PharmaShots Weekly Snapshot (December 02-06, 2019)

1.  Sage Therapeutics Reports Results of SAGE-217 in P-III MOUNTAIN Study for Major Depressive Disorders

Published: Dec 05, 2019 | Tags: Sage Therapeutics, Reports, Results, SAGE-217, P-III, MOUNTAIN Study, Major Depressive Disorders

 2. UCB Reports Results of Bimekizumab in P-III BE SURE Study for Moderate-To-Severe Chronic Plaque Psoriasis

Published: Dec 06, 2019 | Tags: UCB, Reports, Results, Bimekizumab, P-III, BE SURE, Study, Moderate-To-Severe, Chronic Plaque Psoriasis

3.  Bio-Thera Reports NMPA’s Acceptance of IND for BAT2206 Proposed Biosimilar of Stelara (ustekinumab)

Published: Dec 04, 2019 | Tags: Bio-Thera, Reports, NMPA, Acceptance, IND, BAT2206, Proposed Biosimilar, Stelara, Ustekinumab

4.  Bayer And Simulations Plus Collaborate to Advance ADMET Predictor for Improving Data Integrity in Drug Discovery

Published: Dec 05, 2019 | Tags: Bayer, Simulations Plus, Collaborate, Advance, ADMET Predictor, Data Integrity, Drug Discovery

5. Y-mAbs Reports EMA’s Acceptance of Pediatric Investigation Plan for Omburtamab

Published: Dec 05, 2019 | Tags: Y-mAbs, EMA, Approval, Pediatric Investigation Plan, Omburtamab

6.  Novartis Reports Results of QMF149 in P-III PALLADIUM Study for Patients with Uncontrolled Asthma

Published: Dec 06, 2019 | Tags: Novartis, Reports Results, QMF149, P-III, PALLADIUM Study, Uncontrolled Asthma

7. FDA and NIH Launch CURE ID Crowdsourcing App for Patients with Infectious Diseases

Published: Dec 05, 2019 | Tags: FDA, NIH, Launch, CURE ID, Crowdsourcing App, Infectious Diseases

8. Cerecor to Acquire Aevi Genomic Medicine for ~$22.6M

Published:  Dec 05, 2019 | Tags: Cerecor, Acquire, Aevi Genomic Medicine, $22.6M

9. AstraZeneca Signs an Agreement with Gatehouse Bio to Identify New Therapies Targeting Respiratory and Cardiovascular Diseases

Published: Dec 04, 2019 | Tags: AstraZeneca, Signs, Agreement, Gatehouse Bio, Identify, New Therapies, Targeting, Respiratory, Cardiovascular Diseases

10. Bayer Collaborates with Children’s Hospital of Philadelphia to Develop Oral Non-Replacement Therapy for the Treatment of Hemophilia

Published: Dec 05, 2019 | Tags: Bayer, Collaborates, CHOP, Develop, Oral Non-Replacement Therapy, Hemophilia A and B

11.  Philips Collaborates with Humana to Deliver Remote Monitoring Capabilities to Select Medicare Advantage Members

Published: Dec 04, 2019 | Tags: Philips, Collaborates, Humana, Deliver, Remote, Monitoring Capabilities, Medicare Advantage Members

12.  AstraZeneca and MSD’s Lynparza (olaparib) Receive NMPA’s Approval as 1L Maintenance Therapy for BRCA-Mutated Advanced Ovarian Cancer

Published: Dec 05, 2019 | Tags: AstraZeneca, MSD, Lynparza, olaparib, Receive, NMPA, Approval, 1L, Maintenance Therapy, BRCA-Mutated Advanced Ovarian Cancer

13. Takeda Collaborates with Enzyre to Develop Diagnostic Device to Regulate Coagulation Status in Patients with Hemophilia at Home

Published: Dec 05, 2019 | Tags: Takeda, Collaborates, Enzyre, Develop, Diagnostic Device, Regulate, Coagulation Status, Patients, Hemophilia, Home

14.  Novartis Highlights its Blockbuster Portfolio at R&D Day 2019

Published: Dec 05, 2019 | Tags: Novartis, Highlights, Blockbuster Pipeline, 25+, Products, R&D Day 2019

15. Novartis Collaborates with Amazon to Leverage Cloud Services for its Business Operations

Published: Dec 04, 2019 | Tags: Novartis, Collaborates, Amazon, Leverage, Cloud Services, Business Operations

16. Lannett Reports Results of Biosimilar Insulin Glargine in Human Clinical Study to Treat Patients with Type 2 Diabetes

Published: Dec 04, 2019 | Tags:  Lannett, Reports, Results, Biosimilar Insulin Glargine, Human Clinical Study, Treat, Patients, Type 2 Diabetes

17. LEO Pharma Collaborates with Portal Instruments to Develop Needle-Free Drug Delivery Device

Published: Dec 04, 2019 | Tags: LEO Pharma, Collaborate, Portal Instruments, Develop, Needle-Free Drug Delivery Device

18. BMS’ Orencia (abatacept) Receive the FDA’s Breakthrough Therapy Designation to Prevent Acute Graft-Versus-Host Disease After Stem Cell Transplant

Published: Dec 04, 2019 | Tags: Myovant Sciences, Reports, Results, Relugolix, P-III, HERO Study, Men, Advanced Prostate Cancer

19.  Eris Lifesciences Acquires Novartis’ Zomelis (vildagliptin) in India for $13M

Published: Dec 03, 2019 | Tags: Eris Lifesciences, Acquires, Novartis, Zomelis, vildagliptin, India, $13M

20.  Veracyte Signs an Exclusive License Agreement with NanoString for its nCounter FLEX System

Published: Dec 03, 2019 | Tags: Veracyte, Signs, Exclusive, License, Agreement, NanoString, nCounter FLEX System

21. Johnson & Johnson Vision Launches TECNIS Toric II 1-Piece IOL as a New Monofocal Option for Cataract Patients with Astigmatism in the US

Published: Dec 03, 2019 | Tags: Johnson N Johnson Vision, Launches, TECNIS Toric II 1-Piece IOL, New Monofocal Option, Cataract Patients, Astigmatism, US

22.  Roche’s Tecentriq + CT (abraxane and carboplatin) Receive the US FDA’s Approval for the Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer

Published: Dec 04, 2019 | Tags: Roche, Tecentriq, CT, abraxane, carboplatin, Receive, US, FDA, Approval, Treatment, Metastatic Non-Squamous Non-Small Cell Lung Cancer

23.  Merck KGaA and Ping An Good Doctor Collaborate to Support Health Management in China

Published: Dec 04, 2019 | Tags: Merck, Ping An Good Doctor, Collaborate, Support, Health Management, China

24.  Ethicon Launches VISTASEAL Fibrin Sealant (Human) for Sealing Off Bleeds During Surgery

Published: Dec 03, 2019 | Tags:  Ethicon, Launches, VISTASEAL Fibrin Sealant (Human), Sealing Off, Bleeds, Surgery

25.  StemoniX Collaborates with Atomwise to Form a Joint Venture Targeting Rett Syndrome

Published: Dec 03, 2019 | Tags: StemoniX, Collaborates, Atomwise, Joint Venture, Targeting, Rett Syndrome

26. Kamada Collaborates with Alvotech to Commercialize its Six Biosimilar Products in Israel

Published: Dec 02, 2019 | Tags: Kamada, Collaborates, Alvotech, Commercialize, Six, Biosimilar, Products, Israel

27. GE Healthcare Signs an Agreement with Affidea to Deploy Digital Imaging Technologies

Published: Dec 02, 2019 | Tags: GE Healthcare, Signs, Agreement, Affidea, Deploy, Digital Imaging Technologies

28. Seattle Genetics and Astellas Collaborate with Merck to Evaluate Enfortumab Vedotin + Keytruda (pembrolizumab) for Metastatic Urothelial Cancer

Published: Dec 02, 2019 | Tags: Seattle Genetics, Astellas, Collaborate, Merck, Evaluate, Enfortumab Vedotin, Keytruda, pembrolizumab, Metastatic Urothelial Cancer

29.  Gene Techno Science Signs an Agreement with Kishi Kasei to Co-Develop Biosimilar of Aflibercept

Published: Dec 03, 2019 | Tags: Gene Techno Science, Signs, Agreement, Kishi Kasei, Co-Develop, Biosimilar, Aflibercept

30. AstraZeneca Divests Commercial Rights of Seroquel and Seroquel XR to Cheplapharm in the US and Canada

Published: Dec 03, 2019 | Tags: AstraZeneca, Divests, Commercial Rights, Seroquel, Seroquel XR, Cheplapharm, US, Canada

 31. STADA to Acquire Biopharma’s Pharmaceutical Prescription and Consumer Health Business to Expand Its Footprint in Ukraine

Published: Dec 02, 2019 | Tags: STADA, Acquire, Biopharma, Pharmaceutical Prescription, Consumer Health Business, Expand, Presence, Ukraine

32. Astellas to Acquire Audentes Therapeutics for $3B

Published: Dec 02, 2019 | Tags: Astellas, Acquire, Audentes Therapeutics, $3B

33. Baxter to Acquire Seprafilm Adhesion Barriers from Sanofi for $350M

Published: Dec 02, 2019 | Tags: Baxter, Expand, Advanced, Surgery Portfolio, Acquisition, Seprafilm Adhesion Barrier

34. Neurocrine Signs a License Agreement with Xenon to Develop Therapies for Epilepsy

Published: Dec 02, 2019 | Tags: Neurocrine Biosciences, Xenon Pharmaceuticals, Agreement, Develop, Epilepsy

35. Mylan and Biocon Launch Ogivri (biosimilar, trastuzumab) in the US

Published: Dec 02, 2019 | Tags: Mylan, Biocon, Launch, Trastuzumab, Biosimilar, Ogivri, trastuzumab-dkst, US

36. Merck’s Keytruda (pembrolizumab) Receives FDA’s Priority Review for sBLA to Treat High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC)

Published: Dec 02, 2019 | Tags: FDA, Priority Review, Merck,  sBLA, KEYTRUDA, pembrolizumab, High-Risk, Non-Muscle Invasive Bladder Cancer, NMIBC

38. Chipscreen Bioscience’s Epidaza (chidamide) Receives NMPA Approval for Breast Cancer Indication

Published: Nov 29, 2019 | Tags: Chipscreen Bioscience, Chidamide, Epidaza, Breast Cancer Indication, Receives

39. Fosun Pharma’s FN-1501 Receives the US FDA’s Orphan Drug Designation for Leukemia

Published: Dec 02, 2019 | Tags: Fosun Pharma, Leukemia, FN-1501, Receives, FDA, Orphan Drug Designation

40. Y-mAbs Reports Initiation of Rolling Review of BLA for Naxitamab to the US FDA to Treat Neuroblastoma

Published: Nov 29, 2019 s| Tags: Y-mAbs, Initiates, Rolling, BLA, US, FDA, Naxitamab, Neuroblastoma

41. Roche Reports Results of Satralizumab in P-III SAkuraSky Study to Treat Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD)

Published: Dec 02, 2019 | Tags: Roche, Satralizumab, neuromyelitis optica spectrum disorder, P-III, SAkuraSky Study