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.”
Awareness around the potential opportunities created by artificial intelligence has never been higher, but pharma’s biggest challenge in 2019 will be adopting and scaling the right technology to improve patient outcomes, says an industry executive.
The more outsourcing experience a pharma company has, the less important its proximity to contract manufacturing partners becomes, outlines Novo Nordisk VP.
Eli Lilly and Company and AC Immune have signed an agreement for the research and development of tau aggregation inhibitor small molecules, and AC Immune signed a strategic partnership with WuXi biologics.
Most CROs are struggling with employee retention, a challenge not new to the industry, which has seen turnover levels at or above 20% for seven of the last 10 years, according to a recent report.
By Jim Kremidas, executive director, Association of Clinical Research Professionals
This time next year, I hope I can write a column with the headline “2019: The year of cooperation and communication in the clinical trial industry.” We’ve made some exciting progress toward that end in 2018. Now it’s time to take it to the next level.
The Indian government seeks to boost local drug production by stipulating that the ‘local content’ of domestic products is 75% and 10% for those that are non-domestic.
The biopharma industry is on the precipice of making personalized medicine a reality with access to massive amounts of data, computing power, and artificial intelligence to run in silico clinical trials, says GNS Healthcare CEO.
Almac announced it has increased its supply of neo-antigen peptides for individualized cancer treatments with the addition of another stream of GMP manufacturing.
By Jessica Knott, senior communications manager, Society for Clinical Research Sites
The Society for Clinical Research Sites builds its focus and programming around improving site sustainability. However, a troubling and ever-present factor within the clinical research industry is that, by and large, many of the problems facing the site...
Clinical trials suggest that long-acting injectable antipsychotics should be expanded into a broader range of clinical settings and patient populations, says Premier Research executive.
Heavily indebted Teva says consolidating its global headquarters in Israel will generate “significant savings from a business and operations point of view”.
Global regulatory agencies had a busy 2018. Here, we take a look back at some of the key developments throughout the year, as the industry navigated challenging politics, pressure to increase transparency, and the rapidly evolving digital health space.
TrialScope this year awarded several companies for their clinical trial data transparency efforts as the industry makes strides to engage patients and the larger health care community.
The Pistoia Alliance hopes to facilitate “seamless data integration” between various industry stakeholders, including life sciences companies and CROs, via an open and freely available data format.
Roquette has purchased a majority stake in excipient manufacturer Crest Cellose, in an aim to increase its footprint in India’s generic pharmaceutical market.
The UK Government has granted Arcinova funds to develop its digital manufacturing platform to produce patient-specific medicine at an accelerated rate.
Generics drug portfolios are diversifying, prices are stabilising, and while competition remains intense, the worst of price erosion appears to be over, claims Clarivate Analytics executive.
Elpis Biomed is scaling its proprietary ‘direct cellular reprogramming platform’ – and has its sights set on becoming a global provider of high-quality human cells, with strategic partnerships soon to be announced, says the company’s founder.
This second phase of the two-phase expansion project will increase the company’s bioanalytical capabilities at the site by 50% when the expansion is complete in 2020.
CROs are taking steps to improve study start-up as collaboration with sites and sponsors continues to be a challenge, one which a unified clinical operations model aims to address.
Biorasi plans to scale several aspects of its global CRO business following a PE investment – and while it does not plan to “buy size,” smaller strategic acquisitions are not out of the question, says company executive.
Smithers Avanza’s Bioanalytical Services division is adding 18,500 square feet of laboratory space in New Jersey to support the development of biotherapeutics.
If approved by President Trump, the five-year farm bill – which removes hemp from the federal controlled substance list – could help advance cannabinoid R&D, says Nexien Biopharma.
Histo-Scientific Research Laboratories and Vet Path Services have merged to create one company dedicated to providing histology, pathology, and archiving services to the biopharmaceutical, medical device, and contract research industries.
Merck’s agreement with Cyclica will establish efficiency in its small molecule therapy development with access to Cyclica’s AI protein screening platform.
The expansion collates WuXi AppTec’s technology platform small molecule capabilities, including screening, discovery biology, pharmacology, and process R&D.
