The U.S. House of Representatives passed two spending packages that boosted funds for both the FDA and the NIH, but device and generic drug makers saw other benefits. The House legislation would allow makers of biosimilars and generic drugs to sue brand names for blocking access to the index article, but also repealed the medical device tax, a change that would bolster development of the novel therapies that are the industry’s lifeline. Both spending bills carry numerous provisions related to the health care economy and will go to the Senate for passage, hopefully before the government runs out of money Dec. 20. Read More
Medford, Mass.-based startup Sofregen Medical Inc. has picked up $8 million in a series B round led by Anzu Partners LLC. The money is earmarked for continued development of Sofregen’s silk protein-based technology and for commercialization of its U.S. FDA-cleared Silk Voice for people with vocal cord problems. Read More
San Francisco-based Velano Vascular Inc. has closed the second tranche of a $25 million financing that is slated to back ongoing commercialization of its PIVO device that uses an existing peripheral IV line for a blood draw. It also aims to roll-out a new, undisclosed product in 2020. Read More
Digital therapeutics have made great strides in recent years, with Pear Therapeutics Inc. playing a key role. Now, the company has reported the dosing of the first patient in part two of a study assessing Pear-006 – which Pear Therapeutics is developing in collaboration with Basel, Switzerland-based Novartis AG – to address depressive symptoms in multiple sclerosis (MS). Read More
TORONTO – “I don’t want this to die in the lab. We’re putting a lot of effort into this and we have to commercialize it.” With those words Oleksandr Bubon, chief technology officer of Thunder Bay, Ontario-based startup Radialis Inc., in 2016 reported ambitious plans for an imaging device that detects early stage cancer tumors in the densest breast tissue. Not only will its novel “gapless” design prevent radiation needed to treat cancer cells from escaping, a common problem in conventional positron emissions tomography (PET), its manufacture and commercialization starts here in a northern Ontario city of just over 110,000 people. Read More
