A sometimes contentious policy roundtable on how to handle Alzheimer’s disease therapies followed the July 15 meeting of the California Technology Assessment Forum, an independent evidence appraisal committee of the Institute for Clinical and Economic Review (ICER). CTAF’s 15 panelists voted unanimously that the evidence was not adequate to prove Biogen Inc.’s recently approved Aduhelm (aducanumab) superior to supportive care alone.
Members of the California Technology Assessment Forum (CTAF), an independent appraisal committee of the Institute for Clinical and Economic Review (ICER), discussed – and voted on – the safety vs. efficacy and other aspects of Biogen Inc.’s embattled Aduhelm (aducanumab), the amyloid beta-targeting therapy recently approved for Alzheimer’s disease. It didn’t go well for Biogen.
Despite assembling the largest body of data the FDA said it may ever see for a drug intended to treat anemia due to chronic kidney disease, Fibrogen Inc. will have to get even more trial data to push roxadustat over the finish line in the U.S. – if the FDA follows the advice of its Cardiovascular and Renal Drugs Advisory Committee.
Following November’s equity investment that brought it a 14% ownership in Protomer Technologies Inc., Eli Lilly and Co. has acquired the privately held company engineering protein and peptide therapeutics that sense molecular activators. If development and commercial milestones are met, the deal could be worth more than $1 billion.
Safety will be the focus July 15 when the FDA’s Cardiovascular and Renal Drugs Advisory Committee dives into the data for Fibrogen Inc.’s roxadustat as a treatment for anemia due to chronic kidney disease.
The M&As that are the current business model of the drug and device world are in for increased scrutiny under the executive order U.S. President Joe Biden signed July 9. Answering the administration’s call for a whole-of-government-approach to increasing competition in the U.S., the Department of Justice “will closely examine its antitrust guidelines and policy statements to better educate the public on its enforcement priorities, and it will heighten its efforts to prevent mergers that would result in excessive consolidations of purchasing power,” U.S. Attorney General Merrick Garland said.
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.
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