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.”

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Eisai and METAvivor plan to debut the latest 'This is MBC' campaign at the San Antonio Breast Cancer Symposium (SABCS).

Ei­sai re-ups metasta­t­ic breast can­cer aware­ness cam­paign with strik­ing pa­tient pho­tographs

Eisai is debuting the newest ads in its long-running “This is MBC” campaign this week. In what’s become an annual tradition, Eisai and metastatic breast cancer advocacy partner METAvivor will show the striking photographs of people living with metastatic breast cancer first at the San Antonio Breast Cancer Symposium (SABCS).

The new “Imagine” campaign features 12 patients photographed around waterfalls to symbolize that same kind of sudden drop into a pool that MBC causes in a person’s life, said Beth Fairchild, co-founder of #CancerCulture who was the president of METAvivor six years ago when the campaign began. Fairchild, who is living with MBC, has helped create all of the annual “This is MBC” campaigns.

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Pfiz­er and BioN­Tech look to toss Mod­er­na patent suit, call­ing claims 'unen­force­able'

Pfizer and BioNTech took a swing at Moderna’s Covid-19 patent claims in Massachusetts federal court on Monday, calling them “invalid,” “overbroad” and “unenforceable.”

The defendants also filed counterclaims against the Cambridge, MA-based biotech, seeking a dismissal of the case, recovery of court fees and an official judgment invalidating Moderna’s claims.

Moderna sued Pfizer and BioNTech back in August, alleging that the partners’ Covid-19 vaccine Comirnaty copied parts of Moderna’s vaccine technology patented before the pandemic, when it was developing an mRNA vaccine for MERS, another respiratory illness.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Glen­mark hit with warn­ing let­ter over pro­ce­dures, qual­i­ty con­trol is­sues at In­dia man­u­fac­tur­ing plant

The generics producer Glenmark Pharmaceuticals has been handed a warning letter by US regulators.

The letter, which was sent to the manufacturer on Nov. 22, noted issues from an inspection over the summer at Glenmark’s facility in the town of Colvale, India, in the state of Goa.

According to the letter, the FDA found that Glenmark’s investigation of rejected batches of drugs “failed to extend to other batches, dosage strengths, and drug products.” The warning letter also noted that the site had failed to establish “adequate written procedures” for production and process control to ensure drugs have the correct strength, quality and purity.

Klick Health is lighting the way, literally, this holiday season to encourage connection for lonely seniors in long-term care facilities.

Klick Health an­nu­al hol­i­day spot­light se­nior lone­li­ness and the pow­er of con­nec­tion

Every year Klick Health leans into a cause for the holidays, and this year it’s highlighting the sometimes lonely season for seniors. So Klicksters, as employees call themselves, decided to brighten one nursing home community in hopes of inspiring others to do the same.

Klick literally lit up the Tony Stacey Centre for Veterans Care, a long-term care home in Toronto where 75% of residents receive no visitors during the holiday season. The agency brought staff and family along with lighting crews and musicians for a “Light the Way” event, creating a video of the experience debuting on Tuesday.

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Sum­i­to­vant sub­sidiaries En­zy­vant and Al­ta­vant merge in­to com­bined com­pa­ny

Two Sumitovant Biopharma entities are merging under one name, effective immediately.

Enzyvant Therapeutics and Altavant Sciences announced they have merged to form a singular entity focused on developing therapies for patients with rare diseases. The combined company will keep the name Enzyvant and along with clinical development will eventually include in-house manufacturing.

Bill Symonds, the current CEO of both Altavant and Enzyvant, is now CEO of the merged company.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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