Tristan Mañalac

1 week ago | biospace.com | Tristan Mañalac

The FDA has three big decisions slated for the back half of April, two of which are for Regeneron’s blockbuster franchises. Read below for more. Following an initial rejection in October 2023, Regeneron and Sanofi are again trying to expand their anti-inflammatory antibody Dupixent into chronic spontaneous urticaria (CSU). The FDA’s decision is due on April 18. To support their bid for label expansion, the pharma partners submitted data from the Phase III LIBERTY-CUPID clinical program.

1 week ago | biospace.com | Tristan Mañalac

Senators Todd Young (R-IND) and Alex Padilla (D-CA) on Thursday filed a bill to help revitalize biotech in the U.S. as a key component of national security and economic productivity. The bill seeks to establish the National Biotechnology Coordination Office (NBCO), which would reside under the Office of the President and be responsible for harmonizing federal initiatives on biotech and for streamlining regulatory pathways.

2 weeks ago | biospace.com | Tristan Mañalac

Amgen’s anti-CD19 antibody Uplizna showed durable and deepening treatment effects for patients with generalized myasthenia gravis, maintaining improved function and disease activity through 1 year of follow-up, according to a data drop on Wednesday. Leerink analysts in a Wednesday note said that responses to Uplizna “progressively improved out to week 52,” adding that its end response is “comparable” to other drugs in the same therapeutic class, such as UCB’s Rystiggo and argenx’s Vyvgart.

2 weeks ago | biospace.com | Tristan Mañalac

The Fourth Circuit Court of Appeals on Tuesday reversed a lower court’s order to reinstate thousands of federal workers previously fired by the Trump administration, including more than 2,000 probationary workers at the Department of Health and Human Services. In its ruling on Tuesday, the appellate court took the government’s side, noting that the district court “lacked jurisdiction” over the case.

2 weeks ago | biospace.com | Tristan Mañalac

President Donald Trump appears to be making good on his threats to the pharma industry, announcing on Tuesday that “major” tariffs are coming, in an attempt to force companies to move their manufacturing operations to the U.S., according to several media reports. Speaking in front of the National Republican Congressional Committee, Trump said “we’re going to be announcing very shortly a major tariff on pharmaceuticals,” according to reporting from The Guardian.