Democratic presidential hopefuls Sens. Cory Booker, D-N.J., and Bernie Sanders, I-Vt., have proposed legislation to establish a Bureau of Prescription Drug Affordability and Access and give the federal government the authority to control list prices and dismantle patent protections for drugmakers that don't cooperate. The Prescription Drug Affordability and Access Act would require companies to justify proposed prices by disclosing costs for research and development, marketing, and executive salaries, among other measures.
Comedian Billy Gardell and patient Jane Austin and featured in a web series about managing diabetes. Novo Nordisk created the series to promote its diabetes drug Ozempic.
Viracta Therapeutics' investigational candidate VRx-3996, or nanatinostat, in combination with valganciclovir, was granted fast track status by the FDA as a treatment for patients with relapsed or refractory lymphoid malignancies that are positive for the Epstein-Barr virus.
Shionogi's antibiotic Fetroja, or cefiderocol, was approved by the FDA as a treatment for complicated urinary tract infections in adults, including patients with kidney infections due to susceptible gram-negative bacteria. Fetroja was previously granted the Qualified Infectious Disease Product designation, giving it market exclusivity in the US for an additional five years.
An FDA panel unanimously recommended expanded approval for Amarin's fish oil-based drug Vascepa. The drug is intended as an addition to statins for reducing the chance of heart attack and strokes in high-risk patients.
Sarepta has partnered with StrideBio in a deal that launches with an upfront payment of $48 million to develop adeno-associated virus-based treatments for four targets -- Angelman syndrome, Dravet syndrome, Niemann-Pick disease and Rett syndrome.
Johnson & Johnson's newly approved Ebola vaccine will be tested in a real-world setting when it is administered to 50,000 people in the city of Goma in the Democratic Republic of Congo. "The introduction of a second vaccine is not meant to replace [Merck's] vaccine, but to complement it and hopefully provide us with an additional tool in the fight against future Ebola outbreaks," said John Johnson, project lead for the medical charity group Medecins Sans Frontieres.
North Carolina State University scientists have developed a group of recombineering tools that allow them to modify nearly any type of plant DNA, even crops such as rice, corn and tomatoes. Details of their work are reported in the journal The Plant Cell.
British gasification company Eqtec announced that its subsidiary, Eqtec Iberia SLU, will build a 1.18 megawatt biomass gasification plant to be located in France. The company also provided an update on its 2 MW biomass project underway in North Fork, Calif.
Cardinal Health and Magnolia Medical have partnered on a distribution deal involving Magnolia's Steripath Gen2 Initial Specimen Diversion Device, which reduces blood culture contamination. No details of the deal were disclosed.
- Page 1