PharmTech Europe, Weekly Alert
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PharmTech Europe
17 October 2017

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Top Stories

Sanofi to Expand Influenza Vaccine Production Facility

The company is investing EUR 170 million (US$201 million) to expand its vaccine manufacturing site in France for its newest influenza vaccine.
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Bavarian Nordic Secures BARDA Contract for Smallpox Vaccine

The Danish biotechnology company has been awarded a sole-source BARDA contract valued at more than $539 million for a freeze-dried smallpox vaccine.
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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

Storm Impact on Drug Supply

FDA and manufacturers strive to prevent drug shortages from Hurricane Maria.
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HHS Sponsors Development of Antibiotic-Resistant, Anti-Biowarfare Antibiotic

BARDA has entered a $12-million contract with biopharmaceutical firm Achaogen for the late-stage development of an antibiotic against resistant bacteria, and as a potential treatment for biowarfare agent.
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More Industry News
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Regulatory News

EMA Updates Guidelines on Excipients in Labeling

Europe updates the guideline on excipients information in labeling and packaging.
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FDA and EMA Announce Updates to Adverse Event Reporting Systems

Both regulatory bodies are working on enhancements to their respective adverse event reporting systems in efforts to increase transparency and safety monitoring of drugs.
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More Regulatory News

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Bio/Pharma News

J&J Invests in Biologic Manufacturing Capacity Expansion in Ireland

Johnson & Johnson’s Janssen Sciences Ireland UC will invest more than EUR 300 million to expand manufacturing capacity for biologic medicines at its Ireland facility.
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Pfizer Considers Fate of Consumer Healthcare Biz

The company is considering options for a full or partial separation of its consumer healthcare business, either through a spin-off, sale, or other transaction.
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More Bio/Pharma News

Supplier News

GE Healthcare Opens 3D-Printing Lab

GE Healthcare opened a 3D printing lab in Sweden that will speed the launch of products for bio/pharma manufacturing, such as a custom chromatography column.
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G-Con and IPS to Collaborate on Turnkey Modular Projects

The iCON brand aims to offer flexible, rapidly deployable systems for biopharmaceutical manufacturing.
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More Supplier News

FEATURED TOPICS

Formulation

Managing Potentially Potent APIs

CDMOs have established strategies for handling new chemical entities with unknown biological activity.
/ read more /

 

Process Validation

Cleaning Validation for APIs

The industry needs a single standard cleaning limit at 25 mg/m2.
/ read more /

Outsourcing

Up and Away, M&A

Mergers and acquisitions are positive for the CDMO industry, but there is a downside.
/ read more /

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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Event Profile

CPhI Worldwide 2017

Date: 24-26 October 2017
Venue: Messe Frankfurt, Germany
CPhI Worldwide, together with co-located events ICSE, InnoPack, P-MEC and FDF, hosts more than 42,000 visiting pharma professionals over three days. 2,500+ exhibitors from 153 countries gather at the event to network and take advantage of more than 150 free industry seminars. The exhibition covers every sector of the pharmaceutical market under one roof.
/ Read more/


UPCOMING WEBCASTS

Enteric Capsule Technologies to Help Fast-Track Pharmaceutical Drug Development
Live Webcast: Thursday, October 17 at 9am EDT
Register now


Excipient Selection to Enable the Performance of Skin Delivery Dosage Forms
Live Webcast: Wednesday, Oct. 18, 2017 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register now


Analytical Challenges in Extractables Studies of Plastic Single-Use Bioprocess Bags
Live Webcast: Tuesday, October 31 at 11:00am EDT
Register now


ON DEMAND WEBCAST

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


Events

CPhI Worldwide

Messe Frankfurt, Germany

24–26 October 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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