Bio Pharma Dive
OCTOBER 18, 2021
Though the study's primary goal was missed, Biogen claimed there were some signs its drug, tofersen, could slow the disease's progression. The company is now engaging with regulators to discuss tofersen's future.
World of DTC Marketing
OCTOBER 21, 2021
SUMMARY: Medicare spent nearly $600 million over a three-year period to pay for four cancer drugs with no clinical benefit an analysis published Monday by JAMA Internal Medicine found. More than $170 million of this spending was for products voluntarily withdrawn by their manufacturers after clinical trials showed that they did not improve overall survival in people with various types of cancer.
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pharmaphorum
OCTOBER 19, 2021
The work of the UK’s HTA body, the National Institute for Health and Care Excellence (NICE), is often heatedly debated, and this time it’s for holding back a clinical guideline. Leela Barham looks into the controversy. Updating a previous clinical guideline. NICE began their work to update a 2007 clinical guideline on Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in January 2018.
NY Times
OCTOBER 21, 2021
The company said that in a study, boosters cut down the number of breakthrough infections among fully vaccinated people by more than 95 percent.
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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
OCTOBER 19, 2021
A closely watched competitor to Merck's molnupiravir failed a Phase 2 study, prompting its makers to change their strategy in a move that could delay an answer on the drug's efficacy until late next year.
Outsourcing Pharma
OCTOBER 19, 2021
To fully reap the benefits of tech advances, a company leader advises, a life-sciences firm must embrace change and connection throughout the operation.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
NY Times
OCTOBER 18, 2021
The agency may act this week, when it is expected to authorize booster shots for recipients of the Moderna and Johnson & Johnson vaccines.
Bio Pharma Dive
OCTOBER 21, 2021
The biotech won EU approval for two gene therapies, Zynteglo and Syksona, both of which it's now said it will pull from market after difficulties negotiating reimbursement.
Pharma Times
OCTOBER 21, 2021
Givlaari uses ‘gene silencing’ RNA interference technology, to target the production of pathogenic compounds in people AHP
pharmaphorum
OCTOBER 19, 2021
A new poll of clinical trial sponsors has found that around nine out of 10 of them are running decentralised trials with the help of digital technologies, a big increase on pre-COVID-19 levels. The survey by Veeva Systems found a big increase in the adoption of technologies that enabled remote trials during COVID-19, with increased use of tools such as remote monitoring, electronic data collection and consent forms, and web portals for studies.
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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
OCTOBER 20, 2021
Despite major accomplishments in the plant-based dairy space over the last few years, the animal-based dairy sector is proving there is still room for innovation. Taking notes from the VegTech sector , the dairy industry is diversifying to meet personal and planetary health targets, prioritizing nutrition and sustainability, along with flavor and accessibility. .
Bio Pharma Dive
OCTOBER 19, 2021
Following discussions with the FDA, the companies plan to submit zuranolone for approval in major depressive disorder and postpartum depression over the next roughly year and a half.
BioSpace
OCTOBER 19, 2021
The idea of using mRNA has been around for some time, but only in recent years has it become practical. The COVID-19 pandemic provided the opportunity for the technology to push ahead.
pharmaphorum
OCTOBER 21, 2021
Twitter has been used by health professionals for over a decade to share medical knowledge and education. Until late-2018 they had only 140 characters to do this, increasing to 280 at that time. There have been some collaborative ways to have meaningful interactions on the platform including Twitter journal clubs. Four ways HCPs are using Twitter for medical education.
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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
OCTOBER 20, 2021
Barry Callebaut, a manufacturer of high-quality chocolate and cocoa products, is introducing a nutraceutical fruit drink made with the cacaofruit itself, called Elix. The new beverage has a zesty, fruity flavor that claims to promote circulatory health. In addition, the company created a product that keeps all the nutrients of the cacaofruit intact in order to provide the consumer with a nutraceutical beverage.
Bio Pharma Dive
OCTOBER 19, 2021
Drugs from Vertex can effectively treat the lung disease in as much as 90% of patients. Gene therapy could be a solution for the remaining 10%, but the path forward is challenging.
BioSpace
OCTOBER 20, 2021
Novavax is having problems getting its COVID-19 vaccine to the finish line. Shares plunged more than 23% in premarket trading today after reports that it is having manufacturing problems.
pharmaphorum
OCTOBER 18, 2021
Roche has claimed an earlier-than-expected FDA approval for its checkpoint inhibitor Tecentriq in non-small cell lung cancer (NSCLC), giving the drug a lead in early-stage cases that can be treated with surgery. The US regulator has cleared Tecentriq (atezolizumab) as adjuvant treatment after surgery and platinum-based chemotherapy in patients with tumours in which 1% or more cells express the PD-L1 biomarker, to try to stop the cancer recurring.
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.
Pharma Times
OCTOBER 18, 2021
Dupilumab (also known as Dupixent) will be available to patients through injections
Bio Pharma Dive
OCTOBER 21, 2021
A third dose was 96% effective in preventing COVID-19 compared to a placebo in a Phase 3 trial of previously vaccinated adults. Missing details, however, leave some questions unanswered.
BioSpace
OCTOBER 18, 2021
While it has yet to reach clinical trials, preclinical results with the company’s specially-tailored adeno-associated virus have been fortuitously auspicious.
pharmaphorum
OCTOBER 21, 2021
Analysts were predicting sales of Biogen’s recently approved Alzheimer’s therapy Aduhelm may start to gather a little momentum in the third quarter, but the drug seems to be going into reverse. As it turned out, Aduhelm (aducanumab) made just $300,000 in the three-month period from July to September, against analysts’ estimates of $12 million, suggesting that few patients are being treated with the $56,000 a year therapy.
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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.
BioPharma Reporter
OCTOBER 19, 2021
Announcing a new partnership, Autolomous and Vineti say they are integrating their technology to ensure scalability when cell and gene therapies become standard of care.
Bio Pharma Dive
OCTOBER 19, 2021
The drugmaker plans to switch over to a commercial business model late next year or early in 2023, said Jennifer Taubert, head of J&J's pharma division.
BioSpace
OCTOBER 18, 2021
The concern relates to the risk of two rare heart inflammation conditions, myocarditis and pericarditis, that have been linked to the Pfizer and Moderna mRNA vaccines.
pharmaphorum
OCTOBER 22, 2021
In the latest Health Innovators video chat, pharmaphorum’s founder, Dr Paul Tunnah, chats with the founder and CEO of digital mental health pioneer Healios. Rich Andrews explains his background in big pharma and his inspiration for moving into the start-up space with Healios and its focus on mental health and neurodiverse conditions for children and adolescents.
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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
OCTOBER 22, 2021
The US Food and Drug Administration (FDA) has approved Cyltezo (adalimumab-adbm) as the first interchangeable biosimilar for Humira (adalimumab) for the treatment of several inflammatory conditions. This means AbbVie, maker of the world’s top-selling drug Humira, could be in for some stiff competition. Boehringer Ingelheim’s Cyltezo has become the second interchangeable biosimilar approved by the FDA, and the first approved interchangeable monoclonal antibody.
Bio Pharma Dive
OCTOBER 18, 2021
The company hopes a "streamlined" sales force can turn around a drug launch that's failed to meet expectations amid tough competition from rival medicines.
BioSpace
OCTOBER 18, 2021
With the Delta variant of coronavirus spreading globally, the pandemic still has a tight grip on the world. Many people around globe are struggling to come to terms with the aftermath of the pandemic, much like a century ago with the Spanish flu.
pharmaphorum
OCTOBER 22, 2021
Sanofi and Regeneron’s Dupixent has become the first biologic drug to show activity in prurigo nodularis (PN), raising the hope of a new treatment option for the rare and highly debilitating skin disease. The two companies are still waiting for the results of a second phase 3 trial, due in the first half of next year, but if that is positive expect to file for approval of Dupixent (dupilumab) in the new indication before the end of 2022.
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