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PharmaShots Weekly Snapshots (December 27- 31, 2021)

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PharmaShots Weekly Snapshots (December 27- 31, 2021)

Immunovant Provides an Update to Initiate P-III Trial of Batoclimab for the Treatment of Myasthenia Gravis

Published: Dec 31, 2021 | Tags: Immunovant, P-III Trial, Batoclimab, Myasthenia Gravis

Lexicon Reports Submission of NDA to the US FDA for Sotagliflozin to Treat Heart Failure in Adults with Type 2 Diabetes

Published: Dec 31, 2021 | Tags: Lexicon, NDA, Sotagliflozin, Heart Failure, Type 2 Diabetes

Bharat Biotech Reports Results of Covaxin (BBV152) in P-II/III Trial for the Treatment of COVID-19

Published: Dec 31, 2021 | Tags: Ocugen, Bharat Biotech, Covaxin, BBV152, P-II/III Trial, COVID-19

Xeris’s Recorlev (levoketoconazole) Receives the US FDA’s Approval for Endogenous Hypercortisolemia in adult With Cushing’s Syndrome

Published: Dec 31, 2021 | Tags: Xeris, Recorlev, levoketoconazole, US, FDA, Approval, Endogenous Hypercortisolemia, Cushing’s Syndrome

Madrigal Provides Update in the P-III (MAESTRO-NAFLD-1) Trial of Resmetirom for the Treatment of Non-Alcoholic Steatohepatitis

Published: Dec 31, 2021 | Tags: Madrigal, P-III, MAESTRO-NAFLD-1 Trial, Resmetirom, Non-Alcoholic Steatohepatitis

Jazz Reports First Patient Enrollment in P-II Clinical Trial of JZP150 for the Treatment of Post-Traumatic Stress Disorder

Published: Dec 31, 2021 | Tags: Jazz, P-II, Clinical Trial, JZP150, Post-Traumatic Stress Disorder

Bio-Thera Initiates P-I Clinical Trials of BAT6026 for the Treatment of Advanced Solid Tumor

Published: Dec 30, 2021 | Tags: Bio-Thera, Initiates, P-I, Clinical Trials, BAT6026, Cancer

Cantargia Reports Updated Interim Results of Nadunolimab in P-I/IIa (CANFOUR) Trial for the Treatment of Pancreatic Cancer

Published: Dec 30, 2021 | Tags: Cantargia, Nadunolimab, P-I/IIa, CANFOUR Trial, Pancreatic Cancer

Siemens Healthineers’s CLINITEST COVID-19 Antigen Test Receives the US FDA's EUA for the Prevention of COVID-19

Published: Dec 30, 2021 | Tags: Siemens Healthineers, CLINITEST, COVID-19, Antigen Test, US, FDA, EUA, COVID-19

Antengene Reports First Patient Dosing in P-Ib/II (REACH) Study of ATG-016 for the Treatment of Advanced Solid Tumors

Published: Dec 30, 2021 | Tags: Antengene, P-Ib/II, REACH Study, ATG-016, Advanced Solid Tumors

Janssen Reports Submission of BLA to the US FDA for the Approval of Teclistamab to Treat Multiple Myeloma

Published: Dec 30, 2021 | Tags: Janssen, BLA, US, FDA, Approval, Teclistamab, Multiple Myeloma

Amylyx Reports US FDA Acceptance of NDA and Priority Review for AMX0035 to Treat ALS

Published: Dec 30, 2021 | Tags: Amylyx, US, FDA, Priority Review, NDA, AMX0035, ALS

Celularity’s CYNK-001 Receives the US FDA’s Fast Track Designation for the Treatment of AML

Published: Dec 29, 2021 | Tags: Celularity, CYNK-001, US, FDA, Fast Track Designation, AML

Hansa Biopharma Reports First Patient Enrollment in (ConfIdeS) Trial of Imlifidase for the Treatment of Patients with Kidney Transplant

Published: Dec 29, 2021 | Tags: Hansa Biopharma, ConfIdeS Trial, Imlifidase, Kidney Transplant

Sorrento Reports Results of COVISTIX COVID-19 Test to Detects Omicron Variant

Published: Dec 29, 2021 | Tags: Sorrento, COVISTIX, COVID-19 Test, Omicron Variant

Palatin Reports the Initiation of P-III (MELODY-1) Trial for PL9643 to Treat Dry Eye Disease

Published: Dec 29, 2021 | Tags: Palatin, P-III, MELODY-1 Trial, PL9643, Dry Eye Disease

Kiniksa Reports Results of Mavrilimumab in P-III Trial for the Treatment of COVID-19-Related ARDS

Published: Dec 29, 2021 | Tags: Kiniksa, Mavrilimumab, P-III, Trial, COVID-19-Related ARDS

Daiichi Sankyo Reports Submission of NDA to MHLW for Valemetostat to Treat T-Cell Leukemia/Lymphoma

Published: Dec 29, 2021 | Tags: Daiichi Sankyo, NDA, MHLW, Valemetostat, T-Cell Leukemia/Lymphoma

LEO Pharma’s Adbry (tralokinumab) Receives US FDA’s Approval for the Treatment of Atopic Dermatitis

Published: Dec 28, 2021 | Tags: LEO Pharma, Adbry, tralokinumab, US, FDA, Approval, Atopic Dermatitis

BridgeBio Pharma Reports 12 Months Data of AG10 (acoramidis) in P-III (ATTRibute-CM) Study for the Treatment of Transthyretin Amyloidosis

Published: Dec 28, 2021 | Tags: BridgeBio Pharma, AG10, acoramidis, P-III, ATTRibute-CM Study, Transthyretin Amyloidosis

I-Mab’s TJ271 (enoblituzumab) + Keytruda (pembrolizumab) Receives NMPA’s IND Approval to Initiate P-II Clinical Trial for Solid Tumors

Published: Dec 28, 2021 | Tags: I-Mab, TJ271, enoblituzumab, Keytruda, pembrolizumab, NMPA, IND, Approval, P-II, Clinical Trial, Solid Tumors

Merck and Eisai's Keytruda (pembrolizumab) + Lenvima (lenvatinib) Receive MHLW's Approval for the Treatment of Endometrial Carcinoma

Published: Dec 28, 2021 | Tags: Merck, Eisai, Keytruda, pembrolizumab, Lenvima, Lenvatinib, MHLW, Approval, Endometrial Carcinoma

Shionogi Entered into a Commercialization Agreement with Susmed for Digital Therapeutic App to Treat Insomnia

Published: Dec 28, 2021 | Tags: Shionogi, Susmed, Digital Therapeutic App, Insomnia

ITM Signs an Exclusive License Agreement with Grand Pharma to Develop & Commercialize Oncological Radiopharmaceutical Therapies in the Greater China

Published: Dec 28, 2021 | Tags: ITM, Grand Pharma, Oncological, Radiopharmaceutical Therapies, Greater China

Boehringer Ingelheim Publishes the Results of Spesolimab in P-II (Effisayil 1) Trial for Generalized Pustular Psoriasis in NEJM

Published: Dec 27, 2021 | Tags: Boehringer Ingelheim, Spesolimab, P-II, Effisayil 1 Trial, Generalized Pustular Psoriasis, NEJM

Daiichi Sankyo Reports First Patient Dosing in P-III (DESTINY-Lung04) Trial of Enhertu (trastuzumab deruxtecan) as 1L Treatment of HER2 Mutant Metastatic NSCLC

Published: Dec 27, 2021 | Tags: Daiichi Sankyo, P-III, DESTINY-Lung04 Trial, Enhertu, trastuzumab deruxtecan, HER2 Mutant Metastatic NSCLC

Merck and Ridgeback’s Molnupiravir Receive MHLW’s Approval for the Treatment of COVID-19

Published: Dec 27, 2021 | Tags: Merck, Ridgeback, Molnupiravir, MHLW, Approval, COVID-19

Innovent Reports the NMPA Acceptance of sNDA for Tyvyt (sintilimab) + Byvasda (biosimilar, bevacizumab) for EGFR-Mutated Non-squamous NSCLC

Published: Dec 27, 2021 | Tags: Innovent, NMPA, sNDA, Tyvyt, sintilimab, Byvasda, biosimilar, bevacizumab, EGFR-Mutated, Non-squamous NSCLC

Quidel to Acquire Ortho Clinical Diagnostics for ~$6.0B

Published: Dec 27, 2021 | Tags: Quidel, Acquire, Ortho Clinical Diagnostics, ~$6.0B

Aarvik Therapeutics Signs a Research Collaboration with ArriVent Biopharma to Develop and Commercialize Novel Cancer Therapeutic

Published: Dec 27, 2021 | Tags: Aarvik Therapeutics, Research Collaboration, ArriVent Biopharma, Noval Cancer Therapeutic

Related Post: PharmaShots Weekly Snapshots (December 20 - 23, 2021)


Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

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