About the Author Reprints Companies generally can set the prices for approved drugs because the US government doesn’t regulate medicine prices, as other countries do. The powerful pharmaceutical lobby has repeatedly fended off such proposals that would cut into profits.Trump also boasted about his high poll numbers nationwide and in the early voting states of Iowa and New Hampshire. He slammed President Barack Obama and bashed Republican rivals, specifically Jeb Bush and Ted Cruz. By Associated Press Jan. 26, 2016 Reprints Trump says Medicare could save $300 billion if it negotiated drug prices. John Minchillo/AP Related: Washington has big hopes, but little power, to negotiate drug prices PoliticsDonald Trump says Medicare should negotiate drug prices Tags Donald Trumpdrug pricespolicyPresidential campaign Associated Press Republican front-runner Donald Trump says he could save Medicare billions of dollars by getting the massive federal agency to negotiate prices with the major pharmaceutical companies.Trump told an enthusiastic crowd of about 1,000 people packed into a high school gymnasium Monday night in Farmington, N.H., that Medicare could “save $300 billion” a year by getting discounts as the biggest buyer of prescription drugs.Said Trump: “We don’t do it. Why? Because of the drug companies.”advertisement
Rise and shine. Another hectic day is on the way. Of course, busy is good, as they say, so no need to kvetch, yes? So time to dig in to the usual routine of deadlines and phone calls and whatnot. As always, we are helped along by a few cups of stimulation, which are especially comforting since a new study says they do not make our heart race any faster. So feel free to join us. Meanwhile, you have a splendid day and let us know if you hear anything interesting …US Senator Joe Manchin (D-W.Va.) plans to filibuster the nomination of Dr. Robert Califf as Food and Drug Administration commissioner, making him the fourth senator to raise objections. “The FDA and Commissioner’s number one priority should be public health and it is inappropriate for the FDA Commissioner to have had such close financial ties with the pharmaceutical industry,” he said in a statement.Artisan Partners, a major shareholder in Johnson & Johnson, urged several activist investors to pressure the company to consider separating its three product divisions, Reuters reports. Artisan, which manages nearly $100 billion, also suggested the health care giant should look at replacing board members and review standards for executive pay and financial reporting.advertisement [email protected] PharmalotPharmalot, Pharmalittle: More Robert Califf opposition, J&J settling thousands of lawsuits @Pharmalot Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Tags FDAJohnson & JohnsonRobert Califf Alex Hogan/STAT Chinese regulators halted drug imports from four drug makers for violating good manufacturing practices, and India’s Aurobindo Pharma was sanctioned for delaying an inspection, Regulatory Focus says.Despite speculation, Biogen has not specifically ruled out raising prices again this year for its multiple sclerosis drugs, TheStreet tells us.Novartis said US government and commercial insurers are taking longer to cover new medicines than in Europe, which contributed to weak sales of its new Entresto heart failure treatment, Reuters reports.The FDA agreed to review a Merck drug that may prevent the recurrence of the Clostridium difficile superbug, The Wall Street Journal writes.Vertex Pharmaceuticals hasn’t yet provided guidance on its newest cystic fibrosis drug, and The Boston Business Journal provides some reasons. Ed Silverman By Ed Silverman Jan. 28, 2016 Reprints About the Author Reprints Roche CEO Severin Schwan believes drug makers should expect tough scrutiny on pricing ahead of the US presidential election and focus on more innovative products to avoid further pressure, The Financial Times writes. “If you have truly differentiated medicines … then I do believe that societies will continue to reward this innovation and this is particularly true in the US,” he said.Johnson & Johnson is moving to settle thousands of lawsuits filed by women who blamed the company’s vaginal-mesh inserts for their injuries, according to Bloomberg News. The health care giant agreed to pay more than $120 million to resolve between 2,000 to 3,000 lawsuits that alleged women suffered organ damage and constant pain by mesh devices that that were surgically inserted but eroded in their bodies.advertisement
Related: Landmark effort to speed drug approvals nears critical phase in Congress Currently, companies in the United States that want to sell high-risk devices, such as implants designed to support and sustain life, must first demonstrate that their products are reasonably safe and effective — usually through clinical trials. Related: Republicans seize on reports critiquing FDA to push for agency reforms By Sheila Kaplan June 28, 2016 Reprints WASHINGTON — Medical device companies have argued that streamlining the regulatory process at the Food and Drug Administration could help get their devices onto market more quickly and ultimately help save lives.But a new study comparing US and European approaches to medical devices suggests that doing so could also carry significant risks for patient safety.The two-continent study — led by Harvard Medical School researchers — comes as Congress is considering legislation that would make it easier to get drugs and medical devices through the regulatory process.advertisement Kesselheim said the researchers did not expect to find such striking results.The medical device industry has argued that the regulatory process can be streamlined without sacrificing patient safety.One of the industry’s major trade groups, the Advanced Medical Technology Association, said it was reviewing the BMJ study but cautioned that it “touches on a complex issue” that may make it difficult to compare the US and European systems.“It is important to note that the EU has recently taken steps to significantly strengthen its oversight of medical devices,” said Ralph Ives, the group’s executive vice president for global strategy and analysis.Kesselheim said he believes speeding up the approval process for devices in the United States would be problematic.It “moves our regulatory system closer to the European system, at the same time that the people in Europe are trying to come up with proposals to move their system closer to ours,” he said.A bill that would accelerate the approval of drugs and medical devices, known as the 21st Century Cures Act, passed the House late last year. The Senate could consider its own version of the legislation in the coming weeks. In the European Union, by contrast, medical devices can be sold as long as they perform “as intended” and “are likely to be safe.” They generally get to market faster than in the US.advertisement HealthMedical devices get to market faster in Europe — but are tied to more safety issues In the new study, published Tuesday in the BMJ, researchers found that medical devices that were first approved in the European Union were associated with a greater rate of safety issues than devices first approved by FDA.Researchers examined 309 devices, 206 of which were approved by the FDA and the EU. Sixty-three percent were approved first in the EU.The researchers found that the devices approved first by the EU were three times more likely to require safety alerts and recalls.The study was led by Dr. Aaron S. Kesselheim, along with Thomas J. Hwang and Dr. Jessica M. Franklin, all of Harvard, as well as Elisaveta Sokolov of King’s College in London.“There are well-known differences between the systems for device authorization in the US and the EU,” said Kesselheim. “I think there is a concern that the EU is trading speed for safety, and I think that’s what is borne out in the study.” The process for approving medical devices like pacemakers differs between the US and the European Union. APStock Tags FDAmedical devicespolicyregulations
[email protected] By STAT staff May 28, 2019 Reprints About the Author Reprints Don’t MissWe want your pick for the best health and science books to read this summer Summer is around the corner. And STAT wants to know which books with health, medicine, or science themes you’d recommend people toss in their vacation bag.Fill out the form below, and you may see your pick in our upcoming list. To get a little inspiration, check out our past summer book lists from 2018, 2017, and 2016.The submission period has ended. STAT staff CHARLY TRIBALLEAU/AFP/Getty Images
@Pharmalot About the Author Reprints Pharmalot [email protected] Ed Silverman Tags Congressdrug pricingpharmalittleSTAT+ 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. Pharmalittle: Pelosi claims trade deal shows progress on drug issues; Novartis suffers another trial setback Alex Hogan/STAT Unlock this article — plus daily coverage and analysis of the pharma industry — 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. GET STARTED Log In | Learn More What is it? Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. By Ed Silverman Nov. 1, 2019 Reprints What’s included? 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 modest. We hope to spend time with one or two short people, enjoy a musical event, and check in on some Pharmalot ancestors. And what about you? This is a fine time to spend time outdoors and enjoy the seasonal changes. You could bolster the economy by purchasing a few sweaters, plan a holiday getaway, or perhaps make time for someone special. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon …House Speaker Nancy Pelosi says progress is being made every day toward approving the trade agreement President Trump worked out with Canada and Mexico, Reuters writes. Democrats say they are working closely with the U.S. Trade Representative to get their concerns addressed. They have pressed for measures to ensure good enforcement of labor and climate provisions of the deal, as well as changes in provisions dealing with pharmaceuticals.
Biotech New data show Bluebird, Bristol CAR-T drug could be pioneering myeloma therapy. Competitors may be close behind 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. Damian Garde 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. ORLANDO, Fla. — On the eve of a major blood disease research meeting here, Bluebird Bio and Bristol-Myers Squibb have released results from a pivotal clinical trial of their CAR-T therapy targeting multiple myeloma.The data for the CAR-T treatment called ide-cell (formerly BB2121) have been highly anticipated because they could lead to the first regulatory approval for a personalized cell therapy in this type of lethal blood cancer. The drug achieved all of the study’s efficacy and safety goals. At the same time, the results raise some questions about the treatment’s commercial potential and may leave the door open for competing multiple myeloma therapies to surpass it relatively soon. What’s included? Log In | Learn More [email protected] Ruby Wallau for STAT @damiangarde Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Adam Feuerstein What is it? About the Authors Reprints [email protected] By Adam Feuerstein and Damian Garde Dec. 6, 2019 Reprints National Biotech Reporter Damian covers biotech, is a co-writer of The Readout newsletter, and a co-host of “The Readout LOUD” podcast. @adamfeuerstein GET STARTED Tags ASHbiotechnologyBostonCAR-Tdrug developmentSTAT+
Amid ongoing concerns over the cost of insulin, a leading physicians group is calling for a raft of measures that would increase affordability for the life-saving diabetes treatment, a move that comes as the incoming Biden administration readies its agenda for addressing prescription drug prices.At the top of its list, the Endocrine Society would like to see the federal government negotiate pricing with drug companies, as well as place limits on future wholesale price hikes that are tied to the overall inflation rate and restrict the out-of-pocket costs borne by people with diabetes. What is it? @Pharmalot Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED GET STARTED Endocrinologists urge federal lawmakers to act to lower insulin costs What’s included? Ed Silverman About the Author Reprints KEREM YUCEL/AFP via Getty Images Log In | Learn More Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. By Ed Silverman Jan. 12, 2021 Reprints Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Pharmalot STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. [email protected] Tags diabetesdrug pricingSTAT+