Sen­ate De­moc­rats may have all the votes they need to pass ma­jor drug pric­ing re­form, af­ter Sen. Kyrsten Sine­ma (D-AZ) re­port­ed­ly pledged her sup­port on Thurs­day — but will they fit it in be­fore re­cess?

Sine­ma said she has agreed to “move for­ward” with the rec­on­cil­i­a­tion bill with some stip­u­la­tions, in­clud­ing the re­moval of a car­ried tax pro­vi­sion, ac­cord­ing to re­cent re­ports. The bill is still ex­pect­ed to re­duce the deficit by $300 bil­lion, and Sen. Chuck Schumer (D-NY) said that he now an­tic­i­pates “sup­port from the en­tire Sen­ate De­mo­c­ra­t­ic con­fer­ence,” the Wash­ing­ton Post re­port­ed. 

With the In­fla­tion Re­duc­tion Act, @Sen­at­eDems will:

✅Low­er en­er­gy costs and in­vest in clean en­er­gy
✅Bring down pre­scrip­tion drug prices
✅Close tax loop­holes and re­duce the deficit
✅En­sure no small busi­ness or fam­i­ly mak­ing un­der $400,000 a year will see their tax­es go up

— Chuck Schumer (@Sen­Schumer) Au­gust 4, 2022

“We have agreed to re­move the car­ried in­ter­est tax pro­vi­sion, pro­tect ad­vanced man­u­fac­tur­ing, and boost our clean en­er­gy econ­o­my in the Sen­ate’s bud­get rec­on­cil­i­a­tion leg­is­la­tion. Sub­ject to the Par­lia­men­tar­i­an’s re­view, I’ll move for­ward,” Sine­ma said in an emailed state­ment.

The bill needs sup­port from every Sen­ate De­mo­c­rat to pass, and just last week, Schumer struck a deal with hold­out Sen. Joe Manchin (D-WV). If passed, the bill would en­able Medicare ne­go­ti­a­tions and cap se­niors’ out-of-pock­et costs at $2,000 per year.

“Tonight, we’ve tak­en an­oth­er crit­i­cal step to­ward re­duc­ing in­fla­tion and the cost of liv­ing for Amer­i­ca’s fam­i­lies,” Pres­i­dent Joe Biden said in a state­ment on Thurs­day. “The In­fla­tion Re­duc­tion Act will help Amer­i­cans save mon­ey on pre­scrip­tion drugs, health pre­mi­ums, and much more.”

In­dus­try ex­ecs have blast­ed the pro­posed leg­is­la­tion, ar­gu­ing that it would chill in­no­va­tion, par­tic­u­lar­ly for small mol­e­cules.

“This is a bill that has far more neg­a­tives than it has pos­i­tives in it. And I think frankly al­though it may not be short term that chal­leng­ing from a fi­nan­cial stand­point, I think the long-term im­pli­ca­tions of this bill are pret­ty sig­nif­i­cant,” Ab­b­Vie’s CEO Rick Gon­za­lez said dur­ing the com­pa­ny’s Q2 call last week.

Pfiz­er’s CEO Al­bert Bourla said last week:

In re­al­i­ty, it’s not a price ne­go­ti­a­tion be­cause they are forc­ing their will by im­ple­ment­ing a [ 95% ] tax ac­cord­ing to pre­vi­ous guid­ance. That will cost the in­dus­try sig­nif­i­cant, we es­ti­mate $270 bil­lion over 10 years. There is a pos­i­tive pro­vi­sion there, that they are re­duc­ing the out-of-pock­et cost for the pa­tient. That’s a sig­nif­i­cant one, but it’s too lit­tle and too late.

In­dus­try trade group PhRMA CEO Stephen Ubl called the bill an “his­toric mis­take,” point­ing to re­cent Uni­ver­si­ty of Chica­go re­search which sug­gests the pro­posed leg­is­la­tion would lead to an es­ti­mat­ed 135 few­er drug ap­provals through 2039 and a $663 bil­lion drop in R&D spend­ing.

The Con­gres­sion­al Bud­get Of­fice (CBO), how­ev­er, es­ti­mat­ed the bill would re­duce drug­mak­ers’ 1,300 to­tal ap­provals by on­ly about 10 drugs over the next three decades.

Big Phar­ma is fight­ing like hell against the In­fla­tion Re­duc­tion Act—be­cause they KNOW it will LOW­ER DRUG COSTS.

Via @SenAmyK­lobuchar pic.twit­ter.com/nwKHWvwYa3

— Sen­ate De­moc­rats (@Sen­at­eDems) Au­gust 4, 2022

While the Sen­ate is out to­day, they’re re­con­ven­ing to­mor­row for a po­ten­tial vote, ac­cord­ing to Politi­co. 

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.