Bristol Myers Squibb announced results from the open-label switch period of Early AMPLE, a Phase IV exploratory biomarker study assessing the differences by which Orencia (abatacept) and another treatment, adalimumab, interfere with disease progression in moderate-to-severe early rheumatoid arthritis (RA) patients who tested positive (seropositive) for certain autoantibodies. Findings of the open-label switch period showed that early seropositive RA patients treated with Orencia demonstrated substantial clinical improvements at week 48, sustaining the level of responses achieved at week 24 compared to adalimumab. In seropositive patients switching from adalimumab to Orencia, the efficacy responses generally increased over the open-label period to week 48. These results are featured in a poster presentation at the European E-Congress of Rheumatology (EULAR) 2020.
The fight against Chikungunya disease has got a major boost with CEPI, the global Coalition for Epidemic Preparedness Innovations, and its Indian arm Ind-CEPI, announcing a new partnering agreement with a consortium comprising Hyderabad-based Bharat Biotech (BBIL) and the International Vaccine Institute (IVI) to promote the development of a vaccine against the disease.
AGC Biologics, a global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has announced that it will partner with Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, on large-scale GMP production of a critical component of Novavax’ coronavirus vaccine candidate, NVX-CoV2373. AGC Biologics will manufacture Matrix-M™, the adjuvant component of the vaccine, in order to enhance the immune response and stimulate high levels of neutralizing antibodies.
NVX-CoV2373 is a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology. AGC Biologics will optimize process development for scaled-up production of Matrix-M to significantly increase Novavax’ capacity to deliver doses in 2020 and 2021.
“We are quickly ramping up to successfully deliver this vital vaccine component to Novavax,” says AGC Biologics’ CEO Patricio Massera. “The urgency to help produce a vaccine to combat COVID-19 could not be higher.”
“AGC Biologics’ mission is to work side-by-side with our partners to produce life-saving and extending products,” says Mark Womack, CBO of AGC Biologics. “Partnering with Novavax to manufacture this vaccine component is an amazing opportunity to make a profoundly positive difference.”
“We have been impressed with AGC Biologics’ level of collaboration and commitment,” says Timothy J. Hahn, SVP, Process Technology at Novavax. “They are an important strategic partner in expanding our supply chain of adjuvant for NVX-CoV2373 and for other vaccines being developed at Novavax, including our recombinant seasonal influenza vaccine, NanoFlu.”
CLICK HERE TO SUBSCRIBE,
PHARMATUTOR's DAILY EMAILS
Do Not Forget to Verify
(Click on Subscription link in your inbox)
--------
