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PharmTech Europe
07 January 2020

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As 2020 begins, marking the start of a new year and a new decade, the editors of Pharmaceutical Technology Europe have reviewed the stories that have been featured in print and online over the past 12 months and compiled a list of the top 20 that have proved most popular. Listed in this newsletter are the top 10 news stories and the top 10 feature stories from 2019.


TOP 10 NEWS STORIES

CPhI Worldwide 2020 Will Return to Milan, Italy

CPhI Worldwide organizers have revealed that the 2020 edition of the pharma event will return to the Fiera Milano venue in Milan, Italy.
/ read more /


EMA Implements the Next Phase in its Relocation Plan

The European Medicines Agency has announced that its physical relocation to Amsterdam will be complete in March 2019.
/ read more /


US and Europe Reach Mutual Recognition Agreement Goal on Inspections

Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented.
/ read more /


Novartis Appoints New Sandoz CEO

On April 24, 2019, Novartis announced the appointment of Richard Saynor as CEO of Sandoz effective no later than Aug. 1, 2019.
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Thermo Fisher Scientific to Acquire Brammer Bio

A $1.7-billion acquisition of CDMO Brammer Bio establishes Thermo Fisher Scientific in viral vector manufacturing.
/ read more /


Catalent to Acquire Paragon Bioservices for $1.2 Billion

Catalent’s acquisition of Paragon Bioservices will provide expertise in expanding gene therapy market.
/ read more /


Danaher to Acquire GE’s Biopharma Business

The $21.4-billion acquisition will create stand-alone business within Danaher’s life-sciences portfolio.
/ read more /


Bristol-Myers Squibb to Acquire Celgene in $74-Billion Deal

Merger cites combined strengths in oncology, immunology and inflammation, and cardiovascular disease.
/ read more /


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FDA Expands Scope of API Impurity Investigation

While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.
/ read more /


Hospira Facility in India Receives Warning Letter

FDA sent a warning letter to Hospira Healthcare India Pvt. Ltd. for CGMP violations including data integrity issues.
/ read more /

TOP 10 FEATURE STORIES

Key Considerations in Stability Testing

Harmonization of best practices and regulatory requirements will enable developers to find the best stability testing approach.
/ read more /


Smarter Packaging Comes to the Pharma Market

Active and intelligent packaging technologies benefit brand owners, caregivers, and patients.
/ read more /


Putting Endotoxins to the Test

This article discusses current methods of endotoxin testing, its importance to the industry, sustainability issues relating to the process, and best practices.
/ read more /


Real-Time Measurement of Coating Film Thickness

Optical coherence tomography can improve quality control and development of coated dosage forms by allowing film thickness to be measured in real time.
/ read more /


Embracing the Digital Factory for Bio/Pharma Manufacturing

New technologies in the digital factory enhance quality, efficiency, and flexibility for bio/pharmaceutical manufacturing.
/ read more /


Avoiding Excipient Variability

Knowing the source and understanding the impact on CQAs is crucial to optimum drug formulation and processing.
/ read more /


Patient Centric Drug Development Comes of Age

Easier access to information, targeting smaller patient populations, and increased regulatory focus on patient outcomes are driving patient centric drug development.
/ read more /


Considering Protein and Peptide Delivery

New approaches seek to address formulation and delivery challenges for these complex molecules.
/ read more /


Container Closure Integrity Testing of Finished Sterile Injectable Product

As regulatory guidance has evolved, changes in CCIT testing have also become apparent. In this article, possible CCIT strategy approaches are outlined.
/ read more /


The Solubility Conundrum

Early adoption of the right approach to address solubility can deliver significant benefits.
/ read more /


PRODUCT PROFILE

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Events

SMi Group’s 12th Annual Conference and Exhibition: Pre-Filled Syringes and Injectable Drug Devices 2020

London, UK

15–16 January 2020

SMi’s 9th Annual Pharmaceutical Microbiology Conference

London, UK

20–21 January 2020

Pharmapack

Paris, France

5–6 February 2020


more events

eBOOKS

Regulatory Sourcebook and Reference, September 2019

Pharmaceutical Technology’s Regulatory Sourcebook and Reference highlights regulatory trends and enforcement actions, risk-based studies for analytical procedure validation, and generic drug applications, as well as a detailed analysis of pharmacopoeia requirements, challenges with compliance.

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