Bio Pharma Dive
SEPTEMBER 19, 2022
The FDA's clearances of Zynteglo and Skysona are a boost to Bluebird, and could help lift the research field after a series of setbacks. But selling the high-priced therapies will be a challenge.
Pharmaceutical Technology
SEPTEMBER 19, 2022
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AstraZeneca ’s Evusheld (formerly AZD7442) for Covid-19 in the European Union (EU). This therapy is intended to treat adult and adolescent Covid-19 patients aged 12 years and above, who do not need additional oxygen and are at greater disease progression risk.
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Bio Pharma Dive
SEPTEMBER 19, 2022
The French company, still aiming to rebound from a Phase 3 study failure two years ago, will pay about $41 million for Versantis and its experimental liver disease drugs.
Pharmaceutical Technology
SEPTEMBER 19, 2022
The US Food and Drug Administration (FDA) has awarded Accelerated Approval for bluebird bio ’s Skysona (elivaldogene autotemcel; eli-cel) for slowing neurologic dysfunction progression in early, active cerebral adrenoleukodystrophy (CALD) patients. The treatment is indicated for usage in boys aged four to 17 years with CALD. Through certain Qualified Treatment Centers in the country, Skysona is anticipated to be made available commercially by the end of this year.
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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.
Bio Pharma Dive
SEPTEMBER 19, 2022
Elevate pharma product development and marketing through collaboration with physician experts
Worldwide Clinical Trials
SEPTEMBER 19, 2022
Emerging evidence showing therapeutic benefit of psychedelics for mental illnesses such as major depressive disorder , substance use disorder , and post-traumatic stress disorder , has captured the interest of clinical researchers, the general public, and Netflix-watchers. Researchers exploring psychedelic trials are faced with unique safety challenges for protecting patients and site staff because of the profound nature of the psychedelic experience and the requirements for psychotherapy that a
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
SEPTEMBER 19, 2022
The European Commission (EC) has granted approval for Bristol Myers Squibb ’s (BMS) fixed-dose combination, Opdualag (nivolumab and relatlimab), as first-line therapy to treat advanced (unresectable or metastatic) melanoma. The treatment is indicated for usage in adult and adolescent patients aged 12 years and above with tumour cell PD-L1 expression less than 1%.
NPR Health - Shots
SEPTEMBER 19, 2022
For bands on tour, one positive COVID test can spell disaster. With audiences increasingly unmasked and institutional support drying up, safety is left mostly to the artists themselves.
STAT News
SEPTEMBER 19, 2022
The overuse of antibiotics and other antimicrobials in raising farm animals for food may not be equivalent to Covid-19 and climate change as threats to human health, but it is right up there. This practice contributes to antibiotic-resistant infections, which are now a leading cause of death worldwide. The annual death toll from antimicrobial resistance could reach 10 million by 2050 — more people than currently die from cancer.
NPR Health - Shots
SEPTEMBER 19, 2022
While cases have decreased dramatically, there are still thousands of cases being reported across the world. (Image credit: Ted S.
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.
Outsourcing Pharma
SEPTEMBER 19, 2022
Gladstone Institutes seek FDA approval for human clinical trial after single-dose, intranasal TIPs treatment for SARS-CoV-2 infection limits transmission in infected animals by decreased viral shedding.
STAT News
SEPTEMBER 19, 2022
In a move reflecting simmering controversy over diversity and equity, Pfizer has been accused of running a racially discriminatory fellowship program because it “categorically excludes” white and Asian American applicants, according to a lawsuit filed by an advocacy group that includes doctors, patients, and policymakers. But some legal experts question whether the argument can succeed.
NPR Health - Shots
SEPTEMBER 19, 2022
After he lost a bet, actor Ryan Reynolds had his colonoscopy filmed. His doctor detected a polyp, which can be a precursor to cancer. He's now urging others to get screened for colon cancer.
STAT News
SEPTEMBER 19, 2022
Chronic kidney disease, already a problem affecting millions of Americans , is only expected to become more prevalent as the country ages. For those with the disease, a transplant is the ideal treatment, but dialysis is their reality. Hundreds of thousands of Americans flock to clinics three times a week to have their blood filtered through — in the absence of a functioning kidney — a machine or their abdomen.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
NPR Health - Shots
SEPTEMBER 19, 2022
Can the warmth of a parent's chest be a boon to babies, especially premature births? In the 1970s, Colombian researchers found it did. The technique has gone global. Ivory Coast is the latest convert.
STAT News
SEPTEMBER 19, 2022
Former NIH director and current White House science adviser Francis Collins told a group of journalists late last week about his passion for both the Cancer Moonshot and the new biomedical research agency known as ARPA-H. But he also revealed his pain at seeing people spurn mRNA Covid vaccines developed with breathtaking speed and lamented that he and other health officials failed to communicate the ever-changing science behind Covid recommendations.
Medical Xpress
SEPTEMBER 19, 2022
If a woman contracts COVID-19 during her pregnancy, the infection, even if it's mild, damages the placenta's immune response to further infections, a UW Medicine-led study has found.
STAT News
SEPTEMBER 19, 2022
Is the Covid-19 pandemic over? President Biden told Scott Pelley of “ 60 Minutes” it was. The Sunday night interview aired just days after the director-general of the World Health Organization, Tedros Adhanom Ghebreyesus, said the end may be in sight — though Tedros clearly didn’t mean it was days away when he predicted it.
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
Medical Xpress
SEPTEMBER 19, 2022
UC San Diego Health is the first hospital system in San Diego to offer a new, highly targeted and precisely placed radiation therapy that delays tumor regrowth while protecting healthy tissue in patients with brain cancer.
STAT News
SEPTEMBER 19, 2022
You’re reading the web edition of Health Care Inc., STAT’s weekly newsletter following the flow of money through the health care system. Sign up here to get it in your inbox. The rise of the Medicare Advantage stock. If you ever needed evidence of just how much Wall Street salivates over the profitability of Medicare Advantage, look no further than Humana’s investor day last week.
Medical Xpress
SEPTEMBER 19, 2022
Scientists have created a face mask that can detect common respiratory viruses, including influenza and the coronavirus, in the air in droplets or aerosols. The highly sensitive mask, presented September 19 in the journal Matter, can alert the wearers via their mobile devices within 10 minutes if targeted pathogens are present in the surrounding air.
STAT News
SEPTEMBER 19, 2022
Meta is facing mounting questions about its access to sensitive medical data following a Markup investigation that found the company’s pixel tracking tool collecting details about patients’ doctor’s appointments, prescriptions, and health conditions on hospital websites. During a Senate Homeland Security and Governmental Affairs Committee hearing on Sept. 14 , Sen.
Advertiser: Aggregage
New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!
Medical Xpress
SEPTEMBER 19, 2022
Immune checkpoint inhibitor (ICI) therapy is a type of treatment for melanoma, the deadliest form of skin cancer, which blocks proteins on tumor or immune cells that prevent the immune system from killing cancer cells.
STAT News
SEPTEMBER 19, 2022
It seemed interminably slow then, what with all the haze and fear of fresh plague, but in hindsight it was a medical marvel: From January 2020 to February 2021, researchers proved four different effective therapies for patients hospitalized with Covid-19 — a lightning pace for drug research, where progress is often measured in decades. That picture has changed starkly.
Medical Xpress
SEPTEMBER 19, 2022
Infants can differentiate most sounds soon after birth, and by age 1, they become language-specific listeners. But researchers are still trying to understand how babies recognize which acoustic dimensions of their language are contrastive, a linguistics term that describes differences between speech sounds that can change the meanings of words. For example, in English, the letters b and d are contrastive, because changing the b in "ball" to a d makes it into a different word, "doll.".
STAT News
SEPTEMBER 19, 2022
WASHINGTON — One of Washington’s most prominent drug pricing patient groups is tapping an advocate who has fought for access to medicines for nearly two decades as its new leader. Merith Basey, who most recently led a group that promotes access to medicine by pressuring universities, took the helm of Patients for Affordable Drugs as the group is fighting to defend implementation of Democrats’ major drug pricing reform package , including a brand-new Medicare drug price
Medical Xpress
SEPTEMBER 19, 2022
Of the many ways to treat cancer, the oldest, and maybe most tried and true, is surgery. Even with the advent of chemotherapy, radiation therapy, and more experimental treatments like bacteria that seek and destroy cancer cells, cancers, very often, simply need to be cut out of a patient's body.
STAT News
SEPTEMBER 19, 2022
Rep. Robin Kelly admits that the word “diversity” has scared some of her Republican colleagues away from her effort to improve representation in clinical trials. “It’s been a little tough on the other side of the aisle,” Kelly said at a recent STAT event. “I don’t want to put one broad brush on everybody, but … they feel like the government’s putting their nose in something a little bit too much.
The Pharma Data
SEPTEMBER 19, 2022
The antibody medicines sotrovimab and casirivimab- imdevimab aren’t recommended for cases with COVID- 19, says a WHO Guideline Development Group of transnational experts in The BMJ. These medicines work by binding to the SARS- CoV- 2 shaft protein, neutralising the contagion’s capability to infect cells. moment’s strong recommendation replaces former tentative recommendations for their use and is grounded on arising substantiation from laboratory studies that these medicines ar
Medical Xpress
SEPTEMBER 19, 2022
Neurobiologist Margaret Livingstone never expected to publish a study on maternal attachment and bonding in monkeys. However, in the course of her research on how visual object recognition develops in infant macaques, she made a series of surprising observations about their mothers, and she knew she had to share it.
STAT News
SEPTEMBER 19, 2022
How will my surgeon get paid? That’s a question few people ask as they think about having surgery. But it is worth asking, and the answer should factor into decision-making. For most surgeons, the answer is a compensation model that incentivizes more surgery — and bigger surgery — making it hard to ignore the dollar signs attached to these procedures.
Medical Xpress
SEPTEMBER 19, 2022
Several factors increase the risk of heart attack, such as high blood sugar (hyperglycemia), obesity, abnormal cholesterol levels, high blood pressure (hypertension), and smoking. A study conducted in Brazil and reported in an article published in the journal PLOS ONE has measured the impact of these factors. The researchers analyzed data for the Brazilian population collected between 2005 and 2017, determining the number of deaths attributed to each risk factor.
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