Citing the urgent need for new drugs to treat neurological diseases, the US Food and Drug Administration has shaken up its review teams to encourage experts to work across disciplines and identify new opportunities for treatment.
Verona Pharma Plc has reported positive top-line data from a Phase 2a trial of its inhaled drug for patients with cystic fibrosis, a rare inherited disease that causes impaired lung function and premature death. The data showed an improvement in lung function that was statistically significant.
Novartis has announced a collaboration with Pear Therapeutics Inc to develop digital therapeutics for patients with schizophrenia and multiple sclerosis using mobile and desktop software. The new products would deliver clinically-proven treatments such as cognitive behavioural therapy.
AstraZeneca Plc has spun out six compounds from its early-stage pipeline in inflammation and autoimmunity into a new company in order to share the cost of development with a group of financial institutions. The stand-alone company has Series A funding of $250 million.
After one volunteer died and four others were seriously injured during a clinical study in France in 2016, the European Medicines Agency revised its rules for first-in-human studies to tighten the requirements for the dosing of experimental drugs in humans. Introducing the changes in 2017, the agency said that clinical trial protocols are now more complex than ever before and sponsors will need to work harder to exercise oversight.
A zinc finger nuclease gene editing technology is to be used to develop ex vivo cell therapies for cancer, under a new research collaboration between the Gilead Sciences company Kite and Sangamo Therapeutics Inc.
Targovax ASA ended 2017 with a cash balance of NOK 261.6 million (€27.1 million), aided by a capital increase in the third quarter, which enabled the company to sustain heavy investments in its oncolytic virus and peptide vaccine platforms.
A group of international investors including New Enterprise Associates (NEA) has agreed to support a CHF40 million (€34.65 million) capital raising initiative by Addex Therapeutics Ltd to bring its lead product for dyskinesia into registration studies.
AstraZeneca Plc has won a new indication for its checkpoint antibody Imfinzi (durvalumab) from the US Food and Drug Administration to reduce the risk of non-small cell lung cancer progressing. Imfinzi targets the programmed death ligand-1 (PD-L1).
Roche is to advance its strategy for delivering personalised medicines with the acquisition of Flatiron Health Inc, a company with technology for analysing real-world data from cancer patients. Roche is to pay $1.9 billion for the 87.4% of the company it doesn’t already own.