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FDA Approvals: September 2022 Recap

Digital Pharmacist

CDER relies on its understanding of science and regulatory procedures to support and provide advice to pharmaceutical companies in testing and manufacturing, to then bring these new therapies to the market to aid patients and their health. The FDA granted the approval of Relyvrio to Amylyx Pharmaceuticals Inc.

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Remicade biosimilar options for affordable treatment

The Checkup by Singlecare

From a breakthrough drug to standard-of-care treatment, Remicade (infliximab) has a storied history of treating autoimmune disease —when the immune system mistakenly identifies healthy tissues as foreign and initiates an attack. Inflectra Approved by the FDA in 2016, Inflectra (infliximab-dyyb) was the first biosimilar to Remicade.

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Humira generic availability, cost, and dosage

The Checkup by Singlecare

While nonbiologic drugs are made with chemicals and have a known structure, most biologics are complex mixtures and cannot be easily identified or characterized, according to the Food & Drug Administration (FDA). Continue reading to learn more about FDA approved Humira biosimilars, which are made by various drug companies.

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Advancing microbiome innovation

European Pharmaceutical Review

The recent FDA approvals of two microbiome products in the US, in November 2022 and April 2023, 1-2 represent a significant milestone, maturing the industry and paving the way for advancement and regulatory clearance of additional microbiome products in broader indications. Notably, from one donor to another, significant variations exist.

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Innovation in biosimilars: Leading companies in neuro-degenerative receptor binding drug compositions

Pharmaceutical Technology

GlobalData’s analysis also uncovers the companies at the forefront of each innovation area and assesses the potential reach and impact of their patenting activity across different applications and geographies. AC Immune and F. Hoffmann-La Roche are the other key patent filers in neuro-degenerative receptor binding drug compositions.

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Developing a first-in-class small molecule drug for inflammatory disease

European Pharmaceutical Review

TNF-alpha is an immune modulating cytokine whose dysregulation can lead to prolonged inflammatory responses and is known to drive disease in a range of autoimmune and inflammatory disorders. MYMD-1 has shown effectiveness in pre-clinical and clinical studies in regulating the immune system.

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Incannex engages QPS for CannQuit and ReneCann

Pharmaceutical Technology

Australian pharmaceutical company Incannex has appointed Quest Pharmaceutical Services (QPS) to advance CannQuit-N (Nicotine), CannQuit-O (Opioid) and Renecann Products in the USA and the European Union (EU). French company Eurofins Scientific is currently developing and manufacturing both products.