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PharmTech Europe
14 February 2017

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Top Stories

A New Location for EMA?

Pharmaceutical Technology spoke with Tommy Fanning, head of biopharmaceuticals for IDA Ireland, to get a perspective on how Brexit may affect the pharmaceutical industry.
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Moving Forward with Adaptive Licensing

Early-access schemes aim to make medicines available to patients faster but the regulatory framework remains unclear especially for biologics that involve complex manufacturing.
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Pfizer Reacts to Trump's Comments and Discusses Pipeline in Its Q4 Earnings Call

A change in the tax code could help the company create more jobs in the United States, while fewer FDA regulations could help reduce drug prices, according to Pfizer CEO Ian Read.
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PODCAST

Chris Procyshyn, CEO of Vanrx, sat down with Pharmaceutical Technology to discuss automation in aseptic processing.

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Industry News

ISPE Announces 2017 Facility of the Year Award Winners

The International Society for Pharmaceutical Engineering (ISPE) and its Facility of the Year Awards program announced its 2017 category award winners.
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Austrian Centre of Industrial Biotechnology and GE Healthcare Form Cell Line Engineering Pact

This three-year partnership will explore and identify new tools and methods to modify and optimize the Chinese hamster ovary (CHO) cell line performance.
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More Industry News

Regulatory News

FDA Issues Warning Letter to Facta Farmaceutici S.p.A.

The warning letter cited GMP violations for finished drug products.
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Inadequate Cleaning Validation Cited in FDA Warning Letter

FDA's Warning Letter to an Indian API manufacturer alleges cGMP violations and improper cleaning and validation.
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More Regulatory News

Bio/Pharma News

Nemaura Pharma Receives Funding to Develop Biologic Micropatch System

The investment will be used to advance Nemaura’s R&D programs, which include liquid vaccines that have been reformulated for administration through the skin using its micropatch drug delivery technology.
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Amgen's PCSK9 mAb Shown to Protect Against Heart Attack and Stroke

According to results from the FOURIER trial, Repatha significantly reduced the risk of cardiovascular events and death in patients with atherosclerotic cardiovascular disease.
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More Bio/Pharma News

Supplier News

Capsugel Announces Commercial Availability of Modular Automated Sampling Technology

Modular Automated Sampling Technology (MAST) allows direct aseptic transfer of bioreactor samples to analytical devices, providing rapid and reliable data in bioprocessing.
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Dr. Reddy's Expands European Operations

Dr. Reddy’s has expanded its commercial operations in Europe with the introduction of its range of generic drugs in France.
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More Supplier News

FEATURED TOPICS

STANDARDS & REGULATIONS

Staffing and Preparation for Audits

Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to handle audits and inspections during business expansion.
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PACKAGING

Blister Packaging Moves Forward

Advances in materials and equipment for pharmaceutical blister packaging protect quality and enhance shelf life.
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VIEWPOINTS

Beyond Distractions, Pharma Moves On

Translating campaign promises to predictions for bio/pharma is difficult, but optimism prevails.
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FILL/FINISH

Taking a Closer Look at Parenteral Contaminants

Visual inspection of parenteral vials is the first step in a root cause investigation.
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Product/Service Profile

MEGGLE Excipients & Technology

MEGGLE – Our Heart beats for Lactose
MEGGLE Excipients & Technology is a global leader in manufacturing lactose for the pharmaceutical industry. Supporting supply chain security with manufacturing facilities in Europe and North America, MEGGLE offers a broad product portfolio of lactose excipients, co-processed technologies and excipient contract manufacturing.
/ Read more /

Shimadzu

Changes Everything – LCMS-8060 triple quadrupole mass spectrometer expands UFMS family
Shimadzu's LCMS-8060 is designed to push the limits of LC/MS/MS quantitation for applications requiring the highest sensitivity and robustness while delivering a meaningful solution for routine LC/MS/MS analyses.
/ Read more/


UPCOMING WEBCAST

Around the World in Clinical Trials: New Regulations and Country Specific Challenges
Live Webinar: Tuesday, February 28 at 11:00am EST
Register now


Events

Sartorius Research Xchange Forum 2017

22–23 February, 2017

CPhI Istanbul

8–10 March, 2017

Pharmaceutics & Novel Drug Delivery Systems

13–15 March, 2017


more events

Reference Library

Pharmaceutical Technology presents its Analytical Testing Resource Guide combo

A compilation of articles in a three-handbook set covering general Analytical Testing and Stability in the manufacture, packaging, storing, and testing of formulated products.
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More Reference BookS

eBOOKS

Quality Throughout the Supply Chain

Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain.

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