Disagreement over offsets for an additional $15.6 billion in COVID-19 funding forced the supplemental pandemic funds recently requested by the White House to be cut from the fiscal 2022 spending bill, so the U.S. House would have the votes to pass the $1.5 trillion omnibus spending package late March 9.
An analysis of brain scans of participants in the UK Biobank has shown there are significant differences between the condition of the brain before and after mild COVID-19 infection. These included a reduction in overall brain size, reduction in grey matter thickness in the orbitofrontal cortex and hippocampal gyrus, and changes in markers of tissue damage in regions functionally connected to the primary olfactory cortex. Infected participants also showed, on average, a larger cognitive decline than participants who had not contracted COVID-19.
If the U.S. SEC goes forward with amendments it proposed March 9 to enhance and standardize cybersecurity-related disclosures, public biopharma and med-tech companies will have more reporting to do.
New legislation providing a tax incentive for Australian medical innovations was introduced in Australia’s House of Representatives, and industry stakeholders are lauding the move. The measure, providing a special tax regime on income derived from patents, a “patent box,” will apply for income years beginning on or after July 1.
The indirect impact of the Russian invasion of Ukraine on the life sciences sector continues to grow, as the West responds with more and more sanctions against Russia. In one of the latest moves, the European Commission announced March 4 that it is suspending cooperation with Russian entities in research, science and innovation.
The world’s largest genomics study in patients with life-threatening COVID-19 infections has uncovered 16 new genetic variants associated with severe disease and drawn up a roadmap for research into new therapies and diagnostics. The research involved comparing the complete genome sequences of 7,491 patients admitted to 224 intensive care units in the U.K. against those of 48,400 participants in Genomics England’s 100,000 Genomes project, and of a further 1,630 people who had mild COVID-19. While some of the gene variants found in the Genomicc study affect the function of a protein, others influence the amount of the protein that is expressed. An example is mucin-1, where overexpression led to worse outcomes.
The U.S. FDA does not have legal authority to impose recalls on most regulated products, making the March 3 final guidance for voluntary recalls a key policy declaration for industry. The guidance recommends that recalling firms make extensive use of electronic communication to announce a recall, but the referenced FDA guidance for electronic communications was finalized in 2006 and makes no reference to social media as an electronic conduit for recall information.
LONDON – The European Commission (EC) has put forward proposals for a Data Act that is intended to both give users greater rights over their own data and allow greater third-party access. The Act sets out who can use and access data generated in the EU across all sectors of the economy. It is pitched by the EC as opening the doors to an under-used resource that will in turn promote research and innovation and create new markets in information services.
New drug and device regulations going into effect in Canada are serving as a reminder of the extended life of the COVID-19 pandemic. After two years of interim orders regulating the importation and sale of drugs and devices for COVID-19 clinical trials and the conduct of those trials, Canada is issuing long-term regulations that will incorporate most of the provisions of the temporary orders.
The U.S. Patent Trial and Appeal Board’s (PTAB) decision Feb. 28 that Broad Institute scientists were the first to invent the use of CRISPR/Cas9 genome editing in eukaryotic cells is just another chapter in the ongoing saga of who has patent rights to various elements of the CRISPR platform.