IT & Data Management
Cyclerion Provides Information On Schizophrenia Treatment
Positive top-line statistics from Cyclerion Therapeutics' clinical investigation of CY6463 for the treatment of cognitive impairment associated with schizophrenia have been released. It concerns people with stable schizophrenia who are taking a stable dose of a single atypical antipsychotic...
Clinical Trials
Tallac Reveal They Have Served Their First TAC-001 Patient
In a phase 1/2 clinical trial for patients with locally advanced or metastatic solid tumours, Tallac Therapeutics has reported that the first patient has received treatment with TAC-001. TAC-001 is the first clinical candidate from the company's innovative toll-like...
Drug Research
September May Bring Updated COVID-19 Booster Shots To Market
According to the US Department of Health and Human Services, booster shots from Moderna and Pfizer that have been upgraded to target Omicron coronavirus subvariants may be made accessible in the early fall, subject to approval by federal health...
Drug Research
Zoryve Cream By Arcutis Receives FDA Approval For Psoriasis
Pfizer previously held out hope that Eucrisa would become the trendiest topical treatment for inflammatory skin conditions. However, the ointment never took off because of adverse reactions and funding problems. Arcutis Biotherapeutics, a young biotech company, is now introducing...
Drug Research
Issues With Accelerated Approval Remain A Problem For FDA
The use of excessively fragile efficacy data and delays in sponsors' presenting living proof from post-approval trials, as well as the approval of some crucial drugs based on preliminary clinical evidence, continue to be controversial issues. Under the programme,...
Drug Research
The Ratio of NA To NAM As A Test For Cell Therapy Sterility
According to research, the ratio of nicotinic acid (NA) to nicotinamide (NAM) considerably rises when living microorganisms are present inside 24 hours. This ratio can be used as a biomarker to identify microbial contamination in cell therapies at an...
IT & Data Management
Regulators Agree To Work Together On The Unification of RWE
Real-world evidence (RWE) should be included in regulatory decision-making, according to a declaration backed by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The International Coalition of Medicines Regulatory Authorities (ICMRA) released a...
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