Eisai
Dec 19, 2023
Eisai Submits Marketing Authorization Application for Tasurgratinib; CHMP Issues Positive Opinion for Biogen’s SKYCLARYS; European Commission Approves Merck’s KEYTRUDA + Chemotherapy HER2-ve Gastric or GEJ Adenocarcinoma; BMS Provides Update on RELATIVITY-123 Trial; Kyverna Therapeutics Granted FDA Fast Track Designation for KYV-101; Verrica and Torii Pharma Announces Positive Top-line Results from a Confirmatory Phase 3 Trial of TO-208
Eisai Submits Marketing Authorization Application In Japan for Anticancer Agent Tasurgratinib For Biliary Tract Cancer With FGFR2 Gene Fusion Eisai Co., Ltd. has officially submitted a request for marketing authorization in Japan for tasurgratinib succinate, its internally developed tyrosine kinase inhibitor tar...
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Oct 02, 2023
Challenges in the Pursuit of Alzheimer’s Disease Treatment Breakthroughs: Drug Clinical Trial Failures
Alzheimer’s, the most common type of dementia, particularly with an increasing geriatric population, presents a major global crisis. The disease mostly occurs in sexagenarians, but it may manifest in quadragenarians. It is one of the most prevalent neurodegenerative disorders with a multifactorial pathogenesis. It ...
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Sep 26, 2023
LEQEMBI Intravenous Infusion Approval; Novartis’ Presented Updates on Lutathera; FDA Accepts Submission to Add PH-ILD to YUTREPIA Label; FDA Issues CRL to BLA for Pegfilgrastim-cbqv; FDA Fast Track Designation to Therpay, MWTX-003; EC Approves TEPKINLY (epcoritamab) for R/R DLBCL
Disc Medicine Receives FDA Fast Track Designation for MWTX-003 for the Treatment of Polycythemia Vera On Sept. 20, 2023, Disc Medicine, Inc. (NASDAQ: IRON) announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to MWTX-003 for the treatment of patients with Polycyt...
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Jul 11, 2023
FDA Grants Priority Review for Zolbetuximab BLA; FDA Traditional Approval for LEQEMBI for Alzheimer’s Disease; Iovance Announces Regulatory and Clinical Updates for TIL Therapy in Advanced NSCLC; Biophytis Seeks FDA Approval to Launch Phase 3 Study of Potential Treatment of Sarcopenia; Orphan Drug Designation to Marker Therapeutics’s MT-401 for AML Treatment; Axsome Therapeutics Initiates Phase 3 Trial of Solriamfetol for ADHD
Astellas Announces FDA Grants Priority Review for Zolbetuximab Biologics License Application Astellas Pharma Inc. announced that the FDA has accepted and granted Priority Review for the company's Biologics Licence Application (BLA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-target...
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Mar 07, 2023
Incyte’s Clinical Trial for Myelofibrosis; Eisai and Bioge’s Leqembi; FDA Approves Reata Pharmaceuticals’ SKYCLARYS; Temferon Lands FDA Orphan Drug Status for Glioblastoma; Harbour BioMed Announces Results from Phase III Trial of Batoclimab; FDA Fast Track Designation to Ikena’s AHR Antagonist IK-175
Incyte Halts Phase III Clinical Trial for Myelofibrosis Incyte announced the termination of Phase III LIMBER-304 trial after the results of a pre-planned interim analysis conducted by an independent data monitoring committee (IDMC) revealed that the study is unlikely to meet the primary endpoint in the int...
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Jan 17, 2023
FDA Approves Luye’s Rykindo; EU Approves AstraZeneca’s Tezspire; Oramed Announces Trial Results of ORMD-0801; Eisai and Biogen File Lecanemab in the EU; AbbVie and Anima Biotech Announce Collaboration; AstraZeneca’s Avillion Receives FDA Approval
FDA Approves Luye Pharma’s Rykindo for Schizophrenia Luye Pharma has received its first FDA approval for Rykindo, an injectable formulation of the antipsychotic risperidone administered every two weeks. Rykindo has been approved by the US Food and Drug Administration for the treatment of schizophrenia as well as...
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Jan 10, 2023
Ipsen to Acquire Albireo; Chiesi Farmaceutici to Buy Amryt Pharma; Takeda Presents Phase III Results of TAK-755 for cTTP; ACELYRIN Acquires ValenzaBio; FDA Approves LEQEMBI for Alzheimer’s Disease; Orphan Drug Designation to Lantern Pharma’s LP-284 for MLL
Ipsen to Acquire Albireo for USD 952 Million Ipsen, a French pharmaceutical company, has offered USD 42 per share for the US biotech Albireo and its rare disease treatment Bylvay, continuing a recent spree of merger and acquisition activity. Albireo, a Boston-based business, is valued at USD 952 million under th...
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May 02, 2019
The Business Cocktail
EISAI now solely responsible for lemborexant Eisai today announced that its U.S. subsidiary has bought out Purdue Pharma L.P.’s rights in the worldwide collaboration for the development and commercialization of lemborexant, an investigational sleep-wake regulation agent being studied for the treatment of multip...
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Mar 27, 2019
Alzheimer’s drug fails! Is it time to move on?
Alzheimer’s is one of the diseases which are irreversible and untreatable. With causes still unknown adds to the further conundrum. But for more than two decades now Scientists from everywhere have been working on the “amyloid hypothesis". It has been a long-standing theory that brains of the people affected ...
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Dec 18, 2018
HER2 Drug Meets Phase 1b; Neurons ward off Alzheimer’s; Bristol-Myers, H3 Biomedicine discover RNA splicing
HER2 Vaccine Candidate Meet Phase 1b Study An Australian biotech company stated its Human Epidermal Growth Factor Receptor 2 (HER2) vaccine candidate, HER-Vaxx, successfully finished its phase 1b clinical trial and head to a phase 2 study. The first tranche of data from the 14-patient trial comes...
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