PharmaShots Weekly Snapshot (January 20-24, 2020)

1. Epizyme’s Tazverik (tazemetostat) Receives the US FDA’s Accelerated Approval as the First Therapy for Epithelioid Sarcoma

Published: Jan 23, 2020 | Tags: Epizyme, Tazverik, tazemetostat, Receives, US, FDA, Accelerated Approval, First Therapy, Epithelioid Sarcoma

2. Evarsana Signs an Agreement with Evoke Pharma to Commercialize Gimoti in the US

Published: Jan 23, 2020 | Tags: Evarsana, Signs, Agreement, Evoke Pharma, Commercialize, Gimoti, US

3. Pfizer to Launch Two Oncology Biosimilars at Lowest Wholesale Acquisition Cost in the US

Published: Jan 24, 2020 | Tags: Pfizer, Launch, Two, Oncology Biosimilars, Lowest Wholesale Acquisition Cost, US

4. Roche Reports Results of Tecentriq (atezolizumab) in P-III IMvigor010 Study for Patients with Muscle-Invasive Urothelial Cancer

Published: Jan 24, 2020 | Tags: Roche, Reports, Results, Tecentriq, atezolizumab, P-III, IMvigor010, Study, Patients, Muscle-Invasive Urothelial Cancer

5. Janssen Receives EC’s Approval for the Expanded Use of Stelara (Ustekinumab) to Treat Pediatric Patients with Moderate to Severe Plaque Psoriasis

Published: Jan 23, 2020 | Tags: Janssen, Receives, EC, Approval, Expanded Use, Stelara, Ustekinumab, Treat, Pediatric Patients, Moderate to Severe Plaque Psoriasis

6. Merck & Co’s Keytruda (pembrolizumab) Receives Health Canada’s Approval as 1L Treatment for Advanced Renal Cell Carcinoma

Published: Jan 23, 2020 | Tags: Merck & Co, Keytruda, pembrolizumab, Receives, Health Canada, Approval, 1L, Treatment, Advanced Renal Cell Carcinoma

7. Evotec and Indivumed Collaborate to Develop Therapies for Patients with Non-Small Cell Lung Cancer

 Published:  Jan 23, 2020 | Tags: Evotec, Indivumed, Collaborate, Develop, Therapies, Patients, Non-Small Cell Lung Cancer

8. Bayer Reports Submission of MAA to the EMA for Pre-Filled Syringe to Administer Eylea (aflibercept solution for intravitreal injection)

Published: Jan 23, 2020 | Tags: Bayer, Reports, Submission, MAA, EMA, Pre-Filled Syringe, Administer, Eylea, aflibercept, Intravitreal Injection

9. Bayer’s Nubeqa (darolutamide) Receives MHLW’s Approval for Men with Non-Metastatic Castration-Resistant Prostate Cancer

Published: Jan 23, 2020 | Tags: Bayer, Nubeqa, darolutamide, Receives, MHLW, Approval, Men, Non-Metastatic Castration-Resistant Prostate Cancer

10. Roche Reports Results of Risdiplam in FIREFISH Study for Infants with Type 1 Spinal Muscular Atrophy

Published: Jan 23, 2020 | Tags: Roche, Reports, Results, Risdiplam, FIREFISH Study, Infants, Type 1, Spinal Muscular Atrophy

11. Genialis Collaborates with Oncologie on Precision Medicine Initiative in Gastric Cancer

Published: Jan 22, 2020 | Tags: Genialis, Collaborates, Oncologie, Precision Medicine Initiative, Gastric Cancer

12. GSK’s Belantamab Mafodotin Receives FDA’s Priority Review for Relapsed or Refractory Multiple Myeloma

Published: Jan 21, 2020 | Tags: GSK, Belantamab Mafodotin, Receives, FDA, Priority Review, Relapsed, Refractory, Multiple Myeloma

13. Theramex to Acquire Commercial Rights of MSD’s Zoely to Expand its Footprints

Published: Jan 22, 2020 | Tags: Theramex, Acquire, Commercial Rights, MSD, Zoely, Expand, Footprints

14. Medtronic’s Micra AV Receives the US FDA’s Approval as the World’s Smallest Pacemaker to Treat AV Block

Published: Jan 21, 2020 | Tags: Medtronic, Micra AV, Receives, US, FDA, Approval, World, Smallest, Pacemaker, Treat, AV Block

15. Horizon Therapeutics’ Tepezza (teprotumumab-trbw) Receives the US FDA’s Approval as the First Therapy for Thyroid Eye Disease

Published: Jan 21, 2020 | Tags:  Horizon Therapeutics, Tepezza, teprotumumab-trbw, Receives, US, FDA, Approval, First Therapy, Thyroid Eye Disease

16. Fresenius Kabi Forms a Joint Venture in Collaboration with Bio-Techne and Wilson Wolf to Advance Cell and Gene Therapies

Published: Jan 21, 2020 | Tags: Fresenius Kabi, Forms, JV, Bio-Techne, Wilson Wolf, Advance Cell, Gene Therapies

17. MD Anderson to Acquire Bellicum’s Manufacturing Facility for $15M

Published: Jan 21, 2020 | Tags: MD Anderson, Acquire, Bellicum, Manufacturing Facility, $15M

18. OBI Pharma’s OBI-999 Receives the US FDA’s Orphan Drug Designation to Treat Gastric Cancer

Published: Jan 21, 2020 | Tags: OBI Pharma, OBI-999, Receives, US, FDA, Orphan Drug Designation, Treat, Gastric Cancer

19. Janssen’s Darzalex (daratumumab) Combination Regimen Receives EC’s Approval for Transplant Eligible Patients with Newly Diagnosed Multiple Myeloma

Published: Jan 20, 2020 | Tags: Janssen, Darzalex, daratumumab, Combination Regimen, Receives, EC, Approval, Transplant Eligible, Patients, Newly Diagnosed Multiple Myeloma

20. PhoreMost Signs Multi-Project Drug Discovery Collaboration with Otsuka Pharmaceutical to Identify Novel Targets

Published: Jan 21, 2020 | Tags: PhoreMost, Signs, Multi-Project, Drug Discovery, Collaboration, Otsuka Pharmaceutical, Identify, Novel Therapies

21. Inotrem Signs a Worldwide License agreement with Roche Diagnostic for CDx Test in Septic Shock

Published: Jan 21, 2020 | Tags: Inotrem, Signs, Worldwide, License Agreement, Roche Diagnostic, CDx Test, Septic Shock

22. Jazz Pharmaceuticals’ Sunosi (solriamfetol) Receives EMA’s MAA for Excessive Daytime Sleepiness in Adults with Narcolepsy or Obstructive Sleep Apnea

Published: Jan 20, 2020 | Tags: Jazz Pharmaceuticals, Sunosi, solriamfetol, Receives, EMA, MAA, Excessive Daytime Sleepiness, Adults, Narcolepsy, Obstructive Sleep Apnea

23. Pharming Receive EMA’s Approval to Establish New Facility for Manufacturing Ruconest (conestat alfa)

Published: Jan 21, 2020 | Tags:  Pharming, Receives, EMA, Approval, Establish, New Facility, Manufacturing, Ruconest, conestat alfa

24. Roche’s Polivy (polatuzumab vedotin) Based Combination Regimen Receives EC’s Approval for Patients with R/R Diffuse Large B-Cell Lymphoma

Published: Jan 21, 2020 | Tags: Roche, Polivy, polatuzumab vedotin, Based, Combination Regimen, Receives, EC, Approval, Patients, R/R, Diffuse Large B-Cell Lymphoma

25. Novartis’ Mayzent (siponimod) Receives EC’s Approval to Treat Patients with Secondary Progressive Multiple Sclerosis with Active Disease

Published: Jan 20, 2020 | Tags: Novartis, Mayzent, siponimod, Receives, EC, Approval, Treat, Patients, Secondary Progressive Multiple Sclerosis, Active Disease

26. TB Alliance Collaborates with Hongqi Pharma to Commercialize New Therapy for Highly Drug-Resistant Forms of TB in China

Published: Jan 16, 2020 | Tags: TB Alliance, Collaborates, Hongqi Pharma, Commercialize, New Therapy, Highly Drug-Resistant Forms TB, China

27. Astellas to Establish a New Manufacturing Facility for API of Prograf in Toyama Technology Center

Published: Jan 17, 2020 | Tags: Astellas, Establish, New Manufacturing Facility, API, Prograf, Toyama Technology Center

28. CMS Signs a License Agreement with Zydus for Desidustat in Greater China

Published: Jan 20, 2020 | Tags: CMS, Signs, License Agreement, Zydus, Desidustat, Greater China

29. Cyclica and AUM Biosciences Collaborate to Develop Novel Cancer Therapies Under Project Nexus

Published: Jan 15, 2020 | Tags: Cyclica, AUM Biosciences, Collaborate, Develop, Novel, Cancer Therapies, Under, Project Nexus

30. AstraZeneca’s Imfinzi (durvalumab) + Tremelimumab Receive the US FDA’s Orphan Drug Designation for Liver Cancer

Published: Jan 20, 2020 | Tags: AstraZeneca, Imfinzi, durvalumab, Tremelimumab, Receive, US, FDA, Orphan Drug Designation, Liver Cancer

31. AstraZeneca’s Lynparza (olaparib) Receives the US FDA’s Priority Review for HRR-Mutated Metastatic Castration-Resistant Prostate Cancer

Published: Jan 20, 2020 | Tags: AstraZeneca, Lynparza, olaparib, Receives, US, FDA, Priority Review, HRR-Mutated Metastatic Castration-Resistant Prostate 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 tuba@pharmashots.com

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