FDA Grants Accelerated Approval for PADCEV® with KEYTRUDA® for Urothelial Cancer

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Seagen Inc. (Nasdaq: SGEN) announced the U.S. Food and Drug Administrati...

April 04, 2023 | Tuesday | News
Sanofi/Regeneron's Dupixent's Performance in Eosinophilic Esophagitis Sets Stage for Future Therapies: Spherix Global Insights

In 2017, Sanofi/Regeneron announced the FDA approval for the first biologic agent to treat atopic dermatitis (AD). The success of that drug, Dupixent (dupi...

April 04, 2023 | Tuesday | News
Galapagos and NovAliX enter into an integrated drug discovery collaboration

Galapagos to transfer drug discovery and research activities in Romainville, France to NovAliX, a drug-discovery focused Contract Research Organization (...

April 03, 2023 | Monday | News
Synthetic Periwinkle: Emulating Nature For Drug Discovery

With its resplendent flowers, the Madagascar periwinkle plant (Catharanthus roseus) easily draws attention to itself, both in a natural setting and in ...

April 01, 2023 | Saturday | Analysis
Cabaletta Bio Receives FDA Clearance of IND Application for CABA-201 for Treatment of Systemic Lupus Erythematosus

CABA-201 data package and experience from prior autoimmune cell therapy INDs informed Phase 1/2 clinical trial design, including the initial dose to be eva...

March 31, 2023 | Friday | News
NEC Establishes Subsidiaries in Europe for Strengthening Global AI Drug Development Business

Today, NEC and NOI announced that NOI will be realigned as a subsidiary of NEC Bio B.V. (NB) in Hilversum, Netherlands, a newly established wholly owned su...

March 31, 2023 | Friday | News
COVID-19 Infection Shown to Significantly Increase Drug Clearance of Therapeutic Monoclonal Antibodies

Patients with inflammatory diseases being treated with therapeutic monoclonal antibodies (mAbs) such as Infliximab may experience a significant increase in...

March 30, 2023 | Thursday | News
TandemAI launches TandemViz™ 1.0 - a web-based GUI for integrated computational analysis and experimental data

TandemAI today announced the release of TandemViz™ 1.0, the company’s proprietary web-based platform that provides its growing roster of drug d...

March 29, 2023 | Wednesday | News
Sanofi receives marketing approval for its diabetes drug Soliqua™ in India

Sanofi (India) announced that it has received marketing authorization for its diabetes drug Soliqua™ (in pre-...

March 28, 2023 | Tuesday | Regulatory
Merck KGaA Secures Exclusive Worldwide Rights to BAVENCIO® (avelumab)

Merck KGaA, Darmstadt, Germany regains exclusive worldwide rights to develop, manufacture and commercialize BAVENCIO from Pfizer Deal is the latest exam...

March 28, 2023 | Tuesday | News
Agenus’ Botensilimab in Combination with Balstilimab Shows 33% Durable Responses in Ovarian Cancer

Patients treated suffered from platinum resistant/refractory ovarian cancer Previous PD-(L)1/CTLA-4  combinations have reported only 3-10% re...

March 28, 2023 | Tuesday | News
Incyte's Pemazyre® (pemigatinib) Approved in Japan for Myeloid/Lymphoid Neoplasms (MLNs)

ncyte (Nasdaq:INCY) announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Pemazyre® (pemigatinib), a selective fi...

March 28, 2023 | Tuesday | News
EMA Validates Marketing Authorization Application for Henlius' HANSIZHUANG (Serplulimab)

HANSIZHUANG (serplulimab) is the first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (SCLC) The EC and the FDA previously granted...

March 26, 2023 | Sunday | News
CancerVax Universal Cancer Vaccine Being Developed by UCLA

CancerVAX, Inc., developer of a breakthrough universal cancer vaccine that will use the body’s immune system to fight cancer, today announced that it...

March 18, 2023 | Saturday | News

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