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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 Int J Drug Policy. doi:10.1016/j.drugpo.2024.104587

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Educating Patients about Generic Drugs: Strategies for Success

Drug Patent Watch

Generic drugs play a crucial role in providing affordable medication options to patients. As healthcare professionals, it’s our responsibility to educate patients about generic drugs and empower them to make informed decisions about their treatment options. What Are Generic Drugs?

Drugs 71
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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

To increase demand for products during the novel coronavirus pandemic, the US Food and Drug Administration (FDA) has already approved at-home testing and investigated the effectiveness of malaria pills and other antiviral drugs to treat Covid-19 9. FDA approves first treatment for Covid-19. Source link.

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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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Drug labeling authority, UDI program reviewed by Harvard-based researchers

The Pharma Data

The authority to change drug labels outside of considerations for new safety information “could encourage third parties, such as academic investigators, insurance companies, and cooperative trial groups, to initiate such changes,” they wrote. . Posted 17 May 2021 | By Jeff Craven .

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Keeping Your Company’s Federal Contracting Options Safe in the Face of Pending BIOSECURE Act Legislation

FDA Law Blog: Biosimilars

Effect on FDA approvals— In cases where a biological product or drug needs to change aspects of its manufacturing processes to avoid using a covered equipment or service, will it need to file supplements with FDA for the CMC update?