Thu.Jul 21, 2022

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Freeline gives detailed look at hemophilia gene therapy results

Bio Pharma Dive

The London-based drugmaker is currently seeking a partner to continue development of the hemophilia B treatment, which has shown promise in testing but trails a rival therapy from CSL Behring and UniQure.

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The fairytale of DTC TV ads

World of DTC Marketing

The pandemic is changing consumer behavior, and there is zero chance they will return to their carefree spending ways. Using the same ads to advertise prescription drugs repeatedly is a waste of money and doesn’t lead to sales. According to a 2019 study from Kantar , a whopping 70 percent of consumers say they see the same ads over and over again.

Marketing 266
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AstraZeneca to deliver Covid-19 antibody therapy doses to Switzerland

Pharmaceutical Technology

AstraZeneca has signed a deal with the Federal Office of Public Health (FOPH) of Switzerland to deliver over 1,200 doses of antibody therapy, tixagevimab and cilgavimab combination (AZD7442), for Covid-19 prevention and treatment. Tixagevimab and cilgavimab are two long-acting antibodies (LAABs) obtained from the B-cells of patients convalescing following Covid-19.

Antibody 264
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Roche CEO Schwan, who guided company as cancer drug powerhouse, to step down next year

Bio Pharma Dive

The drugmaker’s current diagnostics chief Thomas Schinecker will take over as CEO in March, while Schwan will seek election as chair of Roche’s board.

Drugs 278
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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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ESG Top Trends: Technology trends

Pharmaceutical Technology

The pharma industry has deeply rooted environmental, social, and governance (ESG) issues that challenge sustainability. Overcoming these challenges requires collaborative, proactive steps to achieve sustainability goals and turn the reputation of this industry around. Listed below are the key technology trends impacting the ESG performance in the healthcare sector, as identified by GlobalData.

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Amazon to buy One Medical for $3.9B

Bio Pharma Dive

The all-cash deal for the San Francisco-based company follows months of speculation about a potential acquisition, but Amazon as the buyer comes as a surprise.

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Assembly Bio scraps hepatitis B drug, cuts staff after clinical setback

Bio Pharma Dive

Two top executives will depart in a restructuring that will reduce the California biotech’s staff by 30% and prioritize a pair of preclinical research programs.

Drugs 152
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ESG Top Trends: Macroeconomic trends

Pharmaceutical Technology

As part of ESG (Environmental, Social, and Governance), the social good delivered by robust healthcare systems are at the core of healthy populations. The Covid-19 pandemic has demonstrated how vital patient access to quality and affordable healthcare is for patients all over the world. Healthy and safe citizens are critical to functioning economies.

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American gun violence has immense costs beyond the death toll, new studies find

NPR Health - Shots

Two new studies outline the massive financial, social and health care costs of America's gun violence epidemic on victims and the large pool of often forgotten survivors.

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Twill taps YourCoach for DtX-health coaching integration

pharmaphorum

Health coaching ecosystem YourCoach Health and digital therapeutics company Twill (formerly Happify Health ) are teaming up to offer access to YourCoach’s cross-specialty health coaches via Twill’s Duet platform, the companies announced today. “Digital therapy has been around for a really long time,” YourCoach Cofounder and CEO Marina Borukhovich told pharmaphorum.

Doctors 137
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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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The first U.S. case of polio since 2013 has been detected in New York

NPR Health - Shots

The patient, who has developed paralysis but is no longer contagious according to the AP, may have contracted the virus overseas. The CDC says no cases of polio have originated in the U.S. since 1979.

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N.Y. state detects polio case, first in the U.S. since 2013

STAT News

New York State reported Thursday that it has detected a case of vaccine-derived polio in a person in Rockland County, north of New York City, the first such recorded case in the United States since 2013. In a statement, the state department of health said the person, who was not identified, was infected with a type 2 vaccine-derived poliovirus, which would have come from oral polio vaccine used in a number of countries, but not the United States.

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What to know about Paxlovid, the COVID drug President Biden is using to speed recovery

NPR Health - Shots

Paxlovid has been highly effective at reducing the risks of hospitalization and death, but some patients report a "Paxlovid rebound" in which the disease returns.

Drugs 131
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Roche CEO Severin Schwan to stand down after 14 years

pharmaphorum

Long-serving Roche chief executive Severin Schwan is stepping down, to be replaced next March by Thomas Schinecker, currently head of diagnostics at the Swiss group. Schwan (pictured above) has been nominated as chair of Roche’s board of directors however, to succeed Christoph Franz will not seek re-election after more than eight years in the role, so will still be intimately involved in the company’s affairs.

Sales 119
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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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Biden tests positive for COVID and shows mild symptoms, White House says

NPR Health - Shots

The 79-year-old president "will isolate at the White House and will continue to carry out all of his duties fully during that time," a White House statement said.

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Biden picks renowned cancer surgeon Monica Bertagnolli as NCI chief

STAT News

WASHINGTON — The Biden administration has selected Monica Bertagnolli, a renowned surgical oncologist, as the next director of the National Cancer Institute, according to two sources familiar with the decision. Bertagnolli, currently a surgeon at Dana-Farber Cancer Center and a professor at Harvard Medical School, will take the reins of the country’s largest biomedical research institute — a $7 billion agency that funds the lion’s share of U.S. cancer research and is

Research 116
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Infertility patients fear abortion bans could affect access to IVF treatment

NPR Health - Shots

As more states outlaw abortion, some define human life as starting at fertilization. Some patients and health care workers worry that this could jeopardize in vitro fertilization treatments.

In-Vitro 121
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STAT+: 5 burning questions about Amazon’s $3.9 billion acquisition of One Medical

STAT News

With its acquisition of One Medical , Amazon is setting its sights squarely on shaking up primary care. The company announced plans Thursday morning to acquire One Medical, which went public in 2020, for $18 per share in a deal valued at more than $3 billion. The deal will bring Amazon — which has launched a growing health care business that includes telehealth, brick-and-mortar clinics, and a pharmacy service — a valuable set of assets.

Pharmacy 105
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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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Even before the Dobbs ruling, more Americans were traveling for abortions

NPR Health - Shots

A report from the Guttmacher Institute finds that state abortion restrictions do not necessarily correlate to a lower abortion rate, as more patients travel out of state.

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Opinion: The health care industry’s lax approach to nurses’ mental health needs to change

STAT News

Since the start of the Covid-19 pandemic, the dire state of nursing has been grist for endless headlines , studies , and think pieces , as has the epidemic of clinician mental health  problems. People like me who are concerned about nursing have been hoping that this moment might actually be a catalyst for progress and a step toward enacting some of the reforms the profession needed well before SARS-CoV-2 changed lives around the world.

Nurses 105
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Ex-GSK vaccine chief to lead new UK biotech Vicebio

pharmaphorum

GSK’s former head of vaccines R&D – Dr Emmanuel Hanon – is heading up a new biotech called Vicebio that will go up against his former employer with a vaccine against respiratory syncytial virus (RSV) infections. The London-based company was founded by venture capital firm Medicxi in 2019, but has now come out of stealth mode with financial backing of €18 million and a platform based on a ‘molecular clamp’ technology developed by researchers at the University of Queensland (

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Opinion: 6 ways to bolster FDA’s guidance for diversifying participation in clinical trials

STAT News

It has been nearly 25 years since the Food and Drug Administration first issued guidance related to racial, ethnic, age, and gender populations underrepresented in clinical trials (see “Timeline: Related prior FDA guidance” ). Yet it and other agency guidance and clear documentation of unequal representation have yielded little progress in improving clinical trial diversity.

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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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Even if you're the president, it's hard to avoid a breakthrough COVID infection

NPR Health - Shots

With his positive test for COVID-19, President Biden joins the throngs of Americans who have contracted the coronavirus even though they are vaccinated and boosted.

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STAT+: Serving as a ‘clinical colleague,’ AI shows potential to reduce sepsis deaths in real-world studies

STAT News

Three studies published Thursday found that an AI platform developed by Bayesian Health and Johns Hopkins University reduced deaths from sepsis by 18.2% in real-world use when physicians responded promptly to its alerts, a finding that suggests AI has potential to become an important tool in battling a leading cause of deaths in hospitals. The company and Hopkins researchers tested the platform at five hospitals in the Northeast — both academic and community-based — with more than

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Former U.N. 'relief chief' shares his secret for coping with crises: a 'sunny gene'

NPR Health - Shots

From 2017 to 2021, Sir Mark Lowcock was the U.N.'s "relief chief," the world's most senior humanitarian official. He talks to NPR about what inspired him and why crises are getting worse.

Gene 100
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Amazon to acquire One Medical for $3.9 billion in a bold bet on primary care

STAT News

Retail giant Amazon announced plans Thursday to acquire primary care company One Medical in a cash deal valued at $3.9 billion. The goal of the $18 per share deal is to offer more convenient and affordable health care both in-person and virtually, the companies said. The two aim to combine One Medical’s technology and team with “Amazon’s customer obsession, history of invention, and willingness to invest in the long-term,” One Medical CEO Amir Dan Rubin said in a stat

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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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Bid to expand Keytruda use in head and neck cancer therapy fails

pharmaphorum

While immunotherapies have transformed treatment of many types of cancer, they do sometimes fail to have an impact – as Merck & Co has just observed in a study of Keytruda in head and neck cancer. The PD-1 inhibitor missed the mark in the phase 3 KEYNOTE-412 trial in 780 newly-diagnosed patients with head and neck squamous cell carcinoma (HNSCC), a notoriously hard-to-treat form of cancer.

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President Biden tests positive for Covid-19, but has ‘very mild symptoms’

STAT News

President Biden tested positive for Covid-19 Thursday — a coronavirus case that reflects both the high ongoing levels of transmission of the virus and its ability to cause infections even in people who have layers of protection. Biden, 79, has “very mild symptoms” and has started taking the antiviral Paxlovid, the White House said.

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Is FDA Going to Get A Little Help From Its Friends at the PTO?

FDA Law Blog

By Sara W. Koblitz — Drug pricing has been a hot button issue in the U.S. for decades, and patent protections have been cited as a source of “ gamesmanship ” allowing brand companies to keep drug prices high. Yet, as long as FDA and FTC have been trying to address anticompetitive behavior, the U.S. Patent and Trademark Office (PTO) has been relatively absent from these discussions.

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STAT+: As health care faces nursing shortages, burned-out nurses are flocking to remote jobs

STAT News

Burned out and fed up with their work conditions, nurses are stepping away from the bedside in droves, leaving empty positions and for-hire signs lingering in hospitals and clinics around the country. Some of those nurses are now hunting for remote roles, which have grown more popular as telehealth has taken off. It’s a hot job market: Care Medical, the practice powering Amazon’s virtual-first medical platform Amazon Care, has offered $15,000 sign-on bonuses for “mobile tele

Nurses 98
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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.