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Young Boy Dies in Trial for Pfizer Duchenne Gene Therapy
A young boy died in a trial for Pfizer’s experimental gene therapy for Duchenne muscular dystrophy, the company told patient advocates Tuesday.
The boy was enrolled in Daylight, a trial studying the treatment in boys aged 2 or 3. The boy had received the therapy early last year, Pfizer told the advocates in a note posted online by Parent Project Muscular Dystrophy.
Pfizer said the boy died of cardiac arrest, but that it was still working to understand what happened and the exact cause.
AstraZeneca to Withdraw COVID Vaccine Globally as Demand Dips
AstraZeneca (AZN.L) said on Tuesday it had initiated the worldwide withdrawal of its COVID-19 vaccine due to a “surplus of available updated vaccines” since the pandemic. The company also said it would proceed to withdraw the vaccine Vaxzevria’s marketing authorizations within Europe.
“As multiple, variant COVID-19 vaccines have since been developed there is a surplus of available updated vaccines,” the company said, adding that this had led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied.
According to media reports, the Anglo-Swedish drugmaker has previously admitted in court documents that the vaccine causes side effects such as blood clots and low blood platelet counts. The firm’s application to withdraw the vaccine was made on March 5 and came into effect on May 7, according to the Telegraph, which first reported the development.
The Serum Institute of India (SII), which produced AstraZeneca’s COVID-19 vaccine under the brand name Covishield, stopped manufacturing and supply of the doses in December 2021, an SII spokesperson said.
Endo Health Ordered to Pay More Than $1.5 Billion in Opioid Criminal Case
In the second-largest fine ever levied on a pharmaceutical company, Endo Health Solutions was ordered to pay nearly $1.1 billion in criminal penalties and another $450 million in criminal forfeiture for illegally marketing its Opana ER prescription opioid.
The company, which last month pleaded guilty to a misdemeanor, admitted that, from April 2012 through May 2013, some of its sales representatives marketed its medicine, also known as oxymorphone, to doctors by touting the drug as abuse-deterrent, as well as resistant to tampering and crushing. Yet Endo lacked the clinical trial data to support those assertions, according to federal officials.
“Through extensive false advertising efforts to conceal oxymorphone’s deleterious effects, Endo Health Solutions demonstrated a callous disregard for the safety and well-being of the people who were prescribed this highly addictive drug,” said Jeffrey Veltri, special agent in charge in the Miami Field Office of the U.S. Federal Bureau of Investigation, in a statement.
Pfizer Agrees to Settle Over 10,000 Zantac Lawsuits, Bloomberg News Reports
Pfizer (PFE.N) has agreed to settle more than 10,000 lawsuits about cancer risks related to the now-discontinued heartburn drug Zantac, Bloomberg News reported on Wednesday, citing people familiar with the deal.
The agreements cover cases in U.S. state courts but don’t completely resolve the company’s exposure to Zantac claims, the report said, adding that financial details of the deals were not immediately available.
In 2020, the U.S. Food and Drug Administration asked drugmakers to pull Zantac and its generic versions off the market after a cancer-causing substance called NDMA was found in samples of the drug.
Thousands of lawsuits began piling up in federal and state courts against Pfizer, GSK (GSK.L), Sanofi (SASY.PA) and Boehringer Ingelheim.
Novo Asks for More Time to Answer Sanders on Ozempic’s Price
Novo Nordisk A/S is asking for more time to answer questions from U.S. Senator Bernie Sanders on the prices of Ozempic and Wegovy, the company’s blockbuster drugs for diabetes and weight loss.
“We plan to respond to the latest inquiry in a timely manner; however given the tight turnaround requested, we will need additional time to develop our response,” a spokesperson for the Danish drugmaker said Tuesday in an emailed response to questions.
Chairman of the Health, Education, Labor and Pensions Committee, Sanders had set a deadline of May 8 for Novo to respond to a series of questions on the medications’ cost and manufacturing. The Vermont independent lawmaker has said he doesn’t support broad Medicare coverage of drugs for weight loss at their current prices because of their potential budget impact on the U.S. health program for seniors.
In a letter dated April 24, Sanders said his committee was undertaking an investigation into “the outrageously high prices” that the company charges for its drugs in the U.S. He’s called the cost of Ozempic, listed in the U.S. for $968.52 for a month’s supply of weekly injections, “totally absurd.”
Sanders’ inquiry came after a study published in JAMA Network Open that found a month’s supply of Ozempic could be profitably made for less than $5.
Lilly Gets a Date With FDA to Discuss Alzheimer’s Med Donanemab
Mark your calendars: Eli Lilly will come before the FDA’s advisory committee to discuss Alzheimer’s disease medicine donanemab June 10.
The exact questions to be discussed are not yet known, but, as always, the FDA will publish its materials for the meeting two days beforehand, which will include the voting questions and the agency’s take on the issues. Lilly will also provide a rebuttal.
Speaking to Fierce Biotech last month, executives from Lilly said the issues are likely to surround labeling for donanemab. The FDA has balked at the fact that patients stopped taking the therapy once they achieved amyloid clearance, as seen on imaging tests.
Since this is a change in the standard of care for Alzheimer’s, where patients typically take a drug for the rest of their lives to manage their condition, the FDA wants to learn more, Dawn Brooks, Ph.D., Lilly’s global development leader for donanemab and the pharma’s other lead Alzheimer’s drug remternetug, said last month.
Three Roundup Lawsuits Cleared for Remand to Massachusetts Federal Court if Settlement Not Reached
The U.S. District Judge presiding over all coordinated pretrial proceedings in Roundup non-Hodgkin’s lymphoma lawsuits brought throughout the federal court system has rejected a motion to dismiss three lawsuits originally filed in the District of Massachusetts, clearing the way for the cases to be remanded for trial in about two weeks if the parties fail to settle the claims.
Over the past nine years, Bayer and its Monsanto subsidiary have faced more than 167,000 lawsuits throughout the U.S., each raising similar allegations that users were not adequately warned about the risk of developing non-Hodgkin’s lymphoma from Roundup, either when using the product in an agricultural setting or around the home.
The litigation emerged in 2015 when the World Health Organization’s International Agency for Research on Cancer (IARC) decided to classify glyphosate in Roundup as a probable cancer-causing agent. However, even after paying more than $10 billion in Roundup settlements in recent years, Bayer and Monsanto have continued to face a steady stream of jury trials involving plaintiffs who rejected settlement offers, as well as new claims that continue to be filed as former users develop non-Hodgkin’s lymphoma.
Currently, hundreds of claims are centralized in the federal court system before U.S. District Judge Vince Chhabria in the Northern District of California, where several large waves of claims are being prepared for remand to different federal district courts for trial. Even more are filed in state courts nationwide, including Missouri, Pennsylvania, New Jersey and California, where a series of non-Hodgkins lymphoma lawsuits are already scheduled to go before juries in the coming months.
Tailored Vaccine Could One Day Treat Eczema in Children
New research from a multidisciplinary team at Trinity College Dublin suggests a “tailored vaccine” might hold the key to treating bacteria-driven flares of eczema in children. The work has been published in JCI Insight.
The team has taken several leaps forward in understanding how the immune response works in cases of eczema driven by the common, troublesome Staphylococcus aureus bacterium, and in doing so they have identified new cellular targets for a vaccine.
The researchers, from Trinity’s Schools of Medicine, Computer Science and Statistics, as well as from Biochemistry and Immunology, uncovered important “immune signatures” in children with infected flares of eczema. Pinpointing these signatures provides them with specific new targets, which is helpful from a theoretical vaccine design perspective.
Whooping Cough Epidemic Sweeps Europe, Health Agency Says
European countries have reported a surge in whooping cough cases in 2023 and the first quarter of 2024, with 10 times as many identified as in each of the previous two years. In total, nearly 60,000 cases were reported by European Union and European Economic Area countries over the period, the European Centre for Disease Prevention and Control said on Wednesday, with 11 deaths in infants and eight among older adults.
European countries have reported a surge in whooping cough cases in 2023 and the first quarter of 2024, with 10 times as many identified as in each of the previous two years.
In total, nearly 60,000 cases were reported by European Union and European Economic Area countries over the period, the European Centre for Disease Prevention and Control said on Wednesday, with 11 deaths in infants and eight among older adults.
Most European countries routinely immunize children against pertussis and many also vaccinate pregnant women to protect their babies. The ECDC said some countries may want to consider giving boosters to older children and adults too, as immunity can wane.
