Upcoming events in the coming weeks and months include two FDA advisory committee meetings; MAGI 2024: The Clinical Research Conference; and webinars on medical device cybersecurity, overcoming common clinical trial…
After receiving reports of T-cell malignancies in patients who received treatment with BCMA- or CD19-directed autologous CAR-T cell immunotherapies, the agency has announced an investigation into the issue and is…
This edition of Quick Notes highlights recalls for Excela sodium bicarbonate, sodium chloride and cysteine hydrochloride, Novartis cyclosporin, Bayer larotrectinib, Unomedical VariSoft infusion sets and SoClean CPAP cleaner. Source: Drug…
FDA investigators found that visual inspectors manipulated particle and defect counts to keep finished products within rejection limits in a May 1-12 inspection of Intas Pharmaceuticals’ Ahmedabad facility, earning the…
UK-based medical devicemaker LivaNova reported that it detected disruption of portions of its information technology systems as a result of a cybersecurity incident. Source: Drug Industry Daily
The troubled U.S. drug supply chain remains in the spotlight with President Biden announcing nearly 30 new actions to help bolster supply chain resilience, including convening a new White House…
Aldeyra Therapeutics on Monday announced receipt of an FDA complete response letter (CRL) for the NDA of reproxalap, for the treatment of dry eye disease, asking the company to conduct…
Sponsors of drugs being developed to treat or prevent COVID-19 should consider the importance of enrolling older adults, including those 75 and older, in drug trials and even consider running…
This edition of Quick Notes highlights an ITC decision to investigate Lilly’s claims of Mounjaro trademark infringement, an FDA motion to dismiss an SCA pharmaceuticals lawsuit and AbbVie’s lawsuit against…
A new eligibility checker for the UK’s Medicines and Healthcare products Regulatory Agency’s (MHRA) International Recognition Procedure (IRP) has gone live, enabling drugmakers to determine if their drug will be…