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PharmTech Europe

22 March 2016

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Top Stories

FDA and EMA Warn of Adverse Events
Associated with Zydelig

Both agencies warn of increased rates of serious adverse events, including death, during clinical trials of Zydelig (idelalisib).
/ read more /


AAI Pharma and Cambridge Major
Laboratories Rebrand as Alcami

With a new name formed from the legacy company names, Alcami offers development services, analytical testing, and API and finished drug development and manufacturing.
/ read more /


INTERPHEX 2016 KEYNOTE SERIES: BIOPROCESSING CHALLENGES

Pharmaceutical Technology and BioPharm International are sponsoring a Keynote Series discussion on bioprocessing challenges at INTERPHEX 2016.

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Industry News

Teva Pharmaceuticals Recalls Amikacin Sulfate Injection USP

The company recalls one lot of amikacin sulfate injection USP, 1 gram/4mL (250 mg/mL) vials due to the potential presence of glass particulate in one vial.
/ read more /


PhRMA Releases New Policy Solutions for Delivering Innovative Treatments to Patients

PhRMA says the proposals are aimed at modernizing the drug discovery and development process, promoting value-driven health care, engaging and empowering consumers, and addressing market distortions.
/ read more /


More Industry News

Regulatory News

CDER Revises MAPP on Prioritization Review of ANDAs

CDER is now prioritizing review of generic drug products for which there is only one approved drug product on the market.
/ read more /


EMA Elects Chair of Management Board

The European Medicines Board elects Christa Wirthumer-Hoche as chair of their Management Board.
/ read more /


More Regulatory News
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Bio/Pharma News

GSK CEO to Retire in March 2017

Sir Andrew Witty, CEO of GlaxoSmithKline, has said that he plans to retire from the company in March 2017, after nearly 10 years in the position.
/ read more /


Investigational Cannabidiol Medication Shown to Reduce Seizures

GW Pharmaceuticals released Phase III trial results on Epidiolex, which was shown to decrease monthly convulsive seizures in children by 39%.
/ read more /


More Bio/Pharma News

Supplier News

ANGUS Unveils a New Division

ANGUS reveals ANGUS Life Sciences as a new company division that will serve pharmaceutical, biotechnology, and agriculture markets.
/ read more /


DPT and Confab Complete $10 Million Capital Investment

The investment includes facility upgrades and expansion of development capabilities.
/ read more /


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FEATURED TOPICS

FACILITIES

Flexibility vs. Right-Sizing: Determining the Right Facility Size

Choosing the right facility size requires tailoring the design for current needs as well as anticipating the future.
/ read more /

GMPs

How Important is Data Integrity to Regulatory Bodies?

Data integrity is a widespread, global problem that must be addressed.
/ read more /

MANUFACTURING

Gaining Insight from Process Control Data

Integrated data and cloud-based solutions can be used for process optimization.
/ read more /

DRUG DEVELOPMENT

Outsourcing Formulation Development for High-Potency Compounds

The author lists five key areas to consider when selecting a CDMO to develop highly potent formulations.
/ read more /


Product/Service Profile

Shimadzu

MIURA GO-xHT – most powerful clean-up system for dioxins and PCBs
Shimadzu has released the revolutionary GO-xHT clean-up system from MIURA Institute of Environmental Science. Shimadzu is the official distributor in Europe for introduction of the Go-xHT system.
/ Read more /


KEYNOTE SERIES AT INTERPHEX 2016

At INTERPHEX 2016, Pharmaceutical Technology and BioPharm International are sponsoring a Keynote Series addressing leading bio/pharma industry issues.

Innovations in Solid Dosage Development and Manufacturing

Oral solid-dosage forms are the leading drug delivery method, but new development and manufacturing technologies are offering new options for patients. Experts will discuss advances in drop-on-demand manufacturing, polymer thin films for drug delivery, and manufacturing of minitablets.
Tuesday, April 26, 1–3:30 pm
Learn more

Contract Services Market: 2016 Update

How will consolidation in the bio/pharmaceutical and contract services market, a changing financial market, and an active political and regulatory year shape the fortunes of the contract services market? In his annual presentation, industry expert Jim Miller will offer his perspectives on the contract services landscape for the next few years.
Wednesday, April 27, 10:30 am – 11:30 am
Learn more

Strategies and Innovations to Reduce Drug Shortages and Improve Availability of Medicines

Aging facilities and equipment, inadequate operator training, a lack of quality control, tighter regulatory enforcement, and business decisions to eliminate unprofitable product lines contribute to ongoing shortages vital drug products. In this session, industry thought leaders will identify triggers for drug shortages, methods to avoid production line shutdowns and update facilities, and innovative industry efforts to fulfill demand for needed therapies.
Wednesday, April 27, 1:30 – 3:15 pm
Learn more

Panel Discussion: Addressing Sterile Manufacturing Challenges

Sterile injectables have been in extremely short supply, and industry efforts have been focusing on root causes involving infrastructure, quality, and efficiency. Experts involved in this work discuss recent initiatives, and offer insights into what must be done to prevent injectables shortages in the future.
Wednesday, April 27, 3:30 – 4:30 pm
Learn more


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Engineering the Mechanical properties of Amorphous Spray-Dried dispersions
On Demand
Capsugel Dosage Form Solutions will present a webinar discussing the aspect of engineering spray-dried dispersion properties, with a particular emphasis on the impact of atomization and drying rate on powder mechanical properties.
Read more



Webcasts

Successful Binding of Peroxide-Sensitive APIs

On Demand

In this live webinar, experts will showcase how to formulate a peroxide-sensitive drug using a binder that combines high binding strength with no peroxide formation at all.
Sponsored by BASF


Capsule Filling: Manufacturing Efficiency and the Added Value of Technical Service

On Demand
As challenging new formulations are developed, how prepared is your team to optimize the formulation performance in encapsulation? This webinar will provide insight into improving productivity in the use of capsules for pharmaceutical products for both the formulator and supply chain. Capsule filling technologies, dosing options, excipients, capsule selection, and other factors will be discussed. An example from the field will illustrate encapsulation practices.
Sponsored by Capsugel


more webcasts

on pharmtech tv

PharmTech TV

Umetrics

Australian Centre of Industrial Biotechnology (acib)

Locked4Kids

Events

BIO Europe Spring 2016

4-6 April, 2016 | Stockholm, Sweden

Global Drug Delivery and Formulation Summit

23-25 May, 2016 | Berlin, Germany

Chemspec Europe 2016

1-2 June, 2016 | Basel, Switzerland


more events

REFERENCE LIBRARY

Pharmaceutical Technology presents its Analytical Testing Resource Guide combo

A compilation of articles in a three-handbook set covering general Analytical Testing and Stability in the manufacture, packaging, storing, and testing of formulated products.
/ Click here /


More Reference Library

eBOOKS

Bioprocessing and Sterile Manufacturing 2015 eBook

This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.

more ebooks
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