PharmaShots Weekly Snapshot (June 03 – 07, 2019)

1.STADA to Acquire GSK’s OTC Portfolio for the Expansion of its Consumer Health Business in Europe

Published: Jun 07, 2019 | Tags: STADA, Acquire, GSK, OTC, Portfolio, Expansion, Consumer Health Business, Europe

2. Vertex to Expand its Collaboration with CRISPR Therapeutics to Develop Therapies for Duchenne Muscular Dystrophy and Myotonic Dystrophy Type 1

Published: Jun 06, 2019 | Tags: Vertex, Expand, Collaboration, CRISPR Therapeutics, Develop, Therapies, Duchenne Muscular Dystrophy, Myotonic Dystrophy Type 1

3.Novartis’ LysaKare (arginine hydrochloride/lysine hydrochloride) Solution Receives CHMP’s Positive Opinion for Reduction of Kidney Exposure to Radiation During PPRT with Lutathera

Published: Jun 05, 2019 | Tags: Novartis, LysaKara, arginine hydrochloride/lysine hydrochloride, Solution, Receives, CHMP, Recommendation, Reduction, Kidney Exposure, Radiation, During, PPRT, Lutathera

4.Novartis Reports Histology Data of CFZ533 (iscalimab) in Kidney Transplantation for Extended Survival of Transplanted Organs

Published: Jun 06, 2019 | Tags: Novartis, Reports, Histology Data, CFZ533, iscalimab, Kidney Transplantation, Extended, Survival, Transplanted Organs

5. GSK’s Nucala (mepolizumab) Receives FDA’s Approval for its Two New Self-Administered Methods for Patients with SEA and EGPA

Published: Jun 06, 2019 | Tags: GSK, Nucala, mepolizumab, Receives, FDA, Approval,Two, New, Self-Administered, Methods, Patients, SEA, EGPA

6. AstraZeneca Reports Results of Calquence (acalabrutinib) in P-III ELEVATE-TN Trial for Patients with Previously Untreated Chronic Lymphocytic Leukemia

Published: Jun 06, 2019 | Tags: AstraZeneca, Reports, Results, Calquence, acalabrutinib, P-III, ELEVATE-TN, Trial, Patients, Previously, Untreated, Chronic Lymphocytic Leukaemia, CLL

7. Celgene Reports FDA and EMA’s Acceptance of NDA for Ozanimod to Treat Relapsing Forms of Multiple Sclerosis

Published: Jun 06, 2019 | Tags:Celgene, Reports, FDA, EMA, Acceptance, NDA, Ozanimod, Treat, Relapsing, Forms, Multiple Sclerosis

8. Oncolytics Biotech Signs a Clinical Trial Collaboration with Merck KGaA and Pfizer

Published: Jun 05, 2019 | Tags: Oncolytics Biotech, Signs, Co-Development, Clinical Trial, Collaboration, Merck KGaA, Pfizer

9. Enzyvant Reports FDA’s Acceptance of BLA for RVT-802 to Treat Pediatric Congenital Athymia

Published: Jun 06, 2019 | Tags: Enzyvant, Reports, FDA, Acceptance, BLA, RVT-802, Treat, Pediatric Congenital Athymia

10.Takeda Reports Results of Ninlaro (ixazomib) in P-III TOURMALINE-AL1 Study in Patients with Relapsed or Refractory Systemic Light-Chain Amyloidosis

Published: Jun 05, 2019 | Tags: Takeda, Reports, Results, Ninlaro, ixazomib, P-III, TOURMALINE-AL1 Study, Patients, Relapsed, Refractory, Systemic Light-Chain Amyloidosis

11. Bayer Signs a Research and Development Collaboration with Arvinas for its PROTAC Technology

Published: June 04, 2019 | Tags: Bayer, Signs, Research, Development, Collaboration, Arvinas, PROTAC Technology

12.BioMarin’s Vimizim (elosulfase alfa) Receives NMPA’s (CFDA) Approval for Treatment of Morquio A Syndrome

Published: June 04, 2019 | Tags: BioMarin, Vimizim, elosulfase alfa, Receives, NMPA, CFDA, Approval, Treatment, Morquio A Syndrome

13.Puma Biotechnology Reports Results of PB272 (neratinib) in P-III NALA Trial for Patients with 2L+ HER2+ Metastatic Breast Cancer #ASCO2019

Published: June 04, 2019 | Tags: Puma Biotechnology, Reports, Results, PB272, neratinib, P-III NALA Trial, Patients, HER2+ Metastatic Breast Cancer, #ASCO2019

14.Roche Reports Results of Venclexta/Venclyxto (venetoclax) in P-III CLL14 Study for Chronic Lymphocytic Leukemia #ASCO2019

Published: June 04, 2019 | Tags: Roche, Reports, Results, Venclexta/Venclyxto, venetoclax, P-III, CLL14 Study, Chronic Lymphocytic Leukaemia, #ASCO2019

15. Eli Lilly’s Emgality (galcanezumab-gnlm) Receives FDA’s Approval for Episodic Cluster Headache in Adults

Published: June 04, 2019 | Tags: Eli Lilly, Emgality, galcanezumab-gnlm, Receives, FDA, Approval, Episodic, Cluster, Headache, Adults

16. Astellas and Seattle Genetics Report Results of Enfortumab Vedotin in P-II EV-201 Study for Patients with Locally Advanced or Metastatic Urothelial Cancer #ASCO2019

Published: June 03, 2019 | Tags: Astellas, Seattle Genetics, Report, Results, Enfortumab Vedotin, P-II, EV-201 Study, Patients, Locally Advanced, Metastatic, Urothelial Cancer, #ASCO2019

17. Celgene and Acceleron Report FDA’s Acceptance of BLA for Luspatercept to Treat Myelodysplastic Syndromes and Beta-Thalassemia

Published: June 04, 2019 | Tags: Celgene, Acceleron, Report, FDA, Acceptance, BLA, Luspatercept, Treat, Myelodysplastic Syndromes, Beta-Thalassemia

18. Takeda Reports Results of Takhzyro (lanadelumab) in P-III HELP Study for the Prevention of Hereditary Angioedema Attacks

Published: June 03, 2019 | Tags: Takeda, Reports, Results, Takhzyro, lanadelumab, P-III, HELP Study , Prevention , Hereditary Angioedema, HAE Attacks

19. Roche Reports Results of Xofluza (baloxavir marboxil) in P-III BLOCKSTONE Study for the Prevention of Influenza

Published: June 04, 2019 | Tags: Roche, Reports, Results, Xofluza, baloxavir marboxil, P-III, BLOCKSTONE, Study, Prevention, Influenza

20.Merck’s Zerbaxa (ceftolozane and tazobactam) Receives FDA’s Approval for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia in Adults

Published: June 03, 2019 | Tags: Merck, Zerbaxa, ceftolozane, tazobactam, Receives, FDA, Approval, Hospital-Acquired, Ventilator-Associated, Bacterial Pneumonia, Adults

21. AstraZeneca and Merck Report Results of Lynparza (olaparib) in P-III SOLO3 Study for Platinum-Sensitive Relapsed Germline BRCA-mutated Advanced Ovarian Cancer #ASCO2019

Published: June 03, 2019 | Tags: AstraZeneca, Merck, Reports, Results, Lynparza, olaparib, P-III, SOLO3, Study, Platinum-Sensitive, Relapsed, Germline BRCA-mutated Advanced Ovarian Cancer, ASCO2019

22.Novartis Reports Results of Capmatinib in P-II GEOMETRY mono-1 Study for Non-Small Cell Lung Cancer with MET exon-14 Skipping Mutation #ASCO2019

Published: June 03, 2019 | Tags: Novartis, Reports, Results, Capmatinib, P-II, GEOMETRY mono-1, Study, Non-Small Cell Lung Cancer, MET exon-14 Skipping Mutation, ASCO2019

23. Novartis Reports Result of Kisqali (ribociclib) + Endocrine Therapy in P-III MONALEESA-7 Study for HR+/HER2- Advanced Breast Cancer #ASCO2019

Published: June 01, 2019 | Tags: Novartis, Reports, Result, Kisqali, ribociclib, Endocrine Therapy, P-III, MONALEESA-7, Study, HR+/HER2-, Advanced, Breast Cancer, #ASCO2019

24. Sanofi Reports Results of Isatuximab Combination Therapy in P-III ICARIA-MM Study for Relapsed/Refractory Multiple Myeloma #ASCO2019

Published: June 01, 2019 | Tags: Sanofi, Reports, Results, Isatuximab, Combination Therapy, P-III, ICARIA-MM, Study, Relapsed/Refractory, Multiple Myeloma, ASCO2019

25. Novartis Reports Results of Xolair (omalizumab) in Two P-III Studies for Chronic Rhinosinusitis with Nasal Polyps in Adults

Published: June 03, 2019 | Tags: Novartis, Reports, Results, Xolair, omalizumab, Two, P-III, Studies, Chronic Rhinosinusitis, Nasal Polyps, Adults