Q4 2016 Outlook Report
Q4 2016 Outlook Report
$750.00
In this report, we cover catalysts from 23 drugs, devices and diagnostics expected to occur in Q4 2016. We have also included a list of Large Impact catalysts in the drug and device/diagnostic areas through Q4 2016.
Publisher: Biomedtracker
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| In this report, we cover catalysts from 23 drugs, devices and diagnostics expected to occur in Q4 2016. We have also included a list of Large Impact catalysts in the drug and device/diagnostic areas through Q4 2016. In addition, each drug’s likelihood of Phase/PDUFA review success and overall Likelihood of Approval (LOA) given their particular phase, drug class, and disease group are provided.
Our Q3 2016 Outlook Report highlighted several high-impact catalysts. The results of these catalysts can be found on Page 5 of this report. Biomedtracker Likelihood of Approval (LOA) opinions successfully predicted 46% of catalyst outcomes that occurred in Q3 2016. Additionally, the catalyst calendars are provided in Excel by downloading the supplemental material above.
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Table of Contents (Download support material included)
Outcomes of Biomedtracker’s Large Impact Catalysts from the Q3 2016 Outlook Report ……………………… 5
Drugs …………………………………………………………………………………………………………………………………………. 6
Solanezumab for Alzheimer’s Disease (AD) (LLY) …………………………………………………………………………… 6
Opdivo for Bladder Cancer (BMY) ………………………………………………………………………………………………. 6
Solithera for Community Acquired Pneumonia (CAP) (Antibacterial) (CEMP) ……………………………………. 7
RHB-104 for Crohn’s Disease (RDHL) …………………………………………………………………………………………… 8
Jardiance for Diabetes Mellitus, Type II (Boehringer Ingelheim) ……………………………………………………… 8
LixiLan for Diabetes Mellitus, Type II (SNY)…………………………………………………………………………………. 10
Xultophy for Diabetes Mellitus, Type II (NVO) …………………………………………………………………………….. 10 ALN-PCSsc for Dyslipidemia/Hypercholesterolemia (MDCO) ………………………………………………………… 11 Actimmune for Friedreich’s Ataxia (HZNP) …………………………………………………………………………………. 12 Tenofovir alafenamide fumarate for Hepatitis B (HBV) Treatment (Antiviral) (GILD) ………………………… 13 Heplisav for Hepatitis B Prevention (Vaccines, Antiviral) (DVAX) …………………………………………………… 14 Fostamatinib for Immune Thrombocytopenic Purpura (ITP) (RIGL) ……………………………………………….. 14 Plecanatide for Irritable Bowel Syndrome (IBS) (SGYP) ………………………………………………………………… 15 Ampyra for Ischemic Stroke (ACOR) ………………………………………………………………………………………….. 16
Ocrevus for Multiple Sclerosis (MS) (RHHBF) ……………………………………………………………………………… 18
Lutathera for Neuroendocrine Tumors (NET) (AAAP) ………………………………………………………………….. 18
Glesatinib for Non-Small Cell Lung Cancer (NSCLC) (MRTX) ………………………………………………………….. 19
Sarilumab for Rheumatoid Arthritis (RA) (REGN) ………………………………………………………………………… 20
Devices & Diagnostics …………………………………………………………………………………………………………………. 21
Nanostim for Bradycardia/Conduction defects/Ventricular dyssynchrony (STJ) ………………………………. 21 HeartMate 3 for Congestive Heart Failure (CHF) and Cardiomyopathies (STJ) ………………………………… 22 t:slim X2 Slim Insulin Pump for Diabetes Mellitus, Type I/II (TNDM) ………………………………………………. 22 SENTINEL Cerebral Protection System for Embolic Stroke Prevention (Claret) ………………………………… 23
Lutonix 035 DCB PTA Catheter for Peripheral Arterial Disease (PAD) (BCR) …………………………………….. 24
Q4 2016 Large Impact Drug/Device Catalysts………………..…………………………………………………………………………25
Figure: Solanezumab for Alzheimer’s disease (AD) (LLY)
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