Ban Unvaccinated Children From Schools, Experts Urge Amid Growing Measles Crisis — as They Discuss Possibility of Mandatory MMR Jabs + More
Source: Children’s Health Defense
Ban Unvaccinated Children From Schools, Experts Urge Amid Growing Measles Crisis — as They Discuss Possibility of Mandatory MMR Jabs
Health officials are calling for unvaccinated children to be barred from schools as a measles outbreak sparks fears of wider spread. The warning came from Emma Best, chairman of the London Assembly Health Committee, following a panel session examining the growing number of infections in the capital.
She said excluding pupils who have not had the MMR jab may soon be necessary if vaccination rates continue to fall. She told the Daily Mail:
“We might not be at the stage of making vaccination mandatory, but we are faced with a very worrying reality if we carry on on this trajectory. Obviously no one wants to see children out of school, but there is a point where it becomes too dangerous for an unvaccinated child to be in that environment.”
FDA Warns Novo Over Unreported Potential Ozempic Side Effects, Deaths
Novo Nordisk A/S got a warning letter from the US Food and Drug Administration for not reporting all suspected side effects in patients who took its blockbuster diabetes drug Ozempic. Among the cases were two deaths and a suicide, the agency said in a March 5 letter and accompanying report.
The FDA didn’t stipulate whether the deaths or other side effects were linked to the drug. Novo said it plans to address the FDA’s concerns “expeditiously and holistically.” It’s been working with the agency on an action plan since an inspection early last year, the company said in a statement. The warning letter comes as Novo battles to win back patients in the growing market for medicines like Ozempic and related compounds for obesity, where it has ceded the lead to rival Eli Lilly & Co. The US is the largest market for the drugs.
Novo realized in April 2024 there had been a failure to properly report serious adverse events involving Ozempic and other drugs going back as far as 2020, according to the FDA inspection report. The company attempted to fix the issue, but FDA investigators at its US headquarters in Plainsboro, New Jersey, said they found more than 300 reports that hadn’t been sent to the agency. Some were more than 1,000 days late.
GLP-1 Drugs Like Ozempic Can Raise Bone and Tendon Injury Risk, Study Suggests
The miracle of rapid weight loss has always come with fine print. Until recently, it read mostly like a list of digestive complaints — stomachaches, constipation — generally unpleasant but tolerable and rarely severe. New research presented this month suggests the drugs may affect something more structural: bone. In an analysis of nearly 150,000 patients, researchers found that people taking GLP-1 medications faced a significantly higher risk of skeletal disorders.
Over five years, the risk of osteoporosis — a disease that weakens bones and makes them brittle — was nearly 30 percent higher. The risk of gout, a painful inflammatory arthritis which results from needlelike crystals forming in the joints, rose 12 percent. And the risk of osteomalacia, a softening of the bones caused by a low mineral-to-bone ratio that was rarer in the study, increased by more than 150 percent.
US FDA Approves Leucovorin for Ultra- Rare Genetic Disorder Causing Autism-Like Symptoms
The U.S. FDA on Tuesday approved leucovorin, a decades-old generic drug, for use against an ultra-rare disorder called cerebral folate deficiency, but not for children with the much broader diagnosis of autism that it had promised last autumn to help, citing a lack of data.
The approval for the rare genetic disorder, which causes autism-like symptoms, is a significant step back from the government’s September press conference when President Donald Trump and Health Secretary Robert F. Kennedy Jr. promoted the drug as a treatment for autism symptoms.
“So while we did originally approach this with a broad scope, as we looked through the scientific data, we ended up narrowing our scope to come to the strongest data evidence that we could find to support the approval,” a senior U.S. Food and Drug Administration official told reporters on a press call ahead of the approval announcement.
The FDA said it approved GSK’s (GSK.L) Wellcovorin, the branded version of leucovorin, based on a systematic review of the published literature on the topic rather than clinical trial data. It was not feasible to conduct a randomized controlled trial due to the rareness of the disease, a second official said.
Study Links Fluoroquinolone Antibiotics to Increased Risk of Panic Attacks
A new study by a team of Canadian researchers hints at a potential link between fluoroquinolone antibiotics and increased risk of panic attacks. Although fluoroquinolones are among the most widely prescribed antibiotics, they’ve been linked to an array of side effects, including tendinitis and tendon rupture, peripheral neuropathy (a nerve condition that causes weakness, numbness, and pain in the hands and feet), and central nervous system effects.
These associations have led the Food and Drug Administration (FDA) to revise its black box warning labels for fluoroquinolones several times. Despite frequent case reports of panic attacks following fluoroquinolone use, no large-scale studies have looked at the potential association.
The study, published late last week in the Journal of Antimicrobial Chemotherapy by researchers from Western University in Ontario, included a systematic review and meta-analysis of 12 relevant studies and an analysis of individual case safety reports (ICSRs) identified in the FDA’s Adverse Event Reporting System (FAERS) database.
The 12 studies, published from 2004 to 2024, included four clinical trials and eight papers describing 11 case reports. The FAERS analysis compared ICSRs for fluoroquinolones (ciprofloxacin, levofloxacin, and moxifloxacin) and two comparator drugs—azithromycin and trimethoprim/sulfamethoxazole.
Cancer Drug Pulled From Market Over Safety Concerns
The cancer drug tazemetostat (Tazverik) is being voluntarily withdrawn in the U.S. and all other markets over concerns about secondary cancers, drugmaker Ipsen announced.
The company also said it is discontinuing all active trials of the EZH2 inhibitor and any expanded access programs.
Based on data from single-arm trials, tazemetostat in 2020 received accelerated approvals from the FDA for patients with previously treated follicular lymphoma and an EZH2 mutation and for patients with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection.
Ipsen’s decision to pull the drug for both indications was based on emerging safety data from SYMPHONY-1, a confirmatory phase Ib/III study evaluating lenalidomide (Revlimid) plus rituximab with or without tazemetostat in follicular lymphoma. In its statement, the company said the study’s independent data monitoring committee “advised that, based on adverse events of secondary hematologic malignancies, the risks may outweigh potential benefits for patients within this treatment regimen.”
Novo Nordisk Receives FDA Warning Linked to US Inspection in 2025
Novo Nordisk said on Tuesday it had received a warning letter from the U.S. Food and Drug Administration regarding an inspection at the Danish drugmaker’s site in Plainsboro, New Jersey, in early 2025. The company has undertaken an action plan that includes addressing gaps in its capability to prevent adverse effects or any other drug-related problems once the medicines are on the market, it said. It has also kept the agency informed on the progress.
“The Warning Letter largely seeks additional details on these measures to confirm current and future regulatory compliance; it does not make any conclusions about the quality or safety of our medicines,” the company said. Although the inspection took place in 2025, the warning letter was issued in early March.
Novo first responded to the Form FDA 483, a type of inspectional observation document, within the agency’s deadline on March 3, 2025, and has shared seven updates since then.
Leerink Questions Whether BioNTech Can Thrive Without Their ‘Founders’ Insight’ as Stock Drops
In BioNTech’s search for a new CEO — following the announcement earlier Tuesday that Uğur Şahin, M.D., and his wife and CMO Özlem Türeci, M.D. will depart by the end of the year to establish a new start-up — the German company is seeking a new leader with “experience in late-stage development and commercial execution,” chief financial officer Ramon Zapata said in a quarterly conference call.
With several readouts of potential products expected by the end of this “catalyst-rich year,” according to the company, Sahin said that this is the “perfect timing for transition.”
Analysts from Leerink Partners agreed, calling the transition a “logical step,” in a note to investors.
While Şahin and Türeci’s new company will pioneer next-generation mRNA innovation, BioNTech will focus on late-stage execution and preparations for commercialization with the goal of becoming a “multi-product company by 2030,” it explained (PDF) in its Q4 presentation.
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