Novotech has been engaged by Revive Therapeutics Ltd, a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, to pursue human clinical trials for Bucillamine in the treatment of infectious diseases, including…
FDA relaxes infusion pumps and thermometers guidelines
The Food and Drug Administration (FDA) has released relaxed guidelines for infusion pumps and clinical thermometers due to the COVID-19 pandemic. The relaxed guidance hopes to increase the availability of these devices which are currently in high demand, and adds…
Iceland’s Sidekick produces national COVID-19 patient tracker
The Iceland-based digital health company Sidekick has adapted its technology to provide remote monitoring, triage and support for COVID-19 patients with the help of the Reykjavik-based computer games firm CCP. Sidekick is providing the country’s emergency management authorities with a…
GSK to collaborate with Chinese biotech on COVID-19 vaccine
GlaxoSmithKline has announced plans to collaborate with China’s Xiamen Innovex on a potential vaccine to treat the COVID-19 coronavirus. The companies are testing a recombinant protein-based coronavirus vaccine candidate, known as COVID-19 XWG-03, which is being developed by Innovax with…
Servier to acquire Danish cancer biotech Symphogen
France’s Servier has signed a deal to buy the Danish biotech Symphogen, which specialises in antibody-based therapies for cancer. Neither party disclosed financial details of the deal, which involves a straight transaction where Servier will buy all of the Copenhagen-based…
COVID-19 patient registry could inform lockdown exit strategy
Recruitment for a patient registry app for COVID-19 is underway, which could help governments find their way out of lockdown by remote monitoring of symptomatic and asymptomatic patients following diagnosis. Digital research company ObvioHealth has launched the Obvio-19 platform, which…
EMA won’t clear chloroquine for COVID-19 without trial data
The European drugs regulator has stopped short of granting widespread use of the drug chloroquine against COVID-19, days after the FDA said it could be used under emergency measures to fight the outbreak. An unproven medicine against COVID-19, chloroquine and…
Fate Therapeutics Strikes Multi-Billion Dollar Cell Therapy Deal with Janssen
Fate Therapeutics, the company announced a multi-billion dollar deal with Janssen Biotech to develop cell therapies for the treatment of cancer. The partnership will leverage San Diego-based Fate Therapeutics’ induced pluripotent stem cell (iPSC) product platform and Janssen’s proprietary tumor-targeting…
COVID-19 outbreak triggers regulatory interventions in Indo-Pacific region
The alarming worldwide diffusion of COVID-19 has inspired numerous governments to intervene to counter the spread of the disease. For their part, regulatory bodies that govern medical devices have taken steps to ease import restrictions and expedite registration processes for needed…
Global Regulatory & Consumer Insights (GR-CIS) providing Regulatory affair services and Expertise for Potential COVID-19 Treatments,Vaccines and Diagnostics
By GR-CIS | April 03, 2020 – GR-CIS, a scientifically backed Regulatory service organization actively advise stakeholders on potentials COVID-19 vaccines and treatment studies. The organization has also taken significant steps over the past few months to ensure that the…
