PharmaShots Weekly Snapshots (June 27

Inceptor Bio Enters into Collaboration with the University of Minnesota for the Development of iPSC Platform to Treat Cancer

Published: July 1, 2022 | Tags: Inceptor Bio, University of Minnesota, iPSC, Platform, Cancer, Biotech
Sensorion’s SENS-401 Receives Australia’s Approval for the Initiation of Proof-of-Concept Trial to Treat Hearing Impairment

Published: July 1, 2022 | Tags: Sensorion, Sens-401, Hearing Impairment, Regulatory, Proof-of-Concept Trial, US, FDA, EMA, Australia, France

Pfizer Reports NDA Submission of Paxlovid to the US FDA for the Treatment of COVID-19

Published: July 1, 2022 | Tags: Pfizer, Paxlovid, nirmatrelvir, ritonavir, Covid-19, Regulatory, EPIC-HR, EPIC-SR, US FDA
Sanofi Pauses Patient Enrollment in P-III Studies of Tolebrutinib for the Treatment of Multiple Sclerosis and Myasthenia Gravis in the US

Published: July 1, 2022 | Tags: Sanofi, Tolebrutinib, Multiple Sclerosis, Myasthenia Gravis, Clinical Trial, P-III Studies, US

Blueprint Medicines Signs $1.25B Agreement with Sixth Street & Royalty Pharma in Exchange for Royalties of Ayvakit and Gavreto

Published: July 1, 2022 | Tags: Blueprint Medicines, Sixth Street, Ayvakit, Gavreto, Thyroid Cancers, Pharma, $1.25B, Financing Agreement, Royalties

Takeda Reports Results of Takhzyro (lanadelumab) in P-III (SPRING) Study for the Prevention of HAE Attacks in Children Aged 2 to <12 Years

Published: July 1, 2022 | Tags: Takeda, Takhzyro, lanadelumab, Hereditary Angioedema Attacks, Clinical Trial, P-III, SPRING Study

AstraZeneca Reports Results of Imfinzi in P-III (AEGEAN) Trial for the Treatment of Non-Small Cell Lung Cancer

Published: June 30, 2022 | Tags: AstraZeneca, Imfinzi, Non-Small Cell Lung Cancer, Clinical Trial, P-III, AEGEAN

Astellas Entered into an Exclusive License Agreement with Generian to Develop and Commercialize Novel Small Molecules for Undruggable Indications

Published: June 30, 2022 | Tags: Astellas, Generian, Mitobridge, Small Molecules, Pharma

Ascentage Reports the US FDA’s Acceptance of IND Application for APG-5918 to Treat Solid Tumors and Hematologic Malignancies

Published: June 30, 2022 | Tags: Ascentage, APG-5918, Solid Tumors, Hematologic Malignancies, Regulatory, US, FDA, IND

GBT Reports Initiation of the P-II/III Study of GBT601 for the Treatment of Sickle Cell Disease

Published: June 30, 2022 | Tags: GBT, GBT601, Sickle Cell Disease, Clinical Trial, P-II, P-III, EU, Middle East, South America, US

Merck Reports the Launch of Merck Digital Sciences Studio to Support Early-Stage Biomedical Startups

Published: June 30, 2022 | Tags: Merck, New Jersey Innovation Institute, Merck Digital Sciences Studio, Regulatory

Jaguar Entered into a Licence Agreement with SynWorld to Commercialise Canalevia in China to Treat Diarrhea in Dogs

Published: June 30, 2022 | Tags: Jaguar, SynWorld, Canalevia, Diarrhea, Pharma, China

Oculis Reports the First Patient Enrollment of OCS-01 in P-III (OPTIMIZE) Trial for the Treatment of Inflammation and Pain Following Cataract Surgery

Published: June 29, 2022 | Tags: Oculis, OCS-01, Inflammation, Pain, Cataract Surgery, Clinical Trial, P-III, OPTIMIZE Trial,

Iktos Collaborated with Galapagos to Discover Optimised Lead Therapies Using AI Technology

Published: June 29, 2022 | Tags: Iktos, Galapagos, Optimised Lead Therapies, AI Technology, Pharma

Beyond Air’s LungFit PH Receives the US FDA’s Approval for the Treatment of Hypoxic Respiratory Failure in Term and Near-Term Neonates

Published: June 29, 2022 | Tags: Beyond Air, LungFit PH, Hypoxic Respiratory Failure, Regulatory, MedTech, Near-Term Neonates, US, FDA, Approval

Jazz Reports Results of Nabiximols Oromucosal Spray in P-III (RELEASE MSS1) Trial for the Treatment of Multiple Sclerosis Spasticity

Published: June 29, 2022 | Tags: Jazz, Nabiximols Oromucosal Spray, Multiple Sclerosis Spasticity, Clinical Trial, P-III, RELEASE MSS1 Trial

Astellas Collaborated with Sutro Biopharma to Advance Novel Immunostimulatory Antibody-Drug Conjugates for Cancer

Published: June 29, 2022 | Tags: Astellas, Sutro Biopharma, Antibody-Drug Conjugates, Cancer, Pharma

NewAmsterdam Entered into an Exclusive License Agreement with Menarini Group to Commercialize Obicetrapib for Cardiovascular Diseases in the EU

Published: June 29, 2022 | Tags: NewAmsterdam, Menarini Group, Obicetrapib, Cardiovascular Diseases, Pharma, EU

Kite’s Yescarta (axicabtagene ciloleucel) Receives EC’s Approval for the Treatment of Relapsed or Refractory Follicular Lymphoma

Published: June 28, 2022 | Tags: Kite, Yescarta, axicabtagene ciloleucel, Follicular Lymphoma, Regulatory, EC, Approval

AstraZeneca and Merck Receive CHMP Positive Opinion of Lynparza (olaparib) as Adjuvant Treatment for HER2-Negative High-Risk Early Breast Cancer

Published: June 28, 2022 | Tags: AstraZeneca, Merck, Lynparza, Olaparib, Breast Cancer, Regulatory, CHMP

Novartis Presents Results of Kesimpta (ofatumumab) in P-III (ASCLEPIOS I/II) and (ALITHIOS) Open-Label Extension Trial for RMS at EAN 2022

Published: June 28, 2022 | Tags: Novartis, Kesimpta, ofatumumab, Relapsing Multiple Sclerosis, Clinical Trial, P-III, ASCLEPIOS I/II, ALITHIOS, Open-Label Extension Trial

Basilea Reports Results of Ceftobiprole in the P-III (ERADICATE) Study for the Treatment of Staphylococcus Aureus Bacteremia

Published: June 28, 2022 | Tags: Basilea, Ceftobiprole, Staphylococcus Aureus Bacteremia, Clinical Trial, P-III, ERADICATE Study

Astellas Reports the US FDA’s Clinical Hold on the P-I/II (FORTIS) Trial of AT845 for the Treatment of Adults with Late-Onset Pompe Disease

Published: June 28, 2022 | Tags: Astellas, AT845, Late-Onset Pompe Disease, Clinical Trial, US, FDA, Clinical Hold, P-I/II, FORTIS Trial

Kuria Entered into a Licensing Agreement with Scohia for SCO-116 to Treat Ophthalmic and Dermal Disease

Published: June 28, 2022 | Tags: Kuria, Scohia, SCO-116, Ophthalmic, Dermal Disease, Pharma

The US FDA Launches 5-Year Action Plan for Neurodegenerative Disease

Published: June 27, 2022 | Tags: US, FDA, Neurodegenerative Disease, Regulatory, Launches, 5-Year, Action Plan

AbbVie’s Rinvoq (upadacitinib) Receives the CHMP’s Recommendation for Approval to Treat Active Non-Radiographic Axial Spondyloarthritis

Published: June 27, 2022 | Tags: AbbVie, Rinvoq, upadacitinib, Non-Radiographic Axial Spondyloarthritis, Regulatory, CHMP, Approval

Ascletis Presents Results of ASC22 (envafolimab) in P-IIb Trial for the Treatment of Chronic Hepatitis B at EASL ILC 2022

Published: June 27, 2022 | Tags: Ascletis, ASC22, envafolimab, Chronic Hepatitis B, Clinical Trial, P-IIb Trial, EASL, ILC, 2022

Intellia and Regeneron Present Updated Interim Data of NTLA-2001 in P-I Study for the Treatment of Transthyretin Amyloidosis at EASL 2022

Published: June 27, 2022 | Tags: Intellia, Regeneron, NTLA-2001, Transthyretin Amyloidosis, Clinical Trial, P-I Study, EASL 2022

BMS’ Breyanzi (lisocabtagene maraleucel) Receives the US FDA’s Approval for the Treatment of Large B-cell Lymphoma

Published: June 27, 2022 | Tags: BMS’ Breyanzi, lisocabtagene maraleucel, Large B-cell Lymphoma, Regulatory, US, FDA, Approval

Ipsen Entered into a Definitive Merger Agreement to Acquire Epizyme for ~$247M

Published: June 27, 2022 | Tags: Ipsen, Epizyme, Tazverik, rituximab, lenalidomide, EZM0414, Cancer, Multiple Myeloma, Diffuse Large B-Cell Lymphoma, Follicular lymphoma M&A, Acquire, Epizyme, ~$247M