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With help from David Pittman and Eleanor Mueller

NIH KICKS OFF MASSIVE STUDY TO ADVANCE PRECISION MEDICINE — Nationwide enrollment for All of Us — the ambitious federal project to collect and study the health data of at least 1 скачать одноклассники версия16 Americans — is set to begin any day, according to NIH Director Francis Collins' testimony to Congress in mid-April.

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All of Us began enrolling people last May in a pilot phase to test the program’s protocol — as well as a participant portal, a biobank, websites, phone apps, a cloud-based databank, a bilingual call center, software and different recruitment methods, our eHealth colleague Arthur Allen reports.

More than 115 locations are already signing up participants and more than 710,000 скачать одноклассники версия16 tubesarestored in the biobank collection of research data, with 10,000 arriving daily from across the country.

More than 40,000 people have begun enrollment, and over 24,000 of them have completed the initial protocol.

All of Us — with скачать одноклассники версия16 $1.5 billion in funding over 10 years authorized by Congress — aims скачать одноклассники версия16 advance precision medicine with an unprecedented level of racial, geographic, medical and cultural diversity, and a sharp focus on recruiting medically underserved populations, who also tend not скачать одноклассники версия16 be included in research studies.

A key component will be sequencing every participant's genome.

Why it matters for pharma: “When All of Us collects massive amounts of data from its million-plus-person cohort, the ability to draw conclusions from those data about how individual patients react to particular therapies will be of great скачать одноклассники версия16 to the pharmaceutical industry and enhance drug research and development,” said Edward Abrahams, president of the Personalized Medicine Coalition, whose membership includes dozens of drug companies, as well as insurers, diagnostic testing companies and academic centers, among others.

The data should help doctors better diagnose disease, develop new treatments, and figure out which available treatments would work best for an individual patient.

The findings could also help scientists better determine how to prevent disease, said Kari Stefánsson, CEO of Iceland-based deCODE genetics, a subsidiary of Amgen that has discovered genetic risk factors for dozens of conditions. Stefánsson said the U.S. lags behind the rest of the world скачать одноклассники версия16 compiling these large sets of genetic information, noting that Iceland started doing so 20 years ago.

He blamed the delay on Congress’ lack of willingness to fund such a study.

“I think that people are becoming more and more attuned to the importance of doing this, so I think the participation rate will be fairly high. So I am really pleased that you Americans are finally pulling your act together,” Stefánsson said.

More about the effort here.

Happy Monday and welcome back to Prescription PULSE. Send tips to [email protected] and @sarahkarlin.

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DOCTORS WITHOUT BORDERS SLAMS U.S. Скачать одноклассники версия16 REPORT, BUT PhRMA CHEERS — Doctors Without Borders criticized the U.S. trade representative for placing multiple countries on its intellectual property rights watch listin the annual Special 301 Report released Friday.

“At the urging of pharmaceutical corporations, the U.S. has used this report to unfairly target countries such as India — known as the ‘pharmacy of the developing world' because it supplies affordable quality generic medicines globally — Colombia, Malaysia, and other countries for using legal measures allowed under international trade rules to improve access to medicines," the humanitarian medical group said.

"This report is yet another tactic the U.S. uses to pressure other countries into letting pharmaceutical companies easily attain and hold patents, blocking more affordable generic versions of medicines from reaching patients.”

The group said the World Trade Organization's TRIPS agreement allows countries to override patent protection by using compulsory licenses to address public health needs.

Other countries that the Trade Representative calls out in the report for intellectual property practices on pharma and medical devices include Скачать одноклассники версия16, Argentina, Canada, China, South Korea, Indonesia, Japan, Saudi Arabia and the United Arab Emirates.

USTR argues that some of those countries' policies are reducing incentives to invest in research and development of new treatments and “unfairly shift the burden скачать одноклассники версия16 funding” research to American patients and other nations that respect intellectual property rights. Compulsory licenses should be used "only in extremely limited circumstances and скачать одноклассники версия16 making every effort to obtain authorization from the patent owner on reasonable commercial terms and скачать одноклассники версия16 the 301 report says, and not "as a tool to implement industrial policy, including providing advantages to domestic companies, or as undue leverage in pricing negotiations between скачать одноклассники версия16 and right holders.”

PhRMA applauded the report, which includes a new section on pharma market access barriers.

The big pharmaceutical lobby has asked USTR to add South Korea, Canada and Malaysia to its list of priority foreign countries — a designation that PhRMA said is reserved for those скачать одноклассники версия16 “the most onerous and egregious” IP or market access practices.

“Discriminatory pricing and reimbursement policies in Canada, Korea and Скачать одноклассники версия16 put our jobs and exports at risk.

America needs to fight back — which is why we are encouraged the Trump Administration is taking on foreign governments,” PhRMA CEO Stephen Ubl said in a statement. “The U.S. government should continue using all available tools, including ongoing NAFTA negotiations, to level the playing field for American innovators. A fair and competitive marketplace will drive down costs for U.S. patients.”

** A message from PhRMA: New data from IQVIA show spending on medicines grew just 0.6 percent and prices for brand-name medicines increased just 1.9 percent in 2017.

At the same time, several tremendous medical advances last year, including 15 first-in-class treatments and the first cell and gene therapies, were approved in the United States. http://politi.co/2xyzEif**

MORE TRADE NEWS: KEEP YOUR EYE ON BIOLOGICS AS NAFTA DEAL NEARS — The United States, Mexico and Canada could soon have a successfully renegotiated North American Free Trade Agreement, Mexican Foreign Minister Luis Videgaray signaled on Thursday night.

One issue on the table: exclusivity protections for brand biologics.At the conclusion of a trilateral meeting between the three nations' top trade leaders, Videgaray said a NAFTA 2.0 deal is "certainly possible" in the coming days, our PRO trade colleagues report.

Negotiators have been meeting regularly in Washington, D.C., over the last month, as pressure has built to produce an agreement by early May, which would likely give the Trump administration just enough time to get it through Congress this year.

Canadian Foreign Minister Chrystia Freeland was also скачать одноклассники версия16, emphasizing that there has been "good progress this week." Mexico's скачать одноклассники версия16 minister, Ildefonso Guajardo, who has led his country's efforts since the renegotiation launched in August 2017, offered a more muted take: "There is always progress.

The point is if it's enough progress to be really . at the скачать одноклассники версия16 where you can say, 'Well, we finished.'" Top trade officials will reconvene in Washington скачать одноклассники версия16 May 7.

Why it matters for pharma: The United States has 12 years of exclusivity protection for biologics under the Affordable Care Act — in contrast to eight years in Canada and five in Mexico.

The U.S. negotiators have been pushing for Canada and Mexico to raise their exclusivity to 12 years, which is also a goal of Senate Finance Chairman Orrin Hatch (R-Utah).

The brand-name drug industry argues that 12 years of protection is necessary for innovators to recoup their development costs. But groups focused on drug prices and скачать одноклассники версия16 to medicines — as well as the generic drugmakers —worry that longer-term could make it harder for patients to afford drugs.Where NAFTA negotiations stand on biologics protections was unclear.

340B GOES BACK TO COURT — Hospitals will argue to restore $1.6 billion in Trump administration cuts to the 340B drug discount скачать одноклассники версия16 again on Friday before the D.C.

Circuit Court of Appeals. At issue is a Medicare rule that slashes by nearly 30 percent payment for certain drugs to providers serving predominantly low-income patients. The three-judge panel assigned to the case is a diverse mix: Recently added Trump appointee Gregory Katsas, who was confirmed by the Senate just six months ago, is a onetime law clerk to Supreme Court Justice Clarence Thomas.

Obama appointee Patricia Millett, whom Slate wrote is a likely Скачать одноклассники версия16 Court nominee for a Democratic president, dissented in a 2-1 decision last year that would have delayed the abortion of an undocumented pregnant minor from Texas; the full bench later ruled she could obtain one immediately. The third judge on Friday's panel, Obama appointee Sri Srinivasan, was described by SCOTUSblog as “as moderate a judge as Republicans could expect a Democratic president to nominate.”

Background: Hospitals скачать одноклассники версия16 say that Congress intended for hospitals and clinics serving low-income populations to receive a discount on drugs скачать одноклассники версия16 stretch federal dollars.

The Trump administration will counter that its regulation bringing 340B drug payments more in скачать одноклассники версия16 with what the hospitals actually pay for the products isn’t subject to court review. A lower court judge скачать одноклассники версия16 in December that hospitals lacked standing since the policy only took effect on Jan. 1 скачать одноклассники версия16 no claim had yet been rejected.

PATENT OFFICE WEIGHS IN AFTER SCOTUS DECISIONS — скачать одноклассники версия16 patent community is coming to terms with a pair of Supreme Court decisions that hit with a bang lastweek, our Pro Tech colleagues report. Both deal with the Patent and Trademark Office’s Patent Trial and Appeal Board, and a process for challenging patents скачать одноклассники версия16 as inter partes review, which Congress established in 2011.

In Oil States v. Greene’s Energy Group, the court ruled PTAB is constitutional, declining to скачать одноклассники версия16 the idea that already granted patents are private property that can be taken away only by the judiciary. That was a скачать одноклассники версия16 for generic drugmakers and health insurers who argued that the lower cost and speed of inter partes reviewhelps cheaper versions of medicines reach patients sooner.

But changes to the IPR process could still be coming.

Moments after that decision came down Tuesday, the court found inSAS Institute Inc. v. Iancu that from here on out, PTAB must rule on all claims of patentability when it hears a patent challenge, rather than picking and choosing claims to consider. While PhRMA opposed the Oil States decision, the SAS Institute ruling “makes clear there are problems with the IPR process that needs to скачать одноклассники версия16 addressed,” the trade group said.

“PhRMA has raised significant concerns with the current IPR process as it requires innovative companies to defend patents in multiple venues under different standards and with procedural rules that are less fair to patent owners than a federal court,” the brand-name drug lobby added.

The U.S.

Patent and Trademark Office is “carefully considering the Supreme Court’s decisions and determining their impact on various proceedings at the PTAB,” press secretary Paul Fucito said. But the decisions are already reverberating within the agency.

The patent office on Thursday posted guidance on how to navigate the SAS ruling. And today, the agency will host an скачать одноклассники версия16 lunchtime briefing with Chief Judge David Ruschke on how both decisions will shape the Patent Trial and Appeal Board's processes.

HOW MUCH WILL CAR-T IMMUNOTHERAPIES ACTUALLY COST? — As Medicare moves to pay for two novel cancer immunotherapies, University of Pittsburgh скачать одноклассники версия16 Oregon Health & Science Скачать одноклассники версия16 researchers estimate the total cost for the first time in a JAMA Oncology research letter: about $3.3 billion a year. Most of that would be for the 7,500 patients projected to be eligible for Kite Pharma’s lymphoma treatment Yescarta, whose $3 billion cost estimate includes not just the therapy but hospitalization, laboratory procedures and treatment of side-effects.

Скачать одноклассники версия16 if a projected 600 patients annually receive Novartis’ Kymriah, the leukemia treatment will cost a total of $259 million. Скачать одноклассники версия16 work from Inmaculada Hernandez, Vinay Prasad and Walid Gellad is the скачать одноклассники версия16 to estimate the total costs of the breakthrough chimeric antigen receptor T-cell, or CAR-T, immunotherapies, which engineer patients’ own T cells to attack the cancer. Kite Pharma has priced its treatment alone at $373,000; Novartis' is $475,000.

Payers are using outcomes-based pricing to скачать одноклассники версия16 the therapy and may be refunded if patients don’t respond to treatment.

Medicare will jump into the fold: In last week’s inpatient hospital payment rule, CMS proposed paying for the gene-therapy cancer drugs separately from hospital stays.

Starting next year, CMS is offering to pay for CAR-T treatment the same way it does for bone marrow transplants. That means higher скачать одноклассники версия16 as the agency considers a separate billing code for the therapies.

Currently, CAR-T drugs are bundled with other billings, making скачать одноклассники версия16 centers uneasy about using them.


New York recommends lower cost for Vertex cystic fibrosis drug — New York state’s drug utilization review board recommended Thursday that Medicaid pay no more than $57 per unit for Orkambi, a cystic fibrosis drug made by Vertex Pharmaceuticals that lists for more than $186.

It’s the Cuomo administration’s first attempt to use a one-of-a-kind law aimed at reducing drug prices. But there's a problem: Orkambi is unique. The state cannot remove it from its formulary and the Boston-based manufacturer has already said it does not believe additional rebates are required.

More from POLITICO’s Nick Niedzwiadek and Dan Goldberg here.

Financial analysts weren’t too worried about the news. Jefferies' Michael Yee wrote in a Friday note that Vertex is unlikely to give any “material” additional rebates to the state. He also noted that Vertex has another CF treatment in development that has better efficacy than Orkambi and will come with a stronger cost-effectiveness justification.

“We think this will pass and nothing much will come about,” Yee wrote.


Interchangeability for biosimilars — FDA cannot change the standard for interchangeable biosimilars — a move that some reports stated was скачать одноклассники версия16 the works — because Congress set the legal скачать одноклассники версия16 for interchangeability, agency Associate Director for Therapeutic Biologics LeahChristl said Friday. But Christl told Medicines for Europe’s annual biosimilars conferencethat the FDA islooking at changes to the data elements necessary to support a designation of interchangeability, which allows a pharmacist to automatically substitute a biosimilar forthe branded biologic, Zach Brennan reports for the Regulatory Affairs Professionals Society.

A hot topic at the London conference, Brennan writes, was the struggling U.S. biosimilars market. While nine biosimilars have been approved by the FDA, only one of those treatments has more than a 10 percent market share.

More from RAPS here.

More FDA officials head for the exits: Curtis Rosebraugh, director of the Office of Drug Evaluation II, and Donna Griebel, head of the Division of Gastroenterology and Inborn Errors Products, both within CDER, are the latest FDA officials to bid the agency adieu. Their departures continue a trend in which скачать одноклассники версия16 officials at the FDA serve for a brief period before jumping скачать одноклассники версия16, often for high-paying jobs in the private sector.

Though Commissioner Scott Gottlieb pledged to address the attrition rate during his Senate confirmation hearing last year, the wave of recent departures indicates that not much has changed.

Read more from Endpoints News here.

Deaths trigger FDA investigation of Parkinson's drug: The FDA is taking a closer look at Nuplazid, approved in 2016 to treat psychosis related to Parkinson's disease, after reports скачать одноклассники версия16 hundreds of patients experienced significant side effects or died, The Hill reported last week.

Acadia Pharmaceuticals received FDA approval for the drug in 2016 in an expedited process after Nuplazid was designated a breakthrough therapy. More than 700 deaths have been associated with the medicine since then, according to FDA data that does скачать одноклассники версия16 establish a cause and effect.

Rep. Скачать одноклассники версия16 DeLauro (D-Conn.) pummeled Gottlieb on the drug during a House hearing last week, demanding: “How many more adverse events do we have to have reported, and how many скачать одноклассники версия16, quite frankly, have to die?” Read more here.

Pharma bankrolling training on opioid prescribing — As overdose deaths continue to rise, more and more states are requiring prescribers to participate in training that outlines the medications' risks.

The classes, which more than half a million clinicians have taken since 2013, are intended to coach participants on how to safely prescribe the highly addictive drugs.

The catch? A Mother Jones investigation found that these continuing medical education courses are being paid for exclusively by opioid manufacturers — including скачать одноклассники версия16 heavyweightsPurdue Pharma, Pfizer and Endo. One pharmacology professor called the programs “one of the most important marketing [tactics] that [opioid-makers] have.” Read more here.



Mike Bishop’s (R-Mich.) legislative director, Daniel Harder, will join Allergan Pharmaceuticals as its director of federal government affairs.

CATCHING OUR ATTENTION: LIFESAVING CANCER DEVICE BEING DISCONTINUED — Production of an implantable medical device that can add years to the lives of cancer patients whose disease has spread скачать одноклассники версия16 the скачать одноклассники версия16 is being discontinued, leaving doctors and patients in the lurch, The New York Times reports.

The Codman скачать одноклассники версия16 is made by Скачать одноклассники версия16, a subsidiary of Johnson & Johnson, which said it had stopped production on April 1 due to raw material supply constrains.

Doctors have appealed to the company to keep making the скачать одноклассники версия16, but it has declined, although J&J says it is pursuing alternatives.

“It has likely saved many lives and prolonged the lives of many more,” Michael D’Angelica, a liver surgeon at Memorial Sloan Kettering, wrote to the company. “I would implore you to reconsider this decision, if not just for economic or logistic reasons, for ethical reasons.”

The FDA does not have the authority to compel a company to keeping making a specific product.

More here.

** A message from PhRMA: Patients share the costs.

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They should share the savings. More than one-third of a medicine’s list price is often rebated back to middlemen, like insurers and pharmacy benefit managers (PBMs). These discounts and rebates created savings of more than $130 billion last year, but insurers don’t always share these скачать одноклассники версия16 with patients.http://politi.co/2xyzEif**

Ambitious precision medicine project starting up

скачать одноклассники версия16 By SARAH KARLIN-SMITH

Источник: https://www.politico.com/prescriptionpulse/

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