North Car­oli­na Re­pub­li­can Sen. Thom Tillis made a name for him­self in the 2020 elec­tion cy­cle as the dar­ling of the phar­ma in­dus­try, ac­cept­ing hun­dreds of thou­sands in cam­paign con­tri­bu­tions, even from the likes of Pfiz­er CEO Al­bert Bourla.

Those con­tri­bu­tions have led Tillis to at­tempt to re-write patent laws in phar­ma’s fa­vor, a move which failed to gain steam in 2019, and re­quest for a third time since Jan­u­ary that the FDA should help stop “the false nar­ra­tive that patent pro­tec­tions are to blame for high drug prices.”

In a let­ter dat­ed Wednes­day, Tillis told FDA com­mis­sion­er Rob Califf that the FDA should con­duct “an in­de­pen­dent as­sess­ment and study” on the con­nec­tion be­tween patents and high drug prices. Pre­vi­ous­ly, Tillis wrote to lament the work of the Ini­tia­tive for Med­i­cines, Ac­cess & Knowl­edge (I-MAK), which has claimed that bio­phar­ma­ceu­ti­cals “are of­ten pro­tect­ed by dozens or hun­dreds of patents each, with an al­leged ef­fect of block­ing gener­ic com­pe­ti­tion for 30 to 50 years or longer per drug.”

In­deed, drugs like Ab­b­Vie’s Hu­mi­ra and Am­gen’s En­brel have used fortress­es of patents to pro­tect their block­busters from com­pe­ti­tion for decades.

The FDA, ac­cord­ing to Tillis, has nev­er re­spond­ed to any of his re­quests.

Tahir Amin, co-founder of I-MAK, told End­points News that he re­spond­ed to Tillis in March, adding via email:

This is an un­for­tu­nate dis­trac­tion from the great work done by the House Over­sight Com­mit­tee cul­mi­nat­ing in the Ma­jor­i­ty Staff Re­port at the end of last year in­ves­ti­gat­ing ris­ing phar­ma­ceu­ti­cal drug prices com­pa­nies and the link to patent­ing prac­tices. It would be in the greater in­ter­est of Amer­i­cans who are strug­gling to pay for their med­i­cines if the Sen­ate would be ask­ing these ques­tions and de­mand­ing more trans­paren­cy and da­ta from the phar­ma­ceu­ti­cal com­pa­nies.

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

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.

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.”

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.

Back in 2018, Swiss drugmaker Ferring Pharmaceuticals made a big bet on Minnesota-based Rebiotix, buying up the company for its experimental poop-based drug implant to treat an infection caused by C. difficile, a potentially dangerous bacteria, in a new way.

Four years later, Ferring’s fecal microbiota transplant, dubbed RBX2660 or Rebyota, will face the FDA’s adcomm of outside vaccine experts on Sept. 22, debating whether the agency should license the transplant as a treatment for adults following antibiotic treatment for recurrent C. difficile infection.