An addition to In2Bones Global's CoLink Forefoot Bone Plating System intended for bone stabilization in post-surgical healing has been granted clearance by the FDA. The company will market the addition under its existing CoLink View brand.
ERS Genomics granted Charles River Laboratories nonexclusive access to CRISPR-Cas9 patents. Charles River intends to use the technology with its short hairpin RNA library to develop knock-in and knockout cell lines with drug discovery applications.
An orphan drug designation was granted by the FDA to Spruce Biosciences' SPR001, which is being developed to treat patients with congenital adrenal hyperplasia. The company anticipates top-line data from an ongoing midstage study evaluating the safety and efficacy of the drug next year.
A follow-on financing round raised $276 million for GW Pharmaceuticals. The company recently filed a new-drug application for Epidiolex, or cannabidiol, for Dravet and Lennox-Gastaut syndrome, and intends to submit to the European Medicines Agency a marketing application of the drug for the same indications.
The reform of the Renewable Fuel Standard could be on its way following confirmation of a meeting between President Donald Trump and nine senators. The Trump administration had ruled in favor of reforming the biofuels policy in a way that will protect jobs in the agriculture and refining industries.
Stryker agreed to pay $662 million for Entellus Medical in a deal that represents about a 50% premium to Entellus' closing share price Wednesday. Entellus' portfolio of minimally invasive devices, designed for treating ear, nose and throat diseases, is expected to complement Stryker's instrument business.
Edwards Lifesciences unveiled its goals for 2018 at its annual investor conference, saying it expects to see about 12% earnings growth on a sales gain of about 9% next year as it continues to make aggressive investments to provide patients with breakthrough treatments. Edwards said it is looking to reach some "meaningful clinical milestones" that will indicate its progress in accelerating transcatheter mitral and tricuspid programs and launch a number of products, including its Inspiris surgical valve, in the US and Europe next year.
A deal with investors brought in about $50.2 million for London-based Advanced Oncotherapy, which makes next-generation proton therapy systems for treating patients with cancer. The money, which will be provided in three tranches, will be used for continued technical development of the first LIGHT system, as well as to install the system at a facility in London.
A round of Series C financing pulled in $28.7 million for Lumicell, a Wellesley, Mass.-based company that develops technologies for image-guided cancer surgery. The proceeds will be used for continued development of the company's LUM System pipeline, including plans for a pivotal trial in breast cancer and expansion of studies in four more solid tumor cancers.