HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thurs­day fi­nal­ized its de­ci­sion to with­draw a rule, pro­posed just be­fore for­mer Pres­i­dent Don­ald Trump left of­fice, that would’ve caused thou­sands of HHS and FDA reg­u­la­tions to au­to­mat­i­cal­ly ex­pire if they weren’t re­viewed with­in two years, and every 10 years there­after.

The de­ci­sion fol­lows the fil­ing of a law­suit last March, in which sev­er­al non­prof­its al­leged that the out­go­ing ad­min­is­tra­tion plant­ed “a tick­ing time­bomb” for HHS, es­sen­tial­ly forc­ing it to de­vote an enor­mous amount of re­sources to the un­prece­dent­ed and in­fea­si­ble task of re­view­ing thou­sands of reg­u­la­tions reg­u­lar­ly.

“The SUN­SET fi­nal rule, if im­ple­ment­ed, would have sig­nif­i­cant­ly al­tered the op­er­a­tions of HHS with con­sid­er­able neg­a­tive reper­cus­sions for a di­verse ar­ray of stake­hold­ers,” the fi­nal with­draw­al post­ing on Thurs­day said. “We now con­clude that these sig­nif­i­cant reper­cus­sions were not ad­e­quate­ly con­sid­ered in is­su­ing the SUN­SET fi­nal rule in part be­cause the process to pro­mul­gate the rule was ex­treme­ly un­usu­al, if not un­prece­dent­ed.”

As far as the on­go­ing lit­i­ga­tion, HHS added, “At the par­ties’ joint re­quest, the San­ta Clara lit­i­ga­tion has thus far been stayed.”

Had this with­draw­al of the SUN­SET rule not gone through, the FDA, ac­cord­ing to HHS, would have faced the mas­sive task of re­view­ing over 7,000 sec­tions of the CFR that were pro­mul­gat­ed by the agency and which are more than 10 years old or would be­come more than 10 years old dur­ing the first five years the rule would be in ef­fect, rep­re­sent­ing over 95% of the FDA’s cur­rent reg­u­la­tions.

And the fi­nal rule pro­vides no ex­cep­tions to avert the ex­pi­ra­tion of a reg­u­la­tion if it’s not re­viewed, even in the event of a pan­dem­ic, a pub­lic health emer­gency, or an­oth­er de­clared na­tion­al emer­gency.

FDA and HHS al­so ex­plain how they reg­u­lar­ly re­view their reg­u­la­tions, par­tic­u­lar­ly for FDA in re­sponse to cer­tain cit­i­zen pe­ti­tions.

“It should be not­ed at the out­set that HHS rec­og­nizes the im­por­tance of ret­ro­spec­tive re­view, al­ready con­ducts ret­ro­spec­tive re­views, and in­tends to con­tin­ue to con­sid­er how to im­prove these ex­ist­ing process­es,” the de­part­ment said in the Fed­er­al Reg­is­ter on Thurs­day.

The FDA al­so main­tains a web­site con­tain­ing its eco­nom­ic im­pact analy­ses of FDA reg­u­la­tions, with links to at least 170 reg­u­la­to­ry im­pact analy­ses the agency has de­vel­oped since 2012.

And the SUN­SET rule would’ve been tough on the en­ti­ties cov­ered by the reg­u­la­tions too, the with­draw­al no­tice from HHS says.

“For ex­am­ple, one com­menter ex­pressed con­cern that if the SUN­SET fi­nal rule is not with­drawn, their ad­vo­ca­cy or­ga­ni­za­tion would need to redi­rect re­sources to mon­i­tor the sta­tus of the ap­prox­i­mate­ly 2,000 FDA reg­u­la­tions and then, if need­ed, in­vest at least 40 to 100 hours per rule to pro­vide com­ments,” HHS said. “The ac­tu­al ex­pi­ra­tion of reg­u­la­tions could lead to con­fu­sion among stake­hold­ers and un­der­mine pre­dictabil­i­ty and con­fi­dence in many sec­tors reg­u­lat­ed by the De­part­ment.”

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.