINTS

Calling All Authors

The editors seek drug development experts to contribute technical articles for 2017.
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BEST PRACTICES

Improving Air Quality from Vacuum Pumps

Consider the purity of exhaust air emitted by vacuum pumps in addition to the purity of compressed air used in the pharmaceutical process.
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Product/Services Profile

Anton Paar

Small, smart and powerful – Anton Paar's MCP 150 polarimeter impresses with its sophisticated features
Anton Paar`s compact MCP 150 polarimeter is a one-size-fits-all solution: Although it is compact, it provides full 21 CFR Part 11 compliance, including electronic signature requirements.
/ Read more/

Capsugel

Vcaps® Enteric
Vcaps® Enteric is a fully compliant capsule technology that simplifies drug enteric delivery implementation from early stage development to commercial manufacturing.
/ Read more/

EtQ

EtQ Reliance Solution for Life Sciences
EtQ is the leading Quality, Compliance and EHS Management software provider for identifying, mitigating and preventing high-risk events through integration, automation and collaboration.
/ Read more /


Event Profile

CPhI & PMEC India 2016

Date: 21-23 November 2016
Venue: Bombay Exhibition Centre, Goregaon, Mumbai and MMRDA Grounds, BKC, Mumbai
The Indian pharmaceutical industry is all set to experience South Asia's largest Pharma event CPhI and P-MEC 2016, which will be concurrently held at the Bombay Exhibition Centre (BEC) and Bandra Kurla Complex (BKC) in Mumbai.
/ Read more /

ManuPharma 2016

Date: 30 November -1 December 2016
Venue: The Westin Grand Frankfurt
Europe's first peer-led pharma event for Heads of Tech Ops, Heads of Manufacturing Ops and Site Leads
ManuPharma 2016 provides you with a "how to" guide to transform your manufacturing strategy to best meet changing product portfolio, regulatory and customer requirements.
/ Read more /


UPCOMING WEBCAST

Get to Clinic Faster: Navigating Complex Biologics through Development and Manufacturing
Live Webinar: Wednesday, November 16 at 1:00pm EST
Register now


ON DEMAND WEBCASTS

Employing a Lean Lab Approach to Optimize Lab Processes: Part 2 “Improve Productivity”
On-Demand
Learn more


Don't let your diluent be the weakest link in your drug product
On-Demand
Learn more


Events

AAPS Annual Meeting and Exposition

13–17, November 2016 | Denver, Colorado

Pharma Blockchain Bootcamp

16, November 2016 | Edison, New Jersey, United States

CPhI Istanbul

8–10, March 2016 | Istanbul, Turkey


more events
 

Reference Library

Pharmaceutical Technology Outsourcing Guide

Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations.
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More Reference BookS

eBOOKS

Bioprocessing & Sterile Manufacturing eBook

Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems.

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