Drug Discovery Today
MAY 31, 2022
Talk from Roche engineer Tiffany McIntire will highlightopportunities for the pharma sector to reinvent packaging to bemore focused on patient needs in areas such as medication takenorally
Drug Channels
JUNE 2, 2022
Today’s guest post comes from Bonnie Briggs, Associate Director of Clinical Effectiveness at Wolters Kluwer, Health. Bonnie describes how pharmaceutical care would benefit from standard medical record identification. She then discusses the practical issues behind implementing and adopting such a system. To learn more, download the Wolters Kluwer free ebook: Drug Data Unity: Realistic and Idealistic Futures for Information Exchange.
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Drug Patent Watch
MAY 30, 2022
Annual Drug Patent Expirations for VIMOVO Vimovo is a drug marketed by Horizon and is included in one NDA. It is available from one supplier. There are nine patents protecting…. The post New patent expiration for Horizon drug VIMOVO appeared first on DrugPatentWatch - Make Better Decisions.
PerkinElmer
JUNE 3, 2022
The current SARS-CoV-2 pandemic has highlighted the substantial threat posed by pathogenic coronaviruses to humans. To date, over six million people have died from COVID-19 across the globe and more than 500 million cases have been reported. 1 Although effective COVID-19 vaccines have been developed, variants of SARS-CoV-2 have already emerged for which vaccines are less effective, and many people remain unvaccinated due to certain medical conditions, personal choice, or global access challenges
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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 Today
JUNE 2, 2022
The topic of this month’s newsletter from Drug Discovery Today is “Cancer”.
Drug Channels
MAY 30, 2022
Summer unofficially began over the weekend. Let’s turn up the heat with these sizzling news bites straight from the Drug Channels grill: SaveonSP gets sued Thoughts on the Medicaid accumulator rule opinion CVS buys AmerisourceBergen’s specialty pharmacy Fresh data on hospitals’ cancer drug profiteering Plus, Dr. Glaucomflecken explains Aetna’s prior authorization policies.
Drug Discovery Digest brings together the best content for drug research and development professionals from the widest variety of industry thought leaders.
The Pharma Data
JUNE 2, 2022
Today, the U.S. Food and Drug Administration launched a new initiative, Supplement Your Knowledge , to help educate, inform, and broaden consumer, educator and healthcare professional understanding of dietary supplements. More than half of all Americans take dietary supplements daily or on occasion. Today’s Supplement Your Knowledge resources will provide reliable information about the potential benefits and risks associated with dietary supplements, such as vitamins, minerals, and herbs, they m
EG Life Sciences
JUNE 2, 2022
In his last talk at Bio-IT World, Dr. Terry Barnhart spoke of the potential of Agile practices in pharmaceutical innovation. At the most recent Bio-IT World conference , Barnhart shows how Agile practices not only bring products to market faster – they also save lives. As we have discussed in previous Lean Coffees about the intersections between Agile practices and Biopharma, organizations can incorporate Agile practices without using the "Agile" label or terminology , and a major example is Ope
The Open Targets Blog
MAY 31, 2022
Lorenzo Bomba was a postdoctoral fellow in the Soranzo group, which uses large-scale genomic analysis to study the human variation linked to cardiometabolic traits and diseases. He recently published the results of an Open Targets project which found new associations between genes and blood metabolites in the American Journal of Human Genetics.
Drug Patent Watch
MAY 31, 2022
Annual Drug Patent Expirations for OLUMIANT Olumiant is a drug marketed by Eli Lilly And Co and is included in one NDA. It is available from one supplier. There are…. The post New patent for Eli Lilly drug OLUMIANT appeared first on DrugPatentWatch - Make Better Decisions.
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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.
The Pharma Data
JUNE 2, 2022
Boehringer Ingelheim gains exclusive global rights to a panel of cancer-specific antibodies to enable the development of targeted cancer therapies These engineered antibodies may allow for specific targeting of tumor cells without binding to healthy cells This partnership allows Boehringer Ingelheim to strengthen its tumor cell-directed Antibody-Drug Conjugate (ADC) and immune cell-targeted (T-cell engager) portfolio.
Altus Drug Development
MAY 31, 2022
From natural health products to life-saving medicines, all pharmaceutical products must undergo an analytical method development process. Through analytical method development, validation, and transfer, drug development and manufacturing are kept safe, efficient, and compliant with the law. What is analytical method development? Analytical method development is the creation of a set of experimental conditions to perform analytical procedures in chemical samples.
National Drug & Alcohol Research Centre Blog
MAY 30, 2022
Dr Ryan Courtney and Jack Anderson Tobacco smoking is the leading preventable cause of death, globally. In 2019, approximately 14% of Australians aged 14 years or older were current smokers. That’s approximately 2.9 million Australians. On World No Tobacco Day , Dr. Ryan Courtney and his team would like to highlight the importance of quit smoking research in low socioeconomic populations and provide details on an exciting new technology-based quit support study that begins recruitment in June 20
Drug Patent Watch
MAY 31, 2022
Annual Drug Patent Expirations for EPHEDRINE+SULFATE Ephedrine Sulfate is a drug marketed by Akorn, Amneal, Dr Reddys Labs Ltd, Endo Ventures, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma,…. The post New patent for Endo Ventures drug EPHEDRINE SULFATE appeared first on DrugPatentWatch - Make Better Decisions.
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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
The Pharma Data
JUNE 2, 2022
Six African nations will join a partnership pioneered in Ghana using technology to track and better tackle sickle cell disease (SCD) Includes expanded rollout of an app to track babies diagnosed with SCD that is designed to work even with intermittent internet access, supporting early and effective care Partnership also broadens knowledge of disease burden and clinical pathway, enabling policy makers to include SCD as healthcare priority Hydroxyurea, current global standard of care for SCD, will
Altus Drug Development
MAY 31, 2022
Everyone is interested in having access to the best healthcare available. However, many patients end up having to face the fact that many treatments are unfeasible, too expensive, or potentially counter-conducive. Knowledge of issues within the healthcare system is not unknown to those in charge. However, dealing with them often requires making structural changes many industry players are not willing or able to perform.
Broad Institute
JUNE 3, 2022
Search By admin June 3, 2022 Breadcrumb Home Search Show results from www.broadinstitute.org intranet.broadinstitute.
Drug Patent Watch
MAY 31, 2022
Annual Drug Patent Expirations for PLUVICTO Pluvicto is a drug marketed by Aaa Usa Novartis and is included in one NDA. It is available from one supplier. The generic ingredient…. The post New patent for Aaa Usa drug PLUVICTO appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
JUNE 1, 2022
AstraZeneca’s Chief Executive Officer, Pascal Soriot, today received a British knighthood for services to UK life sciences and leadership in the global response to the COVID pandemic in the Queen’s Birthday Honours 2022. Leif Johansson, AstraZeneca Chair, said: “I am delighted for Pascal, his family, and all those at AstraZeneca with this recognition of his remarkable contribution to UK life sciences and response to the pandemic.
Altus Drug Development
MAY 31, 2022
Value-added medicines offer the medical world the opportunity to increase the quality of treatments as well as expand access to healthcare for more people. By improving the efficiency of the healthcare system, value-based healthcare contributes to its sustainability, addresses inefficiencies related to medicines, and offers economic advantages to all parties involved in medical treatments.
Translation
MAY 28, 2022
Companies invest more than $2 trillion in R&D annually to stay ahead of competition, identify new products, and find new sources of revenue. These R&D efforts are fundamental to solving some of the world’s most challenging problems like combating climate change and curing diseases. Today, 80% of companies that invest in R&D partner with outside innovators.
Drug Patent Watch
MAY 30, 2022
Annual Drug Patent Expirations for YOSPRALA Yosprala is a drug marketed by Genus Lifesciences and is included in one NDA. It is available from two suppliers. There are five patents…. The post New patent expiration for Genus Lifesciences drug YOSPRALA appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
JUNE 1, 2022
Blocking an immune response-related enzyme holds promise in preventing or treating severe COVID-19 symptoms by reducing inflammation, tissue injury and blood clots in the lungs, new research in mice suggests. Scientists who have long studied this molecule’s functions in bacterial infections traced development of extensive lung damage in infected mice to heightened levels of the enzyme triggered by the invading SARS-CoV-2 virus.
Altus Drug Development
MAY 31, 2022
Thanks to oral formulation, many drugs crucial for the health and well-being of millions of people can be administered and save countless lives. The field of drug formulation is in a constant state of innovation, creating a plethora of challenges to overcome, but also opening up a world of opportunities. What is oral formulation? Oral formulation is the development and manufacturing of pharmaceuticals designed for oral delivery.
The Connected Lab
MAY 31, 2022
Digital transformation is revolutionizing pharmaceutical research and manufacturing. Driven by technologies such as advanced automation, smart sensors, artificial intelligence and machine learning, digital transformation provides new opportunities for organizations to streamline workflows, boost productivity and improve quality throughout the value chain.
Drug Patent Watch
MAY 29, 2022
Annual Drug Patent Expirations for ADVIL+PM Advil Pm is a drug marketed by Glaxosmithkline and is included in two NDAs. It is available from four suppliers. There are three patents…. The post New patent expiration for Glaxosmithkline drug ADVIL PM appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
JUNE 1, 2022
The United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to efanesoctocog alfa (BIVV001) for the treatment of people with hemophilia A, a rare and life-threatening bleeding disorder, based on data from the pivotal XTEND-1 P hase 3 stud y. Sanofi and Sobi ® collaborate on the development and commercialization of efanesoctocog alfa.
Drug & Device Law
JUNE 2, 2022
Despite our use of plural pronouns, almost all of our posts come from a single author. We occasionally have guest posts by multiple authors or a post that pairs one of us with a subject matter expert. For this post, however, all seven authors of the Blog are joining together. We are just simple defense hacks writing about product liability law and some other things that matter to medical product manufacturers.
The Pharma Data
JUNE 1, 2022
Zuranolone 50 mg demonstrated a statistically significant and clinically meaningful improvement in depressive symptoms at Day 15, the primary endpoint, and at Days 3, 28, and 45, key secondary endpoints. Zuranolone 50 mg was generally well-tolerated and demonstrated a safety profile consistent with prior studies. Postpartum depression is one of the most common medical complications during and after pregnancy impacting approximately 1 in 8 women annually in the U.S.
The Pharma Data
MAY 31, 2022
BIIB122 is an inhibitor of LRRK2, a potential novel target intended to impact the underlying biology and slow the progression of Parkinson’s disease Phase 2b LUMA to enroll approximately 640 participants with early-stage Parkinson’s disease; most advanced clinical study of a LRRK2 inhibitor. Denali Therapeutics Inc. (NASDAQ: DNLI), and Biogen Inc. (NASDAQ:BIIB) today announced that dosing has commenced in the global Phase 2b LUMA study to evaluate the efficacy and safety of BIIB122 (DNL151), as
The Pharma Data
MAY 31, 2022
Study Showed Significant, Sustained Reduction in Lipoprotein(a) During Treatment Period. Lipoprotein(a) Reduction was Consistent With Phase 1 Results. Amgen (NASDAQ:AMGN) today announced positive topline data from the Phase 2 OCEAN(a)-DOSE clinical study, evaluating olpasiran (formerly AMG 890) in 281 adult patients with Lipoprotein(a), or Lp(a), levels over 150 nmol/L and evidence of atherosclerotic cardiovascular disease (ASCVD).
The Pharma Data
MAY 31, 2022
– Moderna to become marketing authorization holder in Japan and be responsible for all import, local regulatory, development, quality assurance and commercial activities for Spikevax TM from 1st August 2022 – Companies concluded memorandum of understanding that Takeda will continue to provide distribution support for the Moderna COVID-19 vaccines for a transitional period.
The Pharma Data
MAY 31, 2022
Multidisciplinary Steering Committee established to drive action includes patient advocacy leaders, healthcare professionals, biosimilar experts and industry leaders Action Plan will provide roadmap and tools to improve approvability, accessibility, acceptability and affordability (4As) of biosimilars Sandoz launched initiative to support improved healthcare access, equity and sustainability.
The Pharma Data
MAY 31, 2022
FDA accepts Dupixent ® (dupilumab) for priority review in adult s with prurigo nodularis. Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., if approved Acceptance marks another important step in advancing Dupixent for a broad range of diseases with underlying type 2 inflammation. The U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to
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