PharmaShots Weekly Snapshot (January 28 – February 01, 2019)

ONO Signs a Research Collaboration with Repare Therapeutics for its POL0 Inhibitor Program

Published: 01 Feb,2019 | Tags: Tags: Collaboration, Inhibitor, ONO, POL0, Program, Repare Therapeutics, Research, Signs

Audentes Reports Next Phase Development of AT132 for X-linked Myotubular Myopathy (XLMTM) with RMAT Designatio

Published: 01 Feb,2019 | Tags: Announces, AT132, Audentes, Designation, Development, Next phase, RMAT,X-linked Myotubular Myopathy, XLMTM

Alexion Collaborates with Caelum Biosciences for its CAEL-101 to Treat Light Chain (AL) Amyloidosis

Published: 01 Feb,2019 |Tags: AL, Alexion, Amyloidosis, CAEL-101, Caelum Biosciences, Collaborates, Light Chain, Treat

Bayer Signs an Exclusive License Agreement with Kyoto University for Pulmonary Disorders

Published: 01 Feb,2019  | Tags: Agreement, Bayer, Exclusive, idiopathic pulmonary fibrosis (IPF), Kyoto University, License, Pulmonary Disorders, Signs

Janssen(J&J) Signs an Exclusive Worldwide License Agreement with MeiraGTx for its Gene Therapy Candidates

Published: 01 Feb,2019 | Tags: Basilea, Roche, Collaborates, study, Derazantinib, Tecentriq, atezolizumab, Urothelial Cancer, (UC)

Eli Lilly’s Alimta (pemetrexed) + Keytruda (pembrolizumab) Receives FDA’s Expanded Label Approval for 1L Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC)

Published: 31 Jan,2019 | Tags: Eli Lilly, Alimta, pemetrexed, Keytruda, pembrolizumab, Receives, FDA, Expanded Label, Approval, 1L, Metastatic, Nonsquamous, Non-Small Cell Lung Cancer, NSCLC

Columbia’s Zuckerman Institute Develops an AI-based Brain-Computer Interface (BCI) for People with Aphasia & Amyotrophic Lateral Sclerosis (ALS)

Published: 31 Jan,2019 | Tags: Columbia, Zuckerman Institute, Develops, AI, Brain-Computer Interface, BCI, People, Aphasia, Amyotrophic Lateral Sclerosis, ALS

Merck’s V114 Receives FDA’s Breakthrough Therapy Designation to Prevent Invasive Pneumococcal Disease

Published: 31 Jan,2019 |Tags: Merck, V114, Receives, FDA, Breakthrough Therapy Designation, Prevent, Invasive, Pneumococcal Disease, 22F, 33F, serotypes

Janssen (J&J) Reports Results of Erleada (apalutamide) in P-III TITAN Study for Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Published: 31 Jan,2019 | Tags: Janssen, J&J, Reports, Results, Erleada, apalutamide, P-III, TITAN Study, Metastatic Castration-Sensitive Prostate Cancer, mCSPC

Roche Discontinues P-III CREAD-1 and 2 Trials of Crenezumab in Patients with Early Alzheimer’s Disease (AD)

Published: 31 Jan,2019 | Tags: Roche, Discontinues, P-III, CREAD-1, 2, Trials, Crenezumab, Patients, Early, Alzheimer’s Disease, AD                 

EMA Shifts its Headquarters from London to Amsterdam, The Netherlands

Published: 30 Jan,2019 | Tags: EMA, Shifts, HQ, London, Amsterdam, The Netherlands

Neurocrine and Voyager Collaborate to Develop and Commercialize VY-AADC & VY-FXN01 for Parkinson’s & Friedreich’s Ataxia Disease

Published: 30 Jan,2019 | Tags: Neurocrine Biosciences, Collaborates, Voyager, Gene Therapy Program, VY-AADC, Parkinson’s disease, VY-FXN01, Friedreich ataxia, FA

Sumitomo Dainippon’s Latuda (lurasidone HCl) Receives NMPA’s (CFDA) Approval for Schizophrenia

Published: 30 Jan,2019 | Tags: Sumitomo Dainippon, Latuda, lurasidone HCl, Receives, NMPA, CFDA, Approval, Schizophrenia  

Takeda Reports Results of TAK-003 in P-III TIDES (DEN-301) Trial for Dengue

Published: 30 Jan,2019 | Tags: Takeda, Reports, Results, TAK-003, P-III, TIDES, DEN-301 study, Dengue

Pfizer and Eli Lilly Report Results of Tanezumab in P-III OA study (A4091057) for Moderate-To-Severe Osteoarthritis (OA) Pain

Published: 30 Jan,2019 | Tags: Pfizer, Eli Lilly, Report, Results, Tanezumab, P-III, OA study, A4091057, Moderate-To-Severe, Osteoarthritis, Pain

Zai Lab Receives Priority Review for Zejula’s (niraparib) NDA from NMPA (CFDA), in China)

Published: 29 Jan,2019 | Tags: Zai Lab, Receives, Priority Review, Zejula, niraparib, NDA, NMPA, CFDA, China

Medtronic Launches Mazor X Stealth Edition for Spine Surgery in the US

Published: 29 Jan,2019 | Tags: Medtronic, Reports, Launch, Mazor X Stealth Edition, Spine Surgery, the US

Vertex’s Kalydeco (ivacaftor) Receives Health Canada’s Approval for Cystic Fibrosis (CF) with CFTR Gene Mutation in Children Aged 12 to <24mos.

Published: 29 Jan,2019 | Tags: Vertex’s Kalydeco, ivacaftor, Receives, Health Canada, Approval, Cystic Fibrosis, CF, CFTR Gene, Mutation, Children, Aged, 12 to <24mos.

Innovent Biologics Reports Acceptance of BLA for IBI-305 (bevacizumab, biosimilar) from NMPA (CFDA) to Treat NSCLC Disorders

Published:29 Jan,2019 | Tags: Innovent Biologics, Reports, Acceptance, BLA for IBI-305, bevacizumab, biosimilar, NMPA, CFDA, NSCLC, Colorectal cancer, Malignant Tumors

Purdue Pharma Signs an Agreement with Alivio Therapeutics for its ALV-107

Published: 29 Jan,2019 | Tags: Purdue Pharma, Signs, Agreement, Alivio Therapeutics, ALV-107, IC/BPS, Interstitial Cystitis/Bladder Pain Syndrome

Alexion Reports Results of Ultomiris (ravulizumab-cwvz) in P-III Study in Patients with Atypical Hemolytic Uremic Syndrome (AHUS)

Published: 29 Jan,2019 | Tags: Alexion, Reports, Results, Ultomiris, ravulizumab-cwvz, P-III Study, Patients, Atypical Hemolytic Uremic Syndrome, aHUS

AbbVie’s Imbruvica (ibrutinib) + Gazyva (obinutuzumab) Receives FDA’s Approval, First CT Free Treatment for 1L+ CLL/SLL

Published: 28 Jan,2019 |Tags: AbbVie, Imbruvica, ibrutinib, Gazyva, obinutuzumab, Receives, FDA, Approval, First, CT, Free, Treatment, 1L+, CLL, SLL, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Zimber Biomet’s Rosa Knee System Receives the US FDA’s 510(k) Clearance for Robotically-Assisted Surgeries

Published: 28 Jan,2019 |Tags: Zimber Biomet, Rosa Knee System, Receives, the US FDA, 510(k) Clearance, Robotically-Assisted, Surgeries

Dr. Reddy’s Tosymra (sumatriptan nasal spray) 10mg Receives the US FDA Approval for Acute Treatment of Migraine

Published: 28 Jan,2019 | Tags: Samsung Bioepis, Ontruzant, Biosimilar, transtuzumab, early, advance, breast, cancer, metastatic, gastric, adenocarcinoma, gastroesophageal

Medtronic to Acquire EPIX Therapeutics for its Cardiovascular Technologies

Published: 28 Jan, 2019 | Tags: Medtronic, Acquire, EPIX Therapeutics, Cardiovascular, Technologies, Diamond Temp Ablation system, Arctic Front Advance Cryoablation System

Vertex Signs an Exclusive License Agreement with Merck KGaA for its Two DNA-PK Inhibitor

Published: 28 Jan, 2019 | Tags: Vertex, Signs, Exclusive, License, Agreement, Merck KGaA, Two, DNA-PK Inhibitors, M9831

Mannin Research Signs a Collaboration with Mcmaster University for MAN-01

Published: 28 Jan,2019 | Tags: Mannin Research, Signs, Collaboration, Mcmaster University, MAN-01, Glaucoma, IND