PharmTech Europe, Weekly Alert
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PharmTech Europe
27 March 2018

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Top Stories

Merck & Co., Eisai in Oncology Pact Worth Up to $5.76 Billion

The companies intend to jointly develop and commercialize Lenvima (lenvatinib mesylate) as a monotherapy and an in-combination therapy for treating multiple cancer types.
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ISPE Announces Facility of the Year Awards Category Winners

ISPE announced BioMarin Pharmaceutical, Shire, Vetter, and Wyeth Pharmaceuticals as FOYA Category winners.
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Industry News

EMA Releases Relocation Tracking Tool

EMA has published a new tool that gives a transparent overview of the agency’s relocation to Amsterdam.
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Emerson Partners with NIBRT to Train Future Biopharma Workforce

Emerson will provide NIBRT with technologies to help the institute prepare students for the transition to manufacturing digitization in the biopharmaceutical industry.
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Regulatory News

FDA Program Promises More Transparency in NDA Approvals

The agency’s Clinical Data Summary Pilot program will post redacted Clinical Study Reports in order to help stakeholders understand why FDA approved a new drug application.
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FDA Strengthens Postmarketing Safety Reporting Requirements for Combination Products

The agency published two new guidance documents detailing postmarketing safety reporting requirements for combination products.
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Bio/Pharma News

AbbVie, IMF to Partner on Cancer Research

AbbVie and the International Myeloma Foundation will partner to study the role of a genetic mutation in outcomes of patients with multiple myeloma.
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Biogen to Acquire Asset for Schizophrenia Treatment from Pfizer

Biogen will acquire an AMPA receptor potentiator for cognitive impairment associated with schizophrenia in a deal worth approximately $590 million.
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More Bio/Pharma News

Supplier News

Sartorius Supports ABL Europe in Viral Vector GMP Capacity Expansion

Sartorius has delivered a GMP viral vector manufacturing package solution that includes single-use bioreactors and an automation platform for normal flow filtration, tangential filtration, and mixing.
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Hovione Reports on Recent Capacity Expansion and Future Plans

Hovione plans to continue to expand its sites in Portugal and Ireland for chemical synthesis, spray drying, and laboratory analysis.
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FEATURED TOPICS

SUPPLY CHAIN

Poseidon Takes on the Pharma Supply Chain

Lower costs, fewer opportunities for temperature excursions, and a smaller carbon footprint are making ocean transport more attractive for pharmaceuticals. Poseidon, a new collaborative pharma initiative, seeks to leverage benefits.
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OUTSOURCING

Accelerating Early Drug Development with Translational Pharmaceutics

Mark Egerton, PhD, chief executive officer of Quotient Sciences, shares insights on a new approach to accelerate drug development, which integrates formulation development, real-time adaptive GMP manufacturing, and clinical research within a single platform.
/ read more /

FORMULATION

Removing the Bitter Taste from Drug Development

Integration of formulation development, real-time adaptive GMP manufacturing, and clinical testing using a consumer preference panel can save time and cost in performing taste-masking assessments.
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APIS AND EXCIPIENTS

A New Method for Risk Assessment of Pharmaceutical Excipients

This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.
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Product Profiles

Eurofins BioPharma Product Testing

Comprehensive GMP Laboratory Testing Services
From Starting Materials through Finished Product Testing, Eurofins BioPharma Product Testing’s 28 facilities in 16 countries deliver the most comprehensive scope of harmonized GMP testing services and seamless regulatory acceptance.
/ Read more/


LIVE WEBCASTS

Best Practices for Spray-Dried Dispersion Formulation Selection and Early Development
Live Webcast: Wednesday, March 28 at 11:00 EST
Register now


Dose Design: Bridging Early- and Late-Phase Development
Live Webcast: Tuesday, April 24 at 11:00am EDT
Register now


ON DEMAND WEBCASTS

Successfully Progressing Therapeutic Candidates from Discovery to Development Using Early Developability Assessment Tools
On Demand
Learn more


Real-Time Process Control for Healthy, High-Purity Water Systems
On Demand
Learn more


Events

Making Pharmaceuticals 2018

Coventry, UK

24–25 April 2018

ACHEMA 2018

Frankfurt am Main, Germany

11–15 June 2018


more events

eBOOKS

Vaccines Development and Manufacturing 2017

Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible.

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