Pharmaceutical Technology ePT Weekly
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PharmTech
February 16, 2017
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In this issue

Seattle Genetics Deal with Immunomedics

GPhA Rebrands as AAM

A New Location for EMA?

Top Stories

Concerns Mount Over PDUFA Renewal Timetable

Drug companies are pushing Congress to action on funding for FDA programs and staff to expedite drug reviews and approvals.
/ read more /


Therapeutic Antibodies to Track in 2017, Part I

EvaluatePharma and Pharmaceutical Technology highlight the antibody-based therapeutics that may gain United States Regulatory approval in 2017.
/ read more /

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INTERPHEX 2017 Keynote
Series: Serialization and Traceability

In this keynote session, speakers will look at the state of implementation, as well as best practices, results of pilot tests and research, and discuss a new program designed to help accelerate progress for companies that have not yet addressed requirements.

Learn more

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Industry News

GPhA Rebrands as AAM

The Generic Pharmaceutical Association announces a rebranding campaign to expand access to medicines.
/ read more /

 

Exela Pharma Sciences Recalls Ibuprofen Lysine Injection

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


More Industry News

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Supplier News

Capsugel Announces Commercial Availability of Modular Automated Sampling Technology

Modular Automated Sampling Technology (MAST) allows direct aseptic transfer of bioreactor samples to analytical devices, providing rapid and reliable data in bioprocessing.
/ read more /


 

Dr. Reddy's Expands European Operations

Dr. Reddy’s has expanded its commercial operations in Europe with the introduction of its range of generic drugs in France.
/ read more /


More Supplier News
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INTERPHEX 2017 – Register Today!
Find all of the Solutions you need to Cost Effectively Develop and Manufacture Product. INTERPHEX is a premier pharmaceutical, biotechnology, and medical device development and manufacturing event dedicated to Innovation, Technologies and Knowledge throughout the product development life cycle. It brings 11,000+ global industry professionals together with 600+ suppliers through our no cost technical conference, exhibits, and networking events.
Learn more


Bio/Pharma News

Seattle Genetics Strikes Deal with Immunomedics

The companies entered into a license agreement for Immunomedic’s antibody-drug conjugate sacituzumab govitecan.
/ read more /

 

GW Pharmaceuticals Announces Results from Cancer Trial

The company announced results from a Phase II trial with its THC:CBD drug for the treatment of glioblastoma multiforme.
/ read more /


More Bio/Pharma News

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Pharmaceutical Technology's PharmaMarketplace
Your Connection to Global Pharmaceutical Manufacturing Suppliers
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Regulatory News

Biotech Executives Express Concern Over Immigration Order

A total of 166 biotech executives penned an open letter expressing concern over President Donald Trump’s executive order on immigration.
/ read more /


 

A New Location for EMA?

Pharmaceutical Technology spoke with Tommy Fanning, head of biopharmaceuticals for IDA Ireland, to get a perspective on how Brexit may affect the pharmaceutical industry.
/ read more /


More Regulatory News

FEATURED TOPICS

ANALYTICS

Mass Spec Sheds New Light on Biologics Drug Development

Although limitations must be overcome, mass spectrometry is having a great impact on biologic development and manufacturing.
/ read more /

GMPS

Collaboration Key to Meeting Excipient GMP Requirements

Drug manufacturers need to work closely with excipient suppliers to ensure supply chain safety.
/ read more /

PEER-REVIEWED RESEARCH

Establishing Blend Uniformity Acceptance Criteria for Oral Solid-Dosage Forms

This article introduces the concepts of pooled variance and the central limit theorem, which are intended for establishing acceptance criteria for blend uniformity data of granular powder blends when a significant degree of sampling bias is involved.
/ read more /

QA/QC

A Risk-Based Approach to Stainless Steel Equipment Maintenance

Laboratory tests can determine critical cleaning parameters for passivation treatments used to prevent rouge on GMP stainless-steel equipment.
/ read more /


UPCOMING WEBCASTS

Around the World in Clinical Trials: New Regulations and Country Specific Challenges
Live Webinar: Tuesday, February 28 at 11:00am EST
Register now


Accelerate Bioprocess Development Using the Modular Automated Sampling Technology (MAST) Platform
Live Webinar: Thursday, February 23 at 11:00am EST
Register now


From Bench to Clinic: Preclinical and First-in-Man Development Strategies
Live Webinar: Wednesday, January 18 at 1:00pm EST
Register now


On Demand WEBCASTS

Orally Disintegrating Tablets: A Patient-centric Dosage Form
On Demand
Learn more


Events

IFPAC Annual Meeting

February 27–March 2, 2017

Pittcon 2017

March 5–9, 2017

3rd FDA/PQRI Conference on Advancing Product Quality

March 22–24, 2017

more events

REFERENCE BOOKS

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

Quality Throughout the Supply Chain

Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain.


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