Align Clinical CRO is "committed to operating with speed" as it aims to solve common pre-competitive industry challenges to improve clinical trial execution and collaboration between sponsors and CROs, says exec.
Accelovance and Linical are merging to create a contract research organization (CRO) with a global footprint in response to the need for large-scale, multinational clinical trials.
At DCAT Week, contract manufacturing and development companies from across the globe shared updates and news – from multi-million dollar investments to new business structures and areas of focus.
In this month’s roundup, new CEO’s at Center Point Clinical Services and Clinipace Worldwide, and an equity investment in Dotmatics, which has named a new CFO.
Porton Biopharma will look to develop GMP manufacturing capabilities for Clostridia bacteria as part of a UK collaboration developing aimed at developing microbiome targeted therapeutics.
The active ingredient for Nichi-Iko’s diabetic neuropathy drug will be the first of a number of APIs to be supplied from Eisai’s facility in Vizag, India.
Abzena has completed a remodeling of its new antibody-drug conjugate (ADC) GMP manufacturing suite, which will support customers progressing drug development programs from research into clinical trials.
PPD has expanded its Middleton, WI-based GMP analytical laboratory, increasing its large molecule development capacity with space for more than 100 new employees.
Mitsubishi Tanabe Pharma and Hitachi aim to shorten clinical trial timelines and reduce drug development costs through the use of digital technologies, such as AI.
The US Patent and Trademark Office has granted a notice of allowance for ‘shelf life’ timer technology used to protect time-sensitive biologic materials in transit.
Novartis will sell its stake in a consumer healthcare joint venture to partner GSK and plans to invest the $13bn into its core pharmaceutical businesses.
Syngene International has signed a multiyear agreement with GSK through which the companies will focus on accelerating the discovery of new drug candidates using the CRO’s discovery services platforms.
Ubiquitous M&A activity in the pharmaceutical industry raises several concerns – with many scholars arguing that 70 to 80% of acquisitions end up destroying value.
Watson for Clinical Trial Matching has shown an 80% increase in clinical trial enrollment at Mayo Clinic, which is expanding its partnership with IBM to further develop the cognitive computing platform.
Envigo is increasing its surgical footprint ten-fold to create a West Coast Center of Excellence for surgery and supply myocardial infarction research models regionally.
Parexel’s new medical writing solutions offering will provide communications services throughout the drug development and commercialization process to help sponsors meet higher documentation quality standards, says VP.
IPEC Federation and PDA will publish a technical report in 2019 to provide drugmakers guidelines on how to implement risk assessment challenges of excipient supply.
Grand River Aseptic Manufacturing has purchased a new lot of land to expand its manufacturing capabilities as growth in the market drives demand, says CEO.
AMPAC Fine Chemicals will boost Noramco Inc.’s supply of active pharmaceutical ingredients and intermediates to make abuse prevention and attention deficit disorder treatments, and cannabinoids.
‘Splinter-like’ nanostructures have been developed by researchers in the US to deliver biomolecules straight into patient cells for immune-oncology and gene therapies.
Thermo Fisher Scientific has announced plans to build a supply chain facility, which it says will increase capacity for cold and ambient clinical trial materials in Europe.
An online portal designed to connect sponsors with trial sites and contract research organizations has been launched by the Victorian state government in Australia.
Thermo Fisher Scientific says its proposal to move manufacturing and R&D operations from Ashford, Kent to existing sites in Mexico, China and Denmark was a “very difficult decision.”
More efficient clinical trials may reduce global CRO revenue, potentially slowing adoption of new technology, says Otsuka director – noting that the industry doesn’t often take operational risks, but it must.
Worldwide Clinical Trials has acquired the Continuum Clinical’s Late Stage research practice following a dramatic increase in demand for real-world evidence, says CRO.
The Danish drugmaker says it will take responsibility for commercial manufacturing after acquiring Parkinson’s disease candidate foliglurax in a deal worth up to €905m ($1.1bn).
BiondVax is working closely with a CRO to advance its universal flu vaccine candidate, which will be manufactured in-house and in collaboration with a CMO to support tech-transfer pending a successful trial.
Covance has formed a global immunology and immunotoxicology (I&I) unit, which will be dedicated to the “innovative and complex” approaches required by biologics, says CRO.
CDMO Ardena has purchased active pharmaceutical ingredient and nanomedicine maker ChemConnection, as part of an acquisition strategy focused on development services.
PCI Pharma Services has validated its former Millmount site to help Ireland’s ‘thriving pharma community’ comply with Europe’s Falsified Medicines Directive.
