'Blue Brain Boost': FDA blocks Col­orado cou­ple from im­port­ing and re­selling drugs from Chi­na

A Col­orado-based cou­ple, Mark and Lin­da God­ding, re­ceived a fi­nal de­bar­ment or­der from the FDA, stip­u­lat­ing that they can­not im­port drugs to the US for the next five years.

The de­bar­ment comes as last sum­mer they were each sen­tenced to six months in fed­er­al prison for sell­ing un­ap­proved and mis­brand­ed drugs to treat se­ri­ous med­ical con­di­tions through their on­line busi­ness, known as “Blue Brain Boost.”

The com­pa­ny’s Twit­ter pro­file says it was “Lever­ag­ing dis­cov­er­ies in neu­ro­science to im­prove cog­ni­tive per­for­mance.” The most re­cent post, from Au­gust 2019, said they’re of­fer­ing free ship­ping.

Ac­cord­ing to the plea agree­ment, in De­cem­ber 2016, the cou­ple pur­chased a busi­ness called Mighty Stacks, which did busi­ness through Blue Brain Boost and sold prod­ucts through the web­site, blue­brain­boost.com.

The busi­ness sold prod­ucts iden­ti­fied by the FDA as mis­brand­ed and un­ap­proved new drugs, in­clud­ing Tianep­tine Sodi­um Pow­der, a dan­ger­ous un­ap­proved drug that the FDA warned may be abused, par­tic­u­lar­ly in those with a his­to­ry of opi­oid use dis­or­der and over­dose.

While the Blue Brain Boost web­site iden­ti­fied its prod­ucts as “nootrop­ics,” which are es­sen­tial­ly un­ap­proved drugs false­ly mar­ket­ed as “smart drugs” and “cog­ni­tive en­hancers,” in re­al­i­ty, the cou­ple pur­chased about a dozen drugs from Chi­na and repack­aged and dis­trib­uted them for con­sumer use.

Safe­ty con­cerns were an is­sue with the im­port­ed drugs, and the FDA not­ed:

Ms. God­ding had no knowl­edge of these prod­ucts’ man­u­fac­tur­ers’ prac­tices, where or how the prod­ucts were man­u­fac­tured, the safe­ty of those prod­ucts, or that the prod­ucts were what the sup­pli­ers al­leged them to be, with the mi­nor ex­cep­tion that Ms. God­ding in rare cas­es had the prod­ucts test­ed, some­times af­ter re­ceiv­ing safe­ty com­plaints from her cus­tomers.

The US at­tor­ney’s of­fice said the cou­ple “fraud­u­lent­ly mis­led cus­tomers by ad­ver­tis­ing that their prod­ucts were test­ed by in­de­pen­dent labs and as­sert­ed that they were ‘com­pul­sive’ about qual­i­ty con­trol.”

The cou­ple al­so re­ceived nu­mer­ous vi­o­la­tion let­ters plac­ing holds, not­ing de­ten­tions, or de­mand­ing re­turn of nootrop­ic prod­ucts that were im­port­ed to the US.

“Copies of these no­tices were lo­cat­ed in Ms. God­ding’s desk dur­ing an ex­e­cu­tion of a search war­rant at the God­ding’s ware­house,” FDA not­ed.

The sup­pli­ers al­so shipped their goods to US af­fil­i­ates be­fore ship­ping to God­ding to try to evade the ap­pear­ance of im­ports.

“God­ding emailed a test­ing lab­o­ra­to­ry rep­re­sen­ta­tive to let him know that she was send­ing him 3 grams of tianep­tine sodi­um for test­ing as she did not want to pay the sup­pli­er un­til she had the test re­sults,” the FDA wrote yes­ter­day in the de­bar­ment or­der. “She not­ed in her email that the prod­uct was com­ing to the lab­o­ra­to­ry with a dif­fer­ent sender name and not from Blue Brain Boost, and la­beled as, ‘Al­pha GPC to get it thru cus­toms.’ Ms. God­ding al­so re­ceived emails from Chi­nese sup­pli­ers ex­plain­ing how the sup­pli­ers changed the prod­uct name for easy ship­ment and cus­toms clear­ance.”

Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Teresa Graham, incoming Roche Pharmaceuticals CEO

In­com­ing Roche CEO builds out his top team, tap­ping Genen­tech vet to lead phar­ma di­vi­sion

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

FDA ap­proves GSK's ane­mia drug with safe­ty warn­ing — af­ter bat­ting back sim­i­lar drugs

GSK has secured the first of four US approvals it’s hoping for this year, as the FDA greenlit daprodustat as a treatment for anemia due to chronic kidney disease.

But the FDA limited the use of the drug, to be marketed as Jesduvroq, to patients who have been receiving dialysis for at least four months and stopped short of approving it for patients not dependent on dialysis — in line with the recommendations of the advisory committee it consulted.

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David Kirn, 4D Molecular Therapeutics CEO (via website)

FDA places hold on 4D Mol­e­c­u­lar’s Fab­ry gene ther­a­py

4D Molecular Therapeutics quietly tucked an FDA clinical hold on its Fabry gene therapy into an SEC filing.

Meanwhile, the biotech issued a press release the same day after the closing bell on Thursday touting an IND for another asset, in diabetic macular edema.

The California biotech had paused enrollment of patients in its two trials of the Fabry gene therapy (4D-310) last month after three patients experienced kidney issues, all of which were resolved within four weeks. At the time, 4DMT said it would wait until the second half of this year to look at 12-month clinical data on six patients in the Phase I/II trials, one in the US and one in Taiwan and Australia.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.