#ArQule announced preclinical data demonstrating the potential for #miransertib (ARQ 092), it’s pan-AKT inhibitor, to treat #PIK3CA driven vascular malformations ( #VMs) in a poster at the 2019 American Society of Human Genetics A…lnkd.in/f3SyT94 lnkd.in/fXwtq8A

#Talaris Therapeutics announced the initiation of FREEDOM-1, the company’s Phase 3 clinical trial of #FCR001 in #living #donor #kidney #transplant ( #LDKT) recipients. This pivotal trial will evaluate the safety and efficacy of a s…lnkd.in/fE7wBFq lnkd.in/fXwtq8A

#Takeda Pharmaceutical further bolstered its pipeline in one of its key therapeutic areas, gastroenterology, by acquiring an exclusive global license to develop and commercialize #COUR Pharmaceutical Development’s mid-stage candida…lnkd.in/fdkdGAW lnkd.in/fXwtq8A

#BMS announced that #CheckMate -9LA, a pivotal Phase 3 trial evaluating #Opdivo ( #nivolumab) plus low-dose #Yervoy ( #ipilimumab) given concomitantly with two cycles of chemotherapy for the first-line treatment of advanced non-s…lnkd.in/fuvCk6Y lnkd.in/fXwtq8A

Bridge R&D soon launching new data intelligence tool by Global Pharma/Biotech Company, Drug, Clinical Trials, Technology, Companion Diagnostics, Biomarkers, Patents, Sales, Contacts and many more...

Bridge R&D FDA 2019 Blockbuster drug approvals, For more details please email, [email protected]

Sosei has been notified by its strategic alliance partner hashtag Pfizer that it has dosed the first subject in a clinical trial with a new drug candidate nominated from the multi-target drug discovery collaboration between the two companies.

#FibroGen announced the submission of a NDA to the U.S. FDA for #roxadustat for the treatment of #anemia of chronic kidney disease ( #CKD), in both non-dialysis-dependent (#ND#ND#NDD) and #dialysis- #dependent (DD) CKD patients. lnkd.in/fNxbwFb

#Akari Therapeutics announces that a U.S. FDA investigational new drug application ( #IND) is open for its multicenter Phase III study for the treatment of Pediatric Hematopoietic Stem Cell Transplant-Related #Thrombotic #Microa…lnkd.in/fJPW3rb lnkd.in/fNxbwFb

#Progenics Pharmaceuticals announced positive top line results from the Phase 3 #CONDOR trial evaluating the diagnostic performance and clinical impact of #PyL™ (18F-DCFPyL) in men with biochemical recurrence of #prostate cance…lnkd.in/fbY4fv2 lnkd.in/fNxbwFb

Welcome 2020!!! Time for 2019 Analysis by New Drug Approvals, M&A's and others.... Here is Bridge R&D Insights' upcoming 2016 - 2019 #Mergers & #Acquisitions (M&A's) Activity Analysis Please reach us for more details, Email:…lnkd.in/f_bngSR

#DURECT Corporation announced the results from its Phase 2a clinical trial of DUR-928 in patients with mild to moderate #plaque #psoriasis. Twenty-two patients completed the study, applying DUR-928 topically to the plaque on one ar…lnkd.in/f_7EjbQ lnkd.in/fNxbwFb

#Orphazyme A/S announces 12-month interim data from an open-label extension of a phase 2/3 study of #arimoclomol, an investigational product candidate in development for Niemann-Pick disease Type C ( #NPC). #NiemannPickdiseaseType C

I-Mab Biopharma announced the dosing of the first patient in mainland China in its #registrational study evaluating its human CD38 antibody ( #TJ202 / #MOR202) in patients with #relapsed or #refractory #multiple #myeloma (MM). #Phase2 #Imabbiopharma lnkd.in/fNxbwFb

Top Analysis on US #FDA 2019 First #Drug #Approvals, including Innovators ( #CDER / #CBER), #Biosimilars and #Generics... For complete analysis, please email: [email protected] lnkd.in/f_Zs-j6

Bridge R&D Insights' 2019 #EU First #Drug Approvals Analysis, For more information, please email [email protected] lnkd.in/fuKjU9B

Bridge R&D Insights' Authorized Generics Launches Analysis During 2015 -2019: - Authorized generic drugs (AGs) are introduced to the market with NDA Applicant and Generic companies agreements - Majority of the AGs are due to Patent Invalidation filings f…lnkd.in/f4WAT4V

January 2020 - US #FDA & #EMEA First #Innovator New #Drug #Approvals lnkd.in/f6SmBw4

Bridge R&D analysis on Regulatory Designations versus Likelihood of Approval: On an average, first drug approvals are with regulatory designations from US FDA, EMEA and PMDA stands 38%, 22% and 12% out of total first drug approvals in a year. Pipeline d…lnkd.in/fg5-AdQ

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