Global Briefs: J&J, Pfizer & Biocon
A roundup of news from J&J, Pfizer, and Biocon Biologics. Highlights below.
FDA Issues Complete Response Letter to Biocon Biologics
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Biocon Biologics, for its biologics license application (BLA) for its insulin-R product filed by Biocon Biologics. The CRL cites additional data required in the BLA submission and an expectation of a satisfactory implementation of a CAPA plan pertaining to the pre-approval inspection of the company’s Bangalore facilities in August 2022. Biocon issued a statement on January 7, 2022 that it is the process of addressing the CRL.
Source: Biocon Biologics
J&J Discontinues HIV Vaccine Phase III Trial
Johnson & Johnson (J&J) has discontinued a Phase III clinical trial of its HIV vaccine, Mosaico.
The decision to discontinue the trial follows results of an independent, scheduled data review of the Phase III study of Mosaico. The study’s independent Data and Safety Monitoring Board determined that the regimen was not effective in preventing HIV infection compared to placebo among study participants. No safety issues with the vaccine regimen were identified.
Source: Johnson & Johnson
Pfizer Expands Global Health Initiative To Include Access to More of its Products
Pfizer has expanded its global public health initiative, “An Accord for a Healthier World,” to provide the full portfolio of medicines and vaccines for which it has global rights on a not-for-profit basis to 45 lower-income countries.
Launched in May 2022, the Accord, an initiative focused on reducing health inequities that exist between many lower-income countries and the rest of the world, initially included a commitment from Pfizer for access to all its patented medicines and vaccines available in the US or European Union on a not-for-profit basis to 45 lower-income countries. However, to better align with disease burden and unmet patient needs in these countries, Pfizer says it will now expand its offering under the Accord to include off-patent products to bring the total offering from 23 products to around 500 products.