PharmaShots Weekly Snapshots (January 23

Magenta Therapeutics Pauses the P-I/II Study in AML Patients

Date: Jan 27, 2023 | Tags: Magenta Therapeutics, MGTA-117, AML, Clinical Trial, P-I/II

Ipsen Receives CHMP Negative Opinion for Palovarotene to Treat Fibrodysplasia Ossificans Progressiva

Date: Jan 27, 2023 | Tags: Ipsen, Palovarotene, Fibrodysplasia Ossificans Progressiva, Regulatory, CHMP, the EU

Sound Technologies Collaborates with GE HealthCare to Distribute Vscan Air Across the US for Veterinary Practices

Date: Jan 27, 2023 | Tags: Sound Technologies, GE HealthCare, Vscan Air, Animal Health, US, POCUS

BioArctic & Eisai’s MAA for Lecanemab Receives Approval from the US FDA to Treat Early Alzheimer's Disease

Date: Jan 27, 2023 | Tags: BioArctic, Eisai, Lecanemab, Early Alzheimer's Disease, Regulatory, EMA, US FDA, MAA, BLA, NMPA

Merck Animal Health’s Bravecto Receives the US FDA’s Approval to Treat Asian Long-Horned Ticks in Dogs

Date: Jan 27, 2023 | Tags: Merck Animal Health, Bravecto, Asian Long-Horned Ticks, Animal Health, Regulatory, Dogs, US FDA, Approval, MSD

AC Immune Reports Results of ACI-24.060 in P-Ib/II Trial for the Treatment of Alzheimer’s Disease and Down Syndrome

Date: Jan 27, 2023 | Tags: AC Immune, ACI-24.060, Alzheimer’s Disease, Down Syndrome, Clinical Trial, P-Ib/II, ABATE

Poxel’s PXL770 and PXL065 Receives Orphan Drug Designation from the EC to Treat Adrenoleukodystrophy

Date: Jan 25, 2023 | Tags: Poxel, PXL770, PXL065, Adrenoleukodystrophy, Regulatory, ODD, EC

Bion Signed a Letter of Intent with BetterFedFoods to Develop a Strategic Relationship

Date: Jan 25, 2023 | Tags: Bion, BetterFedFoods, NBO3 Technologies, H3 Enterprises, Animal Health, Omega 3 EPA long-chain fatty acids

Baudax Reports Results of BX1000 in P-II Trial for Neuromuscular Blockade in Undergoing Elective Surgeries

Date: Jan 25, 2023 | Tags: Baudax, BX1000, Undergoing Elective Surgeries, Neuromuscular Blockade, Clinical Trial, P-II

Vistagen Reports First Patient Dosing in P-I Study of PH10 to Treat Major Depressive Disorder

Date: Jan 25, 2023 | Tags: Vistagen, PH10, Pherine Nasal spray, Major Depressive Disorder, P-I, Clinical Trial, First Patient Dosing, the US

Thermo Fisher and AstraZeneca Enters into Multiyear Agreement to Develop Companion Diagnostic Test

Date: Jan 25, 2023 | Tags: Thermo Fisher, AstraZeneca, Tagrisso, Osimertinib, Companion Diagnostic Test, NSCLC, MedTech, Multiyear Agreement, CE-IVD

Ibex, AstraZeneca, and Daiichi Sankyo Enter into a Collaboration to Develop Galen Breast HER2 for the Detection of Breast Cancer

Date: Jan 25, 2023 | Tags: Ibex, AstraZeneca, Daiichi Sankyo, Galen Breast HER2, Breast Cancer, Pharma, SABCS 2022

Helsinn Entered into an Exclusive License and Distribution Agreement with Immedica to Commercialize Akynzeo and Aloxi

Date: Jan 24, 2023 | Tags: Helsinn, Immedica, Akynzeo, Aloxi, CT-induced, nausea, vomiting, Pharma

REGENXBIO Initiates P-I/II Trial of RGX-202 for the Treatment of Duchenne Muscular Dystrophy

Date: Jan 24, 2023 | Tags: REGENXBIO, RGX-202, Duchenne Muscular Dystrophy, Clinical Trial, P-I/II Trial

OncXerna Therapeutics Reports P-II Trial Results of Bavituximab + Pembrolizumab and New Xerna TME Panel Biomarker Data for Advanced Hepatocellular Carcinoma

Date: Jan 24, 2023 | Tags: OncXerna Therapeutics, Bavituximab, Pembrolizumab, Advanced Hepatocellular Carcinoma, New Xerna TME Panel, Clinical Trial, P-II Trial

Hyloris Entered into an Exclusive License and Distribution Agreement with AFT Pharmaceuticals for Maxigesic IV in 9 EU Countries

Date: Jan 24, 2023 | Tags: Hyloris, AFT Pharmaceuticals, Maxigesic IV, ibuprofen IV, paracetamol IV, Pharma

Blueprint Medicines Receives the US FDA’s Acceptance of sNDA for Ayvakit (avapritinib) to Treat Indolent Systemic Mastocytosis

Date: Jan 24, 2023 | Tags: Blueprint Medicines, Ayvakit, avapritinib, Indolent Systemic Mastocytosis, Regulatory, US, FDA, sNDA for

TheracosBio’s Brenzavvy (bexagliflozin) Receives the US FDA’s Approval for the Treatment of Adults with Type 2 Diabetes

Date: Jan 24, 2023 | Tags: TheracosBio, Brenzavvy, bexagliflozin, Type 2 Diabetes, Regulatory, US, FDA, Approval

Priothera Reports the First Patients Enrollment of Mocravimod in P-IIb/III Trial (MO-TRANS) for the Treatment of Acute Myeloid Leukemia

Date: Jan 23, 2023 | Tags: Priothera, Mocravimod, Acute Myeloid Leukemia, Clinical Trial, P-IIb/III, MO-TRANS Trial

HUTCHMED Entered into an Exclusive License Agreement with Takeda to Develop and Commercialize Fruquintinib

Date: Jan 23, 2023 | Tags: HUTCHMED, Takeda, Fruquintinib, Elunate, Metastatic Colorectal Cancer, P-III, FRESCO-2 Trial, Pharma

Ipsen Presents P-III Trial (NAPOLI 3) Results of Onivyde for Metastatic Pancreatic Ductal Adenocarcinoma at ASCO GI 2023

Date: Jan 23, 2023 | Tags: Ipsen, Onivyde, Pancreatic Ductal Adenocarcinoma, P-III, NAPOLI 3 Trial, ASCO GI, 2023

CardioRenal Systems’ RenalGuard Therapy Device Receives the US FDA’s Breakthrough Device Designation for Cardiac Surgery Associated AKI

Date: Jan 23, 2023 | Tags: CardioRenal Systems, RenalGuard Therapy Device, Cardiac Surgery, AKI, Regulatory, US, FDA, Breakthrough Device Designation

Eli Lilly and Boehringer Ingelheim Report the US FDA’s Acceptance of sNDA for Jardiance (empagliflozin) to Treat Chronic Kidney Disease

Date: Jan 23, 2023 | Tags: Eli Lilly, Boehringer Ingelheim, Jardiance, empagliflozin, Chronic Kidney Disease, Regulatory, US, FDA, sNDA

Disc Medicine Entered into an Exclusive License Agreement with Mabwell Therapeutics for Anti-TMPRSS6 Monoclonal Antibodies

Date: Jan 23, 2023 | Tags: Disc Medicine, Mabwell Therapeutics, MWTX-003, TMPRSS6 Monoclonal Antibodies, beta-thalassemia, polycythemia vera, Biotech