Germany-based mbiomics GmbH has raised €13 million in a Series A financing round to accelerate development of microbiome-based medicines. These are live bacterial therapeutics derived from the gut that can potentially be directed against multiple diseases.
Dupixent (dupilumab), a monoclonal antibody approved to treat asthma, atopic dermatitis and three other inflammatory diseases, has now been shown to be effective in chronic obstructive pulmonary disease (COPD), the third leading cause of death in the world. Results of a Phase 3 trial of the drug showed that it achieved a 30% reduction in moderate or severe acute exacerbations in COPD, Sanofi SA announced on 23 March. Dupixent is being jointly developed by Sanofi and Regeneron Pharmaceuticals Inc.
The Roche Group has enlisted the support of Eli Lilly and Company to complete development of a new blood test for the early diagnosis of Alzheimer’s disease. The test has received a breakthrough designation from the US Food and Drug Administration and if approved, would be an additional tool for identifying the low likelihood of amyloid pathology in patients with symptoms of Alzheimer’s disease. It could help determine whether these patients should be tested further.
AbbVie Inc has received a complete response letter (CRL) from the US Food and Drug Administration requesting additional information on a pump that is used to deliver its candidate treatment for Parkinson’s disease, the company announced on 22 March. A CRL is a formal notice from the FDA to a company outlining deficiencies in a new drug application (NDA). The agency did not request additional safety or efficacy studies. AbbVie said it plans to resubmit its regulatory application as soon as possible.
MorphoSys AG reported an increase in revenue and a smaller operating loss in 2022 as it tightened its focus on cancer. The German company is completing development of pelabresib, a product for myelofibrosis, and growing sales of its marketed antibody therapeutic, Monjuvi (tafasitamab) for diffuse large B-cell lymphoma.
Verona Pharma Plc ended 2022 with cash and cash equivalents of $227.8 million and plans to submit a new drug application to the US Food and Drug Administration for ensifentrine, its candidate product for chronic obstructive pulmonary disease (COPD).
Cancer Research UK has entered into a clinical development collaboration with UCB SA of Belgium to advance two candidate antibody therapeutics for cancer into the clinic. Financial details of the partnership were not disclosed.
The deal is one of several involving the UK charity and its division Cancer Research Horizons with institutions and companies across Europe. In November 2022, Cancer Research UK reached an agreement with the Karolinska Institutet in Sweden to validate novel drug targets in cancer.
Bank regulators in the US and UK took further steps on 12 March to protect depositors at Silicon Valley Bank in California and its UK subsidiary following the collapse of the parent company the previous Friday. The US Federal Deposit Insurance Corporation (FDIC) acted first on 10 March by closing the parent bank after a run on deposits. Concurrently, it created a new banking entity to protect insured depositors. This move protected customers with accounts of up to $250,000 – the US federally insured level – but it did not stop the contagion.
Sanofi SA is to acquire Provention Bio Inc of the US giving it a marketed product, Tzield (teplizumab), that has been shown to delay the onset of type 1 diabetes, as well as a pipeline of prospective therapies for other auto-immune diseases. The France-based multinational will pay $25 per share in cash for the Nasdaq-listed company, representing an equity value of about $2.9 billion. A traditional supplier of insulin, Sanofi stepped back from investment in diabetes products in 2019 after seeing an erosion of its market share in the US.
Pfizer Inc has concluded its widely reported merger talks with Seagen Inc with a cash offer to acquire the company for $229 per share representing an enterprise value of about $43 billion. Located in Bothell, Washington, US, Seagen (formerly Seattle Genetics), is one of the first developers of antibody-drug conjugates (ADCs) which are monoclonal antibodies chemically linked to a drug and directed against cancer. The antibody binds to specific proteins on cancer cells and the linker enables the toxic drug payload to enter the cells and kill them.