close
The Wayback Machine - https://web.archive.org/web/20230206081950/https://pharmanewsintel.com/
  • FDA Commissioner Announces New Vision for Human Foods Program

    February 3, 2023 - Based on data and recommendations from an external review by the Reagan-Udall Foundation and the results of an internal study, FDA commissioner Robert M. Califf, MD, MACC, announced a new vision for the Human Foods Program. The concept includes plans to redesign the current prevention and response strategies. The external and internal reviews identified multiple issues with the current...

  • Abbvie Faces Competitor as a New Humira Biosimilar Comes to Market

    February 1, 2023 - On January 31, 2023, Amgen announced that its product AMJEVITA, a Humira biosimilar, is now available in the United States. This new availability threatens the stake that AbbVie has held for decades with its patent on Humira. For many years, Humira was one of the country’s best-selling prescription drugs, amounting to over $135 billion in sales across the US. Although the rollout...

  • FDA Issues Draft Guidance Regarding Lead Levels in Processed Baby Food

    January 31, 2023 - On January 24, 2024, the FDA issued a new draft guidance regarding lead levels in processed baby food meant for children under two as part of its Closer to Zero initiative. The Closer to Zero initiative is focused on researching, analyzing, regulating, and consulting contaminant levels in food, with its primary goal of reducing childhood exposure to contaminants, namely, arsenic, lead,...

  • FDA Issues Draft Recommendation for Updated Blood Donation Guidelines

    January 30, 2023 - On January 27, 2023, the FDA issued a press release linking its new draft recommendation for updated blood donation guidelines. These updated guidelines take a more modern and individual approach to blood donations, echoing the actions of multiple other developed nations, such as the United Kingdom and Canada. Historically, the United States blood donation system has discriminated...


Today's Top Stories

FDA Commissioner Announces New Vision for Human Foods Program

Based on data and recommendations from an external review by the Reagan-Udall Foundation and the results of an internal study, FDA commissioner Robert M. Califf, MD, MACC, announced a new vision for the Human Foods Program. The concept...

Senator Targets Amgen and Indivior Acquisitions for Antitrust Action

Last week, the Senator from Massachusetts, Elizabeth Warren, penned a letter to the Federal Trade Commission (FTC) where she characterized recent consolidation in the pharmaceutical industry as a threat to competition, innovation, and the...

Abbvie Faces Competitor as a New Humira Biosimilar Comes to Market

On January 31, 2023, Amgen announced that its product AMJEVITA, a Humira biosimilar, is now available in the United States. This new availability threatens the stake that AbbVie has held for decades with its patent on Humira. For many...

FDA Issues Draft Guidance Regarding Lead Levels in Processed Baby Food

On January 24, 2024, the FDA issued a new draft guidance regarding lead levels in processed baby food meant for children under two as part of its Closer to Zero initiative. The Closer to Zero initiative is focused on researching,...

FDA Issues Draft Recommendation for Updated Blood Donation Guidelines

On January 27, 2023, the FDA issued a press release linking its new draft recommendation for updated blood donation guidelines. These updated guidelines take a more modern and individual approach to blood donations, echoing the actions of...

NIH Published Draft Recommendation for Pandemic Pathogen Research

As public health officials become increasingly concerned about potential pandemic pathogen (PPP) research, the NIH has published a draft recommendation to guide future research policies and practices. The guidance analyzes and assesses the...

Flexible Prescribing Did Not Increase Buprenorphine Overdose Deaths

Despite common misconceptions, researchers published an article in JAMA Network Open noting that buprenorphine overdose-related deaths did not increase during the COVID-19 pandemic when providers were allowed flexible...

View all stories