PharmaShots Weekly Snapshot (February 04–08, 2019)


1.Galapagos Signs a Worldwide Development & Commercialization Agreement with Evotec for Fibrotic Diseases

Published: 7 Feb,2019 | Tags: Galapago, Signs, Worldwide, Development,Commercialization, Agreement, Evotec,Fibrotic Diseases

2.  Orthofix Medical’s M6-C Artificial Cervical Disc Receives FDA’s Approval for Cervical Disc Degeneration

Published: 7 Feb,2019 | Tags: Orthofix Medical, M6-C, Artificial Cervical Disc, Receives, FDA, Approval, Cervical Disc Degeneration

3. Genagon Signs a Worldwide License Agreement with Ligand for its Omniab Technology 

Published: 8 Feb,2019 | Tags: Genogon, Signs, Worlwide, License, Agreement, Ligand, Omniab, Technology

4. BioMarin Reports Results of Brineura (cerliponase alfa) for Patients with CLN2 Disease Aged 3 to 16 yrs.

Published: 8 Feb,2019 | Tags: BioMarin, Reports, Results, Brineura, cerliponase alfa, Study, CLN2 Disease, Children, 3yrs.

5. Medtronic’s Pipeline Flex Embolization Device Receives FDA’s Expanded Indication Approval for Intracranial Aneurysms (IAs)

Published: 8 Feb,2019 | Tags: Medtronic, Pipeline Flex Embolization, Device, Receives, FDA, Expanded, Indication, Approval, Intracranial Aneurysms, IAs

6. P&G to Acquire “This is L.” for its Feminine Care Products in the US

Published: 7 Feb,2019 | Tags: P&G, Acquire, This is L. , Feminine Care, Product, the US

7. AstraZeneca’s Fasenra Receives Orphan Drug Designation (ODD) For Hypereosinophilic Syndrome (HES)

Published: 7 Feb,2019 | Tags: AstraZeneca, Fasenra, Receives, Orphan Drug Designation,ODD,Hypereosinophilic Syndrome, HES

8. Recordati Licenses Exclusive Commercialization Rights of Juxtapid (lomitapide) from Aegerion Pharmaceuticals

Published: 7 Feb,2019 | Tags: Recordati, Licenses, Exclusive, Commercilization, Rights, Juxtapid, lomitapide, Aegerion Pharmaceuticals  

9. Paratek’s Reports Results of Nuzyra (Omadacycline) in P-III OPTIC and OASIS-1 Studies for Pneumonia and Skin Infections in Adults, Published in NEJM

Published: 7 Feb,2019 | Tags: Paratek, Reports, Results, Nuzyra, Omadacycline, P-III, OPTIC, OASIS-1, Studies, Pneumonia, Skin Infections, Adults, Published, NEJ

10. Sanofi’s Cablivi (caplacizumab-yhdp) Receives FDA’s Approval for Acquired Thrombotic Thrombocytopenic Purpura (aTTP) in Adults

Published: 6 Feb,2019 | Tags:  Sanofi, Cablivi, caplacizumab-yhdp, Receives, FDA, Approval, Acquired Thrombotic Thrombocytopenic Purpura, aTTP, Adults

11. GSK Signs a Worldwide Development & Commercialization Collaboration with Merck KGaA, for $4.2B

Published: 5 Feb,2019 | Tags: GSK, Signs, Worldwide, Development, Commercialization, Collaboration, Merck KGaA, $4.2B

12. Sanofi Report Results of Isatuximab in P-III ICARIA-MM Study for Patients with Relapsed/Refractory Multiple Myeloma (MM)

Published: 6 Feb,2019 | Tags: Sanofi, Report, Results, Isatuximab, P-III, ICARIA-MM study, Relapsed/Refractory, Multiple Myeloma, MM

13. Merck Reports Acceptance of NDA from FDA for Its (Imipenem/Cilastatin) + (Relebactam) for Complicated Urinary Tract and Intra-Abdominal Infections in Adults

Published: 6 Feb,2019 | Tags: Merck, Reports, Acceptance, NDA, FDA, Imipenem/Cilastatin, Relebactam, Complicated, Urinary Tract, Intra-Abdominal, Infections, Adults

14. Kyowa Kirin Signs an Exclusive Commercialization Agreement with Hisamitsu for its HP-3000

Published: 6 Feb,2019 | Tags: Kyowa Kirin, Signs, Exclusive, Commercialization, Agreement, Hisamitsu, HP-300

15. Genentech Signs a Development and Commercialization Agreement with Xencor for its IL-15 & XmAb24306 Programs

Published: 6 Feb,2019 |Tags: Genentech, Signs, Development, Commercialization, Agreement, Xencor, IL-15, XmAb24306 Programs

16. AstraZeneca’s MEDI8897 Receives FDA’s Breakthrough Therapy Designation (BTD) & EMA’s PRIME Designation for Lower Respiratory Tract Infection (LRTI) in Infants

Published: 6 Feb,2019 |Tags: AstraZeneca, MEDI8897, Receives, FDA, Breakthrough Therapy Designation, BTD, EMA, PRIME Designation, Lower Respiratory Tract Infection, LRTI, Infants

17. Eisai and Purdue Report Result of Lemborexant in P-III SUNRISE 2 Study for Insomnia in Adults

Published: 6 Feb,2019 |Tags: Eisai, Purdue, Report, Result, Lemborexant, P-III, SUNRISE 2 Study, Insomnia, Adults

18. BioLineRX’s BL-8040 Receives FDA’s Orphan Drug Designation (ODD) for Pancreatic Cancer

Published: 4 Feb,2019 |Tags: BioLineRX, BL-8040, Receives, FDA, Orphan Drug Designation, ODD, Pancreatic Cancer

19. Eli Lilly Reports Results of Olumiant (baricitinib) in P-III BREEZE-AD1 and BREEZE-AD2 study for Moderate-to-Severe Atopic Dermatitis (AD)

Published: 4 Feb,2019 |Tags: Eli Lilly, Reports, Results, Olumiant, baricitinib, P-III, BREEZE-AD1, BREEZE-AD2, study, Moderate, Severe Atopic Dermatitis, AD

20. Argenx Signs a Worldwide License Agreement with Halozyme for its ENHANZE Technology

Published: 5 Feb,2019 |Tags: Argenx, Signs, Worldwide, License, Agreement, Halozyme, ENHANZE Technology

21. Merck’s KEYTRUDA (pembrolizumab) Receives CHMP Recommendation for 1L Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

Published: 4 Feb,2019 |Tags: Merck, Keytruda, pembrolizumab, Receives, CHMP, Recommendation, 1L, Metastatic, Squamous, Non-Small Cell Lung Cancer,NSCLC

22. Novartis’ Kymriah Receives NICE Approval for R/R Diffuse Large B-cell lymphoma (DLBCL) in Adults

Published: 4 Feb,2019 |Tags: Novartis, Kymriah, Receives, NICE, Approval, R/R, Diffuse Large B-cell Lymphoma, DLBCL, Adults

23. Evolus’ Jeuveau (prabotulinumtoxinA-xvfs) Receives FDA Approval for Moderate-to-Severe Glabellar Lines in Adults

Published: 4 Feb,2019 |Tags: Evolus, Jeuveau, prabotulinumtoxinA-xvfs, Receives, FDA Approval, Moderate-to-Severe, Glabellar Lines, Adults

24. Roche Recalls Lots of Coaguchek Xs Pt Test Strips with FDA’s Class I Warning  

Published: 4 Feb,2019 |Tags: Roche, Recalls, Lots, Coaguchek Xs Pt Test Strips, FDA, Class I, Warning

Shiwani Sharma

Shiwani Sharma is a Senior Editor at PharmaShots. She has in-depth knowledge of lifesciences industry including pharma and biotech sectors. She also covers news in field of Digital Health, Medtech and regulatory approvals from the US FDA, EU, and other global regulatory bodies in the industry. Additionally, she also writes Whitepapers, analysis reports, blogs on pharma and biotech industry. She is graduate in Biotechnology. She can be contacted on shiwani@pharmashots.com

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