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Cell and Gene Therapy, Industry

BioMarin’s hemophilia gene therapy recommended for approval in Europe

June 24, 2022

Via: Biopharma Dive

The regulatory agency that recommends whether new drugs should be approved in Europe has thrown its support behind a gene therapy for the rare bleeding disorder hemophilia A, putting the potentially curative treatment one step closer to market. People with […]


Industry, Vaccines

COVID Vaccines Saved 20 Million Lives Worldwide in First Year

June 24, 2022

Via: Drugs.com

Nearly two-thirds of the world’s population has had at least one COVID-19 vaccine, which has prevented nearly 20 million deaths, new research finds. The study from Imperial College London was the first to quantify the impact of vaccines on a […]


Industry, Vaccines

Moderna says COVID booster works against Omicron subvariants

June 23, 2022

Via: Pharmaphorum

The news came hard on the heels of Moderna’s announcement that it will build a research and manufacturing facility in the UK to produce COVID and other mRNA jabs, and an additional order for 60 million doses that could be […]


Industry, Pharma

US frets over pharma supply chain security

June 22, 2022

Via: Pharmaphorum

In a global economy, across a number of industries, low-margin products are often manufactured in countries where labour is cheap. The pharmaceutical industry is no different, with India and China becoming two of the leading manufacturers and exporters of generic […]


Cell and Gene Therapy, Industry

A biotech startup launches with $38M to develop a cystic fibrosis gene therapy

June 21, 2022

Via: Biopharma Dive

Vertex’s latest treatment for cystic fibrosis is a “triple combination” drug called Trikafta, which like others from Vertex boosts the activity of a protein that’s defective in people with the disease. It has quickly become a go-to treatment, entrenching Vertex’s […]


Industry, Vaccines

EMA Starts Rolling Review of Adapted COVID-19 Vaccines

June 21, 2022

Via: Biopharm International

The European Medicines Agency (EMA) has begun a rolling review of the Spikevax vaccine that has been adapted to protect against two variant strains of SARS-CoV-2, the agency announced on June 17, 2022. The review will focus on non-clinical laboratory […]


Industry, Vaccines

With CDC Approval, COVID Shots For Kids Under 5 Ready for Delivery

June 20, 2022

Via: Drugs.com

After a final sign-off on Saturday from the head of the U.S. Centers for Disease Control and Prevention, COVID-19 vaccines for children younger than 5 have finally become a reality. “This expands eligibility for vaccination to nearly 20 million additional […]


Industry, Vaccines

FDA advisors back COVID jabs for very young children

June 16, 2022

Via: Pharmaphorum

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to zero in favour of both vaccines in this age group, in light of rising rates of hospitalisations and deaths that have been seen in the very young during […]


Industry, Manufacturing, Research and Development, Vaccines

EU governments pressure manufacturers to renegotiate contracts for COVID-19 vaccines

June 15, 2022

Via: PMLiVE

When vaccines became available earlier in the COVID-19 pandemic, countries vied for supply contracts. However, as the need for vaccines begins to slow in Europe, some countries want to amend their contracts to reduce spending and to prevent receiving more […]


Cell and Gene Therapy, Industry

Coave Therapeutics and ABL Enter Gene Therapy Collaboration

June 13, 2022

Via: Contract Pharma

Coave Therapeutics, a clinical-stage biotechnology company focused on developing life-changing gene therapies for CNS (Central Nervous System) and eye diseases, and ABL, a pure play contract development and manufacturing organization (CDMO) specialized in the development and manufacturing of viruses for […]


Industry, Vaccines

FDA staff supportive of Pfizer, Moderna COVID vaccines in young children

June 13, 2022

Via: Biopharma Dive

COVID-19 vaccines have been authorized in the U.S. for a year and a half, with the FDA progressively expanding their clearances to cover broader and broader swathes of the population. Yet they are still unavailable to the youngest children, who […]


Cell and Gene Therapy, Industry

FDA panel backs Bluebird gene therapy despite safety risks

June 9, 2022

Via: Biopharma Dive

An experimental gene therapy could benefit young boys with a rare genetic disease, despite considerable concerns that treatment may cause cancer, a panel of Food and Drug Administration advisers unanimously agreed in a high-profile meeting Thursday. The therapy, an infusion […]