PharmTech Europe, Weekly Alert
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PharmTech Europe
12 December 2017

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Top Stories

An Innovative Excipient System for Film Coating

The low viscosity of Colorcon's Opadry QX, even at solid levels as high as 35%, reduces coating and preparation time compared to traditional hydroxypropyl methylcellulose-based coatings.
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A New Efficient Synthesis of Ospemifene

The method developed by Cambrex uses standard plant equipment and requires only two synthetic steps and one recrystallization, minimizing waste and use of solvents.
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Industry News

Disputes Over Manufacturing Waiver and Other SPC Exemptions

The European Commission's effort to relax supplementary protection certificates to help generic-drug makers and biosimilars producers has sparked strong opposition from the research-based pharmaceutical sector.
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Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA's recently proposed draft guidance for analytical assessment of similarity in biosimilars.
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Regulatory News

EMA Issues Drug Warnings and Review

During the November meeting of the agency's Pharmacovigilance Risk Assessment Committee, review of Esmya (ulipristal acetate) was announced as well as warnings about prostate cancer treatments.
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EMA Updates Brexit Guidance

The agency and the European Commission published updated guidance to answer questions about Brexit.
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Bio/Pharma News

FDA Approves First Biosimilar to Roche's Herceptin

FDA has approved Mylan's biosimilar to Roche's blockbuster anti-cancer biologic, Herceptin.
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Astellas Acquires Mitobridge in $450-Million Deal

The acquisition deepens Astellas' involvement in the development of a pipeline of therapeutics focused on mitochondrial function.
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More Bio/Pharma News

Supplier News

Lonza in Gene Therapy Licensing Agreements

Lonza has entered into strategic license agreements for exclusive rights to a gene-therapy platform for developing treatments for hearing and balance disorders.
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AMRI Expands Bulk API Aseptic Manufacturing Capacity

The contract research, development, and manufacturing organization has expanded API aseptic manufacturing capacity at its Valladolid, Spain, facility.
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FEATURED TOPICS

Formulation

Growing Demand for Taste-Masking Technologies

Taste masking increases drug acceptability and medication adherence in pediatric, geriatric, and other special patient populations.
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Facilities

Designing and Operating Flexible, High-Containment Vaccine Manufacturing

A new facility type integrates next-generation mobile cleanroom systems.
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Standards & Regulations

Managing the Cost of Non-Compliance

Creating a quality culture can prevent the costs and challenges associated with receiving a consent decree.
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Fill/Finish

Moving to Closed Systems for Aseptic Processing

Alternatives to time-consuming, error-prone operations promise to reduce vaccine manufacturing costs and improve facility flexibility.
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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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LIVE WEBCASTS

Risk Assessment and Testing Requirements for Elemental Impurities in Pharmaceutical Products
Live Webcast: Tuesday, December 12 at 11:00am EST
Register now


Considerations for Launching a Biopharm Company in 2018
Live Webcast: Monday, January 8 at 10:00am EST
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ON DEMAND WEBCAST

The Journey to a Successful Biologic License Application
On Demand
Learn more



Events

Pharmapack Europe

Paris, France

7–8 February 2018


more events

eBOOKS

Vaccines Development and Manufacturing 2017

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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