Clinical Trials Drug Trials Regulation 
pharmaphorum
JANUARY 18, 2021
The need for diversity in clinical trial populations has been a topic of discussion across regulators and the industry in general for decades. The post A collaborative approach to greater diversity in clinical trials appeared first on.
pharmaphorum
DECEMBER 1, 2022
Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine.
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Advarra
MARCH 21, 2023
Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?
pharmaphorum
MAY 14, 2021
Kintor posted a press release at the end of April to announce that phase 3 clinical development had begun and since then it has seen its share price rise considerably on the Hong Kong stock exchange. But Reuters reported that the doctor identified as its principal clinical trial investigator has said he is not in charge of the trial.
Delveinsight
AUGUST 12, 2021
The two-year-old Canadian biotech will utilize series A to bring a lineup of SGK1 inhibitors through phase 1 clinical studies. LQTT has a portfolio of in-licensed compounds from Sanofi that prohibit serum/glucocorticoid-regulated kinase 1, or SGK1. Sage Partner and existing backers also participated.
FDA Law Blog
MAY 3, 2021
On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The “responsible party” is the sponsor or principal investigator of the trial. The notice was given to Acceleron Pharma, Inc., 42 C.F.R. §§ 11.10, 11.44(a). 42 U.S.C. §
XTalks
APRIL 26, 2021
Given the success of Oxford’s Phase II trial, the study investigators are now gearing up for a Phase III licensure trial to assess large-scale safety and efficacy in 4,800 children aged 5 to 36 months across four countries in Africa. Developing an efficacious vaccine against malaria has been a huge challenge.
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