Just a month be­fore hand­ing In­ter­cept Phar­ma­ceu­ti­cals a CRL for Ocali­va in NASH, the FDA be­gan eval­u­at­ing the drug for a po­ten­tial risk of liv­er dis­or­der in pri­ma­ry bil­iary cholan­gi­tis (PBC) pa­tients. The probe, which launched in May, was dis­closed by the com­pa­ny deep down in their lat­est quar­ter­ly re­port filed with the SEC, and had not oth­er­wise been com­mu­ni­cat­ed pub­licly by In­ter­cept un­til re­ports sur­faced this week.

The FDA has no­ti­fied us that in the course of its rou­tine safe­ty sur­veil­lance, in May 2020 the FDA be­gan to eval­u­ate a new­ly iden­ti­fied safe­ty sig­nal re­gard­ing liv­er dis­or­der for Ocali­va which the FDA clas­si­fied as a po­ten­tial risk.

Ocali­va was ap­proved in 2016 to treat PBC, a chron­ic dis­ease that af­fects the liv­er’s bile ducts. In­ter­cept spokesman Christo­pher Frates said the biotech is work­ing with the FDA on what will like­ly be a 12-month eval­u­a­tion.

An FDA spokesper­son de­clined to of­fer any ad­di­tion­al in­for­ma­tion aside from what was post­ed in FAERS, the agency’s ad­verse event re­port­ing sys­tem, which states they are “eval­u­at­ing the need for reg­u­la­to­ry ac­tion.”

The probe is the lat­est blow to In­ter­cept in the last few months. In June, the FDA re­ject­ed its NDA for obeti­cholic acid, the ac­tive in­gre­di­ent in Ocali­va, for the treat­ment of NASH. In­ter­cept said reg­u­la­tors want­ed longer term da­ta from their Phase III tri­al to back the sur­ro­gate end­point, re­duc­tion in liv­er fi­bro­sis. Com­pa­ny ex­ec­u­tives ar­gued then that they were blind­sided.

CEO Mark Pruzan­s­ki had said in a state­ment:

At no point dur­ing the re­view did the FDA com­mu­ni­cate that OCA was not ap­prov­able on an ac­cel­er­at­ed ba­sis, and we strong­ly be­lieve that the to­tal­i­ty of da­ta sub­mit­ted to date both meet the re­quire­ments of the Agency’s own guid­ance and clear­ly sup­port the pos­i­tive ben­e­fit-risk pro­file of OCA.

In a Sep­tem­ber SEC fil­ing, In­ter­cept an­nounced that 170 jobs were on the chop­ping block, equal to rough­ly 25% of its staff, in or­der to save cash for its con­tin­ued pur­suit of NASH ap­proval. In­ter­cept shares were down 8% yes­ter­day when news of the FDA probe be­came wide­ly known. An in­vestor on Twit­ter first no­ticed the buried dis­clo­sure.

Back in 2018, the FDA slapped Ocali­va with a black box warn­ing, due to the drug be­ing “in­cor­rect­ly dosed” dai­ly in­stead of week­ly. “To en­sure cor­rect dos­ing and re­duce the risk of liv­er prob­lems, we are clar­i­fy­ing the cur­rent rec­om­men­da­tions for screen­ing, dos­ing, mon­i­tor­ing, and man­ag­ing PBC pa­tients with mod­er­ate to se­vere liv­er dis­ease tak­ing Ocali­va,” it an­nounced.

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.