Just a day after the U.S. FTC released an interim report on harmful pharmacy benefit manager (PBM) practices and appeared before a House subcommittee that encouraged the commissioners to take enforcement action, the agency reportedly was preparing to file suit against the country’s three largest PBMs over their practices in negotiating insulin and other drug prices.
Following an advisory committee’s recommendation in May against approval, the U.S. FDA issued a complete response letter (CRL) to Novo Nordisk A/S for its once-weekly insulin icodec injection for diabetes, which is on the market as Awiqli in several other countries.
In the third-largest acquisition announced this year, pharma giant Eli Lilly and Co. is buying oral integrin therapies developer Morphic Holding Inc. for $3.2 billion. Morphic stock (NASDAQ:MORF) got a tremendous boost from the acquisition, with shares closing 75% upward at $55.74 each on July 8, the day the deal was announced.
Less than a month after the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee handed down a unanimous vote in favor of Eli Lilly and Co.’s Alzheimer’s disease candidate (AD), donanemab, the agency approved the drug as a once-monthly injection for adults with early symptomatic disease. Branded Kisunla, the beta-amyloid antagonist marks the second approved AD drug that has demonstrated in clinical trials an ability to slow cognitive decline, going up against Leqembi (lecanemab) from Biogen Inc. and Eisai Co. Ltd., which won full approval in July 2023, only six months after nabbing an accelerated nod.
The obesity market is hot with Novo Nordisk A/S generating $6.3 billion in sales from its semaglutide-containing drugs, Ozempic, Saxenda, Rybelsus and Wegovy, in the first quarter of 2024 and Eli Lilly and Co. bringing in $2.3 billion for its tirzepatide-containing drugs, Zepbound and Mounjaro, in the same quarter. It appears unlikely the market will be a two-horse race for much longer though.
The BioWorld Biopharmaceutical Index (BBI) saw an 8.15% increase at the close of May, outperforming the Dow Jones Industrial Average, which rose by 2.64%, and the Nasdaq Biotechnology Index, which was up by 0.7%. The BBI previously showed a strong performance in Q1, followed by a dip for all three indices in April, before all rebounded in May.
The recent licensing agreement that Alzpath Inc. signed with Roche AG for use of its pTau217 antibody to develop and commercialize an Alzheimer's disease diagnostic blood test will not only transform the company but also allow patients access to a more cost-effective test, Venkat Shastri, CEO of Alzpath told BioWorld.
For the time being, Madrigal Pharmaceuticals Inc.’s Rezdiffra (resmetirom) stands alone as the only U.S. FDA approved treatment for treating nonalcoholic steatohepatitis (NASH). But new and positive data from multiple companies show Madrigal may soon have company.
Just as it is for terminally ill cancer patients, time is of the essence for people in the early stages of Alzheimer’s disease. Thus, the clinical meaningfulness of Eli Lilly and Co.’s donanemab is the time it gives patients before the disease progresses, Reisa Sperling, a neurology professor at Harvard Medical School and director of the Center for Alzheimer’s Research and Treatment at Brigham and Women’s Hospital, told the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee June 10.
Eli Lilly & Co. has patented aryl hydrocarbon receptor (AhR) agonists reported to be useful for the treatment of psoriasis, atopic dermatitis, ulcerative colitis, Crohn’s disease, graft-vs.-host disease, rheumatoid arthritis, multiple sclerosis and systemic lupus erythematosus.
