Otsuka Pharmaceutical (TYO:4578) and Proteus Digital Health said today that the FDA accepted its resubmitted new drug application for their “smart pill”. The drug-device product combines Abilify and a Proteus ingestible sensor in a single tablet. The FDA is slated to make a decision on the NDA resubmission in the 4th quarter this year. Get the […]
Wall Street Beat
Bain Capital raises $720m life sciences fund
Bain Capital said today that it raised $720 million for its 1st investment fund focused exclusively on the life sciences sector. “We are excited by some of the long-term secular trends in the life sciences space,” Bain Capital Life Sciences managing director Adam Koppel said. “Big pharma is increasingly outsourcing R&D at the same time as many new […]
Private equity shop EQT leads the pack in chase for Ottobock
Private equity shop EQT is reportedly the leading bidder for a stake in Germany’s Ottobock, the world’s largest maker of artificial limbs, as talks with rival PE player CVC continue. EQT and CVC are vying for a 20% share in Ottobock’s bread-and-butter healthcare business ahead of an eventual public listing, “people familiar with the matter” told Reuters. Other bidders, […]
EnteroMedics jumps pre-market on BarioSurg buyout
EnteroMedics (NSDQ:ETRM) said today that it acquired BarioSurg and the gastric vest it developed to treat obesity, sending share prices surging in pre-market trading. The BarioSurg device is designed to be implanted via laparoscopy to wrap the stomach and emulate the effects of conventional bariatric surgery by temporarily reducing the stomach’s volume. St. Paul, Minn.-based […]
Anika touts Phase III data for Cingal knee therapy
Anika Therapeutics (NSDQ:ANIK) touted data today from a Phase III trial for its Cingal hyaluronic acid-corticosteroid combination viscosupplement as a treatment for osteoarthritis-related knee pain. The data showed that treatment with Cingal yielded better immediate and short-term pain relief compared to hyaluronic acid alone and better pain and stiffness relief through 26 weeks compared to saline. […]
Intersect ENT updates on Sinuva steroid-releasing sinus implant
Intersect ENT (NSDQ:XENT) said today that the FDA is slated to make a decision on its new drug application for the Sinuva steroid-releasing sinus implant by January 7, 2018. The Sinuva implant, which was previously called the Resolve implant, is placed during an in-office doctors appointment and is designed to be a treatment option for […]
Triple-combo inhaler for COPD wins recommendation for approval in EU
Chiesi Group said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended that the EMA approve its extra-fine triple combination inhaler for the treatment of chronic obstructive pulmonary disease. The Trimbow device combines an inhaled corticosteroid, a long-acting beta2-agonist and a long-acting muscarinic antagonist. The healthcare group said it is […]
QT Vascular shops coronary assets
QT Vascular said today that it’s in discussions to sell its coronary assets, apart from the Chocolate PTA device it’s already looking to deal to Medtronic (NYSE:MDT). Earlier this month, QT Vascular said Medtronic agreed to pay $28 million for an option on the Chocolate PTA non-drug-coated balloon for treating peripheral vascular disease, after inking a 5-year […]
EuroPCR Roundup: Bioresorbable stents show promise, but metallic drug-eluting stents remain standard
Abbott’s (NYSE:ABT) bioresorbable scaffold has been plagued with a myriad of troubling data, including a study that showed that the device is associated with an increase in thrombosis and target lesion failure. In April, Abbott pulled the stent from European markets. In response to widespread criticism of the technology, the EuroPCR team released a statement this […]
ViaCyte looks to cell replacement therapy to cure Type I diabetes
ViaCyte said today that it will begin clinical trials of its novel islet cell replacement therapy in development as a potential cure for Type I diabetes, after landing regulatory wins from the FDA and Health Canada. The company’s PEC-Direct candidate delivers stem cell-derived pancreatic progenitor cells in a device that is designed to enable direct […]
Alere ticks up on delayed Q4, 2016 prelims
Share prices ticked up today for Alere (NYSE:ALR) after the diagnostics company released long-delayed preliminary financial results for the 4th quarter and full year 2016. Waltham, Mass.-based Alere said in March that it would miss the deadline for releasing last year’s results due to an investigation of inappropriate conduct at its South Korean Standard Diagnostics subsidiary. It […]