Bio Pharma Dive
APRIL 9, 2021
Tidal Therapeutics is the second biotech developing more convenient cell therapies that the French pharma has recently acquired, part of a broader expansion in oncology.
World of DTC Marketing
APRIL 9, 2021
QUICK READ: A two-month analysis of social media and prescription drugs found the number one reason online health seekers use social media is to share and ask questions about medication side effects. I also found an abundance of medication misinformation based on personal experiences and hearsay. In conjunction with leading consumer magazine I worked on a study to determine why people were using social media for information on prescription drugs and to examine and quantify what they were sharing
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pharmaphorum
APRIL 6, 2021
From #MeToo to Black Lives Matter, as a society we have been discussing the relationship between representation and equality more than ever over the last few years. . But while progress is being made in so many areas, people with disabilities are still struggling to find a voice above the accepted narrative, says Ross Lannon, the 27-year-old blogger and multi-media content creator behind A Life on Wheels.
BioSpace
APRIL 7, 2021
A recent study from Ben-Gurion University of the Negev (BGU) found that isolated molecules from probiotic-rich dairy products could have potential as novel drug candidates for fighting against pathogenic bacteria and treating inflammatory diseases.
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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 6, 2021
The influential drug cost watchdog recommended a discount of between 37% and 54% to the $419,500 list price the companies charge for Abecma, a multiple myeloma cell therapy cleared by the FDA in March.
World of DTC Marketing
APRIL 5, 2021
QUICK READ: The nation’s largest for-profit hospital chains saw higher profits , and some more than tripled their net income compared to last year. Some are also increasing their profit margins by forcing out healthcare staff who have seniority and earn more. As bigger corporations acquire smaller hospitals, this trend is accelerating. Maria has been an ER nurse in Southern California for almost 22 years.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
APRIL 5, 2021
Shares of Supernus Pharmaceuticals were climbing in premarket trading this morning after Friday’s announcement the U.S. FDA approved the company’s non-stimulant treatment for ADHD in pediatric patients 6 to 17 years of age.
Bio Pharma Dive
APRIL 8, 2021
Keytruda has become the first drug of its kind to succeed in the so-called adjuvant setting in renal cell carcinoma, continuing an industry-wide push to establish immunotherapy in earlier lines of cancer care.
World of DTC Marketing
APRIL 7, 2021
QUICK READ: The compensation for pharma CEOs is starting to be reported and it’s off the charts. Bob Bradway of Amgen bagged a $20.1 million compensation package in 2020, a slight increase from his $19.6 million total the previous year. Pfizer CEO Bourla’s Pay Climbed 17% to $21 Million in 2020 and Gilead Sciences CEO Daniel O’Day earned a $19 million take home.
Triage Cancer
APRIL 8, 2021
It's spring. We're starting to emerge from, well, a lot of things. Over the past year, I've heard just about every kind of organizing/decluttering/reordering response to our pandemic isolation and work-from-home shifts. Some folks, stuck in their spaces with less to do than usual and feeling claustrophobic, jumped on the decluttering bandwagon and cleared things out with a vengeance.
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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
APRIL 5, 2021
Chimeric antigen receptor (CAR-T) therapy is one of the biggest cancer therapy breakthroughs of our time, but as with any precise science, there is still some fine-tuning to be done to overcome safety risks, limited payload capacity, and the prohibitive cost of manufacturing.
Bio Pharma Dive
APRIL 9, 2021
The EMA has reiterated the benefits of the shot outweigh the risks, but the safety concerns are another hurdle to the vaccine's rollout in Europe.
XTalks
APRIL 6, 2021
Most grocery shoppers won’t soon forget the perplexing moment last spring when shelves were suddenly bare. Where flour, pasta and other shelf-stable goods once sat in abundance quickly emptied to nothing but price tags. The same went for meat and dairy. It was a shocking, yet humbling, sight for most. The news of farmers dumping milk, letting crops rot and euthanizing chickens only added to the disarray.
Pharma Times
APRIL 7, 2021
The NIHR-funded trial will assess whether removing small fibroids and endometrial polyps improves fertility and live births
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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
APRIL 8, 2021
BioSpace takes a look at the annual compensation for the chief executive officers of vaccine developers.
Bio Pharma Dive
APRIL 5, 2021
An unusual partnership to develop a standardized plasma therapy for COVID-19 didn't succeed, but could be a model for collaborations should another public health crisis arise, the drugmakers said.
XTalks
APRIL 7, 2021
As the COVID-19 pandemic shifts with new case surges largely owing to new variants of SARS-CoV-2, the US Food and Drug Administration (FDA) continues to offer up emergency use authorizations (EUA) for tests for the detection of COVID-19 infection, with the latest being antibody and antigen tests from Symbiotic and Quidel, respectively. With the EUA, Symbiotica’s COVID-19 Self-Collected Antibody Test System becomes the first antibody test authorized for collection of dried blood spot samples at h
Intouch Solutions
APRIL 9, 2021
Three Intouchers recently garnered industry attention, and we thought it would be wrong to not talk about it. Learn more about who they are and what makes them exceptional. The post Fine, We’re Humble-Bragging Again appeared first on Intouch Solutions.
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.
Scienmag
APRIL 9, 2021
Credit: (Photo: David Taylor/Phocus Video) ARLINGTON, Va.–The Marine scanned the open field and spotted an enemy tank approaching. Using a handheld tablet, he called for an air strike. A helicopter quickly flew in and launched a rocket, destroying the tank. Removing his goggles, the Marine saw the field remained peaceful and undisturbed. No burning wreckage. […].
Bio Pharma Dive
APRIL 8, 2021
Baricitinib, an oral tablet already authorized to treat COVID-19, fell short of goal in a large Phase 3 study. But Lilly also reported treatment led to a substantial reduction in death.
pharmaphorum
APRIL 9, 2021
The FDA says it has uncovered “deficiencies” in the marketing application for Provention Bio’s much-anticipated drug teplizumab for the prevention of type 1 diabetes (T1D) that could delay its review. The issues are holding up discussions between the agency and company about labeling and post-marketing requirements for teplizumab, and are concentrated around the pharmacokinetics data for the antibody, and whether it is comparable to the drug that its original developer Eli Lill
XTalks
APRIL 6, 2021
The US Food and Drug Administration (FDA) has granted approval to the world’s first non-surgical pulmonary valve to treat severe pulmonary valve regurgitation, a condition often resulting from congenital heart disease. The device, developed by world-leading medical technology company Medtronic , is indicated for both pediatric and adult patients who have severe pulmonary valve regurgitation.
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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.
Scienmag
APRIL 8, 2021
Pulp mill waste hits the road instead of the landfill Credit: UBCO Waste materials from the pulp and paper industry have long been seen as possible fillers for building products like cement, but for years these materials have ended up in the landfill. Now, researchers at UBC Okanagan are developing guidelines to use this waste […].
Bio Pharma Dive
APRIL 6, 2021
Some seven months after acquiring the rest of Akcea Therapeutics, Ionis is laying off most of its subsidiary's staff and turning to Sobi to sell its drugs.
BioPharma Reporter
APRIL 9, 2021
The European Medicines Agency (EMA) is evaluating a possible link between blood clots and Johnson & Johnsonâs COVID-19 vaccine, while also reviewing reports of a bleeding condition in some individuals who received AstraZenecaâs COVID-19 shot.
NY Times
APRIL 5, 2021
A new formulation entering clinical trials in Brazil, Mexico, Thailand and Vietnam could change how the world fights the pandemic.
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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
APRIL 8, 2021
Credit: © Terence Strick The Mfd protein repairs bacterial DNA, but can also, to scientists’ surprise, promote mutation. Bacterial mutations can lead to antibiotic resistance. Understanding this second “role” of the Mfd protein opens up opportunities for combating antibiotic resistance, and also the resistance of tumours to anti-cancer drugs and therapies.
Bio Pharma Dive
APRIL 8, 2021
A deal with Bio-Thera Solutions hands Biogen rights to a late-stage copycat of Actemra, Roche's blockbuster treatment for inflammatory diseases.
BioPharma Reporter
APRIL 8, 2021
Moderna today highlighted the publication of antibody persistence data out to six months following the second dose of its COVID-19 vaccine in The New England Journal of Medicine.
BioSpace
APRIL 5, 2021
Recent advances are giving researchers hope that a functional cure or possibly even complete eradication of the virus is possible.
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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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