PharmaShots Weekly Snapshot (July 22 – 26, 2019)

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

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

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

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

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

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

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

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

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

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

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

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

Allergan Voluntary Recalls Worldwide BIOCELL Textured Breast Implants and Tissue Expanders

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

Celgene Reports Update on its Collaboration with Jounce TherapeuticsCelgene Reports Update on its Collaboration with Jounce Therapeutics

9. Celgene Reports Update on its Collaboration with Jounce Therapeutics

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

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

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

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

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

Synapse Signs an Agreement with Pfizer in Oncology Precision Medicine

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

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

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

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

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

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

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

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

Ligand to Acquire Ab Initio Biotherapeutics for its Antigen Technology

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

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

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

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

Pfizer’s Ruxience (biosimilar, rituximab) Receives FDA’s Approval for Cancer and 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

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

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

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

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

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

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

ViiV Healthcare Initiates CUSTOMIZE Study of Dual- Drug Injectable Regimen for the Treatment of HIV

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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