November 6 / 2014
ISSUE #

| FOCUS |

Understanding and Modeling Product and Process Variation

Variation understanding and modeling is a core component
of modern drug development. {read more}

| FEATURED CONTENT |

Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability

The European Union is strengthening its pioneering role in the regulation of biosimilars by further developing the basic rules for determining the levels of compatibility for this group of drugs. There are, however, some key issues that are not easy to resolve, as evident in a recent workshop on biosimilars organized by the European Medicines Agency (EMA).{read more}

| PEER-REVIEWED RESEARCH |

GE Acquires Cell Culture Media and Sera Assets from Thermo Fisher Scientific

GE acquires Thermo Fisher's HyClone cell culture media and sera products, gene modulation technologies, and magnetic beads businesses. {read more}

When results are critical, run it right. Every time Combining revolutionary sorbents with innovative hardware, Oasis® sample extraction products are the preeminent choice in SPE. Researchers rely on the superior technical performance to achieve unmatched purity, consistency, and quality in their sample preparation methods.

| REGULATORY WATCH |

Biogen Idec, Samsung Bioepis Target Anti-TNF Biosimilars in Europe

Biogen and Samsung Bioepis, a joint venture between Samsung Biologics and Biogen Idec, advance plans for anti-TNF biosimilar product candidates. {read more}

| OUTSOURCING OUTLOOK |

FDA Announces Voluntary Recall from Abrams Royal Compounding Pharmacy

Abrams Royal Pharmacy is recalling all unexpired lots of sterile products dispensed in the US. {read more}

| OUTSOURCING OUTLOOK |

AstraZeneca Issues Statement on Competitor to Nexium

AstraZeneca issues a statement regarding the launch of esomeprazole strontium in the United States. {read more}

The New United States Pharmacopeia (USP) Chapter 41 It's easier than you think!
On December 1, 2013, significant changes to the U.S. Pharmacopeia Chapter 41 on "Balances" went into effect. In the US, this chapter is mandatory! Its implementation is overseen by the US Food and Drug Administration (FDA).

| API SYNTHESIS & MANUFACTURING |

Pfizer, Teva Settle Patent Litigation on Viagra

Pfizer settles its litigation against Teva Pharmaceuticals regarding Pfizer's patent covering the use of Viagra. {read more}

Pall Corporation to Acquire ATMI's LifeSciences Business for $185 milliont

Pall Corporation, a solutions provider in filtration, separation and purification, has signed a definitive agreement with ATMI to acquire ATMI's LifeSciences business unit for $185 million. {read more}

Genzyme Receives Complete Response Letter from FDA on Lemtrada Application

Genzyme plans to appeal FDA's decision that the multiple-sclerosis treatment is not ready for approval. {read more}

Baxter Initiates Worldwide Voluntary Recall

Baxter International recalls dextrose injection and four sodium chloride injections. {read more}

Pfenex Awarded Anthrax Vaccine Contract

Leidos Holdings awards Pfenex a subcontract in support of the development of an anthrax vaccine. {read more}

| WEBCASTS |

Regulatory, Biosafety, and Clinical Considerations for Vaccine Development

On Demand
Sponsored by: SGS Life Science Solutions

Improving Cell Culture Productivity: Best Practices for Automation and Control

On Demand
Sponsored by: Parker Hannifin