BMS Failed to Meet its Primary Endpoint in P-III (CheckMate -914) Trial for Opdivo (nivolumab) + Yervoy (ipilimumab) as Adjuvant Treatment of Localized Renal Cell Carcinoma

Published: July 29, 2022 | Tags: BMS, Opdivo, nivolumab, Yervoy, ipilimumab, Renal Cell Carcinoma, Clinical Trial, P-III CheckMate -914 Trial

Ionis Reports P-IIb (RE-THINC ESRD) Study Results of Fesomersen for the Treatment of End-Stage Renal Disease on Hemodialysis

Published: July 29, 2022 | Tags: Ionis, Fesomersen, End-Stage Renal Disease, Hemodialysis, Clinical Trial, P-IIb RE-THINC ESRD Study

NeuroSense Collaborated with NeuraLight to Advance ALS Oculometric Biomarkers Using AI and ML

Published: July 29, 2022 | Tags: NeuroSense, NeuraLight, ALS, Oculometric Biomarkers, Biotech, AI, ML, P-IIb (PARADIGM) trial, PrimeC

AbbVie’s Rinvoq (upadacitinib) Receives EC’s Approval as an Oral Treatment for Adults with Active Non-Radiographic Axial Spondyloarthritis

Published: July 29, 2022 | Tags: AbbVie, Rinvoq, upadacitinib, EC, Approval, Active Non-Radiographic Axial Spondyloarthritis

Novartis’ Beovu (brolucizumab) Receives NICE Recommendation for Diabetic Macular Oedema

Published: July 29, 2022 | Tags: Novartis, Beovu, brolucizumab, NICE, Diabetic Macular Oedema, Regulatory, P-III KESTREL, KITE Trials

Elevation Entered into an Exclusive License Agreement with CSPC to Develop and Commercialize EO-3021 (SYSA1801) for Solid Tumors

Published: July 29, 2022 | Tags: Elevation, CSPC, EO-3021, SYSA1801, Solid Tumors, Pharma

Organon Entered into a Research Collaboration and Exclusive License Agreement with Cirqle Biomedical for Non-hormonal Contraceptive Therapy

Published: July 28 2022 | Tags: Organon, Cirqle Biomedical, Non-hormonal, Contraceptive Therapy, Pharma

Palisade Bio Reports First Patient Enrollment in P-III Study of LB1148 for Postoperative Return of Bowel Function

Published: July 28 2022 | Tags: Palisade Bio, LB1148, Postoperative, Bowel Function, Clinical Trial,  P-III Study

Eliaz Collaborated with Terumo Blood and Cell Technologies to Develop and Commercialization Novel Therapeutic Apheresis Treatment for AKI

Published: July 28 2022 | Tags: Eliaz, Terumo Blood and Cell Technologies, Novel Therapeutic Apheresis Treatment, Acute Kidney Injury, Sepsis-Induced Acute Kidney Injury, Pharma

AbbVie Submits Regulatory Applications to the US FDA and EMA for Rinvoq (upadacitinib) to Treat Crohn's Disease

Published: July 28 2022 | Tags: AbbVie, US, FDA, EMA, Rinvoq, upadacitinib, Crohn's Disease, Pharma

Lexicon Reports the US FDA’s Acceptance of NDA for Sotagliflozin to Treat Heart Failure

Published: July 28 2022 | Tags: Lexicon, Sotagliflozin, Heart Failure, Regulatory US, FDA, NDA

Cidara Entered into a License Agreement with Melinta to Commercialize Rezafungin for Candidemia and Invasive Candidiasis in the US

Published: July 28 2022 | Tags: Cidara, Melinta, Rezafungin, US, Candidemia, Invasive Candidiasis, Pharma

IDEAYA Entered into a Clinical Trial Collaboration and Supply Agreement with Amgen for IDE397 + AMG 193 in MTAP Deleted Solid Tumors

Published: July 27 2022 | Tags: IDEAYA, Amgen, IDE397, AMG 193, MTAP Deleted, Solid Tumors, Pharma

Moleculera Labs Collaborated with General Genomics to Offer Personalized Therapies for Autoimmune Neuropsychiatric Disorders Using AI

Published: July 27 2022 | Tags: Moleculera Labs, General Genomics, Personalized Therapies, Autoimmune Neuropsychiatric Disorders, AI, Pharma

GBT Receives MHRA’s Marketing Authorization for Oxbryta (voxelotor) to Treat Hemolytic Anemia in Patients with Sickle Cell Disease Aged ≥12 Years in Great Britain

Published: July 27 2022 | Tags: GBT, Oxbryta, voxelotor, Hemolytic Anemia, Sickle Cell, Regulatory MHRA, Marketing Authorization, Great Britain

Janssen Presents P-Ib/II (CHRYSALIS-2) Study Results of Rybrevant (amivantamab-vmjw) for Non-Small Cell Lung Cancer and EGFR Mutations at IASLC 2022

Published: July 27 2022 | Tags: Janssen, Rybrevant, amivantamab-vmjw, Non-Small Cell Lung Cancer, EGFR Mutations, Clinical Trial, P-Ib/II, CHRYSALIS-2 Study, IASLC 2022, 

AbbVie's Rinvoq (upadacitinib) Receives EC's Approval for the Treatment of Adults with Ulcerative Colitis

Published: July 27 2022 | Tags: AbbVie, Rinvoq, upadacitinib, Ulcerative Colitis, Regulatory, EC, Approval

Kelun-Biotech Entered into a Research Collaboration and Exclusive License Agreement with MSD to Develop ADC for Solid Tumors

Published: July 27 2022 | Tags: Kelun-Biotech, MSD, ADC, SKB-264, Solid Tumors, Biotech

Ionis Reports the US FDA Acceptance of NDA and Granted Priority Review of Tofersen for Superoxide Dismutase 1 Amyotrophic Lateral Sclerosis

Published: July 26 2022 | Tags: Ionis, Tofersen, Superoxide Dismutase 1 Amyotrophic Lateral Sclerosis, Regulatory, US, FDA, NDA, Priority Review

Seagen and Astellas Report P-Ib/II (EV-103) Cohort K Trial Results of Padcev (enfortumab vedotin-ejfv) and Keytruda (pembrolizumab) as 1L Treatment for Advanced Urothelial Cancer

Published: July 26 2022 | Tags: Seagen, Astellas, Padcev, enfortumab vedotin-ejfv, Keytruda, pembrolizumab, Urothelial Cancer, Clinical Trial, P-Ib/II, EV-103 Cohort K Trial

ReCor Medical and Otsuka Paradise uRDN System Meet its Primary Endpoint in the (RADIANCE II) US Trial for Hypertension

Published: July 26 2022 | Tags: ReCor Medical, Otsuka Medical Devices, Paradise uRDN System, Hypertension, MedTech, RADIANCE II US Trial

BridgeBio Pharma and Sentynl Receive CHMP Positive Opinion of Nulibry (fosdenopterin) for the Treatment of MoCD Type A

Published: July 26 2022 | Tags: BridgeBio Pharma, Sentynl, Nulibry, fosdenopterin, MoCD Type A, Regulatory, CHMP

Lepu and Hanx Biopharmaceuticals' Puyouheng (HX-008) Receive NMPA Approval for the Treatment of Solid Tumors

Published: July 26 2022 | Tags: Lepu, Hanx Biopharmaceuticals, Puyouheng, HX-008, Solid Tumors, Regulatory, NMPA, Approval

NewAmsterdam Pharma to Go Public via FLAC SPAC Merger for ~$326M

Published: July 26 2022 | Tags: NewAmsterdam Pharma, obicetrapib, cardiovascular disease, M&A, Public, FLAC, SPAC Merger, ~$326M

Ginkgo to Acquire Zymergen for ~$300M

Published: July 25 2022 | Tags: Ginkgo, Zymergen, M&A, Acquire, ~$300M, Horizontal Synthetic Biology Platform

Rona Therapeutics Collaborated with Sanofi for siRNA Therapeutic Portfolio and Technology Platform

Published: July 25 2022 | Tags: Rona Therapeutics, Sanofi, siRNA Therapeutic, Technology Platform, Pharma

Kite Receives CHMP Positive Opinion of Tecartus (brexucabtagene autoleucel) for Relapsed or Refractory Acute Lymphoblastic Leukemia

Published: July 25 2022 | Tags: Kite, Tecartus, brexucabtagene autoleucel, Acute Lymphoblastic Leukemia, Regulatory, CHMP

Daiichi Sankyo and AstraZeneca Report the US FDA Acceptance of sBLA and Granted Priority Review of Enhertu for HER2 Low Metastatic Breast Cancer

Published: July 25 2022 | Tags: Daiichi Sankyo, AstraZeneca, Enhertu, HER2 Low Metastatic Breast Cancer, Regulatory, US, FDA, sBLA, Priority Review

Sandoz Reports the US FDA Acceptance of sBLA for Review of Hyrimoz (biosimilar, adalimumab) to Treat Inflammatory Diseases

Published: July 25 2022 | Tags: Sandoz, Hyrimoz, biosimilar, adalimumab, Inflammatory Diseases, Regulatory, US, FDA, sBLA

Alnylam Receives CHMP Positive Opinion of Vutrisiran for hATTR Amyloidosis in Adult Patients with Stage 1 or 2 Polyneuropathy

Published: July 25 2022 | Tags: Alnylam, Vutrisiran, hATTR Amyloidosis, Polyneuropathy, Regulatory, CHMP, EMA

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