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Presented by Gilead Sciences, Inc.: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By David Lim | Presented by Gilead Sciences, Inc. | With Emily Martin and Lauren Morello | | | — AstraZeneca seeks a new manufacturing partner. — Federal health officials tout vaccine safety for moms. — FDA offers fresh advice on generic drug development during the pandemic. It’s Tuesday, welcome back to Prescription Pulse. Your author — along with the rest of the internet — is wowed by University of Illinois gymnast Evan Manivong’s newly viral Covid-19 vaccination advocacy from last month. As always, send tips to David Lim (dlim@politico.com or @davidalim). | | A message from Gilead Sciences, Inc.: Known to keep pushing. Decades of discovery lie behind every breakthrough. From HIV to viral hepatitis to today’s battle with COVID-19, Gilead scientists have been pushing boundaries for over 30 years. So that we can bring tomorrow’s life-changing therapies forward today. To know more, visit Gilead.com. | | | | | | ASTRAZENECA’S ON THE HUNT — The vaccine maker is seeking a new production partner with the help of the U.S. government after contractor Emergent BioSolutions mixed up ingredients for two Covid-19 vaccines it's simultaneously producing, a senior health official told Sarah Owermohle. The Biden administration told Johnson & Johnson to take over manufacturing at Emergent’s Maryland plant after reports last week that the manufacturer had contaminated 15 million J&J doses with ingredients for AstraZeneca’s shot. AstraZeneca has whittled its prospects down to two potential partners. The company said in a statement Sunday that it is relocating its manufacturing and “will work with the U.S. Government to identify an alternative location for domestic drug substance production.” AstraZeneca already has about 90 million doses on hand of the 300 million it has promised the United States. It’s planning to seek an emergency use authorization from FDA later this month. Emergent is also getting help: $23 million from the feds for new equipment at its Maryland plant. The company is working with the government and AstraZeneca on a “mutually agreed ramp down” of manufacturing the latter’s vaccine. But there’s a catch: AstraZeneca’s shift to a new production partner could have global ripples. The company has relied on Catalent to produce vaccines for Europe, Japan and the international purchasing consortium known as the COVAX Facility, while Emergent made the company’s U.S. supply. It’s unclear if the Catalent plant could take on the added work of making doses for Americans. NOVAVAX DETAILS NEXT STEPS — Maryland-based Novavax outlined Monday its plans for volunteers in U.S., United Kingdom and South Africa clinical trials of its Covid-19 vaccine. The company is offering U.S. and U.K. participants an additional round of injections: those that got placebo shots will get the real vaccine, while those who first got the vaccine will get a placebo shot. Volunteers in its South Africa trial will get a booster shot if they already received the vaccine, or the vaccine if they first got a placebo shot. The trials will remain blinded. "The crossover arms ensure that all participants have access to an active vaccine candidate while allowing Novavax to continue to monitor the safety and efficacy of our vaccine over the long term," Novavax Chief Medical Officer Filip Dubovsky said in a statement. FEDERAL HEALTH OFFICIALS: COVID VACCINES SAFE FOR MOMS — The White House is deploying some of the country’s most trusted scientists to allay fears and debunk misinformation about coronavirus vaccination, pregnancy and fertility that are making millions of mothers, expectant mothers and wanna-be mothers reluctant to take the Covid-19 vaccine, POLITICO’s Joanne Kenen reports. President Joe Biden’s chief medical adviser, Anthony Fauci, recently spent an hour talking about Covid vaccines with LL Cool J, an odd-couple conversation now on YouTube. Marcella Nunez Smith — a Black physician and mother of three who heads the White House Covid-19 Health Equity Task Force — also took part in that town hall. “Should women be concerned about getting a vaccination if they want to have children? Is there a chance they will be sterilized? This is a fear that’s out there,” the rapper asked Fauci, directly confronting some of the misinformation circulating online. “There is no indication whatsoever that the vaccine has anything to do with fertility. So, that’s something that you should take off the table,” replied Fauci, the director of the National Institute of Allergy and Infectious Diseases. He added that vaccinated women have gotten pregnant, and that hundreds of healthy babies have been born to mothers who got their shots during pregnancy. | | | | 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. | | | | | | | | NEW ADVICE ON GENERIC DRUG DEVELOPMENT — The FDA on Monday published new guidance for generic drug developers submitting abbreviated new drug applications during the Covid-19 public health emergency. | | | MDIC REPORT WEIGHS PATIENT INPUT IN DEVICE TRIALS — The Medical Device Innovation Consortium released a report Monday examining how device manufacturers can take into account patient input as they design and develop clinical trials. “Sponsors and regulators increasingly recognize the importance of leveraging patient insights in the conduct of device clinical trials, both in selecting outcomes that matter to patients and designing trial protocols that patients will join and can complete,” the report states. | | | |   | | | | | | COVID-19 AND THE KIDS LEFT BEHIND — While the pandemic’s toll on older Americans has been in the spotlight, an estimated 37,300 to 43,000 children in the U.S. have lost at least one parent to the virus, according to a research letter published Monday in JAMA Pediatrics. The damage to children can be lasting. Loss of a parent in childhood has been linked to higher risk of depression, unintentional death or suicide, as well as poorer educational outcomes. | | | DESANTIS BANS VACCINE PASSPORTS — Florida Gov. Ron DeSantis banned businesses and localities from issuing or requiring a Covid-19 vaccine passport after signing an executive order that will last until he declares the pandemic is over, POLITICO Pro’s Arek Sarkissian reports. DeSantis cited patient privacy as his chief concern. He also called on state executive agency employees to assist in enforcing the order on businesses. Some in the private sector, including cruise lines, have already begun to make passports a requirement for customers as the White House has largely left that choice up to businesses. | | | | JOIN AN IMPORTANT CONVERSATION, SUBSCRIBE TO "THE RECAST" NEWSLETTER: Power dynamics are shifting in Washington and across the country, and more people are demanding a seat at the table, insisting that all politics is personal and not all policy is equitable. "The Recast" is our twice-weekly newsletter that breaks down how race and identity are recasting politics, policy and power in America. Get fresh insights, scoops and dispatches on this crucial intersection from across the country and hear from important new voices that challenge business as usual. Don't miss out, SUBSCRIBE . Thank you to our sponsor, Intel. | | | | | | | | U.K. OFFERS TWICE-A-WEEK RAPID TESTS — Twice-weekly rapid testing will be offered to everyone in England starting Friday, either at their workplaces and schools, from pharmacies or delivered to homes, POLITICO EU’s Annabelle Dickson reports. The so-called lateral flow test program is a bid to detect people who are infected but without symptoms. The program was previously only open to health workers, those going to a workplace, the most vulnerable and the families of school-age children. Downing Street said it sees regular testing as a key tool to keep coronavirus under control as the population is given more freedom as the country comes out of its latest lockdown. MORE NATIONS PAUSE ASTRAZENECA SHOTS — The Netherlands suspended use of the AstraZeneca vaccine for people under age 60, citing concerns about an increased risk of blood clots, as several other EU countries have done before, POLITICO EU’s Paul Dallison reports. The decision came the same day that the U.K.’s Medicines and Healthcare products Regulatory Agency reported that the shot is linked to more cases of thrombosis, although it said the benefits outweigh the risk. "The number and nature of suspected adverse reactions reported so far are not unusual in comparison to other types of routinely used vaccines," the MHRA wrote about the 30 cases it has researched so far. EU CAN INVESTIGATE ILLUMINA — Brussels is one step closer to reviewing biotech company Illumina’s $7 billion deal to acquire cancer-test startup Grail, POLITCO EU’s Thibault Larger reports. France’s top court rejected Illumina’s attempt to prevent the French competition regulator from asking Brussels to look into the purchase, in a move that could open up the deal to be the first caught in new EU efforts to combat so-called “killer acquisitions.” Although the deal didn’t meet the threshold for an investigation in France, the Autorité de la concurrence was able to seek one by Brussels under new guidance on a provision in EU merger rules, Article 22. | | | Claire Brandewie has been hired as a senior director for federal government relations by Sanofi. She previously lobbied for BIO and also was a former aide to Sen. Tim Scott (R-S.C.). | | A message from Gilead Sciences, Inc.: Decades of discovery lie behind every breakthrough. For more than 30 years, Gilead scientists have been pushing the boundaries of what’s possible. We’ve worked to advance the science that has unlocked therapeutics for HIV, viral hepatitis, and even COVID-19.
Today, Gilead therapeutics are at work, effectively providing treatment for millions. But we’re not stopping any time soon. We’re committed to the relentless pursuit of scientific discovery. To keep pushing to the next goal. To bring tomorrow’s life-changing therapies forward today. And then reach farther.
To learn more, visit Gilead.com. | | | | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. — The agency last week identified five topics it intends to focus on as part of its efforts to improve its response to the current pandemic and prepare for future public health emergencies. Among the key focus areas: Improvements to the emergency use authorization process, the use of novel technologies to support facility inspections, and greater supply chain transparency. — Funding to support digital health regulation: FDA quietly announced last week that its Digital Health Software Precertification (PreCert) Pilot Program will receive support through a new funding agreement funneled through an HHS-wide project intended to “modernize healthcare.” The MITRE Corporation will receive $1.9 million to support FDA’s digital health effort, which aims to streamline the regulation of medical software. | | | New polling from Data for Progress finds the pharmaceutical industry is enjoying new popularity with the American public after delivering effective Covid-19 vaccines at record speed, Vox reports. Johnson & Johnson is now testing its Covid-19 vaccine on teenagers, CBS News reports. A Covid-19 vaccine entering clinical trials in Brazil, Mexico, Thailand and Vietnam is the first to use a molecular design widely expected to create more potent antibodies and be easier to make, The New York Times reports. Walgreens will start scheduling vaccine appointments for the Pfizer shot three weeks apart following complaints that the pharmacy chain was routinely spacing doses four weeks apart , the Times reports. A spokesperson for the pharmacy chain tells POLITICO the new functionality allowing the three-week timeframe will be enabled in its scheduler this week. Wisconsin’s state health secretary, and Biden’s pick for No. 2 at HHS, Andrea Palm, managed to wield a vaccination program that took the state from a surge more intense than New York City to one of the fastest vaccination rates in the country, The Washington Post reports. | | | The FDA announced a virtual public advisory committee meeting of the Science Advisory Board to the National Center for Toxicological Research on May 11. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
