Pharmaceutical Technology ePT Weekly
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PharmTech
July 16, 2015
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in this issue

House Approves Landmark “Cures” Legislation
Officials Propose Corporate Tax Holiday
FDA Finalizes Drug Shortage Rule

Top Stories

House Approves Landmark “Cures” Legislation

The 21st Century Cures Act took a giant step forward with a 344–77 approval in the House; the Senate debate is still ahead.
/ read more /


Neurological Disorders Drug Development Pipeline has 420 Candidates, Says New Report

A report released by PhRMA in conjunction with the Epilepsy Foundation reveals that the pipeline is dominated by biologics.
/ read more /


FDA Finalizes Drug Shortage Rule

The agency requires early notification of potential drug shortages.
/ read more /

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Industry News

Officials Propose Corporate Tax Holiday

Senators encourage the repatriation of offshore funds in a new report targeting the pharmaceutical industry.
/ read more /


Imperial Innovations Secures GBP50 Million for UK Biotech Sector

The investment will help strengthen biotech spin-offs from the United Kingdom’s leading research-intensive universities.
/ read more /


More Industry News


Supplier News

DPT Enhances Flexibility and Efficiencies at San Antonio Facility

CDMO for semi-solid and liquid manufacturing realigns operations at Texas facility.
/ read more /


Quotient Clinical Expands Pharmaceutical Sciences Capabilities

The company has doubled its pharmaceutical sciences capacity through the acquisition of a second GMP manufacturing facility.
/ read more /


More Supplier News

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Just released – Tablet Press Replacement Parts and Accessories Catalogs
In addition to efficient, durable and highly-performing tablet compression tooling, Natoli Engineering Company also offers tablet press replacement parts for most makes and models of machines as well as tablet compression accessories to clean, maintain, analyze, and protect your tooling. Download a PDF of our new catalogs or request a quote online at natoli.com.
Learn More



Bio/Pharma News

Teva Launches First Generic Axert Tablets in the US

Teva has launched the generic version of almotriptan malate (Axert), 6.25 mg and 12.5 mg, in the United States.
/ read more /


GSK and Francis Crick Institute Partner on New Scientific Discoveries

This collaboration is said to be the first established between the Crick and a pharmaceutical company.
/ read more /


More Bio/Pharma News


Regulatory News

ICH Moves Genotoxic Impurities Guideline to Consultation

The International Conference on Harmonization has moved ICH M7(R1) Addendum to Step 3 of the ICH process.
/ read more /


EMA Clarifies HPV Vaccine Safety Profile

The European Medicines Agency reviews the safety of human papillomavirus vaccines.
/ read more /


More Regulatory News

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Download Pharmaceutical Technology’s E-Book: Bioprocessing and Sterile Manufacturing.
Click here to download



FEATURED TOPICS

FORMULATION

Solving Poor Solubility to Unlock a Drug's Potential

Modern methods and modeling offer a better way to understand solubility issues and solve today’s complex formulation challenges.
/ read more /

ANALYTICS

A Risk-Based Approach to Data Integrity

Heightened regulatory scrutiny of data integrity highlights the need for comprehensive procedural reviews and strategies for managing mission-critical information.
/ read more /

DRUG DELIVERY

Beyond the Blink: Using In-Situ Gelling to Optimize Opthalmic Drug Delivery

Delivery systems that allow drugs to be administered as liquids, but to form gel within the eye, promise to improve efficacy and patient compliance.
/ read more /

INGREDIENTS

Lack of Expertise Hinders Adoption of Continuous API Synthesis

FDA, Congress, and early adopters look to speed up the use of continuous API manufacturing.
/ read more /


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Solubility Enhancement
Solutions Using Predictive Analytics & Molecular Modeling

On Demand
Learn about a novel, systematic methodology to accelerate solubilization of poorly soluble molecules and speed formulation optimization and process development. Understand how molecular modeling can be used enhance the predictability of solubilization and overcome poor bioavailability.
Learn More



Webcasts

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


Strategies to Accelerate Early Phase Clinical Trials

On Demand
Learn about adaptive clinical trials, patient recruitment strategies, and advanced biomarker analysis tools designed that can accelerate drug development and clinical testing processes.
Sponsored by: SGS

 

more webcasts

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Practical Guidance for Successful Mammalian Cell Banking and Cell Line Characterization
On Demand
Join us for this informative webinar, presented by the team at Eurofins Lancaster Laboratories, to learn about the various aspects of cell banking and cell line characterization, including GMP production master and working cell banks, GMP non-production (e.g. bioassay) master and working cell banks, R&D cell banks or banking for end of production cells.
Learn More



on pharmtech tv

PharmTech TV

Biologics Development and Manufacturing Trends Part 1

Biologics Development and Manufacturing Trends Part 2

Cell Therapies

Building Biopharmaceutical Manufacturing Processes


Events

29th Annual Symposium of The Protein Society

July 22–25, 2015 | Barcelona, Spain

10th Annual Manufacturing Execution System (MES)

August 12–13, 2015 | Philadelphia, PA

Cleaning Validation and Critical Cleaning Processes

August 18–20, 2015 | Philadelphia, PA


more events

REFERENCE BOOKS

Pharmaceutical Technology Drug Delivery Guides

A compilation of articles from Pharmaceutical Technology in a three-handbook set covering 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.
/ Learn more /


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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