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

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

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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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

Clinical Research

Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. The plan, which was released in late June, outlines a science strategy to improve research efforts for ALS. Its content is pertinent given the upcoming FDA Advisory Committee (AdCom) for Amylyx Pharmaceuticals’ ALS drug AMX0035 on 7 September.

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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

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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Vaccination Vaccine Marketing 245

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

Clinical Trials

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 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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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

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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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.

Clinical Supply

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

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

“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

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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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.

Clinical Trials

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

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

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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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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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.

Clinical Supply

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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Pharma Times

AUGUST 12, 2022

Radioligand therapy involves patients with advanced prostate cancer in Great Britain

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pharmaphorum

AUGUST 12, 2022

Recent history should have the pharmaceutical industry questioning some of its fundamental assumptions. The COVID-19 pandemic led to skyrocketing demand for some products while simultaneously constraining supplies due to logistical breakdowns and protectionist practices. The logic of outsourcing production to other countries, primarily China, suddenly looked dubious as Western countries struggled to import the drugs they needed.

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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

Intouch Solutions

AUGUST 12, 2022

“Boomerangs” are employees who leave and then return… and we’re known for the quantity, and quality, of our Boomerangs! Here, we catch up with Steve Morrissey, Director, Digital Production, EVERSANA ENGAGE, about his experience. I began with EVERSANA ENGAGE in a freelance capacity, and then came on full-time for two years. I left briefly, because I was presented an opportunity by senior executives to launch a global platform that could influence the agency world.

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Production 52

Sciensano

AUGUST 12, 2022

Do you know everything there is to know about mosquitoes? Or are the buzzing insects rather unknown territory for you? Sciensano launches a survey to get a better view of the current knowledge and perception of mosquitoes and mosquito-borne viruses among the Belgian population and of what people do to avoid mosquito bites. All adults living in Belgium can fill in the online survey until the end of October.

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Drug Discovery World

AUGUST 12, 2022

Pfizer has launched a Phase III clinical trial of a vaccine to protect people against Lyme disease, in collaboration with pharmaceutical company Valneva. . The Vaccine Against Lyme for Outdoor Recreationists (VALOR) trial will investigate the efficacy, safety and immunogenicity of Pfizer and Valneva’s Lyme disease vaccine candidate, VLA15. . The trial will enrol up to 6,000 participants aged five years and older and will be conducted across 50 sites where Lyme disease is highly endemic.

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Antidote

AUGUST 12, 2022

Recruiting an adequate number of qualified participants is one of the most important aspects of a successful clinical trial — but it is also considered one of the most difficult. Clinical trial recruitment costs make up a major portion of the expenses that study sponsors incur, and when trials have to be delayed due to a lack of participants, each day of the setback can cost sponsors between $600,000 to $8 million.

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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.

Clinical Trials