InnoCare’s Tafasitamab + Lenalidomide Receives Approval from China Regulatory Authority to Treat r/r Diffuse Large B-Cell Lymphoma

Published: July 18, 2022 | Tags: InnoCare, Tafasitamab, Lenalidomide, Diffuse Large B-Cell Lymphoma, Approval, Regulatory

PharmaCyte Initiates the First Phase of the Two-Phase Study Evaluating CypCaps to Lift the US FDA’s Clinical Hold

Published: July 18, 2022 | Tags: PharmaCyte, CypCaps, Cell-in-a-Box Technology, Locally Advanced Inoperable Pancreatic Cancer, US, FDA, Animal Health

Vertex Entered into an Exclusive Four-Year Research Collaboration with Verve Therapeutics to Develop an In Vivo Gene Editing Program for Liver Disease

Published: July 18, 2022 | Tags: Vertex, Verve Therapeutics, In Vivo Gene Editing Program, Liver Disease, Biotech

Sanofi Reports the Selection of IPH6401/SAR’514 in IND-Enabling Studies for Cancer

Published: July 18, 2022 | Tags: Sanofi, IPH6401, SAR’514, Cancer, IND-Enabling Studies, Clinical Trial, ANKET platform

Karyopharm and Menarini's Nexpovio (selinexor) Receive EC's Marketing Authorisation for the Treatment of Multiple Myeloma

Published: July 18, 2022 | Tags: Karyopharm, Menarini, Nexpovio, Selinexor, Multiple Myeloma, Regulatory, EC, Marketing Authorisation

Silverback Therapeutics Entered into a Definitive Merger Agreement with ARS for Neffy to Treat Type I Allergic Reactions

Published: July 18, 2022 | Tags: Silverback Therapeutics, ARS, Neffy, Type I Allergic Reactions, Merger Agreement, Pharma

Takeda Reports P-III (ADVANCE-1) Trial Results of Hyqvia as Maintenance Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Published: July 17, 2022 | Tags: Takeda, Hyqvia, Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Clinical Trial, P-III, ADVANCE-1 Trial

ITM Entered into a Clinical Supply Agreement with Y-mAbs for n.c.a. Lutetium-177 to Treat Solid Tumors

Published: July 17, 2022 | Tags: ITM, Y-mAbs, n.c.a. Lutetium-177, Solid Tumors, Pharma, GD2-SADA: 177Lu-DOTA complex

Eiger's Zokinvy (ionafarnib) Receives EC's Marketing Authorization for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies

Published: July 17, 2022 | Tags: Eiger, Zokinvy, ionafarnib, Hutchinson-Gilford Progeria Syndrome, Processing-Deficient Progeroid Laminopathies, Regulatory, EC, Marketing Authorization

LEO Pharma Reports 32-Week Results from a Post-hoc Analysis of Adbry (tralokinumab-ldrm) in P-III (ECZTRA 3) Trial for Atopic Dermatitis

Published: July 17, 2022 | Tags: LEO Pharma, Adbry, tralokinumab-ldrm, Atopic Dermatitis, Clinical Trial, P-III, ECZTRA 3 Trial

Alvotech Reports the Initiation of Pharmacokinetic Study for AVT03, a Proposed Biosimilar for Prolia and Xgeva to Treat Bone Disease

Published: July 17, 2022 | Tags: Alvotech, AVT03, Prolia, Xgeva, denosumab, Bone Disease, Biosimilar

F-star Entered into License Agreement with Takeda for Immuno-Oncology Bispecific Antibody to Treat Cancer

Published: July 17, 2022 | Tags: F-Star, Takeda, Immuno-oncology Bispecific Antibody, Cancer, Biotech, Fcab Technology, mAb2 Platforms, Gamma Delta (γδ) T cell Engager

AbbVie Collaborated with iSTAR Medical to Develop and Commercialize MINIject Device for Glaucoma

Published: July 16, 2022 | Tags: AbbVie, IStar Medical, MINIject Device, Glaucoma, MedTech

Merck Provides Update of Keytruda (pembrolizumab) in P-III (KEYNOTE-412) Trial for Head and Neck Squamous Cell Carcinoma

Published: July 16, 2022 | Tags: Merck, Keytruda, pembrolizumab, Head, Neck Squamous Cell Carcinoma, Clinical Trial, P-III (KEYNOTE-412) Trial

Apellis Reports the US FDA Acceptance and Priority Review of NDA for Pegcetacoplan to Treat Geographic Atrophy

Published: July 16, 2022 | Tags: Apellis, Pegcetacoplan, Geographic Atrophy, Regulatory, US, FDA, Priority Review

Gilead Signs New Joint Procurement Agreement with the EC to Supply Veklury (remdesivir) for COVID-19

Published: July 16, 2022 | Tags: Gilead, Veklury, remdesivir, COVID-19, Joint Procurement Agreement, EC, Pharma, COVID-19

Innovent's Mazdutide (IBI362) Meet its Primary Endpoint in P-II Study for the Treatment of Type 2 Diabetes

Published: July 16, 2022 | Tags: Innovent, Mazdutide, IBI362, Type 2 Diabetes, Clinical Trials, P-II Study

Innovent and Ascentage Report NMPA Acceptance of NDA and Granted Priority Review Designation for Olverembatinib to Treat Chronic Myeloid Leukemia

Published: July 16, 2022 | Tags: Innovent, Ascentage, Olverembatinib, CML, Regulatory, NMPA, NDA, Priority Review Designation

Roche Collaborated with Avista to Develop AAV Gene Therapy Vectors for the Treatment of Ocular Diseases

Published: July 15, 2022 | Tags:Roche, Avista, AAV Gene Therapy Vectors, Ocular Diseases, Pharma

Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) Receive EU Approval for HER2 Positive Metastatic Breast Cancer

Published: July 15, 2022 | Tags: Daiichi Sankyo, AstraZeneca, Enhertu, trastuzumab deruxtecan, HER2 Positive Metastatic Breast Cancer, Regulatory, EU, Approval

Acadia Reports the NDA Submission of Trofinetide to the US FDA for the Treatment of Rett Syndrome

Published: July 15, 2022 | Tags: Acadia, Trofinetide, Rett Syndrome, NDA, Regulatory, P-III, Lavender study

Rhythm’s Imcivree (setmelanotide) Receives NICE Recommendation for Obesity and Controlling Hunger Caused by POMC or LEPR Deficiency

Published: July 15, 2022 | Tags: Rhythm, NICE, Imcivree, setmelanotide, Obesity, Hunger, Regulatory, POMC, LEPR Deficiency

Incyte's Opzelura (ruxolitinib) Receives the US FDA's Approval for the Treatment of Vitiligo

Published: July 15, 2022 | Tags: Incyte, Opzelura, ruxolitinib, Vitiligo, Regulatory, US, FDA, Approval

Erasca Entered into a Clinical Trial Collaboration and Supply Agreement with Eli Lilly to Evaluate ERAS-601 + Cetuximab for Cancer

Published: July 15, 2022 | Tags: Erasca, Eli Lilly, ERAS-601, Cetuximab, Cancer, Pharma, Supply Agreement

Zomedica Acquires Assisi’s Assets and Provide Drug-Free Solution for Treating Pain

Published: July 14, 2022 | Tags: Zomedica, Assisi, Assets, Acquires, Drug-Free Solution, Animal Health, Pain

PureTech Founded Entity Akili Reports Investigator-Initiated Study Results of AKL-T01 for Systemic Lupus Erythematosus

Published: July 14, 2022 | Tags: PureTech, Akili,  AKL-T01, Systemic Lupus Erythematosus, Clinical Trials, EVO Monitor, Lupus

AbbVie Reports Submission of MAA to EMA for Atogepant to Treat Migraine

Published: July 14, 2022 | Tags: Roche, Perjeta, pertuzumab, HER2-Positive Early Breast Cancer, Clinical Trial, P-III, APHINITY Study, ESMO, 2022

Roche Presents Eight-Year P-III (APHINITY) Study of Perjeta (pertuzumab) for HER2-Positive Early Breast Cancer at ESMO 2022

Published: July 14, 2022 | Tags: Roche, Perjeta, pertuzumab, HER2-Positive Early Breast Cancer, Clinical Trial, P-III, APHINITY Study, ESMO, 2022

SIGA Collaborated with KaliVir Immunotherapeutics to Supply Tpoxx for the Treatment of Smallpox

Published: July 14, 2022 | Tags: SIGA, KaliVir Immunotherapeutics, Tpoxx, tecovirimat, Smallpox, Pharma, Oncolytic Vaccinia Immunotherapy Platform

Calliditas’ Kinpeygo Receive EC's Marketing Authorization for the Treatment of Primary Immunoglobulin A Nephropathy

Published: July 14, 2022 | Tags: Calliditas, Kinpeygo, Primary Immunoglobulin A Nephropathy, Regulatory, EC Marketing Authorization

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