With the world heading straight into a "very tough" stretch of the COVID-19 pandemic in which "too many countries are seeing an exponential increase in cases," according to World Health Organization Director-General Tedros Adhanom Ghebreyesus, two lucrative deals announced Oct. 28 showed little slack in efforts to confront the virus, even as evidence is still developing.
The latest global regulatory news, changes and updates affecting biopharma, including: Lawmakers spill Purdue documents on heels of settlement; Western states join forces to review vaccines; FDA finalizes nicotine drug guidance; CBER tackling guidance agenda; Innovation Alliance voices support for PTAB changes.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aprinoia, Astellas, Astrazeneca, Daiichi Sankyo, Insmed, Passage, Qualigen, Revision, Taysha Gene Therapies.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Allergan, Alx, Ampio, Aurinia, Boehringer, Castle Creek, Clinuvel, Finch, Galera, Gyroscope, Highlight, Orasis, Mediwound, Regentree, Therapeutics Solutions.
LONDON – Three large scale population surveys conducted between late June and the end of September have shown the prevalence of SARS-CoV-2 antibodies in England declined by 26.5% over three months. The findings rest on the results of more than 350,000 self-administered lateral flow blood tests that were carried out at home by volunteers who were randomly selected from general practitioner registers.
The ACTIV-3 phase III study testing Eli Lilly and Co.’s COVID-19 antibody candidate, LY-CoV555, which was paused two weeks ago following a participant’s unexplained illness, has now been halted, the company reported Oct. 26.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA clarifies terms for generics; FDA to hold public meeting on DSCSA; Russia updates COVID-19 guidelines; First Circuit: Prescriber’s perk indeed a kickback; Companies warned for documentation, FAR violations.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Atai Life, Cytodyn, Edigene, Exelixis, Kala, Moderna, Nektar, Pfizer, Prevail, RDIF, Vanda.
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