The FDA’s cam­paign against the “bad ac­tors” op­er­at­ing in re­gen­er­a­tive med­i­cine is far from com­plete.

The reg­u­la­tor on Tues­day ad­mon­ished San Diego-based Stem­Genex Bi­o­log­ic Lab­o­ra­to­ries LLC for mar­ket­ing an un­ap­proved stem cell prod­uct and point­ed out sig­nif­i­cant vi­o­la­tions that could cor­rupt the man­u­fac­tur­ing process, po­ten­tial­ly cul­mi­nat­ing in mi­cro­bial con­t­a­m­i­na­tion that put pa­tients at risk.

The crack­down on clin­ics sell­ing re­gen­er­a­tive med­i­cines for a host of un­ap­proved in­di­ca­tions con­tin­ues to gath­er steam, as the agency makes good on its 2017 promise to en­sure un­scrupu­lous play­ers mar­ket­ing un­proven and of­ten dan­ger­ous prod­ucts are held to ac­count.

The field en­ticed a grow­ing list of com­pa­nies that have “op­por­tunis­ti­cal­ly seized on the clin­i­cal po­ten­tial of re­gen­er­a­tive med­i­cine” to make du­bi­ous claims to pa­tients that of­ten suf­fer from in­cur­able, de­bil­i­tat­ing dis­eases, the agency un­der­scored in a state­ment in Au­gust 2017.

We’ve seeen, and tak­en steps to sup­port, ma­jor progress in re­gen­er­a­tive med­i­cine in re­cent years. But we con­tin­ue to see bad ac­tors ex­ploit field’s promise to mis­lead vul­ner­a­ble pa­tients about safe­ty, ef­fi­ca­cy of treat­ments. Our lat­est en­force­ment ac­tion: https://t.co/NSk­fEYjfCt pic.twit­ter.com/Kv3plSoU­uZ

— Scott Got­tlieb, M.D. (@SGot­tliebF­DA) No­vem­ber 14, 2018

In Stem­Genex’s case, the FDA found the com­pa­ny was pro­cess­ing body fat in­to stro­mal vas­cu­lar frac­tion (SVF) — a cel­lu­lar prod­uct — and “il­le­gal­ly” mar­ket­ing it for se­ri­ous, of­ten life-threat­en­ing dis­eases, in­clud­ing di­a­betes, fi­bromyal­gia, spinal cord in­jury, chron­ic ob­struc­tive pul­monary dis­ease and mus­cu­lar dy­s­tro­phy. And they ad­min­is­ter it by IV, in­hala­tion and di­rect­ly in­to the spinal canal.

This prod­uct, which in­volves more than the min­i­mal ma­nip­u­la­tion of a pa­tient’s adi­pose tis­sue, is reg­u­lat­ed as both a drug and bi­o­log­i­cal prod­uct, but the agency said that no such li­cens­es or ap­provals have been sanc­tioned or ap­plied for.

On the com­pa­ny’s web­site, its pro­pri­etors claim:

Stem­Genex Stem Cell Re­search Cen­tre and af­fil­i­ates do not claim that treat­ment us­ing au­tol­o­gous stem cells are a cure for any con­di­tion, dis­ease, or in­jury. Adi­pose-de­rived stem cell ther­a­py is not a part of FDA ap­proved stem cell ther­a­pies and is not a con­sid­ered a cure for any med­ical con­di­tion. All state­ments and opin­ions pro­vid­ed on this web­site are for ed­u­ca­tion­al and in­for­ma­tion­al pur­pos­es on­ly and we do not di­ag­nose or give med­ical ad­vise via this web­site.

As part of its warn­ing let­ter sent to Stem­Genex on Oc­to­ber 31, FDA al­so list­ed a num­ber of de­vi­a­tions from cur­rent good man­u­fac­tur­ing prac­tice re­quire­ments in the man­u­fac­ture of the SVF prod­uct, in­clud­ing un­val­i­dat­ed man­u­fac­tur­ing process­es and an un­con­trolled en­vi­ron­ment.

The warn­ing let­ter is the lat­est in a slate of warn­ings is­sued by the reg­u­la­tor since last year. Last Jan­u­ary, the FDA slapped a sim­i­lar warn­ing on New Jer­sey-based Amer­i­can CryoStem Corp, in ad­di­tion to warn­ings is­sued to or­ga­ni­za­tions in Flori­da and Cal­i­for­nia in 2017 to ad­dress such prod­ucts be­ing mar­ket­ed.

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.