PharmaShots Weekly Snapshot (July 29– August 02, 2019)


AbbVie's Maviret (glecaprevir/pibrentasvir) Receives European Commission Approval for Treatment-Naive Patients with Chronic Hepatitis C and Compensated Cirrhosis

1.AbbVie’s Maviret (glecaprevir/pibrentasvir) Receives European Commission Approval for Treatment-Naive Patients with Chronic Hepatitis C and Compensated Cirrhosis

Published: Aug 02, 2019 | Tags: AbbVie, Maviret, glecaprevir, pibrentasvir, Receives, European Commission, Approval, Treatment-Naïve, Patients, Chronic Hepatitis C, Compensated, Cirrhosis

Thermo Fisher Enters into a Collaboration with Genome Canada and OICR to Develop NGS Assays for Cancer

2.Thermo Fisher Enters into a Collaboration with Genome Canada and OICR to Develop NGS Assays for Cancer

Published: Jul 30, 2019 | Tags:  Thermo Fisher, Enters, Collaboration, Genome Canada, OICR, Develop, NGS Assays, Cancer

Voluntis’ Oleena Digital Application Receives FDA’s Marketing Approval to Self-Manage Cancer Symptoms

3. Voluntis’ Oleena Digital Application Receives FDA’s Marketing Approval to Self-Manage Cancer Symptoms

Published: Aug 02, 2019 | Tags: Voluntis, Oleena, Digital Application, Receives, FDA, Marketing Approval, Self-Manage, Cancer, Symptoms

Mylan and Biocon Launch Ogivri (biosimilar, trastuzumab) in Australia

4.Mylan and Biocon Launch Ogivri (biosimilar, trastuzumab) in Australia

Published: Aug 01, 2019 | Tags: Mylan, Biocon, Launch, Ogivri, biosimilar, trastuzumab, Australia

Arcellx Signs a Development Evaluation and License Agreement with Pfenex for Advancing SparX Proteins

5. Arcellx Signs a Development Evaluation and License Agreement with Pfenex for Advancing SparX Proteins

Published: Aug 01, 2019 | Tags: Arcellx, Signs, Development, Evaluation, License, Agreement, Pfenex, Advancing, SparX Proteins

Nektar and BMS Receive the US FDA’s Breakthrough Designation for Bempegaldesleukin (NKTR-214) + Opdivo (nivolumab) to Treat Advanced MelanomaNektar and BMS Receive the US FDA’s Breakthrough Designation for Bempegaldesleukin (NKTR-214) + Opdivo (nivolumab) to Treat Advanced Melanoma

6. Nektar and BMS Receive the US FDA’s Breakthrough Designation for Bempegaldesleukin (NKTR-214) + Opdivo (nivolumab) to Treat Advanced Melanoma

Published: Aug 01, 2019 | Tags: Nektar, BMS, Receives, FDA, Breakthrough Designation, Bempegaldesleukin, NKTR-214, Opdivo, nivolumab, Treat, Advanced Melanoma

GSK’s Nucala (mepolizumab) Receives European Commission Approval for Self-Administration in Severe Eosinophilic Asthma

7.GSK’s Nucala (mepolizumab) Receives European Commission Approval for Self-Administration in Severe Eosinophilic Asthma

Published: Aug 01, 2019 | Tags:GSK, Nucala, mepolizumab, Receives, European Commission, Approval, Self-Administration, Severe Eosinophilic Asthma

Sun Pharma Reports Submission of Manufacturing and Marketing Authorization Application of Tildrakizumab in Japan

8. Sun Pharma Reports Submission of Manufacturing and Marketing Authorization Application of Tildrakizumab in Japan

Published: Aug 01, 2019 | Tags: Sun Pharma, Reports, Submission, Manufacturing, Marketing, Authorization, Application, Tildrakizumab, Japan

LEO Pharma’s Enstilar Foam and Taclonex Topical Suspension Receive the US FDA’s Expanded Approval for Plaque Psoriasis

9. LEO Pharma’s Enstilar Foam and Taclonex Topical Suspension Receive the US FDA’s Expanded Approval for Plaque Psoriasis

Published: Jul 31, 2019 | Tags: LEO Pharma, Enstilar Foam, Taclonex Topical Suspension, Receive, US, FDA, Expanded, Approval, Plaque Psoriasis

Exelixis Signs a Research Collaboration and Option to License Agreement with Aurigene to Discover and Develop Therapies for Cancer

10. Exelixis Signs a Research Collaboration and Option to License Agreement with Aurigene to Discover and Develop Therapies for Cancer

Published: Aug 01, 2019 | Tags: Exelixis, Signs, Option, License, Agreement, Aurigene, Discover, Develop, Therapies, Cancer

11. Chimerix Signs an Exclusive Worldwide License Agreement with Cantex for CX-01 to Treat Acute Myeloid Leukemia

Published: Jul 31, 2019 | Tags: Chimerix, Signs, Exclusive, Worldwide, License, Agreement, Cantex, CX-01, Treat, Acute Myeloid Leukemia

Novartis Reports Results of Kisqali in Second Phase P-III MONALEESA-3 Study for HR+/HER2- Advanced Breast Cancer in Women

13. Novartis Reports Results of Kisqali in Second Phase P-III MONALEESA-3 Study for HR+/HER2- Advanced Breast Cancer in Women

Published: Jul 31, 2019 | Tags: Novartis, Reports, Results, Kisqali, Second, Phase, P-III, MONALEESA-3, Study, HR+/HER2-, Advanced, Breast Cancer, Women

Pfizer Signs a License Agreement with Regenxbio for its NAV AAV9 Vector to Treat Friedreich's Ataxia

14. Pfizer Signs a License Agreement with Regenxbio for its NAV AAV9 Vector to Treat Friedreich’s Ataxia

Published: Jul 31, 2019 | Tags:  Pfizer, Signs, License, Agreement, Regenxbio, NAV AAV9 Vector, Treat, Friedreich’s Ataxia

Merck’s Keytruda (pembrolizumab) Receives FDA’s Approval as a Monotherapy for 1L+ Recurrent Locally Advanced or Metastatic Esophageal Cancer Expressing PD-L1 (CPS ≥10)

15. Merck’s Keytruda (pembrolizumab) Receives FDA’s Approval as a Monotherapy for 1L+ Recurrent Locally Advanced or Metastatic Esophageal Cancer Expressing PD-L1 (CPS ≥10)

Published: Jul 31, 2019 | Tags: Merck, Keytruda, pembrolizumab, Receives, FDA, Approval, Monotherapy, Recurrent, Locally Advanced, Metastatic Esophageal Cancer

Bayer’s Vitrakvi (larotrectinib) Receives Health Canada Approval for Advanced Solid Tumors Harboring NTRK Gene Fusion

16. Bayer’s Vitrakvi (larotrectinib) Receives Health Canada Approval for Advanced Solid Tumors Harboring NTRK Gene Fusion

Published: Jul 30, 2019 | Tags: Bayer, Vitrakvi, larotrectinib, Receives, Health Canada, Approval, Advanced, Solid Tumors, Harboring, NTRK Gene Fusion

Gates Foundation Grants $13M to Lyndra Therapeutics for the Development of Once-Monthly Oral Contraceptive

17.Gates Foundation Grants $13M to Lyndra Therapeutics for the Development of Once-Monthly Oral Contraceptive

Published: Jul 30, 2019 | Tags: Gates Foundation, Grants, $13M, Lyndra Therapeutics, Development, Once-Monthly Oral Contraceptive

Biogen and Alkermes Report Results of Diroximel Fumarate in P-III EVOLVE-MS-2 Study for Multiple Sclerosis

18. Biogen and Alkermes Report Results of Diroximel Fumarate in P-III EVOLVE-MS-2 Study for Multiple Sclerosis

Published: Jul 30, 2019 | Tags: Biogen, Alkermes, Report, Results, Diroximel Fumarate, P-III, EVOLVE-MS-2, Study, Multiple Sclerosis

Bayer’s Nubeqa (darolutamide) Receives the US FDA’s Approval for Non-Metastatic Castration-Resistant Prostate Cancer in Men

19. Bayer’s Nubeqa (darolutamide) Receives the US FDA’s Approval for Non-Metastatic Castration-Resistant Prostate Cancer in Men

Published: Jul 31, 2019 | Tags: Bayer, Nubeqa, darolutamide, Receives, US, FDA, Approval, Non-Metastatic Castration-Resistant Prostate Cancer, Men

Merck’s Receives EU’s CHMP Positive Opinion for its Zerbaxa (ceftolozane and tazobactam) and Keytruda (pembrolizumab) + Inlyta (axitinib) Regimen

20. Merck Receives EU’s CHMP Positive Opinion for its Zerbaxa (ceftolozane and tazobactam) and Keytruda (pembrolizumab) + Inlyta (axitinib) Regimen

Published: Jul 29, 2019 | Tags: Merck, Receives, EU, CHMP, Positive Opinion, Zerbaxa, ceftolozane, tazobactam, Keytruda, pembrolizumab, Inlyta, axitinib, Regimen

Novartis’ Lucentis Receive EU’s CHMP Positive Opinion for Retinopathy of Prematurity in Preterm Infants

21. Novartis’ Lucentis Receive EU’s CHMP Positive Opinion for Retinopathy of Prematurity in Preterm Infants

Published: Jul 26, 2019 | Tags: Novartis, Lucentis, Receive, EU, CHMP, Positive Opinion, Retinopathy of Prematurity, Preterm Infants

Eli Lilly Reports Results of Verzenio (abemaciclib) in P-III MONARCH 2 for HR+ and HER2- Advanced Breast Cancer

22. Eli Lilly Reports Results of Verzenio (abemaciclib) in P-III MONARCH 2 for HR+ and HER2- Advanced Breast Cancer

Published: Jul 30, 2019 | Tags: Eli Lilly, Reports, Results, Verzenio, abemaciclib, P-III, MONARCH 2, HR+, HER2-, Advanced Breast Cancer

Exact Sciences to Merge with Genomic Health Forming a New Cancer Diagnostics CompanyExact Sciences to Merge with Genomic Health Forming a New Cancer Diagnostics Company

23.Exact Sciences to Merge with Genomic Health Forming a New Cancer Diagnostics Company

Published: June 29, 2019 | Tags: Exact Sciences, Merge, Genomic Health, New Cancer Diagnostics Company

Merck Reports Results of Keytruda (pembrolizumab) + Chemotherapy in P-III KEYNOTE-522 Study for Triple-Negative Breast Cancer

24. Merck Reports Results of Keytruda (pembrolizumab) + Chemotherapy in P-III KEYNOTE-522 Study for Triple-Negative Breast Cancer

Published: Jul 29, 2019 | Tags: Merck, Reports, Results, Keytruda, pembrolizumab, CT, P-III, KEYNOTE-522, Study, Triple-Negative Breast Cancer

Baxter Launches PrisMax Acute Care System for Acute Kidney Injury in the US

25.Baxter Launches PrisMax Acute Care System for Acute Kidney Injury in the US

Published: Jul 29, 2019 | Tags: Baxter, Launches, PrisMax Acute Care System, Acute Kidney Injury, US

Sanofi Reports Results of Zynquista (sotagliflozin) in P-III InSynchrony Program for Type2 Diabetes and Terminates Its Collaboration with Lexicon

26. Sanofi Reports Results of Zynquista (sotagliflozin) in P-III InSynchrony Program for Type2 Diabetes and Terminates Its Collaboration with Lexicon

Published: Jul 26, 2019 | Tags: Sanofi, Reports, Results, Zynquista, sotagliflozin, P-III, InSynchrony Program, Type2, Diabetes, Terminates, Collaboration, Lexicon

Pfizer’s Upjohn Off-Patent Drug Business to Merge with Mylan to Form a New Pharmaceutical Company

27. Pfizer’s Upjohn Off-Patent Drug Business to Merge with Mylan to Form a New Pharmaceutical Company

Published: Jul 29, 2019 | Tags: Pfizer, Upjohn, Off-Patent, Drug, Business, Merge, Mylan, Form, New Pharmaceutical Company

ViiV Healthcare Reports Submission of MAA to EMA for the Combination of Cabotegravir + Rilpivirine to Treat HIV-1 Infection

28. ViiV Healthcare Reports Submission of MAA to EMA for the Combination of Cabotegravir + Rilpivirine to Treat HIV-1 Infection

Published: Jul 29, 2019 | Tags:  ViiV Healthcare, Reports, Submission, MAA, EMA, Combination, Cabotegravir, Rilpivirine, Treat, HIV-1, infection

Pfizer’s Upjohn Off-Patent Drug Business to Merge with Mylan to Form a New Pharmaceutical Company

29.Pfizer in Talks with Mylan to Merge its Off-Patent Drug Business

Published: Jul 27, 2019 | Tags: Pfizer, Talks, Mylan, Merge, Off-Patent, Drug Business