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3 weeks ago | 
bio.news | Clary Estes
April is Sarocoidosis Awareness Month, an opportunity to raise awareness, promote understanding and research, and create hope for the affected patients and their families.
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1 month ago | 
bio.news | Clary Estes
As part of BIO’s March Patient Advocacy Coffee Chat, Thomas Heymann, President & CEO of Sepsis Alliance, spoke about sepsis—a life-threatening condition caused by the body’s immune system overreacting to an infection—and its link to rare diseases and antimicrobial resistance (AMR). Antimicrobial resistance—or AMR—occurs when the bacteria, viruses, or fungi that make people sick adapt to the antimicrobial medicines designed to treat them and become resistant to those medications.
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1 month ago | 
bio.news | Clary Estes
The Food and Drug Administration’s (FDA) Rare Pediatric Disease Priority Review Voucher (PPRV) Program was top of mind during BIO’s March Patient Advocacy Coffee Chat: Show Your Stripes! The conversation brought together patient advocacy leaders and illustrated both the urgent need for incentives to support rare disease drug development and the power of patient advocacy.
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1 month ago | 
bio.news | Clary Estes
March 8th is International Women’s Day and to mark the occasion, Bio.News is exploring an under researched field of women’s health – autoimmune diseases – with the Society for Women’s Health Research. Despite women making up half of the population, women’s health is still woefully researched and underfunded. This is not only to the detriment of women, but also to biotech innovation as a whole.
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1 month ago | 
bio.news | Clary Estes
“Kidney disease is a major and growing public health concern,” LaVarne A. Burton, American Kidney Fund President and CEO, said in an interview with Bio.News.
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2 months ago | 
bio.news | Clary Estes
The Centers for Medicare & Medicaid Services (CMS) recently announced the 2025 selection of 15 drugs covered under Medicare Part D for price “negotiations” under the Inflation Reduction Act (IRA). The list covers many therapeutic areas, from diabetes and cancer to asthma, arthritis, and more.
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2 months ago | 
bio.news | Clary Estes
Drug development in the rare disease space has seen a vast amount of innovation in recent years, with a number of groundbreaking therapies coming to market. Yet, the unmet need remains high. “There are more than 10,000 rare diseases, and almost none of them have treatments,” said Karin Hoelzer, Senior Director of Patient Advocacy at the Biotechnology Innovation Organization (BIO) at the Goodwin Rare Disease Symposium on February 5 in Boston.
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2 months ago | 
bio.news | Clary Estes
The U.S. Food and Drug Administration’s Accelerated Approval Pathway enables the timely development of treatments for severely ill patients who have few if any other treatment options. It allows for the approval of a treatment on the basis of an intermediate or surrogate endpoint that is reasonably likely to predict clinical benefit.
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2 months ago | 
bio.news | Clary Estes
Despite a pressing demand, schizophrenia has had limited treatment. “Roughly 1% of the entire world population has schizophrenia,” said Boobalan Pachaiyappan, Managing Director and Senior Biotech Analyst at Roth Capital Partners, moderating a panel, Tackling Mental Health through New Targets and Endpoints Progress, during the 2025 Biotechnology Innovation Organization (BIO) CEO and Investor Conference.
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2 months ago | 
bio.news | Clary Estes
The idea of AI supercharging drug development is stirring a lot of excitement. However, a realistic understanding of what AI can and can’t do is important for anyone who wants to understand the innovation and investment potential, explained panelists at the 2025 Biotechnology Innovation Organization (BIO) CEO and Investor Conference in New York. The Feb.
