Pharmaceutical Technology ePT Weekly
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PharmTech
May 10, 2018
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In this issue:

Key Ingredients to Healthcare's Future

FDA Moves to Overhaul New Drug Review Process

GlobalData Reports on Humira Biosimilars Uptake in EU


Top Stories

Takeda to Acquire Shire for $62 Billion

Takeda expands its global and therapy base with announced acquisition of Shire.
/ read more /


J&J's Janssen to Acquire BeneVir for $1 Billion

Johnson & Johnson's Janssen Biotech will acquire biotechnology company BeneVir Biopharm to strengthen Janssen's immunotherapy platform.
/ read more /


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Industry News

GlobalData Reports on Humira Biosimilars Uptake in EU

The data and analytics company reports on the anticipated uptake of Humira (adalimumab)‎‎ biosimilars in the EU once they are launched in 2018.
/ read more /


Pandemic Fears Stoke Calls for New Vaccines and Global Health Initiatives

Public health authorities and the biomedical research community are seeking new strategies to address global health threats.
/ read more /


More Industry News
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Supplier News

Avid Bioservices Expands Process-Development Capabilities

The company has begun expansion efforts for its process-development capabilities and laboratory infrastructure.
/ read more /


Haselmeier, Common Sensing to Partner on Injectable Solutions

The companies will partner to develop smart connected monitoring and support solutions for injectable drugs.
/ read more /


More Supplier News

Bio/Pharma News

Merck, Moderna Expand mRNA Cancer Vaccines Partnership

The companies expanded their partnership to develop and commercialize messenger RNA (mRNA) cancer vaccines to include shared-antigen mRNA cancer vaccines such as mRNA-5671.
/ read more /


Novartis' Sandoz Receives CRL for Biosimilar to Roche's Rituximab

The company received a complete response letter from FDA in response to the biologics license application for a proposed rituximab biosimilar.
/ read more /


More Bio/Pharma News

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Regulatory News

Time to GAIN: Are Your FDA Marketing Exclusivities Eligible for Extension?

Pharmaceutical companies should consider what is required for QIDP designation and whether they can use it to extend the protection afforded to their innovative products.
/ read more /

 

FDA Moves to Overhaul New Drug Review Process

Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.
/ read more /


More Regulatory News

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2018 PDA Container Closure Performance and Integrity Conference
At the 2018 PDA Container Closure Performance and Integrity Conference, June 13-14, 2018 in Bethesda, MD, industry and regulatory experts will address how new packaging design features improve drug delivery system performance and usability while assuring adequate containment and protection for sterile products across the product lifecycle. Learn more and register today!


FEATURED TOPICS

DRUG DEVELOPMENT

Key Ingredients to Healthcare's Future

A skilled workforce is needed to deliver on technology's promising medical advances.
/ read more /

OUTSOURCING

How to Get the Most from Regulatory Outsourcing

Regulatory outsourcing can result in improved compliance, greater transparency, higher productivity, increased cost-effectiveness, and desired strategic outcomes.
/ read more /


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Eurofins Lancaster Laboratories PSS Insourcing Solutions (PSS) is a global, award-winning managed service provider that employs and manages full-time employees to perform a defined scope of work at your facility. Our project-based insourcing solutions are specifically designed to give you laboratory services support with flexible timeframes and no worries about co-employment and other regulatory concerns, at lower costs than fixed headcounts. Learn more about PSS


ANALYTICS

Singlet Determination Revisited

Is there a difference between a specification and a standard?
/ read more /

EXCIPIENTS

A Multifunctional Mineral Excipient

Functionalized calcium carbonate provides high porosity, which enables fast disintegration, and excellent compactibility that results in harder tablets at low compression forces.
/ read more /


UPCOMING WEBCAST

The Pharma Supply Chain Revolution
Thursday, May 24, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register now


ON DEMAND WEBCASTS

Improve Data Transparency and Collaboration Across your Manufacturing Network
On Demand
Learn more


Dose Design: Bridging Early- and Late-Phase Development
On Demand
Learn more


Streamlined Manufacture of Modified Release Matrix Tablets via Direct Compression
On Demand
Learn more

Events

Pharmacopoeia Conference

May 29–30, 2018

BIO International Convention

June 4–7, 2018

American Biomanufacturing Summit 2018

June 14–15, 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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