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Headlines > January 2017

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SCOPE SUMMIT

Outcome Health enters clinical trial space with patient recruitment solution

31-Jan-2017 - Outcome Health is looking to solve the “age-old” issue of patient recruitment in an industry that it says was “ripe for disruption.”

PEOPLE ON THE MOVE

Outsourcing-Pharma's Hiring and Firing Roundup January '17

31-Jan-2017 - Outsourcing-Pharma presents this month's round up of who is moving where in the contract research and manufacturing industry.

Parexel looks to 'bridge gap' to compassionate use studies as demand surges

31-Jan-2017 - Parexel’s expanded Managed Access Program helps biopharmaceutical companies provide compassionate access to patients as the industry faces an increasing public demand for treatment options.

SCOPE Summit

Greenphire: Exostar partnership offers 'extreme benefit' to sites

30-Jan-2017 - Greenphire is now offering Single Sign-On (SSO) through Exostar’s identity and access management platform.

Almac launches temperature management software

30-Jan-2017 - Almac Group has launched a GDP-compliant web-based platform, TempEZ, to provide customers with a single database to store temperature data from the manufacturing stage to patient administration.

PPD opening new Phase I unit in Las Vegas

30-Jan-2017 - The 24-bed clinical research unit in Las Vegas supports PPD’s Phase I and early development clinical research capabilities.

Canadian Lupus drug to enter Phase III with Worldwide Clinical Trials

30-Jan-2017 - Aurinia Pharmaceuticals Inc. will use the CRO Worldwide Clinical Trials’ services for its Phase III trial for Lupus nephritis.

German CDMO migrates 800 staff to newly opened €100m packaging site

26-Jan-2017 - Vetter will close one facility and migrate staff to the now open €100m expansion center for aseptic packaging of injectables at its headquarters in Ravensburg, Germany.

Comment

J&J buying Actelion for $30bn, but should CMOs be concerned?

26-Jan-2017 - With no production sites of its own, we question whether Johnson & Johnson’s manufacturing network is likely to incorporate Actelion’s substantial product portfolio.

SGS expands E&L testing services at New Jersey facility

26-Jan-2017 - SGS SA has expanded its Extractables and Leachables testing services with new equipment and specialist analysts at its facility in New Jersey, US.

scope 2017

CROS NT launches new FSP model focused on 'sustainable quality'

25-Jan-2017 - The Functional Service Provision (FSP) model unveiled at SCOPE Summit this week in Miami addresses staff turnover, flexible pricing, and monitoring.

Diurnal outsources launch of Adrenal drug to Dublin divisions of UDG

25-Jan-2017 - Diurnal has contracted the Ashfield and Sharp divisions of UDG Healthcare to help commercialize the its drug for Addison's disease, Infacort.

scope 2017

Continuum teams with Lyft for clinical trials transportation

25-Jan-2017 - Contiunuum Clinical has asked rideshare firm Lyft to help transport trial subjects to clinical sites in a bid to boost retention. 

Enteris to work on Sanofi oral type 2 diabetes candidate & metabolic peptide for Nordic Bioscience

Sanofi and Nordic Bioscience deals ‘validate’ oral delivery tech, Enteris

25-Jan-2017 - Enteris Biopharma has secured two deals in as many days to use its excipient-based platform to enhance delivery of preclinical peptide candidates.

Wuxi Biologics files IPO prospectus aiming to be gateway to China

25-Jan-2017 - Wuxi Biologics has confirmed its intention to go public in an IPO application that reveals the contracter has seen revenue double and profits increase three-fold since 2014. 

Belgian CDMO to launch generic of vaginal contraceptive device NuvaRing

24-Jan-2017 - Mithra Pharmaceuticals SA will seek US and EU approval for a rival to the NuvaRing contraceptive device in Q2, manufacturing the ring through its independent CDMO platform.

ADMA to buy US Biotest plant and fix problems that derailed RI-002

24-Jan-2017 - ADMA Biologics has agreed to buy production assets from the CMO whose manufacturing deficiencies saw the US FDA reject its lead candidate, RI-002, last year.

Schulman IRB integrates Veeva Vault for real-time IRB updates

24-Jan-2017 - Schulman IRB is integrating its WebPortal platform with Veeva’s eTMF solution to offer real-time IRB status updates and approval documentation to clients.

DSG opens new office in India

24-Jan-2017 - DSG, Inc. has opened a new office in Bangalore, India as it looks to increase efficiency and enhance its data management capabilities.

Mid-sized CROs set to outperform larger providers, analyst

24-Jan-2017 - Quintiles, Parexel and Icon are likely to report declining bookings growth in their upcoming financials, says a Jefferies’ analyst, but mid-sized CROs should fare much better.

Amatsigroup buys French Pyrofree manufacturing specialist Disposable-Lab

23-Jan-2017 - Amatsigroup has acquired single-use processing equipment and packaging tech firm Disposable-Lab SAS as part of a plan to increase its revenue to €50m this year.

Evotec and Asahi Kasei up drug discovery collaboration

23-Jan-2017 - German CRO Evotec says it will invest in its staff and infrastructure to help service a drug discovery deal with Japan’s Asahi Kasei Pharma.

News in brief

WuXi AppTec acquires preclinical CRO

23-Jan-2017 - WuXi AppTec has acquired Shanghai-based HD Biosciences (HDB), a biology-focused preclinical contract research organization (CRO). 

GCP 'Renovation' paper outlines revisions to ICH E8 and E6

23-Jan-2017 - ICH is currently seeking public comment on proposed "modernizations" to the clinical trial design, planning, management, and conduct guidelines ICH E8 and E6.

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