BMS Reports the US FDA Acceptance of sBLA for Priority Review of Reblozyl (luspatercept-aamt) to Treat Non-Transfusion Dependent Beta Thalassemia

Published: Dec 3, 2021 | Tags: BMS, US, FDA, sBLA, Priority Review, Reblozyl, luspatercept-aamt, Non-Transfusion Dependent Beta Thalassemia

Acasti Pharma Reports Interim Results of GTX-104 in the PK Bridging Study for the Treatment of Subarachnoid Hemorrhage

Published: Dec 3, 2021 | Tags: Acasti Pharma, GTX-104, PK Bridging Study, Subarachnoid Hemorrhage

Molecular Partners Enters into a Research Collaboration with University of Bern to Advance MP0533 for the Treatment of AML

Published: Dec 3, 2021 | Tags: Molecular Partners, University of Bern, MP0533, AML

Takeda Launches Livtencity (maribavir) for the Treatment of Post-Transplant Cytomegalovirus Infection in the US

Published: Dec 3, 2021 | Tags: Takeda, Livtencity, maribavir, Post-Transplant Cytomegalovirus, Infection, US

BeiGene and EUSA Receive NMPA’s Approval of Sylvant (siltuximab) in China for Idiopathic Multicentric Castleman Disease

Published: Dec 3, 2021 | Tags: BeiGene, EUSA, NMPA, Approval, Sylvant, siltuximab, China, Idiopathic Multicentric Castleman Disease

Protagonist Collaborates with Janssen to Advance PN-235 (JNJ-77242113) in P-II Clinical Studies for Multiple Indications

Published: Dec 3, 2021 | Tags: Protagonist, Janssen, PN-235, P-II, Clinical Studies, Multiple Indications

ITM Entered into a Research Collaboration with Navigo to Develop FAP-targeting Radionuclide Therapy for Solid Tumors

Published: Dec 2, 2021 | Tags: ITM, Navigo, FAP-targeting Radionuclide Therapy, Solid Tumors

Merck Reports the US FDA’s Acceptance of sBLA for Priority Review of Vaxneuvance for Invasive Pneumococcal Disease

Published: Dec 2, 2021 | Tags: Merck, US, FDA, sBLA, Priority Review, Vaxneuvance, pneumococcal 15-valent conjugate vaccine, Invasive Pneumococcal Disease

UCB Entered into a Co-Development and Co-Commercialization Agreement with Novartis for UCB0599 to Treat Parkinson's Disease

Published: Dec 2, 2021 | Tags: UCB, Co-Development, Co-Commercialization, Novartis, UCB0599, Parkinson Disease

Janssen and Amgen’s of Darzalex Faspro (daratumumab and hyaluronidase-fihj) Receive the US FDA’s Approval for the Treatment of Multiple Myeloma

Published: Dec 2, 2021 | Tags: Janssen, Amgen, Darzalex Faspro, daratumumab, hyaluronidase-fihj, US, FDA, Approval, Multiple Myeloma

Amgen Announces Positive Top-Line Results of Otezla (apremilast) from P-III (DISCREET Study) to Treat Genital Psoriasis

Published: Dec 2, 2021 | Tags: Amgen, Otezla, apremilast, P-III, DISCREET Study, Genital Psoriasis

Astellas Signs a ~$1.6M Research Collaboration with Dyno to Develop AAV Gene Therapy Vectors for Skeletal and Cardiac Muscle

Published: Dec 2, 2021 | Tags: Astellas, ~$1.6M, Dyno, AAV Gene Therapy, Vectors, Skeletal, Cardiac Muscle

Sage and Biogen Report One-Year Results of Zuranolone in the P-III (SHORELINE) Study for the MDD

Published: Dec 1, 2021 | Tags: Sage, Biogen, Zuranolone, P-III, SHORELINE, Study, MDD

Ascentage and Innovent’s Olverembatinib Receive NMPA’s Approval for the Treatment of Chronic Myeloid Leukemia

Published: Dec 1, 2021 | Tags: Ascentage, Innovent, Olverembatinib, NMPA, Approval, Chronic Myeloid Leukemia

AbbVie Submits Application to the EMA for Skyrizi (risankizumab) to Treat Crohn's Disease

Published: Dec 1, 2021 | Tags: AbbVie, EMA, Skyrizi, risankizumab, Crohn's Disease

Pfizer Entered into a Clinical Trial Collaboration with NiKang to Evaluate Combination Therapies for the Treatment of Advanced Clear Cell Renal Cell Carcinoma

Published: Dec 1, 2021 | Tags: Pfizer, NiKang, Combination Therapies, Advanced Clear Cell Renal Cell Carcinoma

Jazz First Patient Enrolled in P-III (IMforte) Trial of Zepzelca (lurbinectedin) + Tecentriq for Extensive-Stage Small Cell Lung Cancer

Published: Dec 1, 2021 | Tags: Jazz, P-III, IMforte Trial, Zepzelca, lurbinectedin, Tecentriq, Extensive-Stage Small Cell Lung Cancer

Synaffix Expands the License Agreement with Mersana to Develop ADCs Targeting Cancers for ~$1B

Published: Dec 1, 2021 | Tags: Synaffix, Mersana, ADCs, Cancers, ~$1B

Taiho Exercised its Option to License Arcus’s Domvanalimab and AB308 for NSCLC in Japan and Other Countries

Published: Nov 30, 2021 | Tags: Taiho, Arcus, Domvanalimab, AB308, NSCLC, Japan

AstraZeneca Signs an Agreement with Genetron Health to Develop and Commercialize NGS-based MRD Assay for Solid Tumors in China

Published: Nov 30, 2021 | Tags: AstraZeneca, Genetron Health, NGS-based MRD Assay, Solid Tumors, China

Junshi’s Toripalimab Receives the NMPA’s Approval as 1L Treatment for Locally Recurrent or Metastatic Nasopharyngeal Carcinoma

Published: Nov 30, 2021 | Tags: Junshi, Toripalimab, NMPA, Approval, Nasopharyngeal Carcinoma

Merck and Eisai’s Keytruda (pembrolizumab) + Lenvima (lenvatinib) Receive EC’s Approval as 1L Treatment of Advanced Renal Cell Carcinoma

Published: Nov 30, 2021 | Tags: Merck, Eisai, Keytruda, pembrolizumab, Lenvima, Lenvatinib, EC, Approval, Advanced Renal Cell Carcinoma

BMS Reports the US FDA Acceptance of NDA for Deucravacitinib to Treat Plaque Psoriasis

Published: Nov 30, 2021 | Tags: BMS, US, FDA, Acceptance, NDA, Deucravacitinib, Plaque Psoriasis

Blueprint Medicines to Acquire Lengo for ~$250M

Published: Nov 30, 2021 | Tags: Blueprint Medicines, Acquire, Lengo, ~$250M

SpringWorks Completes an Enrollment of Mirdametinib in P-IIb ReNeu Trial for the Treatment of NF1-Associated Plexiform Neurofibromas

Published: Nov 29, 2021 | Tags: SpringWorks, P-IIb, ReNeu Trial, Mirdametinib, NF1-Associated Plexiform Neurofibromas

Turnstone Biologics Entered into a Multi-Year Research Collaboration with Moffitt Cancer Center to Advance TIL Immunotherapies for Solid Tumor

Published: Nov 29, 2021 | Tags: Turnstone Biologics, Moffitt Cancer Center, TIL Immunotherapies, Solid Tumor

Qiagen and DiaSorin’s QuantiFERON-TB Gold Plus Assay Receives the US FDA’s Approval for the Treatment of Latent Tuberculosis Infection

Published: Nov 29, 2021 | Tags: Qiagen, DiaSorin, QuantiFERON-TB Gold Plus Assay, US, FDA, Approval, Latent Tuberculosis

The US FDA Placed a Clinical Hold on the Ocugen’s IND Application for Covaxin (BBV152) to Treat COVID-19

Published: Nov 29, 2021 | Tags: US, FDA, Ocugen, IND, Application, Covaxin, BBV152, COVID-19

Clover Initiates P-II Trial of COVID-19 Vaccine as Heterologous Booster for the Treatment of COVID-19

Published: Nov 29, 2021 | Tags: Clover, P-II, Trial, COVID-19 Vaccine, COVID-19

Merck and Ridgeback Provide Update on MOVe-OUT Study of Molnupiravir for the Treatment of COVID-19

Published: Nov 29, 2021 | Tags: Merck, Ridgeback, MOVe-OUT, Study, Molnupiravir, COVID-19

Related Post: PharmaShots Weekly Snapshots (November 22-26, 2021)