Bio Pharma Dive
SEPTEMBER 29, 2020
On Nov. 6, aducanumab will go before a panel of experts who will review it and make recommendations to the FDA. Meanwhile, the drug has also caught the attention of a powerful cost watchdog group.
World of DTC Marketing
SEPTEMBER 30, 2020
HERE”S THE DEAL: Determining how much to spend for the launch of a new drug is a challenge we all face and you have to be ready to shift funds from channels that are failing to provide the lift in brand awareness to channels that hit the bullseye on your objectives. The biggest request we get from clients is guiding them through the process of allocating total DTC spend along with channel allocation.
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Pharma Mirror
SEPTEMBER 29, 2020
Ahead of the CPhI Festival of Pharma (5-16 October, 2020) – global pharma’s largest ever virtual gathering – the CPhI Pharma Index shows only Italy and India have improved their score in 2020, with the majority of industry executives looking for new supply chain partners. The Index – an aggregated confidence score across the five. The post Italy and India the only pharma economies to improve score in 2020 according to the CPhI Pharma Index appeared first on Pharma Mirror Magazine.
pharmaphorum
SEPTEMBER 30, 2020
The signatories of a new Biotech Social Pact with Europe and patients explain why healthcare calls for a new social contract, not a pharmaceutical strategy. As Europe continues its efforts to battle the Covid-19 pandemic, it is rightfully focusing its attention on the longer-term implications of this crisis. One common thread is clearly emerging from EU and national discussions: to reinforce Europe’s “strategic autonomy” and “technological sovereignty” in key industrial sectors.
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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 29, 2020
The world's attention will be on the FDA as it considers initial data from coronavirus vaccine developers. But several other important drugs, including a CAR-T therapy and an Ebola antibody, will also be on the agency's agenda.
XTalks
SEPTEMBER 30, 2020
While it remains unclear why some people become more gravely ill than others when infected with the SARS-CoV-2 virus that causes COVID-19, researchers have found that an immune deficiency may be part of it. Two recent studies have shown that individuals who lack an important immune factor may have reduced ability to fight the virus. The two studies were recently published online in the journal Science, both of which were led by Jean-Laurent Casanova, an infectious disease geneticist at Rockefell
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
SEPTEMBER 28, 2020
The FDA has launched its Digital Health Center of Excellence (DHCoE), as the agency continues with its commitment to advancing use of technology such as mobile health devices, software and wearables to create medical products. Housed within the agency’s Center for Devices and Radiological Health, the DHCoE is part of a wider strategy to encourage development of digital health products and therapeutics.
Bio Pharma Dive
SEPTEMBER 30, 2020
The $200 million investment in CStone Pharmaceuticals puts Pfizer in charge of selling a cancer immunotherapy in the world's second largest drug market.
Intouch Solutions
OCTOBER 1, 2020
Robots are no longer the stuff of science fiction, and as more brands adopt conversational AI, some key considerations can enhance the chatbot user experience. In part one of this two-part series, we’ll talk about chatbots, human users, and live agents, and offer several tips for success. The post Pharma Chatbots: Designing the Human Side of the Experience (Pt.
BioSpace
SEPTEMBER 28, 2020
In addition to cutting staff, findings from the IW-3718-302 Phase III trial has caused the GI-focused healthcare company to discontinue development of IW-3718 and halt enrollment of its second Phase III trial, IW-3718-301.
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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
pharmaphorum
SEPTEMBER 30, 2020
Regeneron’s antibody cocktail seems to reduce levels of coronavirus and improve symptoms in patients, according to early test results. This first data comes from a descriptive analysis from the seamless phase 1/2/3 trial that Regeneron hopes will hurry the medicine dubbed REGN-COV2 to market. The ongoing double-blind trial measures the effect of adding REGN-COV2 to usual standard of care, compared with usual standard of care.
Bio Pharma Dive
OCTOBER 2, 2020
Under his leadership, Merck developed a once overlooked cancer drug into Keytruda, now a top-selling medicine and foundational treatment for more than a dozen types of tumors.
Scienmag
SEPTEMBER 30, 2020
$3 million grant to Hollings Cancer Center researcher focuses on defining changes in collagen structure that are linked to disparities in breast cancer risk, progression and outcome Credit: Medical University of South Carolina An MUSC Hollings Cancer Center researcher received a $3 million grant from the National Cancer Institute to study how patterns of collagens […].
Outsourcing Pharma
SEPTEMBER 30, 2020
The companyâs Phase II trial of ultramicronized PEA has received FDA approval and expects to begin dosing patientparticipants as early as next month.
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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.
pharmaphorum
SEPTEMBER 29, 2020
The pharmaceutical industry is one of the most scientifically innovative and competitive industries, particularly in oncology. As of 2018, there were over 1,100 cancer therapies in development, and as of 2020, 362 of them were cell and gene therapies. As a result, there is a need for continued innovation and increased efficiency in terms of drug development to manage cost, complexity and speed to provide potentially transformative therapies for cancer patients.
Bio Pharma Dive
SEPTEMBER 29, 2020
Preliminary study data suggest the treatment could help people whose bodies aren't already fighting off infection, a finding the biotech is discussing with regulators.
XTalks
SEPTEMBER 28, 2020
Clinicians and patients alike have long been hoping for liquid biopsy tests for cancer screening and diagnosis given their ease, convenience and ability to detect disease-specific mutations. LabCorp (NYSE:LH) may help lead the way with its backing of Resolution Bioscience’s new diagnostic blood test for lung cancer. The leading global life science company is set to introduce Resolution Bio’s ctDx Lung assay , a non-invasive liquid biopsy test for patients with non-small cell lung cancer (NSCLC).
Scienmag
SEPTEMBER 28, 2020
Credit: University of Leeds A major new study has identified 2085 excess deaths in England and Wales due to heart disease and stroke during the peak of the COVID-19 pandemic. On average, that is 17 deaths each day over four months that probably could have been prevented. Excess deaths are the number of deaths above […].
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.
pharmaphorum
OCTOBER 1, 2020
For a long time, venture capital (VC) firms have been controlled mainly by men. But things are changing and women are becoming more influential in life sciences VCs, with an increase in business going to all-female teams. We spoke with two female VC leaders about how women could act as agents for change in this male-dominated world. Last year saw a record amount of venture capital – $17.2 billion – raised by women, according to the financial information company Pitchbook.
Bio Pharma Dive
SEPTEMBER 28, 2020
A month after the FDA surprisingly rejected the rheumatoid arthritis drug, known as filgotinib, and more recently, Jyseleca, it's been cleared by regulators in Europe and Japan.
BioSpace
SEPTEMBER 30, 2020
While CRISPR has been used as a research tool for the most part, the technology is moving toward commercial applications.
JAMA Internal Medicine
SEPTEMBER 29, 2020
This randomized clinical trial evaluates the efficacy of hydroxychloroquine to prevent transmission of SARS-CoV-2 in health care workers with exposure to patients with COVID-19 at 2 hospitals in Philadelphia, Pennsylvania.
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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.
pharmaphorum
OCTOBER 1, 2020
A digital tool that allows doctors to monitor patients with COVID-19 remotely in real time and intervene when treatment is needed has been launched in the UK. The mobile app – developed by digital heath specialist Careology – provides advice on COVID-19 symptoms and links patients with doctors at the London General Practice, a private GP group with around 50,000 people on its books, via online video consultations.
Bio Pharma Dive
OCTOBER 1, 2020
An 18-month investigation by the House Oversight Committee targeted the pricing practices behind the top-selling drugs Revlimid and Copaxone.
BioSpace
SEPTEMBER 29, 2020
Pfizer invested $200 million into the company for a nearly 10% stake to support the development of a checkpoint inhibitor aimed at the oncology market in China.
BioPharma Reporter
SEPTEMBER 30, 2020
The pandemic has required a rethink of how we do business: and CPhI Festival of Pharma is encouraging companies to prioritize sustainability efforts moving forward.
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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.
pharmaphorum
SEPTEMBER 28, 2020
Shares in UK biotech Valirx were up sharpy this morning after its lead drug VAL201 showed evidence of efficacy in advanced prostate cancer in its first clinical trial. The company reported results from 11 patents taking part in the phase 1/2 study which showed a 54.5% overall response rate with VAL201, with a promising safety and tolerability profile.
Bio Pharma Dive
SEPTEMBER 28, 2020
The FDA has suspended the planned start of a late-stage trial of Inovio's experimental shot, dealing another setback to one of the most advanced DNA-based vaccine programs in development.
BioSpace
SEPTEMBER 30, 2020
Alnilam – the bright center star in the middle of Orion’s belt – has navigated its namesake Alnylam to positive results in their ILLUMINATE-B Phase III clinical trial evaluating RNAi therapeutic, lumasiran, in young children with Primary hyperoxaluria Type 1 (PH1).
Triage Cancer
OCTOBER 1, 2020
In our Clinical Trials blog series, we’ve covered topics such as how to find the right clinical trial , how to find and pay for clinical trials , and even if you have rights in a clinical trial. You may have heard a lot about clinical trials, but still have questions about when someone would participate in a clinical trial, or how they work. You are not alone!
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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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