PharmaShots Weekly Snapshots (October 17- 21, 2022)

Revance Submits Supplemental Biologics License Application for Daxxify to Treat Cervical Dystonia

Published: Oct 21, 2022| Tags: Revance, Daxxify, Cervical Dystonia, Regulatory, US, FDA, ASPEN-1, ASPEN-OLS

LEO’s Adtralza Receives the EC Approval for the Treatment of Moderate to Severe Atopic Dermatitis

Published: Oct 21, 2022| Tags: LEO, Adtralza, Atopic Dermatitis, Regulatory, P-III, ECZTRA 6, Corticosteroids

Eyenovia Reports Results of MicroLine in P-III Trial for the Treatment of Presbyopia

Published: Oct 21, 2022| Tags: Eyenovia, MicroLine, Presbyopia, Clinical Trial, P-III, VISION-2, US FDA, NDA

AUM Biosciences to Go Public through Reverse Merger with Mountain Crest for Oncology Therapeutics

Published: Oct 21, 2022| Tags: AUM Biosciences, Mountain Crest, AUM001, AUM601, AUM302, Cancer Indication, M&A, Nasdaq, AUMB

DePuy (J&J)’s Teligen System Receives the US FDA Approval for User-Centric Procedural Control During Spine Surgery

Published: Oct 21, 2022| Tags: DePuy, Johnson & Johnson, Teligen System, Spine Surgery, MedTech, MIS-TLIF, VueLIF-T

HOOKIPA and Roche Enter into a License Agreement to Develop HB-700 and Arenaviral Immunotherapies for KRAS-Mutated Cancers

Published: Oct 21, 2022| Tags: HOOKIPA, Roche, HB-700, Arenaviral Immunotherapies, Lung Cancer, Colorectal Cancer, Pancreatic Cancer, Pharma, R&D, P-Ib

Shionogi Presents Real-World Evidence of Fetroja (cefiderocol) for Treatment Resistant Bacterial Infections at IDWeek 2022

Published: Oct 20, 2022| Tags: Shionogi, Fetroja, cefiderocol, Treatment Resistant Bacterial Infections, Clinical Trial, PROVE, Real-World Evidence, IDWeek, 2022

Ayala Entered into a Definitive Merger Agreement with Advaxis for AL102 and ADXS-504

Published: Oct 20, 2022| Tags: Ayala, Advaxis, Merger Agreement, AL102, ADXS-504, desmoid tumors, Prostate cancer, M&A

Grifols’ Tavlesse (fostamatinib) Receives NICE Recommendation for the Treatment of Refractory Chronic Immune Thrombocytopenia

Published: Oct 20, 2022| Tags: Grifols, Tavlesse, fostamatinib, Chronic Immune Thrombocytopenia, Regulatory, NICE, Recommendation

BMS Presents P-III (CheckMate -76K) Trial Results of Opdivo (nivolumab) for Completely Resected Stage IIB or IIC Melanoma at SMR 2022

Published: Oct 20, 2022| Tags: BMS, Opdivo, nivolumab, Completely Resected Stage IIB, IIC Melanoma, P-III CheckMate -76K Trial, SMR, 2022

Pfizer and BioNTech Receive the EMA’s CHMP Positive Opinion for Comirnaty to Treat COVID-19 in Children Aged 6 Months to ≤5 Years

Published: Oct 20, 2022| Tags: Pfizer, BioNTech, Comirnaty, COVID-19, EMA, CHMP, Positive Opinion, Regulatory

Incyte Published Results of Opzelura (ruxolitinib) in P-III (TRuE-V) Clinical Trial Program for Vitiligo in the NEJM

Published: Oct 20, 2022| Tags: Incyte, Opzelura, ruxolitinib, Vitiligo, P-III TRuE-V Clinical Trial, NEJM

Jazz Entered into an Exclusive License Agreement with Zymeworks to Develop and Commercialize Zanidatamab for Cancers

Published: Oct 19, 2022| Tags: Jazz, Zymeworks, Zanidatamab, Cancers, HERIZON-BTC-01 trial, Pharma

Alvotech & JAMP Pharma Expands its 2020 Agreement for Two Biosimilar Candidates in Canada

Published: Oct 19, 2022| Tags: Alvotech, JAMP Pharma, AVT16, AVT33, 2020, Canada, Pharma, Biosimilar

Teva Reports 3-Year (ARC-HD) Study Results of Austedo (deutetrabenazine) for the Treatment of Chorea Associated with Huntington’s Disease

Published: Oct 19, 2022| Tags: Teva, Austedo, deutetrabenazine, Chorea, Huntington’s Disease, Clinical Trial, ARC-HD Study

Ikena Oncology Entered into a Clinical Trial Collaboration Agreement with AstraZeneca for IK-930 to Treat EGFR-Mutated Non-Small Cell Lung Cancer

Published: Oct 19, 2022| Tags: Ikena Oncology, AstraZeneca, IK-930, EGFR-Mutated, Non-Small Cell Lung Cancer, Pharma

Oculis to go Public via EBAC SPAC Merger for ~$220M

Published: Oct 19, 2022| Tags: Oculis, EBAC, OCS-01, OCS-02, OCS-05, OCS-03, OCS-04, acute optic neuritis, corneal transplant, Public, SPAC Merger, ~$220M, M&A

Amryt’s Mycapssa Receives the EMA’s COMP Positive Opinion Recommending Orphan Disease Designation for the Treatment of Acromegaly

Published: Oct 19, 2022| Tags: Amryt, Mycapssa, Acromegaly, Regulatory, EMA’s COMP, Positive Opinion, Orphan Disease Designation

Lilly to Acquire Akouos for ~$610M

Published: Oct 18, 2022| Tags: Lilly, Akouos, AK-OTOF, Acquire, ~$610M, sensorineural hearing loss, M&A

Kite’s Yescarta Receives the EC’s Marketing Authorization as 2L Treatment of Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma

Published: Oct 18, 2022| Tags: Kite, Yescarta, Diffuse Large B-cell Lymphoma, High-grade B-cell Lymphoma, Regulatory, EC, Marketing Authorization

Fennec Pharmaceuticals Launches Pedmark (sodium thiosulfate injection) in the US

Published: Oct 18, 2022| Tags: Fennec Pharmaceuticals, Pedmark, sodium thiosulfate injection, solid tumors, Pharma, US

Tigen Exercises its Option to License Neoantigen-specific Tumor Infiltrating Lymphocytes for Solid Tumor

Published: Oct 18, 2022| Tags: Tigen, Neoantigen-specific Tumor Infiltrating Lymphocytes, Solid Tumor, Biotech, Ludwig Institute for Cancer Research, CHUV and University of Lausanne

Exacis Entered into an Option to License Agreement with Eterna for Four iPSC Derived NK Cell and T Cell Therapies

Published: Oct 18, 2022| Tags: Exacis, Eterna, Four iPSC Derived NK Cell, T Cell Therapies, RiboSlice, nuclease NoveSlice, ExaNK, ExaCAR-NK, Biotech

Eucure Subsidiary Biocytogen Entered into a Worldwide License Agreement with Syncromune for the Development and Commercialization of Intratumoral Immunotherapy

Published: Oct 18, 2022| Tags: Eucure, Biocytogen, Syncromune, Intratumoral Immunotherapy, YH002, Pharma, Syncrovax technology

Gilead Entered into an Exclusive Option and Collaboration Agreement with MacroGenics to Develop MGD024

Published: Oct 17, 2022| Tags: Gilead, MacroGenics, MGD024, Exclusive Option, blood cancers, acute myeloid leukemia, myelodysplastic syndromes, Pharma

Sage and Biogen Present P-III (SKYLARK) Study Results of Zuranolone for Postpartum Depression at ECNP 2022

Published: Oct 17, 2022| Tags: Sage, Biogen, Zuranolone, Postpartum Depression, Clinical Trial, P-III SKYLARK Study, ECNP, 2022

Mirum’s Livmarli (maralixibat) Receives EMA’s CHMP Positive Opinion for Cholestatic Pruritus in Patients with Alagille Syndrome

Published: Oct 17, 2022| Tags: Mirum, Livmarli, maralixibat, Cholestatic Pruritus, Alagille Syndrome, Regulatory, EMA CHMP

Innovent Reports P-Ib Study Results of Higher-dose Mazdutide (IBI362) for Chinese Patients with Overweight or Obesity

Published: Oct 17, 2022| Tags: Innovent, Mazdutide, IBI362, Overweight, Obesity, Clinical Trial, P-Ib Study, eClinicalMedicine

Bridgebio Pharma Presents 12-Month P-II Study Results of BBP-418 for Limb-Girdle Muscular Dystrophy Type 2i at WMS 2022

Published: Oct 17, 2022| Tags: Bridgebio Pharma, BBP-418, Limb-Girdle Muscular Dystrophy Type 2i, Clinical Trial, 12-Month, P-II Study, WMS, 2022

Regeneron’s Libtayo (cemiplimab) Receives EMA’s CHMP Positive Opinion Recommending Approval to Treat Advanced Cervical Cancer

Published: Oct 17, 2022| Tags: Regeneron, Libtayo, cemiplimab, Regulatory, EMA, CHMP, Positive Opinion, Approval, Advanced Cervical Cancer