Af­ter more than 5 years at the helm of New Jer­sey-based bio­phar­ma CorMedix, Khoso Baluch is re­tir­ing, and the move has trig­gered a rip­ple of change with­in its ex­ec­u­tive lead­er­ship team, lead­ing CFO Matt David to take over as in­ter­im CEO, while main­tain­ing his cur­rent role.

The de­par­ture comes about a month af­ter de­lays at a con­tract man­u­fac­tur­er led to the re­sub­mis­sion of a new drug ap­pli­ca­tion for De­fen­Cath, an an­tibac­te­r­i­al and an­ti­fun­gal treat­ment to pre­vent blood­stream in­fec­tions in pa­tients un­der­go­ing chron­ic he­modial­y­sis. The drug was grant­ed fast-track des­ig­na­tion by the FDA, but de­lays at the CMO’s site led to a com­plete re­sponse let­ter.

Stocks plum­met­ed 24% af­ter news of the de­lays broke. Be­fore the open­ing bell Tues­day, CorMedix’s stock was val­ued at $4.82. The FDA has ap­par­ent­ly told the com­pa­ny that the de­lays were un­re­lat­ed to the man­u­fac­tur­ing of De­fen­Cath.

David joined CorMedix in May 2020 as the CFO and EVP, com­ing over from Ovid Ther­a­peu­tics, where he spent about two years as the head of strat­e­gy. The ma­jor­i­ty of his ca­reer has been in health­care bank­ing, and he re­ceived his MD from New York Uni­ver­si­ty School of Med­i­cine in 2003.

As the com­pa­ny’s board of di­rec­tors — which Baluch al­so re­tired from — moves to re­place the for­mer CEO, Baluch will serve as an ad­vi­sor to en­sure a smooth tran­si­tion.

“I am hon­ored to take on the role of in­ter­im CEO dur­ing this im­por­tant time for the Com­pa­ny,” David said in the press re­lease. “With a strong ex­ec­u­tive team span­ning reg­u­la­to­ry, med­ical af­fairs, clin­i­cal op­er­a­tions and com­mer­cial, and a high­ly sup­port­ive board which in­cludes proven health­care in­dus­try lead­ers, I be­lieve we are well po­si­tioned to con­tin­ue our ef­forts to bring De­fen­Cath to the he­modial­y­sis pa­tient com­mu­ni­ty.”

John Arm­strong, the EVP for tech­ni­cal op­er­a­tions, al­so re­tired Mon­day. Phoebe Mounts, EVP and head of reg­u­la­to­ry com­pli­ance and le­gal, will have di­rect au­thor­i­ty over the com­pa­ny’s tech­ni­cal op­er­a­tions group, in­clud­ing a group of con­sul­tants that are work­ing on ad­dress­ing the sit­u­a­tion with the CMO.

My­ron Ka­plan, the chair­man of the board, said in a state­ment:

On be­half of the en­tire Board, I thank Khoso and Jack for their ded­i­cat­ed ser­vice and con­tri­bu­tions to CorMedix. Khoso has been in­stru­men­tal in re­fo­cus­ing the Com­pa­ny and guid­ing it strate­gi­cal­ly while build­ing a high­ly ex­pe­ri­enced ex­ec­u­tive team. Matt’s en­er­gy and lead­er­ship, with the sup­port of CorMedix’s Board of Di­rec­tors and ex­pe­ri­enced man­age­ment team, en­able him to con­tin­ue the im­por­tant work un­der­way to progress De­fen­Cath, while the CEO search is on­go­ing.

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.