Bio Pharma Dive
AUGUST 29, 2022
With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area.
World of DTC Marketing
AUGUST 30, 2022
Digital ad spending in the industry will reach $15.84 billion in 2022. Although growth in digital budgets is slowing, we estimate the category will see nearly $20 billion in spending in 2024. For every $1 million invested in online banner ads, just 0.1%, or $1,000, derives value for brands, resulting in $999,000 wasted by brands. So why is pharma wasting so much money?
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Pharmaceutical Technology
SEPTEMBER 2, 2022
Novo Nordisk has signed a definitive agreement for the acquisition of clinical-stage biopharmaceutical firm Forma Therapeutics for $20 for each share in cash or a total equity price of $1.1bn. Forma focuses on researching, developing and marketing new therapies for patients with sickle cell disease (SCD), rare hematologic diseases and cancers. Through the acquisition, Novo Nordisk plans to boost its presence in sickle cell disease and rare blood disorders.
Rethinking Clinical Trials
SEPTEMBER 1, 2022
The Health Care Systems Research Network (HCSRN) is accepting abstract submissions and panel presentation submissions for its 2023 Annual Conference until October 7, 2022. This year’s meeting will be held in Denver, Colorado, from February 21 to 23, 2023. The HCSRN is a 19-member research network focused on supporting research institutes aligned with healthcare delivery systems.
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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 2, 2022
Preliminary results from a Phase 1 study show Sangamo’s treatment to be safe and suggest it is working as intended, leading the biotech to move into the trial’s next phase.
World of DTC Marketing
AUGUST 29, 2022
DTC marketers spend a lot of time and money gaining insights into patients and caregivers. That information should be shared with HCPs and insurers to understand better the barriers and opportunities of treating patients. A sales representative for a biotech company shared information with oncologists about patients’ attitudes towards treatment options, including the company’s brand.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Mirror
AUGUST 30, 2022
The RegeneratOR Test Bed is an exciting game changer. The testing facility, located in North Carolina, provides supportive technology at no cost allowing companies to test and prove their cell-based products at various stages of development. The Test Bed utilizes Cytocentric principles, an innovative philosophy of putting the needs of the vulnerable cells front and center while growing and manipulating them in vitro.
Bio Pharma Dive
AUGUST 29, 2022
In a wide-ranging conversation with BioPharma Dive, Booth, a prolific builder of new biotechs, said he’s starting to see positive signs for startups considering an IPO or private financing.
World of DTC Marketing
AUGUST 31, 2022
According to STAT News, “Americans born in 2021 can expect to live for just 76.1 years — the lowest life expectancy has been since 1996, according to a new government analysis published Wednesday. This is the biggest two-year decline — 2.7 years in total — in almost 100 years.” It’s only going to get worse too. The Covid-19 pandemic is the primary cause of the decline, but we are ignoring another statistic.
Pharmaceutical Technology
SEPTEMBER 1, 2022
Guardant Health has extended a partnership with Merck KGaA, Darmstadt, Germany, to aid in expediting precision oncology therapeutics development. Under the collaboration, the companies will use the GuardantINFORM real-world evidence (RWE) platform to boost works for developing Merck’s precision cancer pipeline. The development of therapies for key oncology indications with substantial unmet needs will be the expanded partnership’s focus.
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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
Rethinking Clinical Trials
AUGUST 29, 2022
Dr. Steven Joffe will give a keynote presentation on September 9th. The NIH Pragmatic Trials Collaboratory is launching a special Grand Rounds series to examine ethical and regulatory challenges in pragmatic clinical trials. Over the past decade, the program’s Ethics and Regulatory Core has worked with investigators to navigate ethical and regulatory complexities associated with research conducted within healthcare systems.
Bio Pharma Dive
AUGUST 31, 2022
The blank-check deal gives Ocean another route to public markets after it struggled to price an initial public offering it revealed back in June 2021.
BioPharma Reporter
SEPTEMBER 1, 2022
Arcturus Therapeutics has obtained an award for up to $63.2m from the Biomedical Advanced Research and Development Authority (BARDA): allowing the company to expand its current influenza vaccine program to include development of a pandemic influenza vaccine based on its proprietary self-amplifying mRNA platform.
Pharmaceutical Technology
SEPTEMBER 2, 2022
Multiple myeloma (MM) therapeutics comprise a multi-billion dollar market, among the most valuable in oncology. This is a result of intensive research efforts that have produced regimens that have prolonged patient survival, most of which are a combination of a proteasome inhibitor + an immunomodulatory drug (ie. lenalidomide) + a steroid ± an anti-CD38 antibody.
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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.
NPR Health - Shots
AUGUST 30, 2022
Americans' life expectancy dropped for the second year in a row and is now the lowest it's been since the 1920s. COVID-19 is driving the downward trend, according to CDC data.
Bio Pharma Dive
SEPTEMBER 1, 2022
A well-known physician-scientist who joined Novartis from Harvard, Jay Bradner spent over six years steering the company’s research hub. He will be replaced by Merck executive Fiona Marshall.
STAT News
AUGUST 30, 2022
Americans born in 2021 can expect to live for just 76.1 years — the lowest life expectancy has been since 1996, according to a new government analysis published Wednesday. This is the biggest two-year decline — 2.7 years in total — in almost 100 years. The Covid-19 pandemic is the primary cause of the decline. However, increases in the number of people dying from overdoses and accidents is also a significant factor.
Pharmaceutical Technology
SEPTEMBER 2, 2022
The rate of drug approvals could be on the rise. In a recent report, GlobalData revealed that the US Food and Drug Administration (FDA) approved 122 new drug applications (NDAs) and biologic license applications (BLAs) in 2021. This figure represents a 2.4% increase over the 2016–2020 period average. Yet despite this promising data, it’s a well-known fact that drug launches are under-performing – with around two-thirds of new drugs successfully navigating the long and rocky approval process only
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.
NPR Health - Shots
AUGUST 31, 2022
The inventors of Corbevax said it was cheap, easy to make, effective and safe. They hoped it could bring vaccine equity to countries that can't access costlier shots. Has it lived up to its promise?
Bio Pharma Dive
SEPTEMBER 2, 2022
One day after the FDA’s authorization, the CDC recommended the companies’ omicron-targeted vaccines for most adults and children over 12 years old.
STAT News
AUGUST 30, 2022
Just over three months ago, public health authorities in the U.K., Europe, and the U.S. began to sound the alarm on the arrival of monkeypox. Since then, this long-neglected tropical disease — which until this year was mostly limited to periodic spillovers in the areas of Western and Central Africa where the virus is endemic — has gone global.
Pharmaceutical Technology
SEPTEMBER 2, 2022
The US Food and Drug Administration (FDA) has granted approval for Azurity Pharmaceuticals’ Konvomep (omeprazole and sodium bicarbonate for oral suspension) to treat active benign gastric ulcer. Konvomep is also indicated for lowering the upper gastrointestinal bleeding risk in critically ill patients. It is a combination of a proton pump inhibitor (PPI), omeprazole, and sodium bicarbonate.
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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.
NPR Health - Shots
AUGUST 31, 2022
The way many Americans eat is fueling chronic disease. Here are seven big ideas from the White House's upcoming nutrition conference for how to improve Americans' diets. (Image credit: FREDERIC J.
Bio Pharma Dive
AUGUST 29, 2022
Sold as Pemazyre, the drug, which blocks well-known cancer proteins known as FGFRs, is now also cleared for use in certain patients with very rare and aggressive blood cancers.
STAT News
SEPTEMBER 2, 2022
Sometime this weekend or early next week, pharmacies and doctors’ offices are going to start to receive Covid-19 boosters that have been reformulated to include protection against one of the sub-variants of Omicron. These boosters, from Pfizer and its partner BioNTech as well as from Moderna, are bivalent shots. They target two strains of the SARS-CoV-2 virus, both the original strain that all previous vaccines have protected against, and the Omicron sub-variants BA.4/BA.5.
Pharmaceutical Technology
SEPTEMBER 1, 2022
Analysts at GlobalData predict that the market for point-of-care (POC) diagnostic devices will reach $297.6bn by 2023, a growth of almost $1bn from 2015. While a significant proportion of this increase is due to the volume of lateral flow tests (LFTs) manufactured to perform mass screening of populations for Covid-19 over the last two years, this trend towards POC diagnostics is positive news.
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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.
NPR Health - Shots
SEPTEMBER 1, 2022
One year after a restrictive abortion law took effect, a poll shows a majority of Texans surveyed say they support abortion access in most or all cases. Many say the issue will motivate them to vote.
Bio Pharma Dive
SEPTEMBER 1, 2022
The target company, Forma Therapeutics, started as a developer of cancer drugs but has made the most progress in rare blood disorders, attracting Novo’s attention.
Rethinking Clinical Trials
AUGUST 31, 2022
A new section of the NIH Pragmatic Trials Collaboratory’s Living Textbook of Pragmatic Clinical Trials discusses challenges associated with Evaluating Fitness for Use of real-world data for trials. The section uses a case study from the Harmony Outcomes EHR Ancillary Study (eHARMONY) to describe lessons learned and to provide recommendations for studies considering incorporating real-word data as a data source.
Pharmaceutical Technology
SEPTEMBER 1, 2022
Buildings vacated at the peak of Covid-19 are subject to greater risks of water stagnation due to a lack of flow and activity. Even if buildings have been reopened for some time, there may be unresolved risks within water systems. Returning occupants are at risk of exposure to harmful bacteria. From hospitals and hotels to offices and gyms, water stagnation must be mitigated wherever water may be directly consumed or used for washing.
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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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