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