Timber Reports Completion of End-of-P-II Meeting with the US FDA for to Treat Congenital Ichthyosis

Published: Feb 04, 2022 | Tags: Timber, TMB-001, P-IIb, CONTROL Study, Congenital Ichthyosis

UroGen Initiates P-III (ENVISION) Study of UGN-102 for the Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

Published: Feb 04, 2022 | Tags: UroGen, P-III, ENVISION Study, UGN-102, Non-Muscle Invasive Bladder Cancer

AstraZeneca Entered into an Exclusive License Agreement with Regio Biosciences to Initiate P-IIa Trial of REG-101 for Peripheral Artery Disease

Published: Feb 04, 2022 | Tags: AstraZeneca, Regio Biosciences, P-IIa Trial, REG-101, Peripheral Artery Disease

Seagen Reports Results of Adcetris in P-III (ECHELON-1) Clinical Trial for the Treatment of Advanced Hodgkin Lymphoma

Published: Feb 04, 2022 | Tags: Seagen, Adcetris, P-III, ECHELON-1 Trial, Advanced, Hodgkin Lymphoma

Amgen Signs an Exclusive Multi-Year Research Collaboration and License Agreement with Plexium to Advance Novel Targeted Protein Degradation Therapies

Published: Feb 04, 2022 | Tags: Amgen, Plexium, Protein Degradation Therapies, Cancer

Mersana Entered into a Research Collaboration and License Agreement with Janssen to Advance Novel ADCs for the Treatment of Cancer

Published: Feb 04, 2022 | Tags: Mersana, Janssen, ADCs, Cancer

Kodiak Sciences Reports Completion of Enrollment in P-III (GLEAM and GLIMMER) Trials of KSI-301 for Diabetic Macular Edema

Published: Feb 03, 2022 | Tags: Kodiak Sciences, P-III, GLEAM, GLIMMER Trials, KSI-301, Diabetic Macular Edema

Jazz Reports Completion of the US FDA’s sBLA for Approval of Rylaze (asparaginase erwinia chrysanthemi) to Treat ALL and LBL

Published: Feb 03, 2022 | Tags: Jazz, US, FDA, sBLA, Approval, Rylaze, asparaginase erwinia chrysanthemi, ALL, LBL

Alvotech Entered into an Exclusive License Agreement with BiosanaPharma to Co-Develop AVT23, a Proposed Biosimilar to Xolair (omalizumab)

Published: Feb 03, 2022 | Tags: Alvotech, BiosanaPharma, AVT23, Xolair, omalizumab

PDS Biotech Provides Updates of PDS0101 + Keytruda (pembrolizumab) in P-II (VERSATILE-002) Trial for Advanced Head and Neck Cancer

Published: Feb 03, 2022 | Tags: PDS Biotech, PDS0101, Keytruda, pembrolizumab, P-II, VERSATILE-002 Trial, Head, Neck Cancer

Brickell Biotech Entered into a License Agreement with Carna to Develop and Commercialize BBI-10 for Autoimmune and Inflammatory Diseases

Published: Feb 03, 2022 | Tags: Brickell Biotech, Carna, BBI-10, Autoimmune, Inflammatory Diseases

ViiV Healthcare Entered into a Global Settlement and Patent License Agreement with GSK, Shionogi and Gilead for Dolutegravir and Biktarvy

Published: Feb 03, 2022 | Tags: ViiV Healthcare, GSK, Shionogi, Gilead, Dolutegravir, Biktarvy, HIV

Sarepta Entered into a Research Collaboration and Option Agreement with GenEdit to Develop Gene Editing Therapies for Neuromuscular Diseases

Published: Feb 02, 2022 | Tags: Sarepta, GenEdit, Gene Editing Therapies, Neuromuscular Diseases

Anavex Reports Results of ANAVEX 2-73 (blarcamesine) in P-III (AVATAR) Trial for the Treatment of Rett Syndrome

Published: Feb 02, 2022 | Tags: Anavex, ANAVEX 2-73, Blarcamesine, P-III, AVATAR Trial, Rett Syndrome

Arcutis Reports Completion of Patient Enrollment for Roflumilast in P-III (STRATUM) Trial for the Treatment of Seborrheic Dermatitis

Published: Feb 02, 2022 | Tags: Arcutis, Roflumilast, P-III, STRATUM, Trial, Seborrheic Dermatitis

Pfizer and BioNTech Initiate Rolling Submission for EUA from the US FDA for COVID-19 Vaccine to Treat COVID-19

Published: Feb 02, 2022 | Tags: Pfizer, BioNTech, EUA, US, FDA, COVID-19 Vaccine

Janssen’s Cabenuva (rilpivirine and cabotegravir) Receives the US FDA’s Expanded Label Approval for the Treatment of HIV

Published: Feb 02, 2022 | Tags: Janssen, Cabenuva, rilpivirine, cabotegravir, US, FDA, Expanded Label Approval, HIV

Biogen Exercises its Option with Genentech to Develop and Commercialize Mosunetuzumab for B-Cell Non-Hodgkin’s Lymphoma

Published: Feb 02, 2022 | Tags: Biogen, Genentech, Mosunetuzumab, B-Cell Non-Hodgkin’s Lymphoma

Reviva Reports First Patient Dosing in P-III Study of Brilaroxazine for the Treatment of Schizophrenia

Published: Feb 01, 2022 | Tags: Reviva, P-III Study, Brilaroxazine, Schizophrenia

MaxCyte Signs a Strategic Platform License with Intima Bioscience to Boost Tumor Infiltrating Lymphocytes Programs for Solid Tumor Cancer

Published: Feb 01, 2022 | Tags: MaxCyte, Strategic Platform License, Intima Bioscience, Tumor Infiltrating Lymphocytes Programs, Solid Tumor Cancer

Takeda’s Vonvendi Receives the US FDA’s Approval for the Treatment of Severe Type 3 Von Willebrand Disease

Published: Feb 01, 2022 | Tags: Takeda, Vonvendi, US, FDA, Approval, Severe Type 3, Von Willebrand Disease

Madrigal Reports Results of Resmetirom in P-III (MAESTRO-NAFLD-1) Study for the Treatment of Non-Alcoholic Steatohepatitis

Published: Feb 01, 2022| Tags: Madrigal, Resmetirom, P-III, MAESTRO-NAFLD-1 Study, Non-Alcoholic Steatohepatitis

Kite’s Yescarta (axicabtagene ciloleucel) Receives the US FDA’s Approval for New Label Update in all Approved Indications

Published: Feb 01, 2022 | Tags: Kite, Yescarta, US, FDA, Approval, Label Update, Large B-Cell Lymphoma

Celltrion’s Yuflyma (biosimilar, adalimumab) Receives Health Canada's Approval for the Treatment of Chronic Inflammatory Diseases

Published: Feb 01, 2022 | Tags: Celltrion, Yuflyma, biosimilar, adalimumab, Health Canada, Approval, Chronic Inflammatory Diseases

BMS’s Breyanzi (lisocabtagene maraleucel) Receive CHMP Positive Opinion for the Treatment of Multiple Indications

Published: Jan 31, 2022 | Tags: BMS, Breyanzi, lisocabtagene maraleucel, CHMP, DLBCL, PMBCL, FL3B

Regeneron & Sanofi’s Dupixent (dupilumab) Receive CHMP Positive Opinion for the Treatment of Severe Asthma

Published: Jan 31, 2022 | Tags: Regeneron, Sanofi, Dupixent, dupilumab, CHMP, Asthma

Akeso Reports First Patient Dosing in P-III Trial of Ivonescimab for the Treatment of Non-Squamous Non-Small Cell Lung Cancer

Published: Jan 31, 2022 | Tags: Akeso, P-III Trial, Ivonescimab, Non-Squamous, Non-Small Cell Lung Cancer

Genentech’s Vabysmo Receives the US FDA’s Approval for the Treatment of AMD and DME

Published: Jan 31, 2022 | Tags: Genentech, Vabysmo, US, FDA, Approval, AMD, DME

Pfizer’s Lorviqua (lorlatinib) Receives EC’s Approval as a 1L Treatment for ALK-Positive Advanced Non-Small Cell Lung Cancer

Published: Jan 31, 2022 | Tags: Pfizer, Lorviqua, lorlatinib, EC, Approval, ALK-Positive, Non-Small Cell Lung Cancer

Biogen Entered into an Agreement with Samsung Biologics to Sell Equity Stake in Biosimilar Joint Venture for ~$2.3B

Published: Jan 31, 2022 | Tags: Biogen, Samsung Biologics, Equity Stake, Biosimilar, Joint Venture, ~$2.3B

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