Bio Pharma Dive
OCTOBER 6, 2022
Nested Therapeutics touts a deep bench of scientific leaders and advisers, including Kevan Shokat, whose work drugging KRAS — a cancer-related gene once thought to be undruggable — helped lead to the development of Amgen’s Lumakras.
Pharmaceutical Technology
OCTOBER 6, 2022
Pfizer has acquired all the outstanding shares of the common stock of biopharmaceutical firm Global Blood Therapeutics (GBT) in a deal worth nearly $5.4bn. The total enterprise value comprised debt and the net of cash acquired. With the latest acquisition, GBT became a wholly-owned Pfizer subsidiary. GBT discovers and develops life-changing therapies for ailments with an initial focus on sickle cell disease (SCD).
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Bio Pharma Dive
OCTOBER 6, 2022
A new fast track designation allows Lilly to begin the process of seeking approval of tirzepatide for obesity, though the drug will need to succeed in a second trial to get to market.
Pharmaceutical Technology
OCTOBER 6, 2022
BioLink Life Sciences has received a contract worth $750,000 from the US Biomedical Advanced Research and Development Authority (BARDA) to develop Ramatroban for treating Covid-19 pneumonia patients in the hospital setting. A dual blocker of thromboxane and prostanoid receptors, Ramatroban showed efficacy in animal models of atherosclerosis, respiratory dysfunction, thrombosis and sepsis.
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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
OCTOBER 6, 2022
The pharma will invest in the biotech and co-promote its drug teplizumab if the FDA OKs the medicine as a first-of-its-kind diabetes treatment.
Pharmaceutical Technology
OCTOBER 6, 2022
Intravacc has received a contract worth $14.6m from the US National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID) to develop a prophylactic intranasal vaccine against Neisseria gonorrhoeae (NG). Leveraging its outer membrane vesicles (OMV) platform technology, Intravacc will develop the vaccine. Named NGoXIM, the NG vaccine is based on gonococcal OMVs merged with sustained-release microspheres comprising recombinant human IL-12.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
OCTOBER 6, 2022
According to Adam Bradbury, GlobalData PharmSource analyst “[…] evidence indicates that containment facilities are in high demand and will be increasingly so in future as the oncology pipeline and the use of cytotoxic drugs continues to grow.” But despite this surge in demand, research from GlobalData shows that many CMOs have decreased in-house, non-containment, small molecule manufacturing.
Bio Pharma Dive
OCTOBER 6, 2022
The company opened a packaging facility for its two top-selling products and began work on a plant that will produce next-generation inhalers.
pharmaphorum
OCTOBER 6, 2022
An artificial intelligence-powered digital health worker has been unveiled by the World Health Organisation (WHO) as its latest tool for disseminating reliable health information to the public. Originally developed by New Zealand tech company Soul Machines with support of the Qatar Ministry of Health, the first version of the virtual health worker was used to combat misinformation about the pandemic.
STAT News
OCTOBER 6, 2022
The American Revolution had July 4. The allies had D-Day. And now U.S. patients, held down for decades by information hoarders, can rally around a new turning point, October 6, 2022 — the day they got their health data back. Under federal rules taking effect Thursday, health care organizations must give patients unfettered access to their full health records in digital format.
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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
NPR Health - Shots
OCTOBER 6, 2022
With an outbreak of the deadly disease declared in Uganda, travelers who have been to the African country within 21 days of arriving in the U.S. will be subject to enhanced screening.
STAT News
OCTOBER 6, 2022
The United States is in a (relative) Covid-19 lull, with cases and hospitalizations falling as the wave driven by the BA.5 lineage of the Omicron variant recedes. But as if we needed a portent of an anticipated fall and winter wave , Covid is on the rise in some European countries. What’s different, at least for now, is that there’s not one variant pushing the wave.
NPR Health - Shots
OCTOBER 6, 2022
New policies to keep medical bills from sinking credit ratings sound good but will likely fall short for many hit hardest by debt — especially Black Americans in the South, such as Penelope Wingard.
Pharma Times
OCTOBER 6, 2022
The Airport Region in Central Germany’ presents itself as an attractive location for the international pharmaceutical industry
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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.
STAT News
OCTOBER 6, 2022
The three companies that dominate the global market for insulin have launched various programs to expand the reach of their medicines in dozens of low and middle-income countries — but their efforts remain patchy and equitable access consequently remains out of reach, according to a new analysis. Too often, the manufacturers — Eli Lilly, Sanofi, and Novo Nordisk — do not understand the extent to which the public and private sectors in many poorer countries can afford insulin
NPR Health - Shots
OCTOBER 6, 2022
Erratic weather is just one problem. Many farmers can no longer keep pace with the rising cost of fuel and fertilizer (which previously has been largely imported from Ukraine). What's the solution?
STAT News
OCTOBER 6, 2022
Buried deep within the Inflation Reduction Act’s drug-price negotiation provisions is language that could open the way to a new era of biomedical breakthroughs and smarter health spending. This language does something Medicare hasn’t tried before: It ties payment for treatments to how well they work. Doing so used to be illegal. But it will now be required for some drugs.
BioSpace
OCTOBER 6, 2022
Allogene Therapeutics is launching what it calls the first pivotal Phase II trial of an allogeneic CAR T product in the industry. The ALPHA2 trial will evaluate ALLO-501A in LBCL.
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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.
STAT News
OCTOBER 6, 2022
The United States is going to direct travelers arriving from Uganda, where a fast-growing Ebola outbreak arose in recent weeks, to five airports where they can be screened for possible infection. Starting Friday, U.S.-bound passengers who have been in Uganda within the past three weeks will be routed to JFK, Newark, Atlanta, O’Hare, or Dulles outside Washington, D.C., according to a statement from the U.S. embassy in Uganda.
BioPharma Reporter
OCTOBER 6, 2022
The recent lecanemab trial read-out will have a sizeable impact on the path forward for other biopharmaâs developing treatments for Alzheimerâs disease, says the chief executive of a company developing investigational therapies for rare peripheral amyloid and neurodegenerative diseases.
STAT News
OCTOBER 6, 2022
WASHINGTON – Here in the U.S., it’s “in” to study the social determinants of health. There are programs at Columbia and Emory dedicated to the field. Papers on the topic garner thousands of citations.The federal health department has even crafted an entire plan for addressing this topic, which is broadly defined as the ways a person’s environment impacts their health.
pharmaphorum
OCTOBER 6, 2022
Biological systems are hugely complex, with a staggering number of pathways interacting every millisecond. The downstream effects of just one biological change are enormous. So, when a new disease emerges, researchers have a near-impossible task working upstream from symptoms to identify the underlying cause and biological mechanisms causing disease.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
STAT News
OCTOBER 6, 2022
WASHINGTON — President Joe Biden is pardoning thousands of Americans convicted of “simple possession” of marijuana under federal law, as his administration takes a dramatic step toward decriminalizing the drug and addressing charging practices that disproportionately impact people of color. Biden’s move also covers thousands convicted of the crime in the District of Columbia.
ACRP blog
OCTOBER 6, 2022
Parkinson’s disease (PD) is a neurodegenerative disorder affecting an estimated one million Americans and six million people worldwide. No cure or treatment to slow the progression has yet been found, but research is leading to deeper understanding of PD and its impact. However, this knowledge is hampered by underrepresentation of people of color and other underserved populations in Parkinson’s research studies.
STAT News
OCTOBER 6, 2022
In the run-up to an extremely unusual hearing later this month, newly released documents underscore highly contrasting views taken by the U.S. Food and Drug Administration and a manufacturer toward a controversial drug for reducing premature births, which the agency wants withdrawn from the market. For the first time, the FDA has explained in copious detail why agency officials believe the medication, which is called Makena, should be removed.
pharmaphorum
OCTOBER 6, 2022
In this instalment of Health Innovators, Paul Tunnah, Healthware’s chief content officer, sits down with Dr Anthony Yanni, senior vice president and global head of patient centricity at Astellas Pharma. “Patient centricity” is a central value as pharma companies look to innovate their products and processes, but is it also in danger of losing its meaning and becoming just another pharma business buzzword?
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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.
STAT News
OCTOBER 6, 2022
WASHINGTON — A new survey from the CDC and the FDA suggests that youth vaping rates appear to be dropping, compared to pre-pandemic levels. Just over 9% of middle and high schoolers surveyed earlier this year reported currently using e-cigarettes, according to data published Thursday afternoon. Scientists caution against comparing the last few years too directly, given the disruptive effects of the coronavirus pandemic, but in 2019, 20% of middle and high school students reported current
pharmaphorum
OCTOBER 6, 2022
Servier is already in the process of transforming itself into a much bigger player in cancer, and has just tripled its sales objectives for the category. Fresh with a new brand identity, the France-headquartered pharma group has pledged to grow its oncology sales from its current objective of €1 billion in 2025 to €3 billion in 2030, continuing a diversification of its business from its traditional focus on cardiovascular diseases.
STAT News
OCTOBER 6, 2022
Telehealth company Ro has reached an agreement with the National Institute on Aging to create a registry of patients that could participate in Alzheimer’s disease research, a new approach to tackle the stubborn issue of recruitment for clinical trials. Ro, which is best known for prescribing hair loss and erectile dysfunction medication online, will use its platform to recruit and screen patients who may be at risk of Alzheimer’s or dementia.
BioSpace
OCTOBER 6, 2022
Eliseo Salinas, M.D., head of R&D for Delix Therapeutics offers his perspective on what it takes to become a leader in the life sciences and how to begin that transition.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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