| | | | | |  | | By Sarah Owermohle | Presented by CVS Health | With Zachary Brennan, David Lim, Dan Goldberg and Emily Martin PROGRAMMING NOTE: Prescription PULSE will not publish on Thursday Nov. 26 and Friday Nov. 27. We'll be back on our normal schedule on Monday Nov. 30. | | | — What is going on with remdesivir? WHO decides against it just as FDA doubles down. — Trump seeks final stamp on drug prices with an event and announcement today. — Also today: A landmark Botox decision that could make industry waves. | | A message from CVS Health: Since the start of the pandemic we've used our unique capabilities and unmatched local presence to help respond to the spread of the virus. We've opened 4,000 COVID-19 test sites since March, and administered nearly six million tests. We're helping businesses and universities safely reopen, and look forward to playing a critical role in the vaccine distribution process. None of this would be possible without the tireless efforts of our 300,000 employees. Learn more. | | | It's Friday, welcome back to Prescription Pulse. Dolly Parton, truly working nine to five. As always, send pharma tips and news to sowermohle@politico.com or @owermohle. Loop in David Lim ( dlim@politico.com or @davidalim) and Zachary Brennan (zbrennan@politico.com or @ZacharyBrennan)! | | | WHO ADVISES AGAINST TAKING REMDESIVIR — The World Health Organization's advice against using Gilead's remdesivir, also known as Veklury, for Covid-19 infections puts the global group at odds with U.S. health officials who have made remdesivir the standard of care for hospitalized patients. "The antiviral drug remdesivir is not suggested for patients admitted to hospital with Covid-19, regardless of how severely ill they are, because there is currently no evidence that it improves survival or the need for ventilation," the WHO Guideline Development Group announced late Thursday. The significant change — amid few other options for severely ill patients — is rooted in new evidence from a group of four international trials comparing coronavirus treatments including remdesivir, WHO said. What Gilead says: "We are disappointed the WHO guidelines appear to ignore this evidence at a time when cases are dramatically increasing around the world and doctors are relying on Veklury as the first and only approved antiviral treatment for patients with COVID-19 in approximately 50 countries," Gilead spokesperson Chris Ridley said. What FDA says: The FDA stands by its decision to approve remdesivir, with a spokesperson responding to the WHO by noting that clinical trial results show the drug can speed hospital recoveries. The NIH trial that led to those results was also better designed than a WHO-backed trial showing little to no benefits, the spokesperson said, adding that the WHO trial does "not refute these findings of benefit to patients." FDA doubles down: The agency late Thursday signed off on another emergency use authorization involving remdesivir and Eli Lilly's baricitinib, which is already approved as a rheumatoid arthritis drug. The combo is for those hospitalized with Covid-19 and who are on ventilators or life support. Besides remdesivir, this new combo treatment, and the cheap steroid dexamethasone, the options for severely ill patients are relatively sparse. Where the pandemic stands: U.S. coronavirus cases are soaring across the country, but President Donald Trump has argued that the blossoming caseload is not translating to more mortality (we also just hit 250,000 deaths this week). "THE COVID DRUGS NOW AVAILABLE TO MAKE PEOPLE BETTER ARE AMAZING, BUT SELDOM TALKED ABOUT BY THE MEDIA! Mortality rate is 85% down!" Trump tweeted Thursday morning. PFIZER FILING VACCINE EUA AS SOON AS TODAY — That's according to the CEO of Pfizer's German partner on the coronavirus vaccine, BioNTech's Ugur Sahin, in an interview with CNN this week. "Depending on how fast this [review] is really accomplished, we might get an authorization, or conditional approval already in 2020 which might help us start distribution of the first vaccine batches already in 2020," Sahin said. ...The partners also plan to submit data with the European Medicines Agency within days, a Pfizer spokesperson told our POLITICO Europe colleagues Jillian Deutsch and Sarah Wheaton. (The EMA launched a rolling review of the vaccine's data at the beginning of October.) In an interview Thursday at the POLITICO Health Care Summit, the EMA's new executive director, Emer Cooke, said she expects a vaccine could be authorized "before the end of the year." | | | |   | | | | | | TRUMP SEEKS FINAL STAMP ON DRUG PRICES — Trump will deliver remarks at 2:30 p.m. today on prescription drug prices, the White House announced late Thursday. His sweeping plan to tie U.S. drug payments to lower costs paid abroad could take center stage. Also in the works: a rule to eliminate rebates that cleared the Office of Management and Budget this time last week. What's on the table: Trump has resurrected the long-delayed most-favored nations rule, once called the international pricing index. Besides slashing costs — a long-held promise from the president — advisers pitched him on an added benefit: The rule would hit an industry that Trump believes slow-walked coronavirus vaccine development until after the election. Senior officials worked through last weekend to craft an updated version that could leapfrog draft rule status and be issued as an interim final rule, a move sure to bait legal challenges. Officials projected that the original international pricing index plan could cut Medicare payments by as much as 30 percent. The most-favored nations rule could potentially take savings further by tying prices to European countries that negotiate directly with drugmakers. | | | | TRACK THE TRANSITION, SUBSCRIBE TO TRANSITION PLAYBOOK: As states certify their election results, President-elect Biden is building an administration. The staffing decisions made in the coming days, weeks, and months will send clear-cut signals about his administration's agenda and priorities. Transition Playbook is the definitive guide to what could be one of the most consequential transfers of power in American history. Written for political insiders, it tracks the appointments, people, and the emerging power centers of the new administration. Stay in the know, subscribe today. | | | | | | | | ASTRAZENECA VACCINE LOOKS PROMISING FOR ELDERLY — AstraZeneca and the University of Oxford's coronavirus vaccine appears to be safe in older adults and prompts a similar immune response in this age group as it does in younger people, according to a peer-reviewed study published in the Lancet. While the Phase II results are promising, co-author Sarah Gilbert said "questions remain about effectiveness and length of protection." Andrew Pollard, study lead from the University of Oxford, told the BBC that results from a Phase III trial of the vaccine are expected before Christmas. HHS SIGNS $25M DEAL WITH SIEMENS FOR ANTIGEN TESTS — HHS said Thursday it has signed a $12 million and a $13 million contract with Siemens Healthineers to invest into development and domestic production of two Covid-19 antigen tests, David Lim writes. "Today's contract will enable Siemens to purchase specialized equipment and modify its manufacturing facility in Walpole, MA, to safely ramp up production to 50 million tests per month within a few months," HHS said in a press release. | | | BOTOX'S TRADE SECRET BATTLE — If AbbVie's Allergan gets its way, the biggest threat to its blockbuster wrinkle remover Botox — Evolus' Jeuveau — will be banned from the U.S. for the next 10 years with a decision this afternoon. "There's billions of dollars at stake here," said Ira Loss, senior health care analyst with Washington Analysis. What's happening: Allergan and its Korean partner Medytox have asked the U.S. International Trade Commission to ban Jeuveau — manufactured by Korea's Daewoong Pharmaceuticals and sold in the U.S. by Evolus — because of trade secret theft, Leah Nylen writes. ITC is expected to issue a decision today. The case rests on accusations that a former Medytox employee, who eventually went to work for Daewoong, took trade secrets with him. While there isn't solid proof that he stole from the company — and Daewoong and the scientist denies the charge — a previous judge said the competitor's botulinum toxin was "remarkably similar" to Allergan and Medytox's option. What's at stake: Evolus' Jeuveau has managed to make a notable dent in Botox's empire, in part by offering lower prices. In 2018, Allergan's Botox made up about 75 percent of the market for aesthetic treatments with Ipsen's Dysport and Merz's Xeomin at a distant second and third. But Evolus predicted in 2019 that it could overtake both rivals by the end of this year. | | | | KEEP UP WITH THE GLOBAL HEALTH AGENDA IN 2021: If nothing else, the past year has revealed how critical it is to keep up with the politics, policy, and people driving global health. A new Biden administration comes with the expectation that America will reclaim its leadership on global health. But will it be that easy? What impact could Joe Biden's presidency have on global vaccine access and the international response to the pandemic? Our Global Pulse newsletter connects leaders, policymakers, and advocates to the people, and politics impacting our global health. Join the conversation and subscribe today. | | | | | | | | HOUSE PASSES ORPHAN DRUG, GENERIC LABEL BILLS — The House this week passed one bill that would allow the FDA to require modifications for outdated generic drug labels, and another bill that would close a loophole so drugs that aren't for rare diseases cannot win orphan drug exclusivities, Zachary Brennan writes. The generic drug bill, H.R. 5668, would provide the FDA with the authority to require label updates when relevant data may have to reflect new side effects or other information, even when the brand name drug is no longer marketed. Currently, generic drug labels have to exactly match their reference product labels, even when the reference products are no longer marketed. The orphan drug bill, H.R. 4712, is meant to ensure that the seven years of market exclusivity is restricted to those drugs that treat rare diseases and not other drugs, like opioids, which can obtain orphan drug status through a loophole in the current law. | | A message from CVS Health: Our mission of helping people on their path to better health has never been more relevant, as the nation faces the grim realities of a pandemic. As an essential business our doors have remained open, and our frontline employees have helped millions of customers and patients safely fulfill their health care needs, from filling a prescription to seeing a MinuteClinic practitioner. Our Coram nurses have helped create hospital bed capacity by transitioning eligible IV-therapy patients to home-based nursing care. Use of our telehealth offerings has increased dramatically as more people discover this convenient option. We're not just your corner drugstore – we're a diversified health services company transforming health by meeting people where they are and making health care more accessible, affordable and simply better. Learn more. | | | | | | SHOTS BY DECEMBER? STATES AREN'T SO SURE —Trump says tens of millions of doses of coronavirus vaccines, which hold the promise of blunting a pandemic that has killed a quarter-million Americans, will be delivered to states as soon as December. But interviews that POLITICO's Dan Goldberg and Rachel Roubein conducted with more than two dozen experts who work in pharmacies, rural clinics and public health, as well as state and local officials, reveal serious concerns that states may not be ready to distribute a vaccine by then. Among the issues: States say they need more than $8 billion from the federal government to promote and distribute vaccines. Federal officials haven't told states how many doses they might receive. And nearly a dozen states still have not agreed to share patient data with the CDC. BANKRUPTCY JUDGE APPROVES $8.3 BILLION PURDUE SETTLEMENT — Federal bankruptcy Judge Robert Drain approved Purdue Pharma's $8.3 billion settlement with the Department of Justice. The deal rankled several Democratic attorneys general, who felt it does not go far enough to punish the company's founding family, Dan Goldberg writes. Purdue, the maker of Oxycontin, is accused of fueling the opioid epidemic and will also plead guilty to three counts of criminal wrongdoing, according to the terms of the settlement. The Sackler family, which owned the company, will forfeit $225 million. Drain, who needed to rule on a federal settlement because the company is going through bankruptcy as a means to resolve thousands of civil lawsuits, allowed the agreement to move forward despite opposition from roughly half the states, advocates on behalf of victims of the opioid crisis, and members of Congress. "While our country continues to recover from the pain and destruction left by the Sacklers' greed, this family has attempted to evade responsibility and lowball the millions of victims of the opioid crisis," said New York Attorney General Letitia James. | | | Tech company AbCellera, which searches for antibodies in the natural immune system, named Peter Thiel to its board. | | | — Amazon originally had bigger plans to partner with Pfizer, Johnson & Johnson and Premera on its newly launched online pharmacy, Amazon Pharmacy, Business Insider reported. — President-elect Joe Biden's counselor to the president, Steve Ricchetti, may face pressure to recuse himself from working on any White House drug pricing policy since his brother was hired to lobby for pharmaceutical firms, CNBC reported. — The CEO of a biotech and pharmaceutical trade group warned that industry could sue to try to stop a drug pricing proposal from the Trump administration, The Hill reported. — Insurers will have to give customers their estimated out-of-pocket costs for prescription drugs and the negotiated prices they pay for the drugs because of a new Trump administration rule — that doesn't extend to Medicare and Medicaid, Kaiser Health News reported. | | | FDA announced the issuance and reissuance of emergency use authorizations for molecular diagnostic and antigen tests for Covid-19, excluding multianalyte tests. FDA issued draft guidance on what information to include in labeling for oncology drugs approved for use in combination drug regimens. FDA issued draft guidance in Q&A format to inform applicants of the agency's interpretation of statutory requirements for the development of biosimilars. FDA issued draft guidance with recommendations on the design of bioequivalence studies to support abbreviated new drug applications.
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