Martin Shkreli (Shutterstock)

Mar­tin Shkre­li con­tin­ued to or­ches­trate an­ti-com­pet­i­tive schemes for Dara­prim be­hind bars — FTC

Mar­tin Shkre­li didn’t just blog, read up on drug de­vel­op­ment news and run his biotech busi­ness with a con­tra­band cell phone in prison. Ac­cord­ing to the FTC, he was al­so co­or­di­nat­ing the an­ti­com­pet­i­tive scheme to shield Dara­prim — the drug at the cen­ter of a price-goug­ing con­tro­ver­sy that earned him the “Phar­ma Bro” nick­name — from gener­ic ri­vals.

Back in Jan­u­ary the FTC, to­geth­er with New York’s at­tor­ney gen­er­al, launched a fed­er­al law­suit against Shkre­li, who’s now serv­ing a 7-year sen­tence for de­fraud­ing in­vestors in his hedge fund, al­leg­ing that he ef­fec­tive­ly cre­at­ed a drug mo­nop­oly. While Shkre­li’s no­to­ri­ous move to raise the per tablet price of Dara­prim from $17.50 to $750 was per­fect­ly le­gal, the tac­tics he al­leged­ly de­ployed to box out com­peti­tors weren’t.

“Dur­ing our pre-com­plaint in­ves­ti­ga­tion, the FTC learned that Mr. Shkre­li was com­mu­ni­cat­ing from prison about rel­e­vant mat­ters,” reads a let­ter to Judge Denise Cote.

Specif­i­cal­ly, they found records of his con­ver­sa­tions with ex­ec­u­tives of Vy­era — for­mer­ly Tur­ing and now Phoenixus — in­clud­ing co-de­fen­dant Kevin Mul­leady, which con­tained “in­for­ma­tion rel­e­vant to this case, in­clud­ing about Mr. Shkre­li’s ef­forts from prison to sup­port Vy­era’s scheme to pre­vent gener­ic com­pe­ti­tion to Dara­prim.” There are al­so ma­te­ri­als on his com­mu­ni­ca­tion with at­tor­neys.

The agency wants the court to rule that the com­mu­ni­ca­tions it ob­tained from the Fed­er­al Bu­reau of Pris­ons are not priv­i­leged — and there­fore fair game for the en­su­ing le­gal bat­tle.

Un­like the records on his con­tra­band cell phone, the FTC ar­gues, these calls and emails hap­pened on the prison’s TRU­FONE and TRULINCS sys­tems, which Shkre­li knew could be mon­i­tored and record­ed. Nei­ther at­tor­ney-client priv­i­lege nor the work prod­uct doc­trine should ap­ply here, it writes.

It’s un­clear how much Dara­prim’s pric­ing will be af­fect­ed. A month af­ter the FTC and the New York AG filed their law­suit ask­ing, among oth­er things, to re­store com­pet­i­tive con­di­tions and halt any on­go­ing an­ti-com­pet­i­tive con­duct, the FDA ap­proved the first gener­ic for Dara­prim. Al­though the gener­ic mak­er hasn’t dis­closed how much it’s charg­ing for its copy­cat drug, it was enough to kick Dara­prim off the list of the top 20 most ex­pen­sive treat­ments in the US.

But for Shkre­li and Mul­leady, los­ing the law­suit could mean be­ing barred from the phar­ma in­dus­try in the fu­ture in ad­di­tion to mon­e­tary re­lief.

The prospect could be es­pe­cial­ly tough for Shkre­li, who sought — but was de­nied — a 3-month fur­lough to re­search Covid-19 cures af­ter post­ing a pa­per de­scrib­ing a drug screen and propos­ing RdRp in­hibitors as po­ten­tial treat­ments.

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.

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.

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.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Francesco De Rubertis

Medicx­i's David Grainger and Francesco De Ru­ber­tis pump €200M in­to six com­pa­nies and what they say is a first-of-its kind fund

In what they’re billing as a first for biotech, David Grainger, Francesco De Rubertis and their team at Medicxi have put down a €200 million to sweep up stakes in six companies from their predecessor VC and pump new money into them.

Medicxi didn’t disclose which companies it was investing in but the portfolio draws from Index Ventures Life VI, one of the last funds the Medicxi team launched while they were still part of the multinational, tech-focused VC firm Index Ventures. That team kept advising Index on their life sciences portfolio even after they spun out to form their own firm in the middle of 2016.

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Scripps reach­es $10M set­tle­ment with gov­ern­ment over al­le­ga­tions NIH grants weren't prop­er­ly ac­count­ed for

Scripps Research Institute has settled a case with the Justice Department alleging claims of misappropriated funds, the US attorney for the district of Maryland announced late last week.

Prosecutors said the institute improperly used NIH-funded research grants for non-grant related activities, including working on new grant applications, teaching activities and other administrative tasks. As part of the settlement, Scripps has agreed to pay $10 million.

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.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.