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Headlines > February 2017

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GBSI report outlines steps to improve preclinical research reproducibility

27-Feb-2017 - The Global Biological Standards Institute (GBSI) has outlined an action plan after finding the frequency of irreproducible preclinical research exceeds 50% – costing the US nearly $28bn.

PHARMA OUTSOURCING & PARTNERSHIP GLOBAL CONGRESS 2017 EUROPE

Biogen provides 'relationship advice' for outsourcing in pharma

27-Feb-2017 - Partner relationships should start with the long-term in sight – just like a marriage, says Biogen.

News in brief

QPS tapped for Acticor Biotech FIH study

27-Feb-2017 - Acticor Biotech has contracted QPS to manage a Phase I study of the company’s humanized Antibody Fragment, ACT017.

Pharma Outsourcing & Partnership Global Congress 2017 Europe

Vital statistics? Big Pharma undervaluing commercial data, expert

27-Feb-2017 - Data is a core competence for Big Pharma that should not be outsourced, according to an industry statistics expert.

INC Research expands FSP services

27-Feb-2017 - INC Research has expanded its Functional Service Provider (FSP) service offering to include investigator payment processing in response to increased transparency requirements.

QuintilesIMS eyes revenue growth with refinancing

23-Feb-2017 - QuintilesIMS has announced an offering of senior notes and a proposed debt refinancing as leadership looks to drive revenue growth, according to a Jefferies analyst.

Envigo thyroid hormone assay meets OECD guidelines

23-Feb-2017 - Envigo has developed and validated an analytical method to evaluate the potential effects of thyroid hormone levels in rat F1 offspring.

Ohr Pharmaceutical Inc. shuts sustained release tech lab

23-Feb-2017 - Ohr Pharmaceutical Inc. has halted activities at the laboratory in San Diego, California where research on its sustained release delivery technology was carried out.

Gov’t delay could postpone ClinicalTrials.gov usability, patient recruitment

23-Feb-2017 - Several organizations have penned an open letter to NIH urging it adhere to 21st Century Cures deadlines that if missed, will affect improvements to ClinicalTrials.gov – and ultimately, study start...

Evotec taps into Oxford innovation through £13m grant scheme

22-Feb-2017 - Dubbed LAB282, the £13m (€15M) Oxford University drug discovery program with Evotec has announced two grant winners and a second set of awards of up to £250,000.

PPD collaborating with nephrology expert Frenova

22-Feb-2017 - Pharmaceutical Product Development, LLC (PPD) is expanding its therapeutic expertise through a new collaboration with Frenova Renal Research.

Bioclinica: more stakeholders pushes need for collaboration

22-Feb-2017 - Bioclinica has expanded its eHealth App xChange to make a greater range of technologies available to the increasing number of industry stakeholders – many with differing priorities. 

iCardiac eCOA platform a 'major step forward,' says CEO

22-Feb-2017 - iCardiac’s new eCOA platform, QPoint, can measure clinical outcome assessments from patients at home or during site visits and will soon integrate with emerging wearables.

Icon awarded FDA project to validate PRO instruments

21-Feb-2017 - The US Food & Drug Administration (FDA) has tasked Icon plc to validate three patient-reported outcomes (PRO) instruments in antibacterial drug trials.

AmpTec looking to achieve full GMP compliance for APIs

21-Feb-2017 - AmpTec GmbH is in the process of achieving full GMP compliance for API manufacturers in order to expand its offerings into the clinical space.

News in brief

JSS uses EnduraData cloud to link up Canada and Colombia

21-Feb-2017 - The CRO JSS Medical Research will use EnduraData’s cloud tool to synchronize medical research data between servers in Canada and Colombia, South America.

Granules to expand Indian API plants and US dosage form site

21-Feb-2017 - Granules India will build an API production facility in Bonthapally, Telangana and expand other manufacturing sites in a project backed by the Word Bank. 

Belgian CRO launches EU joint venture with Chromatography Institute

20-Feb-2017 - The Research Institute for Chromatography (RIC) and Anacura have joined forces to create anaRIC biologics, an R&D and GMP analytical specialist CRO for biologics.

CMOs need to increase awareness of offerings, ISR reports

20-Feb-2017 - A "new set of leaders" emerged in the contract manufacturing organization (CMO) industry over the past year, though many remain unheard of, according to a recent report .

EMA: GCP deviations increasing

20-Feb-2017 - The EMA recently updated its Good Clinical Practice (GCP) Q&A to address several contractual arrangement “pitfalls” – specifically with electronic systems vendors.

Clinerion enters Asia through strategic alliance with ASUS Life

20-Feb-2017 - The alliance expands the geographic reach of sponsors, giving customers real-time, EHR-based insight on the Taiwanese patient population.

Selecta hires Lonza to make synthetic vector delivered gene therapy

17-Feb-2017 - Selecta Biosciences Inc. has hired Swiss contractor Lonza to make a gene therapy candidate for the metabolic disease, Methylmalonic Acidemia (MMA).

Strategic CRO takes $100m hit from Pfizer's shelved PCSK9 candidate

17-Feb-2017 - Contract research organisation (CRO) ICON has taken a hit to its book-to-bill ratio after Pfizer dropped its anti-cholesterol candidate bococizumab in November.

Teewinot ups cannabinoid production capabilities

16-Feb-2017 - Teewinot Life Sciences Corporation’s cannabinoids are now available for research and development as the company looks to establish new partnerships.

HPCTC adopts biometric fingerprint tech to register patients

16-Feb-2017 - High Point Clinical Trials Center (HPCTC) has partnered with Verified Clinical Trials to help prevent duplicate enrollment in clinical trials.

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