Con­fi­dent he’ll be ex­on­er­at­ed on fraud charges, Mar­tin Shkre­li is work­ing on an­oth­er at­tempt to “shock and awe”

Mar­tin Shkre­li speaks dur­ing an in­ter­view with Bloomberg on Fri­day, Dec. 23, 2016. Shkre­li said the na­tion­al out­rage over drug pric­ing was blown out of pro­por­tion and height­ened by the U.S. pres­i­den­tial elec­tion, al­though he con­ced­ed he could have pre­dict­ed the blow­back bet­ter. Vic­tor J. Blue/Bloomberg via Get­ty Im­ages

Mar­tin Shkre­li has a date with pro­s­ec­tors at the fed­er­al cour­t­house in two months, but the no­to­ri­ous biotech en­tre­pre­neur still has time to talk with re­porters. And it turns out he’s work­ing on yet an­oth­er biotech start­up as his lawyers pre­pare to de­fend him on crim­i­nal fraud charges.

The re­porter in this case was Shee­lah Kol­hatkar from The New York­er. They met in a Man­hat­tan bar, where Shkre­li con­fi­dent­ly pre­dict­ed his loom­ing ex­on­er­a­tion on fraud charges.

“I think they’ll re­turn a not-guilty ver­dict in two hours,” he told Kol­hatkar. “There are go­ing to be ju­rors who will be fans of mine. I walk down the streets of New York and peo­ple shake my hand. They say, ‘I want to be just like you.’”

Shkre­li nev­er has faced more than a scold­ing from law­mak­ers for the 5000% hike in the price of Dara­prim, an old drug he ac­quired af­ter found­ing Tur­ing. Caught in the bright glare of a scan­dal, on­line mobs shriek­ing dig­i­tal abuse, Shkre­li turned ob­scene­ly de­fi­ant on Twit­ter — which lat­er banned him — and nev­er did back down from the price. He was forced to give up the CEO’s job af­ter the fraud charges hit.

Shkre­li, though, is clear­ly com­mit­ted to his fu­ture as a se­r­i­al en­tre­pre­neur.

In the in­ter­view he men­tioned a new biotech soft­ware com­pa­ny he is hatch­ing. This new ven­ture is called Gödel Sys­tems, but he’s stingy on de­tails.

Ac­cord­ing to a re­cent SEC fil­ing, Shkre­li and his con­fed­er­ates have raised $50,000 of a $1 mil­lion raise, lunch mon­ey com­pared to the larg­er sums raised for Tur­ing and his first start­up, Retrophin, which sued him.

He is, though, hap­py to pre­dict the stun­ning im­pact it will have.

“I haven’t told any­body what it is,” he said. “When I do, it will shock and awe the world.”

You’ve been warned.

Af­ter we pub­lished on Wednes­day, Shkre­li sent me a re­ply. See­ing as he’s been banned from Twit­ter, it seems on­ly fair to add it here:

Lol you love dis­in­for­ma­tion – it must be a loss-of-func­tion mu­ta­tion – do not re­pro­duce

He is very con­sis­tent.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

Pharma brands are trying to figure out new ways to better reach patients and doctors, but also measure results. (Credit: Shutterstock)

Do phar­ma TV and so­cial ads work? Phar­ma mar­ket­ing agen­cies adopt­ing new tech so­lu­tions to find out

It’s a timeworn advertising question — is my ad campaign working? In pharma, that can be an especially difficult question to answer in part because of privacy regulations, but also because the brands spend a lot of money on TV commercials where viewers can’t directly click on an ad.

Healthcare marketing services companies like Lasso and CMI Media Group are trying to change that with new measurement methods and partnerships that aim to get closer to patients’ and physicians’ actions.

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Corey McCann, Pear Therapeutics CEO

Pear Ther­a­peu­tics touts Q2 growth while scal­ing back full-year goals and chop­ping 9% of staff

Pear Therapeutics set some ambitious goals back in March, predicting a five-fold boost in revenue and a surge in new prescriptions for its digital therapeutics. Now the company is scaling back those estimates and chopping 9% of its workforce — an all-too-common occurrence in biotech lately.

CEO Corey McCann unveiled Pear’s Q2 numbers on Thursday, touting a 20% quarter-over-quarter revenue growth totaling $3.3 million. That’s more than double what the company made in Q2 2021, and McCann thinks the team could see a nearly four-fold jump in revenue this year, falling in the range of $14 million to $16 million.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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