BioPharma Dive

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A judge blocked the FDA’s plan to regulate lab developed tests. What now?

1 week ago | biopharmadive.com | Susan Kelly

The Food and Drug Administration’s attempt to increase regulatory scrutiny over laboratory developed tests appears to be dead, much to the relief of clinical labs. The FDA is unlikely to appeal the March 31 federal court order that set aside a final rule asserting the agency’s jurisdiction over LDTs, attorneys who handle regulatory matters said in interviews.
Bluebird says Ayrmid missed deadline for rival takeover bid

1 week ago | biopharmadive.com | Gwendolyn Wu

Bluebird bio is still waiting on a binding takeover bid from Ayrmid Ltd., three weeks after the company said it would pay $15 million more than SK Capital and Carlyle Group offered for the gene therapy maker. In a Wednesday statement, Bluebird board chair Mark Vachon said Ayrmid has yet to present a binding offer or acquire the financing necessary to complete its $45 million proposal.
Startup Glycomine raises $115M to push rare disease drug deeper into testing

1 week ago | biopharmadive.com | Gwendolyn Wu

Glycomine, a biotechnology startup working on a treatment for a rare genetic disorder, has raised a $115 million Series C round to push its lead program deeper into clinical testing. The funding announced Wednesday for the San Carlos, California-based company will support development of its therapy GLM101, which is designed to treat phosphomannomutase 2-congenital disorder of glycosylation, or PMM2-CDG.
Health department layoffs may be illegal, experts say

1 week ago | biopharmadive.com | Rebecca Pifer

The mass layoffs that swept the U.S. health department this month were chaotic and stressful for employees. They may also have been illegal, according to lawyers and federal employment experts. Healthcare Dive spoke to more than a dozen current and former employees at the Department of Health and Human Services, all of whom shared aspects of the reduction-in-force that don’t match how the process is typically done.
J&J keeps forecasts steady as pharma confronts tariff threat

1 week ago | biopharmadive.com | Ned Pagliarulo

Johnson & Johnson is confident it can manage the impact of tariffs on its pharmaceuticals and medical device businesses this year, announcing Tuesday that it will maintain its financial forecast for the year while raising its sales guidance. J&J, which is the first large drugmaker to report results for the first quarter, expects adjusted earnings per share of $10.60 for 2025.
US launches probe that could set stage for pharma tariffs

1 week ago | biopharmadive.com | Ned Pagliarulo

This audio is auto-generated. Please let us know if you have feedback. The Trump administration is investigating the effects of pharmaceutical imports on national security, disclosing Monday a probe that is likely to lay the foundation for sector-wide tariffs in the near future. The investigation, which was announced in a federal notice posted online, appears to be wide-ranging, covering branded and generic medicines, as well the active drug ingredients they contain.
Pharma bosses face down investor angst on tariffs, HHS chaos

1 week ago | biopharmadive.com | Ned Pagliarulo

Pharmaceutical executives are likely to get asked many variations on the same few questions this earnings season as Wall Street seeks answers on how well their businesses will weather the storms now damaging the sector. President Donald Trump has roiled global markets by imposing, and then pausing, steep tariffs on U.S. imports.
Third Harmonic outlines plans for dissolution

1 week ago | biopharmadive.com | Gwendolyn Wu

Third Harmonic Bio plans to wind down operations and sell its assets, including its lead drug candidate, in a liquidation plan the company announced Monday. If approved by stockholders at an annual meeting in early June, the immune drug developer will dissolve in the third quarter of 2025.
FDA plans to phase out animal testing for some drugs

1 week ago | biopharmadive.com | Ned Pagliarulo

The Food and Drug Administration aims to phase out animal toxicology testing for experimental drugs, announcing Thursday a plan to reduce, revise or replace such requirements in favor of newer methods that are more “human relevant.” The agency’s plan outlines several steps by which it intends to move away from considering animal testing the default approach, including by encouraging drugmakers to adopt other methods, like “organ-on-a-chip” systems or computational modeling.
Medtech industry pressures White House to exempt devices from tariffs

2 weeks ago | biopharmadive.com | Ricky Zipp

AdvaMed and nine other healthcare organizations continue to pressure the White House to exempt medical devices and critical supplies from the Trump administration’s tariff policies. AdvaMed, one of the largest medical device industry groups, and organizations including the American Dental Association, the Association of American Medical Colleges and America’s Essential Hospitals sent a letter on April 1 to Jamieson Greer, the White House’s top trade negotiator.