Regulatory flexibility may be warranted for diseases with low prevalence in the US, such as nasopharyngeal carcinoma, or for pediatric tumors, which are difficult to study in multi-regional trials, FDA officials said at the advisory committee review of Innovent/Lilly’s lung cancer drug sintilimab; the agency has no plans to change its regulations on evaluation of foreign clinical data.
With the recent advisory committee review of Innovent Biologics, Inc./Eli Lilly and Company’s Chinese-developed PD-1 inhibitor sintilimab, the US Food and Drug Administration sent a clear message that the regulatory door is closed to most cancer drug applications based solely on clinical trial data from a single country.
However, that same door remains open a crack for a limited group of products, such as those aimed at cancers...
The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.
The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
