A joint study conducted by the EMA and FDA showed that marketing approval decisions were 90% shared for new medicines, as the agencies push for a closer working relationship.
The FDA posted a public missive alongside a warning letter to a Chinese OTC drug manufacturer, highlighting the efforts it had been making to address data integrity issues.
High prevalence of skin disease and diabetes to boost the global revenues of the topical drug delivery market, with uptake in China and India boosting growth.
SGS’ OneVision initiative is working to standardize record-keeping across the global life sciences industry in an aim to accelerate laboratory testing, development, and eliminate paper-based systems.
The cell and gene therapy industry cannot grow without a ‘standardized, systematized, industrialized foundation,’ according to experts from Lonza and Vineti, which have teamed up to advance a ‘vein-to-vein’ delivery network.
Onconova to use Mission Bio’s Tapestri targeted single-cell DNA analysis platform to advance its cancer therapy, rigosertib, into Phase III clinical trials.
Biopharmaceutical companies are increasingly relying on CROs in Japan, says an executive with PRA, which recently established a new subsidiary in the country.
Caprion Biosciences and HistoGeneX join forces, combining the two businesses to provide a source for immune monitoring, protein characterization, and tissue pathology solutions, as immunotherapy landscape evolves.
Eversana adopts Cryoport’s full suite of logistics services, in an alliance expected to ‘drive synergistic growth’ for both companies and answer regenerative medicine demands.
CMIC Group is the first Japanese CRO to join the Align Clinical group and expects to improve execution of clinical trials and collaboration with life sciences companies as the industry grows globally.
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.
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.
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.
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.
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.
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.
US FDA delivers a Form 483 with four observations to Sun Pharma, with one noting that the company took eight years to create design plans for the production of one product.
Zenith-Cognizant Technologies emerges from an acquisition aimed to streamline solutions as more complex “smart factories” become a greater focus in the biopharmaceutical industry.
To investigate blockchain processes and make distribution information retrieval more efficient, the FDA tapped big name companies for a supply chain security pilot program.
Aurobindo has received another Form 483 from the US FDA, after the agency found its response to complaints were ‘not always sound’ for products destined for the US market.
EMA assembles pharmaceutical developers to strengthen antimicrobial pipelines while, in the meantime, a study found the world’s rivers dangerously contaminated.
Although the industry may not be among the ‘frontrunners’, Novo Nordisk is seeing the benefits when it comes to recruitment and developing mutually beneficial partnerships, says director.
Heritage announces a recall of lots of amikacin sulfate injection and prochlorperazine edisylate injection, due to evidence of selected products being non-sterile.
University of Rochester Medical Center joined the global health research network aiming to ‘expand its access to advanced clinical trials’, TriNetX announced.
CRF Bracket is expanding its offering across the Asia-Pacific region with a new Tokyo office to help it better serve the area’s diverse and underserved patient population.
