Prime Minister of the Republic of Serbia Visits SK bioscience to Establish Partnership for Vaccine Localization

Prime Minister Ana Brnabić of Serbia made a historic visit to the headquarters of SK bioscience, a pioneering vaccine and biotech company dedicated to enhancing human health. During her visit, an important memorandum of understanding (MOU) was signed between SK bioscience, the Serbian government, and Frontier Biopharma, with the goal of bolstering vaccine manufacturing in […]

Pfizer and BioNTech Receive U.S. FDA Approval for 2023-2024 COVID-19 Vaccine

Pfizer and BioNTech have received approval from the U.S. Food and Drug Administration (FDA) for their 2023-2024 COVID-19 vaccine, which is tailored to target the SARS-CoV-2 XBB.1.5 sublineage. This vaccine is designed to be administered as a single dose for most individuals aged 5 and older. Pre-clinical data indicates that this updated COVID-19 vaccine produces […]

CEPI partners with University of California, Davis to advance a vaccine against potentially deadly Rift Valley fever virus into clinical trials

In a significant stride towards preventing the deadly Rift Valley fever (RVF), CEPI (Coalition for Epidemic Preparedness Innovations) has joined forces with the University of California, Davis (UC Davis). Their mission: to advance a novel vaccine into clinical trials in Tanzania, a nation where RVF poses a severe threat to rural communities. CEPI will contribute […]

Arcturus Therapeutics and CSL Announce European Medicines Agency Validates Marketing Authorization Application for ARCT-154 Vaccine to Prevent COVID-19

The European Medicines Agency (EMA) has now validated their marketing authorization application, marking a crucial step forward in their journey towards obtaining approval in Europe. This approval decision by the European Commission is anticipated to come to fruition in 2024. What makes this announcement particularly noteworthy are the compelling Phase 3 clinical results that underpin […]

Merck’s ERVEBO Vaccine Now Approved for Children to Combat Zaire Ebolavirus Disease

In a significant development in the realm of public health protection, Merck, known as MSD outside of the United States and Canada, has announced the expansion of ERVEBO’s indication. The U.S. Food and Drug Administration (FDA) has granted approval for the usage of ERVEBO in preventing disease caused by Zaire ebolavirus in individuals as young […]

SK Bioscience and Government Pharmaceutical Organization Collaborate to Strengthen Vaccine Infrastructure in Thailand

In a significant step toward bolstering vaccine infrastructure and pandemic response, SK bioscience and the Government Pharmaceutical Organization (GPO) have joined forces, not only to benefit Thailand but also to extend their influence across the broader Southeast Asia region. The companies have signed a Memorandum of Understanding (MOU) aimed at fortifying the vaccine manufacturing environment […]

CSL Seqirus shipped innovative influenza vaccines for the 2023/24 U.S. season

On July 17, 2023, CSL Seqirus had announced that it had commenced shipping its portfolio of innovative cell-based, adjuvanted, and egg-based influenza vaccines across the U.S. in preparation for the 2023/24 influenza season. The company positioned itself to supply over 55 million doses of influenza vaccines to healthcare providers across the U.S. Dr. Gregg Sylvester, […]

Modern Clinical Trial Data Confirmed Updated COVID-19 Vaccine Generated Robust Immune Response Against Widely Circulating Variants

On August 17, 2023, Moderna, Inc. announced that preliminary clinical trial data have confirmed that its updated COVID-19 vaccine for the fall 2023 vaccination season demonstrated a significant boost in neutralizing antibodies against the EG.5 and FL.1.5.1 variants. These results suggest that Moderna’s updated COVID-19 vaccine may effectively target the expected circulating variants of COVID-19 […]

The Philippines FDA has granted approval for the Phase 3 clinical trial of YS Biopharma’s PIKA Rabies Vaccine

The PIKA Rabies vaccination, utilizing YS Biopharma’s exclusive PIKA adjuvant technology, is a groundbreaking vaccine that enhances immunity and triggers a robust immune response. It has received orphan-drug designation (ODD) from the US FDA for both post-exposure prophylaxis (PEP) for rabies and rabies prevention. Unlike the current vaccine, which requires five visits over a month […]

Xeris Biopharma Has Announced the Initiation of a Phase 2 Clinical Study for Its Investigational Subcutaneous Levothyroxine in Patients with Hypothyroidism

Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a biopharmaceutical company focused on enhancing patients’ well-being through the development and commercialization of innovative products across various therapeutic areas, has reported the dosing of the first participant in a Phase 2 clinical study. This multi-centre, open-label study aims to evaluate the efficacy as a treatment for adults with […]

Arbutus Biopharma Corporation has administered the first dose to a patient in the Supplementary Treatment arm of their Phase 2a triple combination Clinical Trial

Arbutus Biopharma Corporation (Nasdaq: ABUS), a biopharmaceutical company in the clinical stage, known for its profound virology knowledge and dedication to developing innovative therapeutics targeting specific viral diseases, has recently disclosed the dosing of the first patient in the expanded treatment arm of the AB-729 Phase 2a triple combination clinical trial. This trial now includes […]

The FDA has given accelerated approval for QALSODY™ (tofersen) to treat SOD1-ALS, marking a significant scientific advancement as it is the first treatment to target a genetic cause of ALS.

  Biogen Inc. (Nasdaq – BIIB) has announced that the U.S. Food and Drug Administration (FDA) has approved QALSODY™ (tofersen) 100 mg/15mL injection for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a specific genetic mutation.  This approval is based on a reduction in plasma neurofilament light chain (NFL) observed in patients […]