Pharmaceutical Technology

AUGUST 12, 2022

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses. The FDA’s breakthrough device programme is for medical devices or device-led combination products that provide more effective treatment or diagnosis of diseases.

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World of DTC Marketing

AUGUST 12, 2022

PhRMA is lying to protect its profits, and the lies have reached a new height as the Senate moved to adopt modest drug pricing negotiation measures in the Inflation Reduction Act. The bill “could propel us light-years back into the dark ages of biomedical research,” Dr. Michelle McMurry-Heath, president of the Biotechnology Innovation Organization, said last month.

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Pharmaceutical Technology

AUGUST 12, 2022

More than a year and a half after the Brexit deal came into effect, the UK’s pharmaceutical industry is still trying to determine the likely impacts. In principle, the deal could create new opportunities for British pharma companies – not least the chance to work under a more supportive regulatory framework. However, in practice we are seeing a climate of real uncertainty.

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Bio Pharma Dive

AUGUST 12, 2022

An arbitrator ruled against Seagen in a dispute over technology used in Enhertu and other Daiichi Sankyo drugs, stopping an attempt by Seagen to collect lucrative royalties.

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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.

Clinical Trials

Pharmaceutical Technology

AUGUST 12, 2022

The US Food and Drug Administration (FDA) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (fam-trastuzumab deruxtecan-nxki) to treat unresectable or metastatic non-small cell lung cancer (NSCLC) in adults. The treatment is indicated for such patients whose tumours have activating HER2 (ERBB2) mutations and previously received systemic therapy. .

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Bio Pharma Dive

AUGUST 12, 2022

AstraZeneca and Daiichi Sankyo’s drug is the first medicine cleared for lung tumors with mutations to HER2, a gene known for its link to breast cancers.

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Bio Pharma Dive

AUGUST 12, 2022

Ron Wyden, D-Ore., is probing how Amgen paid an average effective tax rate of 12% over the past four years, well below the U.S. statutory rate of 21%.

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Pharmaceutical Technology

AUGUST 12, 2022

Adoptive cell therapy (ACT) is a form of cancer treatment that involves the transfer of immune cells into a patient to help fight the disease, by eliminating cancer cells. These cells can be taken originally from the patient or another individual. The concept behind this form of treatment is that the introduction of these cells will enhance the immune response to disease, often through bioengineering the immune cells to have improved functionality and characteristics, such as longer half-lives.

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Bio Pharma Dive

AUGUST 12, 2022

Pfizer, which competes with Merck in this market, plans to ask the FDA for an expanded approval of its 20-valent shot later this year.

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Pharmaceutical Technology

AUGUST 12, 2022

Ceapro has extended a partnership underway to carry out a further research project with McMaster University for developing an inhalable immuno-therapeutic/-prophylactic for Covid-19-induced lung fibrosis. This project is intended to develop therapies for people suffering from Covid-19’s long-term effects. In August 2019, the parties entered a partnership for new drug delivery system development leveraging the disruptive Pressurized Gas eXpanded Liquid technology (PGX) to streamline drug formulat

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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.

Trials

pharmaphorum

AUGUST 12, 2022

Half a million people in the UK with conditions like blood cancer that prevents them being protected from COVID-19 vaccines are facing another winter shielding, because the government has shelved plans to offer treatment with AstraZeneca’s antibody therapy Evusheld. That’s the position of multiple patient organisations, clinicians and medical groups, who have criticised the Department of Health’s decision to defer procurement of Evusheld supplies until cost-effectiveness agency

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NPR Health - Shots

AUGUST 12, 2022

Two thousand Kaiser mental health workers plan to go on strike Monday. They say Kaiser has failed to follow California law and make sure patients with mental health needs are given prompt care.

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STAT News

AUGUST 12, 2022

The COVID-19 pandemic supercharged in-home care in the U.S. Suddenly it became possible to get a house call from a primary care provider; home-based physical therapy, dialysis, or an infusion of medicine; even a full complement of hospital-level services at home became possible. And Americans overwhelmingly liked it. The Centers for Medicare & Medicaid Services recently proposed a 4.2% cut ($810 million) in home health services, the underpinning of home-based services in Medicare.

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NPR Health - Shots

AUGUST 12, 2022

The FDA issued revised guidance about how often to test after exposure to someone with COVID or after symptoms occur. It's not exactly the same as what the CDC says. What's the best way to proceed?

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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.

Clinical Trials

pharmaphorum

AUGUST 12, 2022

An at-home electroencephalogram (EEG) headset used alongside game-like cognitive tasks developed by UK company Cumulus Neuroscience has been shown to be more effective than lab-based EEG monitoring in a clinical trial. The ‘dry’ EEG system provides an alterative to lab EEG systems using wet electrodes that require gel application, skin preparation, and clean-up procedures that can impede use of the technology in real-world settings.

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NPR Health - Shots

AUGUST 12, 2022

The highly infectious viral disease can lead to permanent paralysis of the arms and legs and even death in some cases. Health officials are urging people to get vaccinated if they haven't been.

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Vaccination Vaccine 118

STAT News

AUGUST 12, 2022

WASHINGTON — Fifteen years later, House Speaker Nancy Pelosi is fulfilling one of her first campaign promises. When she first took the speaker’s gavel in 2007, Pelosi promised six policy accomplishments , on national security, energy, education, and health care. She passed six bills within 100 hours of assuming power. The only promise that didn’t become law was allowing Medicare to negotiate for prescription drugs — until Friday, when the House passed a major hea

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NPR Health - Shots

AUGUST 12, 2022

The PACT Act provides new access to services for American veterans struggling with the health effects of exposure to burn pits. But in Iraq, civilians who were exposed are still on their own.

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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.

Clinical Research

STAT News

AUGUST 12, 2022

The World Health Organization on Friday renamed the two branches of the monkeypox virus, moving away from identifying them with geographic titles and instead giving them Roman numerals. From now on, the Central African, or Congo Basin, clade will be known as Clade I, while the West African clade will be Clade II, the WHO said. Clade I is considered to be more severe.

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NPR Health - Shots

AUGUST 12, 2022

In 2018, a 17-year-old gunman killed 10 people at Santa Fe High School. But even with an influx of time and money for mental health services, the community is still struggling with grief and trauma.

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STAT News

AUGUST 12, 2022

New York state health authorities announced Friday that polioviruses have been found in wastewater from New York City, further amplifying the geographic range at risk of seeing polio cases in the state. The viruses found in New York City do not appear to be genetically linked to the viruses in the recent polio case detected in nearby Rockland County , the state’s department of health said on its website.

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NPR Health - Shots

AUGUST 12, 2022

Students who are exposed to COVID-19 no longer need to quarantine or get repeatedly tested to stay in class. But masks are still recommended for nearly half the country.

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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

Clinical Trials

STAT News

AUGUST 12, 2022

“How To Change Your Mind,” a new four-part documentary about psychedelics , has been hovering around Netflix’s Top 10 this summer. As someone who benefited immensely from therapeutic psychedelics, I am encouraged each time a documentary like this emerges into the mainstream, another sign that these important and beneficial medicines are gaining wider social acceptance.

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NPR Health - Shots

AUGUST 12, 2022

The CDC stopped recommending quarantines or test-to-stay in schools. It's part of a relaxation of COVID guidance that acknowledges the virus is here to stay, and that many people have prior immunity.

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STAT News

AUGUST 12, 2022

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still being discussed, but we hope to hang a bit with our short person, catch up on our reading, and have a listening party with Mrs. Pharmalot. And what about you? The time for a summer getaway is nigh, so you can whip up something fun.

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NPR Health - Shots

AUGUST 12, 2022

Actress Anne Heche, 53, has been hospitalized since last Friday, when she was allegedly speeding in her blue Mini Cooper and crashed into two homes. (Image credit: Alberto E.

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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.

Research

STAT News

AUGUST 12, 2022

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right.  Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Production 98

Pharma Times

AUGUST 12, 2022

Treatment becomes an option for treating visual impairment caused by diabetic macular oedema, regardless of lens status

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Drug Channels

AUGUST 12, 2022

Today’s guest post comes from Divya Iyer, VP, Strategy and Business Development, Pharma Manufacturer Solutions at GoodRx. Divya highlights new GoodRx research on the out-of-pocket cost gap between brand-name and generic prescriptions. She discusses the challenges that providers face when having real-time discussions with patients about out-of-pocket costs.

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Drugs Manufacturing Business Development Branding 71

Pharma Times

AUGUST 12, 2022

Radioligand therapy involves patients with advanced prostate cancer in Great Britain

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Marketing 102

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

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