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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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.
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.
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.
pharmaphorum
APRIL 8, 2021
A digital tool used to treat attention-deficit hyperactivity disorder (ADHD) is being tested to see if it can help counter lingering, fuzzy thinking in COVID-19 survivors, a condition sometimes known as ‘brain fog’ An app called EndeavorRx – developed by PureTech Health-backed Akili Interactive – will be tested in two clinical trials to see if it can improve cognitive function in people who have recovered from COVID-19 but still show cognitive problems weeks or months later.
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.
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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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
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.
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.
Outsourcing Pharma
APRIL 8, 2021
The collaboration will enable Charles River clients to access Valenceâs artificial intelligence platform in their pharmaceutical development projects.
BioSpace
APRIL 5, 2021
The San Jose BioCube life sciences incubator project has undergone a significant renovation that includes a major expansion of its headquarter facilities and also provides housing for new life sciences startups.
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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.
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.
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.
Pharma Times
APRIL 7, 2021
The NIHR-funded trial will assess whether removing small fibroids and endometrial polyps improves fertility and live births
BioSpace
APRIL 8, 2021
Tidal Therapeutics, which does not even have a website, came out of LabCentral in Cambridge. It focuses on developing nanoparticles able to deliver messenger RNA (mRNA) that can reprogram immune cells.
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.
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
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
BioSpace
APRIL 8, 2021
BioSpace takes a look at the annual compensation for the chief executive officers of vaccine developers.
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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
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.
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.
pharmaphorum
APRIL 8, 2021
Gilead’s $21 billion purchase of Immunomedics and its potential blockbuster Trodelvy continues to pay off, as the drug has now been approved by the FDA for triple-negative breast cancer. . Trodelvy (sacituzumab govitecan) was granted accelerated approval by the FDA in April last year, and is now indicated for adults with triple-negative breast cancer who have received at least two previous therapies for metastatic disease.
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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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 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
A deal with Bio-Thera Solutions hands Biogen rights to a late-stage copycat of Actemra, Roche's blockbuster treatment for inflammatory diseases.
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.
BioSpace
APRIL 4, 2021
Cidara Therapeutics inked a deal worth up to $780 million with Johnson & Johnson to develop and commercialize Cidara’s candidate CD388 for the prevention and treatment of seasonal and pandemic influenza.
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