PharmTech Europe, Weekly Alert
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PharmTech Europe
14 November 2017

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Top Stories

Europe Leads the Way in Continuous Manufacturing

The shift toward continuous manufacturing among European pharmaceutical manufacturers has not been accompanied by a similar strong increase in the use of automation and sensor-based on-line monitoring.
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Gottlieb Sends Message About REMS and Market Competition

FDA is exploring ways to keep branded drug companies from using REMS to block the development of generic drugs.
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PharmTech 2017 Employment Trends

The editors of Pharmaceutical Technology Europe invite you to participate in the annual employment survey for individuals involved in bio/pharmaceutical development, formulation, or manufacturing.

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Industry News

Biosimilars Raise Analytical and Policy Challenges

The debate continues over biosimilar naming, interchangeability, and patent protection, as well as lingering concerns in the medical community about the safety of switching patients to new therapies.
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Human Vaccines Project Creates Research Program to Develop Universal Influenza Vaccines

The Human Vaccines Project has created the Universal Influenza Vaccine Initiative, a research program that will aim to understand the human immune system's role in the development of universal influenza vaccines.
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Regulatory News

Fresenius Kabi Recalls Midazolam Injection, USP, 2 mg/2 mL

The voluntary recall is due to blister packages containing the incorrect product.
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FDA Warns Companies Claiming Marijuana Products Cure Cancer

FDA sent warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these statements.
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More Regulatory News

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Bio/Pharma News

Catalent and Grid Therapeutics Form Immuno-Oncology Pact

The companies will collaborate to develop and manufacture Grid's lead therapeutic candidate for the treatment of solid tumors.
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FDA Grants Breakthrough Therapy Designation to GSK's Multiple Myeloma Treatment

The agency gave Breakthrough Therapy Designation to GSK's GSK2857916 monotherapy for the treatment of patients with multiple myeloma who have failed at least three prior lines of therapy.
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More Bio/Pharma News

Supplier News

Vetter Expands in Asia-Pacific

The company has officially opened a local branch office in South Korean to support its existing business in the region.
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Celonic Acquires Glycotope's Biomanufacturing Facility

CDMO Celonic acquired a biomanufacturing facility in Heidelberg, Germany from Glycotope.
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More Supplier News

FEATURED TOPICS

FORMULATION

ODTs Dissolve Drug Administration Challenges

Ralph Gosden, head of product development at Catalent's Swindon, United Kingdom site, explains the opportunities of orally disintegrating tablets as a patient-centric dosage form.
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GMPs

Establishing an Effective Data Governance System

Data governance is necessary for compliance with current regulatory expectations for data integrity in pharmaceutical R&D and manufacturing organizations.
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QUALITY

Using QbD in Topical Drug Manufacturing

Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.
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STANDARDS & REGULATIONS

Making Decisions Based on Risk

Focusing on whether the product meets its defined quality attributes should help one make reasonable, documentable, and defendable risk-based decisions.
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Product Profile

Catalent

Innovative clinical supply solutions
In today’s challenging environment, every clinical study is different and changes can occur during project development which require unique, responsive solutions. Catalent offers flexible services designed to keep studies moving.
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Event Profile

Pharmapack Europe

Date: 7 & 8 February 2018
Venue: Paris Expo, Porte de Versailles, Paris
The event to showcase evolution and revolution in packaging and drug delivery
Pharmapack Europe is an essential event for industry insights and the latest industry innovations that are reimagining the capabilities of pharmaceutical packaging and drug delivery. Join 411 exhibitors and more than 5,290 attendees on 7 & 8 February at Paris Expo, Porte de Versailles!
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ON DEMAND WEBCAST

Excipient Selection to Enable the Performance of Skin Delivery Dosage Forms
On Demand
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Challenges in the Development of Complex Small-Molecule Drugs
On Demand
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Accelerating Method Transfer: Effective Automation of Biological Assays
On Demand
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Beyond the Buy: The Critical Role of Data, Relationships, and Experience in Comparator Sourcing Success
On Demand
Learn more


Events

Pharmapack Europe

Paris, France

7–8 February 2018


more events

eBOOKS

Biologics and Sterile Manufacturing

New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics.

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