BioCentury | Apr 13, 2021
Product Development

FDA requests more data from Provention; plus Iterum, Seagen-Genmab, Pfizer and Gilead

...review of Pfizer’s abrocitinib, XeljanzPfizer Inc. (NYSE:PFE) said FDA has extended the review period for JAK-1...
...adults and adolescents from April to early 3Q21. The agency also extended the review period for JAK...
...sacituzumab govitecan (hRS7-SN-38, IMMU-132) Iterum Therapeutics plc Seagen Inc. Genmab A/S Pfizer Inc. Gilead Sciences Inc. Tissue factor (TF) (CD142) (thromboplastin) Janus kinase-1 (JAK-1) Tumor-associated...
BioCentury | Apr 10, 2021
Product Development

Baricitinib improves on SOC survival benefit in hospitalized COVID patients

...latest data for baricitinib underscore how the JAK...
...p=0.18).Lilly has rights to baricitinib from Incyte.TARGETSJAKJanus kinase Sandi...
BioCentury | Apr 7, 2021
Product Development

April 6 Quick Takes: MGH to pilot AZ digital platform; plus NorthShore-GoPath prostate cancer risk test, baricitinib delay at FDA, MTEM setback

...to agency information requests; a specific PDUFA date was not disclosed. Lilly markets the oral JAK...
...hold by FDA, to focus on TAK-169 and two other clinical ETBs, MT-5111 and MT-6402. TARGETSJAKJanus kinase BC...
BioCentury | Apr 6, 2021
Regulation

April 5 Quick Takes: FDA extends review of Rinvoq in atopic dermatitis; plus Acadia, Supernus

...to severe atopic dermatitis following the agency’s request for an updated assessment of the oral JAK-1...
...FDA for Qelbree in adults in 2H21. Supernus gained $2.99 (11%) to $29.74 Monday.TARGETSJAK-1 – Janus kinase-1 Virginia...
BioCentury | Mar 17, 2021
Product Development

March 17 Quick Takes: FDA extends review of Rinvoq in psoriatic arthritis; plus Merck, PharmaEssentia, Lilly, Roche and more

...patients with active psoriatic arthritis after the agency had requested additional information on the oral JAK-1...
...which blocks both TGFβ and the PD-L1 checkpoint pathway, failed in a Phase III NSCLC trial. TARGETSJAK-1 –Janus kinase-1PD-1...
BioCentury | Mar 11, 2021
Emerging Company Profile

Ventyx emerges with $114M to bring asset-centric immunology plays under one umbrella

...focused on TYK2, a member of the JAK...
...with the other three members of the JAK...
...disease without the adverse effects seen in pan-JAK...
BioCentury | Mar 6, 2021
Product Development

March 5 Quick Takes: A regulatory first for Actemra; plus updates from Lilly-Incyte, Kronos, Junshi, United Therapeutics, Pfizer, Sumitomo Dainippon, Arena, Oyster Point, Azura

...in the Phase III BRAVE-AA2 study of alopecia areata, meeting its primary efficacy endpoint. The JAK-1/JAK-2...
...– Anaplastic lymphoma kinaseCB2 (CNR2) – Cannabinoid receptor 2CD126 - Interleukin-6 receptorJAK-1 – Janus kinase-1JAK-2 – Janus kinase-2NPM1...
BioCentury | Feb 23, 2021
Product Development

Feb. 22 Quick Takes: Sanofi, J&J in COVID vaccine manufacturing deal; plus AZ, Regeneron-Sanofi, Incyte, Ascletis, Novo-Altasciences, Regor

Sanofi (Euronext:SAN; NASDAQ:SNY) will formulate and fill about 12 million doses per month of the single-shot COVID-19 vaccine from Johnson & Johnson (NYSE:JNJ) following authorization. The candidate is under FDA and EMA review.  Sanofi is...
BioCentury | Feb 19, 2021
Product Development

What works, what doesn’t and what’s next for COVID-19: Data Byte

...Danger-Associated Molecular Patterns DPP-4 (CD26) - Dipeptidyl peptidase-4IL-1 – Interleukin-1IL-2 – Interleukin-2IL-6 – Interleukin-6 IL-17A – Interleukin-17A JAK-1/2 – Janus kinase-1/2PPARɑ...
BioCentury | Feb 11, 2021
Deals

Next up: Galapagos, Gilead turn to second IPF program, Toledo molecules after $5B deal’s third setback

...with thrombospondin type 1 motif 5ENPP2 (ATX) – AutotaxinGPR84 – G protein-coupled receptor 84JAK1 – Janus kinase...
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