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Presented by CVS Health: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By David Lim | Presented by CVS Health | With Emily Martin, Alice Miranda Ollstein, Susannah Luthi and Sarah Owermohle. | | | — The Biden administration is preparing to send more AstraZeneca doses abroad. — FDA kicks off a meeting to scrutinize if accelerated cancer drugs lived up to their promise. — Democrats prepare for a drug pricing legislation slog. It’s Tuesday, welcome back to Prescription Pulse. Savings bonds are the latest incentive for young residents of West Virginia to get vaccinated. As always, send tips to David Lim (dlim@politico.com or @davidalim). | | A message from CVS Health: Throughout the pandemic, CVS Health has been there. We’re nearly 300,000 caring employees ensuring millions of Americans can access health care services. We opened 4,800 COVID-19 test sites and administered more than 15 million tests at our stores and through partners in underserved communities. We have given more than 10 million vaccine doses and are offering vaccines in nearly 6,000 stores across 49 states, Puerto Rico, and Washington, D.C. Learn more. | | | | | | NOVAVAX SHOT LOOKS PROMISING FOR GLOBAL EFFORTS — Hopes are growing that a dark-horse coronavirus vaccine from a tiny U.S. drugmaker can shore up supplies in the U.S. and globally as safety concerns and production problems shadow shots from Johnson & Johnson and AstraZeneca, Sarah Owermohle and Carmen Paun report. Novavax has never brought a product to market. The shot entered late-stage clinical trials months after candidates from bigger names like Pfizer and Moderna and had a bumpy start to manufacturing. But its vaccine proved just as potent in a trial and the company is now preparing to file for U.S. authorization in a matter of weeks — potentially leapfrogging AstraZeneca, a former frontrunner. The company has enlisted production partners worldwide after struggling to scrape together the tens of thousands of doses needed for its clinical trials. Now, it’s aiming to pump out 150 million doses a month by the second half of the year through agreements with factories like India’s Serum Institute, which will chip in more than one billion shots. Most of them will go to COVAX, the global vaccine equity effort that aims to supply the world’s poorest countries. By contrast, Pfizer has pledged 40 million shots to COVAX this year and Moderna is still in talks with the facility. “In the U.S. we’re just going to play things by ear and expect to deliver the doses they have asked for,” said Gregory Glenn, Novavax’s president of research and development. “But the rest of the world is really struggling to get vaccinated.” BIDEN: USA PREPARING TO SHARE MORE ASTRAZENECA DOSES — The Biden administration is preparing to send up to 60 million AstraZeneca doses to countries in need over the next several months, once a federal safety review is conducted, according to two senior administration officials. The company has produced about 10 million doses of the vaccine for the U.S. but the FDA has not yet authorized their use, Erin Banco and Adam Cancryn report. The agency is still examining the doses to ensure they meet the necessary quality control standards. An additional 50 million doses are in production, one of the senior officials said. MODERNA ENLISTS SANOFI TO HELP MAKE SHOTS — Global vaccine maker Sanofi will help produce up to 200 million doses of Moderna's Covid-19 vaccine starting in September, the companies announced Monday. Sanofi will fill and finish vials for Moderna's vaccine at its Ridgefield, N.J., plant, Sarah reports. | | | | JOIN AN IMPORTANT CONVERSATION, SUBSCRIBE TO "THE RECAST": Power is shifting in Washington and across the country. More people are demanding a seat at the table, insisting that all politics is personal and not all policy is equitable. “The Recast” is a twice-weekly newsletter that explores the changing power dynamics in Washington and breaks down how race and identity are recasting politics and policy across America. Get fresh insights, scoops and dispatches on this crucial intersection from across the country and hear critical new voices that challenge business as usual. Don't miss out, SUBSCRIBE . Thank you to our sponsor, Intel. | | | | | | | | ACCELERATED CANCER DRUGS UNDER REVIEW — FDA is kicking off a three-day advisory committee meeting today to review three checkpoint inhibitor drugs that obtained marketing authorization for certain indications under FDA’s accelerated approval program. View the agenda here. The drugs — Merck’s Keytruda, Bristol Myers Squibb’s Opdivo and Genentech’s Tecentriq — have struggled in confirmatory trials for various indications. The panel of outside experts is being asked to vote on six questions on whether various indications for the cancer drugs should be maintained, and if so, what studies could prove they have a clinical benefit for patients. FDA ENDING 510(k) REVIEW PILOT — The FDA announced Monday it is ending its Quality in 510(k) Review Pilot Program, an effort to simplify how medical device manufacturers submit applications via eSubmitter software. The agency will stop accepting review file submissions on May 30. “The pilot was a success in producing well-organized submissions,” FDA said. “However, with the creation of eSTAR, the FDA identified additional benefits associated with submission preparation using eSTAR rather than eSubmitter.” | | | DEMS BRACE FOR DRUG PRICING SLOG — As Democrats and their allies watch the odds of White House support for long-promised drug pricing reforms continue to shrink, calls for the House and Senate to go it alone are growing louder, Alice Miranda Ollstein and Susannah Luthi report. The Biden administration wants to avoid a battle with the drug industry, but had wanted to make permanent recent boosts in Obamacare funding — an expensive policy that Democrats thought they’d fund with pharma pricing reform. But over the weekend, the White House found $200 billion that could potentially offset the private Obamacare subsidies, according to the Washington Post. This takes some pressure off Democratic leaders who badly want these subsidies secured before the 2022 midterms. But it also adds to the pressure on progressives and moderates in swing states who want to deliver on years of campaign pledges to tackle high drug costs and worry the Democratic majority is in jeopardy if they don’t. “Seniors have watched all this campaigning and Donald Trump by being all bluster and accomplishing essentially nothing has, if anything, heightened the need to really deliver,” Senate Finance chair Ron Wyden told Alice on Monday night. “This is what elderly voters are gonna be looking at in the fall of 2022.” Wyden and other Democrats say they’re still pushing the White House to include drug price negotiation in the yet-to-be-unveiled “American Families Plan,” Biden’s massive health care and child care package. But with reports circulating that Biden is backing away from the policy, many lawmakers are pushing for Congress to move forward with or without him. “I happen to think it’s an enormously high priority,” Senate Budget Chair Bernie Sanders told Alice on Monday. “And that is what should be done.” But House Speaker Nancy Pelosi’s sweeping drug negotiation plan is likely a non-starter in the upper chamber, and Senate Democrats don’t yet have legislation with certain support from all 50 members. “The political situation now, with a razor-thin majority in the House and a 50-50 Senate, means that the effort to get the votes will be very, very tough,” Rep. Peter Welch (D-Vt.) told reporters on a call on Monday, adding that many Democrats are loath to take on the industry. We’ve got to take seriously how hard this is.” | | | BD REQUESTS ALARIS INFUSION PUMP CLEARANCE — Becton, Dickinson and Company announced Monday it filed a 510(k) application for its beleaguered BD Alaris System. “We believe the Alaris clearance could take up to a year (in-line with our assumption of CY22 relaunch) given the number of outstanding issues and still see some risk that the pump does not return to the market,” Wells Fargo analysts wrote in a research note. | | | NIH STUDYING COVID-19 VACCINES IN THOSE WITH IMMUNE DEFICITS — Researchers at the National Institute of Allergy and Infectious Diseases are enrolling for a clinical trial examining how people with immune deficiencies respond to Covid-19 vaccines. “People with immune disorders are typically excluded from trials of experimental vaccines, and this was the case in the Covid-19 vaccine trials,” NIAID Director Anthony Fauci said. “This new study will characterize the features and adequacy of immune responses to Covid-19 vaccination in people with a range of immune deficiencies and dysregulation syndromes and will provide valuable information about benefits and potential risks in these individuals.” | | | Wednesday: The House Energy and Commerce Health Subcommittee holds a hearing on Covid-19 long haulers at 11 a.m. EST. The House Ways and Means Health Subcommittee holds a hearing on the future of telehealth at 2 p.m. EST. Thursday: The House Judiciary antitrust subcommittee holds a hearing on proposals to lower drug prices and methods to address consolidation in health care markets at 1 p.m. EST. | | | |   | | | | | | NEWSOM MAY APPROVE HEROIN INJECTION SITES — California could become the first place in the nation where people can inject illicit drugs under medical supervision if a proposal to create such sites advances to Gov. Gavin Newsom’s desk, POLITICO Pro’s Victoria Colliver reports. The proposal is quickly advancing in the California Legislature and could force Newsom into a difficult choice: While he once said he was "very, very open" to the concept, signing the bill could leave him vulnerable to attacks that he supported the state-sanctioned use of illegal drugs as he faces a fierce recall effort. N.J. ANTI-VACCINE ACTIVISTS RAISE FUNDS FOR NEW PAC — Anti-vaccine activists in New Jersey have raised more than $18,000 for a new political action committee to fund opposition to state mandatory immunization laws, POLITICO Pro’s Sam Sutton reports. The PAC, called NJ Public Health Innovation, was registered in December and began fundraising in earnest on Jan. 13 — the one year anniversary of a protest that helped kill legislation intended to curb the use of waivers for life saving vaccines. | | | EU ADVANCES LAWSUIT AGAINST ASTRAZENECA OVER SHORTAGES — The European Commission on Monday confirmed it began legal proceedings against AstraZeneca for its vaccine delivery shortages, report POLITICO EU’s Jillian Deutsch and Hans von der Burchard. “The reason indeed being the terms of the contract, or some terms of the contract, have not been respected, and the company has not been in a position to come up with a reliable strategy to ensure the timely delivery of doses," Commission spokesperson Stefan De Keersmaeker said. AstraZeneca shot back Monday morning in a statement saying that the company should deliver almost 50 million doses total to the EU by the end of April, “in line with our forecast.” The company wrote that it believes “any litigation is without merit,” while acknowledging it has faced “manufacturing challenges.” INDIA PLUNGES INTO CORONAVIRUS CRISIS — While the West focuses on vaccination numbers, India is struggling to cope with a Covid-19 crisis mostly caused by the rapid spread of so-called double mutant strain of the virus, POLITICO EU’s Raksha Kumar reports. The country, which totals almost half of all new cases reported globally, recorded the highest number of cases in the world over the weekend as it sees more than 2,500 people die per day from the disease. Experts say those figures are nowhere near actual totals as death numbers are under-reported. Hospitals also report demand for drugs and oxygen to treat Covid-19 is vastly outpacing supply, leading to more deaths. Only 10 percent of the population is vaccinated, despite the country being a lead vaccine manufacturer. | | | CareFirst BlueCross BlueShield announced Monday that Tich Changamire will be its new chief medical officer. Claire McAndrew announced Monday she joined Waxman Strategies as a vice president. | | | | CHECK OUT FDA TODAY: Daily regulatory developments, sent directly to your inbox. AgencyIQ's daily newsletter, FDA Today, provides readers with actionable and insightful explanations of the latest FDA developments impacting the life sciences industry. Sign up for free today. | | | | | | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. Biden signs two FDA bills into law — Two pieces of FDA-focused legislation were signed into law by President Joe Biden late last week. The first law, the Ensuring Innovation Act, redefines how the FDA determines if a drug is “new” to ensure that only truly new products obtain five years of marketing exclusivity – a period during which generic drugs may not enter the market. Drugs that are only somewhat new are eligible for three years of exclusivity. The second law, the Advancing Education on Biosimilars Act, requests (though does not require) the FDA to create and maintain a website to “provide educational materials for health care providers, patients and caregivers” focused on biosimilars. FDA authorizes brain-computer interface device — The FDA has authorized the use of a novel brain-computer interface, or BCI, intended to help rehabilitate patients following a stroke. The device, the IpsiHand System, includes a hand robotic device that is controlled by the patient’s brain waves. | | | The U.K., while suffering massive losses during the pandemic, managed to set up a successful clinical trial of tens of thousands of patients at dozens of hospitals. One major finding — that dexamethasone, a widely available steroid, could treat Covid-19 — has saved hundreds of thousands of lives, Vox reports. Biogen is planning to launch a compassionate use program for tofersen, an experimental ALS drug, in July, Bloomberg reports. | | | FDA published draft guidance for sponsor-investigators of nonclinical testing of individualized antisense oligonucleotide drug products. FDA is holding a public workshop on nonprescription drug facts labels on June 9. | | A message from CVS Health: At CVS Health, we have a long history of working to address physical and mental wellbeing to help people on a better path to overall health. With many still staying home, we’re supporting safer pregnancies by expanding access to prenatal and postpartum care via telemedicine. Nothing should stand in the way of mental health and wellbeing, so we’re increasing remote access to mental health services. Recognizing the strong connection between housing and health, we’re investing in affordable housing to support underserved populations and build healthier communities. Every day, CVS Health works to bring quality, affordable health care into neighborhoods, homes and hands—so it’s never out of reach for anyone. That’s health care, from the heart. Learn more. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
