Remove tag antibody-testing
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Roche’s Early Alzheimer’s Blood Test Gets FDA Breakthrough Device Designation

XTalks

Roche has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Elecsys pTau217 early Alzheimer’s blood test. This test, which is being co-developed with Eli Lilly, has the potential to facilitate earlier and more accurate detection of the disease.

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Sponsored content: Why choose Bethyl antibodies for your R&D

Drug Discovery World

For over 50 years, Bethyl Laboratories (now a Fortis Life Sciences brand) has been dedicated to improving lives by supporting scientific discovery through qualified antibody products and custom services. All of our antibodies are highly validated using six pillars of validation, meaning that our antibodies do what we say they’ll do.

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FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag

pharmaphorum

Daiichi Sankyo has been granted breakthrough status by the FDA for patritumab deruxtecan, a HER3-targeted antibody-drug conjugate (ADC) in clinical trials for lung cancer. The post FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag appeared first on.

Drugs 72
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With rivals threatening, Argenx scores key myasthenia gravis win

pharmaphorum

Argenx only recently scored FDA approval for its intravenous anti-neonatal FC receptor (FcRn) antibody Vyvgart for generalised myasthenia gravis (gMG), but is already looking to defend its franchise with a new subcutaneous version of the drug. After 29 days’ treatment IgG levels were reduced by 66.4% in the IV arm.

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ASH: Argenx cues up a second use for efgartigimod

pharmaphorum

Vyvgart is already approved to treat generalised myasthenia gravis, getting a green light for that indication from the FDA a year ago, and launched with a $225,000 per annum price tag in competition with rival gMG drugs like AstraZeneca/Alexion’s C5 inhibitor Soliris (eculizumab).

Sales 52
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Clover Biopharmaceuticals Announces Positive Phase 1 Data for its Adjuvanted S-Trimer COVID-19 Vaccine Candidates

The Pharma Data

S-Trimer adjuvanted with GSK’s pandemic adjuvant system induced neutralizing antibody titers (seroconversion) in 100% of participants at the selected 9 µg S-Trimer dose in both adult and elderly groups, with geometric mean titers (GMT) greater than 1:1,800. About Trimer-Tag © Technology. About COVID-19 S-Trimer Vaccine.

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Gilead tags Merck for first-line triple negative breast cancer trial

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Gilead’s Trop-2 targeting antibody-drug conjugate Trodelvy (sacituzumab govitecan) will be paired with Merck’s PD-1 inhibitor Keytruda (pembrolizumab) in a new phase 3 trial in previously-untreated subjects with locally advanced or metastatic TNBC. While its headline revenue of $7.4

Trials 52