Bio Pharma Dive
NOVEMBER 30, 2021
While agency advisers raised concerns over molnupiravir's modest benefits and potential risks, a majority felt the antiviral drug is a needed option for COVID-19 patients at high risk of severe disease.
World of DTC Marketing
DECEMBER 3, 2021
LEAD-IN: Yesterday I had a long talk with someone who has been in the industry for over 25 years. She has decided to leave the pharma industry because she said, “patients have been reduced to numbers on an excel spreadsheet” and “I am tired of trying to get coworkers to see them as people with real needs.” According to my WordPress stats, I have over 100 readers a day.
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Pharma Times
NOVEMBER 30, 2021
Following its recent approval of an injectable HIV-1 treatment from the National institute for Health and Care Excellence (NICE), GlaxoSmithKline (GSK) has high hopes in developing a cure for the virus in the future.
pharmaphorum
NOVEMBER 28, 2021
An investigator-led trial of Jazz Pharma’s cannabis extract-based drug Sativex in glioblastoma – an aggressive form of brain cancer – will get underway in the UK next year. The three-year phase 2 trial will be carried out by researchers at Leeds University led by professor of clinical oncology and neuro-oncology Susan Short, and see if adding Sativex (nabiximols) to standard chemotherapy for recurrent glioblastoma can extend survival.
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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
NOVEMBER 29, 2021
After several family members had early heart attacks, Kathiresan vowed to understand why they happen. His research journey has changed medical practice and led to a new biotech startup, Verve Therapeutics, that seeks to prevent them.
World of DTC Marketing
DECEMBER 1, 2021
OPENING: TV is great at creating awareness, but it can also scare patients away if one of your side effects is “may lead to death.” This is one side effect that stands out when your target audience watches your spot along with “serious heart rhythm problems” and “new cancers have happened during treatment.” I understand that DTC marketers are in love with TV even though it’s becoming less effective.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
DECEMBER 2, 2021
Researchers have identified in those patients experiencing blood clots after vaccination a subsequent condition referred to as vaccine-induced immune thrombotic thrombocytopenia (VITT).
Bio Pharma Dive
NOVEMBER 29, 2021
A $250 million acquisition of startup Lengo Therapeutics has given Blueprint a lung cancer drug that could compete with medicines from Takeda and J&J.
World of DTC Marketing
DECEMBER 2, 2021
GOOD MORNING: The FDA is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on measuring consumer perceptions of the information presented in ads. Since when is consumer behavior ever scientific? According to Science Direct “participants who saw exaggerated images (in DTC ads) were more likely than those who saw no image or accurate images to overestimate efficacy.
NY Times
DECEMBER 2, 2021
Spain surpassed others in Europe by avoiding politicized debate about Covid shots. Citizens also largely heeded the health guidance from their leaders.
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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
Pharma Times
NOVEMBER 29, 2021
Analyses provided by UK cancer charity Macmillan has provided insights into the repercussions experienced by patients waiting to receive treatment during the COVID-19 pandemic.
Bio Pharma Dive
NOVEMBER 29, 2021
Several companies, including Pfizer and Moderna, are already at work adapting their coronavirus shots to the newly identified variant, which experts worry could more readily evade vaccine protection.
BioPharma Reporter
NOVEMBER 30, 2021
Australian biotech EnGeneIC, which is developing its nanocell tech for use in infectious diseases (including a COVID-19 vaccine) as well as a cancer treatment, has announced a deal with US biotech ImmunityBio to develop, manufacture and commercialize the tech.
pharmaphorum
DECEMBER 2, 2021
The UK medicines regulator has approved GlaxoSmithKline and Vir Biotech’s antibody for COVID-19, Xevudy, which has been shown to be effective against the new Omicron strain of SARS-CoV-2 in lab testing. Xevudy (sotrovimab) is the second COVID-19 antibody to be approved by the MHRA after Roche/Regeneron’s Ronapreve (casirivimab and imdevimab), which got a green light during the summer.
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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
DECEMBER 1, 2021
The UK government has aimed to expand their COVID-19 vaccination programme, in accordance with guidance from the Joint Committee on Vaccination and Immunisation (JCVI).
Bio Pharma Dive
NOVEMBER 30, 2021
Philip Dormitzer, who helped Pfizer develop shots for COVID-19, RSV and influenza, will become the British pharma's head of vaccine R&D next month.
BioSpace
DECEMBER 2, 2021
Researchers from Harvard University and the U.S. Department of Veterans Affairs (VA) found that the Moderna mRNA vaccine was slightly better than the Pfizer-BioNTech vaccine.
pharmaphorum
DECEMBER 3, 2021
An online training academy that aims to raise the digital skills of NHS health and care workers is due to open its virtual doors next March, according to the Organisation for the Review of Care and Health Apps (ORCHA). The Digital Health Academy – developed with pharma company Boehringer Ingelheim – is part of a drive to get digital health tools and apps used more routinely in the management of health conditions, according to ORCHA.
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
DECEMBER 2, 2021
Scientists and health experts have cautioned that the new variant could have the ability to bypass the effectiveness of vaccines that are currently available.
Bio Pharma Dive
NOVEMBER 30, 2021
While Regeneron is still testing its treatment against the new variant, the biotech is readying contingency plans, including second-generation versions of its drug.
Outsourcing Pharma
NOVEMBER 29, 2021
The biotech firm has presented data from a study that could offer hope to patients with Parkinsonâs, Gaucher, Alzheimerâs and other neurodegenerative conditions.
pharmaphorum
NOVEMBER 30, 2021
The FDA will deliver a verdict on AstraZeneca’s PARP inhibitor Lynparza as an adjuvant treatment for breast cancer in the first quarter of next year, after granting the application a priority review. AZ and partner Merck & Co have filed Lynparza (olaparib) for use in BRCA-mutated, HER2-negative early breast cancer in patients who have already been treated with chemotherapy either before or after surgery and are at high risk of the disease coming back.
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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.
Pharma Times
NOVEMBER 30, 2021
The Scottish government aims to expand and advance their COVID-19 booster programme, following the six cases of the Omicron variant that were reported as of Monday 29 November. This decision is based on advice from the Joint Committee on Vaccination and Immunisation (JCVI).
Bio Pharma Dive
DECEMBER 3, 2021
Usama Malik, chief financial officer of Immunomedics from 2017 to late 2020, is charged with tipping his partner and several relatives of positive study results for the biotech's breast cancer drug.
BioSpace
NOVEMBER 29, 2021
Omicron has caused the U.S. to install travel bans against several South African countries while vaccine makers rush to test their vaccines against it. For that news and more, continue reading.
Outsourcing Pharma
NOVEMBER 29, 2021
A leader from the health tech solutions company explains how progress in genetic testing has helped advance the detection and prevention of breast cancer.
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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.
Pharma Times
DECEMBER 1, 2021
Amid the COVID-19 pandemic, the NHS faces staff and hospital equipment shortages alongside the growing need to reduce the backlog in patient surgeries and treatments.
Bio Pharma Dive
DECEMBER 2, 2021
UCB's experimental pill is one of the most advanced projects that's aimed at blocking accumulation of an abnormal protein in patients' brains.
XTalks
DECEMBER 1, 2021
With all the uncertainty around the new SARS-CoV-2 variant, Omicron (B.1.1.529), diagnostic test makers are assuring people that their COVID-19 PCR tests work just fine in detecting the latest version of the coronavirus. Upon being declared a variant of concern by the World Health Organization (WHO) on Friday last week, companies like Thermo Fisher Scientific, Qiagen, Abbott, Cue Health and Co-Diagnostics have said that their current SARS-CoV-2 assays are able to detect the Omicron variant of th
BioPharma Reporter
DECEMBER 1, 2021
EverImmune, a biotech based near Paris, and specialized in the development of live biotherapeutic products in the field of microbiota oncology, has raised â5m (US$5.7m) in a Series A funding round from undisclosed private investors.
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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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