PharmaShots Weekly Snapshots (February 13

Iveric Bio Reports the US FDA Acceptance of NDA and Granted Priority Review of Avacincaptad Pegol for Geographic Atrophy

Date: Feb 17, 2023 | Tags: Iveric Bio, Avacincaptad Pegol, Geographic Atrophy, Regulatory, US, FDA, NDA, Priority Review

ALX Oncology Reports the First Patient Dosing of Evorpacept in the P-I Study (ASPEN-07) for the Treatment of Urothelial Cancer

Date: Feb 17, 2023 | Tags: ALX Oncology, Evorpacept, Urothelial Cancer, Clinical Trial, P-I, ASPEN-07 Study

Fresenius Kabi Launches Stimufend (biosimilar, pegfilgrastim) for Febrile Neutropenia in the US

Date: Feb 17, 2023 | Tags: Fresenius Kabi, Stimufend, biosimilar, pegfilgrastim, Febrile Neutropenia, Biosimilar, US

Applied Therapeutics Reports P-III trial (INSPIRE) Results of AT-007 for Sorbitol Dehydrogenase Deficiency

Date: Feb 17, 2023 | Tags: Applied Therapeutics, AT-007, Sorbitol Dehydrogenase Deficiency, Clinical Trial, P-III, INSPIRE Trial

Pfizer Reports P-III Trial Results of Zavegepant for the Acute Treatment of Migraine in Adults

Date: Feb 17, 2023 | Tags: Pfizer, Zavegepant, Migraine, Clinical Trial, P-III Trial

Capricor Entered into an Exclusive Commercialization and Distribution Agreement with Nippon Shinyaku for CAP-1002 to Treat Duchenne Muscular Dystrophy in Japan

Date: Feb 17, 2023 | Tags: Capricor, Nippon Shinyaku, CAP-1002, Duchenne Muscular Dystrophy, Japan, HOPE-2 OLE study, Pharma

Arrowhead Gains Full Rights to ARO-PNPLA3 for Patients with Non-Alcoholic Steatohepatitis

Date: Feb 16, 2023 | Tags: Arrowhead, ARO-PNPLA3, Non-Alcoholic Steatohepatitis, Pharma, P-I Trial, TRiM platform

Henlius Reports the US FDA Acceptance of BLA for Proposed Biosimilar Trastuzumab HLX02

Date: Feb 16, 2023 | Tags: Henlius,Trastuzumab, HLX02, breast cancer, gastric cancer, Regulatory, US, FDA BLA

Merck Signs an Exclusive License and Research Collaboration Agreement with Aqilion for Small Molecule Inhibitors of TAK1 Protein

Date: Feb 16, 2023 | Tags: Merck, Aqilion, TAK1 Protein, autoimmune, inflammatory disease Pharma

Coherus and Junshi Biosciences Report P-III Trial (JUPITER-02) Results of Toripalimab for Recurrent or Metastatic Nasopharyngeal Carcinoma

Date: Feb 16, 2023 | Tags: Coherus, Junshi Bioscience, Toripalimab, Nasopharyngeal Carcinoma, Clinical Trial, P-III, JUPITER-02 Trial

BerGenBio Reports P-II Trial Results of BGB324 (bemcentinib) as 2L Treatment of Non-Small Cell Lung Cancer

Date: Feb 16, 2023 | Tags: BerGenBio, BGB324, bemcentinib, Non-Small Cell Lung Cancer, Clinical Trial, P-II Trial

Xilis Collaborated with MD Anderson to Advance Novel Technology and Advances Therapeutic Development

Date: Feb 16, 2023 | Tags: Xilis, MD Anderson, Novel Technology, NK cell therapy, MicroOrganoSphere technology, Pharma

Bavarian Nordic to Acquire Emergent BioSolutions’ Vivotif, Vaxchora and an Under Developed Chikungunya Vaccine

Date: Feb 15, 2023 | Tags: Bavarian, Emergent BioSolutions, Vivotif, Vaxchora, typhoid fever, cholera, chikungunya, M&A, clinical trial, P-III, US, EU

Ipsen, Université de Montréal and IRICoR Expands their Collaboration for Pre-Clinical Stage Program and two New Discovery-Stage Programs

Date: Feb 15, 2023 | Tags: Ipsen, Universite de Montreal, IRICoR, Oncology, Pharma

Seres Therapeutics Reports P-III Trial (ECOSPOR IV) Results of SER-109 for the Prevention of Recurrent C. Difficile Infection

Date: Feb 15, 2023 | Tags: Seres Therapeutics, SER-109, Recurrent C. Difficile Infection, Clinical Trial, P-III, ECOSPOR IV Trial

Mirum Reports sNDA Submission to the US FDA for Livmarli (maralixibat) to Treat Cholestatic Pruritus in Progressive Familial Intrahepatic Cholestasis

Date: Feb 15, 2023 | Tags: Mirum, ivmarli, maralixibat, Cholestatic Pruritus, Progressive Familial Intrahepatic Cholestasis, Regulatory, sNDA, US, FDA

Ferring Launches Rebyota for the Prevention of Recurrence of C. diff Infection in Adults in the US

Date: Feb 15, 2023 | Tags: Ferring, Rebyota, Clostridioides difficile infection, US, Pharma, P-III, PUNCH CD3 trial

Sentia Medical Sciences Extends its Research Collaboration with Neurocrine Biosciences to Discover Novel Peptide Therapies for HPA-Driven Diseases

Date: Feb 15, 2023 | Tags: Sentia Medical Sciences, Neurocrine Biosciences, CRF Peptides, hypothalamic-pituitary-adrenal axis modulated diseases, Biotech

G1 Therapeutics Reports P-III Trial (PRESERVE 1) Results of Trilaciclib for Metastatic Colorectal Cancer

Date: Feb 14, 2023 | Tags: G1 Therapeutics, Trilaciclib, Colorectal Cancer, Clinical Trial, P-III, PRESERVE 1 Trial

Financial Strategies Acquisition Corp. to go Public via Austin Biosciences SPAC Merger for ~$166.3M

Date: Feb 14, 2023 | Tags: Financial Strategies Acquisition Corp, Austin Biosciences Corp, SPAC, Merger, ~$166.3M, M&A

Exelixis and Sairopa Receive the US FDA’s IND Clearance for ADU-1805 to Treat Advanced Solid Tumors

Date: Feb 14, 2023 | Tags: Exelixis, Sairopa, ADU-1805, Solid Tumors, Regulatory, US, FDA, IND

Cullinan Oncology Entered into an Exclusive License with Harbour BioMed to Develop and Commercialize HBM7008 (CLN-418) in the US

Date: Feb 14, 2023 | Tags: Cullinan Oncology, Harbour BioMed, HBM7008, CLN-418, US, solid tumors, Pharma

Merck KGaA Reports P-III Trial (JAVELIN Bladder 100) Results of Bavencio (avelumab) in 1L Maintenance Treatment for Advanced Urothelial Carcinoma

Date: Feb 14, 2023 | Tags: Merck KGaA, Bavencio, avelumab, Urothelial Carcinoma, Clinical Trial, P-III, JAVELIN Bladder 100 Trial

BMS and Exelixis Report P-III Trial (CheckMate -9ER) Results of Opdivo (nivolumab) + Cabometyx (cabozantinib) as 1L Treatment of Advanced Renal Cell Carcinoma

Date: Feb 14, 2023 | Tags: BMS, Exelixis, Opdivo, nivolumab, Cabometyx, cabozantinib, Renal Cell Carcinoma, Clinical Trial, P-III, CheckMate -9ER Trial

Astex Signs a Multi-Year Discovery Collaboration with Cardiff University Medicines Discovery Institute to Identify New Drugs for Neurodegenerative Diseases

Date: Feb 13, 2023 | Tags: Astex, Cardiff University Medicines Discovery Institute, Neurodegenerative Diseases, Pharma

Scilex Acquires Rights for Elyxyb to Treat Migraine in the US and Canada

Date: Feb 13, 2023 | Tags: Scilex, Elyxyb, celecoxib, Migraine, US, Canada, M&A

Ocular Therapeutix Reports Interim 10 Months US Based P-I Clinical Trial Results of OTX-TKI for the Treatment of Wet AMD

Date: Feb 13, 2023 | Tags: Ocular Therapeutix, OTX-TKI, Wet AMD, Clinical Trial, P-I Trial

BMS and 2seventy bio Report P-III Trial (KarMMa-3) Results of Abecma (idecabtagene vicleucel) for Multiple Myeloma

Date: Feb 13, 2023 | Tags: BMS, 2seventy bioAbecma, idecabtagene vicleucel, Multiple Myeloma, Clinical Trial, P-III, KarMMa-3 Trial

REGENXBIO Reports Interim Results of RGX-314 in the P-II Bridging Study for Wet Age-Related Macular Degeneration

Date: Feb 13, 2023 | Tags: REGENXBIO, RGX-314, Wet Age-Related Macular Degeneration, Clinical Trial, P-II, Bridging Study

Pfizer Receives the US FDA’s Approval for Cibinqo (abrocitinib) sNDA to Treat Atopic Dermatitis

Date: Feb 13, 2023 | Tags: Pfizer, Cibinqo, abrocitinib, Atopic Dermatitis, Regulatory, sNDA, US, FDA, Approval