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