Anti-infective drugs approved over the last two decades were able to get through the clinical development and FDA approval processes substantially faster than other drugs, according to a new report from the Tufts Center for the Study of Drug Development.
Antibody-drug conjugates (ADCs) are making a comeback. After a relatively slow start with Adcetris (brentuximab vedotin, Seattle Genetics Inc.) and Kadcyla (ado-trastuzumab emtansine, Roche Holding AG) approved by the FDA in 2011 and 2013, respectively, the regulatory activity has swelled with four FDA approvals over the last nine months.
Academic tech transfer offices are largely still working from home, but the groups have been as busy as ever according to a report from Primary Research Group Inc. that surveyed 37 colleges and universities.
Much of the research on the immune response in patients with COVID-19 has focused on the humoral antibody response. Adaptive Biotechnologies Corp., on the other hand, has focused on cellular immunity to measure the T-cell response to infection with SARS-CoV-2.
Sangamo Therapeutics Inc. continued its collaboration spree, signing up its sixth big pharma/biotech partner: Novartis AG. The three-target deal will use Sangamo's zinc finger protein transcription factors to up-regulate undisclosed genes to treat autism spectrum disorder and other neurodevelopmental disorders.
The number of clinical trials initiated each year has continued to grow every year over the last decade, sans a slight decrease in 2013, according to data presented in a webcast facilitated by Applied Clinical Trials.
In case you haven't heard, Tessera Therapeutics Inc. is working on techniques to write genes into the genome of patients. Tessera, which was developed in Flagship Pioneering Inc.'s Flagship Labs and became a stand-alone incorporated company two years ago, recently came out of stealth mode to highlight its Gene Writing platform based on mobile genetic elements, such as transposons and retrotransposons.
Multiple sessions at the American Association for Cancer Research Virtual Annual Meeting II covered how COVID-19 is affecting cancer patients, from how clinical trials needed to be modified during the pandemic to how real-world evidence can play a role now and in the future.
At a session of the American Association for Cancer Research Virtual Annual Meeting II, multiple FDA regulators gave presentations on various topics to help drug companies understand the ever-evolving oncology regulation.
