Novartis has started a strategic review of its Sandoz generics division following a further sales decline in the third quarter. Sandoz’s sales were down by 1% in the quarter on weak retail demand and price competition for its generic medicines and biosimilars. Announcing the review on 26 October, the company said “options range from retaining the business to separation.”
An experimental breast cancer treatment for patients with estrogen receptor positive and HER2 negative breast cancer has met the primary endpoint in a Phase 3 trial paving the way for regulatory submissions in the US and Europe in 2022, the developers Menarini Group and Radius Health Inc, announced on 20 October.
The US Food and Drug Administration has amended the emergency approvals for three Covid-19 vaccine booster shots to make them available to more people. At the same time, the agency said a booster shot from any of the approved vaccines may be administered to people whose first vaccination was with a different product.
“A single booster dose of any of the available Covid-19 vaccines may be administered as a heterologous booster dose following completion of primary vaccination with a different available Covid-19 vaccine,” the agency said on 20 October.
Janssen Biotech Inc has expanded its European partnerships with a new bispecific antibody deal – this time with F-star Therapeutics Ltd of the UK. Janssen already has projects underway using bispecific technology from Genmab A/S. The deal with F-star will explore new antibody therapeutics that are both bispecific and tetravalent, meaning they simultaneously target immune and tumour cells whilst having two additional sites for antigen binding.
The Roche Group has raised its sales forecast for 2021 following a strong performance of its diagnostics division in the first nine months of the year. While diagnostics account for just 29% of group turnover, they are an important source innovation.
Boehringer Ingelheim has received a second US approval for its anti-inflammatory drug Cyltezo (adalimumab-adbm), a biosimilar version of Humira, one of the most widely sold drugs in the developed world. Humira is still protected by patents which means that Cyltezo will not become commercially available in the US until 1 July 2023.
UK-based STORM Therapeutics Ltd has entered into an exclusive collaboration and licensing agreement with Exelixis Inc to discover potential treatments for cancer by inhibiting enzymes that modify RNA. The initial focus of the partnership will be on ADAR1 (adenosine deaminases acting on RNA), an enzyme that edits double-stranded RNA molecules. In so doing, the enzyme reduces their ability to activate the innate immune system.
The European Medicines Agency has recommended approval of an antibody-drug conjugate (ADC) for the treatment of metastatic triple-negative breast cancer, an aggressive cancer that does not respond to hormonal therapy medicines or medicines that target HER2 protein receptors. The positive opinion was based on data from a Phase 3 trial which showed that the therapy, Trodelvy (sacituzumab govitecan), produced an overall survival figure of 11.8 months and progression-free survival of 4.8 months, compared with 6.9 months and 1.7 months respectively, for chemotherapy.
The US Food and Drug Administration has approved the first allogeneic tissue product for the treatment of children born without a thymus, a condition known as congenital athymia. The product, Rethymic, is a donor derived product that is processed and cultured and implanted into patients to help reconstitute immunity in the absence of a thymus gland. The thymus is located behind the sternum and between the lungs, and is active until puberty. The gland secretes thymosin, a hormone necessary for T cell development and production.
A new biotech company with plans to target ABC transporters, one of the oldest families of proteins, has been launched with $100 million in Series A financing by US-based Atlas Venture and three other groups. Rectify Pharmaceuticals Inc will develop small molecule drugs aimed at restoring dysfunctional ABC transporters to a normal state. These transporters play an essential role in ferrying organic and inorganic molecules across cellular membranes.