Bio Pharma Dive
APRIL 12, 2021
The American Association for Cancer Research's virtual conference featured new data on an emerging immunotherapy target, a new kind of cell therapy and a KRAS reboot.
World of DTC Marketing
APRIL 11, 2021
QUICK THOUGHT: People believe the COVID-19 vaccine was developed in less than a year but that’s not true. Coronaviruses were first encountered in April 1930, when a strange respiratory disease ravaged poultry farms across North Dakota and Minnesota, killing tens of thousands of baby birds. Further scientific research into the virus and recognition that it was not like influenza A, a flu virus known to cause bronchitis, would transpire over the next 30 years. .
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Camargo
APRIL 14, 2021
In 2020, CDER approved 68 NDAs that used the 505(b)(2) pathway, representing important advances in patient care across a wide range of therapeutic areas. 505(b)(2) Drug Improvement Approvals by Year. In spite of an unusual year due to the COVID-19 pandemic, NDA approvals via the 505(b)(2) pathway increased 6% from 64 in 2019 to 68* in 2020 (Figure 1).
pharmaphorum
APRIL 14, 2021
More than 5,000 collaborative studies were thwarted by GDPR rules in 2019 – but is there a way to protect sensitive data while still allowing international health research to thrive? . A coalition of European academy networks has called upon European Union (EU) leaders to rethink how General Data Protection Regulation (GDPR) rules are applied to health data.
Bio Pharma Dive
APRIL 14, 2021
Advisers to the agency agreed to wait for more data before recommending new guidance, but aim to reconvene quickly to decide on whether vaccinations with J&J's should be resumed, and for whom.
World of DTC Marketing
APRIL 13, 2021
QUICK READ: Recent research from Zoom Rx saying that digital interactions with HCPs are myopic and don’t apply to the heavily segmented HCP audience. The future of reaching HCPS is both on and off-line depending on the product, health condition, and specialty. Zoom Rx recently polled HCPs and found 78% of physicians want to maintain some contact with pharma reps.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioPharma Reporter
APRIL 15, 2021
Moderna will take mRNA flu and HIV vaccines into Phase 1 trials this year, as well as beginning a pivotal Phase 3 study for its cytomegalovirus (CMV) vaccine candidate.
Bio Pharma Dive
APRIL 11, 2021
Study results presented at AACR showed Retevmo shrank tumors in nine different cancers, building a case for the type of tissue-agnostic label that only three other medicines have secured.
World of DTC Marketing
APRIL 16, 2021
QUICK READ: According to Setup 30% of Brand marketers say they’re likely/somewhat likely to switch Agencies in the next 6 months. While the consolidation of agencies may be a priority for some pharma companies a good digital agency can add a lot of value. There is a lot of downside to letting your main ad agency do your digital work. Setup also found that one third of brand marketers want their agencies to better understand their business + seek greater transparency and communication between Age
pharmaphorum
APRIL 12, 2021
A scheduled update to the NHS COVID-19 app has been blocked because it allows location tracking – something prohibited by Apple and Google, which developed some of the code it uses. . The new version of the app used in England and Wales was due to become available today to coincide with the relaxation of lockdown rules, with the public now able to attend venues such as non-essential shops, pub beer garden, gyms and hairdressers.
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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
BioSpace
APRIL 14, 2021
Shares of Inovio are climbing in early trading this morning after the company announced its DNA vaccine candidate for COVID-19 induced a robust T-cell response against multiple variants of the SARS-CoV-2 virus.
Bio Pharma Dive
APRIL 14, 2021
Updated study results show Moderna's coronavirus vaccine was strongly protective against COVID-19 through six months. But executives outlined contingency plans in case those effects fade.
World of DTC Marketing
APRIL 15, 2021
QUICK READ: Some deaths will occur during the COVID-19 vaccination rollout, but these deaths would have happened for other reasons and are unrelated to the vaccine. Vaccine-hesitant groups are peddling misinformation online and conspiracy theories aimed at eroding trust in the COVID-19 vaccine are everywhere forcing people to conduct more research. In some instances, vaccine-hesitant activists are manufacturing stories of deaths related to the vaccine that never happened.
pharmaphorum
APRIL 12, 2021
Exscientia was the first company to start human trials of a new drug designed using artificial intelligence (AI) last year, and now says it has started testing of the first AI candidate for immuno-oncology. . Oxford, UK-based Exscientia has been working with German biotech Evotec on the adenosine A2a receptor antagonist, which is being tested as a treatment for adult patients with advanced solid tumours.
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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.
BioPharma Reporter
APRIL 13, 2021
Insights have been gained into the role of the microbiome in disease states such as cancer, and strategies to manipulate the microbiome are quickly emerging, though optimal approaches are not yet known, said experts during an AACR 2021 event this week.
Bio Pharma Dive
APRIL 15, 2021
The decision to end development of a medicine acquired in a $425 million deal last November is another disappointment for Merck's coronavirus effort, which once involved multiple drugs and vaccines.
World of DTC Marketing
APRIL 12, 2021
QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. Patients should be scared.
BioSpace
APRIL 11, 2021
Six months after a COVID-19 diagnosis, more than 33% of people exhibited some form of brain damage, according to a study appearing in Lancet Psychiatry.
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.
NY Times
APRIL 15, 2021
Many cannot produce enough infection-fighting cells to fend off the coronavirus. But researchers are testing one therapy that may help: monoclonal antibodies.
Bio Pharma Dive
APRIL 16, 2021
The request comes less than six months after the FDA authorized Lilly's bamlanivimab, reflecting the spread of virus variants that can elude the drug.
Pharma Times
APRIL 12, 2021
The 2021 Clinical Researcher of the Year – The Americas competition is reaching out to the very best in the industry to take the next step and claim gold.
BioSpace
APRIL 14, 2021
The U.S. CDC said up to 5,800 people who have been fully vaccinated against coronavirus disease 2019 (COVID-19) have been infected by the novel coronavirus following vaccination.
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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
pharmaphorum
APRIL 16, 2021
The active compound in magic mushrooms – psilocybin – seems to be at least as effective as a commercially-available antidepressant in a phase 2 trial, and may work more quickly. . Researchers at Imperial College London’s Centre for Psychedelic Research also say that psilocybin may have a stronger effect and was more likely to help patients achieve remission from depression, although they stress the study was small and more research is needed.
Bio Pharma Dive
APRIL 13, 2021
The FDA and CDC recommended halting vaccinations while they investigate six cases of unusual blood clots in women given the company's shot.
Pharma Times
APRIL 15, 2021
The previously-reported CENTAUR study of AMX0035 in 137 participants with ALS met its primary endpoint of slowing ALS progression
BioSpace
APRIL 12, 2021
The U.S. Food and Drug Administration (FDA) approved a prefilled syringe for self-injection of an allergic diseases treatment developed by Novartis and Genentech, a Roche company.
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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
APRIL 12, 2021
Humans are diverse and communications to engage us need to be inclusive. It’s no longer about talking to a group, a cohort or an imagined section of society – especially in healthcare. Page & Page’s Lisa Jane Lishman outlines why communication and the strategies behind it need to be more personal to ensure that people – whoever they are – feel valued and respected.
Bio Pharma Dive
APRIL 16, 2021
The $85 million acquisition is an unusual and early step for a company like Relay, which went public last July and only just began clinical testing of its lead drugs last year.
Outsourcing Pharma
APRIL 15, 2021
The science service and technologies firm plans to bring the CRO under its Laboratory Products and Services Segment umbrella after the deal is completed.
BioSpace
APRIL 15, 2021
According to the researchers, who published their findings online in Cell, certain experiments can't be conducted in humans, making nearly human hybrids a possible solution to this investigational barrier.
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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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