Despite the new Medicare inflation rebate, the U.S. price of 27 Part B drugs grew faster than inflation in the last quarter of 2022, triggering the new rebate provision in the Inflation Reduction Act. The manufacturers of those single-source drugs will be billed for the rebates in 2025, but Medicare beneficiaries should see a drop in their coinsurance for those drugs, for the next quarter at least. According to the Biden administration, the decrease in out-of-pocket costs for those drugs will range from $2 to as much as $390 per average dose from April 1 through June 30.
Marking the latest Alzheimer’s disease (AD) disappointment, Eli Lilly and Co.’s solanezumab failed in a phase III trial to slow progression of cognitive decline in patients at the preclinical stage of the disease – those with amyloid plaque but no clinical symptoms – prompting the company to terminate development. The Indianapolis-based company is turning its attention instead to phase III AD products donanemab and remternetug.
Three months earlier than anticipated, CMS published its final local coverage determination (LCD) for continuous glucose monitors and included more people with diabetes than expected. The new policy expands coverage from individuals with type 1 diabetes or type 2 diabetes using multiple daily injections of insulin to anyone treated with insulin, essentially doubling the market for manufacturers of continuous glucose monitors (CGMs).
U.S. Sen. Bernie Sanders (I-Vt.) sent letters to Sanofi SA and Novo Nordisk A/S executives on March 1, urging them to follow Eli Lilly and Co.’s example in cutting prices for their insulin products, offering more affordable access for Americans with diabetes. Industry leaders, however, have long argued that the problem goes far beyond list price, as pharmacy benefit managers and health plans have simply not passed their rebates onto consumers.
During two different panels at Biocom California’s Global Life Science Partnering & Investor Conference, executives from a variety of pharmaceutical companies laid out their wants and needs in the current market environment. Large drug companies have relied on biotech companies to build out their pipelines for many years, but the level of outside inventions has been increasing over the last few years.
Confo Therapeutics NV is banking an up-front payment of $40 million from a licensing deal with Eli Lilly and Co. involving its lead asset, CFTX-1554, an oral inhibitor of the angiotensin II type 2 receptor, which is in phase I development for neuropathic pain. The deal includes up to $590 million more in potential milestones and tiered sales royalties. Ghent, Belgium-based Confo could also secure a further $590 million in additional milestones should Indianapolis-based Lilly elect to take forward an antibody-based inhibitor directed against the same target.
Nektar Therapeutics Inc. President and CEO Howard Robin didn’t mince words during a call with investors after market close Feb. 23 to disclose top-line data from a phase II study testing rezpegaldesleukin (rezpeg) in systemic lupus erythematosus, which fell short of partner Eli Lilly and Co.’s criteria for advancing to phase III and raised uncertainty as to how the big pharma might proceed in other indications such as atopic dermatitis (AD).
It’s the season for reevaluation as companies weed out programs that don’t offer much promise. At the head of the line is Sanofi SA’s once-potential myasthenia gravis blockbuster tolebrutinib. A partial clinical hold on the phase III study is part of the reasoning for stopping its development. But so is competition, the company said. Other companies eliminating development programs include Roche Holding AG, Gilead Sciences Inc., AB Science SA and Merck & Co. Inc.
Mantle cell lymphoma (MCL) patients developing resistance to existing BTK inhibitors now have a new treatment option, with the U.S. FDA’s accelerated approval of Jaypirca (pirtobrutinib) from Eli Lilly and Co.’s oncology unit, Loxo@Lilly. It is indicated for use in adults with relapsed or refractory disease who have received at least two lines of systemic therapy, including a BTK inhibitor.
Eli Lilly and Co.’s complete response letter (CRL) from the U.S. FDA relating to accelerated approval of Alzheimer’s disease (AD) candidate donanemab set off a round of speculation regarding not only what the move might mean for the pharma giant but also for others in the embattled therapeutic space and beyond. The answer, if you believe analysts: not much.