June 23

Why Martin Shkreli was arrested

first_img [email protected] Federal prosecutors accused Martin Shkreli of backdating documents, hiding records, and running his companies like a Ponzi scheme. Craig Ruttle/AP The feds also said that Shkreli misappropriated funds in order to repay debts owed by MSMB. For instance, he “improperly reclassified” a $900,000 investment by MSMB Healthcare in Retrophin as a loan, and he transferred money from a Retrophin bank account to the health care fund, according to court documents.Then there was the way Shkreli reacted to an inquiry from the Securities and Exchange Commission, which was curious about his two funds. The indictment chronicles how Shkreli, his attorney, and others devised a scheme to fabricate an investment by MSMB Capital in Retrophin. They “engineered a series of fraudulent transactions that were backdated to the summer of 2012 to create the appearance of an investment by MSMB Capital prior to the SEC inquiry.”By early 2013, Shkreli and his attorney, Evan Greebel, who was also indicted on Thursday, arranged for Retrophin to pay more than $3.4 million in cash and company stock to settle claims made by investors in the two MSMB funds. This was undertaken even though Retrophin was not responsible for making those payments, and the drug maker was never indemnified for the allegedly fraudulent settlement agreements.The indictment charges Shkreli and Greebel with offering four investors “sham” consulting agreements instead of repaying their investments. They took this approach, the documents state, in order to avoid disclosures on financial statements and never properly informed the Retrophin board. Related: “He essentially used his companies like a Ponzi scheme,” said Robert Capers, the US attorney for the Eastern District of New York, during a press conference on Thursday. “He used Retrophin like a personal piggybank.” Capers also accused Shkreli of using backdated documents and hiding records from investors and outside auditors.Shkreli was released on $5 million bond late Thursday. He issued a statement through a spokesman, Craig Stevens, saying that he “strongly denies” the allegations and “is confident that he will be cleared of all charges.”advertisement Biotech exec Martin Shkreli has history of tough tactics Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Tags Martin Shkreli The tale began in 2009, when Shkreli and an unnamed co-conspirator convinced a few investors to put $700,000 in the MSMB Capital Management hedge fund he ran. Shkreli allegedly told the investors that independent auditors were hired, but the indictment says that was not true. The indictment also states that Shkreli never disclosed that he lost all the money in the Elea Capital fund he ran previously, or that he owed $2.3 million stemming from a lawsuit.By November 2010, MSMB held about $700 in assets. But Shkreli managed to persuade four more individuals to invest a total of $2.5 million, having never been told of the losses, according to the indictment.Meanwhile, MSMB bet against the stock of Orexigen Therapeutics, which was developing a prescription diet drug. But, as the indictment describes, the short-selling backfired and the hedge fund lost more than $7 million. There were other trading losses, too, court documents state — although Shkreli hid these losses from investors. One was told that MSMB had a 8.93 percent profit; another was informed that an original $400,000 investment grew to $509,500, the indictment claims.Shkreli was also charged with withdrawing funds that exceeded the permitted fees. By late 2012, MSMB began settling debt for the Orexigen bet, and then proceeded to close out the fund. But the company allegedly told the original investors they nearly doubled their money.And this was just one of the schemes outlined in the indictment.Another involved soliciting about $5 million in a health care fund from investors without disclosing the mishaps and losses. Shkreli told a potential investor that the fund had $55 million in assets under management. But “at no point, from inception to liquidation, did the total amount of investments in MSMB Healthcare exceed $6 million,” the indictment states. About the Author Reprintscenter_img Reviled CEO Martin Shkreli arrested on securities fraud charges Ed Silverman By Ed Silverman Dec. 17, 2015 Reprints This story was updated at 7:55 p.m. on Dec. 17Martin Shkreli may have become infamous for jacking up drug prices, but he was arrested Thursday morning for something more mundane — securities fraud.The grand jury indictment, unsealed in a Brooklyn federal court, paints a disturbing picture and closely tracks an August lawsuit filed against Shkreli by Retrophin, a drug company that Shkreli launched in 2011 but that ousted him last year amid allegations that he defrauded the company.advertisement @Pharmalot “It is no coincidence that these charges, the result of investigations which have been languishing for considerable time, have been filed at the same time of Shkreli’s high-profile, controversial and yet unrelated activities,” Stevens said. He added that federal authorities did not understand the “complex accounting matters” Shkreli used.“At a press conference, the government suggested that Mr. Shkreli was involved in a Ponzi scheme. Ponzi victims do not make money, yet Mr. Shkreli’s investors enjoyed strong results,” Stevens said. “In summary, Mr. Shkreli expects to be fully vindicated.” PharmalotWhy Martin Shkreli was arrested Related:last_img read more

June 23

Pharmalot, Pharmalittle: Purdue snubs New Hampshire subpoena for OxyContin documents

first_imgA decade ago, Mylan Pharmaceuticals decried so-called authorized generics as a threat to the conventional generic drug industry, Bloomberg News writes. There is irony in this, of course, because this is the very same tactic that Mylan is now using to sell a lower-cost version of its own EpiPen device, which is causing an outcry over its price tag and continual price hikes taken by the drug maker.Walgreens Boots Alliance formed a partnership with Prime Therapeutics in hopes of capturing a greater share of the prescription-drug market and better compete with CVS Health, the Wall Street Journal tells us. Prime is a pharmacy benefits manager that is owned by 14 Blue Cross and Blue Shield health plans. The companies will combine specialty and mail-service businesses, and Walgreens will become the preferred pharmacy for Prime to fill their prescriptions.advertisement About the Author Reprints Alex Hogan/STAT Chinese drug sales to the US are growing despite safety concerns, Bloomberg News tells us. Chinese exports of pharmaceutical products and health supplements worldwide jumped 3 percent to $56 billion last year. Meanwhile, more than 5,000 drug factories in China are supplying the domestic market, and more than 500 facilities are registered to sell to the US.A study found that the Praluent med sold by Sanofi and Regeneron Pharmaceuticals reduced the need for apheresis treatment in patients with very high cholesterol by 75 percent versus a placebo, Pharma Times reports. The late-stage study assessed the injectable drug in patients with heterozygous familial hypercholesterolemia, who require regular weekly or biweekly apheresis, an invasive procedure designed to remove LDL cholesterol from the blood.A proposed class action lawsuit filed by New York City police detectives and hotel workers accuses Valeant Pharmaceuticals of racketeering by forcing them to pay exorbitant prices for medicines, Reuters says.Martin Shkreli sold his remaining stake in KaloBios, severing his ties with the drug maker he once led as the company seeks to distance itself from its former chief executive, the Wall Street Journal writes.India’s National Pharmaceutical Pricing Authority is trying to speed the process used to recover money that drug makers overcharged some companies, the Hindu Business Line reports. Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. [email protected] PharmalotPharmalot, Pharmalittle: Purdue snubs New Hampshire subpoena for OxyContin documents center_img Ed Silverman @Pharmalot By Ed Silverman Aug. 30, 2016 Reprints Tags MylanOxyContinPurdue Pharma Rise and shine, everyone, another busy day is on the way. In fact, we have an early speaking engagement, but managed to squirrel away a couple of items for you, which will appear shortly. Meanwhile, the time has come to reach for a cup of stimulation and make our way for the nearest locomotive. As for you, here are some tidbits. Have a smashing day and do keep in touch…The New Hampshire attorney general accused Purdue Pharma, which makes OxyContin, of stonewalling demands for information the company collects about suspected criminal trafficking of its painkiller, the Los Angeles Times reports. In refusing to comply with the subpoena, Purdue cited longstanding objections to the state’s use of a private law firm in an ongoing investigation of the company and other opioid makers.An important clinical trial of the most promising new treatment for Parkinson’s disease in decades might be delayed because of a feud between a key scientist and the Michael J. Fox Foundation, STAT reports. The influential organization had a falling out with a prominent Georgetown University researcher, and it remains unclear whether Georgetown will be able to obtain the medicine from its manufacturer so that the study can proceed.advertisementlast_img read more

June 23

Allergy-proof? Intelligence booster? FDA looks to rein in health claims for baby formula

first_imgIn an unusual move, the agency served up a set of scientific standards for infant formula manufacturers to meet, before touting their products for treatment or prevention of certain medical conditions.This draft proposal suggests that manufacturers conduct research trials and otherwise gather evidence to back assertions of how their products actually function in a baby’s body. Manufacturers and others have 60 days to comment, before the agency adopts a final guideline.advertisement Watch: Saving Bentley’s brain: Daring surgery aims to fix a gaping hole in baby’s skull HealthAllergy-proof? Intelligence booster? FDA looks to rein in health claims for baby formula Privacy Policy By Sheila Kaplan Sept. 8, 2016 Reprints APStock Tags FDAinfancynutrition Please enter a valid email address. Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. The move marks the first time that the FDA has proposed a standard, even a voluntary one such as this, for companies making health claims about a specific food. (The FDA did develop a standard for dietary supplements broadly.) In recent years, formula manufacturers have increasingly developed specialized products, often with vitamins, other nutrients, or additives, which they target to parents eager for their babies to have superior immune systems, digestion, or brains.“Because infancy is a unique, vulnerable period when critical growth and development occur,” the FDA wrote, “great care is necessary to ensure the safety of all modifications to infant formula, even if the purpose of the modification is to more closely mirror the composition and health benefits of human milk.”Agency spokeswoman Lauren Kotwicki said the FDA has seen an increase in the use of health claims on infant formula labeling and that manufacturers who want to use such claims have asked the agency how to substantiate them.The FDA’s action follows publication of a report in the May 2016 issue of Clinical Pediatrics, which studied the labels of 22 infant formula products and found that 13 made claims about treating colic and gastrointestinal symptoms without proof.“There is insufficient evidence to support the claims that removing or reducing lactose, using hydrolyzed or soy protein or adding pre-/probiotics to formula benefits infants with fussiness, gas, or colic,” the authors wrote. “Yet claims like ‘soy for fussiness and gas’ encourage parents who perceive their infants to be fussy to purchase modified formula. Increased regulation of infant formula claims is warranted.” WASHINGTON — If you’ve ever seen the astonishing array of infant formula sold in supermarkets, you might wonder if the stuff can really make your baby smarter, allergy-proof, or less colicky, as advertised.The Food and Drug Administration wonders the same thing.On Thursday, the FDA suggested that the $3 billion infant formula industry consider proving its claims before selling the products.advertisement Leave this field empty if you’re human: Dr. Peter Belamarich, a professor at Albert Einstein College of Medicine and the study’s lead author, welcomed the FDA’s action.“They are trying to rein it in a little bit,” Belamarich said. “It’s an attempt to put the claims under greater scientific scrutiny. It’s a good and terrifically important development.”Belamarich, who works at the Children’s Hospital at Montefiore, said he sees plenty of confused parents.“We see it every day, Belamarich said. “People switching formulas in the hope that what is most often normal baby behaviors is going to be treated by switching formula. There are so many products and so many claims.” Related:last_img read more

June 23

‘Pink,’ a synthetic opioid linked to nearly 50 US deaths, to be banned

first_img By Eric Boodman Nov. 10, 2016 Reprints Tags DEAopioids DEA opts against ban on herbal supplement kratom U-47700, or “pink,” a synthetic opioid. DEA Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. Leave this field empty if you’re human: Eric Boodman General Assignment Reporter Eric focuses on narrative features, exploring the startling ways that science and medicine affect people’s lives. “The whole Russian roulette factor is just heartbreaking because it just goes to show you that any time you mess around with something, it could be your last act,” Payne said.Little is known about how exactly U-47700 works on the brain, besides the fact that it is an opioid, can cause respiratory depression, and can be blocked with naloxone.Dr. Aaron Schneir, a medical toxicologist at the University of California, San Diego Health System, helped in a case of a 22-year-old who had overdosed on the drug earlier this year. At the time, he said, there was not even a sample against which to confirm the molecule’s identity. Since then, though, the number of reports has shot up, and a test has become available.Experts know the risks of the drug, but aren’t sure that making illegal, as the DEA will in classifying it as Schedule 1, will actually stop people from using it.“It’s really hard to police, because you can order it right online from labs in China,” said Payne.“There’s no question it’s dangerous, as other opioids are, particularly these new ones that have never been studied, because there is no idea about what dose to use recreationally,” said Schneir. “But of course heroin is Schedule 1 and it’s still a major problem.” About the Author Reprints [email protected] Privacy Policy Related: “Pink” was first developed in the mid-1970s, by researchers at the chemical company Upjohn (which gave the drug its “U”) who were looking for new painkillers. It is just one of many synthetic drugs that are flooding onto the streets so fast that toxicologists and law enforcement can’t keep up. @ericboodman “We’re seeing new ones every week, or at least every month. We’ve identified over 400 designer synthetic drugs in the last five or six years,” said Rusty Payne, a DEA spokesperson. “So much stuff is coming over that’s being manufactured in these labs in China and elsewhere, people don’t even know what they’re getting.”advertisement The Drug Enforcement Administration is poised to ban a little-known drug called U-47700, also known colloquially as “pink.”The agency, which has the power to ban drugs for two or three years “to avoid an imminent hazard to the public safety,” said Thursday the new regulation will take effect Monday.The DEA has cited 46 deaths in the United States over the last two years in which U-47700 is a confirmed cause. That doesn’t include the widely reported deaths of two 13-year-olds in Utah that were purportedly linked to the drug.advertisement Please enter a valid email address. Health‘Pink,’ a synthetic opioid linked to nearly 50 US deaths, to be banned last_img read more

June 23

Why Biogen is breathing a sigh of relief with the latest Alzheimer’s data

first_imgBiotech What is it? We already know Eli Lilly’s big bet on Alzheimer’s disease didn’t work. But a deep dive into just how it failed has provided a bit of encouragement to Biogen and the many companies still hoping to succeed where their rival fell short.Lilly’s treatment, solanezumab, had no significant effect on the buildup of toxic brain plaques believed by many to be responsible for Alzheimer’s neuron-destroying effects. The company had already disclosed that the treatment failed to improve patients’ cognition and function, but the new data, released Thursday night, shed some important light on the underlying biology. By Damian Garde Dec. 8, 2016 Reprints National Biotech Reporter Damian covers biotech, is a co-writer of The Readout newsletter, and a co-host of “The Readout LOUD” podcast. GET STARTED Log In | Learn More About the Author Reprints Tags drug developmentneurologypharmaceuticals What’s included?center_img Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Why Biogen is breathing a sigh of relief with the latest Alzheimer’s data Damian Garde AP/Biogen [email protected] @damiangarde STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.last_img read more

June 23

Pharmalot, Pharmalittle: The Stada saga concludes

first_img GET STARTED What is it? National Biotech Reporter Damian covers biotech, is a co-writer of The Readout newsletter, and a co-host of “The Readout LOUD” podcast. Good morning, all. Damian Garde here filling in for Ed Silverman on this, the start of another week replete with meetings, deadlines, and all the other trappings of working life. Here are some headlines from around the pharma world to get your morning started. May you conquer all that you must this week, and do keep in touch.After months of rumor and negotiation, German drug maker Stada is finally getting sold, Bloomberg tells us. Private equity magnates Bain Capital and Cinven have teamed up to pay $5.6 billion for Stada, a figure that is nearly 50 percent above its value before takeout talks began. Bain and Cinven have agreed to honor the company’s union contracts and refrain from layoffs for four years. STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. By Damian Garde April 10, 2017 Reprints Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED [email protected] Log In | Learn More Pharmalot center_img About the Author Reprints Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. What’s included? Damian Garde Pharmalot, Pharmalittle: The Stada saga concludes @damiangarde Alex Hogan/STAT Tags financepharmaceuticalslast_img read more

June 23

‘Our health care system values potential,’ drug-pricing report concludes

first_imgPharma APStock Meghana Keshavan By Meghana Keshavan May 24, 2017 Reprints What does the cost of a drug say about society’s values? And what is the market willing to pay for?That’s a loaded question, to be sure, but a new report from life sciences consultancy Trinity Partners tries to dissect the issue a bit. GET STARTED ‘Our health care system values potential,’ drug-pricing report concludes Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. About the Author Reprintscenter_img Biotech Correspondent Meghana covers biotech and contributes to The Readout newsletter. Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. What is it? Log In | Learn More What’s included? [email protected] @megkesh Tags biotechnologydrug pricingpharmaceuticalsSTAT+last_img read more

June 23

McCaskill seeks to repeal law that hampered enforcement against opioid distributors

first_img Lev Facher Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. GET STARTED Sen. Claire McCaskill (D-Mo.) J. Scott Applewhite/AP By Lev Facher Oct. 16, 2017 Reprints Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED WASHINGTON — Sen. Claire McCaskill (D-Mo.) on Monday said she would introduce legislation to repeal a 2016 law that hampered the Drug Enforcement Administration’s ability to regulate opioid distributors it suspects of misconduct.The new bill would rescind a little-noticed law championed last year by Rep. Tom Marino (R-Pa.), who President Trump has since nominated to serve as “drug czar” and director of the Office of National Drug Control Policy. What is it? [email protected] Log In | Learn More center_img McCaskill seeks to repeal law that hampered enforcement against opioid distributors Tags addictionopioidspolicy @levfacher What’s included? Washington Correspondent Lev Facher covers the politics of health and life sciences. About the Author Reprints STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Politics last_img read more

June 23

Assembling yeast chromosomes like Legos has a serious goal: safe lab-made creatures

first_img Jef Boeke really, really wanted to avoid giving his yeast cells a “teeny weeny” chromosome. And not because the other yeast would make fun of them.He was well into his trailblazing project to “write” the first complete genome (“reading,” or sequencing, genomes being so 2000s), with the single-celled organism baker’s yeast the test case. As part of that Synthetic Yeast 2.0 scheme, he and his team had decided to fuse the yeast’s shortest chromosome with a longer one, in order to avoid the teeny-weeny problem — he worried that very short synthetic chromosomes might not be viable. Then a colleague asked, why stop at one? Why not see how many of yeast’s 16 distinct chromosomes you can fuse? [email protected] GET STARTED @sxbegle What’s included? By Sharon Begley Aug. 1, 2018 Reprints Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. What is it? In the Lab center_img Log In | Learn More Senior Writer, Science and Discovery (1956-2021) Sharon covered science and discovery. Assembling yeast chromosomes like Legos has a serious goal: safe lab-made creatures Sharon Begley Tags biotechnologyCRISPRgeneticsresearch About the Author Reprints A microscope image of baker’s yeast. Dr. Gerhard Wanner/ZEISS Microscopy Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.last_img read more

June 23

Join our live chat on Aug. 14: the challenges and innovations in college mental health care

first_img STAT HealthArchived: A live chat discussing the challenges and innovations in college mental health care By STAT Aug. 14, 2018 Reprints [email protected]center_img As a new school year gets underway, colleges are continuing to grapple with rising student demand for mental health services. Some schools have been unable to meet that need, leaving students stuck on weeks-long wait lists. Others are taking steps to better address the mental health needs of increasingly diverse student populations.Join STAT reporter Megan Thielking and Stephanie Pinder-Amaker, Harvard Medical School psychiatry professor and director of the College Mental Health Program at McLean Hospital, for an online conversation about mental health issues on college campuses. They’ll touch on innovative approaches to better addressing student mental health needs, the barriers that keep students from seeking out and receiving treatment, and ways in which the relationship between schools and off-campus providers can be strengthened.Read an archive of the chat below.advertisement About the Author Reprintslast_img read more