Month: June 2021

first_imgPharmalotPharmalot, Pharmalittle: AstraZeneca suffers setback with its blood thinner [email protected] Vertex Pharmaceuticals suffered a setback as the UK’s National Institute for Health and Care Excellence issued draft guidelines rejecting the use of its Orkambi cystic fibrosis treatment, Pharma Times reports. The cost watchdog determined the cost was “considerably higher” than the current standard of care, and so the treatment would not be an effective use of resources, despite an ability to reduce hospitalizations.The US Food and Drug Administration plans to add black box warnings — the most serious type — to all immediate-release opioid painkillers, STAT tells us. These include combination pills containing oxycodone and non-prescription drug ingredients. The move comes three years after the FDA added stronger warnings to long-acting opioid drugs like OxyContin, which slowly release their doses.advertisement Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Top of the morning to you. And a fine one it is. The challenging mid-week slog may have arrived, but we are feeling optimistic thanks to a warm and shiny sun that is enveloping the Pharmalot campus. To celebrate, yes, we are brewing more cups of stimulation in our coffee kettle and working to the rhythm of the snoring mascots. As for you, here are some items of interest. We hope you find them helpful and, of course, that you  have a smashing day …AstraZeneca reported that its Brilinta blood thinner failed to help stroke patients as hoped in a major clinical trial, Bloomberg News tells us. The drug was not significantly better than aspirin, which is the current standard of care, in preventing recurring heart attacks in the 90 days after patients suffered a stroke. The drug is a critical part of plans that call for reaching $45 billion in annual revenue by 2023.Despite a warning from Moody’s credit analysts, investors in bonds backed by risky loans are positive on deals involving Valeant Pharmaceuticals debt, The Financial Times writes. But not everyone is optimistic. “You’d need almost every market participant” in the (collateralized loan obligation) market to agree to a deal, Kevin Kendra, managing director and head of Fitch’s US Structured Credit group, tells Fortune.advertisement About the Author Reprints @Pharmalot center_img Alex Hogan/STAT An Indian court agreed to a hearing next week concerning a government ban on 344 fixed-dose combination drugs, including a popular Pfizer cough medicine, The Hindustan Times reports. Meanwhile, India’s National Pharmaceutical Pricing Authority moved in to back the health ministry in its efforts to curb these drugs by returning more than 200 applications to drug manufacturers, The Economic Times informs us.Sanofi and Regeneron Pharmaceuticals reported a late-stage study of the Praluent injectable drug reduced the need for patients with an inherited form of high cholesterol to have bad cholesterol removed from their blood, Reuters says.Chinese authorities detained 37 people in Shandong province after a $90 million black market ring in vaccines was discovered last week, Reuters tells us. The vaccines — for meningitis, rabies and other illnesses — are suspected of being sold in dozens of provinces around China since 2011, and the government has promised a crackdown.Eli Lilly won US regulatory approval for an injectable drug called Taltz to treat adults with moderate-to-severe plaque psoriasis, according to The Wall Street Journal.A trial is under way in a Miami court where an insurer for Eli Lilly alleges Tyco failed to protect computer data that allowed thieves to break into a warehouse and steal $60 million of drugs in 2010, Security Sales & Integration says.Germany’s Institute for Quality and Efficiency in Health Care decided there is no evidence to cover an added benefit for Novartis’s Cosentyx to treat ankylosing spondylitis and psoriatic arthritis, PMLive writes. Ed Silverman By Ed Silverman March 23, 2016 Reprints Tags AstraZenecacystic fibrosisValeant Pharmaceuticalslast_img read more

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first_img By Associated Press Oct. 10, 2016 Reprints Heart attack patients are getting younger — and more obese About the Author Reprints Attention desk jockeys: Those who sit at work need an hour of exercise a day Tags exerciseheart attack Related: Should you simmer down before sweating it out? Robyn Beck/AFP/Getty Earlier studies have looked at anger and exertion as heart attack triggers, but most were small or in one country, or included few women or minorities. The new study involved 12,461 people suffering a first heart attack in 52 countries. Their average age was 58 and three-fourths were men.advertisement They answered a survey about whether they were angry or upset, or had heavy exertion, in the hour before their heart attack or during the same time period the previous day. That way researchers could compare risk at different times in the same people and the effect of these potential heart attack triggers.Being angry or upset doubled the risk of suffering heart attack symptoms within an hour; heavy physical exertion did the same. Having both at the same time more than tripled the risk for a heart attack.The risk was greatest between 6 p.m. and midnight, and was independent of other factors such as smoking, high blood pressure or obesity.Big caveats: Patients reported their own stress or anger, and people who just had a heart attack may be more prone to recall or think they suffered one of these triggers than they otherwise might have been. Also, strenuous exertion is whatever the patient perceives it to be — for some people that could be climbing stairs and for others, running a marathon. The study also is observational, so it cannot prove cause and effect. But it’s likely to be the best kind of information available — it’s not possible to randomly assign people to be angry and exercise, then see how many have heart attacks.“This is a large enough sample size that we can put stock in the findings,” Jacobs said.“We all need to find ways of modifying our emotional reactions and to avoid extreme anger,” such as distracting ourselves, walking away from the stressful situation, trying to see it from a different perspective, talking it out and getting support from other people, he said.The study’s findings also are biologically plausible. Emotional stress and exertion can raise blood pressure and heart rate, change the flow of blood in the vessels and reduce the heart’s blood supply, said the study leader, Dr. Andrew Smyth of McMaster University. In an artery already clogged with plaque, a trigger could block blood flow and lead to a heart attack.center_img Related: If you’re angry or upset, you might want to simmer down before heading out for an intense run or gym workout. A large, international study ties heavy exertion while stressed or mad to a tripled risk of having a heart attack within an hour.Regular exercise is a healthy antidote to stress and can help prevent heart disease — the biggest problem is that too many people get too little of it. But the new research suggests there may be better or worse times to exercise, and that extremes can trigger harm.“This study is further evidence of the connection between mind and body. When you’re angry, that’s not the time to go out and chop a stack of wood,” said Barry Jacobs, a psychologist at the Crozer-Keystone Health System in suburban Philadelphia and an American Heart Association volunteer.advertisement HealthExercising while angry or upset could carry temporary heart risks, study says Does exercise prevent cancer? “From a practical perspective, there will be times when exposure to such extremes is unavoidable,” Smyth said.“We continue to advise regular physical activity for all, including those who use exercise to relieve stress,” but people should not go beyond their usual routine at such times, he said.The study was funded by the Canadian Institutes of Health Research, other governmental bodies from various countries that participated, and grants from several drug companies.— Marilynn Marchione Related: He had no role in the study, led by the Population Health Research Institute at McMaster University in Hamilton, Ontario. Results were published Monday in the Heart Association journal Circulation. Associated Presslast_img read more

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first_img DURHAM, N.C. — If you leave the American Tobacco Trail and drive east, past Dame’s Almost Famous Chicken & Waffles, Bullock’s Bar-B-Que, and the Truly Blessed Hair Salon, you will eventually come to the world’s largest research park.This 16-square-mile stretch of Piedmont pine forest is home to about 200 companies that develop drugs and devices, run clinical trials, and otherwise push the boundaries of bioscience. GlaxoSmithKline, Merck & Co., and Biogen all have offices here, as do other industry leaders and startups.This is Burr country.advertisement Burr is Senator Richard Burr, and this is the heart of the state’s pharmaceutical and biotech industry, which the veteran lawmaker has spent his career protecting. Now, with Burr facing a strong challenge from a former Democratic state representative, the industry is returning the favor, with pharmaceutical executives and lobbyists pouring money into his campaign.“The industry feels very positive about Senator Burr, because he’s always taken a strong leadership role in policy that we’re interested in,” said Samuel Taylor, president of the state’s bioscience trade group, set in a sprawling brick structure in the rolling hills of The Research Triangle Park, as the area is known. “He’s done a stellar job.”advertisement The Research Triangle Park is the heart of North Carolina’s pharmaceutical and biotech industry. Alex Hogan/STAT, Google EarthIt’s a job that those here in The Research Triangle, and those in the nearby Wake Forest Innovation Quarter, badly want him to keep.Burr, now in his second term following a decade in the House, has been uniquely positioned to press for faster regulatory approval of drugs and medical devices and lower taxes for the industry, and to generally be a booster for his state, which touts itself as the nation’s third-largest biotech cluster, behind Boston and Northern California.His committee posts have given him oversight of both the Food and Drug Administration and Medicare and Medicaid. He is also the chairman of the Select Committee on Intelligence.“I’ve always found him to be somebody who is very thoughtful, smart, and works to learn the issues,” said Stephen Northrup, a partner at Rampy Northrup, a lobbying firm, who got to know Burr as GOP health policy director for the Senate Committee on Health, Education, Labor, and Pensions.Polls, however, show Burr in a tight race with Deborah K. Ross, who served 10 years in the State House and who previously served as director of North Carolina’s American Civil Liberties Union.That has not sat well with the drug industry.“I told my pharmaceutical clients to get down there and help,” said one lobbyist who spoke on condition of anonymity to speak candidly.Drug makers, medical device companies, related health care political action committees, and the companies’ lobbyists and employees, have so far given Burr more than $1.2 million this election cycle, making the industry by far his most generous supporter, according to a STAT analysis.Nearly every firm has chipped in. GlaxoSmithKline, the largest company in The Research Triangle Park, gave $10,000. Abbott Laboratories donated $7,500 to the senator, and its spinoff, AbbVie, gave $9,000. The Bayer Corporation donated $7,000; Davita gave $8,000; Emergent Biosolutions gave $10,000; and Eli Lilly & Co. kicked in $8,000.With the election getting closer, the pharmaceutical and medical-device industry has hosted a series of fundraisers in Washington for Burr. Lobbyists for Abbvie and Johnson & Johnson, for example, invited prospective donors to dine with the senator at an Italian trattoria. King & Spalding, a law firm with a large pharmaceutical practice, threw a fundraiser reception for him on the rooftop of its Pennsylvania Avenue quarters.The Advanced Medical Technology Association, which represents the majority of the nation’s medical technology companies, hosted two events for Burr, who has pushed for the repeal of the medical device excise tax.Some companies have contributed $10,000 to Burr’s campaign, then donated an addition $10,000 to his leadership PAC.That kind of support, industry insiders say, reflects the commitment that Burr has made to them over the years. Leave this field empty if you’re human: PoliticsIn a tight race, one of pharma’s favorite senators gets a little help from his friends By Sheila Kaplan Oct. 25, 2016 Reprints Please enter a valid email address. Medical device makers rally to save their ‘go-to guy’ in Congress center_img Supporters point to Burr’s sponsorship of the FDA Modernization Act of 1997, which cut the agency’s review time for new drug approvals and called for increased patient access to experimental drugs and medical devices. That measure was approved while Burr was in the House.In the Senate, he was a driving force in creation of the Biomedical Advanced Research and Development Authority (BARDA), a federal office that serves as a kind of government venture capital arm for fighting bioterrorism. BARDA develops and buys vaccines, drug therapies, and diagnostic tools for public health threats, such as anthrax, and possible pandemics.Northrup, who worked on the legislation, said Burr deserves more credit for it than he’s usually given.“There would not be a BARDA today if it was not for the work that Senator Burr did,” Northrup said. “That was his first major accomplishment in the Senate, in his first two years.”Jesse Hunt, a spokesman for Burr, said the senator continues to push for funding for BARDA and the National Institutes of Health. Asked about the drug industry’s support, he noted that Ross’s campaign coffers have been filled by liberal Democratic groups and labor unions, which he said were out of step with North Carolina values.Ross’s campaign declined to comment on Burr’s industry support, but throughout the campaign has stressed his support from health insurers.Senator Richard Burr and Democratic challenger Deborah K. Ross participate in a debate in Research Triangle Park, N.C., earlier this month. Gerry Broome/AP“North Carolina voters know better than to trust the insurance industry’s hand-picked candidate to look after their Medicare,” said Cole Leiter, Ross’s press secretary.Burr’s supporters have expressed concern that their candidate could be dragged down by Donald Trump. Burr has stood by Trump, calling for forgiveness after the surfacing of comments in which the Republican candidate suggested sexually assaulting women.Still, here in the biotech center, voters may be more concerned with maintaining North Carolina’s newly strong economy — and with having a friend in the Senate — than with presidential politics.The North Carolina Biosciences Organization is among the groups here supporting Burr, although unofficially. When a reporter came by for a visit, the head of the group, Samuel Taylor, said he had just called the Burr camp, seeking directions on what he might say in the interview.The campaign didn’t call back in time, but Taylor knew how he wanted to put it: “It’s important to have a member of Congress who understands the FDA, and has the respect of the FDA,” he said, “and I think that Senator Burr meets both of those criteria.” Privacy Policy Newsletters Sign up for D.C. Diagnosis An insider’s guide to the politics and policies of health care. Tags biotechFDApharmaceutical industrypolicy Related: Senator Richard Burr is in a tight race with Deborah K. Ross, a former North Carolina state representative. Jim Watson/AFP/Getty Imageslast_img read more

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first_img This disconnect in communication between physicians and patients causes tens of millions of Americans to unnecessarily suffer each year and costs the US health care system as much as $300 billion a year. The missed diagnoses, emergency visits, and silent dissonance over treatment decisions that stem from this disconnect place a significant emotional and physical strain on patients and their physicians.How do we help patients open up and give doctors more tools and time to listen? The first-year medical school curriculum might have an answer.In my Patient Doctor I class, the first skill we were taught as doctors in training was to establish rapport — a mutual feeling of harmony, confidence, and trust — early in conversation with a patient. It could mean anything from mentioning the score of last night’s New England Patriots game to celebrating a mutual love of baklava.Sally and I were both dog people.Rapport fosters honesty and opens up patients to deeper conversations. Asking patients about what they hope to achieve from their care, their long-term health goals, and what’s most important to them helps align goals traditionally favored by health care professionals (healthy vital signs and lab test results, better control of illness, and good quality of life) with the goals that are on the minds of patients like Sally (will I have enough energy and be steady enough on my feet when I go home to take care of my puppy?)Physicians who manage to spend extra time listening to patients with chronic conditions heavily influenced by human behavior, such as type 2 diabetes and smoking, find that promoting preventive habits that are in line with their patients’ own goals increases the likelihood that their patients will follow their treatment plans and improve their long-term health.Another way clinicians can establish rapport is by sharing stories with their patients of others who have been in their shoes. This might be something along the lines of, “Many of my patients like you have been happy with this medication and course of treatment.” This gives patients space to confirm similarities and voice differences that can help guide their care. Sharing accounts of patients with similar illnesses can create a sense of community in what, for many people, can be an isolating experience. It also makes it evident that the doctor has taken the time to understand what makes his or her patients happy.The bottleneck that often impedes such interactions is time. To give physicians more time to listen to their patients, health care organizations need to rethink the value of each hour of a physician’s workday. Giving doctors more time with patients and easing the burden of other tasks, such as recruiting medical scribes to document visits, automating discharge paperwork, off-loading lab orders, and streamlining care transitions, will move the needle toward better long-term patient care and away from the treadmill of efficiency. APStock Sally told me that she suffers from Crohn’s disease, a condition in which the body’s immune system continuously and relentlessly attacks the gastrointestinal tract from the inside out. She had landed in the emergency department because the disease had spontaneously flared up a few hours after dinner, sparking a high fever and intense abdominal pain. The emergency physicians stabilized her, but I could see that she was still distressed.I asked her if she had any ideas why her Crohn’s might have flared up. Sally replied that she had stopped taking her new Crohn’s medications a couple weeks earlier, then added, “You are the first doctor to have asked me that question.” That caught me off guard. How could it be that I, a student with only four months of medical experience under my belt, was the first person to ask what seemed like a basic question?I followed up with the next logical question, “Why did you stop taking your medication?” Sheepishly, she told me that it had been making her nauseous and dizzy, but she had been afraid to mention the side effects to her doctor.Sally isn’t alone in not disclosing important information like that. Many patients hesitate to speak up to their doctors out of the fear that they might be viewed in a negative light and consequently receive worse care.For those who do speak up, doctors often don’t have the time to listen. Seeing dozens of patients a day, and doing the companion paperwork, can make it difficult to spend a few extra minutes listening to patients. A report in the Annals of Internal Medicine put this in context: For every hour that physicians spend seeing patients, they spend two writing notes in electronic health records. Even when clinicians do get time with patients, many — and I’m guilty of this myself — often simply cycle through a checklist of questions, fearing that any deviation will lead the patient on a 20-minute tangent down memory lane. About the Author Reprints Leave this field empty if you’re human: As more health systems transition their focus of care from volume to value, it will be well worth it for them to give physicians extra time with patients to learn their goals, align outcomes, and prevent care complications down the road.I believe that it will ultimately fall to a new generation of clinicians to reconcile the modern patient-provider relationship. Although this bond is fluid and constantly evolving, it should encourage physicians to do what idyllic first-year students are wont to do: lend an ear, give their time, and gather important information about their patients’ health and satisfaction.Luckily for Sally, there are a variety of drug classes to help manage Crohn’s disease that may help her avoid nausea, unnecessary pain, and an emergency room visit. But if she doesn’t feel comfortable and at ease speaking up about her goals and her concerns, and her care team doesn’t make it abundantly apparent that it will be there to listen, we’re more likely to see — but not hear — her again next week.Nisarg A. Patel is a third-year student at Harvard Medical School and Harvard School of Dental Medicine. Improving health care with the simple act of listening [email protected] First OpinionThe doctor will hear you now Nisarg A. Patel The day I zipped my lips and let my patients talk Related:center_img Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. By Nisarg A. Patel March 23, 2017 Reprints Privacy Policy Please enter a valid email address. Related: @nxpatel There’s absolutely no good reason why Sally should have been in the hospital. Not a day over 60, she had come to the emergency department for severe gastrointestinal pain and was then moved to a bed on the 10th floor of one of the hospital’s two towers.I met Sally (not her real name) during my first year in medical school. Every Monday, my job was to take the medical history of one patient. Our class was short on patients that afternoon and my professor, an attending physician at the hospital, had left me to help another student find a patient to interview.That meant I was alone as I walked into Sally’s room. I greeted her and sat down in the chair next to her bed. Monitors on either side of her bed beeped steadily as they kept track of heart rate, blood pressure, and the amount of oxygen in her bloodstream.advertisement I gave her the one thing that first-year students can offer that few others in the hospital can: my undivided time and attention.“What brought you to the hospital?” I asked.advertisement Tags educationpatientsphysicianslast_img read more

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first_img Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED By Andrew Joseph May 16, 2017 Reprints GET STARTED General Assignment Reporter Andrew covers a range of topics, from addiction to public health to genetics. What’s included? What is it? Log In | Learn More He made the emotional plea to his colleagues: Pass this bill.“It might give somebody like my wife a chance to walk,” Texas Representative Drew Springer said through tears late Thursday at the state Capitol in Austin. “I’d trade every one of my bills I’ve passed, every single one of them, to get the chance to hear HB 810.” STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Politics center_img @DrewQJoseph 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. Tags policyresearchstates Andrew Joseph Three bills are under consideration in the Texas Legislature that would affect stem cell clinics and chronically ill patients. Dan Istitene/Getty Images About the Author Reprints [email protected] Texas leans into unproven stem cell treatments, to the dismay of scientists last_img read more

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first_img About the Author Reprints Pharmalot Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. GET STARTED 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. 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. Tags drug pricinglegalpharmaceuticalsSTAT+ By Ed Silverman Sept. 20, 2017 Reprints What’s included?center_img [email protected] Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED @Pharmalot Pfizer accuses J&J of illegally stifling insurance coverage for its biosimilar Mark Lennihan/AP Underscoring the lucrative potential for biosimilars, Pfizer (PFE) has accused Johnson & Johnson (JNJ) of using anti-competitive practices to prevent insurers from covering its version of a best-selling J&J medicine.In a lawsuit filed on Wednesday, Pfizer claims that J&J used various illegal contracting tactics to convince insurers not to cover Inflectra, a biosimilar version of the blockbuster Remicade treatment for rheumatoid arthritis and other diseases. A biosimilar, you may recall, is a nearly identical variant of a brand-name biologic medicine and is expected to provide the same result in patients. Log In | Learn More What is it?last_img read more

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first_img Exclusive analysis of biopharma, health policy, and the life sciences. A success in the laboratory does not necessarily mean that the technology would work in the wild. The lab mosquitoes spent their entire lives in cages about half the size of chest freezers and reproduced differently than they would in the open air.advertisement To test the gene drive, scientists put hundreds of modified and regular mosquitoes into these cages and let them mate. They randomly picked 650 of the eggs laid by the mosquitoes, which they grew into the next generation of bugs. After seven to eleven generations, which took about five to eight months, none of the mosquitoes laid eggs. The gene drive worked.“It’s a really important breakthrough,” said Zach Adelman, a professor of entomology at Texas A&M, who was not involved in the paper.Adelman said that the research is so important because it shows that scientists can overcome a problem that had stymied previous attempts to create working gene drives in mosquitoes — resistance.But much like bacteria develop resistance to antibiotics, so too can laboratory mosquitoes develop resistance to a gene drive. In previous experiments, including work by the same Imperial College team, mosquitoes had small random mutations that immunized them against the gene drive. The mosquitoes passed those protective mutations onto their offspring, blocking the gene drive from spreading the modification that would have destroyed the population. What is a gene drive?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/2018/09/24/gene-drive-lab-mosquitos/?jwsource=clCopied EmbedCopiedLive00:0001:4101:41  Gene drives have the potential to change the genetic makeup of entire populations, like mosquitos that carry malaria. Hyacinth Empinado/STAT The Imperial College scientists created a gene drive that did not fall prey to this type of resistance. They ensured that anytime a mosquito had a random, protective mutation, the gene drive would also sterilize that mosquito — ensuring the protective mutation could not spread.“We have a solution to the functional resistance that arises in gene drives,” said Kyros Kyrou, a Ph.D. student at Imperial College who is the first author on the paper. In the paper, he also acknowledges that there may be other forms of resistance that the team did not find in this trial but that might show up in larger trials.The next step is to test the gene drive mosquitoes in larger cages, which are the size of a room, that more realistically mimic the environment where the mosquitoes might eventually be released in Africa, said Andrea Crisanti, a professor in the life sciences department at Imperial College, who led the research. Related: “With this achievement, the major barriers to saving lives are arguably no longer mostly technical, but social and diplomatic,” said Kevin Esvelt, a Massachusetts Institute of Technology professor who studies gene drives and was not involved in this paper. Privacy Policy STAT+: Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. Please enter a valid email address. This will allow the researchers to test whether other conditions, such as the temperature and variety of light, would impact the effectiveness of the gene drive, Crisanti said. The large cages also have room for more mosquitoes, so researchers could let all of the offspring develop as opposed to randomly picking eggs.And the big cages would allow the mosquitoes to reproduce naturally, which they didn’t have space for in the small cages. The males swarm in cylindrical cloud, and the females dart in, looking for a mate.Larger trials would allow researchers to spot rare mutations that might doom the gene drive that just didn’t show up in the small trial.“When you get up to 1 million mosquitoes, you’re going to see the things that happen one-in-a-million,” Adelman said. By Ike Swetlitz Sept. 24, 2018 Reprintscenter_img For the first time, researchers will release genetically engineered mosquitoes in Africa Related: Adelman and Esvelt said more data are needed to see how far the gene drive could spread across different species of mosquitoes in the wild.As for when the mosquitoes would actually be released into the wild, Crisanti said the decision isn’t up to him.“That is more a political decision rather than a technical one,” Crisanti said.His collaborators are already working on that political process. Crisanti is part of the “Target Malaria” project, an international effort funded mostly by the Bill and Melinda Gates Foundation, which has teams in three African countries — Burkina Faso, Mali, and Uganda — that are building the infrastructure to study and potentially releasing gene drive mosquitoes.So far, the team in Burkina Faso has made the most progress.  In August, it received permission from the national government to release a test batch of 10,000 genetically engineered mosquitoes into the wild. Those mosquitos do not have a gene drive, but they serve as a trial run for the real thing. In the LabScientists use gene drive to eradicate lab mosquitoes for the first time Leave this field empty if you’re human: The cages are maintained by a private company in Terni, Italy, about an hour-and-a-half drive from Rome, Crisanti said. The trials should start by the end of 2018, and data should be available within eight months or a year.One open question is whether the gene drive could spread between different types of mosquitoes. If scientists release a gene drive in the wild that could eliminate large numbers of mosquitoes, they would want to know which mosquito species would die. And the environmental impact of eliminating multiple mosquito species might be different from eliminating just one.Normally, when one species of mosquito mates with another species of mosquito, the offspring are sterile, and so cannot pass on any modified genetic material. But that is not always the case.Anopheles gambiae mosquitoes are extremely closely related to Anopheles coluzzi mosquitoes — the two were actually considered the same species until 2013. And they are also closely related to Anopheles arabiensis mosquitoes.“The gene drive would be able to cross between [Anopheles gambiae and Anopheles coluzzi],” Kyrou said. He added that, “I would not rule out the possibility of our gene drive’s ability to spread into [Anopheles arabiensis] as well.” In a remote West African village, a revolutionary genetic experiment is on its way — if residents agree to it This Anopheles gambiae mosquito carries a gene drive that could wipe out an entire population of mosquitoes. Andrew Hammond For the first time, scientists have used a gene drive to destroy a population of mosquitoes in a laboratory.Genetic engineers at Imperial College London deployed the technique over the past two years, introducing a genetic mutation that spread through the population and eventually sterilized all of the mosquitoes. The group published the results of their work Monday in Nature Biotechnology.Their success is a huge step in the effort to reduce the spread of malaria. Before now, scientists had struggled to create gene drives that successfully spread through a population of mosquitoes and stopped them from reproducing.advertisement Tags geneticspublic healthresearchlast_img read more

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first_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] @NicholasFlorko WASHINGTON —The drug industry’s storied lobbying group isn’t accustomed to bad news — and with its small army of well-connected advocates, it’s even less familiar with surprises.For PhRMA, the news last winter was both. Washington Correspondent Nicholas Florko reports on the the intersection of politics and health policy. He is the author the newsletter “D.C. Diagnosis.” Log In | Learn More By Nicholas Florko Jan. 2, 2019 Reprints Special ReportHow PhRMA finally lost: the inside story of the group’s biggest lobbying failure in years STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. What’s included? Nicholas Florko Mike Reddy for STAT About the Author Reprints GET STARTED What is it? Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Tags Congressdrug pricinggovernment agenciesMedicarepolicylast_img read more

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first_imgWhy? He wanted them to share stories about the patient — his likes and dislikes, what made him special, and other information that would help his caregivers know and relate to the person behind the prostate cancer diagnosis. It was a small gesture that had an overwhelmingly positive effect on the patient and his family.A lightbulb went off for me and I followed suit. I asked my patient permission to email her family members. Her husband revealed the nugget about her Pink Floyd fandom, a fact she hid from even her closest friends.I took the same approach with my next patient. Her family wrote that she was a gospel singer in her church choir. So we played gospel music in the operating room before her surgery, making the sterile and uninviting room less ominous. Her tension and fear dissipated.It was then that something magical happened. The surgical team wanted to know what was up with the different music being played. I explained how it wasn’t about the music but making a human connection. Inquiries about the emails followed. The team members wanted to read them, too. Related: Doctors need to regain patients’ trust. Nurses can help them do that By Benjamin Schwartz May 16, 2019 Reprints Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. She’s worn both a hospital gown and a white coat. Now she wants to change how doctors perceive their patients Luca Bravo/Unsplash As a surgeon who specializes in gynecologic cancer, I have performed thousands of operations over my two-decade career. But the ones my team and I have done since the beginning of this year have been the most fulfilling. The reason? A simple yet remarkable adjustment in how we prepare for surgery has forever changed the way we now practice medicine.The first of these “new” operations started when I asked to have Pink Floyd’s “Comfortably Numb” — a title so dripping with irony that it was impossible for the team not to notice (more on that later) — playing over the sound system as a patient entered the operating room. Although she was understandably tense, nervous, and frightened about having surgery, she relaxed upon hearing the music. I could see that from the smile on her face and the way her shoulders eased.The transformation wasn’t so much due to the soothing nature of the music or the state of relaxation stressed in the lyrics (though I’m sure that contributed to it), but her understanding that the individuals operating on her knew enough to play her favorite music.advertisement Leave this field empty if you’re human: Months before I had been working with a mentor, a “career coach” who was guiding me along the peaks and valleys of my career. During one of our conversations, he revealed that he had prostate cancer and that his physician, Dr. Ash Tewari, had done something quite surprising: Tewari had asked to meet with him and his family, and then asked the family members if he could email them.advertisement This changed our approach to surgery. Our standard protocol had been to take a pre-surgical pause to prepare before a patient entered the operating room. It’s a scripted process in which we discuss important elements of the case. Following the pause, we apply our skills to the person lying before us — often without knowing who they really are.Now we know who they are. Long before surgery is scheduled, we send emails to patients’ family members. Immediately before the surgery, we pause and read the email responses. In a recent case, Daniel, a patient’s 13-year-old grandson, wrote about his grandma’s special meatballs at their Sunday dinners and how he was terrified he’d never see her again or have her be part of those special dinners. “Please do your best today,” he wrote to us. It was a touching tribute — there wasn’t a dry eye among the surgical team. We went from that lump-in-the-throat moment to an adrenalin surge that resulted in a hyper-sense of focus. To a person, our attitude was, “We have to do an amazing job today.”The power of an individual’s story is so strong that it can’t help but focus us on the humanistic side of medicine. It puts us in touch with our collective humanity. Sadly it is something that is most definitely at risk in the way health care is provided in the United States.Technology may advance professional and personal pursuits, but it can also dehumanize us. We become comfortably numb and immune to a very real and damaging byproduct of the ongoing technological evolution. While “process” is paramount to every surgery, the patient — who should always be at the center of care — sometimes disappears. It can happen subtly in ways that surgical teams or other health care providers may not even notice. First OpinionConnecting with patients can keep physicians from becoming ‘uncomfortably numb’ Privacy Policy Tags patientsphysicians Related: What our patient may have perceived as a thoughtful gesture didn’t occur by happenstance. About the Author Reprints Please enter a valid email address. Benjamin Schwartz We need to reiterate the intricacies of the surgical procedure, the prognosis, the expected outcomes and recovery times, but we also need to learn about Daniel’s grandmother, her Sunday dinners and amazing meatballs. We need to guard against dehumanization by learning about our patients’ amazing, individual lives and the impact they have on so many others’ lives, rather than knowing them only as “the gallbladder in room 302.”The power of an individual’s story prevents us from becoming comfortable and focusing only on process. It brings out our best. It’s a reminder that a loved one’s note contains special words that enable us to make the human connection — the very thing that got us into medicine in the first place.Benjamin Schwartz, M.D., is chairman of obstetrics and gynecology at Northwell’s Southside Hospital and regional director of the OB-GYN service line for the health system’s eastern region.last_img read more

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first_img 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. Biotech Vertex to pay startup Kymera $70 million in R&D deal Vertex Pharmaceuticals, the Boston biotech best known for its portfolio of drugs to treat cystic fibrosis, will pay $70 million up front to a Cambridge, Mass., startup that hopes to use a novel approach to treat diseases. It will initially focus on inflammatory disorders and cancers, but the science could potentially apply to a broad range of illnesses.Vertex announced a four-year research and development collaboration Wednesday with Kymera Therapeutics. The privately held startup wants to develop drugs based on Nobel Prize-winning insights into how the body eliminates disease-causing proteins. 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. Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+. First 30 days free. GET STARTED What is it? Jonathan Saltzman — Boston Globe GET STARTED About the Author Reprints What’s included? By Jonathan Saltzman — Boston Globe May 15, 2019 Reprints Scientists at work at Vertex Pharmaceuticals. Barry Chin/The Boston Globe Tags biotechnologyBostondrug developmentfinancerare diseaseSTAT+last_img read more

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