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Tag: clinical trials


Clinical Trials, Industry, Research and Development, Vaccines

Study demonstrates safety and efficacy of co-administering COVID-19 and flu vaccines

June 16, 2021

Via: Pharma Times

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 […]


Cell and Gene Therapy, Industry

Germany approves legislation to improve cell & gene therapy availability

June 15, 2021

Via: EPM Magazine

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 […]


Cell and Gene Therapy, Industry

Biogen’s inherited eye disease gene therapy misses the mark in late-stage trial

June 15, 2021

Via: Pharma Times

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 […]


Industry, News, Vaccines

Pfizer’s COVID-19 Vaccine Protects Against SARS-CoV-2 Variants

June 14, 2021

Via: Genetic Engineering and Biotechnology News

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 […]


Cell and Gene Therapy, Industry

Beigene expands into cancer cell therapy with Shoreline pact

June 9, 2021

Via: Biopharma Dive

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 […]


Cell and Gene Therapy, Industry

Quality considerations for a growing gene therapy field

June 7, 2021

Via: Biopharma Dive

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. […]


Cell and Gene Therapy, Industry, News, Pharma

Iksuda Therapeutics raises $47m to progress ADC pipeline

June 7, 2021

Via: Pharma Times

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 […]


Clinical Trials, Manufacturing, Research and Development

Recro to Expand its Clinical Trial Services Offerings

June 3, 2021

Via: Biopharm International

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 […]


Clinical Trials, Research and Development

4 insights on decentralized trials for biotechs

June 1, 2021

Via: Biopharma Dive

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 […]


Biotech, Cell and Gene Therapy, Industry

Biotech company wins Merck award for platform to help treat muscular and neurodegenerative disorders

May 21, 2021

Via: EPM Magazine

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 […]


Clinical Trials, Research and Development

FDA Promotes Master Protocols to Modernize Clinical Trials

May 20, 2021

Via: Biopharm International

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 […]


Cell and Gene Therapy, Industry, News

Immunotherapy Approach against Hepatitis B Virus Boosts T Cells and Acts as Direct Antiviral

May 17, 2021

Via: Genetic Engineering and Biotechnology News

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 […]