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The future of AI drug discovery & development in immunology and GPCR research

pharmaphorum

A mere six months ago Verily launched the study with Sosei Heptares – a global leader in GPCR structure-based drug design – with an aim to “prioritise protein targets for therapeutic targeting in immune-mediated disease”. Verily’s Immune Profiler can, Kim asserted, “generate more than 8 million immune measures across 24 immune cell subsets”.

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The next generation of immunotherapy? Innate Pharma targets NK cells

pharmaphorum

Founded in 1999, Marseille-based company Innate Pharma is on a mission to develop immunotherapies that take advantage of the body’s innate immune system. The cytokine release prompts T-cells so they can translate that first innate immune response into a long-lasting adaptive immune response.

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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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Trial bias concern scuppers Y-mAbs brain cancer drug in FDA vote

pharmaphorum

Shares in US biotech Y-mAbs Therapeutics have lost almost a third of their value after FDA advisors unanimously rejected its brain cancer therapy 131I-omburtamab in 16 to 0 vote. Changes in standard and supportive care over the time period could also have skewed the results, said the FDA reviewer.

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FDA hands Cassiopea its first approval, for acne drug Winlevi

pharmaphorum

Shares in dermatology specialist Cassiopea, which is listed on the SWX exchange in Switzerland, rose almost 17% after news of the FDA approval emerged. Cassiopea spun out of Ireland-domiciled Cosmo Pharma in 2015. The post FDA hands Cassiopea its first approval, for acne drug Winlevi appeared first on.

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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

The FDA Law Blog

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Javitt & Michael D. Shumsky & Philip Won & Adrienne R. Gaulkin & Jeffrey N.

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Can you take Zyrtec while pregnant?

The Checkup by Singlecare

Being pregnant doesn’t make you immune from allergies—and, in some cases, many find that their allergy symptoms actually get worse during pregnancy. The FDA is beginning to move away from that rating system, says Alyssa Dweck , MD, an OB-GYN and medical adviser for INTIMINA.

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