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A proposal hammered out by the EU, India, South Africa and the U.S. to allow IP waivers for COVID-19 vaccines is headed to all members of the World Trade Organization (WTO) for consideration.
A lack of funding for combination therapies in the U.K. could hold back investment in the country’s biopharma sector – but there are moves afoot to find ways around the issue, pinned by industry on the way the National Institute for Health and Care Excellence (NICE) assesses the value of drugs.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cathvision.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Acrotech, Bayer, Belite, Cellics, Depymed, Idorsia, Exelixis, Petros, Regeneron, Sapience, Taysha.
Isono Health Inc. received FDA clearance for its Automated Three-dimensional Ultrasound with Artificial intelligence (ATUSA) system for breast imaging, a wearable, compact automated whole breast ultrasound system that can acquire high-quality images without requiring a skilled operator. The ultrasound scan takes two minutes to scan the entire breast volume and offers 3D visualization of the breast tissue.
A quartet of companies on May 2 announced three complete response letters (CRLs) that left them scrambling to get back on the path to approval. Hutchmed Ltd.'s surufatinib met with word from the U.S. FDA that two positive phase III studies in China and a bridging study in the U.S. would not support approval of the drug for pancreatic and extra-pancreatic neuroendocrine tumors. A multi-regional clinical trial in the U.S. is needed, the regulator said, brushing aside China-only studies when seeking a U.S. approval.
Australia’s Therapeutic Goods Administration will begin conducting routine risk-based good clinical practices (GCP) inspections for clinical trials of drugs and biologics. The agency outlined in final guidance how it would prioritize inspections, what the process would look like and how it would report and follow up on inspections.
Not satisfied with the findings of a World Trade Organization (WTO) dispute panel, Turkey informed the WTO April 28 that it has initiated arbitration proceedings to review those findings, which involve an EU complaint about measures Turkey employs concerning the production, importation and marketing of prescription drugs.
China’s National Medical Products Administration (NMPA) gave the green light to Pfizer Inc.’s third-generation anaplastic lymphoma kinase (ALK) inhibitor, Lorbrena (lorlatinib), for patients with ALK-positive advanced non-small-cell lung cancer (NSCLC).
In launching the European Health Data Space May 3, the European Commission (EC) heralded it as “a fundamental game-changer for the digital transformation of health care in the EU.”
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