Pharmaceutical Technology ePT Weekly
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PharmTech
November 9, 2017
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In this issue:

FDA Issues Aspirin Marketing Guidance

Almac Group to Acquire BioClin Laboratories

Establishing an Effective Data Governance System

Top Stories

Eli Lilly Wins 2017 Facility of the Year Award

Eli Lilly was awarded the 2017 FOYA Overall Winner for its continuous direct compression manufacturing installation projects.
/ read more /


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.
/ 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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Industry News

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.
/ read more /

 

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.
/ read more /


More Industry News
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Supplier News

Almac Group to Acquire BioClin Laboratories

Almac Group will acquire BioClin Laboratories to expand Almac’s analytical service offerings.
/ read more /

 

Celonic Acquires Glycotope’s Biomanufacturing Facility

CDMO Celonic acquired a biomanufacturing facility in Heidelberg, Germany from Glycotope.
/ read more /


More Supplier News

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At the 2018 PDA Glass Quality Conference, Jan. 23-24, review current developments and explore the future of pharmaceutical glass packaging. Hear from industry and regulatory experts as they discuss the latest research; reliable analytical test methods; pharmacopeial updates; and new process controls, glass handling practices, and inspection techniques. Learn more and register now!


Bio/Pharma News

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.
/ read more /

 

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.
/ read more /


More Bio/Pharma News

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Changing the functional role of capsules in drug delivery
By combining polymer science, engineering and formulation know-how, we are creating breakthroughs in capsule and encapsulation technologies that are changing the functional role of capsules in medical research, drug formulation and drug delivery. Capsugel provides leading-edge solutions that protect high value compounds, optimize delivery to targeted sites in the body, and ensure the best operational performance in capsule filling. To learn more, visit www.capsugel.com.


Regulatory News

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

The voluntary recall is due to blister packages containing the incorrect product.
/ read more /

 

FDA Issues Aspirin Marketing Guidance

The agency published guidance regarding OTC aspirin products that have cardiovascular-related images in their labels.
/ read more /


More Regulatory News

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Connect Upstream for Increased Titers
Increase your titers by developing your own optimized medium and feed strategy in 5 months. The CHOptimizer® media optimization tool box combines the ambr® 15 with an integrated DoE approach for efficient testing of different media mixtures and for spent media analysis.
Our media expert will guide you through this process.


FEATURED TOPICS

Quality

Preparing for the Inevitable: Key Steps for Weathering a Pharmaceutical Recall

Pharmaceutical companies should prepare for the impact of recalls to minimize risk to consumers and the company.
/ read more /

Manufacturing

Pharmaceutical Environmental Pollution and Antimicrobial Resistance

The European Commission is striving to tackle environmental pollution by pharmaceuticals as a means of curbing antimicrobial resistance.
/ read more /


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Formulation

Advances in ADCs

New ADC therapies must overcome manufacturing challenges to reach market.
/ read more /

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.
/ read more /


UPCOMING WEBCAST

Beyond the Buy: The Critical Role of Data, Relationships, and Experience in Comparator Sourcing Success
Live Webcast: Thursday, November 9 at 11:00am EST
Register now


ON DEMAND WEBCASTS

Accelerating Method Transfer: Effective Automation of Biological Assays
On Demand
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Challenges in the Development of Complex Small-Molecule Drugs
On Demand
Learn more


Analytical Challenges in Extractables Studies of Plastic Single-Use Bioprocess Bags
On Demand
Learn more


Excipient Selection to Enable the Performance of Skin Delivery Dosage Forms
On Demand
Learn more


From Candidate to Clinic: Strategies to Select, Assess, Formulate, and Deliver the Right Drug Candidate in the Early Phase
On Demand
Learn more


Events

2017 AAPS Annual Meeting and Exposition

November 12–15, 2017

4th Annual Global Compliance Congress for Life Sciences

November 15–16, 2017

ISPE UK Annual Event

November 30, 2017

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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