Policy
The administration’s direct-to-consumer pharmaceutical sales platform will offer products from Eli Lilly, Pfizer, Novo Nordisk, Amgen and more at a discount, though the impact of such pricing remains to be seen.
FEATURED STORIES
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
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Teva expects to finalize and complete the documentation needed in the coming weeks, followed by a nationwide sign-on process for states, subdivisions and Native American tribes.
Martin Shkreli, commonly known as the “Pharma Bro,” announced Monday he has cofounded Druglike, a Web3 drug discovery software platform, despite a lifetime ban from the pharma industry.
WHO declared the monkeypox outbreak a “public health emergency of international concern [PHEIC].” As COVID-19 wanes, Tonix, SIGA, Emergent Bio and others are now targeting monkeypox.
The U.S. Attorney’s Office was busy indicting nine people for charges related to insider trading. Some charges were unrelated, but three were specific to the biopharma industry.
The complaint alleges the agencies made an error under the Administrative Procedure Act, violating the Food Drug and Cosmetics Act by failing to approve Lumryz.
The announcement signals that the WHO now views the outbreak as significant enough that a coordinated global response is necessary to control it.
FDA Weekly Review looks at the FDA’s actions related to drug approvals, IND approvals, designations and more. Here’s a look at what happened this week.
Pfizer and Flynn Pharma are under the scrutiny of British watchdogs once again, after officials said the companies have been overcharging for an anti-epilepsy medication in the U.K. for over four years.
The whistleblower claim was brought by former employee Michael Bawduniak, who accused the company of paying off doctors to favor its multiple sclerosis drugs over those of its competitors.
Sandoz hopes its high-concentration formulation of an already greenlit biosimilar will be approved by the time AbbVie’s blockbuster drug Humira loses patent protection in the United States.