PharmaShots Weekly Snapshot (June 24 – 28, 2019)

Pfizer’s Zirabev (bevacizumab, biosimilar) Receives the US FDA’s Approval for Five Types of Cancer

1.Pfizer’s Zirabev (bevacizumab, biosimilar) Receives the US FDA’s Approval for Five Types of Cancer

Published: Jun 28, 2019 | Tags: Pfizer, Zirabev, bevacizumab, biosimilar, Receives, US FDA, Approval, Five, Types Cancer

Innovent and Eli Lilly Report NMPA’s Acceptance of NDA for IBI301 (rituximab, biosimilar) for Non-Hodgkin's lymphoma

2. Innovent and Eli Lilly Report NMPA’s Acceptance of NDA for IBI301 (rituximab, biosimilar) for Non-Hodgkin’s lymphoma

Published: Jun 27, 2019 | Tags: Innovent, Eli Lilly, Reports, NMPA, Acceptance, NDA, IBI301, rituximab, biosimilar, Non-Hodgkin’s lymphoma

Sanofi and Regeneron’s Dupixent (dupilumab) Receive CHMP’s Positive Opinion for Moderate-To-Severe Atopic Dermatitis in Adolescents

3. Sanofi and Regeneron’s Dupixent (dupilumab) Receive CHMP’s Positive Opinion for Moderate-To-Severe Atopic Dermatitis in Adolescents

Published: Jun 27, 2019 | Tags: Sanofi, Regeneron, Dupixent, dupilumab, Receive, CHMP, Positive Opinion, Moderate, Severe, Atopic Dermatitis, Adults

4. Apple Disrupting the Healthcare with the Availability of One Drop Blood Glucose Monitor at its Retails Outlets in the US

Published: Jun 27, 2019 | Tags: One Drop, Reports, Availability, Wireless, Blood Glucose Monitors, Apple, Retail Outlets, US

Alexion’s Soliris (eculizumab) Receives FDA’s Approval for Anti-Aquaporin-4 Antibody Positive Patients with Neuromyelitis Optica Spectrum Disorder

5. Alexion’s Soliris (eculizumab) Receives FDA’s Approval for Anti-Aquaporin-4 Antibody Positive Patients with Neuromyelitis Optica Spectrum Disorder

Published: Jun 06, 2019 | Tags: Alexion, Soliris, eculizumab, Receives, FDA, Approval, Anti-Aquaporin-4 Antibody Positive, Patients, Neuromyelitis Optica Spectrum, Disorder

Janssen’s Darzalex (daratumumab) in Combination with Lenalidomide + Dexamethasone Receive FDA’s Approval for Transplant Ineligible Patients with Multiple Myeloma

6. Janssen’s Darzalex (daratumumab) in Combination with Lenalidomide + Dexamethasone Receive FDA’s Approval for Transplant Ineligible Patients with Multiple Myeloma

Published: Jun 27, 2019 | Tags: Janssen, Darzalex, daratumumab, Combination, Lenalidomide, Dexamethasone, Receive, FDA, Approval, Transplant, Ineligible, Patients, Multiple Myeloma

GSK Amends its Development and Commercialization Agreement with Liquidia for Inhaled Therapies

7. GSK Amends its Development and Commercialization Agreement with Liquidia for Inhaled Therapies

Published: Jun 27, 2019 | Tags: GSK, Amends, Development, Commercialization, Agreement, Liquidia, Inhaled Therapies

Sanofi Reports FDA’s Acceptance of BLA for MenQuadfi to Prevent Meningococcal Meningitis

8. Sanofi Reports FDA’s Acceptance of BLA for MenQuadfi to Prevent Meningococcal Meningitis

Published: Jun 27, 2019 | Tags: Sanofi, Reports, FDA, Acceptance, BLA, MenQuadfi, Prevent, Meningococcal Meningitis

AstraZeneca Reports Results of Imfinzi (durvalumab) in P-III CASPIAN Study for 1L Extensive-Stage Small Cell Lung Cancer

9. AstraZeneca Reports Results of Imfinzi (durvalumab) in P-III CASPIAN Study for 1L Extensive-Stage Small Cell Lung Cancer

Published: Jun 27, 2019 | Tags: AstraZeneca, Reports, Results, Imfinzi, durvalumab, P-III, CASPIAN, Study, 1L, Extensive-Stage Small Cell Lung Cancer

Regeneron and Sanofi’s Dupixent (dupilumab) Receives FDA’s Approval for Chronic Rhinosinusitis with Nasal Polyposis

10. Regeneron and Sanofi’s Dupixent (dupilumab) Receives FDA’s Approval for Chronic Rhinosinusitis with Nasal Polyposis

Published: Jun 27, 2019 | Tags: Regeneron, Sanofi, Dupixent, dupilumab, Receives, FDA, Approval, Chronic Rhinosinusitis, Nasal Polyposis

Louisiana Department of Health Launches Innovative Payment Model with Asegua Therapeutics to Eliminate Hepatitis C in Louisiana

11. Louisiana Department of Health Launches Innovative Payment Model with Asegua Therapeutics to Eliminate Hepatitis C in Louisiana

Published: June 26, 2019 | Tags: Louisiana Department of Health, Launches, Innovative Payment Model, Asegua Therapeutics, Eliminate, Hepatitis C, Louisiana

Boehringer Ingelheim and Eli Lilly’s Empagliflozin Receive FDA’s Fast Track Designation for Chronic Heart Failure

12. Boehringer Ingelheim and Eli Lilly’s Empagliflozin Receive FDA’s Fast Track Designation for Chronic Heart Failure

Published: June 26, 2019 | Tags: Boehringer Ingelheim, Eli Lilly, Empagliflozin, Receive, FDA, Fast Track, Designation, Chronic Heart Failure

Daiichi Sankyo to Return Exclusive Development and Commercialization Rights for Four Diagnostic Imaging Agents to GE Healthcare in Japan

13.Daiichi Sankyo to Return Exclusive Development and Commercialization Rights for Four Diagnostic Imaging Agents to GE Healthcare in Japan

Published: June 25, 2019 | Tags: Daiichi Sankyo, Return, Exclusive, Development, Commercialization, Rights, GE Healthcare, Four, Diagnostic Imaging Agents, Japan

Lilly Reports Results of Trulicity (dulaglutide) in P-III AWARD-11 Study for Type 2 Diabetes

14. Lilly Reports Results of Trulicity (dulaglutide) in P-III AWARD-11 Study for Type 2 Diabetes

Published: June 26, 2019 | Tags: Lilly, Reports, Results, Trulicity, dulaglutide, P-III, AWARD-11, Study, Type 2 Diabetes

Eisai Reports Results of Fycompa (perampanel) in P-III FREEDOM Study for Patients with Newly Diagnosed or Untreated Partial Onset Seizures

15. Eisai Reports Results of Fycompa (perampanel) in P-III FREEDOM Study for Patients with Newly Diagnosed or Untreated Partial Onset Seizures

Published: June 25, 2019 | Tags: Eisai, Reports, Results, Fycompa, perampanel, P-III, FREEDOM, Study, Patients, Newly Diagnosed, Untreated, Partial Onset Seizures

Tilt Biotherapeutics Signs an Agreement with Merck KGaA and Pfizer to Investigate the Dual Combination for Solid Tumors

16. Tilt Biotherapeutics Signs an Agreement with Merck KGaA and Pfizer to Investigate the Dual Combination for Solid Tumors

Published: June 25, 2019 | Tags: Tilt Biotherapeutics, Signs, Agreement, Merck KGaA, Pfizer, Investigate, Combination, Oncolytic Virus, TILT-123, Avelumab

Almirall Exercises its Option to License Dermira’s Lebrikizumab for Atopic Dermatitis in Europe

17. Almirall Exercises its Option to License Dermira’s Lebrikizumab for Atopic Dermatitis in Europe

Published: June 25, 2019 | Tags: Almirall, Exercises, Option, License, Dermira, Lebrikizumab, Atopic Dermatitis, Europe

C4X Discovery Signs a Neurodegeneration Drug Discovery Agreement with PhoreMost for Parkinson’s Disease

18. C4X Discovery Signs a Neurodegeneration Drug Discovery Agreement with PhoreMost for Parkinson’s Disease

Published: June 25, 2019 | Tags: C4X, Discovery, Signs, Neurodegeneration, Drug Discovery, Agreement, PhoreMost, Parkinson’s Disease

Bristol-Myers Squibb to Divest Celgene’s Otezla (apremilast) to Gain the US FTC’s Approval on Celgene Acquisition

19. Bristol-Myers Squibb to Divest Celgene’s Otezla (apremilast) to Gain the US FTC’s Approval on Celgene Acquisition

Published: June 24, 2019 | Tags: Bristol-Myers Squibb, Divest, Celgene, Otezla, apremilast, Gain, US, FTC, Approval, Celgene, Acquisition

AbbVie to Acquire Allergan for its Portfolio in Medical Aesthetics and Ophthalmology for $63B

20. AbbVie to Acquire Allergan for $63B

Published: June 25, 2019 | Tags: AbbVie, Acquire, Allergan, $63B, Medical Aesthetics, Ophthalmology

Novartis to Collaborate with Glenmark to Promote, Commercialize and Distribute Three Respiratory Therapies for COPD in Brazil

21. Novartis to Collaborate with Glenmark to Promote, Commercialize and Distribute Three Respiratory Therapies for COPD in Brazil

Published: June 24, 2019 | Tags: Novartis, Collaborate, Glenmark, Promote, Commercialize, Distribute, Three, Respiratory Therapies, COPD, Brazil

Gilead Signs an Agreement with Carna Biosciences to Develop and Commercialize Immuno-Oncology Therapies

22. Gilead Signs an Agreement with Carna Biosciences to Develop and Commercialize Immuno-Oncology Therapies

Published: June 24, 2019 | Tags: Gilead, Signs, Agreement, Carna Biosciences, Develop, Commercialize, Immuno-Oncology Therapies

Allergan’s CoolTone Device Receives FDA’s Clearance to Strengthen, Tone and Firm Abdominal Muscles

23.Allergan’s CoolTone Device Receives FDA’s Clearance to Strengthen, Tone and Firm Abdominal Muscles

Published: June 24, 2019 | Tags: Allergan, CoolTone Device, Receives, FDA, Clearance, Strengthen, Tone, Firm, Abdominal Muscles

Bristol-Myers Squibb Reports Results of Opdivo (nivolumab) in P-III CheckMate-459 Study as 1L Treatment for Patients with Unresectable Hepatocellular Carcinoma

24. Bristol-Myers Squibb Reports Results of Opdivo (nivolumab) in P-III CheckMate-459 Study as 1L Treatment for Patients with Unresectable Hepatocellular Carcinoma

Published: June 24, 2019 | Tags: Bristol-Myers Squibb, Reports, Results, Opdivo, nivolumab, P-III, CheckMate-459, Study, 1L, Treatment, Patients, Unresectable, Hepatocellular Carcinoma

Henlius Reports EMA’s Acceptance of Marketing Authorization Application for HLX02 (trastuzumab, biosimilar)

25. Henlius Reports EMA’s Acceptance of Marketing Authorization Application for HLX02 (trastuzumab, biosimilar)

Published: June 21, 2019 | Tags: Henlius, Reports, EMA, Acceptance, Marketing Authorization Application, HLX02, trastuzumab, biosimilar

Pfizer’s Talzenna (talazoparib) Receives European Commission Approval for Germline BRCA-Mutated Locally Advanced or Metastatic Breast Cancer

26. Pfizer’s Talzenna (talazoparib) Receives European Commission Approval for Germline BRCA-Mutated Locally Advanced or Metastatic Breast Cancer

Published: June 21, 2019 | Tags: Pfizer, Talzenna, talazoparib, Receives, European Commission, Approval, Germline, BRCA-Mutated, Locally Advanced, Metastatic Breast Cancer

Allergan’s BOTOX (onabotulinumtoxinA) Receives FDA’s Approval for Upper Limb Spasticity in Pediatric Patients

27. Allergan’s BOTOX (onabotulinumtoxinA) Receives FDA’s Approval for Upper Limb Spasticity in Pediatric Patients

Published: June 21, 2019 | Tags: Allergan, BOTOX, onabotulinumtoxinA, Receives, FDA, Approval, Upper Limb Spasticity, Pediatric Patients