Pharmalot, Pharmalittle: Defending pharma tax breaks for ads will be challenging, lobbyist says

first_imgPharmalotPharmalot, Pharmalittle: Defending pharma tax breaks for ads will be challenging, lobbyist says Alex Hogan/STAT A database created by ProPublica to track physician prescribing habits is being used by some people to shop around for doctors more likely to give them addictive painkillers. “This is not a new problem for journalists, or others whose business is providing or sharing information. In another era, burglars would read the obituary pages so they could target the homes of people who had just died,” ProPublica editor Stephen Engelberg wrote in a statement.The US Food and Drug Administration is requiring boxed warnings about serious and sometimes disabling side effects caused by a class of antibiotics called fluoroquinolones. The side effects can involve damage to tendons, muscles, joints, nerves, and the central nervous system. Most are sold as generics, but well-known brand names include Bayer’s Cipro and Johnson & Johnson’s Levaquin.Ranbaxy whistleblower Dinesh Thakur plans to join a public interest lawsuit filed by a consumer advocate who wants three manufacturing plants banned, the Economic Times says. The reason for proposed ban? The plants allegedly supplied adulterated drugs. Meanwhile, Sun Pharmaceutical, which acquired Ranbaxy two years ago, it in 2014, insists it is not aware of any current problems at the plants.Several dozen groups wrote the FDA to ditch its plan for naming biosimilars, arguing that specific suffixes attached to each drug name would be easier for physicians.Chiasma may dispute an FDA rejection last month of its rare disease drug that targets acromegaly, which causes a patient’s feet, hands, and internal organs to become enlarged, the Boston Business Journal says. By Ed Silverman May 13, 2016 Reprints Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Tags drug pricesHarvard Medical Schoolopioids About the Author Reprintscenter_img A California ballot initiative designed to cap drug prices may or may not save money, California Healthline writes. If passed in November, the measure would prohibit the state from paying more for medicines than the lowest price paid by the US Department of Veterans Affairs. But a preliminary report by the Legislative Analyst’s Office says it is “highly uncertain” how much will be saved, since VA cost data isn’t known and drug makers could raise prices.John Hendrickson, who succeeded Joe Papa as Perrigo chief executive, skewered the drug maker’s performance under his predecessor, Bloomberg News says. He told analysts the “recent track record of performance against our own expectations is unacceptable.” Said Piper Jaffray analyst David Amsellem: “Basically, Joe Papa just high-tailed it out of Perrigo, and kind of left the company in shambles.” Papa is now running Valeant Pharmaceuticals.advertisement [email protected] Ed Silverman @Pharmalot And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is rather busy. We plan to escort Mrs. Pharmalot to a rent party, accompany one of our short people on a charity mission, and catch up on our reading. And what about you? This is a fine time to enjoy the great outdoors or visit someone special. Perhaps you need to tidy up around your castle. Whatever you do, have a grand time. But be safe. See you soon …A lobbyist warned that it will be challenging to uphold a tax break that allows drug makers to write off money they spend on advertising and marketing, Medical Marketing & Media reports. A Senate bill was proposed in March to end the deduction and it will be “one of the hardest things to defend,” Jim Davidson, chair of the the Advertising Tax Coalition, told an industry conference.Harvard Medical School is loosening some conflict-of-interest rules that currently prevent research scientists from doing work on clinical trials for companies in which they have a financial interest, at least in some situations, according to STAT. The school is raising thresholds on how much income or equity researchers have in a public company before they are barred from doing clinical research.advertisementlast_img read more

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Most scientists believe there is a ‘crisis’ reproducing experiments

first_img David L. Ryan/The Boston Globe Placing trust in science can be easier when findings are confirmed, but a new survey finds that most scientists believe there is a “crisis” in reproducibility.Specifically, 52 percent reported that replicating results is a “significant” problem and another 38 percent believe a “slight crisis” exists. More than 70 percent of researchers have tried and failed to reproduce another scientist’s experiments, according to Nature, which canvassed 1,576 researchers. And more than half of the respondents reported that they failed to reproduce their own experiments.Yet one-third believe that failing to reproduce results means that a study is probably just incorrect, and most of those asked say that they continue to trust published findings. Moreover, 73 percent think that at least half of the papers in their own fields can be believed, with physicists and chemists expressing the most confidence.advertisement Nature wrote that researchers often assume there is usually a “valid reason” for this belief, and the perception is compounded by a lack of incentive to publish positive replications. Moreover, medical journals may be reluctant to publish negative findings, according to Nature. [email protected] @Pharmalot Episode 3: Should we believe published scientific research? By Ed Silverman June 1, 2016 Reprints For instance, a Merck executive recently suggested that drug makers should be entitled to get their money back for potential treatments licensed from universities if the company is unable to reproduce the results in subsequent experiments. In his view, the inability to replicate findings is reason for altering the nature of the relationship between academia and industry.At the same time, the pharmaceutical industry has been under pressure to release trial results in order to verify claims about their medicines. The issue accelerated in the wake of several scandals about undisclosed side effects. Last year, a group of researchers analyzed trial data for a GlaxoSmithKline antidepressant and found the original safety claims could be not reproduced. Related: Ed Silvermancenter_img Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. PharmalotMost scientists believe there is a ‘crisis’ reproducing experiments About the Author Reprints Related: Big drug maker presses for money-back guarantee that its science will work The survey presents a confusing picture at a time when there is growing importance attached to reproducing results.advertisement Turning back to the lab, the survey found that scientists cited several reasons for difficulties reproducing results. More than 60 percent pointed to the pressure to publish and selective reporting as regular issues. More than half cited insufficient replication in the lab, poor oversight, or low statistical power, Nature wrote. And some said the use of specialized techniques, for example, can be difficult to repeat.To improve outcomes, the scientists said that better study designs and better statistics are needed, Nature wrote, adding that one-third of the respondents said their labs had taken steps in the past five years to bolster the odds of replacing results. Tags clinical trialsGlaxoSmithKlinereproducibilitylast_img read more

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House passes Zika bill in early morning vote over Democratic opposition

first_img By Dylan Scott June 22, 2016 Reprints But Senator Patty Murray of Washington, the top Democrat on the Senate subcommittee that funds health programs, called it “a hyperpartisan proposal that is more about throwing red meat to the tea party than actually tackling this crisis.” Are you at risk of contracting Zika virus?Volume 90%Press shift question mark to access a list of keyboard shortcutsKeyboard ShortcutsEnabledDisabledPlay/PauseSPACEIncrease Volume↑Decrease Volume↓Seek Forward→Seek Backward←Captions On/OffcFullscreen/Exit FullscreenfMute/UnmutemSeek %0-9 facebook twitter Email Linkhttps://www.statnews.com/2016/06/22/congress-reach-1-1-billion-zika-deal/?jwsource=clCopied EmbedCopiedLive00:0001:3301:33  A few aspects about where you live can help determine that. Alex Hogan/STAT Obama isn’t threatening to veto the bill — yet. But in a statement late Wednesday, White House press secretary Josh Earnest declared that “once again, Republicans have put political games ahead of the health and safety of the American people, particularly pregnant women and their babies.”The final bill would fall short of the $1.9 billion Obama requested in February to help fight the virus, which threatens to become a public health emergency within the United States if mosquitoes spread the disease that has been linked to serious birth defects.Of the $1.1 billion, the National Institutes of Health would receive $230 million to help with vaccine work. The Centers for Disease Control and Prevention would receive $476 million for work on mosquito control and other readiness and response activities, while the Biomedical Advanced Research and Development Authority would get $85 million for research and development priorities, including rapid diagnostic tests.The State Department and the United States Agency for International Development would receive $175 million to help prevent the spread of Zika-carrying mosquitoes in the United States.The problem, top Democrats said, is the cuts to other programs that Republicans have included to win support from their most conservative members.The $1.1 billion in new funding would be partially offset by $750 million in spending cuts. They would include $543 million from the Affordable Care Act’s transition fund for US territories, $100 million from administrative funds for the US Department of Health and Human Services, and $107 million from the remaining Ebola emergency funding.Democrats also were furious about a section of the bill that would restrict who could provide birth control services — a provision they view as an indirect way of defunding Planned Parenthood.“House and Senate Republicans intend to file a cynical, partisan conference report that includes poison pill riders, [and] offsets and underfunds our veterans by $500 million. I will oppose it,” Senator Barbara Mikulski of Maryland, the top Democrat on the Senate Appropriations Committee, said in a statement.Earnest charged that “the fact that the Republican plan limits needed birth control services for women in the United States and Puerto Rico as we seek to stop the spread of a sexually transmitted disease is a clear indication they don’t take seriously the threat from the Zika virus or their responsibility to protect Americans.”The Senate’s original $1.1 billion Zika package was all new money, but the House’s smaller $622 million bill was fully funded by cuts in other programs.The conference committee that convened in recent weeks included Republicans and Democrats, but Democratic aides were quickly critical of the agreement. 5 lessons from the protracted Zika funding fight “If Zika is going to get funded, there has to be a third act,” said Adam Jentleson, a spokesman for Senate Minority Leader Harry Reid.House Appropriations Committee Chairman Hal Rogers of Kentucky said the agreement was “the product of careful and thorough deliberations between the House and the Senate, and reflects a responsible compromise that can and should be signed into law.”advertisement WASHINGTON — The House passed a $1.1 billion Zika funding bill in the early morning hours Thursday, as Republicans pushed through a final bill worked out by House and Senate negotiators that’s being bitterly criticized by the White House and congressional Democrats.The vote, which came at around 3 a.m., took place as Republicans tried to work around a Democratic sit-in on the House floor that’s being staged to demand votes on gun control. The Zika measure passed 239-171, almost entirely among party lines.It remains to be seen whether President Obama would sign the final bill, released late Wednesday, which still needs to be approved by the Senate. Top Democrats quickly characterized it as a partisan proposal and vowed to oppose it. They said it was full of unreasonable spending cuts and policy changes, especially on women’s health.advertisement PoliticsHouse passes Zika bill in early morning vote over Democratic opposition center_img Related: Tags CongressfundingpolicyZika Virus Matthew Dennis, a spokesman for the Democrats on the House Appropriations Committee, tweeted that Democrats were “not party to the agreement,” and that the agreement was between House and Senate Republicans.Though the Obama administration originally requested $1.9 billion for a Zika response, lawmakers have struggled to produce a funding proposal that could pass through Congress. The administration redirected more than $500 million from the Ebola funds in April while waiting for congressional action.The virus, which started becoming a global concern late last year, has been linked to a birth defect in which babies are born with abnormally small heads. The CDC said last week that three infants had been born in the United States with the condition.This story has been updated with House passage of the bill. Aedes aegypti mosquitos are seen in containers at a lab at the Institute of Biomedical Sciences at Sao Paulo University in Brazil. Nelson Almeida/AFP/Getty Imageslast_img read more

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Paralysis cases could help identify Zika spread, researchers say

first_img Related: What is Guillain-Barré syndrome?Volume 0%Press shift question mark to access a list of keyboard shortcutsKeyboard ShortcutsEnabledDisabledPlay/PauseSPACEIncrease Volume↑Decrease Volume↓Seek Forward→Seek Backward←Captions On/OffcFullscreen/Exit FullscreenfMute/UnmutemSeek %0-9 facebook twitter Email Linkhttps://www.statnews.com/2016/08/31/zika-paralysis-latin-america/?jwsource=clCopied EmbedCopiedLive00:0001:4001:40  By Andrew Joseph Aug. 31, 2016 Reprints @DrewQJoseph [email protected] General Assignment Reporter Andrew covers a range of topics, from addiction to public health to genetics. Zika virus is associated with a host of medical issues, and in Latin America, health officials are now finding that reported cases of the virus track closely with the onset of a temporary paralysis called Guillain-Barré syndrome.Researchers say that means an increase in GBS could be a signal that Zika is spreading. Zika infection can present in many ways, from nearly no symptoms to full-blown febrile illness. Most people tend toward no symptoms, making the dramatic presentation of GBS a more clear sign of infection.“Reports of the Guillain–Barré syndrome could serve as a sentinel for [Zika] and other neurologic disorders linked to [Zika], including microcephaly,” the researchers wrote Wednesday in the New England Journal of Medicine, referring to the birth defect caused by the virus when it infects pregnant women.advertisement “It is clear that increases in the incidence of the Guillain–Barré syndrome to a level that is 2.0 and 9.8 times as high as baseline, as we have reported here, impose a substantial burden on populations and health services in this region,” wrote the team, made up of researchers from the World Health Organization, the Pan American Health Organization, and individual countries’ health ministries.advertisement About the Author Reprints Tags global healthguillain-barreZika Viruscenter_img HealthParalysis cases could help identify Zika spread, researchers say Scientists link Zika firmly to paralysis, as patients in Tahiti know too well This comes after warnings from scientists studying the relationship between Zika and GBS in Tahiti that Latin American countries needed to prepare for the expensive and extensive care that goes along with GBS. ‘I can’t move’: In Colombia, families cope with creeping paralysis tied to Zika Andrew Joseph The researchers found that nearly 1,500 of the more than 164,000 people with confirmed or suspected Zika infection they surveyed came down with GBS. As the number of Zika infections rose and fell during a one-year period ending in March, so did the numbers of people suffering from the temporary paralysis associated with GBS.According to the World Health Organization, there is a “scientific consensus” that Zika causes GBS.The virus is primarily spread by mosquitoes, but can be transmitted through sex. When it infects pregnant women, it can cause debilitating birth defects in their fetuses. For the new report, officials reporting from six countries — Colombia, the Dominican Republic, El Salvador, Honduras, Suriname, and Venezuela — as well as the state of Bahia in Brazil, found GBS surged during the Zika epidemic, with rates increasing from 100 percent in El Salvador to 877 percent in Venezuela.The researchers also found that the incidence of GBS was 28 percent higher in men than women, which matches what scientists have seen in cases of GBS induced by other infections.Studying the link between Zika and GBS has been challenging because other viral illnesses, including the one caused by closely-related dengue virus, also cause GBS. Distinguishing between the two viruses in tests is difficult. Related:last_img read more

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After criticism from scientists, Congress eases its pursuit of faster stem cell therapies

first_imgPoliticsAfter criticism from scientists, Congress eases its pursuit of faster stem cell therapies Tags Congressdrug developmentpolicyresearch Please enter a valid email address. Leave this field empty if you’re human: The changes have not mollified everyone. The advocacy group Public Citizen criticized the idea of allowing the therapies onto the market based on surrogate endpoints and then hoping the post-approval studies show that treatments actually work. Also, the group said, the regenerative medicine components were added to the bill late in the game.“To throw this provision into a large packet without having time to fully vet it and hear from experts in the field and from patient safety advocates is an inappropriate way to advance legislation like this,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “This is a field where we don’t know a lot about the value of these products and it would be best that we not create such expedited pathways until we have a better understanding of this field.”Temple, the president of the international stem cell society, said she and her colleagues were still reviewing the measure, but that in principle, the group was open to using accelerated approval for stem cell treatments as long as the FDA had authority over that decision and as long as the FDA had oversight over the post-approval studies.She said the stem cell field requires particular scrutiny because of the proliferation of largely unregulated “stem cell clinics” that claim to be able to treat everything from autism to heart failure. Critics say FDA regulations on stem cells need to be tightened, not loosened, if the agency is going to be able to push back on the clinics touting unproven and possibly unsafe products.“Many people recognize the promise of stem cell research, including the public, including patients,” she said. “Unfortunately, this had led to a springing up of clinics that are offering unproven therapies, and patients who are persuaded to go to these. And what we’re seeing are really negative outcomes.Temple added: “It’s very important to realize that stem cells are not like drugs. … You want to make sure that you’re really following whether or not the treatments are safe and efficacious.”Despite the improvements over the Regrow Act, Paul Knoepfler, a stem cell scientist at the University of California, Davis, said he was still worried that an experimental therapy would reach patients and that it would turn out not to work, or worse. While he opposed the Regrow Act, he said he has mixed feelings about the regenerative medicine components of the Cures Act.“Because Cures’ language pushes key requirements for data to be at the post-approval rather than pre-approval stage some unsafe, ineffective therapies would almost certainly get approved and go into patients in trials,” he said. “The billion dollar question is whether the potential risks or benefits would materialize more should Cures pass. No one has a crystal ball on this so it’d be a high-risk regulatory experiment.”The Alliance for Regenerative Medicine — a group of companies, researchers, and patient advocacy groups — had also opposed the Regrow Act, but Michael Werner, who cofounded the group, said the language in the Cures Act avoids the worst parts of the original measure.Werner, a partner with the Holland & Knight law firm, said the new regenerative medicine provisions would preserve the FDA’s approval standards and that the agency would work with companies pursuing therapies earlier in the process, offering meetings and faster review.“We think it’s a good thing,” he said. “It strikes the right balance.” Stem cell clinics hawking unproven therapies sprout up across US By Andrew Joseph and Sheila Kaplan Nov. 30, 2016 Reprints “This is very, very important for all aspects of medicine but certainly for regenerative medicine,” said Sally Temple, the president of the International Society for Stem Cell Research.The enthusiasm for stem cell-based treatments has been building for years. The cells, which can be found in tissues from fat to bone marrow, are the renaissance players in that they can develop into specialized cell types. As a result, doctors believe they can be used to replace damaged or dead cells. In small, early studies, scientists have found evidence that stem cells can help stroke victims regain bodily control and close holes in tissue.advertisement General Assignment Reporter Andrew covers a range of topics, from addiction to public health to genetics. Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. But so far, only a tiny number of stem cell-related treatments exist. As exciting as the field is, many scientists warn that therapies derived from stem cells may not be ready for prime time yet. They fear that permitting therapies onto the market without rigorous testing could harm patients. Plus, they say, patients and insurers should not have to pay for treatments that haven’t yet been demonstrated to be safe and effective.The Regrow Act was spearheaded by Republican Senator Mark Kirk of Illinois, who had a stroke in 2012 and said the bill would expand treatment options for people who suffered from strokes or had diseases including Alzheimer’s, Parkinson’s, and diabetes. (Kirk lost his reelection bid this month to Democratic Representative Tammy Duckworth.)The measure would have allowed the Food and Drug Administration to approve stem cell treatments conditionally without the large final-stage clinical trials usually required of a therapy.In its current form, the Cures Act does not allow new stem cell therapies to forgo those Phase 3 trials, when many drugs fail. Instead, it says that regenerative medicine products, which include stem cell therapies, can be granted what’s called accelerated approval by the FDA.Under that program, regulators can green-light a therapy without waiting on a demonstrated clinical benefit. Rather, they can rely on symptoms or other measures — what are called surrogate endpoints — that might indicate the drug is working; a cancer drug, for example, could be approved if it shrinks a tumor, even if it hasn’t shown yet it extends survival.Treatments that go to market under accelerated approval are required to be studied further to ensure that they do in fact show a real benefit as they become available to more patients. The designation is typically used for therapies for serious or threatening conditions for which there are few or no treatment options, according to the FDA.center_img Andrew Joseph @DrewQJoseph About the Authors Reprints [email protected] Privacy Policy Tapping the brakes on an effort to speed new stem cell treatments to patients by relaxing regulations, Congress this week is considering a modified proposal that is attracting cautious support from the research community.Stem cell experts say they are still trying to tease apart how exactly the regenerative medicine sections of the 21st Century Cures Act, a behemoth bill that would expedite drug approval and increase funding for medical research, would affect the field. But a number of vocal critics of the original measure, the so-called Regrow Act, said some of their worries had been assuaged.And exactly how Congress handles the issue matters, they say.advertisement Embryonic stem cells are pictured through a microscope viewfinder. Mauricio Lima/AFP/Getty Images Related:last_img read more

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FDA approves first new sickle cell drug in 20 years

first_img Log In | Learn More Tags drug developmentpolicyrare diseases By Adam Feuerstein July 7, 2017 Reprints About the Author Reprints Senior Writer, Biotech Adam is STAT’s national biotech columnist, reporting on the intersection of biotech and Wall Street. He’s also a co-host of “The Readout LOUD” podcast. What’s included? Biotech [email protected] 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. The FDA approved a new medicine Friday to reduce the complications associated with sickle cell disease, a rare blood disorder.The drug, Endari, is made by privately held Emmaus Medical and is the first new treatment for sickle cell disease to secure FDA approval in almost 20 years. However, the active ingredient in Endari — L-glutamine — is an old chemical that can be purchased over the counter, which could complicate Emmaus’s ability to obtain insurance coverage.center_img 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 What is it? @adamfeuerstein Adam Feuerstein FDA approves first new sickle cell drug in 20 years APStock Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+. First 30 days free. GET STARTEDlast_img read more

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Feds identify prescribers doling out too many opioids to Part D beneficiaries

first_img What’s included? 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. Feds identify prescribers doling out too many opioids to Part D beneficiaries Pharmalot About the Author Reprints In the latest bid to stem the opioid epidemic, investigators at the Department of Health and Human Services have identified excessive prescribing patterns in Medicare Part D involving hundreds of doctors and plan to work with law enforcement authorities to curtail the practice.In a new report, the HHS Office of Inspector General found that 401 prescribers last year wrote more than 256,200 prescriptions for nearly 90,000 Part D beneficiaries who were deemed to be at serious risk because they received “extreme” amounts of opioids or appeared to be doctor shopping. 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?center_img By Ed Silverman July 13, 2017 Reprints Ed Silverman Log In | Learn More @Pharmalot APStock GET STARTED [email protected] Tags opioidspharmaceuticalsSTAT+last_img read more

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Hurt by a drug? You can file suit in California if a clinical trial took place there

first_img Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Pharmalot Ed Silverman @Pharmalot APStock 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. Log In | Learn More What is it? Hurt by a drug? You can file suit in California if a clinical trial took place there Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTEDcenter_img 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. [email protected] About the Author Reprints What’s included? GET STARTED By Ed Silverman July 18, 2017 Reprints Last month, the U.S. Supreme Court made it more difficult for people who file product-liability lawsuits against drug makers to engage in “forum shopping,” a practice in which someone files a lawsuit in a state where courts are seen as more hospitable to consumers.In that closely watched case, the court ruled hundreds of out-of-state plaintiffs failed to demonstrate a sufficient connection between injuries they allegedly suffered from a Bristol-Myers Squibb drug and company activities in California. The state has been a favorite venue for such suits, but the court noted the plaintiffs did not buy or ingest the drug there, and Bristol-Myers is not headquartered there. Tags legalpharmaceuticalsSTAT+last_img read more

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Could cows be the vaccine factories of the future?

first_img Tags HIV/AIDSVaccines By Jonathan Wosen July 20, 2017 Reprints Famously, the word vaccine comes from the Latin word for cow — a namesake that traces back to the late 1700s.Now cows are once again at the cutting edge of vaccine science. Thanks to a quirk of how cows make antibodies, they are helping researchers understand human immunity. Someday, cows could serve as testing grounds for whether vaccines are well-designed. And it’s possible that cow antibodies could treat everything from autoimmunity to infectious disease.A new study on HIV by scientists at Scripps Research Institute explores these possibilities. Cows don’t get HIV, but, when injected with viral proteins, produce antibodies that block HIV infection. The results, which were reported Thursday in Nature, are part of a larger effort to make the first HIV vaccine. advertisement So scientists are keenly interested in other animals that might do it well. Enter cows: Two separate teams of scientists at Scripps made two parallel discoveries in recent years — that broadly neutralizing antibodies for HIV are especially long and gangly, and that cows’ normal antibodies are also long and gangly.That was the inspiration for this study. “It was an alignment of the stars, where we had veterinarians, cow antibody scientists, and HIV scientists all talking and came up with this … relatively simple question to test,” said Devin Sok, the study’s first author and director for antibody discovery and development at the International AIDS Vaccine Initiative.The scientists injected four cows with a protein that mimics HIV’s surface, known as the envelope. They then drew blood samples over the course of a year and isolated antibodies. The antibodies were tested in a dish for their ability to block HIV from infecting cells.What they found surprised them. Within two months, all the cows made antibodies that blocked a variety of viral strains — much faster than in people. And low doses of antibody were enough to block the virus.“We definitely didn’t expect to get the [antibody] response that we did. We didn’t expect the extent of the response or how quick the response developed,” said Sok. “That was kind of mind-blowing.”As to why cows are such good antibody factories, it may have to do with their unique stomachs. Dr. Vaughn Smider, professor of molecular medicine at Scripps, points out that cows’ four-chambered stomachs hold a whopping 20 gallons of digestive microbes. “The cow immune system has to deal with keeping in check all these microorganisms,” said Smider. Cows’ extra-long antibodies “can potentially bind into grooves, crevices, or areas where a typical antibody from humans or mice may not be able to bind.” Privacy Policy Related: For the first time, over half of people worldwide with HIV taking AIDS drugs Women are leading the way in HIV research Related:center_img Antibody factoriesHIV mutates constantly, creating many strains. Broadly neutralizing antibodies are key to an HIV vaccine because they could protect against these various strains. But they’ve proven hard to make in people.“The body in HIV infection — either from natural infection or in response to a vaccine — does not like to make broadly neutralizing antibodies,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. “It just doesn’t do it readily, and it doesn’t do it very well.”advertisement Please enter a valid email address. Carmen Jaspersen/AFP/Getty Images Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. In the LabCould cows be the vaccine factories of the future? Leave this field empty if you’re human: To do this, scientists would take antibody-producing cells from cows, isolate their antibody genes, and transfer them into cell lines that grow easily in a lab, such as E. coli or yeast. They would then tinker with the antibodies to make them more “human-like.” This has already been done with mouse antibodies to create drugs such as alemtuzumab, used to treat leukemia.Smider hopes that, within five to 10 years, cow antibodies will be used for a variety of diseases. He says that their unusual structures could help treat certain cancers, autoimmune disorders, and infectious diseases — such as malaria. Smider is currently working with three different drug companies on this goal.Another possibility is to milk cows for their antibodies — literally. Cow’s milk is rich in antibodies, and there is evidence that drinking milk from cows immunized against various germs can protect against illness. Immuron, an Australian biotech company, makes a pill prepared with powdered milk from immunized cows to protect against traveler’s diarrhea. The product is available over-the-counter in multiple countries, including the U.S., Canada, Australia, and China. Further useThe study is the first to reliably elicit broadly neutralizing antibodies. But Dr. John Mascola, director of vaccine research at NIAID, cautions that there are still obstacles to an effective vaccine in humans.“The study … doesn’t tell us how to make a vaccine for HIV in people, but it does tell us how the virus evades the human immune response,” said Mascola.Mascola believes that HIV vaccine research is at “the end of the beginning.” To complete the journey, scientists will need to make a vaccine that accurately mimics HIV’s envelope and coaxes the immune system to make the right antibodies. Barton Haynes, director of the Duke Human Vaccine Institute, believes cows could help with the first of those two challenges.“There is a debate going on about whether this envelope or that envelope … is good,” said Haynes. “Cows may be a really good model to test that.”Cow HIV antibodies could also be directly given to people. This is not a substitute for a vaccine, which creates long-term immunity to prevent disease. But the antibodies could provide short-term protection or reduce virus levels in those already infected.last_img read more

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Pharmalittle: Sanofi sued for graft in the Philippines; former Valeant CEO goes to arbitration

first_imgPharmalot What is it? Tags pharmaceuticalspharmalittleSTAT+Vaccines Pharmalittle: Sanofi sued for graft in the Philippines; former Valeant CEO goes to arbitration What’s included? Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED 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. @Pharmalot Ed Silvermancenter_img Alex Hogan/STAT GET STARTED By Ed Silverman Dec. 22, 2017 Reprints [email protected] About the Author Reprints And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans, although we have plenty of daydreaming to do, since we will be taking an extended break. The agenda revolves around hanging with all of our short people, catching up on our napping, and remaining open to possibilities. And what about you? You could make time to see someone special. Take an excursion. Count your blessings. Or calculate your tax bill. So many choices, so little time? Well, whatever you do, have a grand time. But be safe. Enjoy, and see you next year, as they say…The parents of children injected with the Sanofi (SNY) dengue vaccine have filed graft charges against former Philippines President Benigno Aquino III, some of his Cabinet members, and key Sanofi executives, The Inquirer reports. They accused the officials of “knowingly” acting in bad faith when they entered into a deal with Sanofi to purchase Dengvaxia and of “gross inexcusable negligence,” saying they failed to review and assess the vaccine’s effectiveness. 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. Log In | Learn More last_img read more

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