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 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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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.
Drug Patent Watch
JULY 29, 2021
Annual Drug Patent Expirations for REYVOW Reyvow is a drug marketed by Eli Lilly And Co and is included in one NDA. It is available from one supplier. There are…. The post New patent for Eli Lilly drug REYVOW appeared first on DrugPatentWatch - 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.
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 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.
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 29, 2021
Annual Drug Patent Expirations for VYVANSE Vyvanse is a drug marketed by Takeda Pharms Usa and is included in two NDAs. It is available from one supplier. There are eighteen…. The post New patent for Takeda Pharms drug VYVANSE appeared first on DrugPatentWatch - Make Better Decisions.
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.
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
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
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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.
Drug Patent Watch
JULY 29, 2021
Annual Drug Patent Expirations for PHOSLO+GELCAPS Phoslo Gelcaps is a drug marketed by Fresenius Medcl and is included in one NDA. It is available from three suppliers. There are two…. The post New patent expiration for Fresenius Medcl drug PHOSLO GELCAPS appeared first on DrugPatentWatch - Make Better Decisions.
NIH Director's Blog: Drug Development
JULY 27, 2021
Caption: Researchers used artificial intelligence to map hundreds of new protein structures, including this 3D view of human interleukin-12 (blue) bound to its receptor (purple). Credit: Ian Haydon, University of Washington Institute for Protein Design, Seattle Proteins are the workhorses of the cell. Mapping the precise shapes of the most important of these workhorses helps to unlock their life-supporting functions or, in the case of disease, potential for dysfunction.
Practical Cheminformatics
JULY 27, 2021
In Cheminformatics, we frequently run into cases where we want to look at leader/follower relationships between chemical structures. For instance, if we've clustered a set of molecules, we might want to start by looking at a table with one example structure for each cluster. We'd then like to be able to select one or more "interesting" clusters and drill down to the cluster members.
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.
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
Drug Patent Watch
JULY 29, 2021
Annual Drug Patent Expirations for NUBEQA Nubeqa is a drug marketed by Bayer Healthcare and is included in one NDA. It is available from one supplier. There are six patents…. The post New patent for Bayer Healthcare drug NUBEQA appeared first on DrugPatentWatch - Make Better Decisions.
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
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.
The Pharma Data
JULY 29, 2021
The U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog.
The Pharma Data
JULY 29, 2021
First IL-5 therapy approved as an add-on treatment in the US for adults with chronic rhinosinusitis with nasal polyps to target eosinophilic inflammation Fourth indication for mepolizumab in the US for eosinophil-driven diseases. today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
The Pharma Data
JULY 29, 2021
Merck known as MSD outside the United States and Canada, today announced that Cristal N. Downing has been appointed chief communications & public affairs officer, a newly created role, effective August 16, 2021. Downing will become a member of Merck’s Executive Team and lead the development, advancement and execution of the company’s communications and public affairs strategy.
The Pharma Data
JULY 29, 2021
6.7 million adults in the U.S. are living with spasticity across a variety of neurologic conditions — BOTOX® has demonstrated efficacy and has an established safety profile with over 10 years of clinical use in adult upper limb spasticity. Allergan, an AbbVie (NYSE: ABBV) company, today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion of BOTOX ® to include eight new muscles for the treatment of upper limb spasticity in adults.
The Pharma Data
JULY 29, 2021
Takeda Will Focus its Efforts on Dengue, Zika and Pandemic Vaccines. (Takeda) and Frazier Healthcare Partners (Frazier) today announced a collaboration to launch HilleVax, Inc. (HilleVax), a biopharmaceutical company to develop and commercialize Takeda’s norovirus vaccine candidate. Takeda has granted a license to HilleVax for the exclusive development and commercialization rights to its norovirus vaccine candidate, HIL-214 (formerly TAK-214), worldwide outside of Japan, in exchange for upfront
The Pharma Data
JULY 29, 2021
today announced that it will report its second quarter financial results on Tuesday, August 3, 2021, after the close of the U.S. financial markets. The announcement will be followed by a conference call with the investment community at 2:00 p.m. PT. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen’s senior management team.
The Pharma Data
JULY 29, 2021
Bayer today provided an update on its five-point plan to address future Roundup litigation risk after its May 27th decision to withdraw from the national class process. The company is now in more control of important aspects of the risk mitigation process and has sketched out two basic scenarios going forward to provide a path to closure of this litigation.
The Pharma Data
JULY 29, 2021
Reports Second Quarter Revenues of $11.7 Billion, an Increase of 16% YoY, or 13% When Adjusted for Foreign Exchange Posts Second Quarter Earnings Per Share of $0.47 and Non-GAAP EPS of $1.93 Delivers Strong Commercial Performance, Including Opdivo’s Return to Growth and Momentum across New Product Portfolio Achieves Significant Regulatory and Clinical Milestones across Product Pipeline Further Strengthens Pipeline through Disciplined Business Development Agreements, including with Agenus and E
The Pharma Data
JULY 28, 2021
– If Approved, Investigational TAK-994 May Provide a Future Treatment Option Targeting the Orexin Deficiency Underlying NT1. today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to TAK-994, 1 its Phase 2 investigational oral orexin agonist, which is designed to selectively target orexin 2 receptors.
The Pharma Data
JULY 28, 2021
Viviane Monges joins Sanofi as Chair of the Supervisory Board of EUROAPI Roy Papatheodorou appointed EVP, General Counsel and Head of Legal, Ethics & Business Integrity Brendan O’Callaghan appointed EVP, Global Head of Industrial Affairs. Karen Linehan and Philippe Luscan, who have led Legal, Ethics & Business Integrity (LEBI) and Industrial Affairs at Sanofi for the last 14 and 13 years respectively have decided to retire.
The Pharma Data
JULY 28, 2021
Across four phase III studies, approximately half of patients receiving faricimab could extend treatment time to every four months – the first time this level of durability has been achieved in phase III nAMD and DME studies If approved, faricimab would be the first and only medicine designed to target two distinct pathways that drive retinal diseases that can cause vision loss The European Medicines Agency has also validated the faricimab Marketing Authorisation Application submission in nAMD a
The Pharma Data
JULY 28, 2021
Teva saved the United States $28.8 billion in 2020, $4.2 billion of which were direct savings to US patients Teva delivered $9.6 billion in savings in 2020 to healthcare systems across nine European countries, including the UK, Germany and Spain The Company supported nearly 250,000 jobs and contributed $52 billion to economic output across 15 countries.
Drug Patent Watch
JULY 28, 2021
Annual Drug Patent Expirations for ZYVOX Zyvox is a drug marketed by Pfizer and is included in three NDAs. It is available from four suppliers. There are two patents protecting…. The post New patent expiration for Pfizer drug ZYVOX appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JULY 28, 2021
Annual Drug Patent Expirations for LUMIFY Lumify is a drug marketed by Bausch And Lomb Inc and is included in one NDA. It is available from one supplier. There is…. The post New patent for Bausch And drug LUMIFY appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JULY 28, 2021
Annual Drug Patent Expirations for ORIAHNN+%28COPACKAGED%29 Oriahnn (copackaged) is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are six…. The post New patent for Abbvie Inc drug ORIAHNN (COPACKAGED) appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
JULY 27, 2021
Acquisition Complements Amgen’s Antibody Research Capabilities Across Therapeutic Areas Acquisition Includes a Portfolio of Early-Stage Oncology Assets, Including a Phase 1 Bispecific Antibody for Patients With Advanced Prostate Cancer. Amgen (NASDAQ: AMGN) and Teneobio today announced an agreement under which Amgen will acquire Teneobio, a privately held, clinical stage biotechnology company developing a new class of biologics called Human Heavy-Chain Antibodies.
The Pharma Data
JULY 27, 2021
AbbVie (NYSE: ABBV) and Calico Life Sciences today announced an extension of their leading-edge collaboration to discover, develop and bring to market new therapies for patients with age-related diseases, including neurodegeneration and cancer. This is the second extension of the collaboration originally established in 2014. Calico is a life sciences company founded by Alphabet together with Calico CEO Arthur D.
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