A U.S. FDA advisory panel saw a number of problems in the clinical trial for the Avertd test for opioid use disorder (OUD), including the fact that the study failed to enroll a sufficiently ethnically diverse body of subjects. Perhaps more damning was that the advisory panel was uncertain as to whether the 15 single nucleotide polymorphisms (SNPs) evaluated in the test were helpful in sorting out which patients were truly at high risk of OUD, leading to an 11-2 vote that the probable benefits of the test do not outweigh the risks.
Cresilon Inc. raised $25 million in a series A-4 financing round led by Paulson Investment Co. The funds will be used to commercialize its plant-based hemostatic gel for human applications and bring it to global veterinary markets. Known as Vetigel in animal medicine, the product is used by veterinarians to instantly stop bleeding in dental and surgical procedures and emergency situations in the U.S., U.K., Europe and Canada.
Enhanc3D Genomics Ltd. has raised £10 million (US$11.3 million) in a series A round to advance development of its Genlink3D technology for directly linking gene regulators in non-coding DNA to their target protein coding genes.
Radiopharm Theranostics Ltd.’s phase II F-18 Pivalate positron emission tomography trial in brain metastases saw positive results with high uptake regardless of the origin of primary tumors, showing that Pivalate could be used to monitor brain metastases.
The White House laid out several timelines Oct. 18 as part of a national biodefense strategy for countering biological threats and enhancing global pandemic preparedness.
Australia’s TGA has opened a consultation on drug-device combination products to help sponsors understand the regulatory pathway through which their products will likely pass since these combination products may not fit within existing definitions for drugs, biologicals or medical devices.
Upheaval at the Biotechnology Innovation Organization (BIO) has resulted in a sudden leadership change. Rachel King, a longtime member of the organization’s leadership and co-founder and former CEO of Glycomimetics Inc., will serve as interim president and CEO.
Andera Partners closed its Biodiscovery 6 fund at €456 million (US$442 million). The venture capital firm will maintain its custom of allocating about two-thirds of the fund to biotechnology and one-third to medical devices and medical technology. The fund just edges past its target of €450 million. It is considerably larger than its immediate predecessor, Biodiscovery 5, which raised €345 million.
The European Commission (EC) has proposed updates to rules regarding product liability, one of which is an update to strict liability policy for pharmaceuticals (and presumably medical devices) that would expand the term of liability to 15 years. The proposal for artificial intelligence (AI) liability would up the ante on transparency into these algorithms, and the combination of the two novel policies would suggest that life science companies may face a more uniform, but potentially more hazardous legal landscape in the EU should these proposals be adopted.
The U.S. Congress has reauthorized several user fee programs at the FDA, and the agency has published the user fee levels for several product types, with most of those fees increasing significantly, an example of which is the increase for new drug applications (NDAs) requiring clinical data from $3.12 million to $3.24 million. Fees for medical device premarket approval (PMA) filings will jump from $375,000 to $442,000, including some hefty adjustments for persistent inflation, a problem that may plague the user fee schedules for fiscal 2024 as well.
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