Topic
Infectious disease: latest medical news
Outbreaks, vaccines, antivirals and global health.
FDA Approves First-of-Its-Kind Chronic Hepatitis B Treatment
Source: FDA
FDA approved Hibsago (bepirovirsen) injection, in combination with existing antiviral therapy, to treat chronic hepatitis B virus infection in certain adults without cirrhosis. BioPharma Dive reports the GSK/Ionis drug is viewed as a potential 'functional cure' for chronic infection.
Why it mattersA new mechanism added on top of standard antivirals changes the HBV treatment conversation for hepatologists, and a new product means a new label, risk-management plan and post-marketing safety surveillance to watch.
Moderna, Merck shares fall on eagerly anticipated cancer vaccine results
Source: BioPharma Dive
In a landmark melanoma study, the Moderna/Merck personalized cancer vaccine (intismeran) plus Keytruda cut the risk of relapse or death by 42%, a result that met Wall Street expectations but triggered a 'sell-the-news' share drop.
Why it mattersThis is a key test of individualized mRNA cancer vaccines in the adjuvant setting; oncologists will want the full ESMO data, and regulators a first look at a new class with its own manufacturing and safety questions.
Ebola vaccine trial begins in DR Congo
Source: Medical Xpress (AFP)
The first clinical trial of an Ebola vaccine in the outbreak gripping the Democratic Republic of Congo began on Friday, according to the head of the World Health Organization.
Why it mattersRunning a trial inside an active outbreak is the fastest route to efficacy data, and the results will inform outbreak-response vaccine strategy across the region.
AMA and EMA issue joint guidance on Ebola vaccine development
Source: EMA
EMA's Emergency Task Force and the African Medicines Agency published a joint position paper to support the timely start of clinical trials for potential Ebola vaccines.
Why it mattersAligned expectations from European and African regulators can cut the time to start trials in an outbreak, which is useful for sponsors planning emergency vaccine programmes.
Daily email: coming soon
The day's approvals, safety signals and trials, in five minutes.
An email edition is on the way. Until then, bookmark this page or follow the RSS feed, a new digest is published every day.
Join the email waitlistOpens your email app. We only use your address to tell you when the email edition launches.