Orphan status rescinded for remdesivir as demand surges
Gilead Sciences’ antiviral drug remdesivir - watched closely as a potential treatment for COVID-19 - has continued to make headlines over the past seven days.
At the beginning of the week Gilead said it was temporarily halting new individual compassionate-use requests for remdesivir, citing "overwhelming demand over the last several days." The company noted that it is working to streamline the emergency access process for the experimental broad-spectrum antiviral and is currently transitioning from individual compassionate-use requests to expanded access programmes. More here
On Wednesday, the FDA withdrew an orphan drug designation it had granted for remdesivir to treat COVID-19 a few days previously. The company, which had made the request, said it will waive all benefits that come with the designation, including an extra seven years of exclusivity for the medication, adding that it "recognises the urgent public health needs posed by the COVID-19 pandemic…[and is] confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir," without the special status. More here
ASCO becomes a virtual reality in response to COVID-19
The annual meeting of the American Society of Clinical Oncology (ASCO), has become the highest profile medical meeting to be affected by the COVID-19 pandemic.
The meeting, which had been due to take place in Chicago between May 29 and June 2, will be delivered in a virtual format, with abstracts also published online and in the Journal of Clinical Oncology as per usual.
Pandemic puts brake on clinical studies
Although the pharmaceutical industry should be robustly positioned in the wake of the COVID-19 pandemic, the impact of the outbreak on clinical trials has emerged as a notable pressure point for the sector. In a list that's likely to keep growing, Pfizer, Bristol Myers Squibb, Eli Lilly and Galapagos have all hit the brakes on enrolling patients in clinical studies, forcing tough decisions around drug development priorities.
Clinical development casualties include CAR-T programmes at Bristol Myers Squibb, as well as Eli Lilly's tirzepatide. More here
Chloroquine gets ringing endorsement
Early results to test the re-purposed anti-malarial chloroquine in COVID-19 patients have had mixed results- which didn't stop US President Donald Trump from declaring the treatment regimen a victory.
The positive commentary quickly motivated biopharma companies to donate their own supplies of the antiviral to the global cause. But the effort failed to overcome stocking piling and shortages of the medicine, with India adding chloroquine and hydroxychloroquine to its do-not-export list, and the White House stepping in to prevent hoarding.
FirstWord discusses COVID-19 treatment options with an expert here.
Bristol Myers Squibb vindication for ozanimod
Bristol Myers Squibb scored an approval where Celgene had failed, winning the FDA's sign-off on multiple sclerosis (MS) treatment Zeposia (ozanimod). The approval marks the latest success for the newly combined entity in executing on Celgene's late stage pipeline- while also easing concerns over the FDA's review capacity in the wake of COVID-19.
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