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CP Wire Articles

Merck Announces Data from Ph III Study of Investigational HIV Therapy Doravirine
  • At Week 96, 73.1 percent of the treatment group achieved viral suppression
  • Previously reported - at week 48 DOR met its primary efficacy endpoint of non-inferiority compared to DRV+r... read more
Tue, 07/24/18 - 09:55 am
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Gilead Announces Data on Truvada for HIV Prophylaxis
  • States with highest use of Truvada for PrEP had significant declines in HIV diagnoses
  • States with the lowest use saw increases in HIV diagnoses
  • Truvada was approved for HIV... read more
Tue, 07/24/18 - 09:43 am
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Microbiome Report for the week ending 7-21-18

SkinBioTherapeutics receives provisional... read more

Mon, 07/23/18 - 04:49 pm
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[sponsored] How to Use Speaker Book's Filters to Track Financial Disclosures

Speaker Book is an application that provides a network of doctors’ financials payments from pharmaceutical companies. In this tutorial, we will be demonstrating how to understand and navigate the... read more

Mon, 07/23/18 - 04:38 pm
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Immunicum AB Announces FDA Approval to Expand Ph Ib/II trial of Cancer Drug
  • Ph II study will include up to 150 patients
  • The study will include testing in head and neck cancer, non-small cell lung cancer and gastric and gastroesophageal junction... read more
Mon, 07/23/18 - 09:57 am
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Alnylam Presents Ph III results of Patisiran in Hereditary ATTR (hATTR) Amyloidosis
  • Changes in familial amyloid polyneuropathy and polyneuropathy disability were significant
  • Earlier indirect comparison of patisiran vs rival indicated patisiran superiority
    • ... read more
Mon, 07/23/18 - 09:40 am
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PureTech Receives Up To $36 Million from Roche to Develop Oral Delivery of Antisense Oligonucleotides
  • Puretech will be eligible to receive payments over $1 billion
  • The company has 11 products under development with affiliates
  • PureTech is focused on developing therapies based... read more
Fri, 07/20/18 - 09:43 am
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Sage Bionetworks Launches Platform to Crowdsource the Evaluation of Curated Alzheimer’s Disease Genomic Analysis



Sage Bionetworks on 7/20/18 announced the launch of the Agora platform (agora.ampadportal.org) an interactive, web-based tool that allows researchers to explore curated genomic analyses of... read more

Fri, 07/20/18 - 09:25 am
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FDA to Consider Foreign Drug Importation When Lack of Competition or Supply Problems Threaten Access

The FDA is forming a work group to consider situations under which the FDA would allow the importation of drugs that would be suitable substitutes for the FDA-approved version of medically-... read more

Thu, 07/19/18 - 12:18 pm
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Takeda Drug Achieves Primary Endpoint of Clinical Remission in Moderately to Severely Active Ulcerative Colitis
  • A statistically significant proportion of patients achieved clinical remission at week 52 compared to placebo
  • Vedolizumab is a humanized monoclonal antibody specifically designed to... read more
Thu, 07/19/18 - 10:07 am
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Bristol-Myers Squibb and Gritstone Oncology Announce Collaboration to Evaluate Novel Immunotherapy Approach in Advanced Solid Tumors



Bristol-Myers Squibb Company (NYSE: BMY) and Gritstone Oncology today announced that the companies have entered into a clinical trial collaboration to evaluate the safety and tolerability... read more

Thu, 07/19/18 - 09:44 am
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Trajenta Meets Primary Endpoint in Cardiovascular Trial
  • Trajenta demonstrated cardiovascular safety in adults with type 2 diabetes and high vascular risk, with no need for dose adjustments regardless of kidney function
  • The study included... read more
Thu, 07/19/18 - 09:31 am
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FDA Approves First Cancer Drug Under New Real Time Review Program
  • Kisqali approved under Real Time Oncology Review Program
  • One of two new programs intended to make the development of cancer drugs more effecient
  • Approval came less than one... read more
Wed, 07/18/18 - 01:20 pm
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Cellectar Reports 33% Overall Response Rate in Phase 2 Interim Data for CLR 131 in Relapsed/Refractory DLBCL Patients
  • Observed responses to date show overall tumor reduction ranged from 60% to greater than 90%
  • Company is expanding trial cohort up to 30 additional patients
  • CLR 131 has orphan... read more
Wed, 07/18/18 - 09:58 am
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Takeda and Ovid Therapeutics Expand Clinical Program for TAK-935/OV935 with New Studies in Rare Developmental and Epileptic Encephalopathies (DEE)
  • TAK-935/OV935 is a first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase
  • TAK-935/OV935 may potentially treat rare epilepsies by inhibiting CH24H to decrease 24HC levels... read more
Wed, 07/18/18 - 09:43 am
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FDA Grants Priority Review and accepts BLA for Sacituzumab Govitecan for the Treatment of Metastatic Triple-negative Breast Cancer
  • PDUFA target date is 1/18/19
  • Sacituzumab govitecan is an antibody drug conjugate (ADC)
  • If appproved it would be the first ADC approved for mTNBC
  • Company has another... read more
Wed, 07/18/18 - 09:27 am
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[sponsored] Speaker Book - The App That Exposes Conflicts of Interest in the Pharmaceutical Industry

SPEAKER BOOK APP is the platform where patients advocates, doctors, and biotech investors can look at conflicts of interest in Pharma to understand what is going on under the surface of... read more

Tue, 07/17/18 - 03:25 pm
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FDA Taking Steps to Empower Consumers' Use of Nonprescription Drugs


FDA commissioner, Scott Gottleib, released a statement on 7/17/18 discussing new draft guidance related... read more

Tue, 07/17/18 - 10:18 am
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Inozyme Pharma Receives Orphan Drug Designation for INZ-701 in the United States and European Union
  • Company received $49 million dollar funding round in November of 2017
  • INZ-701 received Orphan Drug Designation in both US and Europe

Inozyme Pharma (Inozyme) announced... read more

Tue, 07/17/18 - 09:41 am
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Microbiome report week ending 7-14-18

Tue, 07/17/18 - 09:35 am
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