And so it went at the drug industry’s biggest showcase, the J.P. Morgan Healthcare conference that’s running all week in the heart of this city’s financial district. As executives and investors shuttled from meeting to meeting, seeking deals, many dismissed public outrage at the industry as misguided.Public anger at drug companies is “an abomination,” Ron Cohen, chairman of the big industry group BIO, said at the Biotech Showcase.advertisement By Rebecca Robbins Jan. 12, 2016 Reprints BusinessDrug makers dismiss outrage over high prices as ‘abomination’ SAN FRANCISCO — The protesters carried handwritten signs accusing drug maker Gilead Sciences of greed for pricing its breakthrough hepatitis C drug at $84,000 per treatment.So it perhaps wasn’t surprising that during a panel discussion here Monday, a Gilead executive was asked how he lives with himself.Gregg Alton, the executive vice president for corporate and medical affairs, joked that he goes running. Then his tone turned serious as he talked about research, innovation, and the value of life-saving new drugs. “I sleep quite well,” he concluded.advertisement Related: Live Blog: Updates from JP Morgan Healthcare Conference But it was Gilead Sciences that was in the hot seat Monday. Outside the stately old hotel where the J.P. Morgan conference is being held, a handful of protesters marched with signs declaring “Gilead = Greed,” “Public Health Not Private Wealth,” and “Jail Gilead Drug Profiteers.” Gilead President John Milligan, however, said drug pricing is “more of a campaign issue than an actual issue,” the San Francisco Business Times reported.The company, based in Foster City, Calif., has drawn the ire of lawmakers, doctors, and patients for the the price of its hepatitis C drug Sovaldi. Gilead has made about $27 billion in sales for Sovaldi and a sister drug, Harvoni, since the former was introduced in 2013.Gilead defends the price by explaining that Sovaldi can cure patients of hepatitis C, preserving their health and eliminating the need for expensive treatments later in life, including liver transplants.The company was also keen on Monday to spotlight its work on other drugs.Milligan opened his presentation by talking about Gilead’s efforts to “help the globe” by developing and distributing medications for HIV, Ebola, and the parasitic disease visceral leishmaniasis, among other conditions.Gilead’s work on some of those drugs has drawn protests in the past, especially from AIDS activists concerned about access to the HIV medication. But Sovaldi has taken center stage lately. All the talk about pharma profiteering, Cohen said, is “a perversion of reality.”Many drug makers have raised prices in the past year. And a slew of new drugs have hit the market with eye-popping price tags: cancer drugs at more than $11,000 a month; cholesterol drugs at more than $14,000 a year. Then there’s Martin Shkreli, the pharma executive who bought up a decades-old drug and hiked the price 5,000 percent, turning himself into a target of nationwide protests before he was arrested last month on securities fraud charges. Related: The price of the drug has become a burden not just for individual patients but also for the Medicaid system. Some states have begun restricting access to the drug to patients in the most dire condition. Last year the Kaiser Family Foundation estimated that Sovaldi had boosted Medicare’s annual drug costs by between $2 and $6.5 billion.In a poll conducted jointly this fall by STAT and and the Harvard T.H. Chan School of Public Health, more than 9 of 10 respondents said it was “unreasonable” to price a hypothetical hepatitis C drug in the manner that Gilead did. (That poll did not specifically name the company.)And a Senate investigation released last month found that Gilead knew its prices would make the drug inaccessible for many Americans. “If Gilead’s approach is the future of how blockbuster drugs are launched in America, it’s going to cost billions and billions of dollars to treat just a fraction of patients in America,” Senator Ron Wyden (D-Ore.) said at the time. Related: Activists protest the high price of Gilead drugs outside the J.P. Morgan Healthcare Conference in San Francisco. Rebecca Robbins/STAT STAT-Harvard poll: Dismayed by drug prices, public supports Democrats’ ideas Tags drug pricesJPM16pharmaceutical industry Gilead pricing for Sovaldi hepatitis C drug slammed by senators
Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Alex Hogan/STAT [email protected] @Pharmalot The New England Journal of Medicine is coming under attack, ProPublica writes. Some physicians are questioning whether the publication is losing relevancy and reputation. The journal and its top editor have resisted correcting errors and lag other journals in an industry-wide push for more openness in medical research. Some have also complained that the journal dismisses dissent with a “paternalistic arrogance.”A Florida jury ruled that Tyco Integrated Systems was not liable for the theft of more than $60 million worth of prescription drugs from an Eli Lilly warehouse in Connecticut six years ago, the Associated Press reports. Lilly’s insurer, the National Union Fire Insurance, alleged Tyco failed to adequately report security weaknesses at the warehouse. The insurer said thieves obtained information from a Tyco report and used it to break into the building.advertisement About the Author Reprints Ed Silverman A Valeant Pharmaceuticals board committee did not find additional accounting issues that would require more restatements, Bloomberg News says, adding the drug maker plans to file its annual report on or before April 29. The board examined how the drug maker accounted for revenue through the Philidor Rx Services mail-order pharmacy, which Valeant allegedly used to boost prescriptions and circumvent some insurance reimbursements.FDA medical staffers supported the use of an Intercept Pharmaceuticals drug as a monotherapy in patients with liver disease who did not respond to standard treatment, Reuters reports. The drug is being reviewed for use in patients with primary biliary cirrhosis, a rare liver disease caused by an autoimmune destruction of the bile ducts. An FDA advisory panel meets Thursday to review the medication.The FDA is being warned to regulate medical device cybersecurity more firmly, according to Regulatory Focus. The warning comes after the US Department of Homeland Security issued an advisory about more than 1,400 cybersecurity vulnerabilities that affect versions of an automated supply cabinet used in hospitals and other health facilities to dispense medicines.Johnson & Johnson is making a renewed push in Africa to boost sales of new drugs to fight HIV/AIDS and other illnesses, The Wall Street Journal writes. And J&J will invest $50 million in Tesaro and license a potential prostate cancer drug from the company, the paper adds.The US Centers for Medicare & Medicaid Services will delay enforcement of a rule that changes the way state Medicaid agencies reimburse pharmacies for prescription medicines, Modern Healthcare reports.European regulators backed the use of an Eisai breast cancer drug called Halaven to treat liposarcoma, according to Pharma Times.The new FDA draft guidelines for labeling requirements for biosimilar medicines will become a burden for Indian generic drug makers, TwoFour Insight says.Samsung Bioepis and Biogen filed a lawsuit in the UK against AbbVie over its strategy of filing patents designed to block biosimilar versions of its Humira rheumatoid arthritis treatment, Reuters reports. Hello, everyone, and welcome to the middle of the week. And congratulations are in order for having made it this far. On that note, why not forge ahead? After all, consider the alternatives. This calls for a nice cup of stimulation and, as always, you are invited to join us. Remember, no prescription is required. And now, onward. Here are some tidbits to get you going. Hope you conquer the world and do drop us a line when you run across something fascinating …Pfizer and Allergan called off their $160 billion merger after the US Treasury Department this week issued new rules to thwart tax inversions. The deal was designed to lower their corporate tax rate from about 24 percent to 17 percent, and save roughly $35 billion in taxes. The decision is a big victory for the Obama administration, whose rules were more aggressive than many tax experts had expected. Pfizer will pay Allergan a $150 million breakup fee. The US Food and Drug Administration approved Inflectra, a biosimilar version of Johnson & Johnson’s Remicade, to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, and psoriasis, Reuters writes. The new version is made by Celltrion and will be marketed by Pfizer’s Hospira unit. This is only the second biosimilar approved by the FDA. Analysts expect the drug to become available later this year.advertisement By Ed Silverman April 6, 2016 Reprints Tags AllerganJohnson & JohnsonPfizer PharmalotPharmalot, Pharmalittle: Pfizer and Allergan call off their merger
Related: The Naegleria fowleri amoeba seen under the microscope. Dr. Visvesvara/CDC “Even with the best drug combinations, the fatality rate is over 98 percent,” said Dennis Kyle, an infectious disease researcher at the University of South Florida. “People are dying from this disease all the time, and we really have nothing to treat it effectively.”But Kyle and his team are working to change that reality. Borrowing from techniques used to develop drugs for diseases like malaria, they have created the first high-volume screening setup to hunt for compounds that kill N. fowleri. With the help of collaborators, Kyle has amassed a collection of over 30,000 natural compounds gathered from far-flung corners of the globe, including microbes fished out of mangrove swamps, salty Antarctic oceans, and off sea sponges in the Gulf of Mexico.advertisement Kyle’s lab can screen about 7,500 compounds in 72 hours, an improvement over other methods that took scientists about a week to evaluate a handful of candidate molecules. The speed not only allows his team to examine more compounds, it also means they are screening for fast-acting compounds — an important consideration for an infection that can kill within days of initial symptoms. In test-tube studies, some of these fast-acting compounds are 20 times more potent than miltefosine. Pearce said the team has already identified hundreds of compounds that kill amoeba in the lab.A different tack to finding a treatment for N. fowleri infection is being pursued by a research group in Seattle. Rather than broadly screening a bunch of compounds in a bottom-up fashion, the Seattle Structural Genomics Center for Infectious Disease aims to design a drug from the top down. They are using X-rays to understand the structure of proteins that keep N. fowleri alive, and then using computer modeling to develop compounds to target them.Working alongside Kyle, the Seattle group is in the early stages of investigating 157 different N. fowleri proteins. The researchers hope their different approaches will meet in the middle, said Robin Stacy, senior project manager for the center, using computer modeling to tweak Kyle’s most promising compounds.Cedric Pearce stands in his culture room surrounded by a quarter of a million test tubes filled with fungi. David Wilson, Chris English/UNC GreenboroLast year Kyle’s group reported their first drug candidates, after screening about 150 synthetic antimicrobial chemicals. The team is now testing eight of those compounds in mice, hoping to identify versions that can cross the blood-brain barrier. At the same time, they continue to search for even more potent compounds from nature.Their work “looks quite promising,” said Elizabeth Winzeler, a developmental biologist who studies malaria at the University of California, San Diego, and who is not involved in the research. “We and others in the field have used the same kind of approach and it’s worked quite well” to develop treatments against malaria. She cautioned, though, that the steps in drug development are numerous and complex and that it’s not unusual for a decade to pass between the discovery of molecular candidates and when drugs make it to the shelf.A moving targetFinding a treatment may be more important than ever as unusual cases have startled US health officials in the last five years. Infections contracted in Minnesota lakes — 600 miles farther north than ever before — and the first deaths from treated tap water have led some experts to hypothesize that a changing climate is expanding the range and transmission routes of these amoebas.“It’s not hypothetical. It’s occurring,” said Michael Beach, associate director of the healthy water division of the CDC’s National Center for Emerging, Zoonotic, and Infectious Diseases. “We’ve seen first cases in Kansas, first cases in Indiana, first cases in Minnesota, and the first case since 1969 in Virginia.”Beach urges awareness but not fear. To reduce the already-tiny risk of infection, the CDC recommends people use distilled and sterile water for nasal rinses, not submerge their heads in warm and brackish water, and consider wearing nose clips during water sports. Listen: Episode 13: The superbugs are winning the battle against us In the LabScientists scour the globe for a drug to kill deadly brain-eating amoeba Funding for research, meanwhile, has been rising but is still sparse. The National Institutes of Health awarded less than $800,000 in grants to scientists studying N. fowleri for 2016 — and about two-thirds of that went to Kyle and Pearce’s group.One reason for the low dollar amount is the rarity of the disease relative to others, says Lee Hall, chief of the Parasitology and International Programs Branch of the NIH’s National Institute of Allergy and Infectious Diseases. Another is that few researchers have applied for grants to study this disease.Kyle and Pearce are planning to apply for a new grant in September, and this time they will be asking for “a lot more money,” said Pearce.“There’s a significant need for more research,” said Kyle. “Better awareness of this in the research community is as important as it is in the general community.”This article has been updated to correct the number of US deaths from N. fowleri. A radically simple idea may open the door to a new world of antibiotics Related: Tags amoebabrain The deaths hit the headlines every summer, sometimes five or six of them across the country. They’re newsworthy for their rarity and for how innocuous the events leading up to them are — it’s usually a young person who was swimming in a lake, got some water up their nose, and within days, was dead.The cause is an amoeba called Naegleria fowleri, which when it infects the brain, causes massive swelling that is almost always fatal. Over the past half-century, 135 people in the US have died of the infection.That rarity means that hardly any research money exists to find treatments. The best line of attack at present is a combination of drugs designed for other conditions.advertisement By Lindzi Wessel July 22, 2016 Reprints Adding this supply to their arsenal of synthetic compounds and already-approved FDA drugs, the team is optimistic that they will eventually find something that can enter the human brain and take the amoeba out.Chemical warfareThe amoebas, which are thought to thrive in the soil and scum layers of warm waters, enter the brain when water is forced up the nose. Once there, they feed on brain matter, leading to rapid inflammation. Of all US victims, only three have survived. The antimicrobial drug miltefosine is the most promising existing treatment, and is credited with helping save two children in 2013. But it’s considered an investigational treatment, and others treated with the drug have not survived.Kyle and his group hope that a systematic survey of natural compounds will turn up a better drug.“We think that microorganisms use chemical warfare — if you like — to kill other things that might be fighting for the same resources,” said Cedric Pearce, one of Kyle’s collaborators and founder of Mycosynthetix, a small company which boasts a library of 55,000 fungal strains from all over the world.
APStock [email protected] By Ed Silverman April 6, 2017 Reprints Tags drug pricinginfectious diseasepharmaceuticalspublic healthSTAT+ Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. 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. 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 Reprints A decade ago, United Nations officials implored the pharmaceutical industry to expand access to medicines to low- and middle-income countries, and many companies have heeded the call. But a new analysis finds that evidence to evaluate and report the effectiveness of these initiatives is lacking.First, the good news: The number of initiatives operated by 21 global drug makers increased to 102 in 2015 from just 17 in 2000. And of the 120 access to medicines programs that were identified, 48 percent donated pharmaceuticals and 44 percent relied on a strategy for reducing prices. Only 22 percent involved licensing to other companies. Ed Silverman Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED GET STARTED Pharmalot What’s included? What is it? Log In | Learn More @Pharmalot Most drug makers promise access for poor patients. There’s no evidence their plans work
What is it? How one small biotech exploits a loophole in a federal transparency law Log In | Learn More A gene therapy for a rare disease is unlikely to come cheap, so one fledgling biotech recently reached out to experts for insights into winning over cost-conscious hospitals. And to lure these experts to a so-called advisory meeting, the company used an enticing pitch — each attendee would be given a $3,000 honorarium, along with paid airfare and lodging for two-day session in November.However, AveXis (AVXS) dangled something else: The compensation would not be reported to a federal database to which industry must submit payments made to physicians. Known as OpenPayments, the database was launched three years ago in response to concerns that medical practice and research may be unduly influenced by financial relationships between doctors and drug and device makers. What’s included? Pharmalot 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. By Ed Silverman Aug. 22, 2017 Reprints @Pharmalot Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. About the Author Reprints Ed Silverman 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. GET STARTED [email protected] Tags pharmaceuticalsSTAT+
The Pharmalot View 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. [email protected] What is it? 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. Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Log In | Learn More Over bitter protests from the pharmaceutical industry, California this month enacted a law that requires drug makers to explain and justify prices for some medicines.Predictably, those who backed the effort are hailing the move as a significant victory, because they hope this will become the first step toward reining in drug prices. @Pharmalot California Gov. Jerry Brown signed the bill into law this month. Rich Pedroncelli/AP California just passed a law to rein in drug prices. Here’s why it’s unlikely to make much difference Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED About the Author Reprints GET STARTED What’s included? By Ed Silverman Oct. 24, 2017 Reprints Ed Silverman Tags drug pricinglegalpharmaceuticalspolicystates
Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Keeping the register ringing: Many old drugs have plenty of new patents Ed Silverman @Pharmalot 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. 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. By Ed Silverman Nov. 8, 2017 Reprints Toby Talbot/AP What is it? What’s included? Log In | Learn More [email protected] GET STARTED Tags legalpharmaceuticalsSTAT+ Pharmalot About the Author Reprints To most people, “evergreen” refers to a tree that manages to keep its leaves no matter what. But the term has another, highly contentious meaning when discussing prescription drugs — the use of additional patents to extend the monopoly on a medicine and keep cash registers ringing.Drug makers have long argued their patent modifications reflect substantive enhancements, but the practice has prompted complaints that companies often make minor changes in order to thwart generic competition. And a new study shows the approach may be more pervasive than thought — at least 74 percent of medicines associated with new patents were already on the market. Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED
The mail-order drug company PillPack prepackages consumers’ pills and ships them. Pat Greenhouse/The Boston Globe Business Log In | Learn More 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. Across the country, upstart pharmacies are turning the prescription drug business on its head, offering digitally enabled mail-order offerings and more convenient ways for customers to get, and take, their medications. Massachusetts company PillPack, for instance, is pre-sorting drugs into daily regimens and shipping them to customers nationwide; another business, Capsule, is filling prescriptions on demand and delivering them to homes and workplaces across New York City.But their ability to grow is largely controlled by existing competitors, including major pharmacy benefit managers who have been accused of twisting contract terms to block pharmacies’ access to their millions of U.S. customers. What is it? Tags MedicaidMedicarepharmaceuticals What’s included? [email protected] National Technology Correspondent Casey covers the use of artificial intelligence in medicine and its underlying questions of safety, fairness, and privacy. He is the co-author of the newsletter STAT Health Tech. 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. About the Author Reprints @caseymross By Casey Ross April 6, 2018 Reprints Unlock this article — plus daily market-moving biopharma analysis — by subscribing to STAT+. First 30 days free. GET STARTED Casey Ross Feds broaden the definition of ‘pharmacy’ in a bid to level playing field for startups