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Headlines > March 2017

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update - US FDA declines to comment on potential investigation

EMA says CRO monitoring activity not location based

30-Mar-2017 - The EMA has stressed its monitoring of CROs is location independent after raising concerns about third Indian contractor in two years.

People on the move

Outsourcing-Pharma’s Hiring and Firing Roundup March ‘17

29-Mar-2017 - Outsourcing-Pharma.com presents this month’s roundup of who is moving where in the contract research and manufacturing industry. 

Feature

Meeting the drug pricing debate at the clinical trial site level

29-Mar-2017 - The inability to identify the best clinical trial sites is a big problem – and one of the major challenges negatively affecting drug pricing and sponsors, says CEO.

WuXi's LabNetwork integrates with Reaxys chemistry database

29-Mar-2017 - WuXi AppTec’s LabNetwork is collaborating with Reaxys in order to simplify customer’s purchasing decisions and expand exposure to the WuXi eCommerce platform.

Butterworth Labs aims for 60% capacity increase by 2020

29-Mar-2017 - Butterworth Laboratories Ltd has secured an additional facility in Hampton, Middlesex as it aims to increase capacity by 60% over the next three years.

Bracket: PE investment to support growth, innovation

29-Mar-2017 - The private equity firm, Genstar capital, has acquired the clinical trial technology and specialty services provider, Bracket.

Pfizer CentreOne: service expansions one step in fulfilling pledge to grow capabilities

28-Mar-2017 - Pfizer CentreOne has recently expanded its fill-finish and highly potent solid oral dose service offerings at two of its contract manufacturing facilities as it aims to fulfill a promise to grow its...

INC Research supporting LLS master trial with Medidata

28-Mar-2017 - INC Research and Medidata are among those supporting the Leukemia & Lymphoma Society’s (LLS) novel, multi-arm clinical trial for acute myeloid leukemia (AML).

Single IRB model will 'dramatically accelerate' treatment delivery, says NIH

28-Mar-2017 - The National Institutes of Health (NIH) has reached a milestone in its goal of accelerating multisite clinical studies through a single institutional review board (IRB) model.

EMA looks to suspend 331 drugs due to ‘misrepresentation of study data’ at Indian CRO

27-Mar-2017 - Sandoz and Aurobindo are among drugmakers which will need to provide alternative bioequivalence data after the EMA recommended suspension of medicines tested by Micro Therapeutic Research Labs.

Avista completes $4m facility expansion at former Microtest Labs

27-Mar-2017 - The expanded facility features an additional 4,200 square feet of space to enhance its microbiology, sterility testing, and microbial ID service offerings.

PCI ups cryogenic storage capacity at Rockford site by 400%

27-Mar-2017 - PCI Clinical Services (PCI) has announced a second 400% increase in cryogenic storage capabilities as it looks to support “considerable growth.”

Icertis: clinical trial agreement solution reduces contract timelines

27-Mar-2017 - Icertis had upgraded its Clinical Trial Agreement and Budgeting solution – which the company says can reduce contract cycle times by up to 80%.

Caladrius: 'Hitachi will unlock full potential of cell therapy CDMO PCT'

24-Mar-2017 - Hitachi Chemical Co. America will increase its presence in the cell therapy development and manufacturing space through the $75m acquisition of Caladrius Biosciences subsidiary PCT.

update

PPD launches CRA apprenticeship program

23-Mar-2017 - PPD is offering "on-the-job" training through a new, competency-based clinical research associate (CRA) apprenticeship program.

Axim taps CRO for cannabinoid product development and clinical trials

23-Mar-2017 - Axim Biotech has contracted an ophthalmology CRO to support upcoming product development and clinical trials for its cannabinoid-based therapeutics.

Divi's Labs' Vizag plant banned from shipping to US

23-Mar-2017 - Indian API firm Divi’s Laboratories has been banned from shipping drug ingredients made at its Vizag plant to the US.

update with comment from FDA

US FDA criticizes Indian drug firm USV for problems at multiple sites

22-Mar-2017 - The US FDA has called on Indian drug firm USV Private Limited to rethink how its tests for microbial contamination at its manufacturing facilities.

Marken obtains two operating licenses in Argentina

22-Mar-2017 - Marken has secured two new operating licenses in Argentina, allowing it to provide a full range of logistics services to the country’s clinical trial market.

DCAT WEEK '17

Alcami launches new customer portal and mobile app

22-Mar-2017 - Alcami has launched a new customer portal and mobile application as part of its strategy to further diversify the company.

DCAT WEEK '17

CDMOs outline new initiatives, investments at DCAT Week

21-Mar-2017 - Manufacturers are investing in capacity and technology to help close the “market gap” for services while expanding to new locations across the globe.

DCAT WEEK '17

DCAT 17: Outsourcing-Pharma goes to New York

21-Mar-2017 - Didn't make it to New York, New York? Outsourcing-Pharma did and we bring you the best of Twitter from this CDMO-heavy event:

Envigo adding non-animal tech ahead of new regulations

20-Mar-2017 - Envigo is developing new In vitro tests in advance of the Comprehensive In Vitro Proarrhythmia Assay (CiPA) recommendations expected at the end of the year.

7 DHL stations to receive IATA CEIV pharma certifications in 2017

20-Mar-2017 - DHL Global Forwarding plans to certify seven US stations in the Americas throughout 2017 with the remaining global stations slated for certification by the end of the second quarter.

CROs form strategic alliance to provide end-to-end services

20-Mar-2017 - The strategic alliance between Metrion and Concept will provide clients with a fully integrated ion channel drug discovery service.

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