Pharmaceutical Technology ePT Weekly
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PharmTech
December 7, 2017
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In this issue:

Binding Site Expands mAb Portfolio

Moving to Closed Systems for Aseptic Processing

FDA Approves First Biosimilar to Roche's Herceptin

Top Stories

Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity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majors are among the industry stakeholders who have commented and raised questions about FDA's recently proposed draft guidance for analytical assessment of similarity in biosimilars.
/ read more /


New Report Stresses Importance of Affordable Drugs

Experts slam drug prices and endorse government price negotiations and curbs on drug advertising.
/ read more /


PharmTech 2017 Employment Trends

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

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Overcoming Resistance and Migrating to Content Automation
Automation can help organizations in the life sciences streamline a content delivery process that may already be strained by quality controls, limited resources, or compliance issues.
Learn more


Industry News

FDA Warns of Amino Acid Shortage Due to
Hurricane Maria

In a recently released statement, FDA Commissioner Scott Gottlieb warned of an amino acids supply shortage and gave an update on a saline supply shortage, both due to the impact of hurricanes on Puerto Rican manufacturing facilities.
/ read more /


EMA Updates Brexit Guidance

The agency and the European Commission published updated guidance to answer questions about Brexit.
/ read more /


More Industry News

Supplier News

Binding Site Expands mAb Portfolio

Binding Site has introduced a number of new monoclonal antibodies targeting infectious diseases, including cytomegalovirus, hepatitis (A, B, C, and D), herpes, human immunodeficiency virus (HIV), rubella, and toxoplasma.
/ read more /


Biocad Announces New Manufacturing Site in North Africa

Avista Pharma Solutions facility and equipment upgrades at its Longmont, Colorado facility support processing of potent compounds.
/ read more /


More Supplier News
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Bio/Pharma News

Astellas Acquires Mitobridge in $450-Million Deal

The acquisition deepens Astellas' involvement in the development of a pipeline of therapeutics focused on mitochondrial function.
/ read more /


Orchard Therapeutics Opens Gene Therapy Laboratory Facility

The company has opened a new California facility that, combined with its existing site in Foster City, CA, will quadruple its laboratory footprint for gene therapy products.
/ read more /


More Bio/Pharma News

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.
/ read more /


FDA Approves First Biosimilar to Roche's Herceptin

FDA has approved Mylan's biosimilar to Roche's blockbuster anti-cancer biologic, Herceptin.
/ read more /


More Regulatory News

FEATURED TOPICS

Facilities

Designing and Operating Flexible, High-Containment Vaccine Manufacturing

A new facility type integrates next-generation mobile cleanroom systems.
/ read more /

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.
/ read more /


Vaccines

Making Vaccines Accessible

Despite the challenges and high cost of development, vaccine innovation is at an all-time high, as new approaches aim to improve global access.
/ read more /

Manufacturing

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.
/ read more /


UPCOMING WEBCASTS

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


Risk Assessment and Testing Requirements for Elemental Impurities in Pharmaceutical Products
Live Webcast: Tuesday, December 12 at 11:00am EST
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The Journey to a Successful Biologic License Application
Live Webcast: Thursday, December 7 at 12:00pm EST
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ON DEMAND WEBCASTS

Partnership of Chemical Engineers and Chemists Optimizes Process Development
On Demand
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Beyond the Buy: The Critical Role of Data, Relationships, and Experience in Comparator Sourcing Success
On Demand
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Accelerating Method Transfer: Effective Automation of Biological Assays
On Demand
Learn more


Challenges in the Development of Complex Small-Molecule Drugs
On Demand
Learn more


Events

Achieving Efficient Facilities

December 11–12, 2017

Next Frontier for Single-Use Technologies

December 12–13, 2017

Pharmapack Europe

February 7–8, 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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