Tag: clinical trials

June 16, 2021

The study, co-authored by Seqirus, was conducted as part of a Phase III clinical trial of Novavax’s COVID-19 vaccine NVX-CoV2373 in the UK. The co-administration sub-study enrolled a total of 431 volunteers, all of whom had received a flu vaccine […]

June 15, 2021

The parliament advocated for an increase in the number of NUB inquiries that can take place each year. NUB inquiries are used by hospitals to gain short term reimbursement for innovative treatment and diagnostic methods, supplementing the standard Diagnosis Related […]

June 15, 2021

The Phase III STAR study enrolled 169 adult males with a genetically confirmed diagnosis of choroideremia. It evaluated the safety and efficacy of a single subretinal injection of the investigational gene therapy. The primary endpoint was the proportion of patients […]

June 14, 2021

The good news about vaccines and variants continues to roll in. Last week, a study reported that Johnson & Johnson’s COVID-19 vaccine protected against all of the SARS-CoV-2 variants of concern. Now, Pfizer’s COVID-19 vaccine has been shown to protect […]

June 9, 2021

Beigene has quickly become a force in cancer drug development, earning approvals in the U.S. and China for its targeted therapy Brukinsa and immunotherapy tislelizumab. The biotech is developing a slate of small molecule and antibody drugs aimed at several […]

June 7, 2021

The approvals of Roche’s Luxturna (2017) for inherited retinal disease and Novartis’ Zolgensma (2019) for spinal muscular atrophy are indicative of a resurgence in the gene therapy field after a decline due to the death of a patient in 1999. […]

June 7, 2021

This includes the company’s lead pre-clinical ADC candidate IKS03, a potentially ‘best-in-class’ CD19-targeted asset for B-cell cancers. Iksuda will use the funds to support the progression of IKS03 into first-in-human Phase I clinical trials, and will also be used to […]

June 3, 2021

Recro Pharma, a contract development and manufacturing organization (CDMO), announced on June 2, 2021 that it has expanded the clinical capabilities of its clinical trial services (CTS) offerings. The added capabilities include clinical-scale sachet and blister packaging for clinical trial […]

June 1, 2021

The COVID-19 pandemic accelerated the adoption of decentralized clinical trials (DCTs) by biopharma companies. The clinician-patient relationship will always be key to clinical trials, but decentralized aspects such as direct-to-patient shipments and telehealth are here to stay. Here are four […]

May 21, 2021

VectorY was chosen for its development of proprietary and partnered programs based on a novel adeno-associated viruses (AAV) platform for the treatment of muscular and neurodegenerative disorders. The company currently has a pipeline of vectorized antibodies, including two in pre-clinical […]

May 20, 2021

One lesson of the COVID-19 pandemic is the importance of being able to assess potential new therapies and vaccines quickly and reliably and in ways that can adapt to changing scientific evidence and public health needs. FDA has responded to […]

May 17, 2021

Scientists at University College London (UCL) have identified a new immunotherapy against hepatitis B virus (HBV), the world’s most common cause of liver cancer. The team’s study using immune cells isolated directly from patient liver and tumor tissue, showed that […]