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Headlines > July 2017

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Syngene expands Amgen collaboration as it recovers from fire incident

31-Jul-2017 - Syngene International is doubling the footprint of its research and development center following an expanded research collaboration with Amgen Inc.

Boehringer Ingelheim taps Philogen DNA-encoded chemistry tech

31-Jul-2017 - Boehringer Ingelheim and Philogen have signed a multi-target research agreement to discover and optimize new small molecule therapeutics for unmet medical needs.

Chiltern acquisition improves competitiveness of offerings, says Covance CEO

31-Jul-2017 - LabCorp has acquired Chiltern for $1.2bn to create a global contract research organization (CRO) with more than 20,000 employees.

Avantor site launches with biopharma lean

27-Jul-2017 - Avantor has opened a research centre in New Jersey, US offering gene to protein expression and drug delivery contract services.

Icon acquires Mapi Group, ups financial guidances

27-Jul-2017 - Icon plc is expanding its commercialization offerings through its has acquisition of Mapi Group, a global research company.

EMA revises guideline on first-in-human clinical trials

27-Jul-2017 - The adapted guideline stresses a sponsor’s responsibility to define the uncertainty associated with the medicines tested in clinical trials.

STA: Pilot program to enable CMO use in China is a 'huge opportunity'

27-Jul-2017 - The Chinese pharmaceutical industry sets a positive outlook for regulatory harmonization as its Marketing Authorization Holder pilot program progresses.

News in brief

Smithers extends accreditation scope for medical device testing

26-Jul-2017 - Testing services provider Smithers Pira has extended its ISO/IEC 17025:2005 scope of accreditation for medical devices.

BASF selects Icertis ICM to modernize its global contracting process

26-Jul-2017 - BASF SE has selected the Icertis Contract Management (ICM) platform to automate its contracting processes and improve visibility into contractual obligations and deviations.

Patient iP's clinical trial matching solution tops 14m patient records

26-Jul-2017 - Patient iP has been growing its Connected Site Network over the past two years – as it aims to curate one of the largest patient-centric, longitudinal clinical data sets in the world,...

Recipharm installs dedicated production line for prostate cancer depot

26-Jul-2017 - Recipharm has installed a dedicated production line to make prostate cancer drug Liproca Depot for Swedish pharma firm LIDDS AB.

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....

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