The US Food and Drug Administration has requested permanent injunctions against stem cell clinics in two regions of the country to prevent them from administering unapproved stem cell treatments to patients with cancer and other diseases. The move comes nearly 10 months after it issued warning letters to the clinics.
A Phase 3 trial evaluating a combination of the checkpoint antibody Tecentriq (atezolizumab) and the kinase inhibitor Cotellic (cobimetinib) in patients with metastatic colorectal cancer failed to meet its primary endpoint of overall survival, Roche announced on 10 May.
Evotec AG ended the first quarter confidently predicting that it will achieve double-digit revenue and profit growth this year largely due to the expansion of its global business following the acquisition of Aptuit LLC in 2017.
Abcam Plc has decided not to pursue a proposed offer for Horizon Discovery Group Plc having been rebuffed by the gene-editing company, which is based in Cambridge, UK. Abcam is a pharmaceutical services company, also based in Cambridge.
InflaRx NV of Germany has raised a net $57.1 million from a primary and secondary offering of its shares on Nasdaq to support its portfolio of drugs for inflammatory diseases that target the complement system, a component of the innate immune system.
Takeda Pharmaceutical Company Ltd has won the agreement of Shire Plc to a takeover that values the Ireland-based company at $62 billion and will potentially strengthen Takeda’s position in the US. Although headquartered in Dublin, Shire generates most of its business from the US.
The UK gene therapy company Autolus Ltd has filed papers with the US Securities and Exchange Commission for a proposed initial public offering of its shares on Nasdaq. The offering will take the form of American Depositary Shares each representing one ordinary share in the company.
The UK cancer vaccine company Scancell Holdings Plc has raised £8.7 million from existing and new shareholders in order to advance its portfolio of early clinical stage vaccines for melanoma, non-small cell lung cancer and other solid tumours.
Fresh from a successful initial public share offering (IPO) on Nasdaq, MorphoSys AG is progressing plans for the potential commercialisation in the US of its first wholly-owned product – an antibody therapeutic for aggressive lymphoma.
Novartis has received a new cancer indication for its chimeric antigen receptor T (CAR-T) cell therapy Kymriah (tisagenlecleucel) enabling the gene therapy to be administered to a broader group of patients. The new indication is for large B cell lymphoma, including diffuse large B cell lymphoma (DLBCL).