Bio Pharma Dive
AUGUST 16, 2021
The FDA cleared Welireg, which Merck picked up in its $1 billion takeover of Peloton Therapeutics, to treat certain tumors associated with a rare genetic disease.
World of DTC Marketing
AUGUST 17, 2021
SUMMARY: You should never choose an agency based on size. It should be because they are a good fit with your brand team and can take your digital marketing to the next level while ensuring that everything they do is best in class. Debra called me up in a bit of a panic. She had received a proposal from her digital agency to build their product website and a proposal for paid media.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
NY Times
AUGUST 20, 2021
Federal regulators are winding down the process of licensing Pfizer’s two-dose coronavirus vaccine, setting up an approval possibly by Monday and possibly kicking off a wave of new mandates.
BioSpace
AUGUST 16, 2021
Moderna is expected to launch a human clinical trial as early as this week for an mRNA-based vaccine against HIV and indicated that it is looking for 56 people ages 18 to 50 who are HIV-negative.
Advertisement
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
AUGUST 17, 2021
Lilly Bio-Medicines will be split into separate neuroscience and immunology groups, while the Loxo cancer research division will merge with Lilly Oncology.
World of DTC Marketing
AUGUST 18, 2021
SUMMARY: I believe the biggest challenge facing pharma companies doesn’t come from legislation or R&D. It comes from being able to recruit and hold onto people who have a passion for the industry and get discouraged by a culture of endless meetings and matrix decision making. Here are some suggestions on how, I believe, pharma can attract and keep great employees.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
AUGUST 19, 2021
As governments and now even businesses push citizens to get vaccinated against COVID-19, anti-vaxxers are loading up more ammo for their argument with this week's report.
Bio Pharma Dive
AUGUST 20, 2021
Citing family health reasons, Gorsky will transition to the role of executive chairman and pass his torch to Joaquin Duato, currently vice chairman of J&J's executive committee.
Drug Patent Watch
AUGUST 16, 2021
I’ll be leading a workshop on generic portfolio management, and also giving a talk, at the 14th annual Marcus Evans event on Portfolio Planning and Partnerships for Generics. The event…. The post Upcoming workshop on generic portfolio management appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
AUGUST 16, 2021
Health Canada has started a rolling review of Merck & Co’s molnupiravir, an oral antiviral therapy treatment for COVID-19 partnered with Ridgeback Biotherapeutics. The Canadian regulator will start reviewing early safety, quality and efficacy data for the drug while late-stage clinical trials are still underway, in the hope of approving the drug quickly of results are positive.
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
BioSpace
AUGUST 19, 2021
Toronto saw the biggest growth in technology jobs of any North American city between 2015 and 2020, while Vancouver, British Columbia also made the top five.
Bio Pharma Dive
AUGUST 19, 2021
Developers of the complex treatments raised $14 billion between January and June, nearly three-quarters of last year's record-setting total, according to numbers compiled by the Alliance for Regenerative Medicine.
BioPharma Reporter
AUGUST 16, 2021
CureVac and GSK said their jointly advanced second-generation mRNA COVID-19 vaccine candidate, CV2CoV, demonstrated improved immune response and protection in a preclinical study.
pharmaphorum
AUGUST 19, 2021
Novartis’ Rydapt has become the first and only licensed treatment for rare and life-threatening blood disorder systemic mastocytosis (SM) to be cleared for routine NHS use, after getting a green light from NICE. The decision means around 170 people with advanced SM in England and Wales will be eligible for treatment with oral, twice-daily drug, which since 2018 has also been cleared for NHS treatment of a form of acute myeloid leukaemia.
Advertisement
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.
BioSpace
AUGUST 15, 2021
?In a preclinical study published in PNAS, scientists from Feinstein Institutes for Medical Research presented a new approach to treating diseases that involve inflammation and pain, like arthritis.
Bio Pharma Dive
AUGUST 16, 2021
The decision from the regulator ends a three-month study pause that had stalled Rocket's development of of the Danon disease treatment.
NY Times
AUGUST 16, 2021
Johnson & Johnson is sending shots from South Africa to other parts of the world. African countries are waiting for most of the doses they’ve ordered.
pharmaphorum
AUGUST 17, 2021
Rapid advances in the use of artificial intelligence (AI) in healthcare and medicines development are at risk of outstripping current regulatory frameworks, according to a new report. The International Coalition of Medicines Regulatory Authorities (ICMRA) has recommended that a new permanent working group be set up to keep tabs on the use of AI and make sure that regulations can accommodate new developments.
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.
BioSpace
AUGUST 17, 2021
?Scientists from The Christie NHS Foundation Trust have begun human trials on the use of aspirin and avelumab in treating patients diagnosed with triple-negative breast cancer.
Bio Pharma Dive
AUGUST 16, 2021
Positive results help validate the $1 billion acquisition that gave Lilly access to lebrikizumab. Even so, the company could face tough competition from Regeneron and Sanofi's Dupixent.
Pharma Times
AUGUST 16, 2021
VHL is a rare genetic disease which puts patients at risk of developing benign blood vessel tumours and several cancers
pharmaphorum
AUGUST 15, 2021
In the latest episode of the podcast Dominic Tyer speaks with Dr Maria Ines ‘Mari’ Mitrani, chief science officer at the clinical-stage biopharmaceutical company Organicell Regenerative Medicine. They looked at the development of regenerative medicine and where Organicell hopes to add to that field. Then, with the company pivoting to try and help tackle Covid, they also discussed how that change was made possible and where Organicell’s focus will be.
Advertisement
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.
BioSpace
AUGUST 17, 2021
A Sackler family heir said in a court appearance that the family, which owns OxyContin drug maker Purdue Pharma, holds a “moral responsibility” to lend its help in combating the U.S. opioid crisis but noted it will not give billions of dollars to a legal settlement unless broad legal protections.
Bio Pharma Dive
AUGUST 18, 2021
The pharma's immunotherapy Jemperli can now be used for a wider array of cancers that are "mismatch repair-deficient," matching an indication held by Merck's top-seller Keytruda.
XTalks
AUGUST 16, 2021
Due to changes brought on by the COVID-19 pandemic, where and how people work in the food and beverage industry are evolving. According to a recent report by Deloitte and FMI-The Food Industry Association (FMI), the industry is already looking ahead and planning for its next steps in the evolving post-pandemic workplace. The report, entitled “Future of work: The state of the food industry,” outlines conclusions from 150 surveys and 15 interviews with food industry leaders.
pharmaphorum
AUGUST 17, 2021
In latest episode of our Health Innovators video interview series, Dr Paul Tunnah speaks to Daphne Zohar, the co-founder and CEO of PureTech Health. They discuss the publicly-listed biotech’s pipeline projects and focus on the BIG (brain-immune-gut) axis as well as PureTech’s interest in digital therapeutics. Daphne explains how she built an impressive team of board advisors for her company, plus the challenges and experience of fund raising.
Advertisement
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.
BioSpace
AUGUST 15, 2021
If you find yourself in a hybrid work environment where you will be splitting your working hours between the office and home, here are a few tips to help you succeed while working.
Bio Pharma Dive
AUGUST 16, 2021
A new study demonstrates that PrismRA can predict the likelihood of not achieving a clinically meaningful response of at least a 50% improvement in symptoms in targeted therapy-naïve patients.
Pharma Times
AUGUST 19, 2021
Public consultation launches on proposed changes aiming to provide earlier access to new treatments
pharmaphorum
AUGUST 19, 2021
A common set of standards for randomised clinical trials (RCTs) aims to help researchers develop the drugs and interventions of the future – no matter what they do or where they are based. The Good Clinical Trials Collaborative (GCTC) has published a draft guidance document, and is asking for the life sciences sector to make its views known. The publication, which is out for public consultation until 15 September, said RCTs played a central role in generating the evidence needed to inform the de
Advertisement
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.
Expert insights. Personalized for you.
323 
Let's personalize your content