Covid-19 roundup: CDER ponders a move to virtual adcomms; conservative group urges easier access to hydroxychloroquine
It’s all hands on the virtual deck at the FDA. And the folks at CDER are considering setting up a new online approach to holding adcomm meetings going forward.
Mark Senak, who writes the Eye on FDA blog, posed a series of questions for CDER, including one on adcomms, which are being interrupted as the coronavirus pandemic spreads in the US and around the globe.
As of now, the FDA is canceling all non-essential meetings at the agency, including the adcomms, through April. But CDER does see a possible opportunity for going virtual — a big deal in an industry that relies on these meetings to keep its R&D strategy intact.
Here’s the exchange between Senak and CDER on the adcomms:
Does FDA plan on attempting virtual advisory committee meetings?
As this remains a dynamic situation, we will continue to assess and calibrate our approach. Where possible the agency will leverage technology to host meetings allowing for remote participation. We thank you for your patience. In considering necessary steps for protecting public health, including our sponsors, our committee members and our workforce, we are cancelling or postponing all non-essential meetings through the month of April. We will reassess on an on-going basis for future months. Where possible the agency will leverage technology to host meetings allowing for remote participation.
→ A conservative group called the Job Creators Network — which includes Home Depot co-founder Bernard Marcus as a key backer — is calling on President Trump to clear away the “red tape” and make hydroxychloroquine more easily available.
The drug is frequently cited by Trump as a possible short-term panacea for the Covid-19 outbreak. It’s also uncertain whether it will help at all or cause more damage than good — something that is being tested in a clinical program now. In the meantime, it’s become one of the most popular drugs available, making supplies scarce. And that’s what the group wants Trump to fix.
“We’re not advocating that people should take the drug,” a spokesperson told the Wall Street Journal. “We’re advocating that doctors should have the opportunity to prescribe it if they want to do so. The problem is no one can find it. It’s a supply-side issue.”
→ British Prime Minister Boris Johnson has tested positive for coronavirus — on Wednesday, he addressed Members of Parliament in the House of Commons.
Over the last 24 hours I have developed mild symptoms and tested positive for coronavirus.
I am now self-isolating, but I will continue to lead the government’s response via video-conference as we fight this virus.
— Boris Johnson #StayHomeSaveLives (@BorisJohnson) March 27, 2020
→Another set of drug developers have thrown their hat into the anti-Covid-19 ring. In addition to programs from Moderna, which is allied with the NIH — and BioNTech, as well as CureVac — Sanofi is also working on an mRNA vaccine approach with Translate Bio, in addition to its previously unveiled traditional vaccine program. (Endpoints Link)
Hep B vaccine maker Dynavax is also working on a vaccine, in collaboration with the University of Queensland as part of a Coalition for Epidemic Preparedness (CEPI) initiative.
→ Existing diagnostic tests bank on PCR technology, which is engineered to hone in on the virus’ RNA genome. However, if the person recovers from the coronavirus infection, that evidence disappears. However, antibody tests — which rely on blood instead of nasal or throat swabs — are expected to reveal who has had the infection but was asymptomatic and has recovered. Once collected, this information will reveal the full scope of the pandemic and inform containment strategies across the globe. It will also help researchers working on plasma therapies, which require blood from survivors.
New York-based Henry Schein on Thursday said it was making available an antibody test (greenlit by the FDA under emergency guidance), which delivers results within 15 minutes from a pinprick with no instrumentation required. The company expects to have at least several hundred thousand tests available by March 30 and significantly increased availability beginning in April, it said.
Meanwhile, the United Kingdom is working on its own antibody tests; scientists in Singapore have used to trace chains of transmission, and the CDC reportedly has plans for its own.
→ Ironwood Pharma, which sells the bowel drug Linzess with partner Allergan, said the pandemic is impacting enrollment in its late-stage gastroesophageal reflux disease trial. Nearly 70% of the enrollment target has been hit, but the company no longer expects to report top-line data in the second half of 2020.
→ A glove shortage is reportedly looming, as Malaysia — the country that dominates production — reels from staff cuts in plants as a result of a lockdown in the region.
→ The US military, according to Reuters, plans to stop disclosing some of the more “granular data” about infections within its ranks, fearing the information may be used by adversaries.
For a look at all Endpoints News coronavirus stories, check out our special news channel.