PharmaShots Weekly Snapshots (December 12

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 | Tags: Janssen, 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