Indoco confirms receipt of a warning letter from the US FDA and the agency posts details of a Form 483 for two different facilities in the space of one week.
Recursion Pharmaceuticals plans to partner with big pharma on rare disease programs after raising $121m to build out its machine learning-enabled platform, which draws on an in-house developed dataset to support drug discovery and development.
Longboat Clinical’s new offering connects potential clinical trial participants with enrolling study sites and provides insights into online patient recruitment campaigns in real-time.
The two regulatory agencies have confirmed the addition of the last country to their mutual recognition agreement, with GMP inspections by Slovakia given a positive assessment.
The global drug discovery market is expected to reach $68bn in 2028, according to a Visiongain report, with revenue gains driven by flexibility, agility, and the ability to innovate, says Evotec executive.
DSP Clinical provides flexible monitoring support to sponsors and CROs through a new co-monitoring service that takes advantage of fluctuations in employee demand.
Elligo expands its Research Ready network and adds its first oncology practice through a partnership with Austin Cancer Center, which is currently enrolling patients for breast cancer studies.
Alten Calsoft Labs launches its first initiative for blockchain through its scalable clinical trial platform BioPharma Ledger to address life sciences processes using BlockApps middleware.
Repositive ‘increases visibility’ while ‘maintaining confidentiality’ as it makes its directory of preclinical cancer models publicly browsable as part of the relaunch of its Cancer Models Platform.
The US FDA published another warning letter sent to Akorn, which details cases of improper investigation into faulty batches, failure to exercise controls over data, and ‘poor aseptic behaviour’.
Saama and Tufts are teaming up to examine how sponsors and CROs are using automation and information technology in an aim to identify new solutions and optimize drug development.
Following Gilead’s funding of Lyndra’s technology, the latter company offers exclusive rights to its therapeutics platform for long-acting HIV therapies formulations.
Pharma and regulators are using machine learning to accelerate various pharmacovigilance activities – as the number of adverse event reports increases 10-12% each year, says Eli Lilly advisor.
AG Mednet provides imaging services to Median Technologies in support of the company's portfolio of clinical trials, including "large programs" in China.
PPD’s patient access business unit AES will support clinical trial enrollment of participants in the Synexus HealthyMinds Registry, which aims to register 30,000 adults for a five-year study.
Fresenius Medical Care integrates Frenova Renal Research into its global office in an aim to extend clinical research activities and reach more than 550 researchers.
StemoniX opens a new facility in California to house its research team working on its high-throughput microOrgan technology platforms for drug discovery and preclinical development.
Highlighting the threat of AMR, the UK government has worked with the pharma industry to develop a new antibiotics payment model based on ‘usefulness’ to the NHS.
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.
