PharmaShots Weekly Snapshot (May 27–31, 2019)

1.Genmab’s Darzalex (daratumumab) + Bortezomib + Thalidomide and Dexamethasone (VTd) Receive FDA’s Priority Review to sBLA Filing for Frontline Multiple Myeloma

Published: May 30, 2019 | Tags: Genmab, Darzalex, daratumumab, Bortezomib, Thalidomide, Dexamethasone, Receive, FDA, Priority Review, sBLA, Filing, Frontline Multiple Myeloma

2. Merck Reports Result of Keytruda (pembrolizumab) in P-III KEYNOTE-048 Study as a 1L Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

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

4. Roche and GE Healthcare Launch NAVIFY Tumor Board 2.0 for Personalized Treatment Decision in Cancer Care

Published: May 31, 2019 | Tags: Roche, GE Healthcare, Launches, NAVIFY Tumor Board 2.0, Personalized, Treatment, Decision, Cancer Care

5. Sumitomo Dainippon Pharma Signs a Co-Promotion & Commercialization Agreement with Novartis for Diabetes in Japan

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

8. Philips Reports Results of Stellarex .035 Low-Dose Drug-Coated Balloon in Two Clinical Studies for Peripheral Arterial Disease

Published: May 29, 2019 | Tags: Philips, Reports, Results, Stellarex .035, Low-Dose, Drug-Coated Balloon, Two Clinical Studies, Peripheral Arterial Disease

9. Roche’s Tecentriq (atezolizumab) Combination Therapy Receives Health Canada’s Approval for Metastatic Non-Squamous Non-Small Cell Lung Cancer in Adults

Published: May 29, 2019 | Tags: Roche, Tecentriq, atezolizumab, Combination Therapy, Receives, Health Canada, Approval, Metastatic Non-Squamous Non-Small Cell Lung Cancer, Adults

10. Novartis Reports Results of QMF149 (indacaterol acetate and mometasone furoate) in P-III QUARTZ Study for Inadequately Controlled Asthma

Published: May 30, 2019 | Tags: Novartis, Reports, Results, QMF149, indacaterol acetate, mometasone furoate, P-III, QUARTZ, Study, Inadequately, Controlled, Asthma

11. Bayer Signs a Worldwide Agreement with Roche’s Foundation Medicine to Develop and Commercialize CDx for Cancer

Published: May 29, 2019 | Tags: Bayer, Signs, Worldwide, Agreement, Roche, Foundation Medicine, Develop, Commercialize, CDx Cancer

12. Ziopharm Signs an Exclusive License Agreement with NIH to Develop and Commercialize TCRs Targeting Neoantigen for Cancer

Published: May 28, 2019 | Tags: Ziopharm, Signs, Exclusive, License, Agreement, NIH, Develop, Commercialize, TCRs, Targeting, Neoantigen, Cancer

13. Arvinas’ ARV-110 Receives the US FDA’s Fast Track Designation for Metastatic Castration-Resistant Prostate Cancer in Men

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

16. Celgene’s Revlimid (Lenalidomide) + Rituximab Receive FDA’s Approval for Previously Treated Follicular Lymphoma or Marginal Zone Lymphoma in Adults

Published: May 28, 2019 | Tags: Celgene; Revlimid; Lenalidomide; Rituximab; Receive; FDA; Approval; Follicular Lymphoma; Marginal Zone Lymphoma

17. Eli Lilly Signs an Exclusive Worldwide License Agreement with Centrexion Therapeutics for its CNTX-0290

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

21. Santhera Reports Submission of Marketing Authorization Application to the EMA for Puldysa (Idebenone) in Duchenne Muscular Dystrophy

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,

23. Novartis’ Zolgensma (onasemnogene abeparvovec-xioi) Receives FDA’s Approval for Spinal Muscular Atrophy in Pediatric Patients

Published: May 24, 2019 | Tags: Novartis, Zolgensma, onasemnogene abeparvovec-xioi, Receives, FDA, Approval, Spinal Muscular Atrophy, Pediatric, Patients

24. Pfizer Reports Results of Lyrica (pregabalin) in P-III Study for Primary Generalized Tonic-Clonic Seizures

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