PharmaShots Weekly Snapshot (February 24-28, 2020)

1. Companion Medical’s InPen Diabetes Management System Receives the US FDA’s Approval for Fixed Dosing and Meal Estimation

Published: Feb 28, 2020 | Tags: Companion Medical, InPen Diabetes Management System, Receives, US, FDA, Approval, Fixed Dosing, Meal Estimation

2.  Takeda’s Vedolizumab SC Receives CHMP’s Positive Opinion as a Maintenance Therapy for Moderately to Severely Active UC or CD

Published: Feb 28, 2020 | Tags: Takeda, Vedolizumab SC, Receives, CHMP, Positive Opinion, Maintenance Therapy, Moderately to  Severely Active, UC, CD

3.  Gates Foundation Forms an Alliance with Global Pharma Companies to Develop PAN-TB Drug Regimen for Tuberculosis

Published: Feb 27, 2020 | Tags: Gates Foundation, Forms, Alliance, Global Pharma Companies, Develop, PAN-TB, Drug Regimen, Tuberculosis

4.  Fujifilm’s CAD EYE Receives CE Mark to Support the Detection of Colonic Polyp Utilizing AI in the EU

Published: Feb 25, 2020 | Tags: Fujifilm, CAD EYE, Receives, CE Mark, Support, Detection, Colonic Polyp, Utilizing AI, EU

5.  Boehringer Ingelheim Collaborates with Trutino Biosciences to Develop New Therapies Utilizing On-Demand-Cytokine Platform

Published: Feb 27, 2020 | Tags: Boehringer Ingelheim, Collaborates, Trutino Biosciences, Develop, New Therapies, Utilizing,s On-Demand-Cytokine Platform

6. Biogen Signs an Exclusive Worldwide License Agreement with Sangamo to Develop Gene Therapies for Multiple Neurological Diseases

Published: Feb 27, 2020 | Tags: Biogen, Signs, Worldwide, License Agreement, Sangamo, Develop, Gene Therapies, Multiple Neurological Diseases

7. Co-Diagnostics Receives CE Mark for its Logix Smart Coronavirus PCR Test

Published: Feb 24, 2020 | Tags: Co-Diagnostics, Receives, CE Mark, Logix Smart Coronavirus PCR Test

8. GSK Reports the Acceptance of EMA’s MAA for Zejula (niraparib) as 1L Maintenance Treatment for Platinum-Responsive Advanced Ovarian Cancer

Published: Feb 27, 2020 | Tags: GSK, Reports, Acceptance, EMA, MAA, Zejula, niraparib, 1L, Maintenance Treatment, Platinum-Responsive, Advanced Ovarian Cancer

9. Esperion Receives the US FDA’s Approval for Nexlizet (Non-Statin LDL-Cholesterol Lowering Therapy)

Published: Feb 27, 2020 | Tags: Esperion, Receives, US, FDA, Approval, Nexlizet, Non-Statin, LDL-Cholesterol Lowering Therapy

10. Hikma Signs an Exclusive License Agreement with Glenmark to Commercialize Ryaltris (olopatadine hydrochloride and mometasone furoate nasal spray) in the US

Published:  Feb 27, 2020 | Tags: Hikma, Signs, Exclusive, License Agreement, Glenmark, Commercialize, Ryaltris, olopatadine hydrochloride, mometasone furoate, nasal spray, US

11. Gemini Therapeutics Signs a Research Agreement with SERI to Identify New Therapies for Age-related Macular Degeneration

Published: Feb 26, 2020 | Tags: Gemini Therapeutics, Signs, Research Agreement, SERI, Identify, New Therapies, Age-related Macular Degeneration

12.  Gilead Reports the Initiation of Two P-III Studies of Remdesivir to Treat COVID-19

Published: Feb 26, 2020 | Tags: Gilead, Reports, Initiation, Two, P-III, Studies, Remdesivir, Treat, COVID-19

13.  Eisai Signs a License Agreement with FUJI YAKUHIN for Dotinurad to Treat Hyperuricemia and Gout in China

Published: Feb 25, 2020 | Tags: Eisai, Signs, License Agreement, FUJI YAKUHIN, Dotinurad, Hyperuricemia, Gout, China

14. The US FDA Upgrades the Purple Book to Assist the Transparency in Biosimilars

Published: Feb 24, 2020 | Tags: US, FDA, Upgrades, Purple Book, Assist, Transparency, Biosimilars

15. Johnson & Johnson in Collaboration with Apple Launch Heartline Study App in the US

Published: Feb 25, 2020 | Tags: Johnson & Johnson, Collaboration, Apple, Launch, Heartline Study

16. Takeda Exercises its Exclusive Option to Acquire PvP Biologics for ~$330M

Published: Feb 26, 2020 | Tags: Takeda, Exercises, Exclusive, Option to Acquire, PvP Biologics, ~$330M

17. WuXi Biologics and Vir Biotechnology Collaborate for the Global Development of Antibodies Against COVID-19

Published: Feb 25, 2020 | Tags:  WuXi Biologics, Vir Biotechnology, Collaborate, Global Development, Antibodies, Against, COVID-19

18. Novartis Collaborates with DNDi to Develop LXE408 for Visceral Leishmaniasis

Published: Feb 25, 2020 | Tags: Novartis, Collaborates, DNDi, Develop, LXE408, Visceral Leishmaniasis

19. Genentech Collaborates with Bicycle Therapeutics to Develop and Commercialize Bicycle-Based Immuno-Oncology Therapies

Published: Feb 25, 2020 | Tags: Genentech, Collaborates, Bicycle Therapeutics, Develop, Commercialize, Bicycle-Based Immuno-Oncology Therapies

20.  FMCNA’s Novalung ECMO System Receives the US FDA’s Approval for Acute Respiratory and Cardiopulmonary Failure

Published: Feb 24, 2020 | Tags: FMCNA, Novalung, ECMO, Receives, US, FDA, Approval, Acute Respiratory, Cardiopulmonary Failure

21.  Takeda’s Alunbrig (brigatinib) Receives the US FDA’s Priority Review to Treat ALK + Metastatic Non-Small Cell Lung Cancer

Published: Feb 25, 2020 | Tags: Takeda, Alunbrig, brigatinib, Receives, US, FDA, Priority Review, ALK + Metastatic Non-Small Cell Lung Cancer

22. STADA Acquires GSK’s Consumer Healthcare Portfolio to Expand its OTC Business

Published: Feb 24, 2020 | Tags: STADA, Acquires, GSK, Consumer Healthcare Portfolio, Expand, OTC, Business

23. AstraZeneca to Divest Global Rights of Movantik (naloxegol) to RedHill Biopharma

Published: Feb 25, 2020 | Tags: AstraZeneca, Divests, Global Rights, Movantik, naloxegol, RedHill Biopharma

24. Roche Reports Acceptance of BLA for Fixed-Dose SC Combination of Perjeta and Herceptin to Treat HER2-Positive Breast Cancer

Published: Feb 25, 2020 | Tags: Roche, Reports, Acceptance, BLA, Fixed-Dose SC Combination, Perjeta, Herceptin, HER2-Positive Breast Cancer

25. Sanofi to Establish New Company to Provide Active Pharmaceutical Ingredients in the EU

Published: Feb 25, 2020 | Tags: Sanofi, Establish, New Company, Provide, Active Pharmaceutical Ingredients, EU

26. GSK Signs a Research Collaboration with Clover for the Evaluation of Coronavirus (COVID-19) Vaccine

Published: Feb 24, 2020 | Tags: GSK, Signs, Research Collaboration, Clover, Evaluation, Coronavirus, COVID-19, Vaccine

27. Paratek Signs an Exclusive License Agreement with Almirall for SEYSARA (sarecycline)

Published: Feb 24, 2020 | Tags: Paratek, Signs, Exclusive, License Agreement, Almirall, SEYSARA, sarecycline

28. Asuragen’s AmplideX Fragile X Dx and Carrier Screen Kit Receives the US FDA’s Approval for Detecting Fragile X Syndrome (FXS)

Published: Feb 10, 2020 | Tags: Asuragen, AmplideX, Fragile X Dx, Carrier Screen Kit, Receives, US, FDA, Approval, Detecting, Fragile X Syndrome, FXS

29.  Lundbeck’s Vyepti (eptinezumab-jjmr) Receives the US FDA’s Approval to Prevent Migraine in Adults

Published: Feb 22, 2020 | Tags: Lundbeck, Vyepti, eptinezumab-jjmr, Receives the US FDA’s Approval to Prevent Migraine in Adults

30. Eli Lilly’s Trulicity (dulaglutide) Receives the US FDA’s Approval to Reduce MACE in T2D Adults

Published: Feb 22, 2020 | Tags: Lundbeck, Vyepti, eptinezumab-jjmr, Receives the US FDA’s Approval to Prevent Migraine in Adults

Published: Feb 21, 2020 | Tags: Eli Lilly, Trulicity, dulaglutide, Receives, US, FDA, Approval, Reduce, MACE, T2D, Adults

31. Novartis Reports Acceptance of Ofatumumab’s (OMB157) sBLA from the US FDA and EMA to Treat Relapsing Forms of Multiple Sclerosis (RMS)

Published: Feb 24, 2020 | Tags: Novartis, reports, Acceptance, Ofatumumab, OMB157, sBLA, US, FDA, EMA, Treat, Relapsing, Form, Multiple Sclerosis, RMS