DUBLIN – Having spent more than 150 years devoted to marketing tobacco, Philip Morris International Inc. is now embracing human health and wellness as part of what it calls a “beyond nicotine” strategy, under which it has tabled a £1.50 (US$2.07) per share offer for Vectura Group plc. The offer implies an enterprise value of £852 million or about $1.2 billion for Chippenham, U.K.-based Vectura, which majors in formulation and device development for inhaled drugs.
Following a priority review, the FDA approved Bayer AG’s Kerendia (finerenone) for chronic kidney disease (CKD) associated with type 2 diabetes (T2D). A non-steroidal mineralocorticoid receptor antagonist, Kerendia targets a key driver in CKD and has proven positive as well with regard to cardiovascular outcomes – risked especially by patients with loss of kidney function.
U.S. Rep. Carolyn Maloney (D-N.Y.) came out swinging against the biopharma industry’s innovation talking point July 8 when she released a House Oversight Committee staff report on U.S. drug prices and the games drug manufacturers play to delay competition.
The U.S. Supreme Court has agreed to take up one piece of the 340B conundrum that’s pitting biopharma against hospitals and catching the Department of Health and Human Services in between. The case the court agreed to hear, the American Hospital Association (AHA) v. Becerra, focuses on whether HHS has the authority to cut Medicare reimbursement rates to reflect the steep discounts 340B hospitals get on certain prescription drugs.
Compass Pathways Ltd. has joined with a U.K. hospital and an academic establishment to research the role of psychedelic medicine in new models of mental health care. The London-based company signed a memorandum of understanding with South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry, Psychology and Neuroscience at King’s College London to launch the project.
In June, Morphosys AG acquired Constellation Pharmaceuticals Inc. in a deal worth $1.7 billion in which the German biotech monetizes a royalty from a big-selling antibody, spending the lump sum on research into small-molecule BET inhibitors. It’s a bold move and one that perhaps demonstrates a renewed interest in small-molecule drugs after a period when antibody-based molecules have been the dominant force in the market for branded drugs.
Just months after Jazz Pharmaceuticals plc's inventory of a therapy key to treating certain acute lymphoblastic leukemia and lymphoblastic lymphoma patients appears to have run out, FDA approval has arrived for an alternative: a recombinant version of the medicine the company developed, Rylaze (asparaginase Erwinia chrysanthemi (recombinant)).
As the first flagship action of Europe’s plan to beat cancer, the European Commission launched its Cancer Knowledge Center June 30. The new online platform will map the latest evidence on cancer, provide health care guidelines and quality assurance schemes, and monitor and project trends in cancer incidence and mortality across the EU, where cancer is the No. 1 killer for people younger than 65.
Poxel SA and Sumitomo Dainippon Pharma Co. Ltd. said their first-in-class drug, Twymeeg (imeglimin hydrochloride), won its first approval in Japan, where it could change the treatment regimen for type 2 diabetes.
New FDA breakthrough therapy designations awarded for two investigational Alzheimer's disease (AD) candidates, Eli Lilly and Co.'s donanemab and the Bioarctic AB-Eisai Co. Ltd.-developed asset lecanemab (BAN-2401) underline ongoing willingness at the U.S. regulator to invest deeper attention in the potential of amyloid plaque reduction to slow progress of the disease, a critical and costly challenge estimated to affect more than 6 million Americans.
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