Ex-FDA of­fi­cials ask SCO­TUS to take up J&J talc case; An­no­vis shows da­ta from PhII Parkin­son's tri­al

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.”

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

Can South Dako­ta's trans­genic cows help treat the flu?; A speedy re­view for Mer­ck­'s Pre­vnar ri­val in kids

Wednesday brought another win for South Dakota’s biggest transgenic cow so far.

SAB Biotherapeutics, which develops treatments by collecting and distilling antibodies from cows with humanized immune systems, announced that its antibody treatment for flu passed an early-stage challenge study.

Volunteers were intentionally exposed to the flu virus and then given infusions of the SAB antibody treatment or placebo. Those who received the antibody treatment saw a significantly greater reduction in viral load and symptoms than those who received placebo. The company didn’t release numbers but said the p-value was 0.026.

Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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