Photo: Allen G. Breed/AP Images (file)

Gener­ic abor­tion drug man­u­fac­tur­er sues West Vir­ginia over re­stric­tions

One of the gener­ic man­u­fac­tur­ers of a drug used to end ear­ly preg­nan­cies sued West Vir­ginia’s at­tor­ney gen­er­al to­day, claim­ing that fed­er­al law and the FDA’s reg­u­la­tions su­per­sede West Vir­ginia’s law ban­ning the drug.

The case will like­ly be close­ly fol­lowed, giv­en the fact that med­ica­tion abor­tions are now the ma­jor­i­ty of all abor­tions, and as the Supreme Court last Sep­tem­ber re­voked the right to abor­tion, paving the way for bans in al­most all cas­es. And if West Vir­ginia’s re­stric­tions are over­turned, as Gen­Bio­Pro claims they “func­tion­al­ly dis­place FDA’s judg­ment in ap­prov­ing mifepri­s­tone and im­pos­ing a REMS,” this might be a test case for oth­er states.

But the suit notes that even be­fore Roe v. Wade was over­turned, West Vir­ginia had re­stric­tions around the use of mifepri­s­tone, in­clud­ing a wait­ing pe­ri­od re­quire­ment be­fore ob­tain­ing it, and a pro­hi­bi­tion on ob­tain­ing it via telemed­i­cine.

“Fed­er­al law pre­empts West Vir­ginia’s Ban and Re­stric­tions,” the gener­ic drug com­pa­ny Gen­Bio­Pro wrote in its suit in West Vir­ginia dis­trict court Wednes­day. “These laws im­per­mis­si­bly re­strict pa­tients’ ac­cess to mifepri­s­tone and Gen­Bio­Pro’s op­por­tu­ni­ty and abil­i­ty to mar­ket, pro­mote, and sell the med­ica­tion in the State.”

The com­pa­ny al­so makes clear that Con­gress au­tho­rized the FDA, and on­ly the FDA, to im­pose its re­stric­tions on ac­cess to mifepri­s­tone.

“West Vir­ginia can­not over­ride FDA’s de­ter­mi­na­tions about the ap­pro­pri­ate re­stric­tions on a med­ica­tion that FDA ap­proved for use and Con­gress sub­ject­ed to this en­hanced reg­u­la­to­ry regime,” they added.

Ear­li­er this month, the FDA an­nounced that cer­tain phar­ma­cies could be­gin dis­pens­ing mifepri­s­tone. Af­ter con­duct­ing a “com­pre­hen­sive re­view” of mifepri­s­tone’s risk eval­u­a­tion and mit­i­ga­tion strat­e­gy (REMS) — which pre­vi­ous­ly re­quired pa­tients to re­ceive the drug in a clin­ic, med­ical of­fice or hos­pi­tal — the agency ap­proved a mod­i­fi­ca­tion that per­mits cer­ti­fied phar­ma­cies to sell Dan­co Lab­o­ra­to­ries’ brand-name Mifeprex pills and the gener­ic man­u­fac­tured by Gen­Bio­Pro.

Gen­Bio­Pro’s suit al­so al­leges that West Vir­ginia law vi­o­lates the Com­merce Clause “by pre­vent­ing providers from pre­scrib­ing mifepri­s­tone via telemed­i­cine,” mean­ing that pa­tients are re­quired to vis­it a health­care pro­fes­sion­al in per­son to ob­tain a pre­scrip­tion.

Since 2019, when it first won ap­proval for its gener­ic mifepri­s­tone, Gen­Bio­Pro said it has mar­ket­ed and sold ap­prox­i­mate­ly 850,000 units of the drug.

Mean­while, pre­vi­ous phar­ma com­pa­nies have chal­lenged state bans on cer­tain drugs, like with the pow­er­ful opi­oid Zo­hy­dro in Mass­a­chu­setts in 2014, and won in court.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Sen. Maria Cantwell (D-WA) (Drew Angerer/Pool via AP)

Sen­ate com­mit­tee ad­vances PBM bill as bi­par­ti­san re­forms gain trac­tion

Pharmacy benefit managers are beginning to see enemies on both sides of the aisle: On Wednesday, a US Senate committee advanced to the full chamber a bill to increase PBM transparency and crack down on what lawmakers and critics say are deceptive practices.

The Senate Committee on Commerce, Science and Transportation advanced the bill by a bipartisan 18-9 vote, after hearing testimony last February documenting how PBMs control several key areas of the drug distribution and payment system. The Pharmacy Benefit Manager Transparency Act, introduced by committee chair Maria Cantwell (D-WA) and Budget Committee ranking member Chuck Grassley (R-IA), would make it unlawful for PBMs to engage in:

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.