PharmaShots Weekly Snapshots (April 24 - 28, 2023)

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PharmaShots Weekly Snapshots (April 24 - 28, 2023)

Evecxia Therapeutics Receives Notice of Allowance from the US PTO Covering EVX‑101

Date: Apr 28, 2023 | Tags: Evecxia Therapeutics, EVX‑101, Regulatory, Patent, USPTO, 17/877, 699

Zura Bio Reports $80M Financing and Licensing of ZB-106 from Eli Lilly for Autoimmune Diseases

Date: Apr 28, 2023 | Tags: Zura Bio, Eli Lilly, Tibulizumab, ZB-106, Rheumatoid Arthritis, Sjogren’s Syndrome Pharma, P-Ib

Daewoong Pharmaceutical and Vitalli Bio Enters into Global License Agreement to Develop  DWP213388 for Autoimmune Disease

Date: Apr 28, 2023 | Tags: Daewoong Pharmaceutical, Vitalli Bio, DWP213388, License Agreement, Pharma, Korea, ~$477M

Takeda Reports BLA Resubmission to the US FDA for Entyvio as a Maintenance Therapy for Ulcerative Colitis

Date: Apr 28, 2023 | Tags: Takeda, Entyvio, Ulcerative Colitis, Regulatory, US FDA, BLA, VISIBLE 1

Elicio Therapeutics Report the First Patient Dosing of ELI-002 7P in P-I/II Trial for KRAS/NRAS Mutated Solid Tumors

Date: Apr 28, 2023 | Tags: Elicio Therapeutics, ELI-002 7P, KRAS/NRAS Mutated Solid Tumors, Clinical Trial, P-I/II, AMPLIFY-7P, P-I, AMPLIFY-201

Innoblative’s SIRA RFA Electrosurgical Device Receives a Breakthrough Device Designation from the US FDA for Breast Cancer Treatment

Date: Apr 28, 2023 | Tags: Innoblative, SIRA RFA, Electrosurgical Device, Breast Cancer, Medtech, Regulatory, US FDA, Breakthrough Device Designation 

Eli Lilly Reports P-III Trial (SURMOUNT-2) Results of Tirzepatide for Obesity or Overweight and Type 2 Diabetes

Date: Apr 27, 2023 | Tags: Eli Lilly, tirzepatide, Obesity, Overweight, Type 2 Diabetes, Clinical Trial, P-III, Surmount-2 Trial

Seres Therapeutics and Nestlé Health Science Receive the US FDA’s Approval of VOWST for the Prevention of Recurrence of C. Difficile Infection

Date: Apr 27, 2023 | Tags: Seres Therapeutics, Nestlé Health Science, Vowst, C. Difficile Infection, Regulatory, US, FDA, Approval

Ultromics’ EchoGo Amyloidosis Receives the US FDA’s Breakthrough Device Designation to Detect Cardiac Amyloidosis

Date: Apr 27, 2023 | Tags: Ultromics, Echogo Amyloidosis, Cardiac Amyloidosis, Regulatory, Medtech, US FDA, Breakthrough Device Designation

Galapagos Reports Initiation of P-III Trial (OLINGUITO) for Filgotinib to Treat Active Axial Spondyloarthritis

Date: Apr 27, 2023 | Tags: Galapagos, Filgotinib, Active Axial Spondyloarthritis, Clinical Trial, P-III, Olinguito Trial

Novartis Presents P-III Trial (APPOINT-PNH) Results of Iptacopan for the Treatment of Paroxysmal Nocturnal Hemoglobinuria at EBMT 2023

Date: Apr 27, 2023 | Tags: Novartis, Iptacopan, Paroxysmal Nocturnal Hemoglobinuria, Clinical Trial, P-III, APPOINT-PNH Trial, ebmt, 2023

BMS Receives EMA’s CHMP Positive Opinion Recommending Approval of Camzyos (mavacamten) for Symptomatic Obstructive Hypertrophic Cardiomyopathy

Date: Apr 27, 2023 | Tags: BMS, Camzyos, Mavacamten, Symptomatic Obstructive Hypertrophic Cardiomyopathy, Regulatory, EMA, CHMP, Positive Opinion, Approval

Belite Bio Presents 18-Month Interim Results from P-II Study (LBS-008-CT02) of Tinlarebant for Stargardt Disease at ARVO 2023

Date: Apr 26, 2023 | Tags: Belite Bio, Tinlarebant, Stargardt Disease, Clinical Trial, P-II, LBS-008-CT02 Study, ARVO, 2023

Assertio Holdings to Acquire Spectrum Pharmaceuticals for ~$291M

Date: Apr 26, 2023 | Tags: Assertio Holdings, Spectrum Pharmaceuticals, Rolvedon, ~$291M, M&A

Morphic Reports P-IIa Trial (EMERALD-1) Results of c for the Treatment of Ulcerative Colitis

Date: Apr 26, 2023 | Tags: Morphic, MORF-057, Ulcerative Colitis, Clinical Trial, P-IIa, EMERALD-1 Trial

Akebia Receives EC’s Marketing Authorisation of Vafseo (vadadustat) for the Treatment of Symptomatic Anaemia

Date: Apr 26, 2023 | Tags: Akebia, Vafseo, Vadadustat, Symptomatic Anaemia, Chronic Kidney Disease, Regulatory, EC, Marketing Authorisation

Biogen and Ionis Receive the US FDA’s Approval of Qalsody (tofersen) for the Treatment of Amyotrophic Lateral Sclerosis

Date: Apr 26, 2023 | Tags: Biogen, Ionis, Qalsody, Tofersen, Amyotrophic Lateral Sclerosis, Regulatory, US, FDA, Approval

Stablix Entered into a Collaboration and License Agreement with Vertex to Discover and Develop Targeted Protein Stabilization Therapies

Date: Apr 26, 2023 | Tags: Stablix, Vertex, Protein Stabilization Therapies, Restoracs, Biotech

Samsung Bioepis Presents 52 Weeks P-III Study Results of SB15, Proposed biosimilar to Eylea (aflibercept) for Neovascular Age-Related Macular Degeneration at ARVO 2023

Date: Apr 25, 2023 | Tags: Samsung Bioepis, SB15, Biosimilar, Eylea, Aflibercept, Neovascular Age-Related Macular Degeneration, P-III study, ARVO, 2023

GSK Reports EMA’s Validation of MAA for Jemperli (dostarlimab) to Treat dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer

Date: Apr 25, 2023 | Tags: GSK, Jemperli, Dostarlimab, dMMR/MSI-H, Endometrial Cancer, Regulatory, EMA, MAA

NewAmsterdam Pharma Reports the Completion of Patient Enrollment in P-III trial (BROOKYLN) of Obicetrapib for Heterozygous Familial Hypercholesterolemia

Date: Apr 25, 2023 | Tags: Newamsterdam Pharma, Obicetrapib, Heterozygous Familial Hypercholesterolemia, Clinical Trial

Rhythm Pharmaceuticals Launches Imcivree (setmelanotide) for Obesity and Control of Hunger in Bardet-Biedl Syndrome in Germany

Date: Apr 25, 2023 | Tags: Rhythm Pharmaceuticals, Imcivree, Setmelanotide, Obesity, Bardet-Biedl Syndrome, Germany, Regulatory

Eli Lilly to Sell Baqsimi to Amphastar for ~$1B

Date: Apr 25, 2023 | Tags: Eli Lilly, Amphastar, Baqsimi, Hypoglycemia, Diabetes, ~$1B, M&A

3B Pharmaceuticals Entered into an Amended and RestatedLicense Agreement with Novartis for FAP-Targeting Peptide Technology

Date: Apr 25, 2023 | Tags: 3b Pharmaceuticals, Novartis, Fap-Targeting Peptide Technology, FAP-2286, P-I, Lumiere Trial, Pharma

AstraZeneca Presents P-III Trial (NEURO-TTRansform) Results of Eplontersen for Hereditary Transthyretin-Mediated Amyloid Polyneuropathy at AAN 2023

Date: Apr 24, 2023 | Tags: Astrazeneca, Eplontersen, Hereditary Transthyretin-Mediated Amyloid Polyneuropathy, Clinical Trial, P-III, Neuro-Transform, AAN, 2023

CymaBay Therapeutics Publishes P-III Study (ENHANCE) Results of Seladelpar for the Treatment of Primary Biliary Cholangitis in Hepatology

Date: Apr 24, 2023 | Tags: Cymabay Therapeutics, Seladelpar, Primary Biliary Cholangitis, Hepatology, Clinical Trial, P-III Enhance Study

The US FDA Lifts Clinical Hold for MaaT Pharma’s MaaT013 to Treat Acute Graft-versus-Host Disease

Date: Apr 24, 2023 | Tags: Maat Pharma, MAAT013, Acute Graft-Versus-Host Disease, Clinical Trial, US, FDA, Clinical Hold

Medtronic’s MiniMed 780G System Receives the US FDA’s Approval for the Treatment of Type 1 Diabetes

Date: Apr 24, 2023 | Tags: Medtronic, Minimed 780g System, Type 1 Diabetes, Regulatory, Medtech, US, FDA, Approval

LianBio Reports the NMPA Acceptance of NDA and Granted Priority Review of Mavacamten for Obstructive Hypertrophic Cardiomyopathy

Date: Apr 24, 2023 | Tags: Lianbio, Mavacamten, Obstructive Hypertrophic Cardiomyopathy, Regulatory, NMPA, NDA, Priority Review 

Apellis Presents P-III Studies (OAKS) and (DERBY) Results of Syfovre (pegcetacoplan) in Patients with Geographic Atrophy at ARVO 2023

Date: Apr 24, 2023 | Tags: Apellis, Syfovre, Pegcetacoplan, Geographic Atrophy, Clinical Trial, P-III, Oaks, Derby

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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