PharmaShots Weekly Snapshots (April 11-15, 2022)

BMS and Nektar End Global Clinical Development Program for Bempegaldesleukin + Opdivo in Renal Cell Carcinoma and Bladder Cancer

Published: Apr 15, 2022 | Tags: BMS, Nektar, Bempegaldesleukin, Opdivo, Renal Cell Carcinoma, Bladder Cancer

SonoScape Receives the US FDA’s Approval for its Endoscopy System

Published: Apr 15, 2022 | Tags: SonoScape, US, FDA, Approval, Endoscopy System, HD-550

Boehringer Ingelheim and Autigen Collaborate to Discover and Develop Novel Treatments for Hearing Loss

Published: Apr 15, 2022 | Tags: Boehringer Ingelheim, Autigen, Collaborate, Discover, Develop, Novel Treatments, Hearing Loss

Valneva Received MHRA’s Conditional Marketing Authorization for its Inactivated COVID-19 Vaccine

Published: Apr 15, 2022 | Tags: Valneva, MHRA, Conditional Marketing Authorization, Inactivated COVID-19 Vaccine

Pfizer and BioNTech Seek Approval for Booster Dose of their COVID-19 Vaccine in Children 5 Through 11 Years of Age

Published: Apr 15, 2022 | Tags: Pfizer, BioNTech, Approval, Booster Dose, COVID-19 Vaccine, Children

Amneal Receives the US FDA’s Approval for Alymsys (biosimilar, bevacizumab)

Published: Apr 15, 2022 | Tags: Amneal, US, FDA, Almysys, biosimilar, Bevacizumab

Merck’s V116 Receives the US FDA’s Breakthrough Therapy Designation for the Prevention of Invasive Pneumococcal Disease & Pneumococcal Pneumonia

Published: Apr 14, 2022 | Tags: Merck, V116, US, FDA, Breakthrough Therapy Designation, Invasive Pneumococcal Disease, Pneumococcal Pneumonia

CG Oncology Presents Interim Results of CG0070 + Keytruda (pembrolizumab) in P-II (CORE1) Study for NMIBC Unresponsive to Bacillus Calmette-Guerin at AACR 2022

Published: Apr 14, 2022 | Tags: CG Oncology, CG0070, Keytruda, pembrolizumab, P-II, CORE1 Study, NMIBC, Bacillus Calmette-Guerin, AACR, 2022

Sanofi Publishes Results of Rilzabrutinib in P-I/II Study for the Treatment of Immune Thrombocytopenia in NEJM

Published: Apr 14, 2022 | Tags: Sanofi, Rilzabrutinib, P-I/II Study, Immune Thrombocytopenia, NEJM

Halozyme Entered into a Definitive Agreement to Acquire Antares for ~$960M

Published: Apr 14, 2022 | Tags: Halozyme, Acquire, Antares, ~$960M

AbbVie and Genmab Report Results of Epcoritamab in P-I/II (EPCORE NHL-1) Trial for the Treatment of R/R Large B-cell Lymphoma

Published: Apr 14, 2022 | Tags: AbbVie, Genmab, Epcoritamab, P-I/II, EPCORE NHL-1 Trial, Large B-cell Lymphoma

Astellas’ Padcev (enfortumab vedotin) Receives EC’s Approval for the Treatment of Locally Advanced or Metastatic Urothelial Cancer

Published: Apr 14, 2022 | Tags: Astellas, Padcev, enfortumab vedotin, EC, Approval, Urothelial Cancer

LENZ Signs an Exclusive License Agreement with Ji Xing for LNZ100 (aceclidine) and LNZ101 (aceclidine + brimonidine) to Treat Presbyopia in Greater China

Published: Apr 13, 2022 | Tags: LENZ, Ji Xing, LNZ100, LNZ101, Presbyopia, Greater China

Apexigen Presents Results of Sotigalimab + Pembrolizumab in P-II Trial for the Treatment of Metastatic Melanoma at AACR 2022

Published: Apr 13, 2022 | Tags: Apexigen, Sotigalimab, Pembrolizumab, P-II Trial, Metastatic Melanoma, AACR, 2022

AbbVie Presents Results of Navitoclax + Ruxolitinib in P-II (REFINE) Trial for the Treatment of Myelofibrosis at AACR 2022

Published: Apr 13, 2022 | Tags: AbbVie, Navitoclax, Ruxolitinib, P-II, REFINE Trial, Myelofibrosis, AACR 2022

GSK to Acquire Sierra Oncology for ~$1.9B

Published: Apr 13, 2022 | Tags: GSK, Acquire, Sierra Oncology, ~$1.9B

Boehringer Ingelheim and Eli Lilly Receives the Health Canada Marketing Authorization for Jardiance (empagliflozin) to Treat HFpEF

Published: Apr 13, 2022 | Tags: Boehringer Ingelheim, Eli Lilly, Health Canada, Marketing Authorization, Jardiance, empagliflozin, HFpEF

Actinium Entered into a License and Supply Agreement with Immedica for Iomab-B (131I apamistamab) in EU and MENA Countries

Published: Apr 13, 2022 | Tags: Actinium, Immedica, Iomab-B, 131I apamistamab, EU, Middle East, North Africa

Takeda Reports Results of Takhzyro (lanadelumab) in P-III (SHP643-301/ SPRING) Study for the Treatment of Hereditary Angioedema

Published: Apr 12, 2022 | Tags: Takeda, Takhzyro, lanadelumab, P-III, SHP643-301, SPRING Study, Hereditary Angioedema

Engitix Expanded its 2020 Collaboration and License Agreement with Takeda to Develop New Anti-Fibrotic Therapies for Inflammatory Bowel Disease

Published: Apr 12, 2022 | Tags: Engitix, 2020, License Agreement, Takeda, Anti-Fibrotic Therapies, Inflammatory Bowel Disease

BMS Presents Results of Opdivo (nivolumab) in P-III (CheckMate-816) Trial as Neoadjuvant Treatment for Resectable Non-Small Cell Lung Cancer at AACR 2022

Published: Apr 12, 2022 | Tags: BMS, Opdivo, nivolumab, P-III, CheckMate-816 Trial, Resectable, Non-Small Cell Lung Cancer

Lilly Presents Results of Lebrikizumab in P-III (ADhere) Study for the Treatment of Atopic Dermatitis at RAD 2022

Published: Apr 12, 2022 | Tags: Lilly, Lebrikizumab, P-III, ADhere Study, Atopic Dermatitis, RAD, 2022

BioNTech Entered into an Exclusive Research Collaboration with Matinas BioPharma to Evaluate Novel Delivery Technology for mRNA-Based Vaccines

Published: Apr 12, 2022 | Tags: BioNTech, Matinas BioPharma, Technology, mRNA-Based Vaccines

Ardelyx Amends 2017 Agreement with Kyowa Kirin for Tenapanor to Treat Hyperphosphatemia in Japan

Published: Apr 12, 2022 | Tags: Ardelyx, Amends, 2017, Agreement, Kyowa Kirin, Tenapanor, Hyperphosphatemia, Japan

Junshi and Coherus Present Results of Toripalimab in P-III (JUPITER-02) Study as 1L Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma at AACR 2022

Published: Apr 11, 2022 | Tags: Junshi, Coherus, Toripalimab, P-III, JUPITER-02 Study, Nasopharyngeal Carcinoma, AACR, 2022

BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III (ALPINE) Trial for the Treatment of Chronic Lymphocytic Leukemia

Published: Apr 11, 2022 | Tags: BeiGene, Brukinsa, zanubrutinib, P-III, ALPINE Trial, Chronic Lymphocytic Leukemia

Gannex Reports First Patient Dosing in P-II Clinical Trial of ASC42 for the Treatment of Primary Biliary Cholangitis

Published: Apr 11, 2022 | Tags: Gannex, P-II, Clinical Trial, ASC42, Primary Biliary Cholangitis

Telix Entered into a Licence Agreement with Lilly to Develop and Commercialise Olaratumab for Cancer

Published: Apr 11, 2022 | Tags: Telix, Lilly, Olaratumab, Cancer

Amgen Presents Results of Lumakras (sotorasib) in P-I/II (CodeBreaK 100) Trial for KRAS G12C-Mutated Advanced Non-Small Cell Lung Cancer at AACR 2022

Published: Apr 11, 2022 | Tags: Amgen, Lumakras, sotorasib, P-I/II, CodeBreaK 100 Trial, KRAS G12C-Mutated, Advanced, Non-Small Cell Lung Cancer, AACR 2022

Blueprint Presents Proof-of-Concept Data of BLU-945 in P-I/II (SYMPHONY) Trial for EGFR-Mutant Non-Small Cell Lung Cancer at AACR 2022

Published: Apr 11, 2022 | Tags: Blueprint, BLU-945, P-I/II, SYMPHONY Trial, EGFR-Mutant, Non-Small Cell Lung Cancer