Eight for­mer FDA of­fi­cials, in­clud­ing for­mer FDA com­mis­sion­er An­drew von Es­chen­bach and mul­ti­ple deputy com­mis­sion­ers, sub­mit­ted an am­i­cus brief to the Supreme Court yes­ter­day — ask­ing for the Court to re­view the Mis­sis­sip­pi Supreme Court de­ci­sion that ruled against J&J ear­li­er this year.

Mis­sis­sip­pi’s com­plaint in 2014 ac­cused the mega-com­pa­ny of vi­o­lat­ing con­sumer pro­tec­tion laws by not dis­clos­ing ovar­i­an can­cer risks to women posed by its ba­by pow­der con­tain­ing talc.

J&J sought sum­ma­ry judg­ment in its ap­peal to the court, ar­gu­ing the Mis­sis­sip­pi Con­sumer Pro­tec­tion Act doesn’t ap­ply to the la­bel­ing of prod­ucts reg­u­lat­ed by the fed­er­al Food and Drug Ad­min­is­tra­tion. The Mis­sis­sip­pi Supreme Court dis­agreed, and af­firmed a low­er court’s pre­vi­ous rul­ing.

The for­mer of­fi­cials ar­gue that no­tice-and-com­ment rule­mak­ing, which the FDA of­fi­cials say is rarely used, sub­verts and up­ends the FDA’s sys­tem and au­thor­i­ty over la­bel­ing.

“By strip­ping the FDA’s la­bel­ing de­ci­sions of pre­emp­tive ef­fect un­less they first un­der­go no­tice-and-com­ment rule­mak­ing, the de­ci­sion leaves the agency with an im­pos­si­ble choice: sac­ri­fice the flex­i­bil­i­ty it needs to over­see thou­sands of prod­ucts in an ever-shift­ing mar­ket, or al­low its sci­en­tif­i­cal­ly sound warn­ings to be crowd­ed out by con­flict­ing state-im­posed la­bels,” the of­fi­cials wrote.

The ex-of­fi­cials fur­ther re­it­er­at­ed that the FDA lacks time and re­sources to run every de­ci­sion through no­tice-and-com­ment rule­mak­ing.

“Ac­cord­ing to the Mis­sis­sip­pi Supreme Court, that re­al­i­ty means FDA must share la­bel­ing au­thor­i­ty with all 50 states, any one of which can re­quire a la­bel specif­i­cal­ly re­ject­ed by FDA as sci­en­tif­i­cal­ly un­sound,” the of­fi­cials wrote.

Ul­ti­mate­ly they want the Supreme Court to “clar­i­fy the law of pre­emp­tion and pre­vent the Mis­sis­sip­pi Supreme Court’s de­ci­sion from dis­rupt­ing FDA’s vi­tal func­tions,” the writ­ers said.

An­no­vis Bio un­veils Phase II ef­fi­ca­cy da­ta for Parkin­son’s dis­ease treat­ment

Penn­syl­va­nia biotech An­no­vis Bio re­leased re­sults from the sec­ond part of a Phase II clin­i­cal tri­al of Parkin­son’s drug can­di­date AN­VS401 in 54 pa­tients, which found that once-dai­ly AN­VS401 was su­pe­ri­or to place­bo in im­prov­ing mo­tor func­tion.

The first part of the study made head­lines and caused share prices to soar up­wards of 140% af­ter pa­tients’ cog­ni­tive im­prove­ment scores in­creased by 30% back in May for sub­jects with ei­ther Parkin­son’s dis­ease or Alzheimer’s dis­ease.

The sec­ond part of the study ex­pand­ed on the orig­i­nal 14 AD and 14 PD pa­tients by re­cruit­ing an ad­di­tion­al 40 PD pa­tients, who were treat­ed with ei­ther 0mg, 5mg, 10mg, 20mg, 40mg or 80mg of AN­VS401 once dai­ly. Safe­ty and two psy­cho­me­t­ric as­sess­ments were con­duct­ed at day 0 and day 25, com­par­ing AN­VS401-dosed PD pa­tients with those dosed with place­bo.

When com­pared to the place­bo group, sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ments in a WAIS psy­cho­me­t­ric cod­ing test were ob­served in PD pa­tients tak­ing AN­VS401 5mg, 20mg and 80mg once dai­ly, high­light­ing in­creased mo­tor dex­ter­i­ty, as well as speed and ac­cu­ra­cy com­pared to place­bo. PD pa­tients treat­ed with AN­VS401 10mg and 20mg once dai­ly showed sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ments in the UP­DRS psy­cho­me­t­ric test com­pared to base­line.

These re­sults pro­vide guid­ance as to what dosage to use in up­com­ing Phase III stud­ies in both AD and PD pa­tients, ac­cord­ing to a com­pa­ny state­ment.

“We are still an­a­lyz­ing cer­tain bio­mark­er da­ta from the 54 PD pa­tients and will share the re­sults when they are avail­able. We will be ask­ing the FDA for a meet­ing to re­ceive guid­ance on next steps in clin­i­cal de­vel­op­ment in light of the AD/PD Phase II clin­i­cal re­sults,” said An­no­vis founder, pres­i­dent and CEO Maria Mac­cec­chi­ni in a state­ment.

IpiNovyx Bio clos­es $10 mil­lion seed fi­nanc­ing round

With a fo­cus on au­toim­mune and in­flam­ma­to­ry dis­eases, IpiNovyx Bio closed a $10 mil­lion seed fi­nanc­ing round to­day, the com­pa­ny an­nounced in a state­ment.

The fi­nanc­ing, led by Vi­va BioIn­no­va­tor of Vi­va Biotech, al­so had par­tic­i­pants such as Eli Lil­ly and the New York-based IpiNovyx founder Or­ange Grove Bio. Funds raised will go to­ward ad­vanc­ing so-called im­muno­pro­tea­some in­hibitors in­to hu­man tri­als.

“Pa­tients suf­fer­ing from au­toim­mune and in­flam­ma­to­ry dis­eases are faced with lim­it­ed treat­ment op­tions and most ther­a­pies that are avail­able are non-se­lec­tive and car­ry sig­nif­i­cant tox­i­c­i­ty con­cerns. We are ea­ger to con­tin­ue our re­search in this area and work to ad­vance these best-in-class im­muno­pro­tea­some in­hibitors in­to hu­man clin­i­cal tri­als,” said Carl Nathan, a Cor­nell im­mu­nol­o­gist and one of the sci­en­tif­ic founders at IpiNovyx.

“This seed fund­ing will en­able the com­pa­ny to rapid­ly progress through pre­clin­i­cal stud­ies and in­to the clin­ic with the goal of de­liv­er­ing life chang­ing ther­a­pies to pa­tients suf­fer­ing from au­toim­mune and in­flam­ma­to­ry dis­eases,” said Marc Ap­pel, co-founder and CEO of both IpiNovyx and Or­ange Grove Bio, in a state­ment.

Aditxt to ac­quire AiPhar­ma, the rights hold­er of Covid-19 an­tivi­ral Avi­gan by end of No­vem­ber

Vir­ginia biotech Aditxt said to­day that it en­tered a trans­ac­tion agree­ment to reach a de­fin­i­tive agree­ment by the end of No­vem­ber to ac­quire AiPhar­ma, which holds ex­clu­sive rights to Avi­gan and all for­mu­la­tions of an­tivi­ral favipi­ravir, used in dif­fer­ent coun­tries as a Covid-19 an­tivi­ral treat­ment.

The oral an­tivi­ral pill has ei­ther full mar­ket­ing au­tho­riza­tion or EUA in a num­ber of mar­kets as a treat­ment for Covid-19, in­clud­ing Mex­i­co, In­dia, In­done­sia, Thai­land and Malaysia, ac­cord­ing to a com­pa­ny state­ment. Oth­er coun­tries buy­ing the drug un­der com­pas­sion­ate use pro­grams in­clude the Unit­ed King­dom, Unit­ed Arab Emi­rates, Greece, Hun­gary and Sau­di Ara­bia.

“The suc­cess­ful com­ple­tion of this ac­qui­si­tion would ac­cel­er­ate our com­mer­cial­iza­tion plans in the in­fec­tious dis­ease space,” said Aditxt co-founder and CEO Am­ro Al­ban­na. “While ini­tial­ly tar­get­ing COVID-19, our com­bined clin­i­cal and com­mer­cial plat­form would po­ten­tial­ly ad­dress un­met needs in oth­er vi­ral in­di­ca­tions. We look for­ward to part­ner­ing with the team at AiPhar­ma and its con­sor­tium mem­bers.”

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.