News

With two products on the market and four wholly-owned compounds in late-stage development, Denmark’s Zealand Pharma A/S has positioned itself to grow as an independent biopharma company.

Lundbeck A/S continued to bear the fruits of a rolling restructuring programme as earnings before interest and taxes (EBIT) as a percentage of revenue in 2017 grew to 25.6%, up from 14.7% a year earlier. This was just above the company’s target of 25%.

Novartis has expanded an alliance with Science 37 Inc of the US to launch up to 10 clinical trials over the next three years that will be conducted at a participant’s home or a physician’s officer rather than at a formal clinical trial site. Science 37 is a mobile technology and clinical trial company.

With new evidence showing that the biological changes associated with Alzheimer’s disease start earlier than expected, the European Medicines Agency has revised its guideline for companies developing drugs for the disease.

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.