Thu.Aug 04, 2022

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Tapping into pharma’s growing opportunities in digital health

Pharmaceutical Technology

Soaring patient numbers are stretching hospital capacity across the globe, forcing healthcare providers and their partners to think laterally about how to meet the demand without doubling their resources. Smarter diagnostic tools and more sophisticated remote- and self-care models will have an increasingly important role to play, as long as any advances are seen to deliver excellent outcomes and a better patient experience.

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Amgen bets almost $4B on a biotech and its inflammation drugs

Bio Pharma Dive

The deals hands Amgen a few clinical programs and a marketed therapy in Tavneos, which was approved last year to treat a group of autoimmune diseases.

Drugs 292
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North America is seeing a hiring boom in pharmaceutical industry machine learning roles

Pharmaceutical Technology

North America extended its dominance for machine learning hiring among pharmaceutical industry companies in the three months ending May. The number of roles in North America made up 63.9% of total machine learning jobs - up from 62.6% in the same quarter last year. That was followed by Europe, which saw a 0.6 year-on-year percentage point change in machine learning roles.

Marketing 264
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Novo shares tumble after latest setbacks for closely watched obesity drug

Bio Pharma Dive

The Danish drugmaker lost tens of billions in market value after revealing a key clinical study for Wegovy won't be stopped early and production issues are still being ironed out.

Drugs 152
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Sinovac’s Covid-19 vaccine gets approval for use in children in Hong Kong

Pharmaceutical Technology

Sinovac Biotech has reported that its Covid-19 vaccine, CoronaVac, obtained approval from the Health Bureau of the Government of the Hong Kong Special Administrative Region of the People's Republic of China for usage in children of the age six months to three years. The consensus interim recommendations on Covid-19 vaccine use in children aged six months or above in Hong Kong were released by the Scientific Committee on Vaccine Preventable Diseases and the Scientific Committee on Emerging and Zo

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ElevateBio, Boston Children’s launch startup to test new approach to “off-the-shelf’ cell therapy

Bio Pharma Dive

Spun out of a Boston Children’s research lab, the biotech is the first to emerge from a partnership ElevateBio and the hospital struck to create new cell and gene therapy companies.

More Trending

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US declares monkeypox a federal public health emergency

Bio Pharma Dive

“We're prepared to take our response to the next level in addressing this virus, and we urge every American to take monkeypox seriously,” HHS Secretary Xavier Becerra said Thursday.

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COVID-19 health concern increases in July: Poll

Pharmaceutical Technology

The health concern over COVID-19 in July 2022 increased averaging at 27.7%, compared to 23.9% recorded in June 2022 , shows the COVID-19 concern index, which is measured by responses to an ongoing poll Verdict launched in March 2020. The poll has been tracking how the concerns over coronavirus have been changing over time. The poll asked how concerned the respondents were about the spread of coronavirus and included five options to choose from - very concerned, slightly concerned, neither concer

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U.S. declares monkeypox outbreak a public health emergency

STAT News

The Biden administration declared the ongoing monkeypox outbreak a public health emergency on Thursday, a move that comes amid growing case counts and a groundswell of criticism over the way the administration has handled the outbreak. The declaration comes as news stories chronicle a series of missteps in the administration’s response to the outbreak, from its failure to rapidly divert vaccine stockpiled as a hedge against bioterrorism to combat spread of monkeypox to its slow decision-m

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Business optimism declines in July 2022: Poll

Pharmaceutical Technology

Business optimism declined in July 2022 compared to June 2022, amid concerns over inflation as the cost-of-living pressures on households continued to grow in countries such as the UK, revealed the analysis of an ongoing poll by Verdict. Verdict has been conducting the poll to study the trends in business optimism during COVID-19 as reflected by the views of companies on their future growth prospects amid the pandemic.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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How to protect the people you care about from extreme heat

NPR Health - Shots

Heat waves can take a toll on our health, and some people are especially vulnerable. But you can do a lot to look out for those who are at higher risk of heat-related illness.

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Moderna reports total revenues of $4.7bn in Q2 2022

Pharmaceutical Technology

Moderna has reported total revenues of $4.7bn in the second quarter (Q2) of the fiscal year 2022 as against $4.4bn in the year-ago quarter. For the first half (H1) of the year, total revenue stood at $10.8bn, a growth from $6.3bn in the same period in 2021. The revenue growth was attributed to the rise in sales of the company's Covid-19 vaccine. For the three months ended on 30 June 2022, the basic earnings per share (EPS) stood at $5.55, a decline from $6.93 in Q2 last year.

Sales 130
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Patients seeking novel weight loss drugs find a ‘wild west’ of online prescribers

STAT News

Briana Lawson was ready to knock her diabetes into remission. For years, the 47-year-old health care consultant had treated her high blood sugar with metformin. But to avoid a lifetime of medication, she knew she’d need to lose weight. She’d tried fad diets, Weight Watchers, Nutrisystem, and had even considered surgery when the results didn’t stick.

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White House declares monkeypox a public health emergency

NPR Health - Shots

Declaring a public health emergency can free up resources to help the administration respond to the monkeypox outbreak. So far more than 6,000 people in the U.S. have been infected.

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The New Age of Decentralized Clinical Trials

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.

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Polioviruses found in wastewater samples in 2 N.Y. counties, suggesting continued spread

STAT News

New York State health authorities revealed Thursday that they had detected additional polioviruses in wastewater sampled in two counties north of New York City, findings that signal continued spread of the viruses in the region. The positive wastewater samples were found in Rockland County, where health authorities revealed two weeks ago that a man in his 2os had been paralyzed by so-called vaccine-derived polioviruses, and in neighboring Orange County as well.

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Keytruda fluffs its lines in prostate, liver cancer trials

pharmaphorum

Two phase 3 trials of Merck & Co’s Keytruda in metastatic castration-resistant prostate cancer (CRPC) and advanced liver cancer have ended in failure, proving once again that cancer immunotherapy studies can be a hit-and-miss affair. The CRPC trial – KEYNOTE-921 – looked at the combination of Keytruda (pembrolizumab) with docetaxel in more than 1,000 patients who had not been treated with chemotherapy before, but who had seen disease progression despite earlier treatment with an anti-h

Trials 105
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Opinion: The outsized effect of ‘modest’ price controls on pharmaceutical innovation

STAT News

Drug price controls in the U.S. Senate are being met with dire warnings that such an approach will stifle innovation, shut off the pipeline of new medicines, and cost lives down the road. Is innovation so fragile that a modest reduction in profits of global giants could seriously impact the supply of new drugs? Small companies originate more than half of all new medicines.

Medicine 111
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The Qualities of a Great Webinar Presenter

XTalks

A great webinar presenter needs to have good communication skills to engage and connect with their audience, whether they’re in the same room as them or joining online. A webinar presenter also needs to be able to effectively communicate their message and keep people engaged throughout their presentation. Are you looking to improve your webinar presentations?

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Accelerating Clinical Supply Through Integrated Drug Development

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.

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With monkeypox vaccine in high demand, NIH to test approaches to stretch supplies

STAT News

As the monkeypox outbreak continues to grow, one thing seems abundantly clear. The global need for monkeypox vaccine outstrips the supply, and will likely continue to do so for quite some time. Scientists at the National Institutes of Health are getting ready to explore a possible work-around. They are putting the finishing touches on the design of a clinical trial to assess two methods of stretching available doses of Jynneos, the only vaccine in the United States approved for vaccination again

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How can the pharma industry address the gap in talent recruitment and development?

pharmaphorum

Across the economy, several industries have seen a significant increase in staff turnover due to several factors including the COVID-19 pandemic, burnout, and increasing demand for workplace flexibility. This has resulted in staff and talent shortages, meaning that industries have been forced to respond quickly to stay afloat. In particular, for the pharmaceutical industry, these talent shortages bring about a host of difficult challenges.

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STAT+: Amgen to acquire ChemoCentryx for $4 billion, adding newly approved drug for autoimmune disorder

STAT News

Amgen said Thursday that it will acquire the small drugmaker ChemoCentryx for $4 billion to obtain a newly approved medicine that treats patients with a serious autoimmune condition. ChemoCentryx is being purchased for $52 per share, or a 116% premium to its Wednesday closing price.

Medicine 105
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Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

FDA Law Blog

By Sophia R. Gaulkin & Alan M. Kirschenbaum — In a recent decision, the Second Circuit upheld the HHS Office of the Inspector General (OIG)’s position that Pfizer’s proposed copay assistance program for its high-cost heart treatment would violate the Federal Anti-Kickback Statute (AKS). Pfizer, Inc. v. U.S. Department of Health and Human Services et al. , July 25, 2022.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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New research digs into the genetic drivers of heart failure, with an eye to precision treatments

STAT News

When coronary arteries are blocked, starving the heart of blood, there are good medications and treatments to deploy, from statins to stents. Not so for heart failure, the leading factor involved in heart disease, the top cause of death worldwide. “It’s what’s on death certificates,” said cardiologist Christine Seidman.

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Amgen splashes out on ChemoCentryx and its blockbuster hopeful

pharmaphorum

Ten months after ChemoCentryx scored an unexpected FDA approval for autoimmune disease therapy Tavneos, Amgen has swooped in with a $3.7 billion bid to buy out the company. The $52-per-share offer would give Amgen a drug that some analysts have described as a pipeline in a pill with $1 billion-plus sales potential, and is a sizeable premium on ChemoCentryx’ pre-deal announcement share price of just over $24.

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Covid has settled into a persistent pattern — and remains damaging. It may not change anytime soon

STAT News

Our tussle with Covid-19 — after a harrowing introduction and then wave upon wave of infections — seems to have settled into a persistent pattern. It may stay that way for a while. While Covid is not nearly the threat it once was, transmission of the coronavirus remains at sky-high levels. At the same time, the death rate has dropped thanks to vaccinations and improved treatments, and the overwhelming majority of people in the United States have developed some level of protection,

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Open Orphan to commence influenza human challenge study

Pharma Times

Candidate exhibits a novel mechanism of action and differs considerably from previously approved drugs

Drugs 119
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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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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Opinion: Addressing social drivers of health is a big opportunity for tech entrepreneurs

STAT News

Some of the best business opportunities in health care will involve developing technologies that analyze and address the factors that contribute to health disparities. These opportunities have the potential to help people — especially those who remain neglected or entirely unserved by today’s health care system — maintain their health through proactive, holistic care, reducing the need for doctor and hospital visits.

Doctors 98
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Vaxess starts Phase 1 trial for H1 influenza vaccine patch

BioPharma Reporter

Vaxess Technologies has launched a phase 1 trial for its H1 influenza vaccine patch: outlining its mission to increase access to vaccines via the shelf-stable, sustained-release patch.

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STAT+: Pharmalittle: U.S. government blunder contributed to monkeypox vax shortage; Amgen to pay $4 billion for ChemoCentryx

STAT News

Top of the morning to you. Another steamy day is unfolding here at the Pharmalot campus, where the short person will soon leave for a day of summertime fun. As for the rest of us, well, we can only dream. But our to-do list will keep us busy, including online meetings with some interesting folks. Hopefully, you can relate. Either way, it is time to get cracking and fire up the coffee kettle.

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RoslinCT and Lykan Bioscience combine to create advanced cell therapy CDMO

BioPharma Reporter

Edinburgh CDMO RoslinCT and Massachusetts CDMO Lykan Bioscience will combine to create a global advanced therapies CDMO: offering significantly expanded manufacturing capacity.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.