Jaime Gavazzi

Investigational drug takes advantage of an accelerated review process for oncology treatments

In July 2023, Australia became the first country to permit psychiatrists to prescribe 3,4-methylenedioxymethamphetamine (MDMA) and psilocybin for use in psychedelic-assisted psychotherapy to treat certain mental health conditions (MDMA for post-traumatic stress disorder [PTSD] and psilocybin for treatment-resistant depression [TRD]). This change in regulation directly followed an action taken by the US Food and Drug Administration (FDA) that could accelerate similar changes in the US. It also… Show more

In July 2023, Australia became the first country to permit psychiatrists to prescribe 3,4-methylenedioxymethamphetamine (MDMA) and psilocybin for use in psychedelic-assisted psychotherapy to treat certain mental health conditions (MDMA for post-traumatic stress disorder [PTSD] and psilocybin for treatment-resistant depression [TRD]). This change in regulation directly followed an action taken by the US Food and Drug Administration (FDA) that could accelerate similar changes in the US. It also came on the heels of positive published results from a clinical program evaluating MDMA as a treatment for PTSD that is close to seeking regulatory action. Show less

The Liver Meeting—the American Association for the Study of Liver Diseases (AASLD) 2022 annual meeting—returned to in-person attendance for the first time in 2 years since the COVID-19 public health emergency began and included a virtual option. Comprised of scientists and healthcare professionals, AASLD is the leading organization committed to preventing and curing liver disease. The “hottest meeting in hepatology,” according to the AASLD, included plenary sessions, presentations and over… Show more

The Liver Meeting—the American Association for the Study of Liver Diseases (AASLD) 2022 annual meeting—returned to in-person attendance for the first time in 2 years since the COVID-19 public health emergency began and included a virtual option. Comprised of scientists and healthcare professionals, AASLD is the leading organization committed to preventing and curing liver disease. The “hottest meeting in hepatology,” according to the AASLD, included plenary sessions, presentations and over 4,800 scientific abstracts highlighting the latest scientific advancements in the field of hepatology. Research and clinical trial updates were provided in many specific liver disease areas, including hepatitis, fibrosis, nonalcoholic fatty liver disease, cirrhosis, nonalcoholic steatohepatitis, transplantation, and so on. Along with groundbreaking research in hepatology, many presentations included the impact of COVID-19 on patients with these diseases. This report highlights a selection of presentations about treatment updates provided during the conference. Show less

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The 2022 American Academy of Neurology (AAN) annual meeting returned to in-person attendance for the first time in 2 years since the COVID-19 public health emergency began. AAN is the largest association of neurologists and neuroscience professionals with over 38,000 members. This meeting included plenary sessions and over 2,400 scientific abstracts highlighting the latest scientific advancements in brain disease. Research and clinical trial updates were provided in many specific disease areas,… Show more

The 2022 American Academy of Neurology (AAN) annual meeting returned to in-person attendance for the first time in 2 years since the COVID-19 public health emergency began. AAN is the largest association of neurologists and neuroscience professionals with over 38,000 members. This meeting included plenary sessions and over 2,400 scientific abstracts highlighting the latest scientific advancements in brain disease. Research and clinical trial updates were provided in many specific disease areas, including Parkinson's, Huntington's, amyotrophic lateral sclerosis, migraine, multiple sclerosis, epilepsy, narcolepsy, Alzheimer's, and so on. Along with groundbreaking research in neurology, many presentations included the impact of COVID-19 on patients with these diseases and ongoing neurology clinical trials. This report highlights a selection of presentations about treatment updates provided during the conference. Show less

The 40th Annual J.P. Morgan Healthcare Conference was conducted as a virtual conference for the second consecutive year due to the COVID-19 pandemic. Being the largest investment symposium in the healthcare industry, the conference brought together thousands of investors around the globe and hundreds of companies from the whole global healthcare landscape, that includes pharmaceutical companies, medical device firms, healthcare service providers, and profit and not-for-profit organizations… Show more

The 40th Annual J.P. Morgan Healthcare Conference was conducted as a virtual conference for the second consecutive year due to the COVID-19 pandemic. Being the largest investment symposium in the healthcare industry, the conference brought together thousands of investors around the globe and hundreds of companies from the whole global healthcare landscape, that includes pharmaceutical companies, medical device firms, healthcare service providers, and profit and not-for-profit organizations. This report covers a selection of company presentations given over the duration of the conference. Show less

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The 21st World Vaccine Congress, held on May 4-6, 2021, virtually, was organized by Terrapinn and engaged academia, researchers, technology companies, pharmaceutical executives, scientists and military personnel in a 3-day discussion about the current state of global vaccine development. COVID-19 largely dominated panel discussions and presentations, comprising the majority of sessions. The meeting opened with the conference chair, Gregory Poland (Mayo Clinic), and subsequent presentations… Show more

The 21st World Vaccine Congress, held on May 4-6, 2021, virtually, was organized by Terrapinn and engaged academia, researchers, technology companies, pharmaceutical executives, scientists and military personnel in a 3-day discussion about the current state of global vaccine development. COVID-19 largely dominated panel discussions and presentations, comprising the majority of sessions. The meeting opened with the conference chair, Gregory Poland (Mayo Clinic), and subsequent presentations outlined ongoing clinical studies for vaccines to prevent COVID-19, including emerging technologies that could change the landscape of vaccine administration and the efficacy of vaccines against variants of concern. In addition to COVID-19, presenters offered results from studies of cancer vaccines for melanoma, human papillomavirus and glioblastoma and an update on a Food and Drug Administration-approved cholera vaccine under evaluation for use in pediatric patients. The entirety of day 3 consisted of panel discussions about COVID-19 vaccines for pediatric patients, tackling future pandemics, the threat of misinformation in a public health emergency, and the use of databases to streamline COVID-19 efforts. Dr. Poland provided take-home remarks that emphasized the need for preparedness and said, "While COVID-19 was a surprise, it should not have been a shock. We have been warned many times in many ways." He concluded that, moving forward, 2 significant cultural problems remain: "scientific illiteracy and the false notion of the democratization of expertise." Show less

The efforts to end the COVID-19 pandemic have been multifaceted: epidemiological data for understanding, vaccines and non-pharmaceutical interventions for prevention, and new or repurposed drugs for treatment. In this blog post, Monia Tumminello, Manager, Cortellis Regulatory Intelligence™, and Jaime Polychrones, Medical Writer, Cortellis Regulatory Intelligence, discuss the regulatory response to therapeutic development, from issuing new guidance to fast track and conditional approvals.

While it may seem like the whole world is on pause due to COVID-19, clinical trials in the U.S. can continue with adjustments to conditions or protocols while still adhering to regulations and ensuring patient safety.

As SARS-CoV2 continues to spread, resulting in Coronavirus Disease 2019 (COVID-19) in patients, we examine FDA guidance on in vitro diagnostic testing and respirator use in healthcare settings and highlight current trials for treatment and vaccines.