GigaGen is developing a recombinant polyclonal antibody therapy (rCIG) to treat COVID-19. First uses are envisioned as treatments for severely ill coronavirus patients and individuals at high risk of contracting the disease, including healthcare professionals. “We are working toward an…
FDA greenlights expanded remote patient monitoring to keep patients out of coronavirus-slammed hospitals
Dive Brief: FDA on Friday issued a policy to facilitate greater use of remote patient monitoring technologies to cut back on hospital visits and thereby minimize risk of exposure to COVID-19 while also reducing the burden on providers during the current…
Dyson receives government ventilator order; Airbus, UK-based constructors in Formula One expects go-ahead
BBC News reports that the firm has designed a new ventilator which still needs to get regulatory clearance and is set to be built at its plant in Wiltshire. Dyson is working with Cambridge-based The Technology Partnership. The Guardian has…
EU regulators to propose 1-year MDR delay
Dive Brief: The European Commission is working on a proposal to delay enforcement of the EU Medical Device Regulation by one year, a spokesperson saidWednesday. Policymakers are aiming to submit the proposal in early April, and are imploring the European…
Medtech industry asks for FEMA’s help allocating ventilators to frontlines
Dive Brief: As ventilator manufacturers scale up production across the U.S. to address a critical need for the breathing machines, AdvaMed on Tuesday sent a letter to the Federal Emergency Management Agency asking for designation of a single agency to…
Following Outcry, Gilead Sciences Seeks to Rescind Orphan Drug Designation for COVID-19 Drug
A day after it was announced remdesivir had received Orphan Drug designation for treatment of COVID-19 from the U.S. Food and Drug Administration, Gilead Sciences submitted a request for the regulatory agency to rescind that offer after an outcry was raised…
Avadel Pharmaceuticals Completes the REST-ON Phase 3 Pivotal Trial of FT218 for Excessive Daytime Sleepiness and Cataplexy in Patients with NarcolepsyTopline data from the REST-ON study expected in Q2 2020
DUBLIN, Ireland, March 25, 2020 (GLOBE NEWSWIRE) — Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today…
Novavax Shares Spike After Successful Late-Stage NanoFlu Vaccine Trial
Gaithersburg, Maryland-based Novavax announced positive topline data from its pivotal Phase III clinical trial of NanoFlu, its seasonal flu vaccine. The primary objectives were non-inferior immunogenicity of NanoFlu compared to Sanofi’s Fluzone Quadrivalent based on several 28-day metrics. Company shares…
Gilead halts ‘compassionate use’ of potential coronavirus drug
Gilead has said it has stopped accepting “compassionate use” requests for its potential coronavirus antiviral remdesivir because it cannot keep pace with demand as health systems become overwhelmed. Remdesivir is seen as the best hope in the fight against the…
Pharma steps up as coronavirus cases soar to 400,000-plus
With the coronavirus pandemic gathering momentum outside China, AstraZeneca has said it will donate 9 million face masks to healthcare workers around the world. The first shipments of the face masks are already en route to Italy, according to AZ,…
