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Navigating Regulatory Hurdles in Drug Development

DrugBank

In 2020, the FDA halted Johnson & Johnson’s COVID-19 vaccine production at a contract manufacturing facility after discovering quality control issues. One notable success story is Moderna’s mRNA vaccine development for COVID-19, which benefited from early regulatory engagement and streamlined approval pathways.

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Takeda to seek approval of new kind of narcolepsy drug after study data

BioPharma Drive: Drug Pricing

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ISSUE 44 — The Importance of Cytokine Release Assays to Derisk the Development of Immunomodulatory Drugs

Alta Sciences

Nonclinical safety assessment serves as a cornerstone in drug development, providing essential data to identify early signs of potential toxicity and inform subsequent clinical trial design. CAR T cells) WHAT IS THE BENEFIT OF NONCLINICAL CYTOKINE RELEASE EVALUATION?

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Merck’s ENFLONSIA Receives ACIP Recommendation for Protecting Infants from Severe RSV

The Pharma Data

CDC panel backs long-acting monoclonal antibody to protect infants during their first RSV season; drug also included in federal Vaccines for Children program Merck , operating as MSD outside the United States and Canada, has announced a key regulatory milestone for its respiratory syncytial virus (RSV) prevention program. What Is ENFLONSIA™?

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The Long Road to End Tuberculosis

Codon

Even after microbiologists discovered the bacterium that causes the illness in 1882, it wasn’t until the 1920s that researchers were able to develop a vaccine for TB. These breakthroughs have significantly curbed cases, with vaccination reducing the odds of death by 74 percent. tuberculosis , to develop the vaccine.

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FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche

BioPharma Drive: Drug Pricing

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. The FDA’s prescribing information includes warnings and precautions for an effect on heart rhythms, liver toxicity, lung inflammation and other potential health issues.

FDA
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Every Claim You Make, Every Step You Take…CVM Will Be Watching You

FDA Law Blog: Biosimilars

Zenrelia comes with serious warnings, including a boxed warning against the use of Zenrelia during vaccination. CVM also objected to the truncation of other information about the timing of vaccines in these promotional materials. Further, information presented on the adverse reaction data was inconsistent with the PI.