Author: admin

Your ancestors’ poor diet may have ‘scarred’ your gut microbes

No Comments

first_img [email protected] These 6 super-salty foods will now come with a warning Related: @DrewQJoseph By Andrew Joseph Jan. 13, 2016 Reprints When those mice were bred while on the low-fiber diets, their offspring had even lower bacterial diversity than their parents. This got worse with every generation the scientists studied, producing what the authors called a “diet-induced ratcheting effect” in the paper published Wednesday in Nature.Erica Sonnenburg, the paper’s lead author and a senior research scientist at Stanford, explained that if a mouse did not have a lot of one type of bacteria in its gut when it had pups, those bacteria had less of a chance of being passed on. That process happened anew with each generation.And when the offspring mice were eventually given high-fiber diets, the diversity of their gut bacteria recovered less and less with each generation. By the fourth generation, some of the species of bacteria from the first generation of mice had gone extinct in this family line.“Those microbes aren’t there to rebound,” Sonnenburg said.Mice who had a low-fiber diet had a less diverse microbiome, which affected the diversity of their offspring’s gut bacteria, a new study found. NatureWhat did help rejuvenate the bacteria in fourth generation: fecal transplants. The researchers transferred fecal matter from control mice into the study group, and found that that, combined with a high-fiber diet, restored full diversity in their gut bacteria.Because the study was in mice, it means the same findings might not be occurring in people. But researchers said at the least the study provided yet another reason people should be incorporating fiber into their diets.“Everybody accepts that we pass on our human genes to our children, but what we really need to think about and consider is our children inherit a microbial set of genes from us,” Sonnenburg said.Kelly Swanson, who has studied how fiber supports the gut microbiome, said the new paper dovetails with the recently updated nutritional guidelines that continue to recommend eating a variety of fruits and vegetables and whole grains — all fiber-rich foods.“To me it adds another reason to eat your fiber,” said Swanson, a professor of animal and nutritional sciences at the University of Illinois at Urbana-Champaign. He added that a fiber-rich diet was all the more important if it is indeed true that microbial diversity is so difficult to repopulate once gone. Andrew Joseph The diversity of the gut bacteria in the second group of mice soon waned, with some strains seeming to disappear, the researchers found. But when those mice started eating a fiber-rich diet, most of the bacteria recovered, a finding that echoed what other scientists have found.advertisement General Assignment Reporter Andrew covers a range of topics, from addiction to public health to genetics. About the Author Reprintscenter_img In the LabYour ancestors’ poor diet may have ‘scarred’ your gut microbes The lack of fiber in our modern-day Western diets has been much bemoaned — it correlates with lower diversity of gut microbes, higher risk of heart disease, and heavier body weight.But a study in mice adds a new layer: That lack of fiber may not just be hurting our health, but that of our children and great-grandchildren, by way of their gut bacteria.Researchers found that mice’s depleted bacterial diversity as a result of low-fiber diets gets passed on to offspring, and that loss of diversity cannot be easily reversed in future generations.advertisement In a commentary also published in Nature on Wednesday, University of Michigan microbiologist Eric Martens wrote that scientists are getting a clearer picture of how diet shapes gut bacteria, and the role those “microbial partners” play in digesting complex carbohydrates.“It remains to be determined whether some of this functionality has already been lost in some people and, if so, to what extent,” Martens wrote.But, he added, “You just might consider choosing a salad at lunch today or an extra serving of beans at dinner. Future generations may thank you, too.” For the study, the researchers transplanted gut microbes from a person into mice bred without their own microbiomes. Some of the mice had diets full of fiber, while some were deprived of fiber. Related: The lack of fiber in our modern-day Western diets may not just be hurting our health, but that of our children and great-grandchildren, by way of their gut bacteria. Joe Raedle/Getty Images New dietary guidelines tougher on meat, easier on cholesterol Tags bacteriamicrobiomenutritionlast_img read more

This biotech company is trying to make a rare disease drug cheaper. Will it work?

No Comments

first_imgBusinessThis biotech company is trying to make a rare disease drug cheaper. Will it work? Related: Allison Moore, who has Charcot-Marie-Tooth, or CMT, is the founder of the Hereditary Neurotherapy Foundation. Pharnext, a French drug maker, is developing a treatment for the disorder. Chantal Heijnen for STAT If Pharnext succeeds in its plans, it will charge $20,000 to $60,000 for annual treatments — a hefty sum, but considerably less than the kinds of drug prices that have triggered allegations of price-gouging among patients and consumer advocates. It could also show other drug makers that it’s possible to drastically reduce research-and-development costs to produce breakthrough treatments, which in turn would allow them to charge less.Pharnext has “been a game-changer,” said Allison Moore, who has Charcot-Marie-Tooth, or CMT, and is the founder of the Hereditary Neurotherapy Foundation.advertisement “We are a little bit romantic, but not that much.” How a system meant to develop drugs for rare diseases broke down Related: By Dylan Scott Jan. 20, 2016 Reprints “I do think that they will deliver on the pricing,” she said. “If the pricing can be low, that can also be a trend for these other rare diseases.”center_img It remains to be seen whether that’s the case. But experts who track drug pricing said that the company’s reported strategy seems unusual.“First, they revealed what their pricing would be for a drug that hasn’t been approved. … Companies tend not to reveal anything about pricing before approval,” said Joshua Cohen, an associate professor at the Tufts Center for the Study of Drug Development. “Second, they are not going with a price that would maximize their profits. This is not unheard of, but not common. As with any commodity-selling company, drug firms usually price their products in such a way as to maximize profits.”Dr. Brian O’Sullivan of the Children’s Hospital at Dartmouth, who has written about drug prices, called Pharnext’s stated approach “refreshing.”“I think that there’s been a lot of concern in the general public about people looking to make the biggest possible profit,” he said. “You don’t have to make billions when you could make hundreds of billions.” Dr. Daniel Cohen, chief executive of Pharnext An estimated 2.8 million people worldwide have been diagnosed with a disease known as Charcot-Marie-Tooth disorder, an inherited muscular atrophy condition. The disease causes debilitating muscle weakness that can sometimes require leg braces.There is no existing drug to treat it.Pharnext, a French drug maker developing a treatment, hopes to change that. But what may set the firm apart is less its work on an experimental drug than its stated determination to do something else: keep the drug affordably priced.advertisement STAT-Harvard poll: Dismayed by drug prices, public supports Democrats’ ideas The question is if the company can make the economics work. The drug industry and its defenders have repeatedly said that high prices are justified by the high cost of developing new drugs. Research is expensive, and much of it fails. Even former Turing Pharmaceuticals CEO Martin Shkreli, who has received so much public scorn, rationalized a 5,000 percent price increase in part by saying that his company planned to invest in research for treating rare diseases.That might be argument that much of the public does not accept — about 53 percent of Americans say the drive for company profits is driving the cost of prescription drugs. But there’s no disputing that research and development requires significant investment.Some drug companies will spend upwards of $1 billion to develop drugs for rare diseases, and then price the treatment at $100,000 or more per year.Left: Pharnext has mapped Alzheimer’s disease in the brain to help combine existing drugs with the company’s experimental agent; Right: Pharnext’s facilities in Paris, France. Courtesy PharnextDr. Daniel Cohen, the chief executive of Pharnext, who launched his career by helping map the human genome, said it doesn’t have to be that way.“Do we want to charge less to save the system, or do we want to make short-term money?” Cohen said in an interview with STAT. He and his colleagues came down somewhere in the middle.“We are a little bit romantic, but not that much,” he said.Pharnext has developed a process known as pleotherapy, which it said could hold promise for the future of drug-making. It involves combining existing drugs and repurposing them to treat new conditions and lowering the doses involved to ward off side effects. The firm’s treatment for the main strain of CMT will probably cost $40 to $50 million to develop if all goes well, Cohen said. By keeping research costs in check, Pharnext says it will be able to charge consumers less. Pharnext hasn’t yet gotten its first product to market yet, however — and likely won’t until 2019, assuming the CMT treatment is approved.Still, Cohen is seen by some as a mirror image of Shkreli, who was unapologetic about hiking prices, saying his decision was justified by his desire to pursue cures for rare diseases and his responsibility to shareholders.Cohen said he didn’t want to be critical of Shkreli. But he also said that the current research-and-development model is too expensive because it fails too often and that financial interests tend to exacerbate the problem.“If there is exaggeration from companies — to over, over, overprice despite a small cost — I would say this might exist,” Cohen said. “But frankly, the guilty is not the company. The guilty is Wall Street because they put pressure on people.”Pharnext’s medical philosophy is a bit unorthodox in the age of personalized medicine, especially given Cohen’s role at its origins in documenting the human genome. The bottom line, he said, is that highly individualized treatment is often too expensive to produce and that leads to higher prices. Combining older drugs, on the other hand, could be cheaper and a cocktail that treats Alzheimer’s disease might also help treat Parkinson’s, broadening the patient pool and in turn helping lower prices.Allison Moore, who has CMT, displays the braces she must wear on her legs. The disease causes debilitating muscle weakness that can sometimes require leg braces. Chantal Heijnen for STATNot everyone is sold on his approach. Several experts pointed out that the actual ingredients being used by Pharnext — the older drugs that make up his cocktail — are available at a very cheap price.“It’s wonderful to develop a therapy for rare conditions, which, if truly effective in improving quality of life for patients, should be rewarded,” said Dr. Walid Gellad, a professor who studies drug prescribing at the University of Pittsburgh, adding that he had not examined Pharnext’s plans extensively. “But I’m not sure I see altruism here as opposed to limits on what people will pay for these older drugs in combination.”Even those who praised Cohen’s pricing philosophy acknowledged that he isn’t investing the same kind of money into basic research that other companies are.“It’s a little easier for them to say they’re going to price it lower because they’re not putting as much in on the front end,” O’Sullivan said, though he added that “some other companies have used that as an excuse to overcharge.”Regardless of altruism or lack thereof, Cohen will have an important ally: patient advocates. After Turing Pharmaceuticals hiked the price of an older anti-parasitic drug by more than 5,000 percent last year, AIDS groups whose constituencies relied on the drug were outraged.Pharnext, on the other hand, has the enthusiastic backing of Moore’s group, the Hereditary Neurotherapy Foundation. Moore met personally with Cohen and his colleagues in Paris in 2013 and helped set up the US trials for their drug.“I really feel it’s not just about making money,” Moore said of Pharnext and Cohen. “He really wants to make a difference.”Correction: An earlier version of this story misstated the hospital where Dr. Brian O’Sullivan works. Tags drug developmentdrug pricesrare diseaseslast_img read more

Can you vape on a plane? The feds finally answer that question

No Comments

first_img“The Department took a practical approach to eliminate any confusion between tobacco cigarettes and e-cigarettes by applying the same restrictions to both,” Foxx said.Last month, during a hearing on the use of vaporizers on planes, California Representative Duncan Hunter made headlines when he pulled out a vaporizer and took a drag to argue that they are safe and should be permitted on planes.advertisement By Elana Zak March 2, 2016 Reprints Can you vape on a plane? The answer is now, very clearly, no.The Department of Transportation on Wednesday issued a final rule explicitly banning the use of electronic cigarettes from US flights, including those arriving in the country from overseas. In a statement, Transportation Secretary Anthony Foxx said the rule “protects airline passengers from unwanted exposure to aerosol fumes.”Previously, only tobacco cigarettes were banned. The new rule aims to clarify that e-cigarettes are included in the existing ban on the smoking of tobacco products aboard planes.advertisement Related: Teens who vape are more likely to later try real cigarettes PoliticsCan you vape on a plane? The feds finally answer that question Tags e-cigarettespolicysmokingtobacco “There’s no combustion. There’s no carcinogens,” the Republican lawmaker said. “This has helped thousands of people quit smoking. It’s helped me quit smoking.”On Wednesday, Hunter’s chief of staff, Joe Kasper, said the Transportation Department’s decision did not come as a surprise.“It’s the heavy hand of the government interfering where it shouldn’t — or at least where companies can determine their own policies,” Kasper said. “This Administration sees vaping as a proxy fight with tobacco, it’s that simple, when in actuality vaping is very different, as both a product and a preference.”In November, the Department of Transportation banned e-cigarettes from checked bags on planes over concerns they could catch fire.E-cigarettes, which have only been around since 2004, remain a controversial topic. Manufacturers say they help people quit smoking, yet public health advocates say they are a gateway to smoking tobacco cigarettes. There is also increasing research showing that some of the flavorings may be hazardous in themselves.A recent STAT-Harvard poll found the majority of Americans believe they are harmful to people’s health. The Department of Transportation is prohibiting vaping on planes. Dan Kitwood/Getty Imageslast_img read more

Rep. Andy Harris: ‘I’m not making a pitch’ to be NIH director

No Comments

first_img Log In | Learn More Unlock this article — plus daily intelligence on Capitol Hill and the life sciences industry — by subscribing to STAT+. First 30 days free. GET STARTED What is it? Alex Hogan/STAT WASHINGTON — Congressman Andy Harris of Maryland has not had a formal interview with President-elect Donald Trump’s transition team for National Institutes of Health director or any other position in the administration, he told STAT.“I’m not making a pitch,” Harris said in an interview. “I just made it clear to some folks who do health care with the Trump team that I would be willing to help, if they thought I could help in any way.” 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. Tags CongresspolicyWhite House By Lev Facher Dec. 20, 2016 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. About the Author Reprintscenter_img Washington Correspondent Lev Facher covers the politics of health and life sciences. [email protected] GET STARTED Rep. Andy Harris: ‘I’m not making a pitch’ to be NIH director What’s included? Politics Lev Facher @levfacher last_img read more

The Broad Institute is testing the limits of what ‘nonprofit’ means

No Comments

first_img Please enter a valid email address. Science, long conceived as a public trust, is now characterized by an ownership culture. Sean Parker’s put up big bucks for cancer. We’ve got questions Related: Read the Broad Institute’s response hereThe Broad is testing how close a nonprofit can be to a corporation. Soon after patents were issued to the Broad for CRISPR-Cas9, its director, Eric Lander, turned to Third Rock Ventures, a company to which he has close personal ties, for an early shot at investing in Editas. That startup was founded by Feng Zhang, a core researcher at the Broad. Editas obtained an exclusive license to CRISPR-Cas9 from patent holders including the Broad for cash and stock equity, and began funneling $34.1 million (by the end of 2016) to reimburse the Broad’s legal fees in its court battle for the rights to CRISPR-Cas9. As millions were flowing from the now publicly traded Editas to the Broad, Editas cofounder David Liu was installed as a core member at the Broad, further strengthening ties between the Broad and its commercial partner. Zhang and colleagues then patented an application of a related genome-editing technique called CRISPR-Cpf1 and, through the Broad and other institutions, granted Editas an exclusive license to use this technology for medical applications.This kind of tight relationship with a for-profit corporation clearly puts the concept of “nonprofit” to the test. How many tens of millions should the Broad be allowed to take from Editas? How many of the founders of Editas should be installed into leadership positions at the Broad? Does granting of exclusive licenses constitute a special favor, a quid pro quo? Those are the kinds of questions that regulators should be asking, but aren’t. Tags CRISPRfinancegenetics Broad Institute prevails in heated dispute over CRISPR patents [email protected] Related: By Jim Kozubek April 25, 2017 Reprints When a federal patent court ruled that the nonprofit Broad Institute of MIT and Harvard could legally license its version of the CRISPR-Cas9 genome-editing system, it opened the door to millions of dollars of revenue for the institute. It also contributed to the seismic shift occurring in science whereby tax-exempt research institutes established under an emerging model of “free market philanthropy” can amass money to further their research and protect their commercial interests.The Broad Institute, a tax-exempt organization established by contributions totaling $1.4 billion by Eli Broad and Ted Stanley, is hardly the only one of these nonprofit models.For instance, Napster cofounder and former Facebook president Sean Parker set up the nonprofit Parker Institute for Cancer Immunotherapy to explore new ways to fight cancer. Its affiliated academic institutions will own the intellectual property for their respective inventions; the institute will help manage patents and licensing in collaboration with those institutions. Facebook founder Mark Zuckerberg and his wife, Priscilla Chan, are investing $600 million to create the Chan Zuckerberg Biohub, which would retain the exclusive right to commercialize its inventions.advertisement First OpinionThe Broad Institute is testing the limits of what ‘nonprofit’ means center_img The Broad, possibly aware that its nonprofit mission could be at risk, published at the end of 2016 a guide to its intellectual property licensing philosophy. It noted that “non-profit institutions [like the Broad] should, in general, favor non-exclusive licenses over exclusive licenses.” The document immediately walked back that principle, saying that investors “would need to make a large investment to turn [intellectual property] into a commercial product” and “could not recoup this investment without exclusive rights.” By the end of the statement, the Broad made a case that special deals were good for everyone as exclusivity “may be appropriate because there is a clear case that it will better serve the public good.” Privacy Policy Leave this field empty if you’re human: Science, long conceived as a public trust, is now characterized by an ownership culture. That is raising questions about how much taxpayers should pay for grants that feed into this culture and its incipient biotech wars. There is something intuitively wrong about a tax-exempt nonprofit organization such as the Broad being so financially aggressive. Taxpayers should not be paying for biomedical research and development that preferentially benefits the scientific elites who hold and legally defend their property ownership.Michael Eisen, a University of California biologist who is now a candidate for US Senate, has argued that taxpayer-funded academic scientists should not patent seminal technologies such as CRISPR-Cas9. In a more nuanced opinion published in Science, patent lawyers Jacob S. Sherkow and Jorge L. Contreras argue that research institutions should limit their use of “surrogate licensors” — such as Editas — which have exclusive licenses to use a nonprofit’s technologies.A clause in contracts between Editas and the Broad allows the company to permit licensing of CRISPR for single-gene targets it doesn’t plan to monetize to other “third parties.” But that clause may be moot, since Editas has the right to sublicense CRISPR and would and could monetize most anything within its grasp.In fact, Editas has already struck up a $737 million partnership with Juno Therapeutics and a $90 million deal with Allergan. Sherkow and Contreras argue that, to be fair, a nonprofit such as the Broad should license CRISPR for only one application at a time — even to a partner like Editas. Sherkow told me that “to the extent they’re going to use exclusive licenses, they should do it narrowly, on a gene-by-gene basis.” In other words, a nonprofit should limit licensing to a specific target. In the CRISPR world, that might mean that the Broad could license to Editas the right to use its genome editing technology on the CEP290 gene to develop treatments for an inherited eye disease, but not hand over the whole basket of patent applications to this one friendly company. Jim Kozubek NewslettersSign up for The Readout Your daily guide to what’s happening in biotech. Under a 1980 law, the public could petition the government to make CRISPR licensing more accessible if the terms of the license are not reasonable — meaning that licensing terms should be affordable and not under the control of a single company. It’s clear the Broad and Editas do not want to allow that.The public benefit of CRISPR is uncertain. An independent report issued in March showed that a dozen candidates vying to become the first gene therapy drug approved by the FDA (none of them developed using CRISPR technology) carry jaw-dropping costs, raising questions about how most folks could even pay for such drugs. CRISPR treatments, if and when they make it to the market, are likely to be equally unaffordable.Competition in biomedical science will continue to ratchet up through the means of large nonprofit hubs and exclusive corporate partnerships. Regulators will need to step up and ensure more equitable fair play for licensing or begin to cut federal funding streams for these nonprofits.As taxpayers, we need to support research by the Environmental Protection Agency, the Food and Drug Administration, and the NIH. But corporate welfare should be subject to the same rigorous standards as public welfare. Biomedical researchers who command surplus cash flows and convey private benefits should be subject to a means test to determine if they should continue to receive public assistance.Writer Jim Kozubek is the author of “Modern Prometheus: Editing the Human Genome with Crispr-Cas9,” published by the Cambridge University Press. Between October 2013 and May 2016, he worked as a data scientist for Brigham and Women’s Hospital with an affiliation to the Broad Institute. About the Author Reprints Alex Hogan/STAT In fact, a nonprofit may not confer a “private benefit” to a corporation. Private benefit is defined as “non-incidental benefits conferred on disinterested persons that serve private interests.” The law says that any private benefit must be relatively insignificant in size to the nonprofit’s overall revenue and a necessary side effect of achieving the nonprofit’s objectives. I asked the Internal Revenue Service and the office of the Massachusetts Attorney General about this, but both declined to comment on how financially entangled the Broad and Editas could legally become and what, if any, breaches could trigger an investigation.The privatization of federally funded science could scarcely have been imagined when national funding was first proposed. During World War II, President Franklin D. Roosevelt directed his chief of military research and development, Vannevar Bush, to create a model for funding science after the war. In Bush’s poetic 1945 document, “Science the Endless Frontier,” he argued for robust funding through the NIH and the creation of the National Science Foundation. These and other efforts led to a briskly expanding scientific research base in the US. In the 1950s, physicist and MIT president Karl Compton noted of scientists in general, “I don’t know of any other group that has less interest in monetary gain.”That’s changed. By 1980, a landmark ruling upheld early biotech patents. The Bayh-Dole Act enabled universities, small businesses, and nonprofit institutions to pursue ownership of inventions that arose from federally funded research. Today, scientists talk openly about “figuring out the model,” whereby public money can be turned into private wealth, and escalating biotech battles are a hot-button issue. The tax-exempt Broad draws National Institutes of Health funding to subsidize dozens of basic research projects, many of them conducted with commercial partners. But it is the Broad’s handling of its own CRISPR business and partnerships that threaten to undermine its nonprofit mission. These relationships can challenge the concept of “public interest,” such as when the Broad sells CRISPR licenses to Monsanto for agricultural applications, since a sizable fraction of the public may not agree that genetically modified crops serve the public interest. Or it might not be in the public interest when a favored corporation reaps a financial benefit, such as when the Broad sells exclusive licenses for CRISPR to Editas Medicine, a company that was spun out of the institute.These nonprofit-corporate partnerships raise questions about the extent to which taxpayers should subsidize tax-exempt biomedical research by nonprofits that retain the rights to license patents and appear willing to defend them in court.advertisementlast_img read more

The 8 make-or-break events that will shape biotech in the coming months

No Comments

first_img What’s included? 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. Business Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED By most measures, biotech investors shouldn’t have too many gripes about the first half of 2017. The go-go years of 2013 and 2014 aren’t making a roaring comeback, but our little corner of Wall Street has outperformed the broader market despite the constant threat of D.C. meddling. As the July Fourth holiday approaches, biotech investors can pause, crack open a can of their favorite hoppy IPA, and consider the stock-moving events and story lines that will make or break the back half of 2017.The following are my picks for the most important events on the docket. STAT Plus subscribers, please weigh in with your selections (or ask about mine) during an exclusive, live online chat with me at 2 pm EDT. Come back to this story a few minutes before 2 to log in and join the conversation. 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. Adam Feuerstein What is it? 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. David Banks/Getty Images The 8 make-or-break events that will shape biotech in the coming months About the Author Reprints By Adam Feuerstein June 28, 2017 Reprints [email protected] Log In | Learn More @adamfeuersteinlast_img read more

The FDA made a ‘grand bargain’ on fast drug approvals, but pharma isn’t holding up its end

No Comments

first_img What’s included? Damian Garde By Damian Garde Aug. 15, 2017 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. National Biotech Reporter Damian covers biotech, is a co-writer of The Readout newsletter, and a co-host of “The Readout LOUD” podcast. What is it? 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. Tags drug developmentpharmaceuticalspolicyresearchSTAT+ @damiangarde center_img GET STARTED Pharma About the Author Reprints Andrew Harnik/AP Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED [email protected] The FDA made a ‘grand bargain’ on fast drug approvals, but pharma isn’t holding up its end The FDA, in an effort to bring promising new therapies to patients as quickly as possible, has introduced a spate of shortcuts to speed up the approval process. Those programs are working as intended, new research finds, but drug companies are often loath to fulfill their obligations.The big idea behind the FDA’s accelerated drug approval program is that regulators will OK a promising drug based on clues that it will improve patient lives, so long as pharma companies later carry out larger trials to confirm those hints of efficacy. But looking at four years of data, a team of researchers found that only 50 percent of those trials actually took place within three years of approval.last_img read more

10 tidbits of investor intel — or, what Adam and Damian learned this week in New York

No Comments

first_img What is it? 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. Mario Tama/Getty Images @adamfeuerstein Adam Feuerstein GET STARTED [email protected] Business Log In | Learn More About the Authors Reprints Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED National Biotech Reporter Damian covers biotech, is a co-writer of The Readout newsletter, and a co-host of “The Readout LOUD” podcast.center_img @damiangarde What’s included? 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. 10 tidbits of investor intel — or, what Adam and Damian learned this week in New York NEW YORK — As biotech speeds through a make-or-break September, a gaggle of banking conferences brought investors here this week, in hopes of separating the lucrative ideas from the lost causes.We came, too, stalking the conference hallways (and open bars) in markedly less expensive clothing to take the pulse of biotech financiers in the middle of a hugely important time for the sector. Here, some scattered observations on biotech’s hottest topics: Damian Garde 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] By Adam Feuerstein and Damian Garde Sept. 14, 2017 Reprints Tags cancerdementiapolicyrare diseaseSTAT+White Housewomen’s healthlast_img read more

How the ‘right-to-try’ movement muscled its way into Washington

No Comments

first_img WASHINGTON — Five years ago, the phrase “right to try” wasn’t yet an inkling in the minds of its staunchest advocates. Today, the pithy shorthand for the campaign to get dying patients access to experimental treatments has been slapped on bumper stickers, emblazoned on T-shirts, and uttered by some of the most powerful figures in Washington.At the White House, President Trump has made clear he sees the issue as a priority. And on Capitol Hill — otherwise largely paralyzed on health care policy — Republicans are working on legislation that could fundamentally alter the way in which terminally ill patients can gain access to drugs. How the ‘right-to-try’ movement muscled its way into Washington 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 Politics Sen. Ron Johnson (R-Wis.) introduced his “right-to-try” legislation in May alongside Jordan McLinn, a young advocate from Indiana who has Duchenne muscular dystrophy. BRENDAN SMIALOWSKI/AFP/Getty Images Erin Mershon [email protected] Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED @eemershon center_img Log In | Learn More By Erin Mershon March 7, 2018 Reprints 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. Senior News Editor Tags Congressend of lifepatientspolicy What’s included? What is it?last_img read more

China may compete with the West for limited opportunities to test Ebola vaccine

No Comments

first_imgHealth Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+. 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. China is making a bid to use its Ebola vaccine in the Democratic Republic of the Congo. It’s a move that could further complicate efforts to test a crowded field of vaccines and therapies in the context of a waning outbreak.The head of the Chinese Center for Disease Control and Prevention (CDC), Gao Fu, is reported to have said that a team of experts will travel to the DRC on Friday, bringing with them an unspecified number of doses of vaccine. What is it? Senior Writer, Infectious Disease Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Helen Branswell Log In | Learn More What’s included? Health workers operate within an Ebola safety zone in the health center in Iyonda, near Mbandaka, Democratic Republic of the Congo, on June 1. JUNIOR D. KANNAH/AFP/Getty Images By Helen Branswell June 8, 2018 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. About the Author Reprints China may compete with the West for limited opportunities to test Ebola vaccine @HelenBranswell GET STARTED Tags global healthinfectious diseaseVaccineslast_img read more