State at­tor­neys gen­er­al sue FDA over abor­tion pill ac­cess re­stric­tions

A dozen De­mo­c­rat at­tor­neys gen­er­al are su­ing the FDA in fed­er­al court in the East­ern Dis­trict of Wash­ing­ton to re­move all re­stric­tions on mifepri­s­tone, a pill used in com­bi­na­tion with an­oth­er med­i­cine to end ear­ly preg­nan­cies.

The suit comes as a Trump-ap­point­ed Texas fed­er­al judge is ex­pect­ed to soon de­cide on whether the pill should be pulled from the mar­ket. Mifepri­s­tone is cur­rent­ly used in more than half of all US abor­tions, ac­cord­ing to the Guttmach­er In­sti­tute. De­mo­c­rat Sen­a­tors have urged US At­tor­ney Gen­er­al Mer­rick Gar­land to quick­ly pre­pare an ap­peal to the de­ci­sion.

State at­tor­neys gen­er­al from Wash­ing­ton, Ore­gon, Ari­zona, Col­orado, Con­necti­cut, Delaware, Illi­nois, Michi­gan, Neva­da, New Mex­i­co, Rhode Is­land and Ver­mont in­di­cat­ed in their suit that the FDA has sin­gled out mifepri­s­tone with an un­nec­es­sary warn­ing, or REMS, on its la­bel.

“This case is about whether it is im­prop­er and dis­crim­i­na­to­ry for FDA to rel­e­gate mifepri­s­tone—a med­ica­tion that has been used over 5 mil­lion times with very low rates of com­pli­ca­tions, very high rates of ef­fi­ca­cy, and which is crit­i­cal to the re­pro­duc­tive rights of the Plain­tiff States’ res­i­dents, as well as vis­i­tors who trav­el to the Plain­tiff States to seek abor­tion care—to the very lim­it­ed class of dan­ger­ous drugs that are sub­ject to a REMS,” the com­plaint reads.

The FDA has al­ready loos­ened some re­stric­tions around mifepri­s­tone since its ap­proval in 2000. In a ma­jor re­cent change, the FDA said it would al­low cer­tain cer­ti­fied phar­ma­cies to dis­pense mifepri­s­tone. Pa­tients still need a pre­scrip­tion to re­ceive the drug, though they aren’t re­quired to see a health­care provider in per­son to get one, the FDA spec­i­fied.

But the AGs main­tained that the FDA has con­tin­ued to ham­per ac­cess by sin­gling out mifepri­s­tone “for a unique set of re­stric­tions” with its REMS.

“FDA’s de­ci­sion to con­tin­ue these bur­den­some re­stric­tions in Jan­u­ary 2023 on a drug that has been on the mar­ket for more than two decades with on­ly ‘ex­ceed­ing­ly rare’ ad­verse events has no ba­sis in sci­ence,” the suit says. “It on­ly serves to make mifepri­s­tone hard­er for doc­tors to pre­scribe, hard­er for phar­ma­cies to fill, hard­er for pa­tients to ac­cess, and more bur­den­some for the Plain­tiff States and their health care providers to dis­pense.”

Two weeks ago, more than a dozen food and drug law ex­perts al­so ar­gued that if the Texas rul­ing hap­pens and mifepri­s­tone is pulled from the mar­ket, the en­tire drug ap­proval process could be ham­strung by pol­i­tics.

Their ar­gu­ments are in re­sponse to a No­vem­ber 2022 Texas law­suit filed by the Al­liance for Hip­po­crat­ic Med­i­cine chal­leng­ing the 2000 ap­proval of mifepri­s­tone. The FDA has al­ready urged the Trump-ap­point­ed Judge Matthew Kac­s­maryk, who is pre­sid­ing over the case, to re­ject a pre­lim­i­nary in­junc­tion filed by abor­tion op­po­nents to with­draw the ap­proval for the drug.

The FDA de­clined to com­ment.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Cedric Ververken, Confo Therapeutics CEO

Dai­ichi Sankyo inks $183M dis­cov­ery deal with GPCR biotech for CNS tar­get

Belgian biotech Confo Therapeutics has landed $183 million, plus potential royalties, in a drug-discovery deal with Daiichi Sankyo.

Early Thursday, Confo Therapeutics put out word of the deal that will be focused on small molecule antagonists to go after an undisclosed target that the company says is associated with CNS diseases.

Confo CEO Cedric Ververken told Endpoints News that Daiichi originally reached out to learn about the biotech’s technology. He added that Confo, founded in 2015, will use its platform to drug a GPCR target that Daiichi has struggled with internally.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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Dif­fu­sion to hand Nas­daq spot to EIP Phar­ma for PhI­Ib de­men­tia study of ex-Ver­tex drug

One of the more than a dozen bidders for Diffusion Pharmaceuticals’ spot on Nasdaq has prevailed.

Boston biotech EIP Pharma will merge with Diffusion in an all-stock deal, with plans to start a Phase IIb clinical trial in the coming months in a common form of dementia with no approved treatments. The combined company will be renamed CervoMed.

The nine-year-old privately-held EIP is working on a former Vertex drug that it will test in a 160-person Phase IIb in patients with dementia with Lewy bodies, or DLB. The National Institute on Aging is expected to fund that trial with a $21 million grant. With the reverse merger, slated for closing in the middle of this year, EIP will be funded through that readout in the second half of 2024. EIP’s equity and debt holders will own about 77.25% of the combined company.

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Ivana Magovčević-Liebisch, Vigil Neuroscience CEO

FDA lifts par­tial clin­i­cal hold on Vig­il Neu­ro­science's TREM2 an­ti­body, re­mov­ing dos­ing cap

When Vigil Neuroscience filed its IPO papers in late 2021, the biotech revealed that the FDA had just cleared its Phase I trial — but with a partial clinical hold that limited dosing to under a certain level.

More than a year later, the FDA has lifted the hold.

Vigil is now free to dose VGL101, an antibody targeting TREM2, at levels higher than 20 mg/kg in its ongoing and future clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), an inherited condition that affects the brain and spinal cord.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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