PharmaShots Weekly Snapshot (May 27-31, 2019)
Published: May 30, 2019 | Tags: Genmab, Darzalex, daratumumab, Bortezomib, Thalidomide, Dexamethasone, Receive, FDA, Priority Review, sBLA, Filing, Frontline Multiple Myeloma
Published: May 31, 2019 | Tags: Merck, Reports, Results, Keytruda, pembrolizumab, P-III, KEYNOTE-048, Study, 1L, Treatment, Recurrent, Metastatic, Head & Neck Squamous Cell Carcinoma
3. Pfenex and Alvogen Report EMA's Acceptance of MAA for PF708 (teriparatide, biosimilar)
Published: May 30, 2019 | Tags: Pfenex, Alvogen, Report, EMA, Acceptance, MAA, PF708, teriparatide, biosimilar
Published: May 31, 2019 | Tags: Roche, GE Healthcare, Launches, NAVIFY Tumor Board 2.0, Personalized, Treatment, Decision, Cancer Care
Published: May 30, 2019 | Tags: Sumitomo Dainippon Pharma, Signs, Co-Promotion, Commercialization, Agreement, Novartis, Diabetes, Japan
6.Janssen Reports Results of Darzalex (daratumumab) in P-III MAIA Study for Patients with Multiple Myeloma Ineligible for ASCT
Published: May 29, 2019 | Tags: Janssen, Reports, Results, Darzalex, daratumumab, P-III, MAIA, Study, Patients, Multiple Myeloma, Ineligible, ASCT
7.Medtronic's SelectSite C304-HIS Deflectable Catheter System Receives FDA's Clearance for HIS Bundle Pacing
Published: May 30, 2019 | Tags:Medtronic, SelectSite C304-HIS Deflectable Catheter System, Receives, FDA, Clearance, HIS Bundle Pacing
Published: May 29, 2019 | Tags: Philips, Reports, Results, Stellarex .035, Low-Dose, Drug-Coated Balloon, Two Clinical Studies, Peripheral Arterial Disease
Published: May 29, 2019 | Tags: Roche, Tecentriq, atezolizumab, Combination Therapy, Receives, Health Canada, Approval, Metastatic Non-Squamous Non-Small Cell Lung Cancer, Adults
Published: May 30, 2019 | Tags: Novartis, Reports, Results, QMF149, indacaterol acetate, mometasone furoate, P-III, QUARTZ, Study, Inadequately, Controlled, Asthma
Published: May 29, 2019 | Tags: Bayer, Signs, Worldwide, Agreement, Roche, Foundation Medicine, Develop, Commercialize, CDx Cancer
Published: May 28, 2019 | Tags: Ziopharm, Signs, Exclusive, License, Agreement, NIH, Develop, Commercialize, TCRs, Targeting, Neoantigen, Cancer
Published: May 28, 2019 | Tags: Arvinas, ARV-110, Receives, US, FDA, Fast Track Designation, Metastatic Castration-Resistant Prostate Cancer, Men
14. Bayer Signs a License Agreement with Sensible Medical for its ReDS Technology in Europe
Published: May 28, 2019 | Tags: Bayer, Signs, License, Agreement, Sensible Medical, ReDS Technology, Europe
15.Prestige BioPharma Reports EMA's Acceptance of Marketing Authorization Application for its Tuznue (trastuzumab, biosimilar)
Published: May 28, 2019 | Tags: Prestige BioPharma, Reports, Acceptance, Marketing Authorization Application, EMA, Tuznue, HD201, Biosimilar
Published: May 28, 2019 | Tags: Celgene; Revlimid; Lenalidomide; Rituximab; Receive; FDA; Approval; Follicular Lymphoma; Marginal Zone Lymphoma
Published: May 28, 2019 | Tags: Lilly, Signs, Exclusive, Worldwide, License, Agreement, Centrexion Therapeutics, CNTX-0290
18. BioMarin Reports Results of Valoctocogene Roxaparvovec in P-III GENEr8-1 Study for Hemophilia A
Published: May 28, 2019 | Tags: BioMarin, Reports, Results, Valoctocogene Roxaparvovec, P-III, GENEr8-1, Study, Hemophilia A
19.Nanobiotix Launches Curadigm Facility with Nanoprimer Technology in France and the US
Published: May 28, 2019 | Tags: Nanobiotix, Launches, Curadigm, Facility, Nanoprimer Technology, France, US
20.Matas to Acquire Kosmolet for its Make-up Brand Nilens Jord
Published: May 28, 2019 | Tags: Matas, Acquire, Kosmolet, Make-up Brand, Nilens Jord
Published: May 27, 2019 | Tags: Santhera, Reports, Submission, Marketing Authorization Application, EMA, Puldysa, Idebenone, Duchenne Muscular Dystrophy
22. Calecim Collaborates with Menarini Asia-Pacific to Expand the Worldwide Sales of its Product
Published: May 27, 2019 | Tags: Calecim, Collaborates, Menarini Asia-Pacific, Expand, Sales, Product,
Published: May 24, 2019 | Tags: Novartis, Zolgensma, onasemnogene abeparvovec-xioi, Receives, FDA, Approval, Spinal Muscular Atrophy, Pediatric, Patients
Published: May 24, 2019 | Tags: Pfizer, Reports, Results, Lyrica, Pregabalin, P-III, Study, Primary Generalized Tonic-Clonic Seizures
25.Novartis' Piqray (alpelisib) + Fulvestrant Receive FDA's Approval for Patients with a PIK3CA Mutation in HR+/HER2- Advanced/Metastatic Breast Cancer
Published: May 24, 2019 | Tags: Novartis, Piqray, alpelisib, Fulvestrant, Receive, FDA, Approval, Patients, PIK3CA, Mutation, HR+/HER2-, Advanced, Breast Cancer