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.”

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Serhat Gumrukçu, Enochian BioSciences co-founder (Seraph Research Institute)

LA biotech founder ar­rest­ed, charged in mur­der-for-hire scheme be­hind 2018 death

A biotech founder has been arrested and charged for his role in a murder-for-hire scheme that resulted in the death of a man in Vermont back in 2018.

Serhat Gumrukçu, the co-founder of Enochian BioSciences, was arrested in Los Angeles, where the company is based, according to the Department of Justice. He was charged alongside Berk Eratay of Las Vegas, and a third person, Jerry Banks of Colorado, was previously arrested for kidnapping and allegedly murdering the victim, Gregory Davis.

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Adam Russell, ARPA-H's incoming acting deputy director

NI­H's new, in­de­pen­dent break­through drug ac­cel­er­a­tor ARPA-H gets its first em­ploy­ee

Despite the controversy of housing it in NIH, HHS Secretary Xavier Becerra on Wednesday afternoon formally announced the establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the NIH, as HHS had previously stipulated that “NIH may not subject ARPA-H to NIH policies.”

Becerra also announced the appointment of ARPA-H’s inaugural employee, Adam Russell, who will serve as acting deputy director.

ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.