Bio Pharma Dive
SEPTEMBER 9, 2021
The French drugmaker bought Principia Biopharma last year for two therapies that block a protein called BTK. The second targets a much bigger disorder, multiple sclerosis.
World of DTC Marketing
SEPTEMBER 9, 2021
SUMMARY: Allowing Medicare to negotiate drug prices is popular with voters because the media has been focused on the high price of some drugs, but this measure won’t lead to lower healthcare costs. Still, in a JAMA study, the median net income (earnings) expressed as a fraction of revenue was significantly greater for pharmaceutical companies than nonpharmaceutical companies (13.8% vs. 7.7%).
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Bio Pharma Dive
SEPTEMBER 9, 2021
Formed as a diagnostics developer, Mammoth Biosciences, which Doudna started with two of her former students at the University of California, has accelerated plans to make gene editing medicines as well.
Pharma Mirror
SEPTEMBER 9, 2021
Sterling Pharma Solutions, a global contract development and manufacturing organisation, today announced the completion of the initial phase of investment at its site in Dudley, UK to create the company’s centre of excellence for research into commercial applications of continuous flow chemistry. Announcement of the investment follows the appointment of Professor Ian R.
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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
SEPTEMBER 9, 2021
An agreement with the Dutch biotech, which could be worth as much as $1.3 billion, expands Lilly's work in genetic medicine research.
XTalks
SEPTEMBER 9, 2021
The US Food and Drug Administration (FDA) has placed a clinical hold on BioMarin Pharmaceutical’s investigational gene therapy BMN 307 for the rare inherited disease phenylketonuria (PKU) over safety concerns found during preclinical testing. The federal regulator suspended BioMarin’s currently ongoing Phase I/II studies of the gene therapy based on interim safety findings from a preclinical study which revealed that mice treated with the therapy at high doses developed tumors on their liver.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
SEPTEMBER 9, 2021
The trial will aim to enrol 640 healthy adults, aged 50- to 70-years-old
Scienmag
SEPTEMBER 9, 2021
Contrary to common thinking, cocaine triggers an addiction only in 20% of the consumers. But what happens in their brains when they lose control of their consumption? Thanks to a recent experimental method, neuroscientists at the University of Geneva (UNIGE), Switzerland, have revealed a brain mechanism specific to cocaine, which has the particularity of triggering […].
pharmaphorum
SEPTEMBER 9, 2021
Increasing public spending on healthcare in Central and Eastern Europe (CEE) could not only result in healthier populations, it could also improve the region’s economic prosperity. That’s according to a new report commissioned by the European Federation of Pharmaceutical Industry and Associations (EFPIA), which explores the health investment and outcomes.
Outsourcing Pharma
SEPTEMBER 9, 2021
The digital therapeutics firm's Neuroglee Connect remote care platform and virtual clinic is for patients with mild cognitive impairment, including Alzheimerâs.
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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
BioSpace
SEPTEMBER 9, 2021
Selecta and Cyrus' partnership will pair Selecta’s immune-modulating ImmTOR platform with Cyrus’ ability to redesign protein therapeutics through its de novo computational approach.
BioPharma Reporter
SEPTEMBER 9, 2021
Adaptimmune Therapeutics, which focuses on solid tumors, has announced a tie-up with Roche's Genentech to develop and commercialize allogeneic cell therapies to treat multiple oncology indications.
Outsourcing Pharma
SEPTEMBER 9, 2021
Nucala, a monoclonal antibody indicated for patients with chronic rhinosinusitis with nasal polyps, has been approved by the Food and Drug Administration.
Drug Channels
SEPTEMBER 9, 2021
Cardinal Health recently released the annual report for its 2021 fiscal year, which ended on June 30. See the links below. Today, I delve into the financials behind Cardinal’s relationship with its largest customer, CVS Health. In Cardinal’s 2021 fiscal year, CVS purchased more than $42 billion in pharmaceuticals from the wholesaler—about double the figure from 10 years ago.
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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.
BioSpace
SEPTEMBER 9, 2021
A recently published study points to a previous SARS infection—plus vaccination—as the key to a robust immunity against SARS-CoV-2.
Scienmag
SEPTEMBER 9, 2021
More than 3 million women of birthing age in the U.S. and 60 million in the world have diabetes—a disease that occurs when blood sugar is too high. Even when controlled with insulin, and blood sugar levels are kept mostly in check, maternal diabetes can cause permanent damage to the fetus. About 300,000 to 400,000 […].
BioSpace
SEPTEMBER 9, 2021
The company aims to make RNA molecules visible and druggable – opening the door to study RNA-based diseases.
Delveinsight
SEPTEMBER 9, 2021
Roche’s Genentech taps Adaptimmune for T-Cell Therapy Collaboration for USD 3 Billion. A collaboration valued more than USD 3 billion, Genentech, a member of the Roche Group, declared it will collaborate with Adaptimmune for developing and commercializing allogeneic T-cell therapies to treat multiple cancer indications. Under their deal Genentech will work with Adaptimmune to develop “off-the-shelf” allogeneic T-cell therapies for up to five shared cancer targets, and a novel allogeneic personal
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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.
BioSpace
SEPTEMBER 9, 2021
Non-negotiables are the factors that you decide must exist or must not exist in order for you to say yes to a position.
Pharma Times
SEPTEMBER 9, 2021
Consultation will also ask for views on whether flu vaccines should be a requirement for health and care staff
BioSpace
SEPTEMBER 9, 2021
Philip Dormitzer explained that there are plenty of reasons to be excited about the prophylactic and therapeutic potential of mRNA.
Pharma Times
SEPTEMBER 9, 2021
Rilzabrutinib missed primary and secondary endpoints as a treatment for pemphigus
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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.
BioSpace
SEPTEMBER 9, 2021
?Acorda Therapeutics is reducing its staff count by 15% effective immediately as it struggles to bring operating costs down and hit expected revenue.
Pharma Times
SEPTEMBER 9, 2021
Positive results revealed from two Phase III trials of potential asthma therapy
BioSpace
SEPTEMBER 9, 2021
Apellis Pharmaceuticals reported topline results from its Phase III DERBY and OAKS clinical trials for geographic atrophy secondary to age-related macular degeneration.
Scienmag
SEPTEMBER 9, 2021
We cannot simply assume that unthinkingly applying digital technologies will inevitably bring about a seamless transition to a “better” digital world—a world in which the values of collective action, common knowledge and civic dignity are the norm—rather than ending up in a world of financial or social exploitation through surveillance capitalism, techno-feudalism and diminished humanity. […].
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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.
BioSpace
SEPTEMBER 9, 2021
?Mammoth will use the funds to build and broaden its stable of next-generation CRISPR products to detect and cure various diseases.
Drug Patent Watch
SEPTEMBER 9, 2021
Annual Drug Patent Expirations for JARDIANCE Jardiance is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from four suppliers. There are six patents…. The post New patent for Boehringer Ingelheim drug JARDIANCE appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
SEPTEMBER 9, 2021
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
Drug Patent Watch
SEPTEMBER 9, 2021
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 four patents…. The post New patent for Genentech Inc drug COTELLIC appeared first on DrugPatentWatch - Make Better Decisions.
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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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