Drug Discovery World
SEPTEMBER 22, 2022
A new bioreactor platform that aims to support the cell and gene therapy (CGT) sector from process development to commercial manufacturing has been launched. The Quantum Flex Cell Expansion System has been created by medical technology company Terumo Blood and Cell Technologies (Terumo BCT). Using the system, developers can complete early process development on the same platform as manufacturing.
Drug Channels
SEPTEMBER 23, 2022
Today’s guest post comes from Lindsey Alves, Vice President of Customer Success at Kalderos. Lindsey describes the challenges facing remote workers who manage government-managed drug discount programs. As she explains, all drug discount stakeholders require novel technology-enabled collaboration tools. To learn more, register for Kalderos’ panel discussion, The Dreaded Duplicate Discounts: Collaborating in the New Hybrid Working Landscape.
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Antidote
SEPTEMBER 21, 2022
September 21 is World Alzheimer’s Day , a day of recognition aimed at increasing awareness of and understanding the issues faced by people living with Alzheimer’s. Though there are many conditions that can cause memory loss , Alzheimer’s is one of the most common — it is estimated that 5.4 million Americans are living with the condition , most of whom are over the age of 65.
Drug Patent Watch
SEPTEMBER 23, 2022
Annual Drug Patent Expirations for ADDYI Addyi is a drug marketed by Sprout Pharms and is included in one NDA. It is available from one supplier. There are four patents…. The post New patent for Sprout Pharms drug ADDYI 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.
Drug Discovery World
SEPTEMBER 23, 2022
The Fall Issue of the Drug Discovery World Magazine is out now. . Featuring? Specialty Spotlight on Neuroscience,? the magazine?is available to download and read for free on the DDW App.? . Key features of the Fall Issue include How AI in Pharma Can Live Up to the Hype, insight into drug repurposing and Moderna explains how mRNA technology may hold the future for a cytomegalovirus vaccine. .
Drug Channels
SEPTEMBER 20, 2022
On October 11, 2022, Drug Channels Institute will release The 2022–23 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. This report—our thirteenth edition— remains the most comprehensive, fact-based tool for understanding and analyzing the large and growing U.S. pharmaceutical distribution industry. We are providing you with the opportunity to preorder this thoroughly updated and revised 2022-23 edition at special discounted prices.
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
SEPTEMBER 23, 2022
Annual Drug Patent Expirations for SLYND Slynd is a drug marketed by Exeltis Usa Inc and is included in one NDA. There are nine patents protecting this drug. SLYND drug…. The post New patent for Exeltis Usa drug SLYND appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery World
SEPTEMBER 23, 2022
The European Commission (EC) has granted marketing authorisation for Alnylam Pharmaceuticals’ AMVUTTRA (vutrisiran) for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis. The RNAi therapeutic has been approved in adult patients with stage 1 or stage 2 polyneuropathy, following positive 18-month results from the HELIOS-A Phase III study.
Drug Channels
SEPTEMBER 21, 2022
The battle for control of the specialty patient continues. In 2022, specialty pharmacies—via white, brown, and clear bagging—now constitute a meaningful share of the distribution channels for provider-administered oncology drugs. However, buy-and-bill appears to have rebounded substantially at hospitals. As I explain below, this resurgence likely reflects the success of vertically-integrated hospital/specialty pharmacy/physician mega-systems against the large insurer/PBM/specialty pharmacy/provi
Olympian Clinical Research
SEPTEMBER 22, 2022
It is estimated that about 14% of the population will experience onychomycosis, more commonly known as toenail fungus, at some point in their lives. Toenail fungus may affect people of all ages, but it is more common in adults over 60. Furthermore, it can quickly spread to other toenails if left untreated. This all-inclusive guide will teach you everything you need to know about toenail fungus, from identifying the symptoms to exploring treatment options.
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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
SEPTEMBER 23, 2022
Annual Drug Patent Expirations for DROSPIRENONE Drospirenone is a drug marketed by Exeltis Usa Inc, Barr, Glenmark Pharms Ltd, Hetero Labs Ltd, Hlthcare, Jubilant Cadista, Mylan Labs Ltd, Watson Labs,…. The post New patent for Exeltis Usa drug DROSPIRENONE appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery World
SEPTEMBER 23, 2022
News round-up for 19-23 September by DDW Editor Reece Armstrong. An interesting week for clinical research and drug approvals, with rare diseases being a key focus for both the FDA and European Commission. The last week has seen data emerge on how Omicron infection could protect against influenza, how breast cancer cells evade therapies, and two approvals on rare diseases in the US and EU.
ProRelix Research
SEPTEMBER 21, 2022
According to the World Health Organization (WHO), cancer is the leading cause of death worldwide, with a death rate of one in six in 2020 (1). Aside from the high […]. The post Cancer Clinical Trials: USA Scenario and Study Designs appeared first on ProRelix Research.
Translation
SEPTEMBER 19, 2022
Like most startups, Halo looks much different today than it did when we started, but the problem we’re solving hasn’t changed — there are thousands of scientific discoveries that never materialize into real-world solutions. At first, we tried to solve this problem by crowdfunding research projects to help leapfrog these nascent technologies over the so-called “valley of death.
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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
SEPTEMBER 23, 2022
Annual Drug Patent Expirations for VABOMERE Vabomere is a drug marketed by Rempex and is included in one NDA. It is available from one supplier. There are six patents protecting…. The post New patent for Rempex drug VABOMERE appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery World
SEPTEMBER 22, 2022
This is the latest episode of the free DDW podcast, “China’s opportunities for global drug discovery breakthroughs”. It covers three articles written for Volume 22, Issue 4 – Fall 2021 of DDW, narrated by DDW Multimedia Editor Megan Thomas. They are called “ Is China entering a new phase for drug discovery? ”, “ Finding drug discovery opportunities in China ” and “ Why biotech in China offers global opportunities ”.
Antidote
SEPTEMBER 20, 2022
Sickle cell disease (SCD) refers to a genetically inherited set of red blood cell disorders that are present from birth. Millions of people are impacted by SCD each year, but it disproportionately impacts Black and African American populations, occurring in about 1 out of every 365 Black or African-American births.
National Institute on Drug Abuse: Nora's Blog
SEPTEMBER 19, 2022
Addiction often goes hand-in-hand with other mental illnesses. Both must be addressed. mfleming Mon, 09/19/2022 - 19:50 Nora's Blog September 27, 2022 Image ©Getty Images/ PeopleImages This op-ed was originally published by The Hill on September 12, 2022 Natalie struggled with a methamphetamine use disorder for more than 9 years. She was one of the fortunate few to receive treatment to address her addiction, yet that help felt incomplete.
Drug Patent Watch
SEPTEMBER 22, 2022
Annual Drug Patent Expirations for BETHKIS Bethkis is a drug marketed by Chiesi and is included in one NDA. It is available from two suppliers. There are three patents protecting…. The post New patent expiration for Chiesi drug BETHKIS appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery World
SEPTEMBER 22, 2022
This is the latest episode of the free DDW podcast, “China’s opportunities for global drug discovery breakthroughs”. It covers three articles written for Volume 22, Issue 4 – Fall 2021 of DDW, narrated by DDW Multimedia Editor Megan Thomas. They are called “ Is China entering a new phase for drug discovery? ”, “ Finding drug discovery opportunities in China ” and “ Why biotech in China offers global opportunities ”.
Advarra
SEPTEMBER 20, 2022
Site selection for clinical trials is often one of the biggest headaches for pharmaceutical sponsors and contract research organizations (CROs). Even with enough due diligence, activated sites can still fail to recruit the desired number of study participants. Reliable industry estimates peg the cost of these under-accruing sites to the pharmaceutical industry at between $600,000 to eight million dollars per day of trial delay.
sptlabtech
SEPTEMBER 20, 2022
Researchers need biobanks to provide high-quality samples via optimal processing, secure storage, and preservation under the appropriate conditions for the lifetime of the sample. Fundamental to the success of a biobank is the ability to preserve high-quality samples for many decades. Automated storage solutions offer both quantitative and more intangible benefits to the biobank workflow, such as integrated sample traceability, secure storage, increased retrieval speed, and sample preservation.
Drug Patent Watch
SEPTEMBER 21, 2022
Annual Drug Patent Expirations for ZUBSOLV Zubsolv is a drug marketed by Orexo Us Inc and is included in one NDA. It is available from one supplier. There are nine…. The post New patent for Orexo Us drug ZUBSOLV appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery World
SEPTEMBER 22, 2022
New trial data has shown consistent cardiovascular benefits from Novo Nordisk’s semaglutide in adults with type 2 diabetes, regardless of baseline blood sugar or kidney function. The results show that treatment with Ozempic (once-weekly semaglutide) or Rybelsus (oral semaglutide) demonstrated consistent reductions in major adverse cardiovascular events (MACE) compared with placebo.
Crown Bioscience
SEPTEMBER 22, 2022
Modern high-content imaging (HCI) and analysis platforms provide simultaneous multi-parameter visualization and quantification of thousands of cells including 3D in vitro models. This highly comprehensive information provides deep insights into the mechanisms of action, toxicity, and synergistic and off-target effects of single and combinations of compounds.
Drug & Device Law
SEPTEMBER 19, 2022
Under Wyeth v. Levine, 555 U.S. 555 (2009) , and PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) , failure-to-warn claims targeting a pharmaceutical are preempted unless the manufacturer could have provisionally changed its warning label without prior FDA approval under the “changes being effected” (“CBE”) provision codified at 21 C.F.R. § 314.70(c)(6)(iii)(A).
Drug Patent Watch
SEPTEMBER 21, 2022
Annual Drug Patent Expirations for VELPHORO Velphoro is a drug marketed by Vifor Fresenius and is included in one NDA. It is available from one supplier. There are ten patents…. The post New patent for Vifor Fresenius drug VELPHORO appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery World
SEPTEMBER 22, 2022
Nefecon has become the first and only approved treatment in the EU for primary immunoglobulin A nephropathy (IgAN), a rare, progressive kidney disease. The European Medicines Agency said that the medicine “was shown to be effective at lowering the level of excess protein in the urine in patients with IgAN, indicating an improvement in kidney function”.
Drug Discovery World
SEPTEMBER 22, 2022
Pfizer has extended its multi-year partnership with CytoReason to use CytoReason’s artificial intelligence (AI) technology for Pfizer’s drug development programs. . Pfizer will make a $20 million equity investment, have options to license CytoReason’s platform and disease models, and fund supplementary project support. This deal which has the potential to be worth up to $110 million over the next five years. .
Drug Discovery World
SEPTEMBER 22, 2022
The latest Omicron variants of Covid could be protective against serious influenza infection, a leading testing expert says. The milder variants have now made Covid-19 less dangerous than the flu, though there is still the risk of developing long Covid. Dr Quinton Fivelman PhD, Chief Scientific Officer at London Medical Laboratory, says: “Finally, there may be a silver lining to the pandemic cloud.
Drug Discovery World
SEPTEMBER 21, 2022
A proof of concept (POC) study has shown the clinical benefit of zapnometinib in patients with severe Covid-19 and supports further evaluation in severe viral diseases. Atriva Therapeutics and investigators will continue to evaluate the RESPIRE data and will provide an update on the full dataset in due course. The POC / Phase IIa RESPIRE study (zapnometinib) in patients hospitalised with moderate-to-severe Covid-19 met its primary endpoint of improvement on the clinical severity status (CSS) sca
Drug Discovery World
SEPTEMBER 21, 2022
Otsuka Pharmaceutical’s Lupkynis (voclosporin) is the first oral treatment to be approved in Europe for the treatment of active lupus nephritis (LN) in adult patients. The drug has received approval from the European Commission (EC) in combination with mycophenolate mofetil (MMF) for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) LN.
Drug Discovery World
SEPTEMBER 21, 2022
Zoe Hughes-Thomas, GSK, will be discussing the ways in which Automation Can Help With The Discovery of Biologics and Biosimilars at the new Tech Theatre at this year’s ELRIG Drug Discovery, supported by DDW. Hughes-Thomas is Associate Director, Head Medicine Design Automation, GSK. The Tech Theatre will feature a series of seminars focused on automation and technology for drug discovery. .
Drug Discovery World
SEPTEMBER 21, 2022
Register now to attend the free webinar, Introduction into Fragment Based Drug Discovery, hosted by DDW and supported by WuXi AppTec. The event will take place on Thursday, October 13 at 3PM BST, 4PM CET, 10AM EST, 7AM PDT. Fragment-based drug discovery (FBDD) is a method used for finding hit compounds as one strategy of hit identification (hit ID) in the drug discovery process.
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