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