In the final days of the Biden administration, the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (CMS) laid out the latest 15 drugs that are subject to negotiated prices, with Novo Nordisk A/S’ GLP-1 drug, Ozempic, for type 2 diabetes at the top of the list, bringing Rybelsus and Wegovy along for the ride because they share the same active pharmaceutical ingredient, semaglutide. The three products – counted as one for the purposes of the negotiation – cost Medicare Part D $14.4 billion over a recent 12-month period, with 2.29 million Medicare enrollees using the drugs. Asthma and chronic obstructive pulmonary disease drug Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), from GSK plc, was the second highest cost drug chosen, followed by Pfizer Inc./Astellas Pharma Inc.’s Xtandi (prostate cancer), and Bristol Myers Squibb Co.’s Pomalyst (multiple myeloma), all of which grossed more than $2 billion in Medicare spend this past year.

EMA investigating potential semaglutide link to eye disease

The EMA has started a review of Novo Nordisk A/S’ GLP-1 receptor agonist, semaglutide, after the Danish regulatory agency raised the possibility it causes an increased risk of suffering from an acute eye condition. After the first report in July 2024, the Danish regulator had received, by Dec. 10, 2024, a total of 19 reports of non-arteric anterior ischemic neuropathy (NAION), a rare condition that affects the small blood vessels at the front of the optic nerve.

What will it take to change obesity guidelines?

It’s one thing for the scientific community to propose a fundamental change to the way obesity is defined and diagnosed. But it’s another for that proposal to be adopted by regulators, especially when the current definition that relies primarily on the body mass index is entrenched in guidance and obesity drug development and approval. While the scientific and clinical community is looking at an approach that sees obesity as a health risk in some instances and a disease in others, it could take years for regulators to switch gears.

China gives nod to Innovent’s limertinib NDA for lung cancer

China’s National Medical Products Administration has given the green light to Innovent Biologics, Inc.’s and Jiangsu Aosaikang Pharmaceutical Co. Ltd.’s NDA for third-generation EGFR tyrosine kinase inhibitor limertinib, for treating adults with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer. In October 2024, originator company, Jiangsu Aosaikang Pharmaceutical Co. Ltd. out-licensed limertinib to Innovent to commercialize the TKI in mainland China. Limertinib is the 14th product in Innovent's commercial portfolio and represents a cutting-edge addition to its strong TKI franchise.

Huntington’s neurodegeneration starts at 150 repeat expansions

Having 35 copies of the CAG triplet in the gene that causes Huntington’s disease is not a problem. Inheriting 40 could be a sign that goes unnoticed for decades, until reaching 80. From there, the process accelerates and neural death occurs when reaching 150 repeats. Huntington’s disease neurodegeneration is not determined by what, but by how much, according to a study conducted at the Broad Institute.

US HHS awards Shionogi $375M to develop COVID-19 PrEP therapy

Shionogi & Co. Ltd. won a $375 million project agreement from the Rapid Response Partnership Vehicle (RRPV) to develop its 3CL protease inhibitor, S-892216, as a long-acting injectable for COVID-19 pre-exposure prophylaxis. The RRPV is a consortium funded by the U.S. Biomedical Advanced Research and Development Authority (BARDA), which is part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. S-892216 is an investigational second-generation 3CL protease inhibitor in development as a long-acting injectable for prophylaxis treatment of SARS-CoV-2.

Holiday notice

BioWorld's offices will be closed in observance of Martin Luther King Jr. Day in the U.S. No issue will be published Monday, Jan. 20.

The BioWorld Insider podcast: a year of interviews and insights

The BioWorld Insider podcast is a monthly dive into the business and science of drug development. Conversations with CEOs and BioWorld analysts in the past 12 months have included a wide range of chats with experts who are shaping the future. Subjects included quarterly reviews for M&As and financings, the slow but steady growth of funding and partnering for therapies to treat women, the impact of artificial intelligence and quantum computing on drug development, rare disease drug development, the costs of delays in clinical trials, and an overview of the one of the year’s biggest conferences, the annual American Society of Clinical Oncology gathering in Chicago.

2024 BioWorld Year in Review

BioWorld’s staff recaps the therapeutic trends and breakthroughs of 2024, the economic highs and lows facing the industry throughout the past year and the regulatory actions that are likely to have implications as biopharma forges ahead in 2025.

2024 BioWorld MedTech Year in Review

BioWorld MedTech’s staff recaps the med-tech and diagnostic trends and breakthroughs of 2024, the economic highs and lows facing the industry throughout the past year and the regulatory actions that are likely to have implications as med tech forges ahead in 2025.

2024 BioWorld Science Year in Review

Taking a look back at the achievements in research this year, including brain maps, pandemic breakthroughs and advances in pregnancy health.

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