Top of the morning to you. The middle of the week is upon us and, since you made it this far, why not forge ahead? After all, there is always light at the end of the proverbial tunnel. You never know what you may accomplish. So please join us as we celebrate this notion with a cup or three of delicious stimulation. (We are foraging for something appropriate since we are on the road.) Meanwhile, we have assembled the latest menu of tidbits to help you along. So please dig in. Have a smashing day and please feel free to forward any secrets you come across. Our “in basket” is always open…
The chief scientist at the World Health Organization says she is leaving the agency, the first of a series of high-profile departures expected at the global health body as it prepares for a post-pandemic future, Reuters writes. The exit of Soumya Swaminathan, an Indian pediatrician, comes as the second term of WHO Director-General Tedros Adhanom Ghebreyesus as leader of the 74-year-old global health agency gets underway. Swaminathan did not offer a reason. Others leaving include Ren Minghui, assistant director for universal health coverage and communicable and non-communicable disease, and Mariângela Batista Galvão Simão, head of access to medicines.
The U.K.’s National Institute for Health and Care Excellence recommended that three Covid-19 therapies can continue to be used to treat patients, but turned down another five treatments over cost-effectiveness concerns, Pharmaphorum notes. Among those rejected is AstraZeneca’s Evusheld, which patient organizations in the U.K. have wanted as an alternative to vaccinations for some vulnerable patient groups. The three medicines that were recommended included Pfizer’s Paxlovid, Roche’s RoActemra, and Eli Lilly’s Olumiant. The guidance is out for comment until Dec. 7, ahead of a second evaluation committee meeting scheduled for Jan. 24.
Novartis is considering the sale of its ophthalmology and respiratory units, Bloomberg News reports. Novartis has been following other large drug companies such as GSK and Johnson & Johnson in looking to cast off consumer or generic businesses and focus on the kind of new drugs that have boosted recent profits. In August, the company announced the spinoff of Sandoz, its generic-drugs unit. The ophthalmology unit alone could fetch about $5 billion. The company’s pipeline of experimental medicines is smaller in the areas of respiratory disease and ophthalmology than for its five core therapeutic areas of heart disease, immunology, neuroscience, solid tumors, and hematology.
After a preliminary review, the U.S. Food and Drug Administration issued a notice suggesting that some lower-dose naloxone hydrochloride (Narcan) products may be safe and effective for use without a prescription, MedPage Today explains. Specifically, naloxone nasal spray up to 4 mg and the intramuscular or subcutaneous naloxone autoinjector up to 2 mg “have the potential to be safe and effective” for over-the-counter access, the agency wrote. However, more “product-specific data” related to the nonprescription user interface design, such as packaging and labeling information, is needed to “make a conclusive determination.”
With cases of drug-resistant tuberculosis on the rise again around the world, GSK has sparked hopes of a new treatment option after reporting Phase 2a data with a novel antitubercular drug for the disease, Pharmaphorum explains. The study of an inhibitor of the bacterial enzyme leucyl t-RNA synthetase (LeuRS) showed that 14 days’ treatment with a low, once-daily dose was able to kill bacteria in patients with drug-susceptible pulmonary tubercolosis with no serious adverse effects. The results suggest that the antibiotic become a component of new, simpler treatment regimens, and its novel mechanism of action raises the hope that it could be used to tackle resistant strains.
A trio of major drugmakers sparred with the U.S. Health and Human Services Department on Tuesday over obligations for providing discounts under the 340B federal program meant to service low-income Americans, Bloomberg News says. Attorneys for Novo Nordisk, Sanofi, and AstraZeneca went before a three-judge panel at the U.S. Court of Appeals for the Third Circuit to dispute whether the program requires the companies to offer steeply discounted drugs through for-profit pharmacies that operate in contract with health-care providers participating in the program.
Takeda Pharmaceuticals agreed to pay $22 million to resolve a proposed class-action suit accusing the company of loading its 401k plan with underperforming and high-cost investment options, according to a filing in Massachusetts federal court, Law360 writes. The settlement, which is expected to benefit about 8,000 people covered by the $1.8 billion plan, requires the company to make several improvements to its plan management process. Takeda pledged to use a competitive bidding process to look for a new plan record-keeper, and it agreed to share the final bid amounts and the terms of any signed contact with the lawyers for the plan participants.
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