Nei­ther Janet Wood­cock nor Joshua Sharf­stein is like­ly to be nom­i­nat­ed as the per­ma­nent FDA com­mis­sion­er, Steve Us­din at Bio­Cen­tu­ry re­ports.

Janet Wood­cock

The White House is look­ing for al­ter­na­tives to Wood­cock, the act­ing chief and long­time CDER di­rec­tor, af­ter op­po­si­tion from sev­er­al De­mo­c­ra­t­ic sen­a­tors who are call­ing on oth­ers to block her nom­i­na­tion if her name is put forth, ac­cord­ing to Us­din. Sharf­stein, the for­mer prin­ci­pal deputy FDA com­mis­sion­er and cur­rent Johns Hop­kins pro­fes­sor, is out of the run­ning al­to­geth­er.

As the va­can­cy at the helm of an agency tasked with over­see­ing the de­vel­op­ment and re­view of Covid-19 vac­cines be­came more con­spic­u­ous by the day — prompt­ing the New York Times to ask, “Who will be the next FDA chief?” — dis­tinct camps had formed around the two lead­ing can­di­dates.

Wood­cock earned plau­dits ear­ly from pa­tient ad­vo­ca­cy or­ga­ni­za­tions and bio­phar­ma­ceu­ti­cal com­pa­nies, the same groups that have spo­ken out against Sharf­stein for lack of ex­pe­ri­ence.

Joshua Sharf­stein

But there was a par­tic­u­lar group of ac­tivists who made their dis­dain for Wood­cock clear: those fight­ing the opi­oid abuse epi­dem­ic. And they be­lieve Wood­cock should be held re­spon­si­ble for “one of the worst reg­u­la­to­ry agency fail­ures in U.S. his­to­ry,” not on­ly over­see­ing but de­fend­ing “harm­ful opi­oid de­ci­sions.”

Sen­a­tors from some of states worst hit by the opi­oid cri­sis were re­port­ed to be her fiercest op­po­nents, in­clud­ing Sen­a­tors Mag­gie Has­san from New Hamp­shire, Ed Markey from Mass­a­chu­setts and Joe Manchin from West Vir­ginia.

Less pub­li­cized, per­haps, was the harsh cri­tique that some in­dus­try in­sid­ers re­served for Wood­cock over what they per­ceived as the loos­en­ing of the FDA’s reg­u­la­to­ry stan­dards, man­i­fest­ed in her de­ci­sion to over­rule FDA staffers and ap­prove Sarep­ta’s eteplirsen with­out clin­i­cal proof that their Duchenne mus­cu­lar dy­s­tro­phy drug works.

In a re­cent let­ter to Pub­lic Cit­i­zen, Wood­cock shut down the watch­dog’s pro­pos­al of a fire­wall be­tween reg­u­la­tors and drug com­pa­nies, ar­gu­ing it would un­nec­es­sar­i­ly “re­duce the ef­fi­cien­cy of FDA’s re­view process and cause de­lays in drug de­vel­op­ment.”

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

The FDA late Wednesday signed off on authorizing the use of heterologous — or what FDA calls a “mix and match” of a primary vaccine series and different booster doses — for all currently available Covid-19 vaccines, in addition to separately authorizing Moderna and J&J boosters.

On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.