Two German networking organisations have announced plans for helping nascent biotechnology and medical device companies start operations in Europe by obtaining crowdfunding, which involves raising small amounts of money from a large number of people, typically via the Internet.
Would-be biotechs will be able to raise €1 million to €10 million with a prospectus and for amounts smaller than €1 million a prospectus will not be needed.
An international investment group led by Life Sciences Partners (LSP) of the Netherlands has provided $45 million in Series D financing to the digital health company Endotronix Inc to commercialise its system for helping physicians treat patients with heart failure from home.
The product platform consists of a remote monitoring system coupled with an implantable pulmonary artery sensor that enables physicians to monitor their patients and detect any worsening of a heart failure.
The Swiss medical device company Luciole Medical AG has raised CHF 5.3 million (€4.7 million) in a Series A financing round to commercialise a minimally-invasive monitoring probe designed to measure blood oxygen levels in the brain, specifically for patients in intensive care.
The US Food and Drug Administration has approved Lumoxiti (moxetumomab pasudotox-tdfk), a new drug developed by AstraZeneca Plc for the treatment of refractory hairy cell leukaemia (HCL), a rare, slow-growing cancer of the blood.
Sanofi SA has continued its ongoing reorganisation under Chief Executive Olivier Brandicourt with a reconfiguration of two of its global business units. The current units include products for diabetes, cardiovascular disease and other legacy products. They will be altered to reflect the company’s geographical priorities.
A new primary care business unit will combine the product portfolios of Sanofi’s current diabetes, cardiovascular and mature products divisions to focus exclusively on mature markets.
Boehringer Ingelheim GmbH has exercised an option to acquire Austria-based ViraTherapeutics GmbH which is developing oncolytic virus vaccines to treat cancer. The transaction has been valued at €210 million.
Galapagos NV has raised $300 million in a secondary offering on Nasdaq two days after the Belgian company and its partner Gilead Sciences Inc announced positive Phase 3 results for a new JAK1 inhibitor to treat rheumatoid arthritis.
The US Food and Drug Administration has issued a ‘complete response letter’ to GlaxoSmithKline Plc rejecting the company’s application for a third indication for mepolizumab (Nucala). The application was to use the drug as an add-on treatment for patients with chronic obstructive pulmonary disease (COPD).
Announcing the rejection on 7 September, GSK said the FDA is requiring more data to support the proposed indication.
Nicox has begun a Phase 2 study of a candidate treatment for glaucoma designed to secure a position in global ophthalmology. The treatment, NCX 470, is being tested in patients with open-angle glaucoma, the most common form of glaucoma, accounting for about 90% of all cases.
As part of an ongoing out-licensing policy, AstraZeneca Plc has reached an agreement to transfer a candidate product for multiple system atrophy to Biohaven Pharmaceutical Holding Company Ltd of the US for further clinical development and commercialisation. The product, AZD3241, has completed a Phase 2a clinical study.