Ear­ly last month, Proven­tion Bio’s shares cratered af­ter dis­clos­ing that the FDA found the phar­ma­co­ki­net­ic pro­files of its po­ten­tial type 1 di­a­betes drug, ac­quired from Eli Lil­ly, dif­fered when man­u­fac­tured by Lil­ly ver­sus Proven­tion.

At the time, the FDA said its con­cerns meant that it was not ready to start post-mar­ket­ing and la­bel dis­cus­sions with the com­pa­ny.

But now, two days ahead of the FDA’s En­docrino­log­ic and Meta­bol­ic Drugs Ad­vi­so­ry Com­mit­tee meet­ing to dis­cuss the drug, known as teplizum­ab, the FDA sound­ed a rel­a­tive­ly pos­i­tive tone on safe­ty and ef­fi­ca­cy. The com­pa­ny’s stock was up about 30% ear­ly Tues­day.

While not­ing some miss­ing da­ta from the com­pa­ny’s tri­als, the FDA said Tues­day that “be­cause the amount of miss­ing da­ta was small, sen­si­tiv­i­ty analy­ses per­formed us­ing dif­fer­ent miss­ing da­ta han­dling ap­proach­es show that the ob­served ef­fi­ca­cy by the pri­ma­ry analy­sis method is suf­fi­cient­ly ro­bust to with­stand con­ser­v­a­tive ap­proach­es in han­dling miss­ing da­ta.”

The ques­tion of what con­sti­tutes sub­stan­tial ev­i­dence of ef­fec­tive­ness will be top of mind for the com­mit­tee to ad­dress, FDA notes, ex­plain­ing how Proven­tion sub­mit­ted a rel­a­tive­ly small, sin­gle place­bo-con­trolled tri­al with the pri­ma­ry end­point of de­lay of clin­i­cal type 1 di­a­betes, as well as ad­di­tion­al da­ta, which FDA said can be used as “con­fir­ma­to­ry ev­i­dence.”

On safe­ty, the brief­ing doc­u­ments did not re­veal any glar­ing red flags, al­though the agency not­ed that “slight­ly more than 10% of pa­tients” in the tri­al “were not able to re­ceive the full course of teplizum­ab sec­ondary to meet­ing pro­to­col-spec­i­fied with­draw­al cri­te­ria.”

The com­mit­tee on Thurs­day will be tasked with not on­ly dis­cussing the clin­i­cal mean­ing­ful­ness of the ob­served me­di­an 2-year de­lay of on­set of type 1 di­a­betes demon­strat­ed in the com­pa­ny’s main study, but vot­ing on an up or down ap­proval ques­tion ahead of the FDA’s de­ci­sion, which is due by Ju­ly 2.

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.

The FDA’s Center for Drug Evaluation and Research on Tuesday released a warning letter sent last week to Amazon CEO Andy Jassy in Seattle for selling mole removal products over-the-counter, or, as the FDA explains, “introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs.”

“There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses,” the agency said in its Aug. 4 warning.

Federal officials said yesterday that shipments of Eli Lilly’s bebtelovimab — one of the final two remaining mAb treatments for Covid-19 — would halt later this month, setting up a commercial market where the government no longer pays for the doses and hospitals and other clinics will have to purchase supplies.

According to ASPR, the arm of HHS that ships Covid-19 drugs, states have ordered 627,536 bebtelovimab courses, and 383,515 courses have been administered as of July 31. The US has paid Lilly a total of about $1.27 billion for all of the courses so far, amounting to about $2,100 per course to start and then receiving a discounted $1,833 ASP for the later part of the deal. According to the Wall Street Journal, Lilly’s list price for bebtelovimab is $2,100 per dose.

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.