Law ex­perts ar­gue that abor­tion drug with­draw­al would 'un­der­mine' the ap­proval process

More than a dozen food and drug law ex­perts ar­gued on Wednes­day that yank­ing the med­ica­tion abor­tion drug mifepri­s­tone from the mar­ket would “un­der­mine the drug ap­proval process far be­yond the con­text of mifepri­s­tone’s ap­proval.”

The com­ments are in re­sponse to a Texas law­suit chal­leng­ing the 2000 ap­proval of mifepri­s­tone, which is used in com­bi­na­tion with miso­pros­tol to end preg­nan­cies with­in the first 10 weeks. Nine­teen schol­ars from sev­er­al uni­ver­si­ties — in­clud­ing Har­vard and Stan­ford’s law schools — ar­gued in an am­i­cus brief that a pre­lim­i­nary or­der to with­draw mifepri­s­tone’s ap­proval would be “un­prece­dent­ed and in­ap­pro­pri­ate.”

“Fi­nal­ly, over­rid­ing FDA’s safe­ty and ef­fi­ca­cy de­ter­mi­na­tion and forc­ing FDA to with­draw a long­stand­ing drug ap­proval would pro­found­ly un­der­mine the statu­to­ry and reg­u­la­to­ry frame­work un­der­pin­ning the ap­proval of new drugs, there­by threat­en­ing pa­tient ac­cess to ther­a­peu­tics and chill­ing in­dus­try re­search and de­vel­op­ment,” they wrote.

The am­i­cus, or “friend of the court,” brief was one of six filed on Wednes­day, in­clud­ing let­ters from the non­prof­it Doc­tors for Amer­i­ca, Re­pub­li­can at­tor­neys gen­er­al and De­mo­c­ra­t­ic at­tor­neys gen­er­al.

While the Re­pub­li­can AGs took is­sue with what they called a “wide-rang­ing mail-or­der abor­tion-drug regime,” De­moc­rats (and one Re­pub­li­can AG) coun­tered that mifepri­s­tone has been “par­tic­u­lar­ly crit­i­cal in pro­vid­ing ac­cess to abor­tion in low-in­come, un­der­served, and rur­al com­mu­ni­ties where pro­ce­dur­al abor­tion may be un­avail­able.”

“And be­cause med­ica­tion abor­tion is the most com­mon method used to ter­mi­nate preg­nan­cy dur­ing the first trimester, elim­i­nat­ing ac­cess to this method will re­sult in more abor­tions tak­ing place lat­er in preg­nan­cy, fur­ther in­creas­ing costs and med­ical risks,” they wrote.

Last month, the FDA urged US Dis­trict Judge Matthew Kac­s­maryk to re­ject a pre­lim­i­nary in­junc­tion re­quest­ed by abor­tion op­po­nents, which would re­quire the with­draw­al of all mifepri­s­tone ap­provals. Reg­u­la­tors ar­gued that a with­draw­al would de­prive peo­ple of a safe and ef­fec­tive drug.

Med­ica­tion abor­tion ac­count­ed for more than half of US abor­tions in 2020, and last month, the FDA ap­proved a mod­i­fi­ca­tion that al­lows cer­tain “spe­cial­ly cer­ti­fied” phar­ma­cies to dis­pense mifepri­s­tone. Pre­vi­ous­ly, poli­cies re­quired pa­tients to re­ceive the drug in a clin­ic, med­ical of­fice or hos­pi­tal, though reg­u­la­tors didn’t en­force in-per­son re­quire­ments at cer­tain times dur­ing the pan­dem­ic.

Up­on con­duct­ing re­views, the FDA said that “there did not ap­pear to be a dif­fer­ence in ad­verse events be­tween pe­ri­ods when in-per­son dis­pens­ing was and was not en­forced.” The mod­i­fi­ca­tion ap­plies to both Dan­co Labs’ brand-name Mifeprex pills and a gener­ic man­u­fac­tured by Gen­Bio­Pro.

“Plain­tiffs are al­so in­cor­rect in as­sert­ing that FDA ap­proved mifepri­s­tone on the ba­sis of in­ad­e­quate ev­i­dence. To the con­trary, FDA has con­duct­ed mul­ti­ple full and com­plete re­views of mifepri­s­tone’s safe­ty and ef­fi­ca­cy, and each time, it act­ed prop­er­ly in de­ter­min­ing that the drug meets the ap­proval stan­dards of the FD­CA and is ap­pro­pri­ate­ly la­beled,” the food and drug schol­ars wrote.

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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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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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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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FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Blue­bird to miss Q1 dead­line for lo­vo-cel fil­ing, shares sliced

Bluebird bio had expected to submit a BLA for its sickle cell disease gene therapy lovotibeglogene autotemcel, or lovo-cel, by Friday. Now, that deadline is getting punted for at least a couple of weeks.

CEO Andrew Obenshain detailed the update during the company’s full-year earnings call Wednesday morning after the gene therapy specialist reported the development in its Q4 and 2022 report.

“We will likely miss the Q1 2023 submission goal,” Obenshain said, noting the application is fully written and ready to go. But bluebird is still waiting on FDA feedback for the company’s CMC module submitted in early March.