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
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
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
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
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
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
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
Related Post: PharmaShots Weekly Snapshots (October 10 - 14, 2022)
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.