DUBLIN – Skysona (elivaldogene autotemcel, Lenti-D), Bluebird Bio Inc.’s gene therapy for cerebral adrenoleukodystrophy, received a nod from the EMA’s Committee for Human Medicinal Products (CHMP) during its May meeting this week, paving the way for a formal European authorization in the coming weeks. It will constitute the first approval for the product. An FDA approval is some way behind – the company will not complete its BLA filing with the FDA until around midyear.
The EMA issued a positive scientific opinion on Glaxosmithkline plc (GSK) and Vir Biotechnology Inc.’s sotrovimab for early COVID-19 treatment. The Committee for Human Medicinal Products (CHMP)’s opinion concerns the monoclonal antibody’s use for adolescents ages 12 and older weighing at least 40 kg (88 pounds), plus adults. All must risk progressing to severe COVID-19 and not require oxygen supplementation.
Where Ilaris (canakinumab) failed, can Kineret (anakinra) succeed? Swedish Orphan Biovitrum AB is reporting that an investigator-initiated phase III study of its interleukin-1 (IL-1) blocker, Kineret, in 594 hospitalized COVID-19 patients with moderate or severe pneumonia, who had a poor prognosis, uncovered what appear to be dramatic benefits.
LONDON – The U.K. is launching a trial to investigate the potential use of seven different COVID-19 vaccines as boosters, to provide safety and immunogenicity data for if/when immune responses to initial vaccination wane and a revaccination campaign is needed later in the year. The trial, at 18 sites across the country, will recruit 2,886 participants who previously received two doses of either Astrazeneca plc or Pfizer Inc./Biontech SE’s COVID-19 vaccines.
For almost two months, Brazil’s health care surveillance agency Anvisa, the European Medicines Agency, and the Directorate-General for Health and Food Safety have been sharing regulatory and confidential information as part of an effort to improve the safety and efficacy of drugs and medical devices.
LONDON – Delaying the second dose of Pfizer Inc./Biontech SE’s COVID-19 vaccine significantly increases the antibody response in people ages 80 to 99, compared to the approved schedule of two doses three weeks apart, according to the latest data from the U.K. coronavirus immunology consortium.
LONDON – Initial results from the U.K. randomized trial assessing mixed COVID-19 vaccine schedules show there is a significant increase in systemic side effects with one dose of Astrazeneca plc’s and one of Pfizer Inc./Biontech SE’s vaccines (in either order), compared to receiving two doses of the same vaccine.
Building on existing guidance and nearly eight years’ experience with biosimilar monoclonal antibodies and fusion proteins, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued a final guidance detailing a streamlined approach to licensing biosimilars.
LONDON – The SARS-CoV-2 variant first detected in India last year has joined those from the U.K., South Africa and Brazil as a “variant of global concern,” the World Health Organization said on May 10.
LONDON – Abingworth announced the final closing of its latest fund at $582 million, bringing the amount committed to the London-based venture capital firm in 2021 to more than $1 billion. The clinical co-development fund 2 will finance and manage late-stage development of phase III programs sourced from pharma and biotech companies, receiving a pre-negotiated fee when a drug is approved. The model obviously has appeal, with the new fund being significantly oversubscribed and exceeding its target of $350 million.
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