PharmaShots Weekly Snapshot (12 November 12 -17, 2018)

 

  1. Ipsen’s Cabometyx (cabozantinib, as monothx) Receives EU Approval for the Treatment of 2L Advance HCC

Published: 15 Nov, 2018 | Tags: Ipsen, Cabometyx, (cabozantinib, as monothx), Receives, EU, Approval, Treatment, 2L, Advance HCC

  1. Arena Pharmaceutical Licenses Exclusive Worldwide Rights of Ralinepag (APD811) to United Therapeutics for $1.2B

Published: 15 Nov, 2018 | Tags:  United, Licenses, Exclusive, Worldwide, Agreement, Arena, Ralinepag, $1.2B

  1. RegenxBio’s RGX-181 (Gene Therapy) Receives FDA’s Orphan Drug Designation for Late-Infantile Neuronal Ceroid Lipofuscinosis Type 2 (CLN2) Disease

Published: 14 Nov, 2018 | Tags: RegenxBio, RGX-181, Gene Therapy, Receives, FDA’s, Orphan Drug Designation, Late-Infantile Neuronal Ceroid Lipofuscinosis Type 2 (CLN2) Disease, IND submission

  1. Bristol-Myers Squibb Receives CHMP Recommendation for Opdivo (nivolumab) + Low-Dose Yervoy (ipilimumab) in 1L RCC Based in P-III CheckMate-214 study

Published: 15 Nov, 2018 | Tags: Bristol-Myers Squibb, Receives, CHMP, Recommendation, Opdivo (nivolumab), Low-Dose Yervoy (ipilimumab), P-III CheckMate-214 study

  1. Dragonfly and Celgene Extended their collaboration from 2017, for the Treatment of Solid and Hematological Cancers

Published: 14 Nov, 2018 | Tags: Dragonfly, Celgene, Collaborates, Expansion, 2017 Deal, Treatment, Solid and Hematological Cancers,

  1. Lilly Files Lasmiditan to FDA for Acute Treatment of Migrane

Published: 14 Nov, 2018 | Tags: Lilly, Reports, Submission, NDA, Lasmiditan, FDA, Acute Treatment of Migrane

  1. Grunenthal Acquires Averitas Pharma for its Peripheral Neuropathic Pain Product, Qutenza (capsaicin)

Published: 14 Nov, 2018 | Tags: Grunenthal, Acquires, Averitas Pharma, Qutenza, (capsaicin), Acorda Therapeutics

  1. Merck Reports Improved Overall Survival Results of Keytruda (pembrolizumab) vs Chemotherapy in KEYNOTE-181 Study

Published: 14 Nov, 2018 | Tags: Merck, Reports, Improved, OS, Results, Keytruda (pembrolizumab), Chemotherapy, KEYNOTE-181 study, 2L, Esophageal Cancer

  1. Wugen Enters into License Agreement with Washington University for its CAR-T Therapy Technologies

Published: 13 Nov, 2018 | Tags: Wugen, Enters, License, Agreement, Washington University, CAR-T Therapy Technologies, Treat, blood cancer

  1. Ferring Signs an Exclusive License Agreement with Invo for its INVOcell Intravaginal Culture (IVC) System in the US

Published: 13 Nov, 2018 | Tags: Ferring, Signs, Exclusive, License, Agreement, INVO, INVOcell intravaginal culture (IVC) system, US

  1. Innovent’s IBI303 (adalimumab, biosimilar) Receives NMPA (CFDA) Approval for Ankylosing Spondylitis (AS), Rheumatoid Arthritis (RA) and Psoriasis in China

Published: 13 Nov, 2018 | Tags: Innovent’s, IBI303, Receives, NMPA, Approval, Treatment, Ankylosing Spondyitis, Rheumatoid Arthritis, Psoriasis

  1. Merck Reports Initiation of BLA Filling for V920 (rVSV∆G-ZEBOV-GP) Under FDA for Ebola Zaire

Published: 13 Nov, 2018 | Tags: Merck, Reports, Initiation, BLA Filling, V920 (rVSV∆G-ZEBOV-GP), Under FDA, Ebola Zaire

  1. GSK’s Trelegy Ellipta (Fluticasone Furoate/Umeclidinium/Vilanterol ‘FF/UMEC/VI’) Receives Expanded Level Approval from EU for COPD

Published: 9 Nov, 2018 | Tags: GSK, Receives, Expanded, IMPACT study, Level, Approval, EU, COPD, ICS, LABA, LAMA, Trelegy Ellipta

  1. AstraZeneca Divests US Rights of Synagis & MEDI8897 to Sobi for Prevention of Serious Lower Respiratory Tract infection (LRTI)

Published: 13 Nov, 2018 | Tags: AstraZeneca, Divests, US Rights, Synagis & MEDI8897, Sobi, Prevention, Serious Lower Respiratory Tract infection (LRTI)

  1. Roche Reports Acceptance of sBLA from FDA for its Tecentriq (atezolizumab) + Abraxane (nab-paclitaxel) for 1L Metastatic Triple- Negative Breast Cancer (TNBC)

Published: 13 Nov, 2018 | Tags: Roche, Reports, Acceptance, sBLA, FDA, Tecentriq (atezolizumab), Abraxane (nab-paclitaxel), 1L Metastatic Triple- Negative Breast Cancer (TNBC), P-III , IMpassion130 study

  1. Amgen Reports Safety & Efficacy Results of Repatha (evolocumab) in OSLER-1 Five-Year Extension Study

Published: 12 Nov, 2018 | Tags: Amgen, Reports, Safety, Efficacy, Results, Repatha, (evolocumab), OSLER-1, Five-Year Extension Study, GOULD

  1. Eisai Reports Results of Lenvima (Lenvatinib) + Keytruda (pembrolizumab) to Treat Metastatic NSCLC Metastatic Melanoma and Metastatic Urothelial Carcinoma

Published: 9 Nov, 2018 |Tags: Eisai, Reports, Results, Lenvima (Lenvatinib, Keytruda (pembrolizumab), Treat, Metastatic NSCLC, Metastatic Melanoma, Metastatic Urothelial Carcinoma

  1. Merck’s Keytruda (pembrolizumab) Receives FDA Approval for the Treatment of Hepatocellular Carcinoma (HCC)

Published: 12 Nov, 2018 | Tags: AstraZeneca, Announces, Acceptance, Priority Review, Lynparza, (olaparib), sNDA, FDA, Patients with BRAC-Mutated Advance Ovarian Cancer,

  1. Regeneron and Sanofi Reports Results of Praluent (alirocumab) in ODYSSEY OUTCOMES study in Patients with MACE events, Presented at AHA 2018

Published: 11 Nov, 2018 | Tags: Regeneron, Sanofi, Reports, Results, Praluent (alirocumab), ODYSSEY OUTCOMES study, MACE events, Presented at AHA 2018

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