Six Former FDA Commissioners Endorse Biden Nominee Califf
Meanwhile, an international coalition of pharma regulators is recommending expanding the use of remote pharma plant inspections. Also: Global Blood Therapeutics' experimental sickle-cell drug has promising results, as does Bellus Health's chronic cough treatment.
The Washington Post:
Former FDA Commissioners Endorse Califf As Head Of Agency, Citing Urgency Of Addressing Omicron
Six former Food and Drug Administration commissioners on Monday endorsed Robert M. Califf to lead the agency, saying the emergence of the omicron coronavirus variant is another reminder of “just how critical it is to have a confirmed commissioner” right now. Califf, a well-known cardiologist and researcher who served as FDA commissioner during the last year of the Obama administration, was nominated for a second stint last month by President Biden. (McGinley, 12/13)
In related news about regulation of the pharmaceutical industry —
Stat:
Coalition Of Pharma Regulators Look To Complement On-Site Inspections
Nearly two years after the Covid-19 pandemic prompted remote inspections of pharmaceutical production plants, an international coalition of regulators is recommending the approach be used to complement on-site visits for the foreseeable future. Although remote inspections posed various limitations on medicines regulators in recent months, the strategy also yielded some productive insights, such as the use of digital technology to gather electronic clinical trial data and additional intelligence about manufacturing sites, according to a new “reflection paper” from the International Coalition of Medicine Regulatory Authorities. (Silverman, 12/13)
And more pharmaceutical industry news —
Stat:
New Global Blood Sickle-Cell Drug Improves Hemoglobin Response
Global Blood Therapeutics said Monday that an experimental treatment for sickle cell disease nearly doubled the production of oxygen-carrying hemoglobin compared to its currently approved medicine — a result that is preliminary but could lead to better outcomes for patients with the inherited blood disorder. In a small, pilot study of six patients, the Global Blood drug called GBT-601 improved hemoglobin levels by an average of 2.3 grams per deciliter compared to baseline. The best responses were seen in two patients with hemoglobin increases of 3.1 grams per deciliter. Hemoglobin in the worst-performing patient rose 1.1 grams per deciliter. (Feuerstein, 12/13)
Stat:
Bellus Health Chronic-Cough Treatment Shows Positive Results
Results released Monday from a Phase 2 study of a chronic cough treatment being developed by Bellus Health exceeded the expectations of financial analysts and boost the company’s chances of eventual approval after an earlier trial of the drug had failed. Bellus said in a press release it expects to meet with the Food and Drug Administration in the second quarter of 2022 and to begin a Phase 3 study of the treatment in the second half of 2022. Roberto Bellini, Bellus’ CEO, said the company is “extremely pleased” with the “compelling” results. (Herper, 12/13)
