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PharmTech Europe
28 February 2017

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Top Stories

Abzena Signs Antibody Manufacturing Development Agreement with UCL

Under the agreement, Abzena will manufacture magacizumab, an antibody created using the 'Abzena inside' Composite Human Antibody technology.
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Can Bigger be Better?

The industry is becoming more consolidated, but there needs to be some strategy behind the mergers and acquisitions.
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PODCAST

Chris Procyshyn, CEO of Vanrx, sat down with Pharmaceutical Technology to discuss automation in aseptic processing.

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Industry News

Amphastar Receives Complete Response Letter for Intranasal Opioid Overdose Med

The regulatory agency rejected the medication, citing various issues related to device use.
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FDA Posts ICH Q11 Q&A Guideline

The ICH Q11 Q&A discusses the development and manufacture of drug substances and the selection and justification of starting materials.
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More Industry News

Regulatory News

Momenta Receives Warning Letter for Generic Copaxone

Momenta's fill/finish contract manufacturer, Pfizer, was cited in the letter.
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International Trade Issues Threaten Global Pharma Operations

Policies limiting imports and immigration generate uncertainty for US and foreign firms.
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More Regulatory News

Bio/Pharma News

Mereo BioPharma's Brittle Bone Disease Drug Accepted for EMA's Adaptive Pathways Program

BPS-804, which is being developed for the treatment of osteogenesis imperfecta (brittle bone disease), has been granted orphan drug designation by both FDA and the European Commission.
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FDA Grants Pfizer Priority Review for Inotuzumab Ozogamicin

FDA granted inotuzumab ozogamicin priority review and accepted its BLA for filing.
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More Bio/Pharma News

Supplier News

PfizerCentreOne Expands Fill/Finish Services in Michigan

The company expanded fill/finish services at its facility in Kalamazoo, Michigan.
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Sartorius and the European Molecular Biology Laboratory Collaborate on Training

Sartorius and EMBL have entered into a corporate partnership program to foster advanced training.
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More Supplier News

FEATURED TOPICS

SUPPLY CHAIN

Collaboration Key to Meeting Excipient GMP Requirements

Drug manufacturers need to work closely with excipient suppliers to ensure supply chain safety.
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ANALYTICS

Evaluating E&L Studies for Single-Use Systems

Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
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GMPs

The GMP/GDP Inspections Landscape—Part II: Considerations and Opportunities

The authors look at challenges and considerations to continuously improve inspection efficiency.
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OUTSOURCING

Viewpoint: Challenges and Opportunities for CDMOs

The outlook for the CMO and CDMO industry may be affected by ever-changing politics.
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Product/Service Profile

Nexera XR

A true multi-talent, the Nexera XR ultra high performance liquid chromatograph has become an indispensable tool in laboratories of versatile industries, such as pharmaceuticals, biochemistry, chemistry, environmental and foods.
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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

CPhI Istanbul

Istanbul, Turkey

8–10 March 2017

Pharmaceutics & Novel Drug Delivery Systems

London, United Kingdom

13–15 March 2017

ISPE 2017 Europe Annual Conference

Barcelona, Spain

3–5 April 2017

Respiratory Drug Delivery (RDD) Europe 2017

Nice, France

25–28 April 2017


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.
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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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