News

Regulatory support for academic medicine

Friday 30 September 2022
Country
Netherlands

The European Medicines Agency has launched a new project to help academic scientists and those working for non-profit organisations understand the regulatory requirements for developing and eventually commercialising cell, gene and tissue engineered therapies. The project complements the agency’s priority medicines scheme, PRIME, which was launched in 2016 to provide support to developers of medicines that meet a major public health need.

New drug for ALS

Friday 30 September 2022
Country
United States

The US Food and Drug Administration has approved a new drug for amyotrophic lateral sclerosis, a rare disease that attacks and kills the nerve cells that control voluntary muscles. In a Phase 2 trial, the drug Relyvrio (sodium phenylbutyrate and /taurursodiol), showed an ability to slow the rate of neuromuscular decline. Moreover in a follow-up study, it extended patient survival compared with a placebo.

Lecanemab meets primary endpoint in Alzheimer’s trial

Wednesday 28 September 2022
Country
Japan

Lecanemab, an antibody therapy targeting amyloid-beta protofibrils in patients with early Alzheimer’s disease, achieved positive results in a Phase 3 study, paving the way for regulatory reviews in the US, EU and Japan, the developer Eisai Inc announced on 28 September. The study, called Clarity AD, met the primary endpoint as well as key secondary targets, confirming that lecanemab’s mechanism of action is able to reduce cognitive clinical decline in Alzheimer's patients. Lecanemab works by binding to soluble amyloid-beta protofibrils.

Meeting Report: Pandemic lessons

Tuesday 27 September 2022

It is not too early to draw lessons from the Covid-19 pandemic, a health emergency that is still affecting the global community. At a meeting of the Sachs Biotech in Europe Forum on 21 September, five pharma executives discussed what has been accomplished thus far, and what still needs to be done to protect against future health crises.

Genfit to acquire Versantis of Switzerland

Monday 19 September 2022
Country
France

Genfit SA of France is to acquire a small Swiss company that specialises in liver diseases in order to expand its clinical-stage portfolio for these complex disorders. The purchase of Versantis AG is expected to complete in the fourth quarter and give Genfit control of VS-01, a liposomal-based therapy for acute-on-chronic liver failure (ACLF), a condition for which no drugs have yet been approved. Genfit will also acquire a small molecule asset and a diagnostic.

New RSV treatment reviewed

Sunday 18 September 2022
Country
Netherlands

A new treatment designed to protect infants from infection from the respiratory syncytial virus (RSV) has received a positive opinion from the European Medicines Agency. The accelerated review was in response to evidence that infections from RSV are on the rise following a relaxation of restrictions that have been in place to prevent Covid-19.

SparingVision raises €75 million for genomic medicines

Wednesday 14 September 2022
Country
France

France-based SparingVision SAS has raised €75 million in a Series B financing round to bring its two lead gene therapy assets into clinical development for the treatment of retinitis pigmentosa, an inherited retinal disorder. The adeno-associated virus vector therapies will deliver mutation agnostic treatments to the eye with a view to correcting the disorder.

Novo, Microsoft partner to apply AI to drug development

Tuesday 13 September 2022
Country
Denmark

Novo Nordisk A/S and Microsoft Inc have entered a partnership to investigate how artificial intelligence can be applied to drug discovery and development. The collaboration draws on Novo’s experience in pharma R&D and Microsoft’s computational services and AI expertise to develop a series of case studies showing applications of the new technologies. Financial terms of the agreement were not disclosed.

EMA recommends bivalent Covid-19 vaccine

Tuesday 13 September 2022
Country
Netherlands

The European Medicines Agency has recommended approval of a bivalent vaccine to protect against two sub-variants of the SARS-CoV-2 virus. The authorisation is for an updated booster shot developed by Pfizer Inc and BioNTech SE to protect people against the omicron subvariants BA.4 and BA.5 in addition to the original strain of SARS-CoV-2. The new vaccine is to be used in people aged 12 years and older who have received at least a primary course of vaccination to prevent Covid-19.

Novo expands into rare blood disorders

Friday 2 September 2022
Country
Denmark

Novo Nordisk A/S, whose main therapeutic focus is diabetes, has expanded its presence in the field of rare blood disorders with an agreement to acquire Forma Therapeutics Holdings Inc of the US. Forma’s lead product etavopivat is a small molecule allosteric activator of the red blood cell isoform of pyruvate kinase. It is being developed to improve anaemia and red blood cell health in people with sickle cell disease.