Opinion: Making the promise of monoclonal antibody therapies available to all
As the U.S. grapples with the lasting effects of the Covid-19 pandemic, it is important…
Category: biologics
Opinion: What does ‘bona fide competition’ actually mean in the biologics market?
On Aug. 29, Medicare released its highly anticipated list of 10 therapies for which it…
STAT+: A Supreme Court review of a contentious patent issue would change the way pharma claims discoveries
In the coming weeks, the Supreme Court is expected to decide whether to review a…
STAT+: FDA approves the first interchangeable biosimilar insulin. Will it really lower the cost?
In a long-awaited move, the Food and Drug Administration has approved the first so-called interchangeable…
Opinion: STAT+: Three steps toward creating a functioning U.S. biosimilars market
The development of safe, effective, and innovative biologic medicines is one of modern medicine’s far-reaching…
Opinion: Three steps can help companies speed FDA approval of new drugs
Drug developers see Food and Drug Administration approval as a difficult uphill climb, requiring large…
Opinion: The Biden administration needs to look beyond ICER for evaluating drug therapies
As breakthrough drugs stream out of biopharmaceutical laboratories, how much they should cost and who…
STAT Plus: Will the ‘patent dance’ cause Amgen to temporarily pull a biosimilar off the market?
In a closely watched case, a federal appeals court must decide whether a biosimilar company…
STAT Plus: Startup Spotlight: Going after immune regulators when they cause disease instead of prevent it
Q32 Bio has two targets in its sights: the two arms of the immune system….
Opinion: Five years on, biosimilars need support from all health care players
Today marks a milestone for the U.S. biosimilar market: the FDA approved our first biosimilar,…
Opinion: From bench to bedside, biologics require excellence at every stage
The Nobel Prize in Medicine will never be awarded for excellence in the formulation and…
Opinion: Biologics lose protection as U.S.-Canada-Mexico trade agreement moves forward
The excision of a key term in the pending United States-Mexico-Canada trade agreement (USMCA), which…
STAT Plus: Lawmakers slip a win for pharma into federal spending package
WASHINGTON — Lawmakers quietly tucked a boost for the pharmaceutical industry in the massive, end-of-year…
STAT Plus: Facing bottlenecks in manufacturing cell therapies, Boston leaders plan to build their own
A group of leading Boston-area universities, hospitals, and corporations will create a new center for…