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…
Biopharma Update on the Novel Coronavirus: April 2
FDA Actions FDA-ARGO SARS-CoV-2 Reference Grade Sequencing Data: The FDA has partnered with Centers for Disease Control and Prevention (CDC), the Biodefense and Emerging Infections Research Resources Repository (BEI Resources) and the Institute for Genome Sciences at the University…
If it comes to rationing, I shouldn’t have to be the one deciding who should live and who should die
Medical school didn’t teach me how to decide which of my patients should live and which should die if it becomes rationing of medical equipment or treatment becomes necessary. But I’ve spent most of my time recently planning for the…
Covid-19 spreads too fast for traditional contact tracing. New digital tools could help
Every strategy for releasing Covid-19’s vise-grip on daily life starts with identifying cases and tracing their contacts — the laborious task of public health workers tracking down people who have crossed paths with a newly diagnosed patient, so they can…
J&J and US government invest $1 billion in COVID-19 vaccine
Johnson & Johnson has announced plans to team up with the US government to invest more than $1 billion in a new vaccine against COVID-19, aiming to begin clinical trials by September. Medical devices giant Abbott has also helped the…
