Bio Pharma Dive
SEPTEMBER 7, 2021
On the heels of a two-day FDA meeting in which experts debated the risks of gene therapy, the biotech said its early-stage PKU treatment was associated with cancer in mice.
Pharma Mirror
SEPTEMBER 7, 2021
The Hague, Pharmacists must be allowed to do more to manage respiratory conditions in communities if the urgent need to address the harmful effects of air pollution on health is to be met, the International Pharmaceutical Federation (FIP) said today. The expansion of pharmacists’ roles in mitigating the health threats of air pollution is among several actions described in a call to action issued by FIP, marking the United Nations International Day of Clean Air for Blue Skies.
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World of DTC Marketing
SEPTEMBER 9, 2021
SUMMARY: Allowing Medicare to negotiate drug prices is popular with voters because the media has been focused on the high price of some drugs, but this measure won’t lead to lower healthcare costs. Still, in a JAMA study, the median net income (earnings) expressed as a fraction of revenue was significantly greater for pharmaceutical companies than nonpharmaceutical companies (13.8% vs. 7.7%).
Camargo
SEPTEMBER 8, 2021
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Some Drugs May Require Reclassification to Devices. On August 9, the FDA published a Federal Register notice requesting information and comments regarding products currently classified as drugs which may require reclassification as devices.
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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
SEPTEMBER 10, 2021
At Morgan Stanley’s healthcare conference, executives detailed how the launch of their Alzheimer’s drug has been slower than expected, due in large part to lingering questions about clinical trial data and insurance coverage.
Pharma Mirror
SEPTEMBER 7, 2021
Increasing burden of chronic diseases and rising awareness about necessity of early warning signs are fuelling the demand of remote patient monitors With the COVID-19 pandemic, health systems or hospitals rapidly adopted remote patient monitoring technology to maintain social distancing and thereby control viral spread. Patients suffering from COVID – 19 need to monitor blood oxygen level and heart rate regularly.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
SEPTEMBER 6, 2021
UK researchers have used artificial intelligence (AI) to develop a way to identify patients with heart failure who would benefit from treatment with beta blockers, by interrogating data from nine landmark clinical trials. The study applied machine learning to trial data involving 15,659 patients who were being treated for heart failure with reduced ejection fraction (HFrEF), a form of heart failure where the left side of the heart isn’t able to pump blood effectively around the body.
Bio Pharma Dive
SEPTEMBER 7, 2021
Wall Street analysts expect little impact on biotech developers after an inconclusive discussion last week. Yet the FDA still appears wary, as shown by a new hold on a BioMarin rare disease treatment.
Pharma Mirror
SEPTEMBER 9, 2021
Sterling Pharma Solutions, a global contract development and manufacturing organisation, today announced the completion of the initial phase of investment at its site in Dudley, UK to create the company’s centre of excellence for research into commercial applications of continuous flow chemistry. Announcement of the investment follows the appointment of Professor Ian R.
World of DTC Marketing
SEPTEMBER 7, 2021
SUMMARY: John F. Kennedy said, “Change is the law of life, and those who look only to the past and present are certain to miss the future”. Change is coming for one simple reason; our country can’t sustain the current costs of healthcare. Today’s pharma CEOs should prepare their organizations for the future, not wasting money with lobbying costs.
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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
BioPharma Reporter
SEPTEMBER 7, 2021
Moderna and the nonprofit Institute for Life Changing Medicines (ILCM) are collaborating to develop a new messenger RNA (mRNA) therapeutic (mRNA-3351) for Crigler-Najjar Syndrome Type 1 (CN-1), an ultra-rare disease.
Bio Pharma Dive
SEPTEMBER 9, 2021
The French drugmaker bought Principia Biopharma last year for two therapies that block a protein called BTK. The second targets a much bigger disorder, multiple sclerosis.
Pharma Mirror
SEPTEMBER 8, 2021
Marseille, France, Provepharm Life Solutions, a private French pharmaceutical company that finds new applications for well-known molecules, today announces a €120 million ($142.3M) strategic funding. Tikehau Capital will provide the funds and joins the group’s pool of banking investors, including Société Générale, BNP Paribas, Banque Populaire Méditerranée, Crédit Agricole Alpes Provence and Bpifrance.
World of DTC Marketing
SEPTEMBER 10, 2021
SUMMARY: Marci Hamilton, a professor at the University of Pennsylvania Constitution, said, “The Constitution is not a suicide pact guaranteeing a right to harm others. The government has the latitude to protect citizens from deadly conditions, especially when the science supporting vaccination is so clear” We, as a nation, can not allow ignorance and stupidity to endanger us all.
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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.
Pharma Times
SEPTEMBER 6, 2021
UK’s chief medical officers will now provide ‘further advice’ on COVID-19 vaccination in this age group
Bio Pharma Dive
SEPTEMBER 7, 2021
Long a bystander in the race to develop so-called allogeneic treatments, the cancer drugmaking giant has joined the fray with a wide-ranging alliance that could be worth up to $3 billion.
pharmaphorum
SEPTEMBER 8, 2021
An artificial intelligence algorithm was able to detect signs of lung cancer on CT scans a year earlier than with traditional methods, according to a new study. CT (computed tomography) scans are already used to spot signs of lung tumours, followed by a biopsy or surgery to confirm whether the tumour is malignant, according to Benoît Audelan, a researcher at France’s National Institute for Research in Digital Science and Technology.
XTalks
SEPTEMBER 9, 2021
The US Food and Drug Administration (FDA) has placed a clinical hold on BioMarin Pharmaceutical’s investigational gene therapy BMN 307 for the rare inherited disease phenylketonuria (PKU) over safety concerns found during preclinical testing. The federal regulator suspended BioMarin’s currently ongoing Phase I/II studies of the gene therapy based on interim safety findings from a preclinical study which revealed that mice treated with the therapy at high doses developed tumors on their liver.
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
SEPTEMBER 8, 2021
Japanâs health ministry is to secure 150 million doses of Novavaxâ vaccine candidate that Takeda is producing. The Japanese government's purchasing agreement is subject to regulatory approvals.
Bio Pharma Dive
SEPTEMBER 8, 2021
The company has previously said it could make up to three billion vaccine doses in 2022, depending on how booster shots are authorized.
pharmaphorum
SEPTEMBER 8, 2021
A 20% to 25% reduction in staffing at the UK Medicines and Healthcare products Regulatory Agency (MHRA) risks undermining the ability of the authority to fulfil its role, according to trade unions. In an open letter to Health Secretary Sajid Javid, Prospect, Unite and three other unions say the decision to slash the MHRA’s current 1,200 workforce by up to 300 workers means that “regulatory decisions may suffer.” Fewer staff will therefore be asked to cover more ground with fewe
XTalks
SEPTEMBER 6, 2021
Nestlé has announced the launch of the largest R+D Accelerator that provides a platform for startups, students and Nestlé intrapreneurs to quickly bring innovation to the market. The Accelerator will be in Lausanne, Switzerland, at Nestlé’s fundamental research center. . All internal and external teams will have access to Nestlé’s facilities, including science, technology and business expertise.
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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.
NY Times
SEPTEMBER 7, 2021
An intubated patient was prescribed the deworming drug by his doctor. Federal health officials have said that it has not been shown to be effective against the coronavirus and that it can be toxic in humans.
Bio Pharma Dive
SEPTEMBER 9, 2021
Formed as a diagnostics developer, Mammoth Biosciences, which Doudna started with two of her former students at the University of California, has accelerated plans to make gene editing medicines as well.
pharmaphorum
SEPTEMBER 10, 2021
A digital health company focusing on neurodegenerative disorders – Neuroglee Therapeutics – has raised $10 million in first-round funding to roll out a virtual neurology clinics for people with cognitive problems caused by dementia. The Singapore startup, which is partnering with the Mayo Clinic on the clinics, said the cash injection will also go towards the development of its pipeline of digital therapeutics (DTx) for Alzheimer’s disease and other neurodegenerative conditions.
Outsourcing Pharma
SEPTEMBER 10, 2021
A leader from ACG Engineering shares insight on how âsmartâ drug manufacturing, accelerated by COVID-19, can best be put to work now and in months to come.
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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
SEPTEMBER 7, 2021
After a two-month long halt, federal officials have given the go-ahead to resume nationwide distribution of Eli Lilly’s COVID-19 monoclonal antibodies bamlanivimab and etesevimab. The pause on the antibody combo was made over concerns of the drugs not being effective against new SARS-CoV-2 variants, back when they were first identified in Brazil and South Africa.
Bio Pharma Dive
SEPTEMBER 8, 2021
The company, which focuses on self-replicating RNA, comes equipped with $40 million from Apple Tree Partners and a stamp of approval from the former research head at Biogen.
pharmaphorum
SEPTEMBER 6, 2021
Amgen and partner AstraZeneca have said their recently filed severe asthma drug tezepelumab has shown impressive results in patients who also have nasal polyps, a common complication of the respiratory disease. Tezepelumab reduced the annualised asthma exacerbation rate (AAER) by 86% in a subgroup of people with severe, uncontrolled asthma and polyps in the NAVIGATOR study, topping the 41% reduction achieved with the first-in-class TSLP inhibitor in the overall study population.
Scienmag
SEPTEMBER 7, 2021
Researchers at the Max Planck Institute of Animal Behavior and University of Konstanz in Germany have identified how large land birds fly nonstop for hundreds of kilometers over the open ocean—without taking a break for food or rest. Using GPS tracking technology, the team monitored the global migration of five species of large land birds […].
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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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