Drug Discovery World
MAY 5, 2023
News round-up for 1-5 May by DDW Digital Content Editor Diana Spencer. My five stand-out news headlines this week all relate to immunotherapy or immunomodulatory therapies for cancer, particularly advances in our understanding of how other factors in the body, i.e., vitamin D levels and the gut microbiome, can impact the patient’s response to treatment.
Drug Discovery Today
MAY 4, 2023
London, UK, 3rd May 2023 / The RSA Group, a leading life sciences executive search firm, has published the latest of its Talent Equity® Reports: No turning back – an analysis of the hybrid working models that have emerged from the pandemic and how they have enabled positive changes to leadership, team dynamics and recruitment and retention of talent in the life science sector.
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Chemical Biology and Drug Design
MAY 1, 2023
We found overexpression of C-FLIPS, MCL-1, and survivin by SphK2 silencing has an effective important modality to enhance cell sensitivity to paclitaxel via the induction of apoptosis in colon cancer cells. Abstract The sphingosine kinase-2 (SphK2), a main component of sphingolipid signal transduction, is reported as an innovative therapeutic candidate for cancer treatment.
Antidote
MAY 3, 2023
Every May is dedicated to Skin Cancer Awareness Month — a national observance designed to raise awareness around skin cancer and encourage people to practice smart prevention tactics as spring transitions into summer. Though skin cancer is the most common type of cancer , forming good sun safety habits can have a direct link to a reduction in its prevalence.
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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.
Drug Discovery World
MAY 5, 2023
Eterna Therapeutics, a life science company focused on mRNA cell engineering, has acquired Exacis Biotherapeutics’ immuno-oncology platform. The acquisition will provide Eterna with a pipeline of allogeneic immuno-oncology products under development for the treatment of haematologic and solid tumours. The deal also provides Eterna with an exclusive global license to produce an unlimited number of mRNA-engineered natural killer (NK) and T-cell therapies derived from induced pluripotent stem cells
Drug Patent Watch
APRIL 30, 2023
Annual Drug Patent Expirations for AGGRASTAT Aggrastat is a drug marketed by Medicure and is included in two NDAs. It is available from one supplier. There is one patent protecting… The post New patent expiration for Medicure drug AGGRASTAT appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery Digest brings together the best content for drug research and development professionals from the widest variety of industry thought leaders.
Drug Channels
MAY 2, 2023
In my most recent video webinar , I explored how the rapid expansion of patient-paid prescriptions—via cash-pay pharmacies and discount card vendors—is transforming the prescription market. Below, I follow the dollar when a patient uses a discount card to pay for a generic drug prescription. As you’ll see, a discount card can save money for consumers by leveraging several quirks of U.S. retail pharmacy pricing.
Drug Discovery World
MAY 5, 2023
The US market for medicines grew by 5% in 2022, reaching a total value of $429Bn on a net price basis. This was driven by a range of factors, including an increase in health services utilisation, which is now back to pre-pandemic levels, and the entry of new medicines into the market. Balancing these drivers of growth was a lack of net price increases for branded drugs and patient out-of-pocket costs per retail prescription remaining under $10.
FDA Law Blog: Drug Discovery
MAY 4, 2023
By McKenzie E. Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. A DCT is a clinical trial where some or all of the trial-related activities, such as administration of the investigational product, data collection, or safety monitoring, occur at locations other than traditional clinical trial sites.
FDA Law Blog: Biosimilars
MAY 3, 2023
By Deborah L. Livornese — FDA posted the last five “deemed final orders” under OTC monograph reform this week. All 33 of the final orders can now be found at OTCMONOGRAPHS@FDA. Under the 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (see our blog post here ), all final monographs (i.e., the regulations formerly found in 21 C.F.R. parts 331 through 358) were deemed to be final administrative orders as of the CARES Act effective date.
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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
MAY 5, 2023
Annual Drug Patent Expirations for PROAIR+DIGIHALER Proair Digihaler is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from one supplier. There are… The post New patent expiration for Teva Branded drug PROAIR DIGIHALER appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery World
MAY 5, 2023
Hosted by DDW and supported by BPS BioScience and AcroBiosystems, ‘Cancer immunotherapy – where will the future opportunities be?’ will be free to attend on May 10 at 8AM PST | 11AM EST | 4PM BST | 5PM CET. Join this free webinar to learn about the biggest opportunities for the future of cancer immunotherapy. In this webinar, you will hear from immunologist Dr Frédéric Triebel, CSO and CMO of Immutep, two experts from DeciBio: Dr Carl Schoellhammer, Principal, and Dr Joe Daccac
Cytel
MAY 5, 2023
As clinical trials become more complex, simulation-guided design approaches are crucial. For this edition of the Industry Voices series, Cytel’s Chief Product Officer & General Manager Scott Gaines discusses how simulation-guided design and Cytel’s Solara® clinical strategy platform have evolved clinical development strategy, enabling sponsors to select optimal designs even as clinical trials involve more study objectives and more sophisticated decision rules, and to better focus on strategi
FDA Law Blog: Biosimilars
APRIL 30, 2023
By Kurt R. Karst & Michael D. Shumsky — On May 2nd, the U.S. Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. That bill is S. 1067, the “ Ensuring Timely Access to Generics Act of 2023 ,” and it would fundamentally transform the playing field for NDA, ANDA, BLA, and aBLA applicants seeking to preserve their rights i
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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
MAY 5, 2023
Annual Drug Patent Expirations for PROAIR+RESPICLICK Proair Respiclick is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from one supplier. There are… The post New patent expiration for Teva Branded drug PROAIR RESPICLICK appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery World
MAY 4, 2023
iOnctura, a clinical-stage biotech developing selective cancer therapies against targets that play critical roles in multiple tumour survival pathways, has exercised an exclusive option with Clavius Pharmaceuticals, adding the novel oral TGF-β pathway inhibitor, IOA-359, to its pipeline. IOnctura also announced it has, in collaboration with the University of Twente (UT), been awarded a grant from Health Holland and KWF (Dutch Cancer Society).
The Premier Consulting Blog
MAY 4, 2023
The global ophthalmic drugs market size was valued at $33.81 billion in 2022 and is expected to grow approximately eight percent from 2023 to 2030 [1]. Given this trend, many biopharmaceutical companies are investing in strategies to develop and commercialize new or existing ophthalmic products that address unmet medical needs. Now, these companies are required to comply with new guidance from the U.S.
Reprocell
MAY 5, 2023
Members of the UK Parliament were impressed and somewhat surprised recently by an exchange between the Prime Minister and the leader of the opposition during Prime Minister’s questions. 1 The opponents exchanged polite introductions and proceeded to debate the issues of the day in a calm and thoughtful manner, without raising their voice. The members were in fact watching an exchange with an AI chatbot, programmed to answer questions of the type often raised in the weekly shouting match.
Drug Patent Watch
MAY 5, 2023
Annual Drug Patent Expirations for BONIVA Boniva is a drug marketed by Roche and Hoffmann La Roche and is included in two NDAs. It is available from one supplier. There… The post New patent expiration for Hoffmann La drug BONIVA appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery World
MAY 4, 2023
New research in mice has identified how gut bacteria alter the body’s response to PD-1 checkpoint blockade immunotherapy, currently used for the treatment of 25 forms of cancer. The findings could inform the design of treatments that boost the efficacy of cancer immunotherapy among patients with suboptimal response. The research by investigators at Harvard Medical School and Dana-Farber Cancer Institute found that specific gut bacteria can affect the activity of two immune molecules – PD-L2 and
Drug Target Review
MAY 5, 2023
Personalised Precision Medicine (PPM) relies heavily on the use of data and artificial intelligence (AI) to tailor treatment plans to an individual’s unique biomarkers , predict their reaction to certain treatments, and target diseases based on their genetic makeup or environmental factors. While PPM holds great promise for improving patient outcomes, it also faces challenges such as data management, security and the escalating costs of research and development.
Drug Channels
MAY 4, 2023
Today’s guest post comes from Justin Smerker, VP of Business Development at RareMed Solutions. Justin introduces us to RareMed Solutions, a patient service provider that caters to patients with complex and rare diseases. To learn about RareMed and their approach to the delivery of patient services for complex or rare conditions, visit www.raremed.com or email info@raremed.com.
Drug Patent Watch
MAY 5, 2023
Annual Drug Patent Expirations for ORLADEYO Orladeyo is a drug marketed by Biocryst and is included in one NDA. It is available from one supplier. There are six patents protecting… The post New patent for Biocryst drug ORLADEYO appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery World
MAY 4, 2023
Adaptyv Bio, a Swiss/US technology company that develops infrastructure and tools for protein designers to engineer better proteins, has built a protein engineering foundry that it says will “pave the way” for protein designers to develop new medicines, novel enzymes and sustainable materials. AI tools like ChatGPT are revolutionising how the world generates text, images and code, a topic recently covered by DDW.
H1 Blog
MAY 4, 2023
Insights for Thought Leading Stakeholder Engagement to Decrease Medication Non-Adherence Pharmaceutical companies have long recognized the importance of engaging key opinion leaders (KOLs) to gain insight and support for clinical research, drug development, and medical education. With the rise of digital technology, pharma can now identify and engage a new generation of health care professionals (HCPs) who are leveraging social media to become influential digital opinion leaders.
Covalent Modifiers
MAY 3, 2023
Mahía, Alejandro , Kiib, Anders , Nisavíc, Marija , Svenningsen, Esben , Palmfeldt, Johan , Poulsen, Thomas Bjørnskov , Angew. Chem. Int. Ed. 2023 , e202304142 [link] Electrophilic groups are one of the key pillars of contemporary chemical biology and medicinal chemistry. For instance, the group of 3-membered N-heterocyclic compounds – such as aziridines, azirines, and oxaziridines – possess unique electronic and structural properties which underlie their potential and applicability as covalent
Drug Patent Watch
MAY 4, 2023
Annual Drug Patent Expirations for STENDRA Stendra is a drug marketed by Metuchen Pharms and is included in one NDA. It is available from two suppliers. There are two patents… The post New patent expiration for Metuchen Pharms drug STENDRA appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery World
MAY 3, 2023
Vicore Pharma, a Swedish clinical-stage pharmaceutical company unlocking the potential of angiotensin II type 2 receptor agonists (ATRAGs), has dosed its first patient with C21 in a clinical study of endothelial dysfunction. Vicore Pharma states that results from the trial are expected in Q4, 2023. The study Vicore is conducting a randomised, double-blind, placebo-controlled, cross-over trial evaluating the effect of ATRAGs on endothelial dysfunction (reflecting blood vessel health) in
addgene Blog
MAY 4, 2023
The biomedical field is often concerned with understanding the cause of diseases and how to treat those diseases. The “cause of disease” often requires understanding the disease genetics and the “treatment” usually requires drugs. While we often think of these two fields as separate, they are deeply intertwined. In this blog we will review how CRISPR technology has brought drug and genetic screens together and expedited the drug discovery pipeline.
DS in Pharmatics
MAY 4, 2023
Diagnosing illnesses and monitoring health is increasingly reliant on utilizing software. For patients, manufacturers must maintain standards and regulations. Companies can be concerned with challenges concerning updated legislation such as the EU’s MDR.
Drug Patent Watch
MAY 4, 2023
Annual Drug Patent Expirations for AUVELITY Auvelity is a drug marketed by Axsome and is included in one NDA. It is available from one supplier. There are one hundred patents… The post New patent for Axsome drug AUVELITY appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery World
MAY 3, 2023
Drug development company Ellipses Pharma now has more than 200 oncology experts from 106 institutions worldwide providing analysis and advice on selection of the most promising potential cancer medicines in its Scientific Affairs Group (SAG). The number of experts joining the SAG has increased by 53% in the last nine months and now comprises 129 specialists in Europe, 53 in the United States and 19 in the Asia-Pacific (APAC) and Middle East-North Africa (MENA) geographies.
Tecan
MAY 4, 2023
By Magali Wolff You could say that the road to in vitro diagnostic medical devices regulation (IVDR) implementation has been rocky. We have read all of the documents, spent hours in meetings and felt our heart stop with every new announcement about the new regulations.
Cytel
MAY 3, 2023
With input by Alind Gupta, Louis Dron, and Jason Simeone. Randomized clinical trials (RCTs) have long been considered the gold standard for assessing the efficacy of medical treatments, but real-world evidence (RWE) is often more representative of routine clinical care. The RCT DUPLICATE study makes great strides in comparing the two, but the study has its limitations: notably, the lack of quantitative bias analysis.
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