mRNA Cancer Vaccine Begins Trials for Non-Small Cell Lung Cancer
An mRNA vaccine has entered human trials as a treatment for lung cancer. Unlike traditional cancer vaccines such as the HPV vaccine, BNT116 is a therapeutic cancer vaccine designed to reduce tumor growth in patients with cancer or prevent its recurrence. BNT116 contains the genetic code for six molecules frequently seen in non-small cell lung […]
Study Finds Repeat Dosing of IVIG and PLEX Common in GBS, Resulting in Harm to Nonresponders
According to randomized controlled trials, repeat intravenous immune globulin (IVIG) dosing and plasma exchange (PLEX) followed by IVIG (combination therapy) have no additional therapeutic benefit in Guillain-Barré syndrome (GBS) nonresponders. Furthermore, the delineation between GBS and acute onset chronic inflammatory demyelinating polyneuropathy (A-CIDP) can be particularly challenging and carries therapeutic implications. In the retrospective study […]
Trial Shows Experimental Cancer Drug Helped Reduce Risk of Death in Common Blood Cancer
Results of a trial of GSK’s experimental cancer drug Blenrep showed that the drug used in combination with other treatments reduced the risk of death by 42 percent in multiple myeloma, at or after first relapse, compared to an existing treatment.
CSL Begins Enrollment for Hizentra Study for POTS
CSL Ltd. has begun enrolling U.S. patients in a Phase III late-stage randomized control trial to assess whether Hizentra subcutaneous immune globulin (SCIG) can alleviate symptoms of postural orthostatic tachycardia syndrome (POTS) — a blood circulation disorder that is one of the most common and disabling symptoms of long COVID with no approved therapies.
Investigational Plasma Kallikrein Inhibitor (Sebetralstat) Reduces Time to Relief from Hereditary Angioedema Attacks
In a Phase III, double-blind, three-way crossover trial, sebetralstat given on-demand for treatment of hereditary angioedema (HAE) attacks was shown to result in faster times to the start of symptom relief, reduction in attack severity and complete attack resolution than placebo treatment.
How FDA Is Working to Accelerate Rare Disease Treatments
Through regulatory pathways and patient engagement, FDA is helping to advance treatment innovations for rare diseases.
Solving Clinical Trial Delays by Accelerating Patient Recruitment
Enrolling patients in clinical trials is a slow and costly process, but software companies are working to address the problem.
First Cancer Patients Receive mRNA Therapy in Clinical Trial
Imperial College Healthcare NHS Trust has enrolled the first United Kingdom (UK) patients who have received an experimental messenger RNA (mRNA) therapy — a type of immunotherapy treatment called mRNA-4359 — in its Phase I/II clinical trial.
First Do No Harm: Increasing Patient Safety
Patient safety is at the heart of healthcare, so it’s imperative to put in place systems and regulations to reduce patient harm.
Study Finds Experimental Alzheimer’s Drug Slows Cognitive Decline
A large clinical trial of Eli Lilly’s experimental Alzheimer’s medication, donanemab found the drug slowed declines in patients’ ability to think clearly and perform daily tasks by more than a third.
