pharma news
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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Jan 03, 2023
Gilead Buys Out Rights to Cancer Therapy from Jounce; FDA Places Clinical Hold on Biogen’s Orelabrutinib; Pfizer Announces Phase 3 BENEGENE-2 Study Result; FDA Approves MediWound’s NexoBrid; UCB Announces FDA Acceptance of BLA Resubmission for Bimekizumab; FDA Approves TG Therapeutics’ Briumvi
Gilead Buys Out Rights to Cancer Therapy from Jounce for USD 67 Million Gilead Sciences must have liked what it saw in a two-year-old collaboration with Jounce Therapeutics for CCR8-targeting cancer immunotherapy because the company has just agreed to own the program fully. The drug in question, GS-1811 (formerl...
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Dec 27, 2022
Gilead Sciences’ Sunlenca Approval; FDA Approves Roche’s CD20xCD3 Bispecific Antibody Lunsumio; EU Approves AstraZeneca’s Imfinzi Plus Chemo; Pfizer Files Blockbuster Hope Etrasimod for Ulcerative Colitis; FDA Approves Mosunetuzumab for R/F Follicular Lymphoma; FDA Breakthrough Therapy Designation to Adagrasib Plus Cetuximab for KRAS G12C–Mutated Advanced CRC
FDA Approves Gilead Sciences’ Sunlenca Sunlenca, a Gilead Sciences therapy for people with multidrug-resistant (MDR) HIV infection that only needs to be taken twice a year, has received FDA approval for the second time of asking. Sunlenca, which is based on the HIV capsid inhibitor lenacapavir, is intended to be...
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Dec 20, 2022
Fourth FDA Approval for AbbVie’s Vraylar; FDA Approves Ferring’s Adstiladrin for NMIBC; Merck and Moderna’s mRNA Cancer Vaccine Trial; EMA Recommends the CSL’s Gene Therapy for Hemophilia B; CHMP Backs Amicus’ Pompe Disease Therapy; Takeda Announces the Phase 3 AURORA Study Result
AbbVie Secures Fourth FDA Approval for Vraylar AbbVie has received its fourth FDA approval for Vraylar, adding major depressive disorder (MDD) adjunctive therapy to a list that includes schizophrenia and manic and depressive episodes in bipolar disorder. According to AbbVie, the approval makes Vraylar (cariprazi...
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Dec 13, 2022
Amgen to Purchase Horizon Therapeutics; IND Clearance to Vertex’s VX-522; FDA Fast-Track Designation for Moleculin’s WP1122; Orphan Drug Designation to Brim’s WP1122; Eisai Presents Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study; UCB Announces Phase 3 Studies for Bimekizumab
Amgen Inc. Agrees to Purchase Dublin-based Horizon Therapeutics Plc. for €24.7 Billion Amgen Inc. has agreed to buy Dublin-based Horizon Therapeutics Plc. for €24.7 billion ($26 billion), in a deal that could face further delays or a breakdown in negotiations. Following Sanofi's withdrawal from the race, c...
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Dec 08, 2022
Olympus Launches New Gynecologic Power Morcellator; Journey Biosciences Launched NaviDKD; GE Board Approves Separation of GE HealthCare; FDA Approval to Enovis’s STAR Ankle; FDA Clearance to Deep Blue Medical’s T-Line Hernia Mesh; NeuroOne Completed Feasibility Study with its OneRF Ablation System
Olympus Launches New Gynecologic Power Morcellator for Its Contained Tissue Extraction System On November 30, 2022, Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, launched the moresolution™ Power Morcellator, manufactured by TROKAM...
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Dec 06, 2022
Nkarta’s Anti-CD19 Allogeneic CAR-NK Cell Therapy, NKX019; Eisai Presents Results of lecanemab for Alzheimer’s Disease; EQRx’s Aumolertinib for EGFR-Mutated NSCLC; FDA Approves Olutasidenib for IDH1-Mutated R/R AML; FDA Orphan Drug Designation to AUM302 for Neuroblastoma; X4 Pharma Announces Results for WHIM Syndrome Drug
FDA Grants Orphan Drug Designation to AUM302 for Neuroblastoma A global clinical-stage biotech company, AUM Biosciences, focused on discovering and developing precision oncology therapeutics, declared that the U.S. FDA has permitted Orphan Drug Designation for AUM302. For the treatment of neuroblastoma, AUM302 i...
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Nov 29, 2022
C4X Discovery and AstraZeneca Signs Deal; FDA Rejects Spectrum’s Poziotinib; Orphan Drug Designation to Tenaya’s Gene Therapy; EC Approves Regeneron’s Libtayo; Response Letter to Poziotinib for Metastatic NSCLC Harboring HER2 Exon 20 Mutations; Japan Approves Trastuzumab Deruxtecan for HER2+ Breast Cancer
C4X Discovery Holdings and AstraZeneca Signs Exclusive USD 402 Million Global License C4X Discovery Holdings has signed an exclusive global license with AstraZeneca worth up to USD 402 million for the development and commercialization of the NRF2 Activator program. The agreement will allow AstraZeneca to develop...
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Nov 22, 2022
FDA Approves Teplizumab to Delay the Onset of Type 1 Diabetes; FDA Backs Ardelyx’s CKD Therapy Xphozah; Merck to Acquire Imago BioSciences; Accelerated Approval to ImmunoGen’s ELAHERE; Regeneron and CytomX Announces Research Collaboration; FDA Grants Priority Review to Epcoritamab R/R LBCL
Merck to Acquire Imago BioSciences, Inc. for USD 1.35 Billion While its rumored acquisition of Seagen has yet to materialize, Merck & Co has continued to bolster its pipeline with smaller transactions, the most recent of which was a USD 1.35 billion agreement to acquire Imago BioSciences and its bomedemstat ...
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Nov 15, 2022
Genentech’s gantenerumab Fails in Phase III Trial; CHMP Recommends’ Dupixent; FDA Clears Imfinzi and Imjudo with chemotherapy; NICE Recommends Ipsen’s Cabometyx (cabozantinib); NICE Backs KEYTRUDA; NRG Announces £16 Million Series A Funding; FDA Backs AstraZeneca’s PT027
Genentech’s gantenerumab Fails in Phase III Trial for Alzheimer’s Disease In yet another setback for an amyloid-targeting drug, Roche's Genentech division has reported disappointing top-line results from its highly anticipated phase III trial of gantenerumab in early Alzheimer's disease. The failure is entirely ...
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