Gene therapy

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Latest Pharma News and Updates for BeiGene, Seagen, Alnylam, Roche, Astellas
BeiGene’s Brukinsa Approval; FDA Approval to Seagen’s TUKYSA; NICE Recommends Alnylam’s Amvuttra; FDA Approves Brenzavvy for Type 2 Diabetes; Roche’s Tecentriq to be Filed for Early-stage Liver Cancer; FDA Lifts Hold on Astellas’ Pompe Gene Therapy

FDA Approves BeiGene’s Brukinsa for CLL/SLL BeiGene's Brukinsa (zanubrutinib) for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) has been approved by the US Food and Drug Administration. CLL is a common type of leukemia, accounting for approximately 25% of all new cases each year. SLL is...

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Pharma News and Updates for Gilead, Biogen, Pfizer, MediWound, UCB
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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Pharma News and Updates for AbbVie, Ferring, Merck, CSL, Amicus, Takeda
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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Pharma News for AstraZeneca, Regeneron, Tenaya, Daiichi, C4X Discovery
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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Gene Therapy: The Next Milestone in Treating Complex Diseases

Gene therapy is an experimental technique that introduces functional genes into a patient’s body to counteract or replace defective ones, thereby curing disease without using pharmaceuticals, radiotherapy, or surgery. Genetic defects that are difficult to treat with drugs or antibodies can be treated with therapy w...

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Pharma News for Zealand Pharma, Amylyx, Sarepta
Zealand Pharma’s Phase III Results of Glepaglutide; FDA Approves Amylyx’s ALS Drug Relyvrio; Novo Nordisk and Ventus Therapeutics Signs Licencing Deal; FDA Approves Futibatinib; Sarepta Files Duchenne Muscular Dystrophy for FDA Approval; Biogen and Eisai’s Lcanemab Phase III Study

Zealand Pharma Announces the Positive Topline Results from its Phase III trial of Glepaglutide Zealand Pharma A/S, a biotech company specializing in peptide-based medicines, announced positive topline results from its phase III trial of glepaglutide. In the evenly randomized double-blind trial, 106 patients with...

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Pharma News for Sangamo, Santen, and Eli Lilly
Daiichi Sankyo’s Ezharmia; Pfizer & Sangamo Hemophilia A Gene Therapy Trial; Approval for Fennec’s Pedmark; FDA Approves UBE and Santen’s OMLONTI; EC Approves AstraZeneca’s Tezspire; FDA Approves Selpercatinib; FDA Grants Accelerated Approval to Eli Lilly’s Retevmo; GSK & Spero Announce Exclusive License Agreement

Daiichi Sankyo Receives the First Approval for its Blood Cancer Drug Ezharmia Daiichi Sankyo has received the first global approval for Ezharmia, a first-in-class dual EZH1 and EZH2 inhibitor for the treatment of patients with relapsed or refractory adult T-cell leukemia/lymphoma (ATL). The Japanese Ministry of ...

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Pharma News for Aktis, Alcon and Takeda
Aktis’s Novel Targeted Alpha Radiopharmaceuticals; Koye Partners with Sonde Health; Novartis to Spin Off Sandoz Business; Alcon to Buy Aerie Pharma; Fast Track Designation to Merck’s MK-2060; FDA Approves Ibrutinib for Chronic GvHD; French Authorities Clears BrainVectis’s Clinical Trial; Takeda’s Dengue Vaccine TAK-003 Gets Approval in Indonesia

Aktis Oncology Raises USD 84 Million To Advance Novel Targeted Alpha Radiopharmaceuticals Aktis Oncology has raised an additional USD 84 million in its Series A round, adding to the USD 72 million raised last year to help bring its radiopharmaceuticals to market. The extension to the first round included Merck's...

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AAV Vectors in Gene Therapy: How Recent Clinical Advances are Unraveling New Potentials?

There has been a renaissance in gene therapy attempts, spurred partly by the discovery and understanding of novel gene delivery vectors. Adeno-associated virus (AAV) is a non-enveloped virus that may be designed to carry DNA to target cells and has sparked considerable interest in the area, particularly in clinical...

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Pharma News and Updates for AstraZeneca, Supernus, and BMS
VBL Therapeutics’ VB-111 (ofranergene obadenovec); BMS’s mavacamten (Camzyos); Merck’s KEYTRUDA; AstraZeneca and Daiichi’s Enhertu; Pfizer/Biohaven’s VYDURA (rimegepant); AstraZeneca’s Ultomiris; Supernus’s Viloxazine (Qlebree); AbbVie’s Rinvoq

FDA Grants Fast Track Designation to VB-111 for Platinium-resistant Ovarian Cancer The FDA has given VBL Therapeutics’ VB-111 (ofranergene obadenovec), a targeted anticancer viral gene therapy, fast track designation for use as a viable therapeutic option in patients with platinum-resistant Ovarian Cancer. VB...

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