PharmaShots Weekly Snapshot (July 22 – 26, 2019)

1.Epizyme Reports FDA’s Acceptance of NDA for Tazemetostat to Treat Epithelioid Sarcoma

Published: Jul 25, 2019 | Tags: Epizyme, Reports, FDA, Acceptance, NDA, Tazemetostat, Treat, Epithelioid Sarcoma

2. Roche’s Tecentriq Receives EU’s CHMP Recommendation for its Approval as 1L Therapy for Extensive-Stage Small Cell Lung Cancer

Published: Jul 26, 2019 | Tags:  Roche, Tecentriq, Receives, EU, CHMP, Recommendation, Approval, 1L, Therapy, Extensive-Stage Small Cell Lung Cancer

3. BMS’ Triple Regimen Receives Positive CHMP Recommendation for its Approval to Treat R/R Multiple Myeloma in Europe

Published: Jul 26, 2019 | Tags: BMS, Triple Regimen, Receives, Positive, CHMP, Recommendation, Approval, Treat, R/R, Multiple Myeloma, Europe

4. Janssen Reports Results of Ponesimod in P-III OPTIMUM Study for Relapsing Multiple Sclerosis

Published: Jul 25, 2019 | Tags: Janssen, Reports, Results, Ponesimod, P-III, OPTIMUM, Study, Relapsing, Multiple Sclerosis

5. Boehringer Ingelheim’s Ofev (nintedanib) Receives FDA’s Advisory Committee Recommendation for Systemic Sclerosis Associated ILD

Published: Jul 25, 2019 | Tags: Boehringer, Ofev, nintedanib, Receives, FDA, Advisory, Committee, Recommendation, Systemic Sclerosis Associated ILD

6. Sanofi Enter into an Exclusive License Agreement with Verastem Oncology to Develop and Commercialize Copiktra (duvelisib) for all Oncology Indications

Published: Jul 25, 2019 | Tags: Sanofi, Enter, Exclusive, License, Agreement, Verastem Oncology, Develop, Commercialize, Copiktra, duvelisib, Oncology, Indications6

7. Regenxbio Signs an Exclusive Development and Commercialization Agreement with Neurimmune for AAV Gene Therapies Targeting Neurodegenerative Diseases

Published: Jul 24, 2019 | Tags:Regenxbio, Signs, Exclusive, Development, Commercialization, Agreement, Neurimmune, AAV Gene Therapies, Targeting, Neurodegenerative Diseases

8. Allergan Voluntary Recalls Worldwide BIOCELL Textured Breast Implants and Tissue Expanders

Published: Jul 24, 2019 | Tags: Allergan, Voluntary, Worldwide, Recalls, BIOCELL, Textured Breast Implants, Tissue Expanders

9. Celgene Reports Update on its Collaboration with Jounce Therapeutics

Published: Jul 23, 2019 | Tags: Celgene, Reports, Update, Collaboration, Jounce Therapeutics

10. BMS Reports Results of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III CheckMate -227 Part 1a Study for 1L Non-Small Cell Lung Cancer

Published: Jul 24, 2019 | Tags: BMS, Reports, Results, Opdivo, nivolumab, + Yervoy, ipilimumab, P-III, CheckMate -227 Part 1a, Study, 1L, Non-Small Cell Lung Cancer

11. Eli Lilly’s Baqsimi (glucagon 3mg) Nasal Powder Receives FDA’s Approval for the Treatment of Severe Hypoglycemia

Published: Jul 24, 2019 | Tags: Eli Lilly, Baqsimi, glucagon, 3mg, Nasal Powder, Receives, FDA, Approval, Treatment, Severe, Hypoglycemia

12. Synapse Signs an Agreement with Pfizer in Oncology Precision Medicine

Published: Jul 23, 2019 | Tags: Synapse, Signs, Agreement, Pfizer, Oncology, Precision Medicine13

13. Celgene Partners with Multiple Sclerosis Association of America Bringing MS MindShift Brain Bulb Hot Air Balloon to Raise Awareness of Multiple Sclerosis and Brain Health

Published: Jul 24, 2019 | Tags:  Celgene, Partners, Multiple Sclerosis Association of America, Bring, MS MindShift, Brain Bulb Hot Air Balloon, Raise, Awareness, Multiple Sclerosis, Brain Health

14. Gilead Reports Updated Results of Descovy in P-III DISCOVER Study for Pre-Exposure Prophylaxis of HIV

Published: Jul 23, 2019 | Tags: Gilead, Reports, Updated, Results, Descovy, P-III, DISCOVER, Study, Pre-Exposure Prophylaxis, HIV

15. Medtronic Solicits the US FDA for Non-Adjunctive Labeling Approval of MiniMed 670G Insulin Pump Sensor

Published: Jul 23, 2019 | Tags: Medtronic, Solicits, US FDA, Non-Adjunctive Labeling, Approval, MiniMed 670G, Insulin Pump Sensor

16. Ligand to Acquire Ab Initio Biotherapeutics for its Antigen Technology

Published: Jul 23, 2019 | Tags: Ligand, Acquire, Ab Initio Biotherapeutics, Antigen Technology

17. Samsung Bioepis’ Hadlima (biosimilar, adalimumab) Receives FDA’s Approval for Autoimmune Diseases

Published: Jul 24, 2019 | Tags: Samsung Bioepis, Hadlima, biosimilar, adalimumab, Receives, FDA, Approval, Autoimmune Diseases

18. Pfizer’s Ruxience (biosimilar, rituximab) Receives FDA’s Approval for Cancer and Autoimmune Diseases

Published: Jul 23, 2019 | Tags: Pfizer, Ruxience, rituximab, biosimilar, Receives, FDA, Approval, Cancer, Autoimmune Diseases

19. Chiasma Reports Results of Mycapssa (octreotide) in P-III CHIASMA OPTIMAL Study as a Maintenance Therapy for Acromegaly  

Published: Jul 23, 2019 | Tags: Chiasma, Reports, Results, Mycapssa, octreotide, P-III, CHIASMA OPTIMAL, Study, Maintenance Therapy, Acromegaly

20. Merck and Eisai’s Keytruda (pembrolizumab) + Lenvima (lenvatinib) Receive FDA’s Third Breakthrough Therapy Designation as 1L Therapy for Hepatocellular Carcinoma

Published: Jul 23, 2019 | Tags: Merck, Eisai, Keytruda, pembrolizumab, Lenvima, lenvatinib, Receive, FDA, Third, Breakthrough Therapy Designation, 1L, Therapy, Hepatocellular Carcinoma

21. AstraZeneca Reports Inclusion of Overall Survival Data in Labelling of Imfinzi (durvalumab) in the US

Published: Jul 22, 2019 | Tags: AstraZeneca, Reports, Inclusion, Overall Survival, Data, Labelling, Imfinzi, durvalumab, US

22. ViiV Healthcare Reports Results of Fostemsavir in P-III BRIGHTE Study for HIV-1 infection

Published: June 22, 2019 | Tags: ViiV Healthcare, Reports, Results, Fostemsavir, P-III, BRIGHTE, Study, HIV-1 infection

23. Sanofi Signs an Exclusive Agreement with Roche for OTC Rights of Tamiflu (oseltamivir phosphate) in the US

Published: Jul 23, 2019 | Tags: Sanofi, Signs, Exclusive Agreement, Roche, OTC Rights, Tamiflu, oseltamivir phosphate, US

24. Baxter’s Myxredlin Ready-To-Use Insulin for IV Infusion Receives FDA’s Approval for Diabetes Mellitus

Published: Jul 22, 2019 | Tags: Baxter, Myxredlin, Ready-To-Use Insulin, IV Infusion, Receives, FDA, Approval, Diabetes Mellitus

25. Gilead Signs an Exclusive Worldwide License Agreement with Durect for its HIV and Hepatitis B Products

Published: Jul 22, 2019 | Tags: Gilead, Signs, Exclusive, Worldwide, License, Agreement, Durect, HIV, Hepatitis B, Products

26. Medtronic Collaborates with Viz.ai to Facilitate Adoption of AI Software for Stroke Centers in the US

Published: Jul 22, 2019 | Tags: Medtronic, Collaborates, Viz.ai, Facilitate, Adoption, AI, Software, Stroke Centers, US

27. Takeda Reports Results of Entyvio (vedolizumab SC) in P-III VISIBLE 2 Study for Moderately to Severely Active Crohn’s Disease

Published: Jul 22, 2019 | Tags: Takeda, Reports, Results, Entyvio, vedolizumab SC, P-III, VISIBLE 2, Study, Moderately, Severely, Active, Crohn’s Disease

28. Celgene’s Otezla (apremilast) Receives FDA’s Approval for Oral Ulcers Associated with Behçet’s Disease

Published: Jul 19, 2019 | Tags: Celgene, Otezla, apremilast, Receives, FDA, Approval, Oral Ulcers, Behçet’s Disease

29. Sandoz Reports Patient Enrollment in P-I/III ROSALIA Study of Proposed Biosimilar Denosumab for Postmenopausal Osteoporosis

Published: Jul 22, 2019 | Tags: Sandoz, Reports, Patient Enrollment, P-I/III, ROSALIA, Study, Proposed Biosimilar Denosumab, Osteoporosis