The pressure on U.S. drug prices continues, with the CMS lining up the drugs for round 3 of negotiations, which will set maximum fair prices to go into effect in 2028. The slate includes 15 drugs and, for the first time, opens the negotiations to Part B drugs, as well as Part D. Consequently, seven of the 15 selected drugs are biologics.
Nader Pourhassan, the former president and CEO of Cytodyn Inc., was sentenced Jan. 23 to 30 months in prison for his role in a securities fraud scheme to deceive investors about the Vancouver, Wash.-based company’s development of leronlimab as a treatment for HIV and COVID-19.
Although the American Academy of Pediatrics has been releasing guidances on vaccines for decades, the 2026 immunization schedule it issued Jan. 26 is creating some buzz given the U.S. CDC’s newly abbreviated childhood schedule that removed several routine recommendations.
Following a clinical hold last October of Intellia Therapeutics Inc.’s Magnitude and Magnitude-2 phase III trials of CRISPR/Cas9 gene editing therapy nexiguran ziclumeran (nex-z) to treat transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and polyneuropathy (ATTR-PN), respectively, the U.S. FDA lifted the hold on Magnitude-2, pushing the company’s shares up by 22% in early trading Jan. 27.
Cardiff Oncology Inc. welcomed Mani Mohindru as interim CEO and simultaneously provided what the company dubbed a “positive” but stock-denting clinical update. The firm rolled out data from the 113-patient phase II trial called CRDF-004, designed to test the oral Polo-like kinase 1 (PLK1) inhibitor onvansertib in first-line, RAS-mutated metastatic colorectal cancer (mCRC). Shares (NASDAQ:CRDF) closed Jan. 27 at $2, down 94 cents, or 32%, as Wall Street took in the results.
1st Biotherapeutics Inc. announced the closing of a ₩31.7 billion series D funding round Jan. 26 to advance its lead phase I oncology asset, FB-849, and portfolio of candidates for neurodegenerative diseases.
After the U.S. House passed a package of spending bills Jan. 22 to fund several agencies and departments, including Health and Human Services, through fiscal 2026, the Senate was expected to quickly follow suit to ensure that no part of the federal government would shut down when the current continuing resolution expires Jan. 30. That was before a confrontation with Immigration and Customs Enforcement in Minnesota turned deadly over the weekend.
Despite pressure on drug pricing, an ongoing threat of tariffs and rising geopolitical tension, the outlook for dealmaking in 2026 is strong. Balanced against the fog of uncertainty, which the industry is navigating, is the stark reality of the coming patent cliff and the fact that the big pharma companies have access to $1.619 trillion with which to replenish their pipelines.
In a lawsuit that’s been bouncing through the courts for years, the U.S. Court of Appeals for the District of Columbia once again cleared the way for several biopharma and medical device companies to potentially be held liable, under the Anti-Terrorism Act, for terrorist attacks against hundreds of Americans in Iraq.
After a roller coaster of a year for Duchenne muscular dystrophy (DMD) gene therapy Elevidys (delandistrogene moxeparvovec), Sarepta Therapeutics Inc. looks to focus on the efficacy narrative in 2026, starting with newly unveiled three-year data showing durable efficacy across all key motor function assessments for treated DMD patients vs. external controls.
RSS
