As geopolitical tensions mount, bipartisan legislation introduced in both the U.S. Senate and the House is calling to prohibit government contracts with certain Chinese biotechs such as BGI (formerly known as Beijing Genomic Institute) and Wuxi Apptec, because they are increasingly seen as national security threats.
A heads up for the biopharma and med-tech industries: The U.S. government is going beyond warning letters to slap companies for violating the FDA’s good manufacturing practice (GMP) regulations. KVK Research Inc., a U.S.-based generic drug manufacturer, pleaded guilty March 6 to two misdemeanor counts of violating the Federal Food, Drug and Cosmetics Act by introducing adulterated drugs into interstate commerce. As part of the plea, the company agreed to pay a proposed fine and forfeiture amount of $1.5 million.
The biosimilars revolution continues with the U.S. FDA’s approval of the first denosumab biosimilars: Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz) from Sandoz Inc. for treating osteoporosis and to prevent bone problems in cancer. The approval puts up a strong challenge to Amgen Inc.’s Prolia, the first biologic for osteoporosis, and Xgeva, for bone cancer.
While members of the U.S. FDA’s Imaging Drugs Advisory Committee weren’t blown away March 5 by the trial performance of Lumicell Inc.’s Lumisight (pegulicianine) in helping breast cancer patients avoid second surgeries due to negative margins following a lumpectomy, they voted 16-2, with one abstention, that the benefits of the imaging drug outweigh its risks, even though those benefits are incremental.
Three U.S. federal government agencies announced that their focus on consolidation in health care markets may soon ramp up, given concerns that consolidation may be affecting the cost and quality of patient care.
The March 5 meeting of the U.S. FDA’s Medical Imaging Drugs Advisory Committee could be the gateway to the first approved intraoperative technology for use in breast cancer that directly examines the lumpectomy cavity for residual cancer.
With two U.S. courts rejecting constitutional challenges to Medicare drug price negotiations, every company that had a drug selected for the first round of negotiations countered Medicare’s initial offer of what it considered a maximum fair price by the March 2 deadline, according to the Biden administration.
Venture capitalists (VCs) on three different panels at Biocom California’s Global Life Science Partnering & Investor Conference gave advice to startups on a range of topics from what they’re looking for before investing to what startups should be doing to find pharma partners.
Despite what appears to be a recovering public financing market for the biopharma industry, with about $20 billion raised so far through follow-on offerings in the first two months of 2024, emerging companies remain in that precarious position between dwindling cash and their next milestone inflection points.
As Cardiff Oncology Inc. dosed the first patient in its phase II study of onvansertib (CRDF-004) in a first-line setting to treat RAS-mutated metastatic colorectal cancer (mCRC), the company also revealed positive efficacy data from its discontinued phase II of onvansertib as a second-line treatment of bevacizumab-naïve RAS-mutated mCRC.