DUBLIN – Enterprise Therapeutics Ltd. raised £29 million (US$41 million) in a series B round to take forward a pipeline of preclinical drug development programs that focus on impaired mucociliary clearance, a pathophysiological mechanism common to chronic respiratory diseases such as cystic fibrosis, chronic obstructive pulmonary disease and severe asthma. Read More
Adynxx Inc. used the same measure to select trial patients as other pain drug developers have used to weed them out – the Pain Catastrophizing Scale (PCS) – and arrived at what the company is calling a phase II success that greases the skids for a non-opioid phase III in a hard-to-treat patient sector. Read More
Genevant Sciences Ltd., a new Cambridge, Mass.-based venture with $37.5 million in committed seed funding from Roivant Sciences Ltd., is aiming to get five to 10 RNA-based therapies into the clinic by 2020 using technology from Vancouver, British Columbia-based Arbutus Biopharma Corp. The jointly owned company will develop RNAi, mRNA and gene editing candidates in-house, a departure from Roivant's typical in-licensing strategy. Genevant will focus on a wide range of genetic diseases, both orphan and non-orphan, Roivant spokesman Paul Davis told BioWorld. Read More
LONDON – Glaxosmithkline plc is divesting Strimvelis, the only approved gene therapy in Europe – along with the rest of its rare disease gene therapy portfolio – to privately held Orchard Therapeutics Ltd., in return for a 19.9 percent stake in the London-based startup. Read More
In what was surely music to the ears of drug and device innovators, the new director of the U.S. Patent and Trademark Office (USPTO) vowed to bring more predictability to the patent system – even if that means some improvising of the inter partes review (IPR) process. Read More
PERTH, Australia – Another battle is brewing over Australia's Research and Development Tax Incentive in the lead up to the annual Federal Budget that is released in early May. Read More
Argenx NV, of Breda, the Netherlands, achieved the third payment-triggering milestone in its collaboration with Leo Pharma A/S, of Ballerup, Denmark, for the approval of a CTA for ARGX-112. Read More
Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., said it secured $16.25 million in new equity capital with several professional high net worth investors. Read More
The FDA Thursday issued a draft guidance, Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination, that should ease the regulatory burden of developing a companion diagnostic for use with an investigational cancer drug or biological product. Read More
