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WuXi Biologics Unveils WuXiHigh™ 2.0 for Ultra-Concentrated Biologics

The Pharma Data

Currently, more than 20% of FDA-approved monoclonal antibodies (mAbs) fall into this category, reflecting a growing industry trend. High viscosity , aggregation risks , and stability issues often complicate both upstream and downstream processes, including manufacturing, packaging, and storage. WuXiHigh™ 2.0: WuXiHigh™ 2.0:

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Limited Evidence for Nalfmefene

Common Sense for Drug Policy Blog

Limited Evidence for Nalfmefene "In 2021, due to the widespread availability of high-potency synthetic opioids like fentanyl, the US FDA approved two high-dose naloxone products, an 8 mg IN spray (Kloxxado) and a 5 mg IM injectable (Zimhi). In 2023, the FDA approved a 2.7

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Impulse Dynamics Announces FDA Approval for Magnetic Resonance Imaging

The Pharma Data

Further, combined with the early successes in improving cardiac performance, now when combined with MRI compatibility, CCM adds to the armamentarium of the cardiologist and electrophysiologist in further optimizing FDA-approved medical therapies in 2021.”

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New gene delivery vehicle shows promise for human brain gene therapy

Broad Institute

But FDA-approved forms of the most commonly used vehicle for packaging and delivering these therapies to target cells, adeno-associated viruses (AAVs), aren’t able to efficiently cross the blood-brain barrier at high levels and deliver therapeutic cargo.

Therapies 137
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Keeping tabs on Covid-19: FDA approves Veklury as first treatment for Covid-19 and Takeda and Moderna bring 50 million vaccines to Japan

The Pharma Data

Dive into this week’s update for more details on the actions taken by the FDA in the ongoing response to the Covid-19 pandemic. FDA approves first treatment for Covid-19. On October 22, the FDA approved the antiviral drug Veklury for use in adult and pediatric patients for the treatment of Covid-19 requiring hospitalization.

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What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Law Blog: Drug Discovery

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies 119
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Researchers reprogram gene therapy viral vectors to bind specific protein targets

Broad Institute

By Allessandra DiCorato July 19, 2023 Credit: Kevin Middleton, Broad Communications A three-dimensional model of adeno-associated viruses (AAVs), which scientists have engineered to package and deliver gene therapies to cells in the body.