HONG KONG – Coreline Soft Co. Ltd. has taken its first step into the Greater China market after receiving approval from Taiwan’s Food and Drug Administration (TFDA) on April 8 for its Aview suite of artificial intelligence (AI) medical solutions.
The management team at Respinova Ltd. is breathing easier with the FDA's 510(k) clearance of the company's Pulsehaler. Using pulsed air pressure, the device opens airways and clears secretions in patients with respiratory diseases. The clearance represents the device’s first endorsement by a regulatory agency, though the company hopes it will soon be joined by others.
TORONTO – The Medipines AGM100, which was developed by Orange County, Calif.-based Medipines Corp. to detect respiratory impairment caused by chronic obstructive pulmonary disease (COPD), has been recruited in the fight against COVID-19 in Canada. Described by company CEO and coinventor Steve Lee as “the world's first noninvasive lung monitor for gas exchange measurement,” the device is undergoing advanced testing.
Royal Philips NV is reporting the launch of Philips Ventilator Bipap A40 EFL, a noninvasive ventilator that aims to help patients with chronic obstructive pulmonary disease (COPD) breathe easier. With its CE mark in hand, the company has tagged initial target markets as France, Italy and the U.K. Additional European markets are expected to come next year.
LONDON – Enterprise Therapeutics Ltd. has sold its TMEM16A cystic fibrosis portfolio to Roche Holding AG for an up-front payment of £75 million (US$96.9 million), with more to come on achievement of predetermined milestones.
DUBLIN – Verona Pharma plc raised $200 million in a combined private placement and share subscription, which ensures the London-based firm has the funds in place to proceed with a phase III program for its lead drug candidate, ensifentrine, as maintenance therapy in chronic obstructive pulmonary disease (COPD). It’s solid evidence that the company’s decision to bring in a new senior management team earlier this year is working. CEO David Zaccardelli and Chief Financial Officer Mark Hahn joined up in February, not long after they had led specialty pharma firm Dova Pharmaceuticals Inc. to a buyout deal with Stockholm-based Swedish Orphan Biovitrum AB, worth up to $915 million.
Chronic obstructive pulmonary disease (COPD) is one of the most dangerous comorbidities for COVID-19 patients – as well as a major cause of death that predates the current pandemic. Pulmonx Corp. has the first minimally invasive valve to treat severe emphysema, which is a form of COPD that accounts for about one-quarter of the patients.
LONDON – Verona Pharma plc reported positive phase IIb results for the nebulized formulation of its dual phosphodiesterase (PDE) 3 and 4 inhibitor, ensifentrine (RPL-554), as an add-on to standard bronchodilation therapy in chronic obstructive pulmonary disorder (COPD).