Q4 2016 Outlook Report – Cover Catalysts from 23 Drugs, Devices and Diagnostics

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.

Indications Covered

  • Alzheimer’s Disease (AD)
  • Bladder Cancer
  • Community Acquired Pneumonia (CAP) (Antibacterial)
  • Congestive Heart Failure (CHF) and Cardiomyopathies
  • Crohn’s Disease
  • Diabetes Mellitus, Type I
  • Diabetes Mellitus, Type II
  • Dyslipidemia / Hypercholesterolemia
  • Friedreich’s Ataxia
  • Hepatitis B (HBV) Treatment (Antiviral)
  • Hepatitis B Prevention (Vaccines, Antiviral)
  • Immune Thrombocytopenic Purpura (ITP)
  • Irritable Bowel Syndrome (IBS)
  • Ischemic Stroke
  • Moderate to Severe Pain
  • Multiple Sclerosis (MS)
  • Neuroendocrine Tumors (NET)
  • Non-Small Cell Lung Cancer (NSCLC)
  • Peripheral Arterial Disease (PAD)
  • Rheumatoid Arthritis (RA)

Table of Contents

  • Outcomes of Biomedtracker’s Large Impact Catalysts from the Q3 2016 Outlook
  • Report
  • Drugs
  • Solanezumab for Alzheimer’s Disease (AD) (LLY)
  • Opdivo for Bladder Cancer (BMY)
  • Solithera for Community Acquired Pneumonia (CAP) (Antibacterial) (CEMP)
  • RHB-104 for Crohn’s Disease (RDHL)
  • Jardiance for Diabetes Mellitus, Type II (Boehringer Ingelheim)
  • LixiLan for Diabetes Mellitus, Type II (SNY)
  • Xultophy for Diabetes Mellitus, Type II (NVO)
  • ALN-PCSsc for Dyslipidemia/Hypercholesterolemia (MDCO)
  • Actimmune for Friedreich’s Ataxia (HZNP)
  • Tenofovir alafenamide fumarate for Hepatitis B (HBV) Treatment (Antiviral) (GILD)
  • Heplisav for Hepatitis B Prevention (Vaccines, Antiviral) (DVAX)
  • Fostamatinib for Immune Thrombocytopenic Purpura (ITP) (RIGL)
  • Plecanatide for Irritable Bowel Syndrome (IBS) (SGYP)
  • Ampyra for Ischemic Stroke (ACOR)
  • Ocrevus for Multiple Sclerosis (MS) (RHHBF)
  • Lutathera for Neuroendocrine Tumors (NET) (AAAP)
  • Glesatinib for Non-Small Cell Lung Cancer (NSCLC) (MRTX)
  • Sarilumab for Rheumatoid Arthritis (RA) (REGN)
  • Devices & Diagnostics
  • Nanostim for Bradycardia/Conduction defects/Ventricular dyssynchrony (STJ)
  • HeartMate 3 for Congestive Heart Failure (CHF) and Cardiomyopathies (STJ) – t:slim X2
  • Slim Insulin Pump for Diabetes Mellitus, Type I/II (TNDM)
  • SENTINEL Cerebral Protection System for Embolic Stroke Prevention (Claret)
  • Lutonix 035 DCB PTA Catheter for Peripheral Arterial Disease (PAD) (BCR)
  • Q4 2016 Large Impact Drug/Device Catalysts

 

Q7.jpg

Figure: Solanezumab for Alzheimer’s disease (AD) (LLY)

Published: 05/10/2016
Number of Pages: 30
Formats: PDF, XLSX
Price: $750

To Procure or for More Info, Please Contact Us

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