This week we take a look at Moderna’s less than ideal flu vaccine trial results, an $8.9 billion settlement by Johnson & Johnson for their talcum powder being carcinogenic, eye drop contamination issues triggering the FDA’s visit to Global Health Pharma’s facility and other top news!
Moderna’s first-ever seasonal flu vaccine, mRNA-1010, did not meet effectiveness expectations in phase 3 of an ongoing study. The vaccine did not exceed the statistical threshold required to claim early success due to a lack of sufficient cases during the interim analysis of a late-stage study in the northern hemisphere. Moderna has upgraded mRNA-1010 to boost immunogenicity against influenza B strains to address the vulnerability, and a confirmatory phase 3 study is scheduled to begin shortly. Despite the flu vaccine setback, investors are interested in Moderna’s potential avenues of development, including tailored cancer therapy and vaccination for the respiratory syncytial virus.
Johnson & Johnson (J&J) has agreed to raise its original $2bn talcum powder lawsuit settlement to $8.9bn after the “Texas two-step” bankruptcy strategy was criticized by a US court. Under this approach, a firm is split into two and then liable claims are passed onto the new company, which files for bankruptcy protection under Chapter 11 to settle legal cases. J&J used this method to handle claims of its talcum powder causing cancer and containing asbestos. Though some plaintiff attorneys have agreed to the new settlement, others remain skeptical of the fairness of the approach.
Top-level biotech CEOs and business officials, including those from Bayer, Absci, Atlas Ventures, and 89bio, are protesting a Texas judge’s decision to halt the FDA’s approval of the abortion pill mifepristone, stating that this decision could weaken the agency’s power and put new innovations at risk. They wrote a letter asking for the FDA’s power to be restored and the decision to be rescinded, as unilaterally reversing medicinal approvals without considering science or evidence could jeopardize the safety of any treatment. The White House and HHS have also announced that they would challenge the judge’s verdict.
Global Health Pharma’s Indian facility has been flagged by the US FDA after two US-based distributors, Delsam Pharma and EzriCare, recalled the company’s eye drops due to links with a drug-resistant strain of bacteria called Pseudomonas aeruginosa. The FDA has reported that the manufacturing process was deficient and raised concerns regarding product sterility, including inadequate testing procedures and a lack of established written procedures for equipment maintenance and cleaning. The report is a preliminary assessment that is to be followed by a final report and a warning letter that is to be issued to the company. The FDA has urged consumers to stop using the products and healthcare facilities to follow strict infection-control recommendations when treating affected patients.
Cigna’s Evernorth has launched the Accredo Rare and Complex Therapeutic Resource Center, a specialty pharmacy program aimed at providing personalized care and support for patients suffering from rare and complex diseases. The program will provide care management services, educational resources, and support services to help patients manage their conditions more effectively. The program will be staffed by a team of clinical pharmacists and nurses who specialize in managing complex therapies, who will work closely with patients, healthcare providers, and payers to develop personalized treatment plans that cater to each patient’s unique needs.
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