Bio Pharma Dive
JUNE 26, 2021
Results published in The New England Journal of Medicine offer the first clinical evidence that CRISPR gene editing inside the body can be safe and effective, a culmination of years of scientific research.
World of DTC Marketing
JULY 1, 2021
SUMMARY: Online health seeker numbers are still very high, indicating that people are doing their research first before asking for a prescription drug. Online health seekers trust pharma products but find product websites hard to read and inconsistent with their needs. Telehealth numbers are dropping rapidly, but people still want to use telehealth to ask for Rx renewals and ask general questions.
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BioPharma Reporter
JUNE 28, 2021
Live biotherapeutic product (LBP) developer, 4D Pharma, says it is building a âstrong body of evidenceâ for its portfolio of bacterial strains in relation to cancer, asthma, and neurodegenerative diseases, while the company also calls its recent dual listing a âtransformational milestoneâ.
BioSpace
JUNE 29, 2021
Innate Pharma has an alternative to T cell-based immunotherapy that has the potential to quickly and safely eradicate solid and metastatic tumors in the body.
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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
JULY 2, 2021
The agency is under pressure to grant full approvals to two coronavirus vaccines and faces important questions on how to handle the next Alzheimer's drugs after Aduhelm. A safety review of several arthritis medicines, meanwhile, is ongoing.
World of DTC Marketing
JUNE 28, 2021
SUMMARY: The debate around Biogen’s Alzheimer’s drug continues to rage. The clinical evidence supporting the approval of the drug is at best “weak.” How could the FDA approve a drug with such poor clinical data? How can Biogen’s employees continue to work for a company that is raping taxpayers for a drug that doesn’t work?
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
JULY 2, 2021
There have been growing reports of women experiencing changes in their menstrual cycle after receiving a shot of a COVID-19 vaccine. Some women have said they got their periods early following vaccination, or that their periods were unusually heavy and/or painful. There have also been reports of post-menopausal women and trans men experiencing bleeding or spotting after getting the shot.
Bio Pharma Dive
JUNE 28, 2021
A study of Gilead's Yescarta found the cell therapy dramatically outperformed chemotherapy and stem cell transplant in treating lymphoma, a result that could support much broader use of the drug.
World of DTC Marketing
JUNE 27, 2021
SUMMARY: According to the NEJM “in participants with overweight or obesity, 2.4 mg of semaglutide once weekly plus lifestyle intervention was associated with sustained, clinically relevant reduction in body weight” In the clinical study, participants were enrolled in an “intensive” behavioral study with 8 weeks low-calorie diet.
BioSpace
JUNE 28, 2021
Tofersen is the furthest along of four ASOs currently in clinical development for ALS and as such, there is quite a bit riding on the results of the VALOR trial which has an estimated completion date of August 31st, 2021.
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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
JULY 1, 2021
The safety of titanium dioxide in food, an additive found in thousands of ultra-processed foods, is now being questioned by the European Food Safety Authority (EFSA) after an in-house study conducted in March. In a surprising twist, the study concluded that the agency no longer considers titanium dioxide a safe food additive. So what does this mean?
Bio Pharma Dive
JUNE 28, 2021
The agency's decision-making process as well as Biogen's pricing of Aduhelm at $56,000 per year are both under the microscope as the repercussions of the controversial OK continue to be felt.
World of DTC Marketing
JULY 2, 2021
SUMMARY: Leadership is the ability to influence or guide others. Too many pharma CEOs are bad leaders because they fear failure, losing power, and focus too much on metrics not important to the rank and file. Six out of 10 employees said they feel demotivated by their CEOs; 70% say CEO pay was too high in general. The median CEO of the drug companies outpaced the more modest pay gains of their employees.
BioSpace
JUNE 29, 2021
The company said it would halt activities and focus its resources and time on liver and obesity research following "disappointing" results of its intranasal COVID-19 vaccine.
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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
JUNE 30, 2021
Blood health and research organization Versiti Inc. is offering a comprehensive diagnostic for COVID-19 vaccine-induced blood clot testing to help in the accurate and prompt diagnosis of the rare but serious blood clots being seen after some individuals are vaccinated with viral vector COVID-19 vaccines such as those from AstraZeneca and Johnson & Johnson.
Bio Pharma Dive
JULY 1, 2021
A five-year alliance with high-profile biotech ElevateBio is designed to get around a bottleneck that has held back the institution’s gene therapy work.
World of DTC Marketing
JUNE 30, 2021
SUMMARY: The pharmaceutical trade publications, except STAT News and Endpoints, have remained silent on the sham approval of Biogen’s Alzheimer’s drug. Pharma trade magazines have become irrelevant, and most could care less what they print, although they try to suck up with phony awards. It’s up to people within the industry to push back and try to be the change we want and need to see.
BioSpace
JULY 1, 2021
Every week there are numerous scientific studies published. This week there was an unusual number of research stories revolving around Alzheimer’s disease. Here’s a look at some of the more interesting ones.
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
JUNE 29, 2021
Moderna says new data indicates its COVID-19 vaccine offers protection against emerging variants, including the seemingly fast spreading Delta variant, first identified in India.
Bio Pharma Dive
JUNE 28, 2021
Wearables can minimize trips to clinic sites and may provide study participants and cancer patients with a feeling of having more control over how they manage their own illness.
pharmaphorum
JULY 2, 2021
AstraZeneca has reported the first phase 2 results with a drug for heart failure with preserved ejection fraction (HFpEF), showing it worked as expected but wasn’t able to provide any clinical benefit to patients. . Daily doses of AZD4831 were able to reduce the activity of myeloperoxidase (MPO), an enzyme linked to tissue and blood vessel damage due to inflammation and scar tissues formation (fibrosis) in models of cardiovascular disease, by 69% after 30 days in the phase 2a SATELLITE stu
BioSpace
JUNE 28, 2021
The groundbreaking success of the mRNA vaccines for COVID-19 by Pfizer-BioNTech and Moderna has led the way for other companies with a vested interest in vaccine development.
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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
JULY 2, 2021
New experimental data pinpoints a molecular component responsible for modulating the damage the flu can wreck on the lungs Credit: Joana Carvalho, IGC 2021 The seasonal flu kills up to 600 000 people a year worldwide and has a century-long history of pandemics. Examples include the Spanish flu in the late 1910’s or the H1N1 […].
Bio Pharma Dive
JULY 1, 2021
Final results from CureVac's large Phase 3 study showed an overall efficacy of just 48%, although the German biotech emphasized stronger protection against more severe disease and in younger adults.
XTalks
JULY 1, 2021
Moderna has won approval from the European Medicines Association (EMA) for branding its COVID-19 vaccine with the name Spikevax. Now the vaccine maker is awaiting the same approval from the US Food and Drug Administration (FDA). Moderna filed its application for the EMA approval in January of this year, which it was granted late last week. With the approval, Moderna’s Spikevax joins Pfizer-BioNTech’s Comirnaty and AstraZeneca’s Vaxzevria with European brand-name approvals.
BioSpace
JUNE 28, 2021
A new study published in Nature offers good news for those who recovered from COVID-19 and were then vaccinated with a mRNA vaccine – a booster may not be needed.
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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.
BioPharma Reporter
JUNE 30, 2021
Cobra Biologics, the gene therapy division of the Charles River owned Cognate BioServices, and Sweden's CombiGene recently announced the successful production and quality assurance of the plasmids to be used in the GMP production of the gene therapy, CG01.
Bio Pharma Dive
JUNE 30, 2021
A pill from Atea Pharmaceuticals rapidly reduced the amount of virus in the blood of patients with COVID-19, a step forward in drugmaker efforts to develop easier-to-take treatments for the disease.
pharmaphorum
JUNE 30, 2021
bluebird bio’s sickle cell disease (CD) gene therapy LentiGlobin is the latest recipient of an ‘innovation passport’ introduced in the UK earlier this year to speed up NHS access to promising new medicines. The designation means that LentiGlobin will be reviewed by the Medicines and Healthcare products Regulatory Agency (MHRA) via the new innovative licensing and access pathway (ILAP) introduced last December.
BioSpace
JULY 1, 2021
Positive results from Sellas Life Sciences Group’s Phase I/II trial using galinpepimut-S (GPS) as a combination therapy with pembrolizumab (Keytruda®) were announced Wednesday, shortly after similarly positive news was issued from a combination study in which GPS was evaluated as a treatment for.
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