Sen. Kyrsten Sinema (D-AZ) (Tom Williams/CQ Roll Call via AP Images)

De­moc­rats se­cure sup­port from key sen­a­tor ahead of po­ten­tial drug pric­ing vote

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. 

“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.

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

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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BREAK­ING: Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck 5 years ago, where the soft spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

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:

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

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.

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

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.”

Sen­ate Dems cling to a sim­ple ma­jor­i­ty to pass some of the biggest drug pric­ing re­forms ever

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.

FDA's vac­cine ad­comm to re­view first fe­cal trans­plant to treat C. dif­fi­cile in­fec­tions

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.