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Headlines > July 2017

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Axim contracts Israel-based CRO for cannabidiol chewing gum clinical trials

25-Jul-2017 - An Israel-based contract research organization (CRO) is conducting a Ph II clinical trial for Axim’s cannabidiol (CBD) and Gabapentin chewing gum product.

Outsourcing platform receives EU-US data security certification

25-Jul-2017 - Science Exchange has been certified under the EU-US Privacy Shield Framework after completing a seven-step process to demonstrate compliance with various data protection requirements.

Feature

Compounding quality concerns: Legislation could 'fundamentally undermine' patient protections

25-Jul-2017 - Citing safety concerns, drug industry stakeholders and public health organizations are urging lawmakers to uphold FDA oversight and enforcement of the 2013 Drug Quality and Security Act (DQSA).

Takeda, Schrödinger sign multi-target research collaboration

24-Jul-2017 - Takeda Pharmaceutical Company Limited and Schrödinger Inc. have formed a multi-target research collaboration that leverages Schrödinger’s in silico platform-driven drug discovery capabilities.

Eurofins acquires India-based preclinical CRO

24-Jul-2017 - Eurofins Scientific has acquired the India-based preclinical CRO Advinus Therapeutics after raising €650m.

Covis Pharma taps Verify ahead of the extended DSCSA mandate

20-Jul-2017 - The Switzerland-based biotech company has selected Verify Brand as its serialization software provider to meet the FDA’s – recently extended – DSCSA deadline.

AB Cube's pharmacovigilance platform joins Bioclinica's eHealth App xChange

20-Jul-2017 - Bioclinica has announced that the safety software company AB Cube has joined its eHealth App xChange – and is touting its platform as “the future of pharmacovigilance.”

Worldwide Clinical Trials advancing cannabis-based formulations for human studies

20-Jul-2017 - Worldwide Clinical Trials is developing a pre-IND plan and designing pilot studies for evaluating the effectiveness of GB Sciences’ proprietary cannabis-based therapeutic, says CMSO.

ABL advancing HIV vaccine as part of 7 year, $318m contract

19-Jul-2017 - ABL, Inc. has been awarded a preclinical development support contract to help advance an HIV vaccine and other biologics candidates.

Eli Lilly licenses Adimab antibody discovery and optimization tech

19-Jul-2017 - Adimab, LLC is transferring its proprietary antibody discovery and optimization platform to Lilly research sites in San Diego and New York.

SQI Diagnostics signs commercial contract with global biotech

19-Jul-2017 - SQI Diagnostics Inc. has signed an agreement to commercialize a custom multiplexed assay for a Waltham, MA-based global biotechnology company's blood disorder drug program.

Glenmark selects Cyndea to make gel capsule drugs

19-Jul-2017 - Cyndea Pharma and Glenmark Pharmaceuticals have partnered to make generic soft-gelatin capsule products for multiple markets.

Catalent expands formulation offerings

18-Jul-2017 - Catalent Pharma Solutions has expanded its OptiForm Solution Suite platform from candidate selection through Phase I.

FDA outlines Cures implementation, touts in silico clinical trials

18-Jul-2017 - The US FDA has revealed its work plan  for implementing aspects of the 21st Century Cures Act, including an investment in in silico tools for use in clinical trials....

AI platform nabs $2m to connect patients and providers with clinical trials

18-Jul-2017 - Mendel.ai has raised $2m in seed funding to advance its artificial intelligence engine that connects doctors and patients with clinical trials.

update

UDG's Ashfield eyes continued growth in most recent acquisition

17-Jul-2017 - UDG Healthcare has acquired Cambridge BioMarketing LLC in a deal worth up to $35m as the healthcare service provider looks to continue expansion in the United States.

Alcami relocating headquarters to RTP, new jobs expected

17-Jul-2017 - Alcami is moving its global headquarters to Research Triangle Park (RTP) in Durham, North Carolina.

Adents passes EMVS certification process to become official gateway provider under EU FMD

17-Jul-2017 - Adents has become an official Certified Gateway Provider following a series of tests with the European Medicines Verification Organization (EMVO) ahead of the EU Falsified Medicines Directive (FMD).

Nitto Denko Avecia’s expanded API site to open in Massachusetts, US

17-Jul-2017 - Nitto Denko Avecia has announced it will launch its expanded Milton, Massachusetts-based oligonucleotide API facility next month.

DIA 2017

When, where, and how? Experts examine the current state of Brexit

13-Jul-2017 - The pharmaceutical industry and regulators are preparing for Brexit and how to best “manage and mitigate” any potential risks the UK’s departure from the EU may pose.

PCI 'ahead of the curve,' expands serialization capabilities at UK-based facility

13-Jul-2017 - PCI Pharma Services continues to expand its serialization capabilities following an extended regulatory deadline that will provide much-needed “breathing room” for the industry.

update

UDG acquires healthcare consultancy firm in $32m deal

12-Jul-2017 - UDG Healthcare plc has acquired the US-based healthcare industry management consulting firm Vynamic LLC as it looks to augment its commercialization services division.

Worldwide Clinical Trials taps Medidata for payments solution

12-Jul-2017 - Worldwide Clinical Trials has planned its rollout and risk mitigation strategy as it implements Medidata’s Payments Cloud to automate site payments, says CFO.

News in brief

Catalent re-ups manufacturing deal for Pfizer Liqui-Gels

12-Jul-2017 - Catalent Pharma Solutions has signed an exclusive long-term supply agreement with Pfizer.

South Korean CRO adopts Instem tech to automate data collection

12-Jul-2017 - Chemon Inc. is automating its preclinical data collection process with Instem’s software solutions and services.

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