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EHA21: Sanofi builds case for rare disease drug sutimlimab after FDA rejection

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Sanofi’s hopes of a speedy approval of first-in-class C1s inhibitor sutimlimab in rare disorder cold agglutinin disease (CAD) were dashed by the FDA, but new phase 3 data keep the drugmaker on track for a resubmission before year-end. Sutimlimab, which Sanofi acquired via its $11.6

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Eli Lilly and Gilead’s combination cuts COVID-19 recovery time

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Lilly is continuing talks with the FDA around the potential for an Emergency Use Authorisation for Olumiant, which has been approved since 2018 in the US to treat rheumatoid arthritis. The drug works by inhibiting janus kinase (JAK1 and JAK2), which has the effect of reducing the activity of the immune system.

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FDA fast-tracks Leap’s gastric cancer immunotherapy

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Leap Therapeutics will get a swift FDA review for its lead drug DKN-01 for a form of gastric and gastroesophageal junction (G/GEJ) cancer after being awarded fast-track status by the regulator. In animal models, neutralising DKK1 has been shown to activate an innate immune response against malignant cells.

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Samsung Biologics, National OncoVenture, and Eutilex obtains IND Approval from FDA

Pharma Mirror

KS) announced another successful Investigational New Drug (IND) clearance from the FDA for its client to begin clinical trials on a cancer immunotherapy, furthering the company’s track record as a premiere CDO service provider in the global market. Samsung Biologics (KRX: 207940.KS) We are extremely glad to.

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ExeVir ready for clinic with variant-targeting llama antibody

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Regeneron and Eli Lilly have already got antibody therapies on the market following emergency approvals by regulators including the FDA but pharma companies are beginning to focus on the threat posed by emerging variants. billion acquisition at the end of 2018, span out of VIB in 2001 and developed drugs based on similar technology.

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How effective is Shingrix?

The Checkup by Singlecare

This rash-causing virus is certainly prevalent, but it’s also avoidable thanks to immunizations like Shingrix. Shingrix contains dead pieces of this virus, called antigens, and adjuvant proteins, which allow the immune system to bolster its defenses against it. “By For most people, yes. a pharmacist, speaker, and medical writer.

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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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