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Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By Katherine Ellen Foley and David Lim | | | | | 
Covid bivalent boosters are proving to be effective against Omicron subvariants. | Justin Sullivan/Getty Image | PFIZER, BIONTECH: BIVALENT COVID BOOSTERS PRODUCE ROBUST IMMUNITY — Pfizer and BioNTech released top-line data Friday morning showing that their updated BA.4/BA.5 bivalent boosters substantially increased antibodies against the Omicron subvariants they targeted compared with previous vaccine iterations, Katherine reports. The new data comes roughly two months after the Biden administration rolled out the bivalent updated vaccines, citing the need to safeguard Americans ahead of an expected winter Covid surge. The boosters were tailored to better protect against the Omicron strains causing the most U.S. cases — a vaccination development that President Joe Biden hailed as “a serious, giant step forward.” A Phase II/III clinical trial, which included 114 participants who had already received three Covid shots, showed the effectiveness of the new booster. Adults 55 and older who received the 30-microgram bivalent booster dose had four times the Omicron subvariant antibodies compared with those in the trial who received the original booster. These adults produced 13.2 times the Omicron subvariant antibody concentrations than they did pre-booster, compared to only 2.9 times the antibody concentration for those in the same age group who received the original booster. Adults 18 to 55 who received the bivalent booster had 9.5 times the Omicron subvariant antibodies compared to pre-booster levels. Biden health officials received a briefing on the Pfizer data last night , POLITICO’s Adam Cancryn reported Thursday. Moderna, which also developed an updated booster, is not expected to submit full data on its vaccine to the FDA and the White House until later this month, people with knowledge of the matter told Adam. IT'S FRIDAY. WELCOME TO PRESCRIPTION PULSE. We’re still thrilled with the news that WMATA is giving us our silver line extensions in less than two weeks … and we’d be even more thrilled if you drop us a line if you’ve submitted comments anonymously to the Reagan-Udall public portal about ongoing reviews of the FDA’s tobacco and food safety operations (emails below). We’ll be discreet. Send tips and feedback to David Lim ( dlim@politico.com or @davidalim ), Lauren Gardner ( lgardner@politico.com or @Gardner_LM ) or Katherine Ellen Foley ( kfoley@politico.com or @katherineefoley ). TODAY ON OUR PULSE CHECK PODCAST , Ben Leonard talks with Megan Messerly about the new report from Senate Cybersecurity Caucus co-founder Mark Warner’s (D-Va.) office, which asks Congress to consider getting HHS to set minimum security standards for the health industry. Plus, Katherine discusses what you should know from Pfizer's and Moderna's earnings calls.
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A new therapy to prevent RSV in babies could be on the U.S. market in 2023. | Getty Images | EC APPROVES FIRST THERAPY TO PREVENT RSV IN ALL BABIES — On Friday, the European Commission approved the first preventive monoclonal antibody from Sanofi and AstraZeneca for respiratory syncytial virus in infants, Katherine reports. Beyfortus, also known as nirsevimab, can be given to all babies, including those who were born prematurely or have other health conditions. It is a single injection of antibodies that can help babies fight off the virus for RSV season, which lasts roughly five months. Because it does not induce antibody production, it is not a vaccine. The companies have asked the FDA to approve Beyfortus and expect the agency to accept their application before the end of the year. They hope to have it on the market for the 2023–2024 RSV season. RSV VACCINES DOMINATE MODERNA, PFIZER Q3 EARNINGS CALLS — This week, competitors Pfizer and Moderna emphasized the roles of products targeting non-Covid upper-respiratory infections in their Q3 earnings calls as the pandemic morphs into an endemic state. Pfizer ’s CEO Albert Bourla touted the company’s RSV vaccines for older adults and pregnant individuals as potential blockbuster products that could be on the market in late 2023 or early 2024. Moderna hopes to roll out late-stage data for RSV vaccines for older adults this winter. Its pediatric RSV vaccine has a fully enrolled early-stage trial, and the company has begun early-stage clinical trials for vaccine combinations: Covid/flu/RSV, RSV/flu vaccines and Covid/RSV vaccines. GSK STOPS TWO TRIALS AFTER NOVEL ANTIBIOTIC CANDIDATE SHOWS STRONG EFFICACY — GSK announced Thursday that it would end two Phase III trials of an antibiotic candidate after it appeared to perform better than existing drugs. The candidate, called gepotidacin, unravels bacterial DNA during replication and could be used to treat uncomplicated vaginal urinary tract infections. The company plans to submit the data in an FDA approval application in the first half of 2023.
| | | FDA ADVISERS QUESTION PULSE OXIMETER ACCURACY — Pulse oximeters used to measure blood oxygen saturation levels perform worse in people with darker skin tones and the FDA should require higher clinical performance standards for the medical devices and improved labeling for their over-the-counter versions, a panel of external experts convened by the agency concluded Tuesday, David reports. “The panel believes that clearly there is a disparate performance in patients with darker skin pigmentation, and this does increase these patients’ risk for whatever disease they might be having,” said Steven Nathan, chair of the advisory committee and medical director of the advanced lung disease and transplant program at Inova Fairfax Hospital. FDA SENDS AMAZON, WALMART WARNING LETTERS OVER UNAUTHORIZED DRUG SALES — The FDA warned Amazon and Walmart on Tuesday to stop selling products that contain nonsteroidal anti-inflammatory drugs not listed on the product ingredient labeling, Katherine reports. In the past, the FDA has usually just gone after manufacturers of products that don’t comply with the agency’s stipulations. But it is also now sending warning letters to companies that distribute illegal products. “After the FDA issued its public safety notice in April, Walmart unpublished the four products from a third-party seller that the FDA specifically identified and blocked them from being sold on our website,” Walmart said in a statement to POLITICO. “We will continue to enhance our systems which are designed to identify and block products prohibited by law or under our policies.” Amazon didn’t respond to requests for comment.
| | | EPA TOUTS GRANTS TO BOOST ETHYLENE OXIDE MONITORING — A new $53.4 million EPA effort to boost monitoring of air pollution includes two projects to monitor for ethylene oxide, a carcinogenic substance used in chemical manufacturing and to sterilize medical devices, POLITICO’s Alex Guillén reports.
| | | FDA: DON’T USE INFANT HEAD-SHAPING PILLOWS — Parents with babies should not use infant head-shaping pillows because they can create a risk of suffocation and death when infants are sleeping, the FDA warned in a safety communication Thursday. “The FDA is not aware of any demonstrated benefit with the use of infant head shaping pillows for any medical purpose,” the agency said. “The safety and effectiveness of these products have not been established for the prevention or treatment of flat head syndrome, or the more serious condition where the developing infant’s skull bones join together too early.”
| | | Richard Rodgers, a member of the boards of directors of Ocuphire Pharma, Sagimet Biosciences and Ardelyx will be an independent director of Novavax’s board of directors. Brian Hose will take over for Robert McLaughlin as CEO of EPIC Pharmacies.
| | | CVS and Walgreens announced this week they have reached tentative deals — approximately $5 billion each — to settle multistate lawsuits related to the opioid crisis, The New York Times’ Jan Hoffman reports . The Times’ Sarah Maslin Nir reports that Teva Pharmaceutical will pay more than $500 million in a similar New York state settlement.
| | | Senate Select Committee on Intelligence Chair Mark Warner (D-Va.) on Thursday published a policy paper outlining ideas to boost cybersecurity in the health care industry, POLITICO’s Ben Leonard reports. Sen. Marco Rubio (R-Fla.) and several Florida House Republicans on Wednesday asked FDA Commissioner Robert Califf for an update on the status of the state’s drug importation program proposal. The FDA issued guidance this week outlining an alternative approach to assess the human carcinogenic risk of drugs. The FDA issued guidance this week containing recommendations on how the agency is implementing its over-the-counter monograph drug user fee program. The FDA issued guidance this week outlining how to cross-label cancer drugs being used in a combination regimen. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
