Good morning, everyone, and welcome to another working week. We have returned from an extended break, which perhaps many of you enjoyed as well. In any event, we hope that any down time was relaxing and invigorating, because now that the calendar has turned another significant page, that predictable crunch of deadlines, online calls, and what-not have returned. So by all means, ease into the routine with a cup of stimulation. Our choice today is a change of pace for us — we are imbibing hot tea, ginger peach with a dollop of honey, to be specific. Feel free to join us. Meanwhile, here is a menu of tidbits for you to consume. We hope your day goes well, and do keep in touch. …
Novo Nordisk is launching its once-daily Wegovy pill in the U.S. on Monday, offering 1.5- and 4-milligram doses at $149 per month for self-paying patients in an intensely competitive weight loss drug market, Reuters writes. The pill was approved by the U.S. Food and Drug Administration last month, a boon to the company as it looks to regain ground lost to U.S. rival Eli Lilly, which awaits FDA approval for its weight loss pill, possibly by March. The Wegovy pill could attract new consumers as Novo looks to revive its fortunes after profit warnings and sliding shares last year. The pill offers more flexibility and an alternative for those who dislike needles used in injectable medications. A key part to success for the pill will be attracting cash-paying consumers who cannot get insurance coverage, a stark shift from the dominant business model where drug pricing is managed through health insurance plans.
Sanofi said the FDA accepted a priority review to potentially expand the current age range for its Tzield type-1 diabetes drug to include children as young as 1 year old, The Wall Street Journal notes. The FDA review could amend the lower end of the range for the drug, which is currently approved for children as young as 8 years old. Tzield would be the first disease-modifying therapy that works to delay stage three type 1 diabetes for children aged 1 and older who currently have stage two of the disease, according to Sanofi. The review comes after positive data from a Phase 4 study, and the anticipated action date for the FDA decision is April 29.Continue to STAT+ to read the full story…