Bio Pharma Dive
JANUARY 27, 2022
The site, which specializes in manufacturing off-the-shelf immunotherapies, was once a key asset for Atara. New owner Fujifilm will still supply the biotech under a long-term agreement.
World of DTC Marketing
JANUARY 24, 2022
Venture capitalists have poured $42 billion into drug development over the past three years. Most small biotech companies rely on venture capitalist funding to develop new drugs but is that a good way to go? not necessarily. VCs invest money in biotech because they see a potential windfall via a profitable acquisition or sale, but when the FDA weighs in with delays, VCs can be ruthless.
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pharmaphorum
JANUARY 27, 2022
Walter Greenleaf, PhD, neuroscientist and digital health expert at Stanford University’s Virtual Human Interaction Lab, tells us about the new book Applied Virtual Reality in Healthcare: Case Studies and Perspectives and why he and his co-authors gathered insights from some of the most prominent figures in the field of medical extended reality (XR).
Scienmag
JANUARY 23, 2022
PITTSBURGH, Jan. 24, 2022 – How fatigued certain activities make an older person feel can predict the likelihood death is less than three years away, according to research published today in the Journal of Gerontology: Medical Sciences by University of Pittsburgh epidemiologists. It is the first study to establish perceived physical fatigability as an indicator […].
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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
JANUARY 26, 2022
U.K.-based Immunocore's treatment, known as Kimmtrak, is also the first T cell receptor drug to have reached market in the U.S. so far.
World of DTC Marketing
JANUARY 25, 2022
Clunky, costly, highly regulated health systems, often dominated by rent-seeking middlemen, are being shaken up by firms that target patients directly, meet them where they are—which is increasingly online—and give them more control over how to access care. Here is a summary of the article from The Economist. “Unicorns” are competing with incumbent healthcare companies and technology giants to make people better and prevent them from getting ill in the first place.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
JANUARY 25, 2022
The UCL study will evaluate the safety and effectiveness of MTL-CEBPA in combination with second line standard of care sorafenib versus the use of sorafenib in isolation
Bio Pharma Dive
JANUARY 26, 2022
The study will test a version of the biotech's COVID-19 shot that's tailored to the infectious variant. New data, meanwhile, help affirm the benefit of a third dose of Moderna's current vaccine.
World of DTC Marketing
JANUARY 26, 2022
This is an exciting time to be in healthcare marketing. We’re witnessing the most significant transformation in healthcare marketing since DTC was approved in the ’90s. We’re moving from an era of “promotional marketing” to an age of “data is key” and “helping patients become consumers of healthcare.” HCP’s are moving quickly into digital.
pharmaphorum
JANUARY 26, 2022
Immunocore has secured a piece of biotech industry history, becoming the first company to get an FDA approval for a cancer therapeutic based on T cell receptor (TCR) technology. The US regulator cleared the company’s lead TCR Kimmtrak (tebentafusp; formerly IMCgp100 ) – a bispecific T cell engager (BiTE) that consists of a soluble TCR targeting gp100 expressed on cancer cells fused to a protein that binds CD3 receptors on lymphocytes – as a treatment for unresectable or metastatic uveal me
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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
XTalks
JANUARY 24, 2022
Fooditive Group , a plant-based ingredient manufacturer, recently developed a vegan version of casein, one of the main animal proteins in milk. The Dutch startup used precision fermentation to create vegan casein, making it possible to replace cow’s milk in dairy products without losing flavor, texture or quality. In developing the vegan casein, Fooditive aims to eradicate the downsides of factory farming, antibiotics, hormones and lactose.
Bio Pharma Dive
JANUARY 27, 2022
Backed by some of biotech's most powerful investors, Septerna is looking to usher in the next chapter of medicines that act on G protein-coupled receptors.
Eye on FDA
JANUARY 26, 2022
FDA’s Office of Prescription Drug Promotion (OPDP) issued the first regulatory action letter for 2022. This one has some notable characteristics. As has been frequently noted, enforcement actions by OPDP have diminished considerably over the years. Another characteristic of recent enforcement actions over the past several years is that smaller, less well-known companies have mostly been the recipients of letters from OPDP.
pharmaphorum
JANUARY 28, 2022
Merck & Co has passed another milestone in its drive to move PD-1 inhibitor Keytruda earlier in the treatment pathway for cancer, with the European Commission approving use of the drug as post-surgery (adjuvant) therapy for renal cell carcinoma (RCC). Adjuvant treatment moves use of the drug into patients with earlier-stage cancer, a key strategy for Merck and other cancer immunotherapy companies as it expands the pool of patients eligible for treatment.
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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.
BioPharma Reporter
JANUARY 26, 2022
Japanâs ministry for health has approved Abecma as a CAR T-cell therapy for adults with relapsed or refractory multiple myeloma who received at least three prior therapies.
Bio Pharma Dive
JANUARY 24, 2022
According to the drugmaker, the FDA asked in a complete response letter for more information related to how the drug's efficacy was measured.
XTalks
JANUARY 28, 2022
Immunocore, a commercial-stage biotechnology company developing T cell receptor (TCR)-based immunotherapies in oncology, autoimmune and infectious diseases, has won approval from the US Food and Drug Administration (FDA) for its novel immunotherapy Kimmtrak (tebentafusp-tabn), making it the first approved treatment for unresectable or metastatic uveal melanoma and first TCR therapeutic to receive regulatory approval.
pharmaphorum
JANUARY 24, 2022
A private equity group has agreed to take over most of IBM Watson Health, seven years after the business was launched with a pledge to revolutionise healthcare data analysis. Francisco Partners is picking up a range of databases and analytics tools – including Health Insights, MarketScan, Clinical Development, Social Programme Management, Micromedex and other imaging and radiology tools – for an undisclosed sum estimated to be in the region of $1 billion.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
BioPharma Reporter
JANUARY 26, 2022
Contract packaging and clinical supply services company Sharp has completed the construction of new purpose-built production suites to facilitate the packaging, storage and distribution of gene therapies at its facility in Heerenveen, The Netherlands.
Bio Pharma Dive
JANUARY 24, 2022
With other COVID treatments ineffective against the variant or in short supply, the FDA is expanding its approval of Veklury to include outpatient use.
XTalks
JANUARY 26, 2022
A field application scientist is a valuable member of any life science company due to their direct interaction with customers. Field application scientists help laboratory groups successfully install and apply the newest scientific supplies, equipment, instruments and software. An application scientist typically works for life science companies that manufacture laboratory tools or provide a service for laboratory use.
pharmaphorum
JANUARY 25, 2022
The area of digital therapeutics is growing rapidly, and in this piece Ben Hargreaves examines why this is the case, how broadly these therapies can be applied and why investment in the area is mounting. To demonstrate how quickly the digital therapeutics space is developing, it is easiest to state that the first such therapy was approved in 2018 and since that point the annual investment in the space has more than doubled in the intervening years.
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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
JANUARY 24, 2022
Annual Drug Patent Expirations for ESBRIET Esbriet is a drug marketed by Genentech Inc and is included in two NDAs. It is available from one supplier. There are twenty-one patents…. The post New patent expiration for Genentech Inc drug ESBRIET appeared first on DrugPatentWatch - Make Better Decisions.
Bio Pharma Dive
JANUARY 28, 2022
The biotech will sell the roughly 50% stake it holds in a biosimilars joint venture to Samsung Biologics for as much as $2.3 billion — cash that analysts expect the drugmaker to invest in M&A.
BioPharma Reporter
JANUARY 26, 2022
Last year was the highest year on record for investments into UK biotech and life science companies: with Â4.5bn ($6bn) raised in public and private financings, representing 60% more than in 2020.
pharmaphorum
JANUARY 25, 2022
Oskar Möbert, Vice President OpenData Europe at Veeva Systems, tells us how they are reimagining customer reference data to boost pharma rep productivity, enable more personalised engagement, and increase patient reach. The medical landscape is generally becoming more complex, both in terms of the range of stakeholders involved in patient care and the rapid explosion of engagement channels. “Our customers need to make decisions based on insights powered by a deep understanding of their tar
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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.
XTalks
JANUARY 28, 2022
UK-based Mamamade, a direct-to-consumer (DTC) plant-based baby food brand, recently closed a record-breaking round of funding, bringing its total pre-seed investment amount to £1.5 million (around $2 million). With a special focus on infant and toddler nutrition, as well as supporting parents, the startup received investments from founders and executives from allplants , Bulb , Design my Night , Heal’s , and Made.com.
Bio Pharma Dive
JANUARY 25, 2022
The biotech raised the Series B round during "probably one of the worst biotech markets" emerging drugmakers have faced in some time, a Metagenomi executive told BioPharma Dive.
BioPharma Reporter
JANUARY 28, 2022
Cryoport, Inc. has entered into a partnership with specialized Belgian CDMO, Cell Matters, to deliver end-to-end cryopreservation services for leukapheresis derived therapies supporting both autologous and allogeneic cell therapies.
pharmaphorum
JANUARY 26, 2022
We have seen a boom in biotech initial public offerings over the last two years, but many of Europe’s offerings have migrated to the United States. So, what can we do to keep home-grown science on European soil? From the Pfizer/BioNTech and Oxford/AstraZeneca vaccines to GSK’s lifesaving antibody treatments, European innovation has played a crucial role in the global response to COVID-19.
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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.
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