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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on

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