After watching Scott Gottlieb, M.D. of the FDA comments regarding the rebate rule changes and a warning tweet on biosimilars, AbbVie investors are bailing out. But the industry watchers claim that they don’t need to be.
Last year the FDA inspected the AbbVie North Chicago manufacturing site during which time they discovered that the company failed to do a proper investigation on five death complaints received relating to Humira and Venclexta treatments. Though the drug maker reported the deaths, it didn’t collate the historical data of the lots in question. It was later discovered that the lots were tied to another 8 to 10 deaths.
This year AbbVie launched Imbruvica, a single tablet for blood cancer treatment. It has been designed as a convenient therapy measure for patients who used the old tablets as often as four times a day. Adapting the new single tablet in their treatment regimens will prove to be an expensive proposition for some patients as the new tablet comes with a price tag of $400 each, triple the cost of the older tablets.
In clinical studies, more than half of patients receiving risankizumab achieved complete skin clearance (PASI 100) at one year (52 weeks) (1) The Biologics License Application is supported by four Phase 3 studies of more than 2,000 patients with moderate to severe plaque psoriasis (1-3) Risankizumab is an investigational compound designed to selectively inhibit IL-23 by binding to its p19 subunit and is being evaluated for the potential to deliver long-term skin clearance for psoriasis patients with 12-week dosing (4)
The U.S. Food and Drug Administration (FDA) issued two Complete Response Letters (CRLs) to South Korean manufacturer Celltrion. One was for a proposed biosimilar for Genentech and Biogen’s Rituxan for lymphomas and leukemias, and a proposed biosimilar to AbbVie’s Humira for rheumatoid arthritis, plaque psoriasis, Crohn’s disease and other autoimmune disorders.
AbbVie (ABBV), a global biopharmaceutical company, and Alector, a privately owned biotechnology company, announced a global strategic collaboration to develop and commercialize medicines to treat Alzheimer's disease and other neurodegenerative disorders.
"This collaboration is the first for Harpoon and highlights the high level of industry interest in best-in-class platform technologies. We are excited about partnering with AbbVie to help generate novel T-cell engagers for the treatment of cancer based on the combination of T-cell receptors with TriTACs," said Jerry McMahon, Ph.D., chief executive officer, Harpoon Therapeutics.
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