PharmaShots Weekly Snapshots (May 15

Alimera Acquires Rights from EyePoint Pharmaceuticals to Commercialise Yutiq in the US

Date: May 19, 2023 | Tags: Alimera, EyePoint Pharmaceuticals, Yutiq, Iluvien, chronic non-infectious uveitis, US, Pharma

Sobi Reports EMA’s Validation of MAA for Efanesoctocog Alfa to Treat Haemophilia A

Date: May 19, 2023 | Tags: Sobi, Efanesoctocog Alfa, Haemophilia A, Regulatory, EMA, Marketing Authorisation Application

AstraZeneca’s Forxiga (dapagliflozin) Receives the NICE Recommendation for Chronic Heart Failure

Date: May 19, 2023 | Tags: AstraZeneca, Forxiga, dapagliflozin, Chronic Heart Failure, Regulatory, NICE, Recommendation

Abbott’s Assert-IQ Insertable Cardiac Monitor Receives the US FDA’s Clearance for Irregular Heartbeats

Date: May 19, 2023 | Tags: Abbott, Assert-IQ Insertable Cardiac Monitor, Irregular Heartbeats, DigiHealth, US, FDA, Clearance

Eli Lilly Publishes P-IIa Study Results of Peresolimab for the Treatment of Rheumatoid Arthritis in the NEJM

Date: May 19, 2023 | Tags: Eli Lilly Publishes P-IIa Study Results of Peresolimab for the Treatment of Rheumatoid Arthritis

AbbVie’s Rinvoq (upadacitinib) Receives the US FDA’s Approval for the Treatment of Adults with Moderately to Severely Active Crohn's Disease

Date: May 19, 2023 | Tags: AbbVie, Rinvoq, upadacitinib, Active Crohn's Disease, Regulatory, US, FDA, Approval

AstraZeneca and Revvity Enters into Licensing Agreement for Pin-point Editing Technology to Treat Cancer and Immune-mediated Diseases

Date: May 18, 2023 | Tags: Revvity, AstraZeneca, Pin-point, Licensing Agreement, Gene editing technology, Biotech, Cas enzyme, T-cells and iPSCs

CANbridge Pharmaceuticals and UMass Chan Medical School Presented Poster from the Preclinical Results of CAN203 at ASGCT 2023 Annual Meeting

Date: May 18, 2023 | Tags: CANbridge Pharmaceuticals, UMass Chan Medical School, CAN203, Clinical Trial, ICV ASGCT 2023, Preclinical Results, SMN expression

Antengene Receives the US FDA’s IND Clearance of ATG-031 for Advanced Solid Tumors or B-Cell Non-Hodgkin's Lymphoma

Date: May 18, 2023 | Tags: Antengene, ATG-031, Advanced Solid Tumors, B-Cell Non-Hodgkin's Lymphoma, Regulatory, US, FDA, IND

Vifor Fresenius Medical Care Renal Pharma and Cara Therapeutics Receive NICE Recommendation of Kapruvia (difelikefalin) for CKD-Associated Pruritus

Date: May 18, 2023 | Tags: Vifor Fresenius Medical Care Renal Pharma, Cara Therapeutics, Kapruvia, difelikefalin, CKD, Pruritus, NICE

enGene to go Public via Forbion European Acquisition Corp. SPAC Merger for ~$135M

Date: May 18, 2023 | Tags: enGene, Forbion European Acquisition Corp, detalimogene voraplasmid, EG-70, BCG-unresponsive, non-muscle invasive bladder cancer, M&A, SPAC, Merger, ~$135M

Roche Reports P-II Study (FENopta) Results of Fenebrutinib for the Treatment of Multiple Sclerosis

Date: May 18, 2023 | Tags: Roche, Fenebrutinib, Multiple Sclerosis, Clinical Trial, P-II, FENopta Study

Amneal Reports the Commercial Availability of Fylnetra (biosimilar, pegfilgrastim) in the US

Date: May 17, 2023 | Tags: Amneal, Kashiv Biosciences, Fylnetra, biosimilar, Neulasta, pegfilgrastim, febrile neutropenia, Biosimilar, US

AstraZeneca Reports P-III Trial (FLAURA2) Results of Tagrisso (osimertinib) for the Treatment of EGFR-Mutated Advanced Lung Cancer

Date: May 17, 2023 | Tags: AstraZeneca, Tagrisso, Osimertinib, Lung Cancer, Clinical Trial, P-III, FLAURA2 Trial

Abbott’s Spinal Cord Stimulation Systems Receives the US FDA’s Approval for Chronic Back Pain

Date: May 17, 2023 | Tags: Abbott, Spinal Cord Stimulation Systems, Chronic Back Pain, Regulatory, MedTech, US, FDA, Approval

X4 Pharmaceuticals to Present P-III Trial (4WHIM) Results of Mavorixafor for the Treatment of WHIM Syndrome at CIS 2023

Date: May 17, 2023 | Tags: X4 Pharmaceuticals, Mavorixafor, WHIM Syndrome, Clinical Trial, P-III, 4WHIM Trial, CIS, 2023

Takeda Reports the US FDA Acceptance of BLA and Granted Priority Review of TAK-755 for Congenital Thrombotic Thrombocytopenic Purpura

Date: May 17, 2023 | Tags: Takeda, TAK-755, Congenital Thrombotic Thrombocytopenic Purpura, Regulatory, US, FDA, BLA, Priority Review

Scribe Collaborated with Prevail to Advance In Vivo CRISPR-based Genetic Therapies for Neurological and Neuromuscular Diseases

Date: May 17, 2023 | Tags: Scribe, Prevail, In Vivo, CRISPR-based Genetic Medicines, Neurological, Neuromuscular Diseases, CRISPR X-Editing technologies, Biotech

Dermavant Reports P-III Study (ADORING 1) Results of Vtama (tapinarof) for Adults and Children with Atopic Dermatitis

Date: May 16, 2023 | Tags: Dermavant, Vtama, tapinarof, Atopic Dermatitis, Clinical Trial, P-III, ADORING 1 Study

IDEAYA Amends Clinical Trial Collaboration and Supply Agreements with Pfizer to Evaluate Darovasertib + Crizotinib Combination in 1L Metastatic Uveal Melanoma

Date: May 16, 2023 | Tags: IDEAYA, Pfizer, Darovasertib, Crizotinib, Metastatic Uveal Melanoma, Pharma

Gilead’s Hepcludex (bulevirtide) Receives NICE Recommendation for the Treatment of Chronic Hepatitis Delta Virus Infection

Date: May 16, 2023 | Tags: Gilead, Hepcludex, bulevirtide, Chronic Hepatitis Delta Virus Infection, Regulatory, NICE Recommendation

Neurocrine Presents P-III Studies (KINECT 3 & 4) Results of Ingrezza (valbenazine) for Tardive Dyskinesia and Schizophrenia or Schizoaffective Disorder at SIRS 2023

Date: May 16, 2023 | Tags: Neurocrine, Ingrezza, valbenazine, Tardive Dyskinesia, Schizophrenia, Schizoaffective Disorder, Clinical Trials, P-III, KINECT 3 & 4, SIRS, 2023

Eisai and Biogen Report the Health Canada Acceptance of New Drug Submission for Leqembi (lecanemab) to Treat Early Alzheimer's Disease

Date: May 16, 2023 | Tags: Eisai, Biogen, Leqembi, lecanemab, Early Alzheimer's Disease, Regulatory, Health Canada, New Drug Submission

Gilead Expands its May 2020 Collaboration with Arcus Biosciences to Include Inflammatory Research Programs

Date: May 16, 2023 | Tags: Gilead, Arcus Biosciences Inflammatory Disease, Pharma

Hummingbird Bioscience Entered into a Clinical Trial Collaboration and Supply Agreement with Merck to Evaluate HMBD-001 for Squamous Non-Small Cell Lung Carcinoma

Date: May 15, 2023 | Tags: Hummingbird Bioscience, Merck, HMBD-001, Squamous Non-Small Cell Lung Carcinoma, Pharma

Innovent’s IBI351 Receives the NMPA’s Breakthrough Therapy Designation for Advanced Colorectal Carcinoma

Date: May 15, 2023 | Tags: Innovent, IBI351, Colorectal Carcinoma, Regulatory, NMPA, Breakthrough Therapy Designation

Aligos Signs a Research Collaboration and Development Agreement with Amoytop to Discover and Develop Oligonucleotides for Liver Diseases

Date: May 15, 2023 | Tags: Aligos Amoytop, Oligonucleotides, Liver Diseases, oligonucleotide platform, Biotech

GSK Presents Results of 5-in-1 Meningococcal ABCWY Vaccine Candidate at ESPID 2023

Date: May 15, 2023 | Tags: GSK, MenABCWY, Bexsero, Menveo, invasive meningococcal disease, Clinical Trial, ESPID, 2023