The European Medicines Agency has created a new forum to discuss the way cancer drugs are developed and administered in order to improve the healthcare outcomes for patients. The forum was launched in late March in partnership with the European Organisation for Research and Treatment of Cancer (EORTC), a non-profit organisation located in Belgium,
Pfizer Inc has taken steps to expand its portfolio of treatments for infectious disease with the acquisition of ReViral Ltd, a UK company with candidate products for respiratory syncytial virus (RSV) infection. The acquisition has been valued at up to $525 million. RSV is a respiratory pathogen which can lead to severe lower respiratory tract infections in young infants and older adults. There is currently no specific treatment for RSV infection, although the antibody therapeutic Synagis (palivizumab), approved for marketing in 1998, helps prevent serious lung infections caused by RSV.
The US Food and Drug Administration has given an accelerated approval to Novartis for a new drug to treat a rare group of genetic diseases known as PIK3CA-related overgrowth spectrum (PROS). The drug, Vijoice (alpelisib), was approved on the basis of real-world evidence from patients who received alpelisib as part of a compassionate use programme.
The PROS group of disorders cause overgrowth in parts of the body due to mutations in the PIK3CA gene. Vijoice is a kinase inhibitor designed to block the PI3K pathway and predominantly the P13K-alpha isoform.
Novartis has put a new strategy into place for its innovative medicines business in order to spur product development and cut costs. The changes will create separate commercial organisations for the US and elsewhere while integrating the group’s corporate, R&D and business development activities for proprietary medicines as a single function. The reorganisation will not affect Novartis’ generics business unit Sandoz which is undergoing a separate strategic review, the company told MedNous.
V-Bio Ventures of Belgium has raised €110 million for its second life science fund in order to support young companies in the medical and agricultural sectors. V-Bio Fund 2 is being supported by many of the limited partners of the company’s first fund as well as new investors. The first fund was supported by the European Investment Fund as a cornerstone investor.
Zealand Pharma A/S, a developer of peptide-based medicines, has appointed a new chief executive and embarked on a plan to restructure its portfolio in order to reduce operating expenses and free up money for research and development. Adam Steensberg will replace Emmanuel Dulac as CEO with a mandate to generate new pharmaceutical assets. Dr Steensberg has been promoted to CEO after having served as chief medical officer and vice president for research and development.
A new paediatric formulation of the HIV medicine Triumeq (abacavir, dolutegravir and lamivudine) has been approved by the US Food and Drug Administration, extending the treatment to children who otherwise would go unprotected. An estimated 1.7 million children globally were living with HIV in 2020 with most deaths from the disease occurring during the first five years of life, according to the Joint United Nations Programme on HIV/AIDS.
The US Food and Drug Administration has given emergency use authorisations for a second booster dose of two messenger RNA (mRNA) vaccines for Covid-19 in order to strengthen protection against the SARS-CoV-2 virus for the elderly and people whose immune systems have been compromised. This follows an examination of clinical data from Israel and elsewhere which showed that a second booster presented no new safety concerns.
A Phase 3 trial of a potential first line therapy for a type of small cell lung cancer which has spread to other parts of the body, failed to meet its co-primary endpoint of progression free survival, the developer Roche announced on 30 March.
The trial was testing tiragolumab, an antibody targeting the immune checkpoint TIGIT, together with Tecentriq (atezolizumab) and chemotherapy. The combination therapy was compared with Tecentriq and chemotherapy alone in 490 people with extensive-stage small cell lung cancer.
A cell-based gene therapy for multiple myeloma has been recommended by the European Medicines Agency for patients with multiple myeloma, an incurable blood cancer that causes plasma cells to grow out of control. Symptoms can include bone fracture or even kidney failure. The drug, Carvykti (ciltacabtagene autoleucel), is a chimeric antigen receptor (CAR) T cell medicine consisting of a patient’s own immune cells which have been engineered to target and kill cancer cells.