Category Press Releases

European Commission approves Roche’s Tecentriq SC, the EU’s first PD-(L)1 cancer immunotherapy subcutaneous injection for multiple cancer types

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted marketing authorisation for Tecentriq® SC (atezolizumab), the European Union (EU)’s first PD-(L)1 cancer immunotherapy for subcutaneous (under the skin) injection. Last year, more than 38,000 people…

Read MoreEuropean Commission approves Roche’s Tecentriq SC, the EU’s first PD-(L)1 cancer immunotherapy subcutaneous injection for multiple cancer types

“LEQEMBI®” Approved for the Treatment of Alzheimer’s Disease in China

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (brand name in China: “乐意保®”, generic…

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Nucala approved in China for use in severe asthma with an eosinophilic phenotype

GSK plc (LSE/NYSE: GSK) today announced that the China National Medical Products Administration has approved Nucala (mepolizumab), as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older. Nucala is the first anti-Interleukin-5 (IL-5) targeting treatment approved…

Read MoreNucala approved in China for use in severe asthma with an eosinophilic phenotype

Vertex Announces Approval of First CRISPR/Cas9 Gene-Edited Therapy, CASGEVY™, for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia in Kingdom of Saudi Arabia

 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the Saudi Food and Drug Authority (SFDA) granted Marketing Authorization for CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited therapy, for the treatment of sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). CASGEVY is approved…

Read MoreVertex Announces Approval of First CRISPR/Cas9 Gene-Edited Therapy, CASGEVY™, for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia in Kingdom of Saudi Arabia

TIVDAK® Supplemental Biologics License Application Accepted for Priority Review by FDA for Patients with Recurrent or Metastatic Cervical Cancer

 Pfizer Inc. (NYSE: PFE) and Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of TIVDAK® (tisotumab vedotin-tftv) to full approval, for the treatment of…

Read MoreTIVDAK® Supplemental Biologics License Application Accepted for Priority Review by FDA for Patients with Recurrent or Metastatic Cervical Cancer

FDA Approves Merck’s KEYTRUDA® Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemoradiotherapy (CRT) for the treatment of patients with FIGO…

Read MoreFDA Approves Merck’s KEYTRUDA® Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer

BIO-TECHNE TO SHOWCASE CELL AND GENE THERAPY MANUFACTURING TOOLS AT PHACILITATE ADVANCED THERAPIES WEEK 2024

Bio-Techne Corporation (NASDAQ: TECH) today announced it will present its portfolio of products and solutions to enable cell and gene therapy development and manufacturing at Phacilitate’s Advanced Therapies Week, taking place January 16-19 at the Miami Beach Convention Center in Miami,…

Read MoreBIO-TECHNE TO SHOWCASE CELL AND GENE THERAPY MANUFACTURING TOOLS AT PHACILITATE ADVANCED THERAPIES WEEK 2024

AskBio Announces Initiation of Phase 2 GenePHIT Trial in Congestive Heart Failure

Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that it is initiating GenePHIT (Gene PHosphatase Inhibition Therapy), a Phase 2 trial of AB-1002 (also known as NAN-101)…

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Merck Expands Colorectal Cancer Portfolio Through Licensing Agreement with Inspirna

Merck, a leading science and technology company, today announced a licensing agreement with Inspirna, Inc. (New York, NY) for ompenaclid (RGX-202), a first-in-class oral inhibitor of the creatine transport channel SLC6A8, and SLC6A8-targeting follow-on compounds. Ompenaclid is currently being evaluated…

Read MoreMerck Expands Colorectal Cancer Portfolio Through Licensing Agreement with Inspirna

Novo Nordisk enters into research collaborations with Omega Therapeutics and Cellarity on novel treatment approaches for cardiometabolic diseases

Novo Nordisk, Omega Therapeutics, Inc. (Nasdaq: OMGA) (“Omega”) and Cellarity Inc. today announced that Novo Nordisk has entered into separate research collaborations with each company. The Omega collaboration will leverage its proprietary platform technology to develop an epigenomic controller designed…

Read MoreNovo Nordisk enters into research collaborations with Omega Therapeutics and Cellarity on novel treatment approaches for cardiometabolic diseases

Depixus Launches Technology Access Program With First MAGNA One™ Instrument Placement

Interactomics pioneer Depixus has launched its game-changing MAGNA™ technology access program with the deployment of the first MAGNA One™ beta prototype instrument in the laboratory of Professor Jean-François Allemand, Department of Physics at the École Normale Supérieure (ENS), Paris. Based…

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Esperion and Daiichi Sankyo Europe Announce $125 Million Amendment to Their Collaboration, Including Resolution of Pending Litigation

Esperion Therapeutics, Inc. (NASDAQ: ESPR) and Daiichi Sankyo Europe GmbH (DSE) the Europeanheadquarter organization of the Japanese pharmaceutical company Daiichi Sankyo Co., Ltd. (TSE:4568), announced today a $125 million amendment to their collaboration, which includes anamicable resolution to their commercial…

Read MoreEsperion and Daiichi Sankyo Europe Announce $125 Million Amendment to Their Collaboration, Including Resolution of Pending Litigation