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PharmTech Europe

29 September 2015

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Top Stories

Shire’s Once-Daily ADHD Tablets Approved in Europe

Intuniv (guanfacine hydrochloride prolonged-release tablets) is the first selective alpha-2A adrenergic receptor agonist licensed for the treatment of attention deficit hyperactivity disorder in Europe.
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NIH Awards Grants for Genomics Research

Six grants from the NIH will help identify variants in the genome’s regulatory regions that affect disease risk, using new computational approaches.
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Import Testing of Pharmaceutical Products Has Limited Safety Benefits and Can Add Risk to Patients

Findings from a study on import testing suggest that import testing does not add significant benefits to the quality or safety of drugs, provided that the products are uninterruptedly controlled according to globally harmonized manufacturing and distribution standards.
/ read more /


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FOCUS ON APIs

Lessons Learned from FDA Inspections of Foreign API Facilities

A study of recent inspection observations allows for baseline trending and continuous improvement.
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Collaborating on GMP Inspections

EU and US regulators are striving to work together on improving GMP inspection efficiencies and avoiding duplication of efforts.
/ read more /


MORE ON APIs

FOCUS ON EXCIPIENTS

Certifying Excipient cGMPs

As EU supplier risk assessment deadlines approach, a number of voluntary third-party auditing and certification options are available.
/ read more /


Excipient Selection for Protein Stabilization

The complex task of stabilizing proteins is made more challenging due to the limited number of approved excipients.
/ read more /


More on Excipients

NEWS AND TRENDS

EMA CHMP Chair Re-elected

Tomas Salmonson is re-elected as Chair of the Committee for Medicinal Products for Human Use.
/ read more /


 

FDA Promotes Its Scientific Mission

A sound scientific framework is needed to ensure that biosimilars coming to market are safe and of high quality.
/ read more /


More News
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FEATURED TOPICS

BIO/PHARMA NEWS

Novo to Build Prefilled Insulin Pen Facility in Iran

Novo Nordisk has invested approximately 70 million Euros in the construction of the manufacturing plant in Iran.
/ read more /

INDUSTRY NEWS

Indian Pharma Sees Surge in M&As

Exports and domestic market have each been valued at more than US$15 billion.
/ read more /

MANUFACTURING

IMA Active Unveils New Tablet Press Machine

The new tablet press machine, Prexima, is designed to deliver higher productivity and efficiency.
/ read more /

QUALITY

Quality by Design in Solid-Dosage Manufacturing

Despite some industry reluctance, QbD is improving the safety of solid-dosage drug products and the manufacturing processes.
/ read more /

FORMULATION

A Matter of Taste

Industry experts share insights about the various approaches used in taste masking and the challenges involved.
/ read more /

OUTSOURCING

CMOs Concerned With Cost of Single-Use Equipment

Suppliers indicate prices for single-use equipment are likely to increase.
/ read more /


Event Profile

Pharma EXPO

Winning Solutions for the Entire Pharmaceutical Lifecycle
Pharma EXPO brings together solutions designed to give pharmaceutical, biopharmaceutical, medical device and nutraceutical companies like yours a competitive edge. Plus, the co-location with PACK EXPO Las Vegas provides the opportunity to explore processing and packaging ideas from all other industries.
/ Register now at pharmaexpo.com /


Webcasts

Addressing Formulation Needs With a Different Technology: Say “Hello” to Ion Exchange Resins

On Demand

Ion exchange resins have long been in the formulator’s toolkit, but only recently have they been used as excipients. Learn the value and benefits ion exchange resins bring to drug formulation challenges such as taste masking, abuse deterrence, controlled release, and more.
Sponsored by Dow


Innovative Tools for the Development and Manufacturing of Biotherapeutic Proteins

On Demand
The biopharmaceutical industry has seen ever increasing innovation over the past five years. Most notably, there has been an increase adoption of high-throughput process development (HTPD) and single-use technologies. Join our webinar to learn effective strategies to match product quality attributes for a biosimilar product and reduce process development timelines.
Sponsored by Patheon


more webcasts

on pharmtech tv

PharmTech TV

The Future of Dosage Forms

Addressing Drug Quality: Aging Facilities

Building Biopharmaceutical Manufacturing Processes

Collaborative Success Strategies for Biopharm Companies

Events

BIOTECHNICA 2015

October 6–8, 2015 | Hannover, Germany

CPhI Worldwide

October 13–15, 2015 | Madrid, Spain

AAPS Annual Meeting

October 25–29 | Orlando, FL, USA


more events

REFERENCE LIBRARY

Pharmaceutical Technology Solid Dosage Combo

Increase your knowledge of solid dosage technology and solid dose tablet manufacturing processes. These comprehensive pharmacology reference guides cover a variety of solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Drug delivery system manufacturing professionals can use the solid dosage manufacturing books to stay current with compressed tablet manufacturing processes, solid dosage processing equipment, tablet-pressing processes, and pharmaceutical industry trends in oral solid dosage manufacturing and solid dosage form development.
/ Click here /


More Reference Library

eBOOKS

Solid Dosage and Excipients 2015 eBook

This eBook examines how advances in technology, equipment, excipients, analytical techniques, software, and manufacturing practices are facilitating the development, scale up, manufacturing, efficacy, and delivery of solid- and semi-solid dosage forms.

more ebooks
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