Pharmaceutical Technology ePT Weekly
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PharmTech
October 5, 2017
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In this issue:

A Multifunctional Mineral Excipient

Amgen to Develop Four Biosimilars in China

FDA Increases REMS Requirements for Opioids

Top Stories

Pharma Gives Update on Puerto Rico Manufacturing Operations

AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, and Eli Lilly and Company said they are working to restore normal operations at their respective facilities and continuing recovery efforts.
/ read more /


AmerisourceBergen Specialty Group to Pay $260 Million Criminal Penalty

The US Department of Justice reports that AmerisourceBergen has pled guilty to illegally distributing misbranded oncology drugs and will pay a $260-million penalty.
/ read more /

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Industry News

FDA Publishes ANDA Guidance Documents

The agency published four guidance documents regarding ANDAs and amendments to ANDAs.
/ read more /


FDA Increases REMS Requirements for Opioids

The agency will require training for healthcare providers who prescribe immediate-release opioids.
/ read more /


More Industry News

Supplier News

Eurofins Opens New UK Testing Facility

Eurofins Scientific has opened a £4-million (US$5-million) pharmaceutical chemistry and microbiology facility in Livingston, Scotland, to support the company's product and water testing businesses in the UK.
/ read more /


Holodiag and Holochem Partner to Offer
Integrated CMC Services

Solid state solutions provider Holodiag and fine chemical R&D provider Holochem join forces.
/ read more /


More Supplier News

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Bio/Pharma News

PnuVax Receives Grant to Advance Pneumonia Vaccine

A grant from the Bill & Melinda Gates Foundation will advance PnuVax's pneumonia vaccine's clinical development and biomanufacturing scale-up using a low-cost manufacturing approach.
/ read more /


Amgen to Develop Four Biosimilars in China

Amgen will collaborate with China's Simcere Pharmaceutical Group, a R&D-driven pharmaceutical company, to co-develop four biosimilars for the Chinese market.
/ read more /


More Bio/Pharma News

Regulatory News

Gottlieb Supports Compounded Drugs

The FDA commissioner made a statement about the agency's efforts to ensure patient access to safe compounded medicines.
/ read more /


Data Integrity and Quality Issues Found at China Facility

FDA sent a warning letter to Shandong Vianor Biotech Co., Ltd. that claimed the company failed to follow proper data integrity and quality control procedures.
/ read more /


More Regulatory News

FEATURED TOPICS

Viewpoints

Process Validation: Do We Need Brainwashing?

Six years after the guidance, it's time to change our quality assurance vocabulary.
/ read more /

Excipients

A Multifunctional Mineral Excipient

Functionalized calcium carbonate provides high porosity, which enables fast disintegration, and excellent compactibility that results in harder tablets at low compression forces.
/ read more /

Manufacturing

Why Bottles with Desiccant Outperform Foil-Foil Blister Packaging

While cold-form, foil-foil (aluminumaluminum) blister packaging is considered the most moisture-protective packaging available, in fact, plastic containers such as bottles and tubes, when combined with desiccants, such as silica gel canisters and packets, will often provide lower internal relative humidity for long time periods.
/ read more /

Analytics

Applying QbD in Process Development

Informatics software can be used to address the challenges of quality by design, such as managing impurity data when developing an impurity control strategy.
/ read more /


UPCOMING WEBCASTS

Analytical Challenges in Extractables Studies of Plastic Single-Use Bioprocess Bags
Live Webcast: Tuesday, October 31 at 11:00am EDT
Register now


Excipient Selection to Enable the Performance of Skin Delivery Dosage Forms
Live Webcast: Wednesday, October 18 at 11:00am EDT
Register now


From Candidate to Clinic: Strategies to Select, Assess, Formulate, and Deliver the Right Drug Candidate in the Early Phase
Live Webcast: Tuesday, October 10 at 2:00pm EDT
Register now


Enteric Capsule Technologies to Help Fast-Track Pharmaceutical Drug Development
Live Webcast: Thursday, October 5 at 11:00am EDT
Register now


ON DEMAND WEBCASTS

Spectroscopy Advances for Improved Reproducibility and Easier Compliance
On Demand
Learn more


Packaging Material and Packaging System Quality for Pharmaceuticals and Biologics
On Demand
Learn more


No-Fuss Continued Process Verification: Automating Process and Product Monitoring
On Demand
Learn more


Emerging Pharma’s Winning Combination: A Science-First Approach to Accelerating Drug Development
On Demand
Learn more


Formulation Selection and in-vitro Screening for Oral Bioavailability Enhancement
On Demand
Learn more


Using Health-Based Exposure Limits (HBELs) to Assess Risk
On Demand
Learn more


Events

Rare Diseases & Orphan Products Breakthrough Summit

October 16–17, 2017

Speed to IND for Biologics

October 19–20, 2017

PDA Visual Inspection Forum

October 23–24, 2017

more events

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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