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PharmTech Europe

16 August 2016

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Top Stories

NICE Draft Guidance Recommends Secukinumab for Treating Ankylosing Spondylitis

NICE recommends secukinumab for the treatment of patients with ankylosing spondylitis.
/ read more /


European Commission Publishes Pharmacovigilance Report

The three-year report emphasizes the roll of collaboration in drug safety.
/ read more /


GSK, Verily to Set Up Bioelectronics Joint Venture

Galvani Bioelectronics will be based in Stevenage, UK, and headed by Kris Famm, GSK's vice president of bioelectronics R&D.
/ read more /


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EXPERT INTERVIEW

Pharmaceutical Technology sat down with Mike Valazza, vice-president of business development at Catalent Pharma Solutions, to discuss modified-release formulations.

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Industry News

FDA awards LIU for research into variability

A $2-million, three-year grant will explore how statistically-based pharmaceutical quality standards might be established.
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FDA Approves First Generic Version of Tamiflu

FDA approved Natco and Alvogen's generic Tamiflu to treat and prevent influenza.
/ read more /


More Industry News

Regulatory News

PharmaTech Recalls Product Due to Contamination Risk

The company is voluntarily recalling liquid products due to possible Burkholderia cepacia contamination.
/ read more /


Hospira Recalls Bupivacaine Hydrochloride Injection, USP

The company is voluntarily recalling one lot of product due to particulate matter.
/ read more /


More Regulatory News

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Bio/Pharma in China
New Initiatives, New Opportunities

On Demand
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Bio/Pharma News

Phase III Trials for Bristol-Myers' Opdivo Fail to Meet Primary Endpoints

Opdivo did not meet primary endpoints in Phase III trials investigating the drug as a monotherapy for untreated advanced non-small cell lung cancer in patients whose tumors expressed PD-L1.
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Biogen Announces Name of Hemophilia Spin-Off Business

The company announced that Bioverativ will be the name of its new hemophilia spin-off business, which is expected to launch in early 2017.
/ read more /


More Bio/Pharma News

Supplier News

MilliporeSigma to Provide Development and Manufacturing Services to Y-mAbs

MilliporeSigma will provide support to Y-mAbs for the development of its monoclonal antibody for the treatment of pediatric brain cancer.
/ read more /


Bristol-Myers Squibb Reacquires Rights to ASLAN002

BMS will reacquire the rights to ASLAN002 (BMS777607) from ASLAN Pharmaceuticals in China, Australia, Korea, Taiwan, and other Asian territories.
/ read more /


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FEATURED TOPICS

MANUFACTURING

Measuring Equipment and Manufacturing Trends

PharmTech's 2016 survey shows general satisfaction with existing solid-dose and parenteral manufacturing equipment, and slow adoption of continuous manufacturing processes.
/ read more /

 

PEER-REVIEWED RESEARCH

Purification of Peptides Using Surrogate Stationary Phases on Reversed-Phase Columns

This paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).
/ read more /

EQUIPMENT

New Equipment Meets Need for Innovation in Pharma Manufacturing

New technology introduced in 2016 aids innovation growth for pharmaceutical manufacturing.
/ read more /

DRUG DELIVERY

Using 3D Printing for Solid-Dosage Drugs

Three-dimensional printing allows unique benefits to be built into solid-dosage forms.
/ read more /


Product Profile

Catalent

Fast Dissolve Oral Dosing of Macromolecules
Catalent's Zydis® orally disintegrating tablet (ODT) fast-dissolve formulation is a unique, freeze-dried oral dosage form that disperses instantly in the mouth, requiring no water.
/ Read more/

Veltek Associates, Inc.

Cart2CoreĀ® - Aseptic Cart Transferring System
VAI's Cart2Core®, a patent pending technology, virtually eliminates the problematic issue of correct aseptic cart transference by making the cart top transferable to a new base at each new classification.
/ Read more /

Event Profile

CPhI Worldwide, ICSE, InnoPack, P-MEC, FDF

Date: Exhibition: 4th-6th October, 2016 Pre-Connect Congress : 3rd October 2016
Venue: Fira de Barcelona Gran Via, Barcelona, Spain
CPhI Worldwide, the world's leading pharmaceutical platform, co-located together with ICSE, InnoPack, P-MEC and FDF, brings together year on year over 36,000 industry experts from 153 countries around the world to meet and greet, do business and shape the future of the global pharmaceutical industry.
/ Read more /

Webcasts

Drug Stability Testing from Development to Shipping

On Demand

In this educational webcast, learn about regulatory expectations and practical approaches to stability testing of drug substances and drug products for clinical trials, packaging, storage, and transportation.
Sponsored by SGS Life Science Services


Employing a Lean Lab Approach to Optimize Lab Processes: Part 1 “Work smarter not harder”

On Demand
When lab workloads seem too high to handle, analysis results or approvals are late, or lead times are exceeded, it is time to take a closer look at a lean lab approach, especially before investing in new resources such as equipment, premises, or personnel.
Sponsored by Mettler Toledo


more webcasts

Events

14th Annual Pharmaceutical IT Congress

28-29 September, 2016 | London, England

CPhI Worldwide

4-6 October, 2016 | Barcelona, Spain

PDA Visual Inspection Forum

25-26 October, 2016 | Berlin, Germany


more events
 

Reference Library

Pharmaceutical Technology Drug Delivery Guides

A three-volume set of drug delivery system handbooks. A compilation of articles related to methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects. Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery.
/ Click here /


More Reference Book

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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