Work­ing from home presents some unique chal­lenges. Just ask a lawyer who rep­re­sent­ed Mer­ck dur­ing its $1.85 bil­lion Pan­dion takeover.

A for­mer FBI trainee has been charged with in­sid­er trad­ing over prof­its he made from buy­ing Pan­dion stock based on pri­vate in­for­ma­tion about the Mer­ck ac­qui­si­tion — which he al­leged­ly learned while work­ing from home with a “ro­man­tic part­ner,” who al­so hap­pened to be an as­so­ciate at a law firm rep­re­sent­ing Mer­ck.

As a re­sult of the pan­dem­ic, Seth Markin, a 31-year-old Penn­syl­va­nia man, fre­quent­ly stayed over at his part­ner’s apart­ment last Jan­u­ary and Feb­ru­ary, around the same time that Mer­ck had com­plet­ed its due dili­gence and filed a pro­pos­al to take over Pan­dion. At the end of Jan­u­ary, his part­ner was as­signed to work on the pro­posed deal.

Markin was present in the apart­ment for work-re­lat­ed calls and — while his part­ner wasn’t look­ing — he al­leged­ly looked through a binder con­tain­ing con­fi­den­tial in­for­ma­tion about the deal, ac­cord­ing to an SEC com­plaint.

The day af­ter his part­ner was as­signed to the Mer­ck case, Markin al­leged­ly be­gan buy­ing up Pan­dion stock. The SEC al­so ac­cused him of tip­ping off a friend, 38-year-old New York City res­i­dent Bran­don Wong. By Feb. 23, 2021 — two days be­fore the deal was pub­licly an­nounced — Markin had pur­chased 2,270 shares of Pan­dion stock.

Wong, who com­mu­ni­cat­ed with Markin us­ing an en­crypt­ed mes­sag­ing ap­pli­ca­tion, bought 35,382 shares of Pan­dion stock. Both Markin and Wong al­leged­ly tipped off oth­ers as well, ac­cord­ing to the SEC.

Af­ter the deal was pub­licly an­nounced, and Pan­dion’s share price soared over 133%, Markin and Wong made rough­ly $82,000 and $1.3 mil­lion, re­spec­tive­ly, in what the SEC says are il­le­gal prof­its.

Mer­ck an­nounced on Feb. 25 that it would shell out $1.85 bil­lion to snap up Pan­dion and its port­fo­lio of reg­u­la­to­ry T cells (Tregs) to treat a range of au­toim­mune dis­or­ders. That in­clud­ed lead IL-2 can­di­date for ul­cer­a­tive col­i­tis PT101, which scored a Phase Ia win ear­li­er that year. Pan­dion re­ject­ed two of­fers for Mer­ck over the last few years be­fore fi­nal­ly ac­cept­ing the lat­est one.

Af­ter the deal an­nounce­ment, Wong al­leged­ly bought Markin a Rolex as a thank-you gift, and paid for some of his ex­pens­es on a trip to Hawaii.

The case is part of a se­ries of in­sid­er charges that the SEC brought against nine in­di­vid­u­als in three sep­a­rate al­leged schemes on Mon­day.

“If every­day in­vestors think that the mar­ket is rigged at their ex­pense in fa­vor of in­sid­ers who abuse their po­si­tions, they are not go­ing to in­vest their hard earned mon­ey in the mar­kets,” Gur­bir Gre­w­al, di­rec­tor of the SEC’s en­force­ment di­vi­sion, said in a state­ment.

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

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, just two weeks after submitting a supplemental BLA. 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.

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.