PharmaShots Weekly Snapshot (March 11-15, 2019)

1. AbCellera Signs a Research Agreement with Bill & Melinda Gates Foundation to Accelerate Global Health Research

Published: March 15, 2019 |Tags: Gates Foundation, Signs, Research, Agreement, AbCellera, Accelerate, Global Health Research

2. Abbott’s MitraClip Device Receives FDA’s Expanded Indication Approval for Secondary Mitral Regurgitation (MR)

Published: March 15, 2019 |Tags: Abbott, MitraClip, Device, Receives, FDA, Expanded, Indication, Approval, Secondary Mitral Regurgitation, MR

Roche’s MabThera (rituximab) Receives EU’s Approval for Rare Autoimmune Disease Pemphigus Vulgaris (PV)

Published: March 15, 2019 |Tags: Roche, MabThera, rituximab, Receives, EU, Approval, Rare, Autoimmune Disease, Pemphigus Vulgaris, PV

Bayer Reports Results of Nifurtimox in P-III CHICO Study for Chagas Disease in Pediatric Patients

 Published: March 15, 2019 |Tags: Bayer, Reports, Results, Nifurtimox, P-III, CHICO, Study, Chagas Disease, Pediatric, Patients

Merck KGaA Collaborates with Iktos for its Artificial Intelligence (AI) Technology

Published: March 15, 2019 |Tags: Merck KGaA, Collaborates, Iktos, Artificial Intelligence, AI, Technology

Merck’s Keytruda + Chemotherapy Receive EU’s Approval for Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

Published: March 14, 2019 |Tags: Merck, Keytruda, Chemotherapy, Receive, EU, Approval, NSCLC

Hoth Therapeutics Signs a License Agreement with UMB and Isoprene Pharmaceuticals

Published:March 14, 2019 |Tags: Hoth Therapeutics, Signs, License Agreement, UMB, Isoprene Pharmaceuticals

Roche’s Hemlibra Receives EU’s Approval for Severe Haemophilia A without Factor VIII Inhibitors

Published: March 14, 2019 |Tags: Roche, Hemlibra, Receives, EU, Approval, Severe, Haemophilia A, Factor VIII Inhibitors

Smith & Nephew to Acquire Osiris Therapeutics for $660M

Published: March 14, 2019 |Tags: Smith & Nephew, Acquire, Osiris Therapeutics, $660M

Retrotope’s RT001 Receives EMA’s Orphan Drug Designation for Infantile Neuroaxonal Dystrophy (INAD)

Published:March 14, 2019 |Tags: Retrotope, RT001, Receives, EMA, Orphan Drug Designation, Infantile Neuroaxonal Dystrophy, INAD

Sun Pharma’s SPARC Signs a Research Collaboration with HitGen to Develop Therapies

Published: March 13, 2019 |Tags:Sun Pharma, SPARC, Announces, Research, Collaboration, HitGen, Develop, Novel, Small Molecules

Exactech to Acquire XpandOrtho for its Ligament-Balancing Technology

Published: March 13, 2019 |Tags: Exactech, Acquire, XpandOrtho, Ligament-Balancinag Technology

Akebia Therapeutics Reports Positive Results of Vadadustat in P-III J01 & J03 Studies for Anemia Due to Chronic Kidney Disease (CKD) in Japan

Published: March 13, 2019 |Tags: Akebia Therapeutics, Reports, Positive, Results, Vadadustat, P-III, J01, J03, Studies, Anemia, Chronic Kidney Disease, CKD, Japan

Secura Bio Acquires WW Commercialization Rights to Novartis’ Farydak for R/R Multiple Myeloma

Published: March 13, 2019 |Tags: Secura Bio, Acquired, WW, Commercialization, Rights, Novartis, Farydak, R/R, Multiple Myeloma

Vertex’s Symdeko (tezacaftor/ivacaftor and ivacaftor) Receives TGA’s Approval for Cystic Fibrosis with CFTR Gene Mutation in Australia

Published: March 13, 2019 |Tags:  Vertex, Symdeko, tezacaftor, ivacaftor, Receives, TGA, Approval, Cystic Fibrosis, CFTR Gene, Mutation, Australia

 Eli Lilly Reports Positive Results of Cyramza (ramucirumab) in P-III RELAY Study for mNSCLC

            Published:March 12, 2019 |Tags: Eli Lilly, Reports, Positive, Results, Cyramza,   ramucirumab, P-III, RELAY, Study, mNSCLC

             Paige.AI Receives FDA’s Breakthrough Designation for its Artificial  Intelligence in Pathology

             Published: March 12, 2019 |Tags: Paige.AI, Receives, FDA,  Breakthrough                         Designation, Artificial Intelligence, Pathology

Allergan Reports Acceptance of NDA from FDA for its Ubrogepant for Migraine

Published:March 12, 2019 |Tags: Allergen, Reports, Acceptance, NDA, FDA, Ubrogepant, Migraine

Pfizer’s Trazimera (trastuzumab-biosimilar) Receives FDA’s Approval for HER-2+ Breast Cancer and m-Gastric/GEJ Cancer

Published:March 12, 2019 |Tags: Pfizer, Trazimera, trastuzumab-qyyp, Receives, FDA, Approval, HER-2, Overexpressing, Breast Cancer, m-Gastric Cancer

AstraZeneca and Seres Therapeutics Enters into Research Collaboration for 3yrs.

Published: March 12, 2019 | Tags: AstraZeneca, Seres Therapeutics, Enters, Research, Collaboration, 3yrs.

Roche’s Tecentriq + Abraxane Receive FDA’s Accelerated Approval for mTNBCa

          Published: March 11, 2019 | Tags: Roche, Tecentriq, Abraxane, Receives, FDA,                  Accelerated,  Approval, mTNBC

          Almirall’s Ilumetri (tildrakizumab) Receives NICE’s Provisional Approval for                  Moderate-To-Severe       Plaque Psoriasis

           Published: March 11, 2019 |Tags: Almirall, Ilumetri, tildrakizumab, Receives, NICE,              Provisional, Approval, Moderate, Severe, Plaque Psoriasis

MSD Signs a License Agreement with King’s College London & Wellcome’s Innovations to Develop Chronic Neuropathic Pain Therapies

Published: March 11, 2019 |Tags: MSD, Signs, License, Agreement, King’s College London, Wellcome’s Innovations, Develop, Chronic, Neuropathic, Pain, Therapies

Roche’s Ventana PD-L1 (SP142) Receives FDA’s Approval for Identifying Triple-Negative Breast Cancer (TNBC) as CDx

Published: March 11, 2019 |Tags: Roche, Ventana PD-L1 SP142, Receives, FDA, Approval, Identifying, Triple-Negative Breast Cancer, TNBC