J&J is the first pharma company to bring an SGLT2 inhibitor to market, but its window of exclusivity in that class may be narrow, given that FDA is slated to assess two other SGLT2s later this year.
Despite lingering skepticism about whether interim data from an ongoing cardiovascular trial would be enough to convince FDA to clear an NDA, Johnson & Johnson’s Janssen Pharmaceuticals Inc. unit gained approval for its type 2 diabetes treatment Invokana (canagliflozin) on March 29.
The drug has been tested in nine clinical trials in more than 10,000 patients, both as a standalone therapy, and...
The newly reconstituted Advisory Committee on Immunization Practices will create new work groups to examine the cumulative impact of vaccine schedules and reexamine some older vaccines.
Sen. Bill Cassidy and HHS Secretary Robert F. Kennedy Jr. agree the disbanding of ACIP did not violate their agreement, but the perception that Kennedy is not following the spirit of the pledge could be more important long-term.
The CDC Advisory Committee on Immunization Practices had only seven members in place as it met for the first time since HHS Secretary Robert F. Kennedy Jr. dismissed the previous panelists. CDC Director nominee Susan Monarez said finding replacements has been difficult.
John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.
John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.
Clarity on payer responses to controversial vaccine recommendations from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices may be coming.
The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.
