FDA urges fed­er­al judge to pro­tect abor­tion pill ac­cess

The FDA has urged US Dis­trict Judge Matthew Kac­s­maryk to re­ject a pre­lim­i­nary in­junc­tion filed by abor­tion op­po­nents to with­draw the ap­proval for the drug used in med­ica­tion-re­lat­ed abor­tions, ac­cord­ing to court fil­ings made avail­able Tues­day.

The fil­ings were sub­mit­ted via a Nov. 2022 law­suit brought in Texas by the Amer­i­can As­so­ci­a­tion of Pro-Life Ob­ste­tri­cians and Gy­ne­col­o­gists and oth­er or­ga­ni­za­tions.

The suit chal­lenges the 2000 ap­proval of the drug mifepri­s­tone, which when used with miso­pros­tol, is ap­proved to stop preg­nan­cies with­in the first 10 weeks. Lawyers for those fil­ing the suit al­so claim that the agency ig­nored the po­ten­tial im­pact of the drug on mi­nors and im­prop­er­ly used its ac­cel­er­at­ed ap­proval au­thor­i­ty to ap­prove mifepri­s­tone.

In its bid for re­jec­tion of the pre­lim­i­nary in­junc­tion, the FDA said the re­quest was “based on spec­u­la­tive al­le­ga­tions of harm” and that the ar­gu­ments made were “un­time­ly, un­ex­haust­ed, and with­out mer­it.” The FDA al­so said that ap­prov­ing the in­junc­tion would cause harm by de­priv­ing peo­ple of a safe and ap­proved drug.

There has been more fo­cus on med­ical abor­tions af­ter the June over­turn­ing of the land­mark case Roe v. Wade. As of Oct. 2, 15 states have en­forced to­tal or up to 15-week abor­tion bans, ac­cord­ing to the Guttmach­er In­sti­tute while 44 states pro­hib­it some abor­tions af­ter a cer­tain point in preg­nan­cy.

“It would up­end the sta­tus quo and the re­liance in­ter­ests of pa­tients and doc­tors who de­pend on mifepri­s­tone, as well as busi­ness­es in­volved with mifepri­s­tone dis­tri­b­u­tion,” lawyers for the FDA said in the fil­ing to Kac­s­maryk.

Mifepri­s­tone, man­u­fac­tured by Dan­co Lab­o­ra­to­ries un­der the name Mifeprex, is the com­pa­ny’s sole prod­uct. On Jan. 3, the FDA said for the first time that mifepri­s­tone will be al­lowed to be dis­pensed at re­tail phar­ma­cies. It is wide­ly used by women seek­ing to end preg­nan­cies med­ical­ly ver­sus sur­gi­cal­ly. Med­ical abor­tions ac­count­ed for 53% of all fa­cil­i­ty-based abor­tions in the US in 2020, ac­cord­ing to the Guttmach­er In­sti­tute.

Dan­co has al­so en­tered the fight, ac­cord­ing to court doc­u­ments filed on Jan. 13. Dan­co has re­quest­ed the abil­i­ty to in­ter­vene in the law­suit to pro­tect its abil­i­ty to sell the drug and avoid go­ing out of busi­ness.

“Forc­ing FDA to with­draw a long­stand­ing ap­proval would seis­mi­cal­ly dis­rupt the agency’s gov­ern­ing au­thor­i­ty as to whether drugs are safe and ef­fec­tive, and would cause Dan­co di­rect and im­me­di­ate harm by shut­ter­ing its busi­ness,” lawyers for the com­pa­ny wrote to the Trump-ap­point­ed judge in ask­ing him to re­ject the pre­lim­i­nary in­junc­tion.

Lawyers for Dan­co took an­oth­er shot at the fil­ers’ ar­gu­ment that ac­cess to the drug caused ir­repara­ble harm.

“A third par­ty’s use of a fed­er­al­ly ap­proved drug does not cause or­ga­ni­za­tions or oth­er providers ‘ir­repara­ble harm.’ That is all the more so when women have been able to law­ful­ly ac­cess the drug for over 22 years,” the fil­ing reads.

US At­tor­ney Gen­er­al Mer­rick Gar­land made a point af­ter the fall of Roe v. Wade to de­clare that states would not be able to ban the use of the abor­tion pill “based on dis­agree­ment with the FDA’s ex­pert judg­ment about its safe­ty and ef­fi­ca­cy.”

Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

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Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

Am­gen launch­es the first US Hu­mi­ra biosim­i­lar at two dif­fer­ent list prices

The bizarre dynamics of the US prescription drug market were on full display once again this morning as Amgen announced that it would launch the first US biosimilar for Humira, the best-selling drug of all time, at two completely different list prices.

One price for Amgen’s Amjevita (adalimumab-atto) will be 55% below the current Humira list price, which is about $84,000 per year, and another at a list price 5% below the current Humira list price, but presumably (pharma companies don’t disclose rebates) with high rebates to attract PBMs and payers.

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New York City in­vests $20M in­to biotech 'in­no­va­tion space' at the Brook­lyn Navy Yard

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Dirk Thye, Quince Therapeutics CEO

Af­ter piv­ot­ing from Alzheimer's to bone con­di­tions, biotech piv­ots again — and halves its head­count

When troubled public biotech Cortexyme bought a private startup named Novosteo and handed the keys to its executive team, the company — which changed its name to Quince Therapeutics — said it would shift its focus from an unorthodox Alzheimer’s approach to Novosteo’s bone-targeting drug platform.

Less than a year later, Quince is pivoting again.

The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release.

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Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

Troy Tazbaz, FDA's newly-named director of the Digital Health Center of Excellence (Oracle via YouTube)

Or­a­cle ex­ec­u­tive Troy Tazbaz named new FDA di­rec­tor of dig­i­tal health

The FDA has found a brand new director of the Digital Health Center of Excellence in Troy Tazbaz, a former senior vice president at Oracle.

According to Tazbaz’s LinkedIn, he took a five-month break after leaving an 11-year career at Oracle before joining the FDA in January. Stat News first reported the hire. Tazbaz also said on his LinkedIn that he biked all the way from Chesapeake Bay to the San Francisco Bay over 58 days during his career break.

Chad Mirkin, Flashpoint co-founder

‘The field is at a flash­point’: New Chad Mirkin-found­ed biotech hopes to make more ef­fec­tive can­cer vac­cines

Following the success of the mRNA Covid vaccines, cancer vaccines are seeing renewed interest after years of middling results. But a group of researchers suggests that more attention needs to be paid not to what goes into those vaccines, but how the parts are put together.

In a recent paper published in Nature Biomedical Engineering, researchers led by Northwestern University’s Chad Mirkin describe how the placement of different antigens in a cancer vaccine impacts its efficacy. The paper builds on past work done by Mirkin’s lab that suggests the structure, or how the parts of a vaccine are arranged, impact a vaccine’s efficacy, not just its components.

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