Novartis saw its operating profit decline in the second quarter but sales of core products such as Entresto for heart failure and Kisqali for breast cancer delivered double-digit sales growth. Turnover for the group as a whole was $12.8 billion, down by 1% from a year earlier. Measured at constant exchange rates, group sales increased by 5%.
Oxford Science Enterprises (OSE), an independent investor in science generated at the University of Oxford, has raised £250 million from a group of new and existing investors enabling it to extend its financial support to start-up companies across the life sciences, healthcare technology and deep technology sector. In addition to providing seed funding, OSE supports later-stage funding rounds for more mature companies in its portfolio.
Enterome has entered into a new partnership to support development of its pipeline of microbiome-based therapeutics – this time with Nestlé Health Science. The deal will deliver €40 million upfront in cash and equity from Nestlé, enabling Enterome to bring its lead immune disease product into the clinic. This product, EB1010, is an inducer of the interleukin-10 cytokine. IL-10 has anti-inflammatory properties that play a central role in maintaining normal tissue homeostasis. EB1010 is being developed to treat inflammatory bowel disease and food allergies.
Agomab Therapeutics NV has secured an additional $40.5 million in Series B funding in order to progress its pipeline of small molecule and antibody therapeutics for regenerating damaged tissue. The latest funding follows $74 million raised in 2021, bringing the total generated from the round up to $114 million. Pfizer Inc led the latest facility through its investment vehicle Pfizer Breakthrough Growth Initiative.
The US Food and Drug Administration has launched a plan to support the development of new medicines for rare neurodegenerative diseases including amyotrophic lateral sclerosis, a progressive disease that affects nerves in the brain and spinal cord, causing loss of muscle control. The plan has been developed in line with new US legislation, the Accelerating Access to Critical Therapies for ALS Act that took effect on 23 December 2021.
The European Medicines Agency has recommended the conditional approval of Roctavian (valoctocogene roxaparvovec), a gene therapy for haemophilia A. If approved, it would be the first gene therapy for this disease in Europe. The conditional approval carries with it a requirement that the developer, BioMarin Pharmaceutical Inc, provide follow-up data from ongoing clinical trials to show the therapy continues to be safe and efficacious for patients.
As part of its strategy to incorporate big data into regulatory decision-making, the European Medicines Agency is to invite pharma companies to apply for a pilot project under which they would submit patient data from clinical trials as part of their marketing authorisation applications. The project is expected to start in September and last up to two years. It would cover about 10 regulatory procedures.
A second booster dose of one of the two messenger RNA (mRNA) vaccines approved in the EU for Covid-19 is being recommended for adults between the ages of 60 and 79 years. This is to protect against a new wave of infections caused by a variant of the SARS-CoV-2 virus. The recommendation was issued on 11 July by the European Centre for Disease Prevention and Control and the European Medicines Agency.
It is often said that cell and gene therapies are a ‘process’ rather than typical drugs. This is based on the fact that their success depends on the quality of their starting materials and how they are manufactured. This could be an autologous chimeric antigen receptor (CAR) T cell-based gene therapy, or any one of the many allogeneic products in clinical development. Manufacturing is the key strategic issue for developers of these therapies, according to speakers at the On Helix annual meeting in Cambridge, UK on 7 July.
AstraZeneca Plc is to pay up to $1.27 billion to acquire the US company TeneoTwo Inc in a bid to strengthen its pipeline of medicines for haematologic malignancies. TeneoTwo’s portfolio features an early clinical stage T cell engager. These are bispecific antibody therapeutics which are engineered to redirect the immune system’s T cells to recognise and kill cancer cells.