Tag Archives: AI

Real-World Data Supports Biohaven Drug, Facilitating FDA Submission for Untreated Neurological Condition

Real-World Data Supports Biohaven Drug, Facilitating FDA Submission for Untreated Neurological Condition

Biohaven has been persevering with the development of troriluzole, a drug aimed at treating the rare neurodegenerative disorder spinocerebellar ataxia (SCA), despite a series of clinical trials and regulatory setbacks. This persistence seems poised to pay off as the company approaches a new drug application, leveraging a novel approach using real-world data to satisfy regulatory […]

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FDA releases draft guidelines for biocompatibility testing of devices

FDA releases draft guidelines for biocompatibility testing of devices

The Food and Drug Administration (FDA) has released a new draft guidance aimed at improving the biocompatibility assessments of medical devices. This guidance was published in response to consistent inadequacies the FDA has observed within premarket submissions, which seem to stem from lab-to-lab variability in analytical chemistry methods. This inconsistency in report outcomes has prompted […]

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Stryker Acquires Nico, Expands Portfolio with Devices to Remove Brain Tumors and Clots

Stryker Acquires Nico, Expands Portfolio with Devices to Remove Brain Tumors and Clots

Stryker Corporation has enhanced its portfolio by acquiring Nico Corporation, marking its fourth takeover in recent months. This acquisition brings into Stryker’s fold Nico’s advanced minimally invasive solutions geared toward brain tumor removal and stroke care. Nico has developed an array of devices designed for navigating and visualizing the brain, excising tumors and clots, and […]

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AI-Created Drug Shows Promising Results in Lung Disease Treatment, Though Competitors Lead

AI-Created Drug Shows Promising Results in Lung Disease Treatment, Though Competitors Lead

Insilico Medicine, a company that leverages artificial intelligence (AI) technology for drug discovery, has developed a drug candidate named ISM001-055 aimed at treating idiopathic pulmonary fibrosis (IPF), a chronic lung disorder that causes irreversible scarring and declines in lung function. The disease, affecting around 5 million people worldwide, primarily older adults, sees a median survival […]

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Overcoming Obstacles: The Importance of Accessibility in PTSD Treatment Beyond MDMA

Overcoming Obstacles: The Importance of Accessibility in PTSD Treatment Beyond MDMA

The pressing issue of Post-Traumatic Stress Disorder (PTSD) in the United States, affecting 13 million citizens including a substantial number of women and veterans, highlights a critical area of concern in healthcare. PTSD, triggered by traumatic experiences ranging from assault to natural disasters, has shown that current standard-of-care therapies are insufficient for many, with approximately […]

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7 Key Insights from Providence’s Chief of Virtual Care Fireside Chat

7 Key Insights from Providence’s Chief of Virtual Care Fireside Chat

Dr. Eve Cunningham, Chief of Virtual Care and Digital Health at Providence, highlighted several pressing issues faced by health professionals today during her interview at the INVEST Digital Health conference. As an OB-GYN specialist, she discussed the overwhelming nature of the Electronic Medical Record (EMR) system. Originally, patient charts comprised a mere folder with a […]

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Millions Use a Drug That Fails to Fulfill Its Promise of Reducing Heart Attack Risk

Millions Use a Drug That Fails to Fulfill Its Promise of Reducing Heart Attack Risk

Heart disease has been the top cause of mortality in the United States for over a century, despite significant advancements in understanding and treating this complex condition. Although there are numerous treatment options available that can minimize the risk of severe cardiovascular incidents such as heart attacks or strokes, there is a persistent issue with […]

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Organon Expands Dermatology Presence with Acquisition of Roivant’s Skin Care Subsidiary

Organon Expands Dermatology Presence with Acquisition of Roivant’s Skin Care Subsidiary

Organon is expanding its presence in the dermatology sector through an acquisition of Dermavant, a subsidiary of Roivant Sciences, primarily focusing on a commercialized plaque psoriasis treatment that may soon be applicable to atopic dermatitis, a more common inflammatory skin condition. Organon’s deal could total up to $1.2 billion, with an upfront payment of $175 […]

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FDA Approves Zevra Drug as First Treatment for Rare, Deadly Metabolic Disorder

FDA Approves Zevra Drug as First Treatment for Rare, Deadly Metabolic Disorder

Zevra Therapeutics recently received FDA approval for its drug Miplyffa, marking a significant development as it becomes the first approved therapy for Niemann-Pick disease type C (NPC), a severe and often fatal metabolic disorder. This approval is particularly impactful as NPC, a rare inherited condition, affects the central nervous system and can lead to death […]

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