Drug Discovery World
JANUARY 6, 2023
News round-up for 2-6 January by DDW Digital Content Editor Diana Spencer. The drug discovery industry has hit the ground running in 2023 with some big announcements in the first week, particularly in cancer research, where there has been good news in pancreatic, urothelial and uveal cancers. . The top stories: . Accelerated development for Covid-19 monoclonal antibody .
Drug Channels
JANUARY 4, 2023
Time for the Drug Channels annual reality check on drug pricing. The data once again tell a different story than you might read in your favorite politician’s Twitter feed or misleading news reports. For 2022, brand-name drugs’ net prices dropped for an unprecedented fifth consecutive year. What’s more, after adjusting for overall inflation, brand-name drug net prices plunged by almost 9%.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Drug Patent Watch
JANUARY 2, 2023
Annual Drug Patent Expirations for TOVIAZ Toviaz is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. There are four patents protecting…. The post New patent expiration for Pfizer drug TOVIAZ appeared first on DrugPatentWatch - Make Better Decisions.
Antidote
JANUARY 3, 2023
Before becoming available to patients, every medication, therapy, and intervention must undergo a rigorous approval process: the clinical trial. Clinical trials are divided into phases that are aimed at testing the safety and efficacy of every potential new treatment before it is able to enter the market.
Advertisement
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.
Drug Discovery World
JANUARY 6, 2023
Orbit Discovery and start-up SanegeneBio have entered into a Master Service Agreement to identify tissue-specific delivery of a wide range of RNA therapeutics. . The agreement covers activities ranging from hit ID to cell-based internalisation studies, with an option for Sanegene to further develop the hits resulting from the screening activities. .
FDA Law Blog: Drug Discovery
JANUARY 4, 2023
By Holly N. Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and controls (CMC). The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide infor
Drug Discovery Digest brings together the best content for drug research and development professionals from the widest variety of industry thought leaders.
Cytel
JANUARY 6, 2023
You may have heard that our clinical trial strategy platform Solara® won the Fierce Life Sciences award for Technology Innovation , so let’s take a closer look at simulation-guided design and what it enables clinical trial sponsors to do.
Drug Discovery World
JANUARY 6, 2023
Cancer Research Horizons and biotech company Turbine have announced a partnership to solve complex diseases. . The partnership will utilise Turbine’s Simulated Cells platform to identify target patient populations who could benefit from CDC7 inhibitor therapy with Cancer Research Horizons’ lead compound CRT’2199. . CRT’2199 originates from Cancer Research Horizons’ Therapeutic Innovation.
FDA Law Blog: Drug Discovery
JANUARY 2, 2023
Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing an essential working knowledge of core FDA concepts, and real-world examples that will help you to excel in your everyday practices. This year’s conference co-chairs include Stacy Cline Amin (Partner, Morrison Forester) and Kurt R.
Drug Patent Watch
JANUARY 6, 2023
Annual Drug Patent Expirations for UPNEEQ Upneeq is a drug marketed by Rvl Pharms and is included in one NDA. It is available from one supplier. There are ten patents…. The post New patent for Rvl Pharms drug UPNEEQ appeared first on DrugPatentWatch - Make Better Decisions.
Advertisement
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.
DS in Pharmatics
JANUARY 6, 2023
Product development is mainly a sequence of activities. Moving forward to the next step depends upon the result of the previous step. A regulatory deficiency in an early stage will therefore carry forward into all later stages. Fundamental CMC deficiencies at an early stage may require complete subsequent product redevelopment.
Drug Discovery World
JANUARY 6, 2023
The United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Bicycle Therapeutics’ BT8009 monotherapy for the treatment of adult patients with previously treated locally advanced or metastatic urothelial cancer. . BT8009 is a potential first in class Bicycle Toxin Conjugate (BTC) targeting Nectin-4, a protein that is highly expressed in urothelial cancer (UC) and other solid tumors. .
Advarra
JANUARY 6, 2023
Budget negotiation is an integral part of a clinical trial’s success. Proper clinical trial financing ensures a site’s internal costs are covered, facilitates better negotiation, and leads to more compliant practices. With the per patient cost in clinical trials averaging around $41k , it is critical to begin with an internal budget appropriately capturing the estimated costs.
Drug Patent Watch
JANUARY 6, 2023
Annual Drug Patent Expirations for VANOS Vanos is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. There are three patents protecting…. The post New patent expiration for Bausch drug VANOS appeared first on DrugPatentWatch - Make Better Decisions.
Advertisement
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
Antidote
JANUARY 6, 2023
Antidote is dedicated to accelerating medical research by bringing sponsors and patients together. Through our clinical trial matching software, strategic partner relationships, extensive database, and patient-centric focus, we’re transforming the way that patients connect with research — and continually measuring our progress so we can refine the process.
Drug Discovery World
JANUARY 6, 2023
Cancer Focus Fund is investing $5 million in funding to support ISA103, ISA Pharmaceuticals’ PRAME-targeting immunotherapy, in a first-in-human study for the treatment of uveal melanoma, a rare ocular cancer. . Cancer Focus Fund was established in collaboration with The University of Texas MD Anderson Cancer Center to provide funding and clinical expertise to advance promising cancer therapies. .
PPD
JANUARY 5, 2023
In an industry survey led by PPD, Thermo Fisher Scientific’s clinical research business, rare diseases emerged as a top therapeutic area in drug developers’ pipelines, with 39% of global biotech and biopharma leaders pursuing therapies in the broad rare disease space. The strong industry focus on rare diseases emerges as drug developers are contending with an already limited patient pool, requiring larger geographies to access these populations and ongoing challenges in patient recru
Drug Patent Watch
JANUARY 5, 2023
[
Reprocell
JANUARY 5, 2023
Laminins are a series of extracellular matrix (ECM) proteins found in all animals. These glycoproteins are a major component of the basal lamina layer of the basement membrane, which is a protein network that forms the foundation on which most cells and organ grow in the body. In vivo , laminins are important for regulating many biological processes, including adhesion, migration, and differentiation.
Drug Discovery World
JANUARY 5, 2023
Synaffix and Hummingbird Bioscience have entered into a licensing agreement that it is hoped will enable Hummingbird Bio to develop an antibody drug conjugate (ADC) programme using Synaffix technology. . Under the terms of the agreement, Synaffix will be eligible to receive up to $150 million, including upfront and milestone payments, plus royalties on net sales. .
Cytel
JANUARY 4, 2023
Returning to Cytel after the winter holidays, I am excited to begin a year that will likely prove memorable for both my colleagues at Cytel and the industry at large. In 2022, Cytel laid the foundations for many projects that will bear fruit this year.
Drug Patent Watch
JANUARY 5, 2023
[
DrugBank
JANUARY 4, 2023
Reflecting back on 2022, we saw our biggest year of growth yet! From offering more products to designing a workplace that wins award after award and finalizing a successful raise, we’ve set ourselves up for 2023 in the best way possible. While we aren’t quite ready to announce our plans for next year, we hope this hints at what’s to come.
Drug Discovery World
JANUARY 5, 2023
AmerisourceBergen Corporation has completed its acquisition of PharmaLex Holding, a provider of tech-enabled services from clinical development consulting to marketing authorisation. . PharmaLex is a global team of scientific, regulatory and safety and compliance (GxP) experts that provide strategic guidance and regulatory support to biopharma companies throughout a product’s lifecycle. .
Olympian Clinical Research
JANUARY 3, 2023
Prurigo nodularis (PN) is a skin condition that causes itchy, hard bumps on the skin. It may be incredibly frustrating to manage, and many people struggle with controlling their prurigo nodularis symptoms. Unfortunately, there currently is no cure for the condition, so long-term management may be necessary. There are several self-care techniques that may help you manage the symptoms associated with the condition.
Drug Patent Watch
JANUARY 4, 2023
Annual Drug Patent Expirations for NARCAN Narcan is a drug marketed by Adapt, Bristol Myers Squibb, and Emergent and, and is included in five NDAs. It is available from seven…. The post New patent for Emergent drug NARCAN appeared first on DrugPatentWatch - Make Better Decisions.
New Drug Approvals
JANUARY 3, 2023
Adagrasib Formula C32H35ClFN7O2 cas 2326521-71-3 Mol weight 604.1174 Antineoplastic Disease Non-small cell lung cancer 2022/12/12 FDA APPROVED, KRAZATI (Mirati Therapeutics) MRTX-849 MRTX849 KRAS G12C inhibitor MRTX849 Adagrasib , sold under the brand name Krazati , is an anticancer medication used to treat non-small cell lung cancer. [1] [2] Adagrasib is an inhibitor of the RAS GTPase family. [1] It is taken by mouth. [1] It is being developed by Mirati Therapeutics. [1] [3] The most common adv
Drug Discovery World
JANUARY 5, 2023
CANbridge Pharmaceuticals has exercised its option to secure the exclusive global rights to develop, manufacture and commercialise a novel gene therapy to treat spinal muscular atrophy (SMA) from UMass Chan Medical School. . Animal data presented in 2022 showed that the gene therapy outperformed the benchmark therapy along multiple key endpoints in a mouse model of SMA.
Practical Cheminformatics
JANUARY 3, 2023
Here’s a roundup of some of the papers I found interesting in 2022. This list is heavily slanted to my interests, which lean toward the application of machine learning (ML) in drug design. I’ve added commentary to most of the papers to explain why I found them compelling. I’ve done my best to arrange the papers according to themes. If I omitted a paper, please let me know.
Drug Patent Watch
JANUARY 3, 2023
Annual Drug Patent Expirations for INTUNIV Intuniv is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There is one…. The post New patent expiration for Takeda Pharms drug INTUNIV appeared first on DrugPatentWatch - Make Better Decisions.
Molecular Design
JANUARY 2, 2023
| next >> I’ll be taking a look at some of the criteria, specifically structural alerts, by which chemical probes are assessed and here’s the link to the Chemical Probes Portal. Before getting into the post there are a couple of points that I need to stress. First, structural alerts derived from analysis of screening hits (defined as responses that exceed a threshold when assayed at a particular concentration) are not necessarily useful for assessing higher affinity compounds for which con
Drug Discovery World
JANUARY 4, 2023
China is expected to record the highest diagnosed prevalence of non-alcoholic fatty liver disease (NAFLD) in 2029, representing 44% of cases within the 16 major pharmaceutical markets (16MM). As a result, the number of clinical trials conducted in the country for this indication is gradually increasing, driven mostly by international pharmaceutical companies.
Drug & Device Law
JANUARY 4, 2023
Our doctor advised it would not be a good idea for us to get Covid-19. We already wheeze after ascending the stairs or rolling the garbage bin to the curb or opening the mail, so any further respiratory burden seems like a bad idea. Thus, even though some have declared the pandemic over, we remain cautious. Good luck inviting us to any public place.
Drug Patent Watch
JANUARY 1, 2023
[
Expert insights. Personalized for you.
130 
Let's personalize your content