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PharmTech Europe
7 February 2017

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Top Stories

Does Pharma Really Want to Overhaul FDA?

In promising to expedite and simplify the FDA approval process, President Donald Trump fails to take account of industry's appreciation of an efficient, rigorous FDA regulatory system.
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Novo Nordisk Collaborates with University of Oxford

Novo Nordisk entered a research collaboration with the University of Oxford focused on Type 2 diabetes.
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PODCAST

Jonathan Knight, vice-president of New Product Development at Cambrex Corp., discusses the environmentally friendly, economical process route that won CPhI's 2016 award for innovation in APIs and intermediates.

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Industry News

Pharmapack Europe Announces 2017 Award Winners

Companies were recognized for their innovative packaging technologies.
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FDA Issues Warning Letter to Facta Farmaceutici S.p.A.

The warning letter cited GMP violations for finished drug products.
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More Industry News

Regulatory News

EMA Recommends Approval of Two Biosimilars

The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.
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President Trump Meets with Pharma Manufacturers

Trump met with pharma manufacturers and makes a statement focused on domestic manufacturing, FDA approvals, and drug pricing.
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More Regulatory News

Bio/Pharma News

Pharma Companies Join Drug Safety Research Project

The £14-million research project aims to better understand adverse drug reactions through a variety of modeling approaches.
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Novartis Expands Antibiotic Capacity in Slovenia

Lek, a Sandoz company, adds capacity to its plant in Prevalje, Slovenia.
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More Bio/Pharma News

Supplier News

Almac Expands in Ireland

The company announced an investment in a new facility in Dundalk, County Louth, Ireland.
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Vetter Starts Operations in Its Center for Visual Inspection and Logistics

Vetter expanded visual inspection facilities and controlled-temperature storage at its Ravensburg Vetter West facility in Germany.
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More Supplier News

FEATURED TOPICS

QUALITY

Defining Quality: Joining the Quality Lab and the Plant Floor

As pharmaceutical quality metrics evolve, they will need to incorporate more of the principles of operational excellence, says consultant Prabir Basu.
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PACKAGING

Predicting Moisture Uptake in Solid Dosage Packaging

Moisture uptake during the end-to-end manufacturing process and supply chain can affect product quality. Simulation tools based on mechanistic models help define storage and handling requirements for oral solid-dosage drugs.
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ANALYTICS

Characterization and Impurity Analysis of Oligonucleotide Therapeutics

Analytical technologies play a key role in the characterization and quantitation of oligonucleotide therapeutics.
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DRUG DEVELOPMENT

Using Microcalorimetry to Accelerate Drug Development

Isothermal titration calorimetry and differential scanning calorimetry are valuable tools that can help accelerate drug development.
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Product/Service Profile

Rommelag AG

Bottelpack aseptic processing
Bottelpack machines allow primary packaging for a wide variety of formulations including inhalation solutions, ophthalmics and parenterals.
/ Read more/


Event Profile/Listing

BIO-Europe Spring® 2017 — 11th International Partnering Conference

Date: March 20–22, 2017
Venue: CCIB Convention Centre, Barcelona
Where the global biotech industry comes to partner
The eleventh annual BIO-Europe Spring® conference is the premier springtime partnering conference for the biotechnology industry. For its 2017 edition, BIO-Europe Spring comes to Barcelona, Spain on March 20–22, 2017.
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UPCOMING WEBCAST

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


Events

Sartorius Research Xchange Forum 2017

22–23 February, 2017

CPhI Istanbul

8–10 March, 2017

Pharmaceutics & Novel Drug Delivery Systems

13–15 March, 2017


more events

Reference Library

Pharmaceutical Technology presents its Process Analytical Technology resource guide combo

A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.
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More Reference BookS

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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