PharmaShots Weekly Snapshot (July 01 – 05, 2019)

1.Fresenius Kabi Voluntary Recalls Two Lots of Fluorouracil Injection Due to Potential for Glass Particulate

Published: Jul 05, 2019 | Tags: Fresenius Kabi, Voluntary, Recalls, Two Lots, Fluorouracil Injection, Potential, Glass Particulate

2.SDSC and Moores Cancer Center Collaboratively Work with CureMatch to Develop Machine Learning Model for the Diagnosis of Bladder Cancer

Published: Jul 02, 2019 | Tags: SDSC, Moores Cancer Center, CureMatch, Develop, Machine Learning Model, Diagnosis, Bladder Cancer

3. Fraunhofer MEVIS’ Experts Develops Intelligent Catheter Navigation System in Germany

Published: Jul 02, 2019 | Tags: Fraunhofer, MEVIS, Experts, Develops, Intelligent Catheter Navigation System, Germany

4. Grifols’ Xembify (20% SC Immunoglobulin) Receives FDA’s Approval for the Treatment of Primary Immunodeficiencies

Published: Jul 04, 2019 | Tags: Grifols, Xembify, 20%, SC, Immunoglobulin, Receives, FDA, Approval, Treatment, Primary Immunodeficiencies

5. SIFI Acquires Laboratoire Gifrer Barbezat’s Dacudoses and Novoptine for $6.7M in France

Published: Jul 04, 2019 | Tags: SIFI, Acquires, Gifrer Barbezat, Dacudoses, Novoptine, $6.7M, France

6. Janssen Returns its Exclusive Rights to Develop and Commercialize Hanmi’s Antidiabetic Obesity Therapy

Published: Jul 03, 2019 | Tags: Janssen, Returns, Exclusive Rights, Develop, Commercialize, Hanmi, Antidiabetic Obesity Therapy

7. Nosopharm Signs an Agreement with Evotec to Accelerate the Development of Antibiotics

Published: Jul 03, 2019 | Tags:Nosopharm, Signs, Agreement, Evotec, Accelerate, Development, Antibiotics

8. Karyopharm’s Xpovio (selinexor) Receives FDA’s Accelerated Approval for Relapsed/Refractory Multiple Myeloma

Published: Jul 03, 2019 | Tags: Karyopharm, Xpovio, selinexor, Receives, FDA, Accelerated Approval, Relapsed/Refractory, Multiple Myeloma

9. Alexion’s Ultomiris (Ravulizumab) Receives European Commission’s Marketing Authorization for Paroxysmal Nocturnal Hemoglobinuria in Adults

Published: Jul 03, 2019 | Tags: Alexion, Ultomiris, Ravulizumab, Receives, European Commission, Marketing Authorization, Paroxysmal Nocturnal Hemoglobinuria, Adults

10. Samsung Bioepis and Genentech Settles Patent Dispute of Trastuzumab Biosimilar-Ontruzant

Published: Jul 04, 2019 | Tags: Samsung Bioepis, Genentech, Settles, Patent Dispute, Ontruzant, biosimilar, trastuzumab

11. Asieris Signs a Worldwide Development and Commercialization Agreement with Photocure for Cevira

Published: Jul 02, 2019 | Tags: Asieris, Signs, Worldwide, Development, Commercialization, Agreement, Photocure, Cevira

12. GSK to Initiate P-III ContRAst Studies of Otilimab to Treat Moderate to Severe Rheumatoid Arthritis

Published: Jul 03, 2019 | Tags: GSK, Initiates, Four, P-III, ContRAst Studies, Otilimab, Moderate, Severe, Rheumatoid Arthritis

13.ViiV Healthcare’s Dovato (dolutegravir/lamivudine) Receives European Commission Marketing Authorization for HIV-1 Infection in Adults and Adolescents

Published: Jul 03, 2019 | Tags:  ViiV Healthcare; Dovato; dolutegravir; lamivudine; Receives; European Commission; Marketing Authorization; HIV-1; Infection

14. Sandoz Launches Generic Gefitinib for Locally Advanced or Metastatic Non-Small Cell Lung Cancer in 13 European Countries

Published: Jul 03, 2019 | Tags: Sandoz, Launches, Generic, Gefitinib, Locally Advanced, Metastatic, Non-Small Cell Lung Cancer, 13, European, Countries

15. Genentech Reports Results of Xofluza (baloxavir marboxil) in P-III MINISTONE-2 Study for Influenza in Children

Published: Jul 02, 2019 | Tags: Genentech, Reports, Results, Xofluza, baloxavir marboxil, P-III, MINISTONE-2, Study, Influenza, Children

16. Varian to Acquire Boston Scientific’s Oncology Assets for $90M

Published: Jul 02, 2019 | Tags: Varian, Acquire, Boston Scientific, Oncology, Assets, $90M

17. Foundation Medicine’s FoundationOne CDx Receives FDA’s Approval as a CDx for Lynparza (olaparib)

Published: Jul 01, 2019 | Tags: Foundation Medicine, FoundationOne CDx, Receives, FDA, Approval, CDx, Lynparza, olaparib

18. Boehringer Ingelheim Signs a License Agreement with Yuhan Corporation to Develop Dual Agonist for Nonalcoholic Steatohepatitis

Published: Jul 01, 2019 | Tags: Boehringer Ingelheim, Signs, License Agreement, Yuhan Corporation, Develop, Dual Agonist, Nonalcoholic Steatohepatitis

19. Teva Reports Results of Fremanezumab in P-IIIb FOCUS Study for Migraine in Adults

Published: Jul 02, 2019 | Tags: Teva, Reports, Results, Fremanezumab, P-IIIb, FOCUS, Study, Migraine, Adults

20. Regeneron and Sanofi’s Libtayo (cemiplimab) Receives European Commission’s Approval for Advanced Cutaneous Squamous Cell Carcinoma

Published: Jul 02, 2019 | Tags: AbbVie, Acquire, Allergan, $63B, Medical Aesthetics, Ophthalmology

21. Biogen Reports Results of Spinraza (nusinersen) in P-II NURTURE Study as a Foundation of Care in Spinal Muscular Atrophy

Published: Jul 01, 2019 | Tags: Biogen, Reports, Results, Spinraza, nusinersen, P-II, NURTURE, Study, Foundation of Care, Spinal Muscular Atrophy

22.Roche’s Tecentriq (atezolizumab) + Abraxane Receives CHMP’s Recommendation for its Approval in Europe

Published: June 28, 2019 | Tags: Roche, Tecentriq, atezolizumab, Abraxane, Receives, CHMP, Recommendation, Approval, Europe

23. Janssen’s Imbruvica (ibrutinib) Receives CHMP Positive Recommendation for its Expanded Use in Chronic Lymphocytic Leukaemia and Waldenstrom’s Macroglobulinemia in Europe

Published: Jul 01, 2019 | Tags: Janssen, Imbruvica, ibrutinib, Receives, Positive, CHMP, Recommendation, Expanded Use, Chronic Lymphocytic Leukaemia, Waldenstrom Macroglobulinemia, Europe

24. AstraZeneca’s Forxiga and Fasenra (Prefilled Syringe and Pen) Receive EU CHMP’s Positive Opinion for CV Outcomes in T2D and Asthma

Published: Jul 01, 2019 | Tags: AstraZeneca, Forxiga, Fasenra, Prefilled Syringe, Pen, Receive, EU, CHMP, Positive Opinion, CV outcomes, T2D, Asthma

25.Pfizer Reports Results of Revatio (sildenafil citrate) in P-III Study for Persistent Pulmonary Hypertension in the Newborns

Published: Jul 01, 2019 | Tags: Pfizer, Reports, Results, Revatio, sildenafil citrate, P-III, Study, Persistent Pulmonary Hypertension, Newborns