Melanie Sena is community editor of Pharmaceutical Technology.

Melanie Sena

 announced the expansion of a new laboratory dedicated to container testing. The expansion will include will a 5000 ft

 laboratory for routine container testing and a Container Closure Integrity Test (CCIT) facility. The laboratory is expected to be complete by February 1, 2014.

The laboratory will contain all instruments required to meet the new USP routine testing directives expected in 2014. In addition, the CCIT laboratory will provide method development, validation, and testing services, which include helium flow, vacuum decay, electrical conductivity, laser diffraction, and residual seal force. The facility will also include onsite capping ability and a full-service package distribution laboratory. The laboratory will be under the direction of Brian Mulhall, who has over 20 years of container and package testing experience.
  
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Whitehouse Laboratories announces the development of a Container Testing Center to open in 2014.

Whitehouse Laboratories Announces Development of Container Testing Center

has decided to stop all clinical trials and cancel plans for regulatory filings for its investigational JAK2 inhibitor, fedratinib.

Following a risk-benefit analysis, including consultation with FDA, study investigators, independent expert neurologists, and neuroradiologists, Sanofi determined that the risk to patient safety outweighed the benefit that fedratinib would bring to patients.

This decision follows recent reports of cases consistent with Wernicke’s encephalopathy in patients participating in fedratinib clinical trials. FDA directed Sanofi to put all fedratinib trials on clinical hold while the company investigated these cases. Sanofi took immediate action requesting that study investigators discontinue fedratinibtreatment for patients in the trials.

Sanofi has notified investigators of all ongoing fedratinib trials, as well as health authorities, of its decision to halt the trials. 

Sanofi discontinues development for its investigational JAK2 inhibitor, fedratinib.

Sanofi Discontinues Fedratinib Development

(GSK) and Amicus Therapeutics have revised their drug-development under which Amicus has obtained global rights to develop and commercialize the investigational pharmacological chaperone migalastat HCl as a monotherapy and in combination with enzyme replacement therapy (ERT) for Fabry disease.

Under the terms of the revised agreement:
  

Amicus will have      sole rights to the global drug development, regulatory and commercial      activities for the next-generation Fabry ERT (migalastat HCl co-formulated      with ERT) as well as migalastat HCl monotherapy

GSK will be      eligible for future regulatory and commercial milestone payments, as well      as royalty payments.

GSK will further      invest $3 million in Amicus through an equity investment in a concurrent      private placement in public equity (PIPE) transaction

GSK and Amicus Therapeutics revise Fabry agreement entered into in July 2012.

GSK and Amicus Therapeutics Revise Migalastat Agreement

, a company that specializes in the development of oral controlled-release products, has signed a manufacturing and license agreement with Epic Pharm, a developer and manufacturer of generic prescription drugs. Under the terms of the agreement, Epic will have the right to manufacture, market, and sell 12 generic drug products owned by Elite in the United States and Puerto Rico. Of the 12 products, Epic will have the exclusive right to market six products and the nonexclusive right to market six additional products. Epic is also responsible for all regulatory and pharmacovigilance matters related to the products and for all costs related to the site transfer for all products. Elite will receive a license fee and milestone payments. The term of the license agreement is five years and may be extended for an additional five years upon mutual agreement.

Elite Pharmaceuticals signs a manufacturing and license agreement with Epic Pharma for 12 generic drug products.

Elite Pharmaceuticals Signs License Agreement With Epic Pharma

 a speciality pharmaceutical company providing topical and transdermal formulation development services, has opened a new £.5 million ($680 thousand) GMP facility in Guildford, United Kingdom.

The investment adds a microbiology laboratory, cleanroom suites, an ICH stability testing area, and quality-control and performance-testing laboratories to support Phase I and II clinical manufacture. The facility also allows for the manufacture of highly potent compounds up to OEB level 4 with a manufacturing batch scale of up to 50 kg and primary packaging, labeling, and randomization services.

MedPharm opens a new topical and transdermal formulation-development services facility in Guildford, United Kingdom.

MedPharm Opens New Facility in UK

Penn Pharma, a provider of integrated drug-development, clinical-trial supply, and manufacturing services, has partnered with

 to open a new facility for the development and manufacture of oncology drugs. The company invested for £14 million ($19 million), built a high-containment manufacturing plant for the production of multiple APIs in batches of 1–120 kg. 

 site offers a geometrically scalable dispensing, granulation, and blending process from powder to capsules. Highly contained equipment trains were designed to minimize the need for personal protective equipment and reduce the use of isolators to a minimum.

Penn Pharma partners with GEA Pharma to open a new facility for the development and manufacture of oncology drugs.