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PharmaShots Weekly Snapshots (December 12 - 16, 2022)

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PharmaShots Weekly Snapshots (December 12 - 16, 2022)

Kintara Therapeutics’ VAL-083 Receives the US FDA’s Orphan Drug Designation for the Treatment of Diffuse Intrinsic Pontine Glioma

Published: Dec 16, 2022 | Tags: Kintara Therapeutics, VAL-083, Diffuse Intrinsic Pontine Glioma, US, FDA, Orphan Drug Designation, Regulatory

Pfizer Entered into a Multi-Year Agreement with Anumana to Develop AI Algorithm for the Detection of Cardiac Amyloidosis

Published: Dec 16, 2022 | Tags: Pfizer, Anumana, Cardiac Amyloidosis, AI Algorithm, low ejection fraction, pulmonary hypertension, hyperkalemia, Pharma

BioCryst Discontinues Development of BCX9930 for Paroxysmal Nocturnal Hemoglobinuria

Published: Dec 16, 2022 | Tags: BioCryst, BCX9930, BCX10013, Paroxysmal Nocturnal Hemoglobinuria, Renal Diseases, Pharma

Guardant Health Reports (ECLIPSE) Study Results of Blood Test for the Detection of Colorectal Cancer

Published: Dec 16, 2022 | Tags: Guardant Health, Blood Test, Colorectal Cancer, Clinical Trial, MedTech, ECLIPSE Study

Sosei Heptares Entered into a Drug Discovery Collaboration with Eli Lilly to Develop and Commercialize Small Molecules for Diabetes and Metabolic Diseases

Published: Dec 16, 2022 | Tags: Sosei Heptares, Eli Lilly, Small Molecules, Diabetes and Metabolic Diseases, Drug Discovery Collaboration, StaR technology, SBDD platform, Biotech

Medtronic Reports the First Patient Enrollment of Hugo Robotic-Assisted Surgery System

Published: Dec 16, 2022 | Tags: Medtronic, Hugo Robotic-Assisted Surgery System, MedTech, Expand URO US clinical trial

Eisai Entered into a Research Collaboration Agreement with Washington University School of Medicine to Develop New Therapies for Neurodegenerative Diseases

Published: Dec 15, 2022 | Tags: Eisai, Neurodegenerative Diseases, dominantly inherited Alzheimer's disease, P-II/III, Tau NexGen Study, Pharma

Sanofi and Regeneron Receive EC’s Approval of Dupixent (dupilumab) for the Treatment of Prurigo Nodularis

Published: Dec 15, 2022 | Tags: Sanofi, Regeneron, Dupixent, dupilumab, Prurigo Nodularis, Regulatory, EC, Approval

Innovent Entered into a Collaboration and License Agreement with LG Chem for Tigulixostat to Treat Gout Disease

Published: Dec 15, 2022 | Tags: Innovent, LG Chem, Tigulixostat, hyperuricemia, Gout Disease, Pharma

Boehringer Ingelheim’s Ofev (nintedanib) Receives NICE Recommendation for the Treatment of Idiopathic Pulmonary Fibrosis

Published: Dec 15, 2022 | Tags: Boehringer Ingelheim, Ofev, nintedanib, Idiopathic Pulmonary Fibrosis, Regulatory, NICE

Ono Entered into a Multi Target R&D Collaboration Agreement with PrecisionLife to Identify Novel Therapeutic Targets

Published: Dec 15, 2022 | Tags: Ono, PrecisionLife, central nervous system disorders, Novel Therapeutic Targets, combinatorial analytics platform, Biotech

Krystal Biotech Reports P-III Trial (GEM-3) Results of Beremagene Geperpavec for the Treatment of Dystrophic Epidermolysis Bullosa

Published: Dec 15, 2022 | Tags: Krystal Biotech, Beremagene Geperpavec, Dystrophic Epidermolysis Bullosa, Clinical Trial, P-III, GEM-3 Trial 

BeiGene Presents P-III Trial (ALPINE) Results of Brukinsa (zanubrutinib) for Chronic Lymphocytic Leukemia at ASH 2022

Published: Dec 14, 2022 | Tags: BeiGene, Brukinsa, zanubrutinib, Chronic Lymphocytic Leukemia, Clinical Trial, P-III, ALPINE Trial, ASH, 2022

AEON Biopharma to Go Public via Priveterra SPAC Merger for ~$475.5M

Published: Dec 14, 2022 | Tags: AEON Biopharma, Priveterra, ABP-450, cervical dystonia, episodic migraine, SPAC Merger, M&A

Moderna and Merck Report P-IIb Study (KEYNOTE-942/mRNA-4157-P201) Results of mRNA-4157/V940 + Keytruda for Stage III/IV Melanoma

Published: Dec 14, 2022 | Tags: Moderna, Merck, mRNA-4157/V940, Keytruda, Stage III/IV Melanoma, Clinical Trial, P-IIb, KEYNOTE-942

GSK Collaborated with Wave Life Sciences to Advance Oligonucleotide Therapies

Published: Dec 14, 2022 | Tags: GSK, Wave Lifesciences, Oligonucleotide Therapies, WVE-006, Bepirovirsen, GSK4532990, hepatitis B infection, Biotech

Novartis Presents P-III Trial (APPLY-PNH) Result of Iptacopan for Paroxysmal Nocturnal Hemoglobinuria at ASH 2022

Published: Dec 14, 2022 | Tags: Novartis, Iptacopan, Paroxysmal Nocturnal Hemoglobinuria, Clinical Trial, P-III, APPLY-PNH Trial, ASH, 2022

Takeda Entered into an Agreement to Acquire NDI-034858 from Nimbus Therapeutics for ~$6B

Published: Dec 14, 2022 | Tags: Takeda, NDI-034858, Nimbus Therapeutics, plaque psoriasis, psoriatic arthritis, ~$6B, M&A

The EU Council Provides Updates on New Cancer Screening Recommendations

Published: Dec 13, 2022 | Tags: EU Council, New Cancer Screening Recommendations, EU4Health Programme, Horizon Europe, 2023 EU4Health work program, Pharma

Mirum’s Livmarli (maralixibat) Receives EC’s Approval for Cholestatic Pruritus in Patients with Alagille Syndrome Aged ≥2 Months

Published: Dec 13, 2022 | Tags: Mirum Pharmaceuticals, LIVMARLI, maralixibat, Cholestatic Pruritus, Alagille Syndrome, EC, Regulatory

Agilent Technologies’ Agilent Resolution ctDx FIRST Test Receives the US FDA’s Approval for Advanced Non-Small Cell Lung Cancer

Published: Dec 13, 2022 | Tags: Agilent Technologies, Agilent Resolution ctDx FIRST Test, Advanced Non-Small Cell Lung Cancer, Regulatory, US, FDA, Approval

Mirati Therapeutics’ Krazati (adagrasib) Receives the US FDA’s Approval as a Targeted Treatment Option for Non-Small Cell Lung Cancer with a KRASG12C Mutation

Published: Dec 13, 2022 | Tags: Mirati Therapeutics, Krazati, adagrasib, Non-Small Cell Lung Cancer, Regulatory, US, FDA, Approval

Arcutis Reports P-III Trial (INTEGUMENT-2) Results of Roflumilast for the Treatment of Atopic Dermatitis in Adults and Children Aged ≥6 Years

Published: Dec 13, 2022 | Tags: Arcutis, Roflumilast, Atopic Dermatitis, Clinical Trial, P-III, INTEGUMENT-2

Janssen Presents Efficacy and Subgroup Analyses from P-III Study (MAIA) Results of Darzalex for Multiple Myeloma at ASH 2022

Published: Dec 13, 2022 | TagsJanssen, Darzalex, Multiple Myeloma, Clinical Trial, P-III, MAIA Study, ASH, 2022

Janssen Reports the BLA Submission of Talquetamab to the US FDA for the Treatment of Relapsed or Refractory Multiple Myeloma

Published: Dec 12, 2022 | Tags: Janssen, Talquetamab, Multiple Myeloma, BLA, US, FDA, Regulatory

Arcellx Entered into a Collaboration and License Agreement with Kite to Co-Develop and Co-Commercialize CART-ddBCMA for Multiple Myeloma

Published: Dec 12, 2022 | Tags: Arcellx, Kite, CART-ddBCMA, Multiple Myeloma, ARC-SparX programs, Pharma

Janssen Presents P-III study (GLOW) Results of Imbruvica (ibrutinib) + Venetoclax for Chronic Lymphocytic Leukemia at ASH 2022

Published: Dec 12, 2022 | Tags: Janssen, Imbruvica, ibrutinib, Venetoclax, Chronic Lymphocytic Leukemia, Clinical Trial, P-III, GLOW Study, ASH, 2022

GSK Presents P-III Trial (MOMENTUM) Results of Momelotinib for the Treatment of Myelofibrosis at ASH 2022

Published: Dec 12, 2022 | Tags: GSK, Momelotinib, Myelofibrosis, Clinical Trial, P-III, MOMENTUM Trial, ASH, 2022

Pfizer Presents P-II Trial (MagnetisMM-3) Results of Elranatamab for the Treatment of Multiple Myeloma at ASH 2022

Published: Dec 12, 2022 | Tags: Pfizer, Elranatamab, Multiple Myeloma, Clinical Trial, P-II, MagnetisMM-3 Trial, ASH, 2022

Novartis Entered into an Exclusive Worldwide License Agreement with Erasca for Naporafenib

Published: Dec 12, 2022 | Tags: Novartis, Erasca, Naporafenib, NRAS mutant melanoma, RAS/MAPK pathway-driven tumors, Pharma

Related Post: PharmaShots Weekly Snapshots (December 05–09, 2022)


Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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