Ab­b­Vie set­tles in­sur­ance fraud suit, agrees to tweak nurse am­bas­sador pro­gram; CStone aims for NSCLC OK with pos­i­tive PhI­II da­ta

Ab­b­Vie has re­solved a Cal­i­for­nia law­suit al­leg­ing in­sur­ance fraud in the pro­mo­tion of its cash cow Hu­mi­ra, pay­ing $24 mil­lion to set­tle things with the state’s in­sur­ance reg­u­la­tor.

The set­tle­ment comes al­most four years af­ter a whistle­blow­er first re­port­ed Ab­b­Vie’s prac­tice of de­ploy­ing reg­is­tered nurs­es to vis­it pa­tients at home or call them by phone to en­sure that Hu­mi­ra pre­scrip­tions are filled. Ab­b­Vie was al­so charged with pro­vid­ing il­le­gal kick­backs to doc­tors in an at­tempt to en­cour­age them to pre­scribe Hu­mi­ra for a range of an­ti-in­flam­ma­to­ry dis­eases.

The com­pa­ny de­nied any wrong­do­ing, and told Reuters that the nurse am­bas­sador pro­gram will con­tin­ue with no sig­nif­i­cant changes. Its ar­gu­ment has long been that they are sim­ply pro­div­ing ed­u­ca­tion and sup­port ser­vices for pa­tients.

It did, how­ev­er, agree to re­view some of its mar­ket­ing prac­tices. Among oth­er things, the am­bas­sadors will now dis­close to pa­tients that they work with Ab­b­Vie and won’t be al­lowed to dis­cuss spe­cif­ic pa­tients with doc­tors or in­sur­ance com­pa­nies. Hu­mi­ra sales reps will al­so be pro­hib­it­ed from invit­ing pre­scrib­ing health care providers to off­site busi­ness meals.

“Ab­b­Vie’s pri­or prac­tices in mar­ket­ing Hu­mi­ra egre­gious­ly put prof­its ahead of trans­paren­cy in pa­tient care and vi­o­lat­ed Cal­i­for­nia law,” said Cal­i­for­nia in­sur­ance com­mis­sion­er Ri­car­do Lara in a state­ment. “This set­tle­ment de­liv­ers im­por­tant re­forms to Ab­b­Vie’s busi­ness prac­tices and a sub­stan­tial mon­e­tary re­cov­ery that will be used to con­tin­ue to com­bat in­sur­ance fraud.” — Am­ber Tong

Eye­ing lu­cra­tive NSCLC mar­ket, CStone re­ports pos­i­tive PhI­II da­ta

CStone is on its way to­ward break­ing in­to the big non-small cell lung can­cer mar­ket.

The Chi­nese biotech re­leased in­ter­im da­ta from a Phase III tri­al Fri­day morn­ing show­ing that its an­ti-PD-L1 can­di­date CS1001, com­bined with plat­inum-based chemother­a­py, met its pri­ma­ry end­point for the first-line treat­ment of stage IV squa­mous and non-squa­mous NSCLC. The av­er­age pro­gres­sion-free sur­vival was 7.8 months for pa­tients us­ing the com­bo ver­sus 4.9 months with on­ly chemother­a­py.

Oth­er key da­ta high­lights in­clud­ed a well-tol­er­at­ed pro­file with no new safe­ty sig­nal de­tect­ed.

Check­point in­hibitors for lung can­cer have al­ready hit the mar­ket in Chi­na, with As­traZeneca’s PD-L1 Imfinzi join­ing the PD-1s made by Mer­ck and Bris­tol My­ers Squibb late last year. Weeks lat­er, Roche scored a PD-L1 green­light for Tecen­triq for the treat­ment of small cell lung can­cer.

But as In­novent, Jun­shi and Hen­grui have shown, do­mes­tic drug de­vel­op­ers are more than will­ing to com­pete on price. Should CStone’s can­di­date gain ap­proval, it could still shift the land­scape con­sid­er­ably. — Max Gel­man

FDA ap­proves Bay­er’s new for­mu­la­tion of old Cha­gas dis­ease drug

Bay­er’s new for­mu­la­tion of ni­fur­timox, an old­er drug used to treat Cha­gas dis­ease, has been ap­proved by US reg­u­la­tors.

The FDA green-lit Lampit on Fri­day morn­ing for use in new­borns and chil­dren un­der 18. Lampit, an an­tipro­to­zoal med­ica­tion, will be avail­able in a new, di­vid­able tablet that can be split by hand and is de­signed to dis­perse in wa­ter for those too young to swal­low. Pa­tients on Lampit will take a treat­ment reg­i­men for 60 days.

Spread by in­sect bites and caused by the par­a­site Try­panoso­ma cruzi, Cha­gas dis­ease can cause con­ges­tive heart fail­ure if left un­treat­ed. The drug re­ceived ac­cel­er­at­ed ap­proval based on the num­ber of pa­tients who be­came IgG neg­a­tive or who showed an at least 20% de­crease in op­ti­cal den­si­ty on two dif­fer­ent an­ti­body tests.

Bay­er is ex­pect­ed to con­tin­ue Phase III tri­als over the next three years to con­firm ef­fi­ca­cy and safe­ty. — Max Gel­man

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

News brief­ing: Tiny Vac­cinex's drug flops in PhII Hunt­ing­ton's tri­al, stock craters; Siol­ta nabs $30M Se­ries B to de­vel­op mi­cro­bio­me drug

Siolta Therapeutics, a microbiome company targeting allergic diseases, raked in a $30 million Series B to develop its lead candidate, STMC-103H. The drug, which has been FDA fast-tracked, is headed for proof-of-concept trials, according to the company. Its various indications include allergic asthma, food allergies, atopic dermatitis, allergic rhinitis, and allergy prevention.

The news comes just after the California-based biotech added a prominent biopharma veteran as an advisor: 20-year Gilead CEO John Martin. The biotech also gained Richard Shames as CMO, who came by way of Protagonist Therapeutics.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

Can a mag­net­ic cell ther­a­py re­place corneal trans­plan­ta­tion? As eight-year jour­ney leads to the clin­ic, two broth­ers un­veil bold vi­sion

Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

Embattled CDC director Robert Redfield (AP Images)

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee de­lays pri­or­i­ty dis­tri­b­u­tion vote; EU re­port­ed­ly in­dem­ni­fy­ing vac­cine mak­ers

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.

Anthony Coyle (Repertoire)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

Zai Lab hauls in $761M from Hong Kong IPO to push Ze­ju­la, more bud­ding can­di­dates in Chi­na — re­port

Zai Lab is set to net more than $761 million from its secondary listing in Hong Kong after pricing the IPO at $72.51 (HKD$562) — just a hair below its Nasdaq closing price on Monday, Bloomberg and Nikkei Asian Review reported.

A pioneer in bringing Western drugs to China, co-founder and CEO Samantha Du has more than tripled Zai Lab’s market cap in the three years it’s been public in the US. The HKEX listing is designed to fund R&D and commercialization for the current portfolio while fueling new in-licensing pacts, the biotech wrote in a filing.

Tae Han Kim, Samsung Biologics CEO (SeongJoon Cho/Bloomberg via Getty Images)

Sam­sung Bi­o­log­ics nets $330M+ deal from As­traZeneca ahead of 'Su­per Plan­t' con­struc­tion

Just a few weeks after announcing plans to construct a $2 billion “Super Plant,” Samsung Biologics is keeping its foot on the gas.

The Korean CDMO has inked a $330.8 million manufacturing contract with AstraZeneca, the companies announced Monday evening, providing the British drugmaker the ability to expand production capabilities in the Asia market. Per terms of the deal, the partnership could be increased to $545.6 million.