Bioverativ agreed to purchase True North Therapeutics in a deal worth up to $825 million, giving Bioverativ worldwide rights to True North's monoclonal antibody TNT009, indicated for the treatment of cold agglutinin disease. Bioverativ was spun off from Biogen earlier this year.
BarioSurg, along with its Gastric Vest System, has been acquired by EnteroMedics for $2 million in cash, 1.38 million unregistered shares of EnteroMedics common stock and 1 million unregistered shares of convertible preferred stock. As part of the transaction, BarioSurg founder and former CEO Raj Nihalani, who invented the Gastric Vest technology, has been tapped to serve as chief technology officer at EnteroMedics.
A higher rate of serious side effects related to heart problems was observed in a late-stage trial of Amgen and UCB's Evenity, or romosozumab, which is intended for treatment of patients with osteoporosis. Serious heart-related problems were reported in 2.5% of patients who received Evenity compared with 1.9% who were given Merck's Fosamax treatment.
A new-drug application has been resubmitted to the FDA by Otsuka Pharmaceutical for its antidepressant Abilify, or aripiprazole, in combination with Proteus Digital Health's ingestible sensor, which allows transmission of psychological data to a patient-worn sensor and app. The FDA had requested more information regarding human factor studies after the company's original filing.
President Donald Trump proposed higher user fees to offset lower FDA funding in his 2018 budget request, but Sen. Lamar Alexander, R-Tenn., has said that the user fee reauthorization bills have been agreed on and will not be renegotiated.
A bill introduced in the House seeks to amend the Federal Food, Drug, and Cosmetic Act to streamline the review process for certain medical devices through an alternative standard. The measure's proposed approach "does nothing to change FDA's robust requirements, but would allow a more efficient process for both the agency and product sponsors," said AdvaMed President and CEO Scott Whitaker.
Success demands resilience in the face of rapidly evolving cyberrisks. Digitization and connectivity drive cost efficiency, speed and better customer experience. These same trends also expose the enterprise to rapidly evolving cyberrisks. Join us at 11 a.m. Eastern on Tuesday, May 30, for the "Are You Ready?" webinar series, in which we will explore actionable ways for organizations to achieve cyberresilience. Register.
On May 12 we experienced one of the most widespread cyberattacks in history. WannaCry, a ransomware virus, hit computers in London, locking computer screens and demanding a ransom of up to $600 in bitcoin to unlock them. Businesses have consistently rated cyberthreats as one of top risks they face, and this most recent event reminds us why. "WannaCry's wormlike behavior and its ability to easily propagate across the organization make this a particularly dangerous strain of ransomware," says Ed Stroz, co-president of Stroz Friedberg, an Aon company. With cyberrisk on the rise and business interruption a growing concern, what key lessons can organizations learn from the WannaCry incident? Read more.
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