Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Fol­low­ing the Supreme Court’s his­toric de­ci­sion on Fri­day to over­turn Amer­i­cans’ con­sti­tu­tion­al right to an abor­tion af­ter al­most 50 years, At­tor­ney Gen­er­al Mer­rick Gar­land sought to some­what re­as­sure women that states will not be able to ban the pre­scrip­tion drug some­times used for abor­tions.

Fol­low­ing the de­ci­sion, the New Eng­land Jour­nal of Med­i­cine al­so pub­lished an ed­i­to­r­i­al strong­ly con­demn­ing the re­ver­sal, say­ing it “serves Amer­i­can fam­i­lies poor­ly, putting their health, safe­ty, fi­nances, and fu­tures at risk.”

John Roberts

Doc­tors and physi­cian groups around the globe sim­i­lar­ly sound­ed alarm bells over the dra­mat­ic move, even as it was ex­pect­ed months ear­li­er. Jus­tices vot­ed 6-3 in fa­vor of over­turn­ing Roe v. Wade, with three of the jus­tices ap­point­ed un­der Pres­i­dent Don­ald Trump join­ing in the ma­jor­i­ty.

Chief Jus­tice John Roberts al­so vot­ed with the ma­jor­i­ty but said he would’ve tak­en “a more mea­sured course” than an out­right re­peal.

In their dis­sent­ing opin­ion, the three lib­er­al jus­tices wrote, “To­day’s de­ci­sion strips women of agency over what even the ma­jor­i­ty agrees is a con­test­ed and con­testable moral is­sue. It forces her to car­ry out the State’s will, what­ev­er the cir­cum­stances and what­ev­er the harm it will wreak on her and her fam­i­ly.”

Physi­cians of­fered sim­i­lar sen­ti­ments in pub­lic state­ments.

“Ex­pe­ri­ence around the world has demon­strat­ed that re­strict­ing ac­cess to le­gal abor­tion care does not sub­stan­tial­ly re­duce the num­ber of pro­ce­dures, but it dra­mat­i­cal­ly re­duces the num­ber of safe pro­ce­dures, re­sult­ing in in­creased mor­bid­i­ty and mor­tal­i­ty,” the NE­JM said in its ed­i­to­r­i­al.

Ster­ling Ran­sone

Ster­ling Ran­sone, pres­i­dent of the Amer­i­can Acad­e­my of Fam­i­ly Physi­cians, sim­i­lar­ly said he was “dis­ap­point­ed and dis­heart­ened” by the de­ci­sion to strike down these long­stand­ing pro­tec­tions.

“Al­low­ing each state to pass their own laws re­gard­ing ac­cess to re­pro­duc­tive health care, in­clud­ing abor­tion ser­vices and con­tra­cep­tion, ex­ac­er­bates in­equities in the health care sys­tem,” Ran­sone said in a state­ment. “These laws dis­pro­por­tion­ate­ly af­fect those pa­tients who are in un­der­rep­re­sent­ed groups and un­der­served ar­eas, which al­ready puts them at in­creased risk of ma­ter­nal death.”

Near­ly half of the 50 states could po­ten­tial­ly pass bills ban­ning abor­tions, which would fol­low years of in­creased re­stric­tions around abor­tions across the South and Mid­west.

The FDA, mean­while, per­ma­nent­ly lift­ed its in-per­son dis­pens­ing re­quire­ments for abor­tion pills in De­cem­ber. Abor­tions with mifepri­s­tone ac­count for about 40% of all abor­tions in the US.

While some may ar­gue that states could put fur­ther lim­i­ta­tions on the use of mifepri­s­tone, lawyers ar­gue that such state-to-state lim­i­ta­tions could be chal­lenged, par­tic­u­lar­ly by phar­ma com­pa­nies.

“If a court were to say a state could ban cer­tain drugs, the im­pli­ca­tions for the phar­ma­ceu­ti­cal in­dus­try are huge. Go­ing to get a [new drug ap­pli­ca­tion] with the FDA is not some puny process, right? It takes hun­dreds of mil­lions of dol­lars and some­times decades of re­search. Com­pa­nies en­dure those costs and time be­cause they think it’s go­ing to lead to a na­tion­wide li­cense to sell a prod­uct. If all of a sud­den states can ban prod­ucts, you can imag­ine com­pa­nies be­ing pret­ty up­set,” Greer Don­ley, an as­sis­tant pro­fes­sor at the Uni­ver­si­ty of Pitts­burgh School of Law, told Bloomberg re­cent­ly.

U.S. At­tor­ney Gen­er­al Mer­rick Gar­land al­so made clear in a state­ment on Fri­day that states would not be able to ban the use of the abor­tion pill:

And we stand ready to work with oth­er arms of the fed­er­al gov­ern­ment that seek to use their law­ful au­thor­i­ties to pro­tect and pre­serve ac­cess to re­pro­duc­tive care. In par­tic­u­lar, the FDA has ap­proved the use of the med­ica­tion Mifepri­s­tone. States may not ban Mifepri­s­tone based on dis­agree­ment with the FDA’s ex­pert judg­ment about its safe­ty and ef­fi­ca­cy.

Mass­a­chu­setts pre­vi­ous­ly sought to ban the use of a par­tic­u­lar opi­oid (most re­cent­ly pulled from the mar­ket) af­ter it won FDA ap­proval, but that ban was over­turned in court.

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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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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.

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:

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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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.

Bernhardt Zeiher, outgoing Astellas CMO (Astellas)

Q&A: Astel­las' re­tir­ing head of de­vel­op­ment re­flects on gene ther­a­py deaths

For anyone who’s been following discussions about the safety alarms surrounding the adeno-associated viruses (AAV) commonly used to deliver gene therapy, Astellas should be a familiar name.

The Japanese pharma — which bought out Audentes Therapeutics near the end of 2019 and later built a gene therapy unit around the acquisition — rocked the field when it reported three patient deaths in a trial testing AT132, the lead program from Audentes designed to treat a rare muscle disease called X-linked myotubular myopathy (XLMTM).

When the company restarted the trial, it adjusted the dose and instituted a battery of other measures to try to prevent the same thing from happening again. But tragically, the first patient to receive the new regimen died just weeks after administration. The therapy remains under clinical hold, and just weeks ago, Astellas flagged another safety-related hold for a separate gene therapy candidate. In the process of investigating the deaths, the company has also taken flak about the way it disclosed information.

Big questions remain — questions that can have big implications about the future of AAV gene therapies.

Bernhardt Zeiher did not imagine any of it when he first joined Astellas as the therapeutic area leader in inflammation, immunology and infectious diseases. But his ascent to chief medical officer and head of development coincided almost exactly with Astellas’ big move into gene therapy, putting him often in the driver’s seat to grapple with the setbacks.

As Zeiher prepares to retire next month after a 12-year tenure — leaving the unfinished tasks to his successor, a seasoned cancer drug developer — he chatted with Endpoints News, in part, to discuss the effort to understand what happened, lessons learned and the criticism along the way.

The transcript has been lightly edited for length and clarity.

Endpoints: I want to also ask you a bit about the gene therapy efforts you’ve been working on. Astellas has really been at the forefront of discovering the safety concerns associated with AAV gene therapy. What’s that been like for you?

Zeiher: Well, I have to admit, it’s been a bit of a roller coaster. We acquired Audentes. Huge amount of enthusiasm. What we saw with AT132 — that was the lead program in XLMTM — was just remarkable efficacy. I mean, kids who went from being on ventilators, not able to eat for themselves, sit up, do things like that, to off ventilators, walking, you know, really — one investigator called it this Lazarus-like effect. It was just really dramatic efficacy. And then to have the safety events that occurred. So they actually occurred within that first year of the acquisition. So we had the three patient deaths. Me and my organization became very, very much involved. In fact, Ed Conner, who had been the chief medical officer, he left after some of the deaths, but I stepped in as the kind of acting chief medical officer, we had another chief medical officer who was involved, and then we had a fourth death, and I became acting again for a period of time.

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