Eye on FDA
JULY 29, 2021
In the face of a crisis situation, it is a given that the clarity and thoroughness of the communications response is key to resolving the issue and mitigating any reputational damage. Perhaps no other decision by the Food and Drug Administration has garnered as much controversy, as the recent one to authorize the accelerated approval a new treatment for Alzheimer’s.
Drug Patent Watch
JULY 16, 2021
Come join me and Wendi Lau from Abbvie as we participate in an interactive roundtable discussion on pharmaceutical portfolio management. We’ll be sharing our expertise and best practices for strategic…. The post DrugPatentWatch and Abbvie discuss Pharmaceutical Portfolio Management appeared first on DrugPatentWatch - Make Better Decisions.
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Drug Discovery Today
JULY 7, 2021
Cambridge Cognition spin-out targets schizophrenia and post-operative cognitive dysfunction
Drug Channels
JULY 30, 2021
Today’s guest post comes from David Holladay, President of Access and Adherence at CoverMyMeds. David discusses how common medication access, adherence, and affordability barriers can lead patients to abandon important therapies. He suggests that technology can connect providers with actionable information at the point of care, thereby giving patients access to data that can lead them to make better decisions.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
The Pharma Data
JULY 29, 2021
econd Quarter 2021 Product Sales Increased 21% Year-Over-Year Primarily Driven by Veklury. Biktarvy Sales Increased 24% Year-Over-Year. Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the second quarter 2021. “We maintained our positive momentum in the second quarter, with both a solid financial performance and strong progress across our increasingly diverse portfolio.
Olympian Clinical Research
JULY 29, 2021
If you suffer from chronic migraines and headaches, you know that the symptoms are no joke. While migraines are primarily known for affecting adults, about 30% of teens (and children) suffer from them as well. Migraines differ from headaches in that they are much more severe, and often accompanied by other symptoms such as nausea, head throbbing, light sensitivity, and more.
Drug Discovery Digest brings together the best content for drug research and development professionals from the widest variety of industry thought leaders.
Drug Patent Watch
JULY 22, 2021
Annual Drug Patent Expirations for LENVIMA Lenvima is a drug marketed by Eisai Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph…. The post New patent for Eisai Inc drug LENVIMA appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery Today
JULY 8, 2021
The topic of this month’s newsletter from Drug Discovery Today is “Cardiovascular Drugs”.
Drug Channels
JULY 27, 2021
Let’s cut through the summer haze with our refreshing breeze of articles and insights. In this issue: The top 10 stingiest hospitals Medicare Part B's savings from biosimilars What happened to hepatitis C drug costs and rebates? Costco beats Medicare Part D Plus, math madness with Duke’s Fuqua business school. P.S. Please join the more than 12,000 consumers of my daily commentary and links to neat stuff at @DrugChannels on Twitter.
The Pharma Data
JULY 29, 2021
Second-Quarter 2021 Revenues of $19.0 Billion, Reflecting 86% Operational Growth; Excluding BNT162b2(1) , Revenues Grew 10% Operationally to $11.1 Billion The 10% Operational Growth Excluding BNT162b2(1) in Second-Quarter 2021 Builds on the 6% Operational Growth Delivered by the Comparable Business in Second-Quarter 2020 Second-Quarter 2021 Reported Diluted EPS(2) of $0.98, Adjusted Diluted EPS(3) of $1.07 Raises Full-Year 2021 Guidance(4) for Revenues to a Range of $78.0 to $80.0 Billion and Ad
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
The ChEMBL-og
JULY 26, 2021
As mentioned in the announcement post of ChEMBL 29 , a new Drug Warnings Browser has been created. This is an updated version of the entity browsers in ChEMBL ( Compounds , Targets , Activities , etc). It contains new features that will be tried out with the Drug Warnings and will be applied to the other entities gradually. The new features of the Drug Warnings Browser are described below.
Pharmaceutical Development Group
JULY 22, 2021
Introduction Food and Drug Administration is a government entity in the United States whose objective is to protect the public by verifying that nutritional supplements are safe to use and accurately labelled. Businesses can even use the FDA Pre-submission to get feedback on possible and planned medical advice, biologics and medication submission. It’s a fantastic service to use, but we have noticed that it’s often overlooked.
Drug Patent Watch
JULY 21, 2021
Annual Drug Patent Expirations for GOCOVRI Gocovri is a drug marketed by Adamas Pharma and is included in one NDA. It is available from one supplier. There are fifteen patents…. The post New patent for Adamas Pharma drug GOCOVRI appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery Today
JULY 18, 2021
~ UK’s biggest trade show for the laboratory industry returns for 2021 ~
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ProRelix Research
JULY 21, 2021
Emergency Use Authorisation Approval Process of US FDA and Treatments Approved for COVID – 19 in the USA The COVID-19 pandemic has transformed the worldwide regulator performing on approval of […]. The post COVID-19 Emergency Use Authorisation Approval Process of US FDA appeared first on ProRelix Research.
The Pharma Data
JULY 29, 2021
Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (NYSE: LLY), and Kumquat Biosciences today announced an exclusive collaboration focused on the discovery, development and commercialization of potential novel small molecules that stimulate tumor-specific immune responses. Through the multi-year collaboration, Kumquat will utilize its small molecule immuno-oncology (IO) platform to discover novel clinical candidates and Lilly has the option to select a certain numb
The ChEMBL-og
JULY 23, 2021
We are pleased to announce the release of ChEMBL 29. This version of the database, prepared on 01/07/2021 contains: 2,703,543 compound records 2,105,464 compounds (of which 2,084,724 have mol files) 18,635,916 activities 1,383,553 assays 14,554 targets 81,544 documents Data can be downloaded from the ChEMBL FTP site: [link]. Please see ChEMBL_29 release notes for full details of all changes in this release: [link] New Deposited Datasets EUbOPEN Chemogenomic Library (src_id = 55, ChEMBL Document
Dark Matter Blog
JULY 19, 2021
Back in 2015, I felt compelled to set out in a new direction in drug discovery. I was in my third year as VP of Chemistry for Celgene. This was a great gig – good people, good science. However, it required a level of travel that began to seem excessive. My kids were old enough to know I was missing and young enough to care. And I live in the “Hollywood” of biotech, the Boston/Cambridge area – there seems to be an exciting new biotech start-up in this neighborhood every six weeks!
Drug Patent Watch
JULY 8, 2021
Annual Drug Patent Expirations for RESCULA Rescula is a drug marketed by Sucampo Pharma Llc and is included in one NDA. There is one patent protecting this drug and one…. The post New patent expiration for Sucampo Pharma drug RESCULA appeared first on DrugPatentWatch - Make Better Decisions.
Drug Channels
JULY 16, 2021
Today’s guest post comes from MMIT's Dinesh Kabaleeswaran, Director of Advisory Services, and John Griggs, Senior Solution Consultant. Dinesh and John discuss the expanding role and importance of integrated delivery networks (IDNs) in specialty medication administration and reimbursement. Dinesh and John also highlight MMIT’s Pulse Analytics solution , which allows pharma manufacturers the ability to monitor drug coverage at the brand and IDN level.
National Drug & Alcohol Research Centre Blog
JULY 13, 2021
Dr Krista Siefried, Clinical Research Lead and Deputy Director of the National Centre for Clinical Research on Emerging Drugs (NCCRED) The first national clinical research priority setting study in the AOD sector in Australia was conducted to determine the focus of clinical research, seed funding, and training programs for The National Centre for Clinical Research on Emerging Drugs (NCCRED).
The Pharma Data
JULY 29, 2021
Baricitinib now authorized for emergency use as monotherapy. Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today the U.S. Food and Drug Administration (FDA) has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir, whereas the EUA was previously restricted to use only in combination with remdesivir.
Olympian Clinical Research
JULY 7, 2021
Social anxiety disorder, sometimes referred to as a social phobia, is a type of anxiety disorder characterized by extreme fear, distress, and anxiety in social settings. It’s important to note that being naturally more shy, reserved, or introverted is not the same thing as having social anxiety. While people with social anxiety may or may not exhibit shyness in social situations, it’s the uncontrollable fear, anxiety, and subsequent avoidance of social situations that differentiates someone with
Dark Matter Blog
JULY 19, 2021
Arrakis has gone through many significant transitions since its founding in 2015. We’ve evolved and matured scientifically. We’ve added investors and partners. And, of course, people come and go. Today, we reach a bittersweet transition at Arrakis. We bid our head of research and employee #005, Jim Barsoum, au revoir , as he marches bravely into a well-earned retirement.
Drug Patent Watch
JULY 7, 2021
Annual Drug Patent Expirations for XHANCE Xhance is a drug marketed by Optinose Us Inc and is included in one NDA. There are thirteen patents protecting this drug. XHANCE drug…. The post New patent for Optinose Us drug XHANCE appeared first on DrugPatentWatch - Make Better Decisions.
Crown Bioscience
JULY 5, 2021
Last month we hosted a webinar with Dr. Ludovic Bourré, Senior Director of Scientific Engagement at Crown Bioscience, focused on the next generation of preclinical models advancing bispecific T cell engager (BiTE) development.
Drug Channels
JULY 26, 2021
Informa Connect’s Hub, SPP and eServices Optimization. Delivered as a Hybrid Event. In-Person: Sep 22-23, New Brunswick, NJ | Virtual: Sep 28-29 www.informaconnect.com/hub-spp/. This important event convenes key stakeholders including manufacturers, specialty pharmacies, hub providers and more for unrivaled collaboration to leverage innovation and optimize access.
The Pharma Data
JULY 29, 2021
P-tau217 in blood showed promise as additional biomarker of efficacy- Donanemab treatment led to 24% lowering of P-tau217 from baseline. Today at the Alzheimer’s Association International Conference © (AAIC © 2021), Eli Lilly and Company (NYSE: LLY) presented two new exploratory analyses of data from the Phase 2 TRAILBLAZER-ALZ study. In the first, greater amyloid plaque changes following donanemab treatment was highly associated with less cognitive decline and participants with greater pl
Practical Cheminformatics
JULY 7, 2021
Another pointer to the FastPages site
Dark Matter Blog
JULY 16, 2021
49 years ago, when I was 16 years old, I wanted to do exactly what I am doing now. The only subject in school that held my interest was biology. As soon as I learned about DNA and RNA, I wanted to be a molecular biologist. I wanted to use molecular biology to create drugs. However, that was 1972, and the biotechnology industry did not exist. Growing up in Shrewsbury, Massachusetts, it was natural for me to attempt to get a summer job up the road at the Worcester Foundation for Biomedical Researc
Drug Patent Watch
JULY 7, 2021
Annual Drug Patent Expirations for MYCAMINE Mycamine is a drug marketed by Astellas and is included in one NDA. It is available from one supplier. There is one patent protecting…. The post New patent expiration for Astellas drug MYCAMINE appeared first on DrugPatentWatch - Make Better Decisions.
Eye on FDA
JULY 14, 2021
Upfront Author’s Note: This is the first posting in a while as I have been working to migrate the subscription service to a new provider. As such, some subscribers were lost in the process. Anyone who signed up for a subscription prior to 2019, would need to sign up again. Apologies for the inconvenience and thanks for your patience. Years ago, a single regulatory action letter issued by FDA’s Office of Prescription Drug Promotion (OPDP) would not have merited a blog posting in and o
Drug Channels
JULY 20, 2021
The 340B Drug Pricing Program continues to expand far more quickly than the overall pharmaceutical market—and some channels are benefiting more than others. As you will see below, mail and specialty pharmacies’ purchases of products that are eligible for 340B discounts have grown by an incredible 56% per year since 2017. That’s about six times faster than the overall mail and specialty market.
The Pharma Data
JULY 29, 2021
Eisai and Biogen Present Preliminary Assessment of the Clinical Effects of Lecanemab Following 18 Months of Treatment in the Open-Label Extension of the Phase 2 Proof of Concept Study at 2021 Alzheimer’s Association International Conference (AAIC) . today announced results of a longitudinal preliminary assessment of the clinical effects of lecanemab (development code: BAN2401) — granted Breakthrough Therapy designation by the U.S.
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