PharmaShots Weekly Snapshot (May 04-08, 2020)

1.Fitbit Launches Heart Study to Validate its Wearable Technology for Identifying Atrial Fibrillation

Published: May 06, 2020 | Tags: Fitbit, Launches, Heart Study, Validate, Wearable Technology, Identifying, Atrial Fibrillation

2.  Celltrion Launches Remsima SC (biosimilar, infliximab) for the Treatment of Autoimmune Diseases in the Netherlands

Published: May 07, 2020 | Tags: Celltrion, Launches, Remsima SC, biosimilar, infliximab, Treatment, Autoimmune Diseases,  Netherlands

3.  GSK to Evaluate Otilimab for Treating Pulmonary Disease Associated with COVID-19

Published: May 06, 2020 | Tags: GSK, Evaluate, Otilimab, Treating, Pneumonia, Associated, COVID-19

4. CoVIg-19 Plasma Alliance to Initiate Clinical Study Evaluating Hyperimmune Therapy for COVID-19 by Summer 2020

Published: May 07, 2020 | Tags: CoVIg-19 Plasma Alliance, Initiate, Clinical Study, Evaluating, Hyperimmune Therapy, COVID-19, Summer 2020

5.  Moderna Anticipates the Initiation of P-III Study of mRNA-1273 for COVID-19 by Early Summer

Published: May 07, 2020 | Tags: Moderna, Anticipates, Initiation, P-III, Study, mRNA-1273, COVID-19, Early Summer

6.  Gilead’s Veklury (remdesivir) Receives MHLW’s Approval for Patients with Severe COVID-19 in Japan

Published: May 07, 2020 | Tags: Gilead, Veklury, remdesivir, Receives, MHLW, Approval, Patients, Severe, COVID-19, Japan

7.  Laurent Receives Health Canada’s Approval to Initiate P-II RESOLUTION Study Evaluating LAU-7b for COVID-19

Published: May 06, 2020 | Tags: Laurent, Receives, Health Canada, Approval, Initiate, P-II, RESOLUTION, Study, Evaluating, LAU-7b, COVID-19

8. Amgen Reports Results of Otezla (apremilast) in P-III ADVANCE Study for Mild-To-Moderate Plaque Psoriasis

Published: May 06, 2020 | Tags: Amgen, Reports, Results, Otezla, apremilast, P-III, ADVANCE, Study, Mild-To-Moderate, Plaque Psoriasis

9. Bausch + Lomb Signs an Exclusive License Agreement with STADA and Xbrane for Xlucane (biosimilar, ranibizumab) in the US and Canada

Published: May 06, 2020 | Tags: Bausch + Lomb, Signs, Exclusive, License Agreement, STADA, Xbrane, Xlucane, biosimilar, ranibizumab, US, Canada

10. Novartis and Incyte’s Tabrecta (capmatinib, INC280) Receives the US FDA’s Approval for Metastatic Non-Small Cell Lung Cancer with METex14

Published: May 06, 2020 | Tags: Novartis, Incyte, Tabrecta, capmatinib, INC280, Receives, US, FDA, Approval, Metastatic Non-Small Cell Lung Cancer, METex14

11. PTC Therapeutics to Acquire Censa Pharmaceuticals to Bolster its Rare Disease Portfolio

Published: May 06, 2020 | Tags: PTC Therapeutics, Acquire, Censa Pharmaceuticals, Bolster, Rare Disease Portfolio

12. Sanofi and Regeneron Report Results of Libtayo (cemiplimab) in a P-II Study as 2L Treatment for Advanced Basal Cell Carcinoma

Published: May 05, 2020 | Tags: Sanofi, Regeneron, Report, Results, Libtayo, cemiplimab, P-II, Study, 2L, Treatment, Advanced Basal Cell Carcinoma

13. Bavarian Nordic Collaborates with AdaptVac to Advance COVID-19 Vaccine Program

Published: May 06, 2020 | Tags: Bavarian Nordic, Collaborates, AdaptVac, Advance, COVID-19, Vaccine Program

14. Regeneron Anticipates the Initiation of Clinical Study for its COVID-19 Antibody Cocktail in June

Published:  May 05, 2020 | Tags: Regeneron, Anticipates, Initiation, Clinical Study, COVID-19, Antibody Cocktail, June

15. NeoGenomics Collaborates with Bayer to Provide NTRK Testing for Patients with Colorectal and Thyroid Cancer

Published: May 05, 2020 | Tags: NeoGenomics, Collaborate, Bayer, Provide, NTRK Testing, Colorectal, Thyroid Cancer Patients 

16. Pfizer and BioNTech Report First Patient Dosing with BNT162 in P-I/II Study for COVID-19 in the US

Published: May 05, 2020 | Tags: Pfizer, BioNTech, Reports, First Patient Dosing, P-I/II, Study, BNT162, COIVD-19, US

17.  Bio-Rad Receives the US FDA’s Emergency Use Authorization for its Droplet Digital PCR Test Kit to Detect COVID-19

Published: May 04, 2020 | Tags: Bio-Rad, Receives, US, FDA, Emergency Use Authorization, Droplet Digital PCR Test Kit, Detect, COVID-19

18. Alexion to Acquire Portola for ~$1.41B

Published: May 05, 2020 | Tags: Alexion, Acquire, Portola, Expand, Commercial Portfolio, $1.14B

19. Vir and Alnylam Anticipate the Initiation of Clinical Study Assessing VIR-2703 By the Year End

Published: May 04, 2020 | Tags: Vir, Alnylam, Anticipate, Initiation, Clinical Study, Assessing, VIR-2703, By the Year End

20. Lilly and Junshi Collaborate to Co-Develop Antibody Therapies for the Treatment of COVID-19

Published:  May 04, 2020 | Tags:  Lilly, Junshi, Collaborate, Co-Develop, Antibody Therapies, Treatment, COVID-19

21. Teva and Celltrion Launch Truxima (biosimilar, rituximab) to Treat Wegener’s Granulomatosis and Microscopic Polyangiitis in the US

Published: May 04, 2020 | Tags: Teva, Celltrion, Launch, Truxima, biosimilar, rituximab, Treat, Wegener’s Granulomatosis, Microscopic Polyangiitis, US

22. Roche Receives FDA’s Emergency Use Authorization for its Elecsys to Detect COVID-19

Published: May 03, 2020 | Tags: Roche, Receives, FDA, Emergency Use Authorization, Elecsys, COVID-19

23. MHLW Expedites the Reviews of Gilead’s Remdesivir to Treat Patients with COVID-19 in Japan

Published: May 04, 2020 | Tags: MHLW, Expedites, Reviews, Gilead, Remdesivir, Treat, Patients, COIVD-19, Japan

24.  Revance and Mylan to Extend Biosimilar to BOTOX Program Decision Beyond April 30, 2020

Published: May 01, 2020 | Tags: Revance, Mylan, Extend, Biosimilar, BOTOX, Program Decision, Beyond, April 30, 2020

25.  Gilead’s Remdesivir Receives the US FDA’s Emergency Use Authorization for the Treatment of COVID-19

Published: May 01, 2020 | Tags: Gilead, Remdesivir, Receives, US, FDA, Emergency Use Authorization, Treatment, COVID-19