PharmaShots Weekly Snapshot (November 18-22, 2019)

1.  Lupin Launches Smart Device for Metered-Dose Inhalers to Support Treatment of Respiratory Diseases in India

Published: Nov 22, 2019 | Tags: Lupin, Launches, Smart Device, Metered-Dose Inhalers, Support, Treatment, Respiratory Diseases, India

2. BioMarin Reports Submission of MAA to EMA for Valoctocogene Roxaparvovec to Treat Severe Hemophilia A

Published: Nov 21, 2019 | Tags: BioMarin, Reports, Submission, MAA, EMA, Valoctocogene Roxaparvovec, Hemophilia A

3.  Medtronic’s IN.PACT AV Drug-Coated Balloon Receives the US FDA’s Approval for the Treatment of Arteriovenous Fistula Lesions

Published: Nov 21, 2019 | Tags: Medtronic, IN.PACT AV Drug-Coated Balloon, Receives, US, FDA, Approval, Arteriovenous Fistula Lesions

4.  GSK and ViiV Healthcare Sign an Exclusive License Agreement with NIH for its Investigational bNAb to Treat and Prevent HIV

Published: Nov 21, 2019 | Tags: GSK, ViiV Healthcare, Signs, Exclusive, License Agreement, NIH, bNAb, HIV Infection

5.  AstraZeneca’s Calquence (acalabrutinib) Receives the US FDA’s Approval for Chronic Lymphocytic Leukemia Under the Project Orbis

Published: Nov 21, 2019 | Tags: AstraZeneca, Calquence, acalabrutinib, Receives, US, FDA, Approval, Chronic Lymphocytic Leukemia, Project Orbis

6.  Knight Therapeutics Signs an Exclusive License Agreement with Onconova for Rigosertib in Canada

Published: Nov 21, 2019 | Tags: Knight Therapeutics, Signs, Exclusive, License Agreement, Onconova, Rigosertib, Canada

7. AbbVie Enters into an Exclusive Option and License Agreement for HPN217 and Expands its Existing Collaboration with Harpoon Therapeutics

Published: Nov 21, 2019 | Tags: AbbVie, Exclusive, Option and License Agreement, HPN217, Expands, Existing Collaboration, Harpoon Therapeutics

8. Aerie’s Rhokiinsa (netarsudil ophthalmic solution, 0.02%) Receives EC’s Approval for Patients with Open-Angle Glaucoma or Ocular Hypertension

Published:  Nov 21, 2019 | Tags: Aerie, Rhokiinsa, netarsudil ophthalmic solution, 0.02%, EC, Approval, Open-Angle Glaucoma, Ocular Hypertension

9. Astellas Signs a License Agreement with Welldoc to Develop and Commercialize Digital Therapies

Published: Nov 20, 2019 | Tags: Astellas, Signs, License Agreement, Welldoc, Develop, Commercialize, Digital Therapies

10.  Sanofi Collaborates with Aetion to Leverage its Evidence Platform for Advancing Regulatory Submissions

Published: Nov 20, 2019 | Tags: Sanofi, Collaborates, Aetion, Leverage, Evidence Platform, Advancing, Regulatory Submissions

11.  Novartis Collaborates with Mila to Transform Therapies with Artificial Intelligence in Canada

Published: Nov 20, 2019 | Tags: Novartis, Collaborates, Mila, Transform Therapies, Artificial Intelligence, Canada

12.  Alnylam’s Givlaari (givosiran) Receives the US FDA’s Approval as the First Therapy for Acute Hepatic Porphyria

Published: Nov 20, 2019 | Tags: Alnylam, Givlaari, givosiran, Receives, US, FDA, Approval, First Therapy, Acute Hepatic Porphyria

13. AbbVie Collaborates with Dragonfly Therapeutics to Develop Therapies for Autoimmune and Oncology Indications

Published: Nov 20, 2019 | Tags: AbbVie, Collaborates, Dragonfly Therapeutics, Develop, Therapies, Autoimmune, Oncology

14.  BMS Reports Update of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III CheckMate -915 Study for Patients with Resected High-Risk Melanoma and PD-L1 <1%

Published: Nov 20, 2019 | Tags: BMS, Reports, Update, Opdivo, nivolumab, Yervoy, ipilimumab, P-III, CheckMate -915, Study, Patients, Resected High-Risk Melanoma, PD-L1 <1%

15.  Merck’s Keytruda (pembrolizumab) Receives EC’s Approval as 1L Treatment for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma

Published: Nov 20, 2019 | Tags: Merck, Keytruda, pembrolizumab, Receives, EC, Approval, 1L, Treatment, Metastatic, Unresectable, Recurrent, Head and Neck Squamous Cell Carcinoma

16. BioVentrix’s Revivent TC Transcatheter Ventricular Enhancement System Receives FDA’s Breakthrough Device Designation for Heart Failure

Published: Nov 19, 2019 | Tags:  BioVentrix, Revivent TC Transcatheter Ventricular Enhancement System, Receives, FDA, Breakthrough Device Designation, Heart Failure

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

Published: Nov 19, 2019 | Tags: Janssen, Darzalex, daratumumab, Combination Regimen, Receives, EC, Approval, Transplant Ineligible Patients, Newly Diagnosed Multiple Myeloma

18.  Myovant Sciences Reports Results of Relugolix in P-III HERO Study for Men with Advanced Prostate Cancer

Published: Nov 19, 2019 | Tags: Myovant Sciences, Reports, Results, Relugolix, P-III, HERO Study, Men, Advanced Prostate Cancer

19. CRISPR Therapeutics and Vertex Report Results of CTX001 from First Two Patients with Severe Hemoglobinopathies

Published: Nov 20, 2019 | Tags: CRISPR Therapeutics, Vertex, Reports, Results, CTX001, Severe Hemoglobinopathies

20. Merck KGaA Collaborates with Personalis to Develop Novel Biomarkers for Cancer Therapies

Published: Nov 19, 2019 | Tags: Merck KGaA, Collaborates, Personalis, Develop, Novel Biomarkers, Cancer Therapies

21. Samsung Bioepis Reports FDA’s Acceptance of BLA for SB8 (biosimilar, bevacizumab)

Published: Nov 19, 2019 | Tags: Samsung Bioepis, Reports, FDA, Acceptance, BLA, SB8, biosimilar, bevacizumab

22. Vertex Collaborates with Molecular Templates to Discover and Develop Conditioning Regimens Enhancing Hematopoietic Stem Cell Transplants

Published: Nov 18, 2019 | Tags: Vertex, Collaborate, Molecular Templates, Discover, Develop, Conditioning Regimens, Enhancing, Hematopoietic Stem Cell Transplants

23.  Janssen Redefines Clinical Trial Design by Leveraging Wearable Technology

Published: Nov 19, 2019 | Tags: Janssen, Redefines, Clinical Trial Design, Leveraging, Wearable Technology

24.  Santhera Reports Results of Idebenone in SYROS Study for Duchenne Muscular Dystrophy

Published: Nov 19, 2019 | Tags:  Santhera, Reports, Results, Idebenone, SYROS, Study, Duchenne Muscular Dystrophy

25.  Alkermes to Acquire Rodin Therapeutics for $950M

Published: Nov 18, 2019 | Tags: Alkermes, Acquire, Rodin Therapeutics, $950M

26. Novartis Collaborates with Biofourmis To Offer Digital Therapeutics for Managing Heart Failures

Published: Nov 18, 2019 | Tags: Novartis, Collaborates, Biofourmis, Digital Therapeutics, Managing, Heart Failures

27.  Merck and Bayer Report Results of Vericiguat in P-III VICTORIA Study for Patients with Worsening Chronic Heart Failure

Published: Nov 18, 2019 | Tags: Merck, Bayer, Report, Results, Vericiguat, P-III, VICTORIA Study, Worsening Chronic Heart Failure

28. Aerie Pharmaceuticals to Acquire Avizorex Pharma to Expand its Footprint in Ophthalmology

Published: Nov 18, 2019 | Tags: Aerie Pharmaceuticals, Acquire, Avizorex Pharma, Expand, Footprint, Ophthalmology

29.  Novo Nordisk Collaborates with Dicerna to Discover and Develop RNAi Therapies for Liver-Related Cardio-Metabolic Diseases

Published: Nov 18, 2019 | Tags: Novo Nordisk, Collaborates, Dicerna, Discover, Develop, RNAi therapies, Liver-Related Cardio-Metabolic Diseases

30.  Novartis’ Adakveo (crizanlizumab) Receives the US FDA’s Approval for Reducing the Frequency of VOCs in Sickle Cell Disease

Published: Nov 15, 2019 | Tags: Novartis, Adakveo, crizanlizumab, Receives, US, FDA, Approval, Reducing, Frequency, VOCs, Sickle Cell Disease

31. Pfizer’s Abrilada (biosimilar, adalimumab) Receives the US FDA’s Approval for Rheumatoid Arthritis

Published: Nov 15, 2019 | Tags: Pfizer, Abrilada, biosimilar, adalimumab, Receives, US, FDA, Approval, Rheumatoid Arthritis

32. Roche to Acquire Promedior for $1.39B

Published: Nov 15, 2019 | Tags: Roche, Acquire, Promedior, $1.39B