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PharmTech Europe
21 February 2017

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Top Stories

The Broad Institute Triumphs in CRISPR Patent Battle

The Patent Trial and Appeal Board ruled in favor of the Broad Institute, allowing the institution to keep patents for its CRISPR-Cas9 gene-editing technology.
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PhRMA Urges USTR to Ramp Up Patent Enforcement Activities Overseas

PhRMA submits comments to the The Office of the United States Trade Representative encouraging protection of US innovation in foreign markets.
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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

Past, Present, and Future Trends Affecting the Bio/pharmaceutical Industry

The year 2017 will present the industry with new challenges, and it is important that companies focus on the issues at hand.
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EDQM Clarifies the Role of Monographs in Determining Biosimilarity

The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.
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Regulatory News

European Commission Approves Once-Daily Tablets for Rheumatoid Arthritis

Baricitinib (Olumiant) is the first JAK inhibitor licensed to treat rheumatoid arthritis in Europe.
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Sterile Manufacturing Deviations Found at Japan Facility

FDA sent a warning letter to Sato Pharmaceutical Co., Ltd. after inspectors found deviations in the facility's aseptic processes.
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Bio/Pharma News

Seattle Genetics Strikes Deal with Immunomedics

The companies entered into a license agreement for Immunomedic's antibody-drug conjugate sacituzumab govitecan.
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GW Pharmaceuticals Announces Results from Cancer Trial

The company announced results from a Phase II trial with its THC:CBD drug for the treatment of glioblastoma multiforme.
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Supplier News

Aurobindo Adds Four Biosimilars From TL Biopharmaceutical

Aurobindo has added four cell-culture derived biosimilars to its product line.
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Symbiosis Announces Plans to Open US Office

The new commercial site, set to be located in Cambridge, Boston, MA, will serve clients on both the East and West Coast.
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FEATURED TOPICS

PEER-REVIEWED RESEARCH

Establishing Blend Uniformity Acceptance Criteria for Oral Solid-Dosage Forms

This article introduces the concepts of pooled variance and the central limit theorem, for establishing acceptance criteria for blend uniformity data of granular powder blends when a significant degree of sampling bias is involved.
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ANALYTICS

Mass Spec Sheds New Light on Biologics Drug Development

Although limitations must be overcome, mass spectrometry is having a great impact on biologic development and manufacturing.
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FORMULATION

Advancements in Extrusion-Spheronization

More agile techniques are improving the development of multiparticulate drug-delivery systems.
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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

Catalent

Dose Form Development
Catalent combines more than 80 years’ development and manufacturing expertise, bringing more customer products to market faster, overcoming bioavailability challenges, enhancing product performance, and ensuring reliable product supply.
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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
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Events

CPhI Istanbul

8–10 March, 2017

Pharmaceutics & Novel Drug Delivery Systems

13–15 March, 2017


more events

Reference Library

Pharmaceutical Technology Drug Delivery Guides

A three-volume set of drug delivery system handbooks. A compilation of articles related to 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.
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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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