The FDA approved Teva's generic for Sabril, the first generic for the drug, as the agency continues to focus its efforts to approve generics that face little competition.
Roche has launched its new cobas pro integrated solutions to reduce manual operations in the lab – as well as new enterprise software for digital pathology.
Key Biologics and Cascade Regional Blood Services’ multi-year agreement will provide researchers with the critical raw material needed for developing cell- and gene-based therapies.
Though larger pharma companies are investing heavily in biologics, the industry is set to be predominantly focused on small molecules moving forwards, claims CAS MD.
Sanofi will use AbSci’s platform to further optimize two of its in-house proteins – and will partner with other companies to accelerate timelines and reduce costs.
Strategikon Pharma releases new modules for its Clinical Maestro software suite – another step in the company’s journey to harmonize sponsor and CRO operations, with further updates slated for later this year, says CCO.
Genetic discoveries have taken place in narrow population groups, say researchers, who for the first time, reveal that such studies are concentrated in a handful of countries – and conducted by a ‘tight-knit group of researchers.’
After a low cost of manufacturing goal was achieved by a consortium for the development of a bioproduction system for vaccines, Univercells will launch its NevoLine system.
Akorn received a warning letter from the FDA on January 4, relating to the inspection of its manufacturing facility in Decatur, Illinois, in April and May 2018.
AstraZeneca and Aptamer Group will collaborate to leverage Aptamer’s platform for targeted delivery of oligonucelotides to the kidney for therapeutic development.
Pressure BioSciences has launched a commercial biopharmaceutical contract service business after acquiring a protein therapeutics platform that it says reduces challenges and manufacturing costs of the growing drug market.
Clinigen’s newly announced business, Clinical Trial Service, will establish an on-demand supply chain for clinical trials and extends agreement with its partner Accord.
Thousand Oaks Biopharmaceuticals raised $45m in Series A financing, enabling the company to expand its CDMO and CMC services as well as its capabilities in global biologics development.
The industry’s pledge to improving the patient experience drove significant change in 2018 and will continue to do so this year, with so-called “convenience” services to become standard, says Greenphire CCO, who outlines several other trends to watch.
University Hospitals Cleveland Medical Center has joined the TriNetX network to increase its research opportunities while benefitting the network of real world evidence and data.
Boston Biomedical Associates and Factory-CRO Group merge to provide global CRO services with specialized operations worldwide, providing continuity in international clinical research.
Clinithink has secured investors to scale its technology, which leverages unstructured data to guide treatment decisions, identify clinical trial participants, and ensure proper reimbursement.
Elligo Health Research has acquired Protenium Clinical Research, a TX-based research group, which will gain access to new technology, support, and career opportunities, says VP.
The EMA recently outlined five strategic goals with a focus on fostering clinical trial innovation, optimizing capabilities in modeling and simulation, as well as exploiting AI and investing in special populations, among other objectives.
Industry 4.0 has been pitched as able to transform the way pharma manufacturing operates, Lawrence Ganti, of Innoplexus, explains how AI can be used to improve efficiency.
For research in areas such as Parkinson’s disease, digital endpoints may soon be used as primary endpoints, allowing for in-home clinical trials to be conducted over longer periods of time, says CRO.
Driven by a more than 20% increase in adverse event volumes, Iqvia has developed a SaaS safety platform designed to reduce the cost and complexity of pharmacovigilance activities – and help companies add value back into their business, says VP.
Upperton Pharma’s new and expanded facilities received a positive inspection from MHRA, enabling both research and development and clinical manufacturing at the site.
Parexel Biotech will support emerging companies from development through commercialization with tailored services and customized guidance, says division lead.
The company’s anticoagulant reversal treatment received a complete response letter from the FDA in 2016 but will be made available today after its approval.
Apptomics is working with BBK and Biotaware to develop the remote health-monitoring platform, which recently served as a digital biomarker to evaluate treatment effects as part of an essential tremor clinical trial.
The two companies will combine technologies to create solid-dose, needle-free vaccines for a number of infectious diseases and emergent threat pathogens.
Access to an increasing amount of information is catalyzing research, while also lending to higher levels of professional burnout on behalf of health care professionals, says company executive.
CytoReason today announced a collaboration with Pfizer – as the machine learning company eyes future partnerships with industry leaders to up the accuracy of its models and affect decision-making throughout the drug development pipeline, says CEO.
Schrödinger closed an $85m (€74) financing round to support an expansion of its computational platform and drug discovery pipeline for internal and external use.
A “strong client request” has prompted the CDMO Rentschler Biopharma to acquire its first US-based facility, which will provide various development and manufacturing services.
The UK Government last week provided an update on the regulation of clinical trials in the event of a “no deal” Brexit, with a commitment to ensure any new requirements are not “unduly burdensome.”
