Remove Immune Response Remove Licensing Remove Regulation
article thumbnail

Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

article thumbnail

South Korea authorises Novavax Covid-19 vaccine as booster dose

Pharmaceutical Technology

The findings showed that the Nuvaxovid booster dose increased immune responses compared to higher levels associated with the protection in Phase III clinical trials. The regulator approved Nuvaxovid for use as a primary series in adolescents aged 12 to 17 years in August last year.

Vaccine 147
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

AbbVie preps filings for lymphoma bispecific licensed from Genmab

pharmaphorum

billion alliance with Genmab to find new cancer therapies, AbbVie has said it is ready to start talking to regulators about filing for approval of the lead drug in the partnership – epcoritamab for large B-cell lymphoma (LBCL). The post AbbVie preps filings for lymphoma bispecific licensed from Genmab appeared first on.

article thumbnail

Malaria Vaccine a Breakthrough Success with 77 Percent Efficacy

XTalks

It is the world’s first and only licensed malaria vaccine and also the first licensed for use against a human parasitic disease of any kind. Moreover, a very strong immune response is needed to fend off the disease. Malaria Vaccine Phase II Trial. Two different doses of the adjuvant (MM) were assessed (25 mcg and 50 mcg).

Vaccine 105
article thumbnail

Medicago, GSK’s plant-made COVID jab clears phase 2

pharmaphorum

.” The interim phase 2 results show that two doses of the plant-derived jab stimulated neutralising antibody levels that are around 10 times higher than those in a panel of sera from patients recovering from COVID-19, with a similar response seen in adults and the elderly.

article thumbnail

BMS swoops on Forbius, snaring another immuno-oncology player

pharmaphorum

Just last week, BMS paid $475 million upfront to license Dragonfly Therapeutics’ DF6002, a long-lasting fusion protein that looks like the “tail” (Fc) end of an IL-12 antibody. The rationale behind the drug is that it causes the area around a tumour to become inflammatory, stimulating an immune response against the cancer.

article thumbnail

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

The Pharma Data

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. CEO and Co-founder of BioNTech. “We