PharmaShots Weekly Snapshot (March 04-08, 2019)

1.Bayer Submits EU’s Marketing Authorization Application to EMA for Darolutamide

Published: 08 Mar,2019 |Tags: Bayer, Submits, EU, Marketing Authorization Application, EMA, Darolutamide2

2. Zeiss’ CIRRUS HD-OCT Receives FDA’s 510 (k) Clearance for Epithelial Thickness Mapping (ETM)

Published: 08 Mar,2019 |Tags: Zeiss, CIRRUS HD-OCT, Receives, FDA, 510 (k), Clearance, Epithelial Thickness Mapping, ETM

3. Janssen (J&J) Reports Positive Results of Rilpivirine + Cabotegravir in P-III ATLAS and FLAIR Studies for HIV

Published: 08 Mar,2019 |Tags: Janssen, Reports, Positive, Results, Rilpivirine, Cabotegravir, P-III, ATLAS, FLAIR, Studies, HIV

4. Oncternal Therapeutics Reverse Merges with GTx

 Published: 08 Mar,2019 |Tags: GTx, Signs, Reverse, Merger, Agreement, Oncternal Therapeutics

5. Shionogi Signs Development & Commercialization Agreement with Akili for its AKL-T01 and AKL-T02 for ADHD & ASD

Published: 08 Mar,2019 |Tags: Shionogi, Signs, Development, Commercialization, Agreement, Akili, AKL-T01, AKL-T02

6. Baxter’s Eptifibatide Receives the US FDA’s Approval for Cardiovascular Diseases

Published: 07 Mar,2019 |Tags: Baxter, Eptifibatide, Receives, the US, FDA, Approval, Cardiovascular, Diseases

7. Alnylam Reports Positive Result of Givosiran in P-III ENVISION Study for Acute Hepatic Porphyria (AHP)

Published: 07 Mar,2019 |Tags:Alnylam, Reports, Result, Givosiran, P-III, ENVISION, Study, Acute Hepatic Porphyria, AHP

8. Vertex Reports Positive Results of Triple Combination Therapy in P-III Studies for Cystic Fibrosis

Published: 07 Mar,2019 |Tags: Vertex, Reports, Results, Triple Combination Therapy, P-III, Studies, Cystic Fibrosis

9. BeiGene and Ambrx Enters into a Worldwide Research and Development Collaboration to Develop Novel Biologics

Published: 07 Mar,2019 |Tags: BeiGene, Ambrx, Enters, Worldwide, Research, Development, Collaboration, Develop, Novel, Biologics

10. Allergan Reports Results of Rapastinel in Four P-III RAP-MD Studies for Major Depressive Disorders (MDD)

Published: 07 Mar,2019 |Tags: Allergan, Reports, Results, Rapastinel, Four, P-III, RAP-MD, Studies, Major Depressive Disorders, MDD

11. Pfizer Exercised its Option to License AnTolRx’s Immune Tolerance Therapy for Type 1 Diabetes (T1D)

Published:  06 Mar,2019 |Tags: Pfizer, Exercised, Option to License, AnTolRx, Immune Tolerance Therapy, Type 1 Diabetes, T1D

12. Pacira to Acquire MyoScience to Expand its Post-Surgical Portfolio

Published: 06 Mar,2019 |Tags: Pacira, Acquire, MyoScience, Expand, Post-Surgical, Portfolio, Exparel, Iovera

13. Genentech Announces FDA’s Acceptance of sNDA for Xofluza (baloxavir marboxil) in Patients with Influenza

Published: 06 Mar,2019 |Tags: Genentech, Announces, FDA, Acceptance, sNDA, Xofluza, baloxavir marboxil, Patients, Influenza

14. Acceleron’s ACE-083 Receives FDA’s ODD for Charcot Marie Tooth Disease (CMT)

Published: 06 Mar,2019 |Tags: Acceleron, ACE-083, Receives, FDA, ODD, Charcot Marie Tooth Disease, CMT, FSHD

15. Celgene’s Fedratinib Receives FDA’s Priority Review to NDA Filing for Myelofibrosis

Published: 06 Mar,2019 |Tags:  Celgene, Fedratinib, Receives, FDA, Priority Review, Myelofibrosis, NDA

16. ProMab Biotechnologies Signs Worldwide License Agreement with NantKwest to Develop Ab for Multiple Myeloma

Published: 05 Mar,2019 |Tags: ProMab Biotechnologies, Signs, Worldwide, License, Agreement, NantKwest, Develop, Ab, Multiple Myeloma

17. Bioxcel, Nektar and Merck KGaA in a Triple Collaboration for Pancreatic Cancer

Published: 05 Mar,2019 | Tags: BioXcel Therapeutics, BTI, Expands, Clinical Collaboration, Nektar, Addition, Merck KGaA, Pfizer

18. Ascendis Pharma Reports Results of TransCon Growth Hormone in P-III Height Study for Growth Hormone Deficiency (GHD) in Children

Published: 05 Mar,2019 |Tags: Ascendis Pharma, Reports, Results, TransCon Growth Hormone, P-III, Height, Study,Growth Hormone Deficiency, GHD, Children

19. Clovis Oncology Launches Rubraca (rucaparib) for Women with Relapsed Ovarian Cancer in Germany

Published: 05 Mar,2019 |Tags: Clovis Oncology, Launches, Rubraca, rucaparib, Women, Relapsed, Ovarian Cancer, Germany

20. Verastem Oncology Reports Results of Copiktra (Duvelisib) in P-III DUO Study in Patients with R/R CLL/SLL

Published: 05 Mar,2019 |Tags: Verastem Oncology, Reports, Results, Copiktra, Duvelisib, P-III, DUO, Study, Patients, R/R, CLL/SLL

21. Biogen to Acquire Nightstar Therapeutics for $800M

Published: 04 Mar,2019 | Tags: Biogen, Acquire, Nightstar Therapeutics, $800M, NSR-REP1, NSR-RPGR

22. Novartis Reports Results of Cosentyx (secukinumab) in P-III Study in Patients with Moderate to Severe Plaque Psoriasis in China

Published: 04 Mar,2019 | Tags: Novartis, Reports, Results, Cosentyx, secukinumab, P-III Study, Patients, Moderate, Severe, Plaque Psoriasis, China

23. Lupus Therapeutics Signs a Research Agreement with Takeda for its TAK-079

Published: 04 Mar,2019 |Tags: Lupus Therapeutics, Signs, Research, Agreement, Takeda, TAK-079

24. Sanofi’s Zynquista (sotagliflozin) and Dupixent (dupilumab) Receives CHMP Recommendation for Type 1 Diabetes and Asthma

Published: 04 Mar,2019 |Tags: Sanofi, Zynquista, sotagliflozin, Dupixent, dupilumab, Receives, CHMP, Recommendation, Type 1 Diabetes, Asthma