Chemical Biology and Drug Design

MARCH 23, 2023

Caffeic acid phenethyl ester (CAPE) demonstrating its anticancer potential through specifically targets genes involved in cell death, cell cycle regulation, angiogenesis, and metastasis in various types of cancers. Abstract Nowadays, there is a lot of public and scientific interest in using phytochemicals to treat human ailments. Existing cancer medicines still run across obstacles, despite significant advancements in the field.

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Antidote

MARCH 24, 2023

The rare, inherited blood disorder hemophilia is estimated to impact approximately 20,000 individuals in the United States , and over 400,000 worldwide. Currently, there is no cure for hemophilia — but through ongoing research, medical experts are continually learning more about the disease.

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FDA Law Blog: Drug Discovery

MARCH 19, 2023

Hyman, Phelps & McNamara, P.C.’s Mark Tobolowsky co-authored the peer-reviewed article “ Microdystrophin Expression as a Surrogate Endpoint for Duchenne Muscular Dystrophy Clinical Trials ” in the recently published edition of Human Gene Therapy. The article arose out of work conducted by the Pathway Development Consortium , a partnership between stakeholders in the AAV gene therapy space.

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Drug Channels

MARCH 21, 2023

Spring is here in sunny downtown Philadelphia, worldwide headquarters of Drug Channels. The vernal equinox has brought us an unexpected bounty of noteworthy news: Thoughts on the recent insulin price cuts by Lilly, Novo, and Sanofi AbbVie gets tougher on alternative funding programs Optum quietly adds a new drug channel role A novel partnership emerges to modernize the 340B program Plus, a celebration of pharmacists’ activities during the COVID-19 pandemic.

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Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Treatment

Chemical Biology and Drug Design

MARCH 20, 2023

Lipidic Nanoparticle drug and technology. Lipidic carriers like Liposomes, Niosomes, Solid-Lipid Nanoparticles, Micelles etc. Abstract Numerous nanotech arenas in therapeutic biology have recently provided a scientific platform to manufacture a considerable swath of unique chemical entities focusing on drugs. Recently, nanoparticulate drug delivery systems have emerged to deliver a specific drug to a specified site.

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Antidote

MARCH 20, 2023

Hepatitis B , sometimes abbreviated to HBV, is a liver infection that is one of the most serious in the world. If left untreated, hepatitis B can cause fibrosis, cirrhosis, hepatocellular carcinoma, and end-stage liver disease.

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Drug Channels

MARCH 24, 2023

Today’s guest post comes from Logan Melchione, Senior Director of Account Management at Paysign. Logan discusses the financial impacts of copay accumulators on manufacturers and patients. She describes how to reduce the strain on manufacturers' programs while also increasing patient access. Click here to learn about the Paysign Solution. Email affordability@paysign.com to set up a meeting with Paysign at Asembia’s Specialty Pharmacy Summit, April 30-May 4.

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FDA Law Blog: Biosimilars

MARCH 22, 2023

By JP Ellison & Faraz Siddiqui — On April 18, the Supreme Court will hear oral argument in two consolidated cases that present the question of whether a defendant can “knowingly” submit a false claim under the Federal False Claims Act when the alleged falsity is based on an objectively reasonable legal interpretation of an ambiguous provision of law and no authoritative guidance from the government warned the defendant away from its interpretation.

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Cytel

MARCH 24, 2023

Last week, we featured our final Winter Weekend Read, the last in a series designed to showcase our complimentary publications on a variety of topics on clinical trial design and data science, all authored by Cytel’s experts.

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Drug Patent Watch

MARCH 21, 2023

Annual Drug Patent Expirations for NUZYRA Nuzyra is a drug marketed by Paratek Pharms Inc and is included in two NDAs. It is available from one supplier. There are ten… The post New patent for Paratek Pharms drug NUZYRA 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.

Clinical Trials

Metabolite Tales Blog

MARCH 23, 2023

Hypha’s Q1 2023 newsletter – Recombinant metabolising enzymes In our Q1 2023 newsletter we focus on Hypha’s recombinant enzymes, in particular new innovations to our PolyCYPs platform. Sign up at the bottom of the page in the link here to receive our quarterly newsletter by email. Read newsletter Biotransformation of pirfenidone to an oxidised metabolite which matches the CYP1A2 product.

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H1 Blog

MARCH 23, 2023

Over the past decade, the cost and time impact to bring drugs to market have been increasing. With the recent trends in healthcare (more diversity and inclusion for both patients as well as physicians) and the economy (recession and hyperinflation), this is not a trend we expect will decrease any time soon. One of the few elements industry players can control is better use of the data elements captured and available to them.

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ACTO

MARCH 23, 2023

Commercial Learning and Development (CL&D) teams at Life Science companies can drive better business outcomes by utilizing the Kirkpatrick Model, which is the gold standard for assessing program performance. This model measures training effectiveness on four levels: Reaction, Learning, Behavior, and Results. By capturing and standardizing data and creating a continuous learning environment, organizations can gain valuable insights into the impact of their training initiatives.

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Drug Patent Watch

MARCH 24, 2023

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Romania. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating… The post Which pharmaceutical companies have the most SPCs in Romania? appeared first on DrugPatentWatch - Make Better Decisions.

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Clinical Trials

Metabolite Tales Blog

MARCH 23, 2023

Molecules that Matter – Rezafungin Rezafungin is an echinocandin with a chemical modification that confers high stability, a longer half-life, and allows for a once-a-week dosing regimen. In March 2023, Cidara, one of our past clients received the fantastic news that rezafungin was approved to treat a group of severe fungal infections commonly faced by hospitalised patients.

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The Premier Consulting Blog

MARCH 22, 2023

For researchers who are developing or working with analytical procedures, the new ICH Q14 Analytical Procedure Development and revised ICH Q2(R2) Validation of Analytical Procedures drafts represent foundational guidance documents. Together, they describe suggested development and validation activities for the lifecycle of an analytical procedure used to assess the quality of drug substances and drug products.

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On Medicine

MARCH 22, 2023

What matters most to patients? A previous study involving brain tumor patients identified that when anti-tumor treatment is understood to be ‘the only option’, the risk and impact of side effects may not be adequately explained to and understood by patients. It was also noted that there is a strong desire for more information to be provided regarding support services.

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Drug Patent Watch

MARCH 24, 2023

Annual Drug Patent Expirations for ABILIFY Abilify is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in six NDAs. It is available from one supplier.… The post New patent expiration for Otsuka drug ABILIFY appeared first on DrugPatentWatch - Make Better Decisions.

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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

Clinical Trials

DS in Pharmatics

MARCH 22, 2023

The Biomedical Advanced Research and Development Authority (BARDA) is) probably best known for its role in Operation Warp Speed and subsequent efforts to accelerate the manufacturing of COVID-19 vaccines. BARDA, formed in 2006, anticipated threats such as the COVID-19 pandemic.

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The Open Targets Blog

MARCH 22, 2023

My name is Manuel Bernal Llinares, I'm the back end lead at Open Targets, where I mentor, supervise and work hand in hand with enthusiastic software engineers to bring our flagship target discovery platform to the life sciences community. In this blog post I introduce to you our next stop in the technical roadmap, which is a step forward on improving our data pipelines and also our FAIRness scoring, a new feature that addresses provenance metadata, reliability and reproducibility in our dat

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Cytel

MARCH 21, 2023

One of the lesser-known complications associated with Multiple Sclerosis is a higher risk of serious infections (SIs). Cytel’s RWE experts conducted a retrospective analysis of claims data to determine the incidence of SIs among people with various types of MS.

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Drug Patent Watch

MARCH 24, 2023

Annual Drug Patent Expirations for XELJANZ+XR Xeljanz Xr is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. There are five patents… The post New patent expiration for Pfizer drug XELJANZ XR appeared first on DrugPatentWatch - Make Better Decisions.

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Codon

MARCH 20, 2023

Papers, news, and press releases in gene-editing, synthetic biology, longevity, software, and neurotechnology. I don’t send these digests via email, because links are boring. Dates: March 13-20, 2023. Subscribe to receive occasional essays about biology and the future. 🧪 Papers AI + Bio Protein-specific signal peptides for mammalian vector engineering.

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Predictive Oncology

MARCH 21, 2023

Dominic Pollard of Cancer Research Horizons and Dr. Pamela Bush of Predictive Oncology discuss the potential impact of their collaboration and how it can advance cancer drug development. This alliance between the world’s largest private funder of cancer research, with 11 marketed drugs and 150 active licenses, and the incorporation of our AI-driven, machine-learning PEDAL platform with access to an extensive biobank of tumor-specific samples, represents a promising win for patients, not just in

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Nvidia Developer: Drug Discovery

MARCH 21, 2023

Creating new drug candidates is a heroic endeavor, often taking over 10 years to bring a drug to market. New supercomputing-scale large language models (LLMs). Creating new drug candidates is a heroic endeavor, often taking over 10 years to bring a drug to market. New supercomputing-scale large language models (LLMs) that understand biology and chemistry text are helping scientists understand proteins, small molecules, DNA, and biomedical text.

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Drug Patent Watch

MARCH 24, 2023

Annual Drug Patent Expirations for XELJANZ Xeljanz is a drug marketed by Pfizer and Pf Prism Cv and is included in three NDAs. It is available from two suppliers. There… The post New patent expiration for Pf Prism drug XELJANZ appeared first on DrugPatentWatch - Make Better Decisions.

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Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. While drugs require Phase I-III clinical trials—and are also subject to post-approval tracking—digital therapeutics, devices, and IVDs may be able to leverage bench testing, animal studies, pilot studies, and training sets.

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Antidote

MARCH 21, 2023

Depression, also known as clinical depression, Major Depressive Disorder, or MDD, is estimated to impact one out of six adults at some point in their lifetime , making it one of the most common mental disorders in the United States. It is estimated that the cost of depression totals $100 billion annually. While there are treatments available, finding the optimal one can place a significant burden on the patient — this is why depression studies are essential for discovering new options.

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Nvidia Developer: Drug Discovery

MARCH 21, 2023

NVIDIA T4 was introduced 4 years ago as a universal GPU for use in mainstream servers. T4 GPUs achieved widespread adoption and are now the highest-volume. NVIDIA T4 was introduced 4 years ago as a universal GPU for use in mainstream servers. T4 GPUs achieved widespread adoption and are now the highest-volume NVIDIA data center GPU. T4 GPUs were deployed into use cases for AI inference, cloud gaming, video, and visual computing.

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Drug Patent Watch

MARCH 24, 2023

Annual Drug Patent Expirations for NOURESS Nouress is a drug marketed by Baxter Hlthcare Corp and is included in one NDA. It is available from one supplier. There are twelve… The post New patent for Baxter Hlthcare drug NOURESS appeared first on DrugPatentWatch - Make Better Decisions.

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Advarra

MARCH 20, 2023

The Food and Drug Administration (FDA) recently released new guidance regarding cellular and gene therapy products, one of which may significantly impact early-phase clinical trials of such products. This guidance particularly addresses biotech companies’ interest in “umbrella” trials—trials designed to evaluate multiple investigational drugs administered as single drugs or as combination drugs in a single disease population.

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Drug Channels

MARCH 19, 2023

Informa Connect’s Annual Life Sciences Commercial Contracts & Chargebacks Congress May 16-17, 2023 The Omni Shoreham Hotel | Washington, DC Hybrid Event informaconnect.com/contracts-chargebacks Exclusive Offer for Drug Channels Readers: Register Now to SAVE 10% * using promo code 23DC10 Informa Connect’s 19th Annual Commercial Contracts & Chargebacks Congress , taking place May 16-17 in Washington, DC, offers crucial updates on policy changes and contracting best practices to increase ef

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NIOSH Science Blog: Drugs

MARCH 23, 2023

The mining industry plays an important role in the U.S. economy and supply chain, with most products derived in part or entirely from mined rocks and minerals. Active mines can be found in all 50 states, Puerto Rico, and the U.S. Virgin Islands, [1] and include underground and surface mines operating in several different sectors, such as coal; metal; nonmetal; and stone, sand, and gravel.

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