Bio Pharma Dive
APRIL 5, 2022
The 170,000-square-foot plant located in North Carolina can now fulfill its primary function: producing commercial-grade Zolgensma, which has become one of the Swiss pharma's top-selling drugs.
World of DTC Marketing
APRIL 5, 2022
The old model of looking at performance in the first six months of product launch isn’t relevant. Today, colossal budget product launches are not returning the same ROI as before. Product launches are going to need to be micro-targeted to specific audiences. What is the definition of a successful pharma product launch? Usually, it’s reaching a certain sales level within a specified time, but that metric is not relevant anymore.
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Bio Pharma Dive
APRIL 5, 2022
The pharma expects peak cardiovascular drug sales to exceed $10 billion next decade, by which time current top sellers Keytruda and Gardasil will no longer be patent protected.
Drug Patent Watch
APRIL 5, 2022
This is a guest post by Ray Miller and Megan E. Bowers, Ph.D. at DLA Piper. Ray may be contacted at raymond.miller@dlapiper.com. When it comes to protecting therapeutic assets, I…. The post The value of method of use patent claims in protecting your therapeutic assets appeared first on DrugPatentWatch - Make Better Decisions.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Bio Pharma Dive
APRIL 5, 2022
A new restructuring plan will result in job cuts across the company, a spokesperson said, as Bluebird awaits regulatory decisions on two of its products.
pharmaphorum
APRIL 5, 2022
It’s no secret that digital technologies are playing a significant role when it comes to shaping the next era of healthcare. Necessity accelerated the adoption of new and sophisticated technologies and systems throughout the COVID-19 pandemic, but this seismic shift towards digital health has opened up a gap in education. To successfully navigate the potential of digital technologies in healthcare, attention must be focused on upskilling professionals in the field to equip them with the necessar
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
APRIL 5, 2022
Data has shown that treatment with Kesimpta is associated with fewer relapses and reduced risk of worsening disability
Scienmag
APRIL 5, 2022
HOUSTON-(April 5, 2022) – Houston Methodist researchers have identified the genetic and molecular fingerprints of different cancer and immune cells in glioblastoma, the deadliest and most common type of brain cancer in adults. Credit: Houston Methodist HOUSTON-(April 5, 2022) – Houston Methodist researchers have identified the genetic and molecular fingerprints of different cancer and immune […].
Pharma Times
APRIL 5, 2022
In contrast to conventional methods, Evonetix uses thermal control which offers greater accuracy and selectivity
Scienmag
APRIL 5, 2022
Throughout the COVID-19 pandemic, creative nudges have prompted people to adopt simple behaviors in the name of public health. These behaviors include fist bumps in place of shaking hands and standing six feet apart, according to a study published in the peer-reviewed journal Population Health Management. Click here to read the article now. Credit: Mary […].
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Outsourcing Pharma
APRIL 5, 2022
Leaders from some of the industryâs most notable companies are working together to streamline and automate IDMP workflow and come up with various standards.
Scienmag
APRIL 5, 2022
Four faculty members in the University of Arizona College of Engineering have received CAREER Awards from the National Science Foundation. Their work ranges from improving drug delivery for disease and managing renewable energy to advancing quantum technology. The CAREER Award is the foundation’s most prestigious recognition of early-career faculty with potential to serve as academic role models […].
Drug Patent Watch
APRIL 5, 2022
Annual Drug Patent Expirations for EXPAREL Exparel is a drug marketed by Pacira Pharms Inc and is included in one NDA. It is available from one supplier. There are two…. The post New patent for Pacira Pharms drug EXPAREL appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
APRIL 5, 2022
WASHINGTON (April 6, 2022)—Latino/a adolescents who took on greater childcare responsibilities due to COVID-19 experienced a significant increase in symptoms of depression, anxiety and acting out behaviors such as aggression. They also experienced a significant drop in their grade point average, according to a study published today in the Journal of Youth and Adolescence.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Drug Patent Watch
APRIL 5, 2022
Annual Drug Patent Expirations for ZTLIDO Ztlido is a drug marketed by Scilex Pharms Inc and is included in one NDA. It is available from one supplier. There are five…. The post New patent for Scilex Pharms drug ZTLIDO appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
APRIL 5, 2022
Cost estimation expert Ricardo Valerdi, a University of Arizona Distinguished Outreach Professor(link is external) of systems and industrial engineering(link is external), traveled to Spain in late March to work with a research team based at the University Carlos III of Madrid, or UC3M, which specializes in informatics – the study of the structure, behavior and interactions of computer […].
Drug Patent Watch
APRIL 5, 2022
Annual Drug Patent Expirations for XOFLUZA Xofluza is a drug marketed by Genentech Inc and is included in two NDAs. It is available from two suppliers. There are six patents…. The post New patent for Genentech Inc drug XOFLUZA appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
APRIL 5, 2022
HOUSTON – (April 4, 2022) – A Rice University-led team of climate scientists and engineers is studying how climate change will impact the frequency and severity of flooding on the Mississippi River thanks to a new grant awarded by the National Science Foundation. Credit: Jeff Fitlow/Rice University HOUSTON – (April 4, 2022) – A Rice […].
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Drug Patent Watch
APRIL 5, 2022
Annual Drug Patent Expirations for VEKLURY Veklury is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are nine…. The post New patent for Gilead Sciences drug VEKLURY appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
APRIL 5, 2022
AMHERST, Mass. – An interdisciplinary team of researchers at the University of Massachusetts Amherst, led by Lynn Adler, professor of biology at UMass Amherst, has been awarded $2.4 million from the National Science Foundation (NSF) to trace how food affects the ability of pathogens to attack plant pollinators. The research will be the first conducted […].
pharmaphorum
APRIL 5, 2022
AstraZeneca’s take on the PCSK9 inhibitor – an antisense drug licensed from Ionis six years ago – has cleared a proof-of-concept trial in high-risk patients with high blood cholesterol, but it remains to be seen where it will fit into the increasingly busy category. Results of the phase 2b ETESIAN trial of AZD8233 showed that the drug was effective, reducing low-density lipoprotein cholesterol (LDL-C) levels by 73% from baseline, when given as a once-monthly subcutaneous injection over 12
Scienmag
APRIL 5, 2022
An international team of health researchers have, for the first time, described how genetic defects influence the spectrum of vision development and cause problems in developing babies’ eyes. Researchers from the University of Leicester led an international effort consisting of 20 expert centres in the largest study of its kind to date, examining the genes […].
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
pharmaphorum
APRIL 5, 2022
Immunocore now has approval on both side of the Atlantic for Kimmtrak – the first cancer therapeutic based on T cell receptor (TCR) technology – after getting a green light from the European Commission. Kimmtrak (tebentafusp) has been cleared to for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM), mirroring its label in the US.
Scienmag
APRIL 5, 2022
A new study provides the first evidence that rising greenhouse gases have a long-term warming effect on the Amundsen Sea in West Antarctica. Scientists from British Antarctic Survey (BAS) say that while others have proposed this link, no one has been able to demonstrate it. Ice loss from the West Antarctic Ice Sheet in the […].
pharmaphorum
APRIL 5, 2022
For many years, those inside the pharma industry have been telling the same old story about innovation: pharma is big, slow, and risk averse. Start-ups move fast and break things. That culture clash makes it hard to innovate the world of pharma at scale and with any rapidity. And investment in pharma followed suit: pharma companies were looked at as stable assets — reliable but unlikely to balloon in value like a tech company might.
Scienmag
APRIL 5, 2022
Researchers from a USC-led consortium have discovered 15 “hotspots” in the genome that either speed up brain aging or slow it down — a finding that could provide new drug targets to resist Alzheimer’s disease and other degenerative brain disorders, as well as developmental delays. The research appears online today in Nature Neuroscience. “The big game-changer […].
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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.
pharmaphorum
APRIL 5, 2022
Gene therapy specialist bluebird bio has said 30% of its workforce will lose their jobs, in a bid to conserve cash as it tried to get its lead programmes over the finish line. The biotech said it wants to eke out its financial reserves while it waits for the FDA’s verdict on betibeglogene autotemcel (beti-cel) in for beta thalassaemia and elivaldogene autotemcel (eli-cel) for cerebral adrenoleukodystrophy (CALD), both due later this year.
Scienmag
APRIL 5, 2022
A new study authored by three NAU researchers found that people with lower socioeconomic status and people from ethnic minority populations have a greater likelihood of severe stroke than white Americans or those of a higher socioeconomic status (SES). But it’s not just that—those groups also are more likely to have a more severe stroke […].
pharmaphorum
APRIL 5, 2022
Cytokinetics’ hopes of resurrecting cardiac myosin inhibitor omecamtiv mecarbil have suffered another setback, after the drug failed to show a benefit in a phase 3 heart failure study. In the METEORIC-HF trial, omecamtiv was unable to show an improved performance in exercise capacity among patients with heart failure with reduced ejection fraction (HFrEF) compared to placebo.
Scienmag
APRIL 5, 2022
Machines can beat the world’s best chess player, but they cannot handle a chess piece as well as an infant. This lack of robot dexterity is partly because artificial grippers lack the fine tactile sense of the human fingertip, which is used to guide our hands as we pick up and handle objects. Credit: Prof. […].
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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