Bio Pharma Dive
NOVEMBER 18, 2021
The biotech will pay $725 million to opt into rights on four experimental medicines developed by Arcus, including ones that could challenge Merck's Keytruda in lung cancer.
World of DTC Marketing
NOVEMBER 18, 2021
SUMMARY: AbbVie continues to profit from Americans by repeatedly raising U.S. prices on its widely-used Humira rheumatoid arthritis drug while cutting the price abroad. AbbVie exploits the U.S. patent system to fend off competitors and increased the price of Humira to $77,000 for a year’s supply, while the price of its cancer drug Imbruvica was raised to $181,529 per year.
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Bio Pharma Dive
NOVEMBER 18, 2021
Immune-boosting drugs like Keytruda are increasingly being tested, and proven effective, alongside surgery before tumors spread widely.
Pharma Mirror
NOVEMBER 18, 2021
Shanghai, China’s pharma industry has seen a record improvement in its overall score, growth potential and biologics according to new data. The China specific findings of the CPhI Annual Report rankings[1] are released ahead of CPhI & P-MEC China – which will take place in hybrid form, with Virtual Expo Connect running digitally from November 18th until December 18th, and the in-person event held at the Shanghai New International Expo Center (SNIEC) December 16-18th, 2021.
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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
BioPharma Reporter
NOVEMBER 18, 2021
Biogen says it is disappointed with feedback received from a European Medicines Agency committee on its aducanumab Marketing Authorization Application: but pledges to continue to engage with the regulator as it considers its next steps.
BioSpace
NOVEMBER 18, 2021
BioNTech is on the Fast Track. This morning, the company announced it received Fast Track Designation from the U.S. Food and Drug Administration for its cancer immunotherapy candidate.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
NOVEMBER 18, 2021
The UKHSA have said that deferring the vaccine dose could help to reduce even further the small risk of heart inflammation following vaccination
BioSpace
NOVEMBER 18, 2021
In a Bloomberg News survey of 25 large insurers, none described the drug as “medically necessary,” and said Aduhelm was still experimental.
XTalks
NOVEMBER 18, 2021
There’s a new macaroni and cheese on the market, and it claims to be “gooder” than the rest. Mac and cheese brand Goodles launched Tuesday after its parent company, Gooder Foods, raised $6.4 million in funding from various venture capital firms and private investors. So, how does Goodles differ from mac and cheese legends Kraft and Annie’s, and where will it fit into the $4.4 billion dry noodle category?
BioSpace
NOVEMBER 18, 2021
Avrobio’s ex vivo lentiviral gene therapy platform led to durable responses measured in years, and significant reductions in disease-related biomarkers that far exceed today’s standard of care.
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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
NOVEMBER 18, 2021
Utah Jazz rookie Jared Butler is sharing his diagnosis of hypertrophic cardiomyopathy (HCM) by partnering with Bristol Myers Squibb (BMS) for its new HCM awareness campaign. Butler said he received the diagnosis during a routine health exam when he was 18; it caught him off guard as he had no symptoms. “The first time I heard the term hypertrophic cardiomyopathy, I was in the doctor’s office in the room getting diagnosed.
BioSpace
NOVEMBER 18, 2021
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones including T helper cells for COVID-19, new gene found that could contribute to type 1 diabetes and more.
pharmaphorum
NOVEMBER 18, 2021
Merck & Co has chalked up another win in drive to move PD-1 inhibitor Keytruda earlier in the treatment pathway for cancer, after the FDA greenlit use of the drug as post-surgery (adjuvant) therapy for renal cell carcinoma (RCC). The checkpoint inhibitor has been approved for use after surgery in patients with RCC – the most common form of kidney cancer – who are at intermediate-high or high risk of the disease recurring.
BioSpace
NOVEMBER 18, 2021
?A recent study has highlighted the need for more stringent Phase II trial protocols on the basis that over 80% of candidate oncology treatments that go into Phase III failed to achieve OS goals.
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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.
pharmaphorum
NOVEMBER 18, 2021
Its vast experience in diabetes and the amount of data collected has propelled Novo Nordisk into exploring new modalities and searching for valuable collaborators, according to the company’s senior VP of global drug discovery Karin Conde-Knape. She discusses which therapeutic areas the company is gaining momentum in and how it aims to build its presence within these areas through external partnerships, in a session at the recent BIO-Europe with pharmaphorum’s founder Paul Tunnah.
BioSpace
NOVEMBER 18, 2021
If the road to success is paved with failures, then the road to an effective, approved drug is paved with flops. Merck and Enanta are adding some painful pavers to their own roads this week.
pharmaphorum
NOVEMBER 18, 2021
Sanofi has made another investment in artificial intelligence, taking a $180 million equity stake in Franco-US startup Owkin with another $90 million in funding for a program to seek out new cancer therapies. The three-year project will focus on four types of cancer, and will deploy Owkin’s predictive biomedical AI models to find new biomarkers and therapeutic targets, as well as building models of the cancers and methods to predict if a patient will respond to a particular treatment.
BioSpace
NOVEMBER 18, 2021
?Scientists from Stanford University investigated the effectiveness of an oral tablet flu vaccine called VXA-A1.1 by Vaxart, which uses cellular correlates of protection.
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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.
Scienmag
NOVEMBER 18, 2021
A new method for creating one of chemistry’s most widely used class of compounds could revolutionize industrial processes, making them cheaper, simpler and more environmentally friendly. Credit: Koji Kubota A new method for creating one of chemistry’s most widely used class of compounds could revolutionize industrial processes, making them cheaper, simpler and more environmentally friendly. […].
BioSpace
NOVEMBER 18, 2021
?The extension will give the FDA sufficient time to look into the drug for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
Scienmag
NOVEMBER 18, 2021
The tiny cosmos of organisms living on a streamer of algae in a river—the algal microbiome—could help scientists learn what turns an environment from healthy to toxic and back again. A multidisciplinary team led by Northern Arizona University has won $3 million from the National Science Foundation to translate the codex contained in the microbiome […].
pharmaphorum
NOVEMBER 18, 2021
A virtual reality system developed by AppliedVR that has been shown in trials to help reduce chronic lower back pain has been approved by the FDA as a prescription digital therapeutic (DTx). The EaseVRx system uses a VR headset and controller to deliver a course of 56 cognitive behavioural therapy (CBT) sessions – each between 2 and 16 minutes long – that are intended to address the physiological symptoms of pain over an eight-week period.
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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.
Scienmag
NOVEMBER 18, 2021
Exotic laser-produced high-energy-density (HED) plasmas akin to those found in stars and nuclear explosions could provide insight into events throughout the universe. Physicists at the U.S. Department of Energy’s (DOE) Princeton Plasma Physics Laboratory (PPPL) have discovered a new way to measure and understand these plasmas, among the most extreme states of matter ever produced […].
BioSpace
NOVEMBER 18, 2021
BioMarin Pharmaceutical scored a first on Friday and provided an option for patients with a rare disease for which there is little recourse.
Scienmag
NOVEMBER 18, 2021
Fear is essential for survival, but must be well regulated to avoid harmful behaviors such as panic attacks or exaggerated risk taking. Scientists at the Max Planck Institute of Neurobiology have now demonstrated in mice that the brain relies on the body’s feedback to regulate fear. The brain’s insular cortex strongly reacts to stimuli signaling […].
BioSpace
NOVEMBER 18, 2021
The U.S. Food and Drug Administration approved COVID-19 vaccine booster shots for all Americans ages 18 and over Friday morning.
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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.
Scienmag
NOVEMBER 18, 2021
Examining health care fault lines, global supply chain instability, and vaccine production efficiency is critical in preparing for future global pandemics. Credit: Egan Jimenez, Princeton University Examining health care fault lines, global supply chain instability, and vaccine production efficiency is critical in preparing for future global pandemics.
BioSpace
NOVEMBER 18, 2021
A Chinese professor at the University of Copenhagen in Denmark is under scrutiny over undisclosed ties to the Chinese military.
Scienmag
NOVEMBER 18, 2021
Florida has experienced numerous harmful algal blooms in recent years. During these blooms, species of cyanobacteria release a variety of toxic compounds, including microcystins, a potent toxin, into local waterways. Human exposure comes from ingestion, direct skin contact or inhalation, and can lead to a variety of symptoms ranging from gastroenteritis, nausea, allergic reactions and […].
BioPharma Reporter
NOVEMBER 18, 2021
This last week saw the EU Commission approve two monoclonal antibodies for the treatment of COVID-19.
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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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