Skyhawk enters an agreement with Merck to discover and develop small molecules to modulate RNA splicing, and expands its existing development agreement with Biogen.
The company initiates operations at its new EU headquarters in Dundalk, Ireland after receiving its manufacturing and importation authorization license from the HPRA.
The Phase I clinical trial is slated for early 2020 and will be first CAR-T cell therapy clinical trial to use Horizon Discovery’s technology, according to the company.
Notocord, an Instem company, will provide data acquisition and analysis services to a research and innovation program to improve risk prediction of cardiovascular adverse events.
Boehringer Ingelheim, Sanofi, Bristol-Myers Squibb, and Evotec are among the top companies with “AI-friendly” CEOs, according to a report, which suggests that these businesses will prosper driven by a more effective application of AI.
Improving the prognostic value of early phase data is among one of several ways to increase the probability of successes in drug development, a process which has become more expensive as failure rates have risen, says an industry expert.
The EMA looks to the future by posting its five key priorities to address in the coming five years, which includes the need to recruit expertise in ‘novel manufacturing technologies’.
Lovelace Biomedical leads a collaboration with The Jackson Laboratory, Exemplar Genetics, Iontox, and the University of Pennsylvania as part of a $20m contract with the NIH.
MediLedger Product Verification Solution, a DSCSA compliant platform, is announced that will assist drug supply chain stakeholders in product verification and authenticity.
Altaire instigates voluntary recall of sterile ophthalmic treatments, after concerns were raised about QA processes in place at its manufacturing facility.
Newly-minted Signant Health named a new CTO, Parexel bolstered its Japan presence, and BioAgilytix’s CEO was appointed to the board of FSD Pharma – a company developing products based on cannabinoids – among other people on the move in June.
Xellia will move US production from its North Carolina manufacturing facility to its site in Ohio to bolster workforce and manufacture generic IV antibiotics.
Strides’ Puducherry, India, facility has received a warning letter from the US FDA, which the company announced will lead to deferrals for 10 pending ANDA approvals.
The strategic advisory company, Trinity, opens a new office in Germany, with leadership joining from Syneos Health to work “hand-in-hand” with biopharma clients.
Innovative Trials will work with an undisclosed global pharmaceutical company to speed up patient recruitment for clinical trials using its proactive site optimization service.
Belong.Life raises $14m as part of a Series B funding round with plans to expand its patient engagement platform, using and complementing Iqvia’s solutions “to transform patient engagement,” says Iqvia VP.
Panelist during the opening session of the DIA Annual Meeting last week stressed the need to work collaboratively, bringing patients into the fold as co-creators of clinical trials to ‘create a whole new landscape for research.’
With Germany’s addition to the US FDA-EMA mutual recognition agreement, only Slovakia is left to be added to the agreement, with the deadline later this month.
MMS Holdings launched its cloud-based quality control application, Automatiqc, to meet quality control needs rapidly through its customizable software, according to the CRO.
Sponsors to benefit from more accurate, shorter, and less costly trials through Shimmer Research and ClearSky Medical Diagnostics partnerships, says company executive.
Navitas Life Sciences taps ThoughtSphere to power its digital and clinical analytics cloud-based clinical data SaaS OneClinical, as the company continues to grow after Kai Research acquisition.
Many sponsors think physicians are unwilling to refer their patients to clinical trials, though the majority have, per a recent BBK survey, which suggest that more patients could be enrolled in studies if doctors had more information about protocols.
Clinical trials are taking longer, drug development costing more, and the stakeholder group expanding – all compounding to create an "industrywide urgency to streamline how trials are run,” says Veeva VP.
Datavant enters partnership with Prognos to expand the latter’s analytics capabilities to determine clinical outcomes and inform decision making as data availability grows.
Parexel launched a delivery model for its FSP services at DIA 2019 Global Annual Meeting in San Diego as the company aims to tailor solutions for biopharma customers.
ArcheMedX’s new digital platform aims to reduce the risks and costs associated with underperforming clinical trials by analyzing the behavior of project teams and site personnel.
Cobra and Symbiosis announce the completion of their collaboration on viral vector development and manufacturing, supported by £1.9m Innovate UK grant.
Live updates from the DIA Global Annual Meeting 2019 in San Diego as industry leaders from over 50 countries and 400 companies discuss the progress and innovations in drug product development.
Phastar expands globally, adding offices in Japan and the US, and enters a partnership with Medidata to transform its increasing data points into insights.
The value generated by the manufacture of medicines has doubled since 2000, with one of the smallest countries in Europe responsible for a significant proportion of the total figure.
Iqvia today launched a new “patient centered endpoints” solution, which captures the patient experience during clinical trials and real world studies, says SVP.
WuXi Clinical is expanding therapeutically - investing ‘heavily’ in oncology, CNS, GI - and plans to continue growing geographically as well, with a mission to bridge the gap between China and the rest of the world.
Parexel and CluePoints to use CSM solutions for preclinical and clinical risk-based monitoring, after regulatory guidelines impact mutual acceptance of data across the US, EU and Japan.
The share price of BMS sank by over 7% after it stated that it would need to divest Celgene’s Otezla, a blockbuster treatment for psoriasis and psoriatic arthritis.
