Bio Pharma Dive
JULY 14, 2021
Sales of Nurtec ODT during the second quarter were double what Wall Street expected. CEO Vlad Coric explained to BioPharma Dive how the biotech did it, despite being far smaller than its chief rival.
World of DTC Marketing
JULY 14, 2021
SUMMARY: There is a talent drain at the agency and DTC levels. More experienced DTC people are being forced to retire. TV still gets the biggest share of DTC budgets, but they don’t drive brand objectives. Talented marketers don’t want a career in pharma because of the culture. Many pharma agencies have allowed and sometimes forced experienced, talented people to leave while replacing them with inexpensive unproven people, and it shows.
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NY Times
JULY 14, 2021
The company said it had determined that daily exposure to five Neutrogena and Aveeno sprays would not cause adverse health effects, but recalled the products out of an abundance of caution.
Pharma Times
JULY 13, 2021
Researchers discover presence of 'autoantibodies' in people with persistent COVID-19 symptoms
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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
JULY 15, 2021
Three months after a rare FDA rejection, Merck has data showing Keytruda can slow the return of triple-negative breast cancer but not, as of yet, proving whether the drug extends lives.
World of DTC Marketing
JULY 15, 2021
SUMMARY: The Committee on Oversight and Reform and the Committee on Energy and Commerce is investigating the approval process for Biogen’s new Alzheimer’s drug. Janet Woodcock acknowledged on Wednesday her agency may have misstepped in the handling of its polarizing approval of a new Alzheimer’s drug. Biogen undertook a secret campaign, termed Project Onyx, to persuade FDA to approve Aduhelm.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
JULY 13, 2021
In 2020, the two partners announced an initial collaboration to integrate Cegedim’s ‘THIN’ European real-world data into Aetion’s evidence platform
Bio Pharma Dive
JULY 12, 2021
The agency said the benefits of vaccination with J&J's shot still "clearly outweigh" the risks, which now include very rare cases of a immune-driven condition known as Guillain-Barré
World of DTC Marketing
JULY 13, 2021
SUMMARY: The FDA has many puzzled as to why they approve some drugs with questionable data and ask for more data on other drugs. The FDA approves drugs on the potential to save a life, the cost of the drugs is never considered in the process. The FDA has been under criticism, but an internal investigation will focus on approval processes, not “why” a drug was approved.
pharmaphorum
JULY 13, 2021
Faced with a looming mental health crisis, the UK government has been urged to invest in the digitisation of service provision across the NHS in England in a new report from think tank Future Care Capital. The study’s author – FCC’s head of policy and research Dr Peter Bloomfield, argues that there has been a lack of support for mental health services for many years in the UK, and the pathways for accessing them are “convoluted, waiting lists are extensive, and outcomes are po
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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
JULY 12, 2021
Vaccine effectiveness against symptomatic disease in at-risk groups is approximately 60% after one dose of either the AZ or Pfizer/BioNTech vaccines
Bio Pharma Dive
JULY 15, 2021
The Cleveland Clinic and Mount Sinai won't yet administer the controversial Alzheimer's drug, while UnitedHealth's CEO said the insurer would need more time to iron out coverage.
Scienmag
JULY 12, 2021
The research forecasts water supply and economic risks as tensions mount over Grand Ethiopian Renaissance Dam Credit: (Photo/NASA-JPL) Rapid filling of a giant dam at the headwaters of the Nile River — the world’s biggest waterway that supports millions of people — could reduce water supplies to downstream Egypt by more than one-third, new USC […].
pharmaphorum
JULY 15, 2021
The UK’s competition authority has issued its largest ever fine of more than £260 million ($360 million) to several pharma companies accused of colluding to hike the price of medicines delivered to the NHS. The Competition and Markets Authority (CMA) took the action against Auden Mckenzie and Actavis UK – now known as Accord-UK – and other companies after an investigation into the price of hydrocortisone tablets, which rose by 10,000% over a 10-year period.
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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
JULY 12, 2021
NICE concluded the cost-effectiveness estimates for Libmeldy are unlikely to be within the range that it would consider an effective use of NHS resources
Bio Pharma Dive
JULY 16, 2021
"Right now, and I think for a while, the access is going to be pretty limited," former CMS and FDA head Mark McClellan said at the meeting, which featured yet another rebuke by experts of Aduhelm.
BioSpace
JULY 14, 2021
The amount is intended to support the company's growing portfolio of RNA technologies and accelerate efforts to develop various treatment approaches in the gene therapy field.
pharmaphorum
JULY 14, 2021
AstraZeneca and Johnson & Johnson are both exploring ways to modify their COVID-19 vaccines to minimise the risk of severe blood clotting reactions that are seen – albeit rarely – in some people receiving the jabs. At the same time, the UK’s National Institute for Health and Care excellence (NICE) is developing guidance to help doctors manage the cases of vaccine-induced immune thrombocytopenia and thrombosis (VITT) and low blood platelet counts that have been seen with the COVID-19 va
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.
XTalks
JULY 16, 2021
Since its inception, plant-based meat has commanded a premium in most grocery stores and restaurants. Despite being inherently more efficient to produce — since it relies on plants rather than animals — plant-based meat is often more expensive than its animal-based counterpart. . Is it because of the technology required to produce it? Perhaps the profit margins?
Bio Pharma Dive
JULY 14, 2021
Formed around research from the Broad Institute's David Liu and Andrew Anzalone, Prime has attracted significant funding from a wide range of high-profile biotech backers.
Drug Patent Watch
JULY 16, 2021
Come join me and Wendi Lau from Abbvie as we participate in an interactive roundtable discussion on pharmaceutical portfolio management. We’ll be sharing our expertise and best practices for strategic…. The post DrugPatentWatch and Abbvie discuss Pharmaceutical Portfolio Management appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
JULY 14, 2021
In this episode of Health Innovators , pharmaphorum founder Paul Tunnah interviews Jo Brewer, senior vice president of allogeneic research at UK company Adaptimmune which is transforming cancer immunotherapy with affinity enhanced T-cell receptors. Adaptimmune’s SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.
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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.
XTalks
JULY 16, 2021
Coca-Cola Zero Sugar has released a new refreshing recipe and bold packaging that provides consumers with a taste more similar to the original and iconic Coke flavor. The new packaging design represents a simpler look that features the Coca-Cola logo, red cues and black Spencerian script, indicating that this beverage is “Now More Delicious.”. “Recognizing that tastes and preferences are always evolving, we’re focused on continuous improvement to give fans the best-tasting Coca-Cola they want—wi
Bio Pharma Dive
JULY 14, 2021
Rival Novo Nordisk has jumped ahead in developing an injectable drug that responds to changes in blood sugar. An acquisition of Protomer Therapeutics could help Lilly close the gap.
BioPharma Reporter
JULY 12, 2021
Antibody responses against the SARS-CoV-2 spike protein were found in 99% of volunteers after the second dose of ReiTheraâs COVID-19 vaccine candidate, according to Phase 2 preliminary data.
pharmaphorum
JULY 13, 2021
Diagnosing Alzheimer’s disease is still a challenge, particularly in its earliest stages, but a new study suggests that subtle changes in behaviour whilst driving could serve as an early warning system. The researchers used GPS logging devices and machine learning as “digital biomarkers” to compare the driving of people who have preclinical Alzheimer’s but are still cognitively normal to a control group of normal age-matched drivers over the course of a year.
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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
JULY 16, 2021
Johnson & Johnson is recalling sunscreens from two of its popular brands over concerns of carcinogenic benzene contamination. In a news release , J&J said it is exercising “an abundance of caution” by pulling its Neutrogena and Aveeno spray sunscreens from shelves. The company said that while benzene is not an ingredient in any of its sunscreen products, it was detected during routine internal testing in some samples of its aerosol sunscreen finished products.
Bio Pharma Dive
JULY 12, 2021
Days after the FDA narrowed the target population for Biogen's drug, the patient advocacy group said it's urging Medicare to adopt a nationwide policy. Payers are seeking guidance, too.
Pharma Times
JULY 12, 2021
BMA research finds the number of doctors per 1,000 people in England is 25 years behind comparable EU nations
pharmaphorum
JULY 14, 2021
James Dempsey breaks down the misconception that culture can’t be measured, and gives tips for how companies can implement a clear culture strategy. In 2014, six years after the global financial crisis forced the world’s biggest financial institutions into some serious navel gazing, the CEO of a major international bank was despairing: “We’ve put in place a best-in-class compliance system, but we can’t stop our people acting badly.
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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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