The Feb. 8 U.S. drug pricing hearing before the Senate Health, Education, Labor and Pensions Committee started out as a spectacle in which Chair Bernie Sanders (I-Vt.) rehashed his usual talking points as he lectured the CEOs of Bristol Myers Squibb Co., Johnson & Johnson and Merck & Co. Inc. about how their companies charge so much more for their drugs in the U.S. than in other countries. But despite the show-trial aspects of the hearing, or what Ranking Member Bill Cassidy (R-La.) called Sanders’ ongoing “CEO-whack-a-mole” agenda, some facts came through that could lead to pricing reforms if Congress has the bipartisan will to do so.
No subpoena will be needed to force the CEOs of Johnson & Johnson (J&J) and Merck & Co. Inc. to appear before the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, as apparently the threat was enough to get the CEOs to agree to testify at a committee hearing on U.S. drug prices.
The U.S. FDA accepted Novocure GmbH’s premarket approval (PMA) application to use its Tumor Treating Fields (TTFields) technology together with standard systemic therapies to treat non-small cell lung cancer (NSCLC) following progression on or after platinum-based therapy. Novocure hopes that the application, under review, will get the green light and the therapy, which uses electric fields to disrupt solid tumors and kill cancer cells, will be on the market in the second half of 2024.
Analysts from the hosting firm talked up their takeaways on biopharma from the J.P. Morgan (JPM) Healthcare Conference and looked ahead to 2024, anticipating a generally better year than those in the recent past.
U.S. Sen. Bernie Sanders (I-Vt.), chair of the Health, Education, Labor and Pensions Committee, is not taking no for an answer after the CEOs of Johnson & Johnson (J&J) and Merck & Co. Inc. declined an invitation to appear before the committee to explain their U.S. drug prices.
The landscape of biopharma deals and M&As has seen a transformative shift, with a year-over-year drop in transaction numbers while value has increased. Overall, biopharma deals saw an uptick in value of nearly 6%, and biopharma M&As concurrently soared 80% higher in value than the previous year.
Merck & Co. Inc. CEO Robert Davis said the pneumococcal vaccines (PCVs) space is “an area where there is still a high unmet need, and what we have is a new vaccine specifically targeted to the adult population that addresses 83% of the residual disease. That's about 30% higher than anyone else that's out there.” Speaking Jan. 9 at the J.P. Morgan Healthcare Conference (JPM), Davis predicted that his firm “will take a majority share” of the market if approved. The Merck candidate, V-116, bears a PDUFA date with the U.S. FDA of June 17.
Merck & Co. Inc.’s deal to pay $23 in cash for Harpoon Therapeutics, bringing the equity value to about $680 million, further invigorated the delta-like ligand 3 (DLL3) development zone, where Amgen Inc. enjoys a lead with its prospect tarlatamab in the same class. DLL3 is an inhibitor ligand of the Notch pathway associated with tumorigenesis.
Receiving a second complete response letter (CRL) from the U.S. FDA for gefapixant to treat refractory and unexplained chronic cough – an indication for which there are no approved treatments in the U.S., Merck & Co. Inc. said it is reviewing the agency’s feedback to determine the next steps, if any, for the oral selective P2X3 receptor antagonist.
