It’s been one thing after another for rusfertide from Protagonist Therapeutics Inc. for the past year. Now the U.S. FDA has told the company it wants to rescind the breakthrough designation, a relatively rare occurrence, based on observed malignancies in a follow-up to September’s clinical hold.
The U.K.’s drugs regulator has approved the COVID-19 vaccine from Valneva SE – although the shot is likely only to be offered to health workers in Scotland after the Westminster government rejected it because rivals beat it to market.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affamed, Atyr, Biogen, Boehringer, Briacell, Direct, Eli Lilly, Novavax, Recbio.
Clinicians are still at liberty to use medical products outside the labeled indication for use, but the U.S. FDA believes radiologists may be unaware of the limitations of radiological computer-aided triage and notification (CADt) software for intracranial large-vessel occlusion (LVOs). The agency advised clinicians that these programs are not intended for use as a substitute for radiologist review of images, but instead should be used only to flag suspect images as part of an effort to triage these patients.
Pharma CEOs have pushed back strongly against intellectual property (IP) waivers for COVID-19 vaccines and therapies, saying that pricing is not the reason why middle- and low-income countries have not received pharmaceutical countermeasures against the pandemic. Senior execs from Pfizer Inc., Eli Lilly and Co., and Roche Holding AG, also expressed concerns about the latest funding package from the U.S. government, which at $10 billion is less than half that originally requested by the White House.
The German Medical Technology Association, BVMed, and the French medical technology industries association, SNITEM, have issued a joint warning highlighting the risk of collapse in patient care throughout the EU.
As part of a series of guidances addressing clinical trial diversity, the U.S. FDA issued a draft guidance April 13 focused on improving enrollment of participants from underrepresented racial and ethnic populations.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeglea, Affamed, Bharat Biotech, Biocardia, Blue Earth, Fera, Gilead, Henlius, Medilink, Myovant, Ocugen, Paradigm, Poxel, Secura, Vistagen, Xortx.
Boston Scientific Corp.’s image-guided programming software, Vercise Neural Navigator with Stimview XT, got the green light from the FDA for use with the company’s deep brain stimulation (DBS) portfolio in patients with essential tremor or Parkinson’s disease. The software, developed in a collaboration with Brainlab AG, provides more sophisticated image-guided programming tools for personalization of the stimulation therapy, halving the time needed for adjustments and increasing precision.
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