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

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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