PharmaShots Weekly Snapshots (May 09-13, 2022)

Gedeon Richter’s Ryeqo (relugolix, estradiol, and norethindrone acetate) Receives NICE Recommendation for the Treatment of Women with Uterine Fibroids

Published: May 13, 2022 | Tags: Gedeon Richter, Ryeqo, relugolix, estradiol, norethindrone acetate, NICE, Uterine Fibroids

Neurocrine Biosciences’ Valbenazine Receives the US FDA’s Orphan Drug Designation for the Treatment of Chorea Associated with Huntington Disease

Published: May 13, 2022 | Tags: Neurocrine Biosciences, Valbenazine, US, FDA, Orphan Drug Designation, Chorea, Huntington Disease

AltruBio Reports the Completion of Patient Enrollment in P-I Clinical Study of Neihulizumab (ALTB-168) for Steroid-Refractory Acute Graft-Versus-Host Disease

Published: May 13, 2022 | Tags: AltruBio, P-I Clinical Study, Neihulizumab, ALTB-168, Steroid-Refractory, Acute Graft-Versus-Host Disease

Astex Reports Results of Decitabine and Cedazuridine (ASTX727 or DEC-C) in P-III (ASCERTAIN) Trial as Fixed-Dose Combination for Acute Myeloid Leukemia

Published: May 13, 2022 | Tags: Astex, Decitabine, Cedazuridine, ASTX727, DEC-C, P-III, ASCERTAIN Trial, Acute Myeloid Leukemia

Formosa and AimMax Report Results of CPN-301 in the P-III Trial for the Treatment of Inflammation and Pain after Cataract Surgery

Published: May 13, 2022 | Tags: Formosa, AimMax, CPN-301, P-III Trial, Inflammation, Pain, Cataract Surgery

Bridgebio Entered into an Exclusive License Agreement with BMS to Develop and Commercialize BBP-398 for the Treatment of Cancer

Published: May 13, 2022 | Tags: Bridgebio, BMS, BBP-398, Cancer

BMS Presents Two-Year Results of Deucravacitinib in P-III (POETYK PSO) LTE Trial for the Treatment of Plaque Psoriasis at EADV 2022

Published: May 12, 2022 | Tags: BMS, Deucravacitinib, P-III, POETYK PSO LTE Trial, Plaque Psoriasis

Intercept Reports First Patient Dosing of Obeticholic Acid + Bezafibrate in the P-II Study for the Treatment of Primary Biliary Cholangitis

Published: May 12, 2022 | Tags: Intercept, Obeticholic Acid, Bezafibrate, P-II Study, Primary Biliary Cholangitis

Roche Reports Interim Results of Tiragolumab + Tecentriq (atezolizumab) in P-III (SKYSCRAPER-01) Study for PD-L1-High Metastatic Non-Small Cell Lung Cancer

Published: May 12, 2022 | Tags: Roche, Tecentriq, atezolizumab, Tiragolumab, P-III, SKYSCRAPER-01 Study, Non-Small Cell Lung Cancer

Taiho Entered into an Agreement to Acquire Cullinan for CLN-081/TAS6417 to Treat EGFR Exon20 Non-Small Cell Lung Cancer

Published: May 12, 2022 | Tags: Taiho, Acquire, Cullinan, CLN-081, TAS6417, EGFR, Exon20, Non-Small Cell Lung Cancer

AbbVie Reports Results of Rinvoq (upadacitinib) P-III (U-ENDURE) Maintenance Study for the Treatment of Crohn’s Disease

Published: May 12, 2022 | Tags: AbbVie, Rinvoq, upadacitinib, P-III, U-ENDURE, Maintenance Study, Crohn’s Disease

Acorda Therapeutics Entered into Distribution and Supply Agreements with Biopas to Commercialize Inbrija in Latin America for Parkinson’s Disease

Published: May 12, 2022 | Tags: Acorda Therapeutics, Biopas, Inbrija, Parkinson’s Disease

Lilly and Incyte’s Olumiant (baricitinib) Receive the US FDA’s Approval for the Treatment of Hospitalized Patients with COVID-19

Published: May 11, 2022 | Tags: Lilly, Incyte, Olumiant, baricitinib, US, FDA, COVID-19

Visus Therapeutics Signs an Exclusive License Agreement with Zhaoke to Develop & Commercialize Brimochol PF and Carbachol PF for Presbyopia

Published: May 11, 2022 | Tags: Visus Therapeutics, Zhaoke, Brimochol PF, Carbachol PF, Presbyopia

UCB Presents Efficacy and Safety Results of Zilucoplan and Rozanolixizumab in P-III (RAISE) & (MycarinG) Study for Generalized Myasthenia Gravis at MGFA 2022

Published: May 11, 2022 | Tags: UCB, Zilucoplan, Rozanolixizumab, P-III, RAISE, MycarinG Study, Generalized Myasthenia Gravis, MGFA, 2022

Sanofi and AstraZeneca Report Results of Nirsevimab in P-III (MELODY) and P-IIb Trials for the Treatment of Respiratory Syncytial Virus

Published: May 11, 2022 | Tags: Sanofi, Nirsevimab, P-III, MELODY, P-IIb Trial, RSV

Cortexyme Entered into an Agreement to Acquire Novosteo for the Treatment of Rare Skeletal Diseases

Published: May 11, 2022 | Tags: Cortexyme, Acquire, Novosteo, Rare Skeletal Diseases

Evotec Expands 2018 Agreement with BMS for Targeted Protein Degradation Therapies

Published: May 11, 2022 | Tags: Evotec, 2018, BMS, Protein, Degradation Therapies

Pfizer to Acquire Biohaven for ~$11.6B

Published: May 10, 2022 | Tags: Pfizer, Acquire, Biohaven, ~$11.6B, Rimegepant, Zavegepant

Elpiscience Receives the US FDA’s IND Clearance of ES014 for the Treatment of Advanced Solid Tumors

Published: May 10, 2022 | Tags: Elpiscience, US, FDA, IND Clearance, ES014, Solid Tumors

BioArctic Partner Eisai Report the Completion of Rolling Submission of BLA to the US FDA for Lecanemab (BAN2401) to Treat Early Alzheimer’s Disease

Published: May 10, 2022 | Tags: BioArctic, Eisai, Rolling Submission, BLA, US, FDA, Lecanemab, Alzheimer’s Disease

Achilles Therapeutics Reports First Patient Dosing of Higher-Dose cNeT in P-I/IIa (CHIRON) Trial for the Treatment of Advanced Non-Small Cell Lung Cancer

Published: May 10, 2022 | Tags: Achilles Therapeutics, cNeT, P-I/IIa, CHIRON Trial, Non-Small Cell Lung Cancer

Monrol Partner Telix Report First Patient Dosing of TLX250 (177Lu-DOTA-girentuximab) in P-II (STARLITE 2) Study for Clear Cell Renal Cell Carcinoma

Published: May 10, 2022 | Tags: Monrol, Telix, TLX250, 177Lu-DOTA-girentuximab, P-II, STARLITE 2 Study, Clear Cell Renal Cell Carcinoma

Mereo BioPharma Reports Results of Alvelestat in P-II (ASTRAEUS) Trial for Alpha-1 Antitrypsin Deficiency-Associated Emphysema

Published: May 10, 2022 | Tags: Mereo BioPharma, Alvelestat, P-II, ASTRAEUS Trial, Alpha-1 Antitrypsin Deficiency, Emphysema

Twist Bioscience Enters into Multiple Agreement with Astellas to Identify Antibodies & Reduce Tumor Microenvironment-Mediated Immunosuppression

Published: May 9, 2022 | Tags: Twist Bioscience, Astellas, Antibodies, CAR Cell Therapy Technology

The US FDA Extends Review Period of Myfembree’s sNDA to Treat Moderate to Severe Pain Associated with Endometriosis

Published: May 9, 2022 | Tags: US, FDA, Myfembree, sNDA, Pain, Endometriosis

Oxurion Reports Results of THR-687 in Part A of P-II (INTEGRAL) Trial for the Treatment of Diabetic Macular Edema

Published: May 9, 2022 | Tags: Oxurion, THR-687, Part A, P-II, INTEGRAL Trial, Diabetic Macular Edema

Elpiscience Partner Compass Report Interim Results of ES104 + Paclitaxel in P-II Study for the Treatment of Biliary Tract Cancers

Published: May 9, 2022 | Tags: Elpiscience, Compass, ES104, Paclitaxel, P-II, Study, Biliary Tract Cancers

Nykode Reports Interim Results of VB10.16 in P-II (VB C-02) Trial for the Treatment of Advanced Cervical Cancer

Published: May 9, 2022 | Tags: Nykode, VB10.16, P-II, VB C-02 Trial, Cervical Cancer

Evofem Presents Results of Phexxi in P-III (AMPOWER) Clinical Trial for the Prevention of Pregnancy at ACOG 2022

Published: May 9, 2022 | Tags: Evofem, Phexxi, P-III, AMPOWER, Clinical Trial, Urinary Tract Infections, ACOG, 2022

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