Drug Discovery Today
JULY 18, 2022
Imagen Therapeutics, a global provider of services to the pharmaceutical cancer drug development industry, is celebrating recent success and preparing for rapid growth following the opening of its headquarters at Sci-Tech Daresbury.
DrugBaron
JULY 19, 2022
Despite the current hype around so called “advanced therapies”, which range from gene editing to cell therapies, and the inexorable advance of biologic therapeutics such as monoclonal antibodies, even in 2022 the majority of drugs in development and reaching patients are still small organic molecules. From enzyme inhibitors to receptor antagonists, allosteric modulators to suicide substrates, small molecules can modulate protein function in uniquely diverse ways.
Antidote
JULY 22, 2022
Skin cancer is more common than any other type of cancer, and melanoma causes a large majority of skin cancer-related deaths. While awareness surrounding melanoma and the importance of sun protection has risen in recent years, CDC research shows that melanoma rates have still doubled over the last three decades.
Drug Patent Watch
JULY 17, 2022
This chart shows the pharmaceutical drugs with the greatest number of patents still in force. The number of patents covering a drug can be indicative of the value of a…. The post Which pharmaceutical drugs have the most patents? appeared first on DrugPatentWatch - Make Better Decisions.
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
Drug Channels
JULY 20, 2022
Cut through the steamy summer haze with our refreshing selection of articles and insights. In this issue: CVS disassociates itself from its chain pharmacy association Payers are paying attention to ICER Benefits of the biosimilar boom A fantastic takedown of health insurance deductibles Plus, I join the Advisory Board of Alto Pharmacy. P.S. Join my nearly 30,000 (!
Advarra
JULY 21, 2022
For decades, many research sites have primarily relied on institutional review board (IRB) oversight provided by committees administered by the local institution conducting the research. Additionally, IRBs administered by independent organizations have always been an option for research sites who do not administer their own local IRB. Recently, federal requirements have shifted to require most multisite clinical trials rely on a single IRB (sIRB) for oversight at all participating sites.
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, 2022
This chart shows the drugs with the most patents in Austria. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.…. The post Which pharmaceutical drugs have the most drug patents in Austria? appeared first on DrugPatentWatch - Make Better Decisions.
Drug Channels
JULY 22, 2022
Today’s guest post comes from Ian Ocilka, Senior VP of Client Solutions at ConnectiveRx. Ian shares an overview of The Evolving Role of Hubs and Patient Services , his recent presentation at Informa Connect's Hub and Specialty Model East conference in June. Click here to watch Ian’s full presentation. Read on for Ian’s insights. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.
Advarra
JULY 19, 2022
For research sites whose communities include large populations of non-English speakers, it may be standard operating procedure (SOP) to obtain a translated version(s) of the study’s informed consent document at the beginning of each study. That way, when a non-English speaking potential study participant shows interest in the trial, researchers can help the potential participant learn more about the research without missing a beat.
Atomwise Blog
JULY 18, 2022
Atomwise scientists are using machine learning to help University of Alberta researchers find compounds that have the potential to regrow damaged nerves. Nerve damage is a common problem following injury in neurological disorders, but regrowing damaged nerves is difficult — especially if the underlying condition has been around for a long time. Even if the underlying disease is curable, nerve damage can still persist.
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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 Patent Watch
JULY 19, 2022
This chart shows the companies which have received the most New Combination exclusivities in the past five years. New Combinations are one of the categories for which the FDA grants…. The post Pharmaceutical companies with the most ‘New Combination’ drugs appeared first on DrugPatentWatch - Make Better Decisions.
Drug Channels
JULY 18, 2022
Informa Connect’s Medicaid Drug Rebate Program (MDRP) Summit. Hybrid Event October 12-14, 2022 | Chicago, IL www.informaconnect.com/MDRP. Don’t miss the Medicaid Drug Rebate Program Summit coming up this fall in Chicago (or virtually). You'll return to the office having mastered complex regulatory guidelines to deliver compliant government pricing and reporting programs.
Advarra
JULY 19, 2022
Advarra experts Sharon Ayd and Leslie Paul answer questions from their webinar, The IND Journey Phase I – Navigating Success. Q: If an emergency use authorization (EUA) is granted, once there is an approved treatment, does that mean that the EUA is no longer valid? A: Yes, the EUA is just temporary. If the sponsor wants their drug approved, they need to complete all clinical studies and submit an application.
Antidote
JULY 19, 2022
Updated July 2022:
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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 22, 2022
Annual Drug Patent Expirations for IXEMPRA+KIT Ixempra Kit is a drug marketed by R-pharm Us Llc and is included in one NDA. It is available from one supplier. There are…. The post New patent expiration for R-pharm Us drug IXEMPRA KIT appeared first on DrugPatentWatch - Make Better Decisions.
Pharma Manufacturing
JULY 20, 2022
Four factors to keep in mind for mAb facility design and operations
Advarra
JULY 18, 2022
To protect human subjects in clinical research, the Food and Drug Administration (FDA) maintains and enforces specific regulations. Research stakeholders must track, document, and store the required information for trial oversight and monitoring to comply with regulations. This blog identifies applicable regulations and outlines regulated documents and data in clinical research and the systems used by sponsors, contract research organizations (CROs), monitors, and research sites to collect, exch
Drug & Device Law
JULY 18, 2022
At the end of the term, the Supreme Court, in Ruan v. United States , 2022 WL 2295024, 142 S. Ct. 2370 (2022), vacated the convictions of a couple of alleged “pill mill” doctors under the Controlled Substances Act upon finding that the government’s proof in their criminal trial did not meet the standard required by 21 U.S.C. §841’s “knowingly or intentionally” scienter (that’s legal Latin for the degree of intent required for a crime or tort) requirement for illegal drug distribution.
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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 22, 2022
Annual Drug Patent Expirations for VRAYLAR Vraylar is a drug marketed by Allergan and is included in one NDA. It is available from two suppliers. There are three patents protecting…. The post New patent for Allergan drug VRAYLAR appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JULY 21, 2022
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.
Drug Patent Watch
JULY 21, 2022
Annual Drug Patent Expirations for VENCLEXTA Venclexta is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are seven patents…. The post New patent for Abbvie Inc drug VENCLEXTA appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JULY 21, 2022
Palbociclib is the generic ingredient in one branded drug marketed by Pfizer and is included in two NDAs. There are six patents protecting this compound. Drug patent litigation for PALBOCICLIB.…. The post New tentative approval for Eugia Pharma drug palbociclib appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JULY 21, 2022
Annual Drug Patent Expirations for INLYTA Inlyta is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from two suppliers. There are four…. The post New patent for Pf Prism drug INLYTA appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JULY 21, 2022
Annual Drug Patent Expirations for ONIVYDE Onivyde is a drug marketed by Ipsen Inc and is included in one NDA. It is available from one supplier. There are sixteen patents…. The post New patent for Ipsen Inc drug ONIVYDE appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JULY 21, 2022
Annual Drug Patent Expirations for SPIRIVA Spiriva is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from two suppliers. There are sixteen patents…. The post New patent expiration for Boehringer Ingelheim drug SPIRIVA appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JULY 21, 2022
Annual Drug Patent Expirations for RINVOQ Rinvoq is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are fifteen patents…. The post New patent for Abbvie Inc drug RINVOQ appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JULY 20, 2022
Annual Drug Patent Expirations for LYMPHOSEEK+KIT Lymphoseek Kit is a drug marketed by Cardinal Health 414 and is included in one NDA. It is available from one supplier. There are…. The post New patent for Cardinal Health drug LYMPHOSEEK KIT appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JULY 20, 2022
Annual Drug Patent Expirations for COTELLIC Cotellic is a drug marketed by Genentech Inc and is included in one NDA. It is available from one supplier. There are six patents…. The post New patent for Genentech Inc drug COTELLIC appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JULY 20, 2022
Annual Drug Patent Expirations for LIVMARLI Livmarli is a drug marketed by Mirum and is included in one NDA. There are two patents protecting this drug. This drug has thirty-two…. The post New patent for MIRUM drug LIVMARLI appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JULY 20, 2022
Annual Drug Patent Expirations for TLANDO Tlando is a drug marketed by Antares Pharma Inc and is included in one NDA. It is available from one supplier. There are eight…. The post New patent for Antares Pharma drug TLANDO appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JULY 19, 2022
Annual Drug Patent Expirations for LYBALVI Lybalvi is a drug marketed by Alkermes Inc and is included in one NDA. It is available from one supplier. There are nine patents…. The post New patent for Alkermes Inc drug LYBALVI appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JULY 18, 2022
Palbociclib is the generic ingredient in one branded drug marketed by Pfizer and is included in two NDAs. There are six patents protecting this compound. Drug patent litigation for PALBOCICLIB.…. The post New tentative approval for Eugia Pharma drug palbociclib appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JULY 18, 2022
Annual Drug Patent Expirations for QSYMIA Qsymia is a drug marketed by Vivus and is included in one NDA. It is available from one supplier. There are six patents protecting…. The post New patent for VIVUS drug QSYMIA appeared first on DrugPatentWatch - Make Better Decisions.
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