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FEATURED STORIES
The FDA has three regulatory milestones in the next two weeks, including a decision on a subcutaneous formulation of an effective multiple sclerosis therapy.
With gene therapies by REGENXBIO and AbbVie, Adverum and others in mid- or late-stage trials, this therapeutic class could soon be an option for this common cause of blindness in the elderly.
Eli Lilly this week announced plans to sell single-dose vials of its weight loss drug Zepbound directly to consumers. Novo Nordisk could adopt a similar strategy for Wegovy as its CEO is set to testify Sept. 24 before the Senate health committee.
Job Trends
BioCryst Pharmaceuticals, Inc. announced that the compensation committee of BioCryst’s board of directors granted 23 newly-hired employees stock options to purchase an aggregate of 128,800 shares, and restricted stock units covering an aggregate of 88,650 shares, of BioCryst common stock.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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In the plaque psoriasis arena, Sotyktu is facing off against Amgen’s Otezla and is facing the threat of upcoming competition from Alumis’ investigational TYK2 inhibitor.
Late-stage data also showed that Johnson & Johnson’s icotrokinra was superior to Bristol Myers Squibb’s Sotyktu at clearing skin and easing symptom severity in patients with plaque psoriasis.
In September 2024, a readout from a separate trial of rocatinlimab elicited mixed reactions from analysts, who found the antibody’s efficacy in that study to be underwhelming.
While the job market is tough for life sciences professionals right now, it won’t always be. Employers must continue striving to create fulfilling work environments, as the market won’t always be in their favor, say biopharma execs.
While drug developers work to mitigate the side effects associated with GLP-1–based obesity drugs, recent studies reveal that myriad variables are causing patients to stop treatment.
As sales of its COVID vaccine plummet, Novavax is looking ahead toward other novel vaccines, brought to market with the help of the company’s pharma partners—something it opted not to do as the pandemic swept the globe in 2020.
The FDA’s Oncologic Drugs Advisory Committee recently voted to narrow the label for checkpoint inhibitors Keytruda and Opdivo in stomach and esophageal cancers based on PD-L1 expression levels—but the high unmet need in these patient populations should also be considered.
On the agenda for the FDA this month are two RNA-based treatments for rare diseases.
Marty Makary, likely FDA commissioner under President Trump, appeared before Congress this week as the agency he’s set to lead continues to be rocked by sweeping changes and about-faces.
While Congress is renewing the priority review voucher program for rare pediatric diseases, the FDA should be required to keep public records of the passes changing hands, too.