News

Lynparza (olaparib) has generated more positive data in prostate cancer, this time as a potential first-line treatment for men with metastatic castration-resistant prostate cancer with or without mutations in homologous recombination repair (HRR) genes. A Phase 3 trial comparing Lynparza against placebo when given in addition to the prostate cancer drug abiraterone showed a statistically significant improvement in radiographic progression-free survival, the developers AstraZeneca Plc and Merck & Co Inc, announced on 24 September.

Advent France Biotechnology completed the first closing of a new venture fund on 30 September, raising €86 million to invest in early-stage European life science companies with a particular focus on France. The European Investment Fund and the French Seed Fund 2 participated in the financing, along with corporate venture funds associated with Boehringer Ingelheim GmbH and Laboratoires Pierre Fabre.

Aglaia Therapeutics SAS, a French start-up company, has raised €4 million in seed financing to start preclinical development of cancer drugs that can overcome a patient’s resistance to current targeted therapies. The company’s portfolio is based on research showing that the abnormal activation of the eIF4F protein complex leads to the synthesis of proteins involved in tumour growth.

AstraZeneca Plc has exercised an option to take full ownership of Caelum Biosciences Inc, a US company with a product in Phase 3 for the treatment of amyloid light-chain (AL) amyloidosis. AL amyloidosis is a rare disease in which misfolded amyloid proteins build up in organs throughout the body, including the heart and kidneys.

AstraZeneca Plc has invested in a UK university spin-out that has a platform for developing vaccines and medicines using self-amplifying RNA. The company, VaxEquity Ltd, was founded in 2020 by Robin Shattock, head of immunology of infection at Imperial College London and Morningside Ventures, a Chinese venture capital and private equity group. Both Morningside and AstraZeneca have made equity investments in the company, the sizes of which were not disclosed.

The US Food and Drug Administration has given an emergency use authorisation for a booster dose of the Pfizer/BioNTech Covid-19 vaccine for individuals 65 years and older and those who are at high risk of the disease. The high-risk population includes people who are healthcare workers and teachers, as well as those in homeless shelters and prisons.

The European Medicines Agency has issued a positive opinion recommending three new indications for Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 in order to treat a group of rare inflammatory diseases. The diseases all involve eosinophils, a type of white blood cell which can build up and cause inflammation.

The US Food and Drug Administration has reorganised its information technology work into a new office and appointed British educated Vid Desai to lead it. The new Office of Digital Transformation will combine all of the functions of the agency’s current IT, data management, and cybersecurity functions in a single unit, reporting directly to the FDA commissioner. It is part of a modernisation drive started in 2019 to operate more efficiently and increase the use of new technologies in the review of medicines and the monitoring food safety.

Jyseleca (filgotinib), a small molecule drug that blocks enzymes contributing to inflammatory diseases, is being recommended by the European Medicines Agency for the treatment of ulcerative colitis. Jyseleca has already been approved in the EU for rheumatoid arthritis. A new indication would broaden the drug’s coverage to include the treatment of adults with moderate to severely active ulcerative colitis who have not responded to earlier treatments.

A novel form of insulin that is intended to accelerate absorption of the hormone by patients with Type 1 diabetes has met the primary endpoint of non-inferiority in a Phase 1 trial compared with NovoRapid, a standard of care. Arecor Therapeutics Plc, the developer, announced the results on 20 September. AT278 is an ultra-concentrated formulation that has been designed to speed absorption of insulin post injection even when delivered at a high concentration.