pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine. In 2021, a CISCRIP Perceptions and Insights Study reported more disruption to daily routines compared to previous years, citing length of visits, travel, and diagnostic tests as top burdens

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Bio Pharma Dive

NOVEMBER 29, 2022

At a medical conference, the companies detailed clinical trial results that could help support approval of their drug, lecanemab. However, some doctors aren’t yet convinced the medicine’s risks are worth its potential benefits.

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Pharmaceutical Technology

NOVEMBER 29, 2022

The National Health Service (NHS) in England, UK, has expedited the rollout of Bayer ’s new life-extending drug, darolutamide, to treat the most advanced kinds of prostate cancer that have spread to other body parts. With the latest development, NHS will become the first healthcare system in Europe to offer this drug to prostate cancer patients. Nearly 9,000 men with prostate cancer will be eligible to receive this treatment.

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STAT News

DECEMBER 2, 2022

SAN FRANCISCO — Scientific meetings about Alzheimer’s disease can be funereal affairs, with researchers from around the world gathering in hopes that the latest in a long line of negative clinical trials might light the path to a long-awaited success. This year was different. Nearly 2,000 people showed up to the Clinical Trials in Alzheimer’s Disease meeting, a conference record, to hear about lecanemab, a drug from Eisai and Biogen that appears to have broken the decades-lo

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Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Medicine

NPR Health - Shots

NOVEMBER 30, 2022

Mayor Eric Adams announced this week that officials will begin hospitalizing more homeless people by involuntarily providing care to those deemed to be in "psychiatric crisis." (Image credit: Michael M.

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Bio Pharma Dive

DECEMBER 1, 2022

The regulatory OK, a milestone for microbiome-based drug research, is for a medicine from Ferring Pharma that treats a recurrent type of gut infection.

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STAT News

NOVEMBER 29, 2022

He Jiankui, the Chinese biophysicist who created the first gene-edited children , had been quiet since completing a three-year prison sentence in April, leaving many to wonder whether he had plans to return to scientific research. Earlier this month, we got his answer. On Nov. 9, He posted photos to Twitter of himself sitting at a computer in a white office.

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NPR Health - Shots

NOVEMBER 29, 2022

Public health experts and social media researchers are concerned that the change could have serious consequences if it discourages vaccination and other efforts to combat the still-spreading virus.

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Vaccine Vaccination Research 145

Bio Pharma Dive

NOVEMBER 30, 2022

The richly funded drugmaker will cut 15% of its workforce, or about 75 employees, as well as stop work on one of its preclinical research programs.

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Pharmaceutical Technology

NOVEMBER 29, 2022

For several decades, researchers have been investigating the role of ketamine in treating depression. Now, efforts are underway to study ketamine’s effects in Parkinson’s disease, fibromyalgia, and Rett syndrome. On November 14, the Canadian developer PharmaTher announced positive data from a Phase I/II study where ketamine was used to treat levodopa-induced dyskinesia in Parkinson’s disease.

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Clinical Supply

STAT News

NOVEMBER 29, 2022

SAN FRANCISCO — A closely watched new treatment for Alzheimer’s disease held up to scrutiny in a detailed scientific presentation Tuesday, as its developers, partners Eisai and Biogen, begin the lengthy process of turning this medicine into what they hope could be a groundbreaking therapy. The drug, lecanemab, slowed the cognitive and functional decline of patients with early-stage Alzheimer’s by 27% relative to placebo in a roughly 2,000-volunteer clinical trial.

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NPR Health - Shots

DECEMBER 1, 2022

When health bills aren't legible — via large-print, Braille or other adaptive technology — blind patients can't know what they owe, and are too often sent to debt collections, an investigation finds.

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Bio Pharma Dive

DECEMBER 2, 2022

The FDA’s decision is a step forward for a type of drugmaking known as “multiplex editing,” which involves editing several genes simultaneously.

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Pharmaceutical Technology

DECEMBER 1, 2022

The US Food and Drug Administration (FDA) has granted approval for Ferring Pharmaceuticals’ faecal microbiota product, Rebyota, to prevent Clostridioides difficile infection (CDI) recurrence in people aged 18 years and above. A live biotherapeutic, Rebyota is intended for usage following the completion of antibiotic treatment. Rebyota’s safety and efficacy were analysed in the largest trial programme in the microbiome-based therapeutics field, including five trials enrolling over 1,000 subjects.

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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

Medical Xpress

DECEMBER 2, 2022

In the older European population, men, as well as those with lower socioeconomic status, weak social ties, and poor health, might experience more difficulties getting informal support and are considered to have a higher risk of worsening frailty state and lower quality of life. This reality is shown in a new doctoral thesis at Umeå university.

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NPR Health - Shots

NOVEMBER 28, 2022

The bottom base of some Green Sprouts products can break off, exposing a solder dot that contains the toxic metal, a federal regulator said. No injuries have been reported from such incidents. (Image credit: U.S.

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Bio Pharma Dive

DECEMBER 1, 2022

The drug is currently in mid-stage testing as a treatment for ulcerative colitis. If it continues to advance, it could be the first approved therapy aimed at a protein known as TL1A, a target multiple other companies are pursuing.

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Pharmaceutical Technology

NOVEMBER 28, 2022

C4X Discovery (C4XD) and AstraZeneca have entered an exclusive global licensing agreement worth up to $402m to develop oral therapy to treat inflammatory and respiratory ailments. The deal has been signed to develop the C4X NRF2 Activator programme for these ailments. Under the agreement, AstraZeneca will be responsible for the development and marketing of oral therapy for inflammatory and respiratory diseases with a key focus on chronic obstructive pulmonary disease (COPD).

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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

STAT News

DECEMBER 2, 2022

You are what you eat. Every year, new scientific discoveries make clear that food is critical to health. In recent years, nutrition research trials have shown that a Mediterranean diet reduces cardiovascular disease; ultra-processed foods increase weight gain; omega-3 fatty acids improve IQ in preterm babies; cocoa prevents heart attacks; and vitamin D supplements do — well, almost nothing.

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NPR Health - Shots

NOVEMBER 26, 2022

Residents held extraordinary late-night demonstrations against Urumqi's draconian "zero-COVID" lockdown after an apartment fire killed 10.

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Bio Pharma Dive

DECEMBER 2, 2022

The approval gives Rigel, a biotech that’s been around since the mid-1990s, its second marketed medicine and a competitor to Servier’s Tibsovo.

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Pharmaceutical Technology

NOVEMBER 30, 2022

Multiple sclerosis (MS) is an autoimmune disease causing chronic inflammation and demyelination of the nerves, affecting around 2.5 million people worldwide. While patients diagnosed with relapsing MS (RMS) have a wide range of marketed treatment options, patients diagnosed with progressive MS, especially primary progressive MS (PPMS), have very limited treatment options.

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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

DECEMBER 2, 2022

The Breakthrough Therapies Act , recently proposed by Senators Rand Paul (R-Ky.) and Cory Booker (D-N.J.) as a way to expand access for therapeutic purposes to potentially beneficial but highly regulated Schedule I substances like psilocybin and LSD, has the right underlying idea but provides a solution that is wrong. The act would automatically reclassify to Schedule II any experimental medicine designated by the Drug Enforcement Agency as a Schedule I controlled substance — defined as a

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NPR Health - Shots

NOVEMBER 30, 2022

In a large study, the experimental Alzheimer's drug lecanemab reduced the rate of cognitive decline by 27 percent in people in the early stages of the disease.

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Drugs 138

Bio Pharma Dive

NOVEMBER 28, 2022

The company will cut its R&D workforce by 75% and discontinue development of its experimental lung cancer drug poziotinib.

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Pharmaceutical Technology

NOVEMBER 30, 2022

Gilead Sciences has received the European Commission’s (EC) expanded marketing authorisation for Biktarvy (bictegravir 30mg / emtricitabine 120mg / tenofovir alafenamide 15mg tablets) for treating human immunodeficiency virus (HIV) infection in virologically suppressed children. The low-dose Biktarvy tablet is indicated for usage in these children aged a minimum of two years and weighing at least 14kg.

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Clinical Supply

STAT News

DECEMBER 2, 2022

The generic drug industry’s lobbying group, the Association for Accessible Medicines, fired its president Dan Leonard, two sources familiar with the decision said Friday evening. It was not immediately clear why Leonard was fired, and AAM didn’t immediately respond to a request for comment. The sources said its members were frustrated that it was late to engage when Congress was debating the Inflation Reduction Act, which gives Medicare the power to negotiate drug prices.

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Pharma Times

NOVEMBER 29, 2022

Bill & Melinda Gates Foundation grant will boost potential of nanoparticle-formulated doggybone DNA

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Bio Pharma Dive

NOVEMBER 30, 2022

The company, which draws on research by Jim Wilson’s lab at UPenn, says the $65 million it raised will support the start of human testing of its lead drug through to initial clinical data.

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Pharmaceutical Technology

NOVEMBER 28, 2022

The UK Government has announced funds worth $24.17m (£20m) to conduct research for developing new obesity therapies and technologies. These therapies and digital tools have been demonstrated to aid people in shedding 20% of their weight. Every year, obesity costs a staggering $7.2bn (£6bn) to the UK National Health Service (NHS), and by 2050, the figure is expected to increase to more than $11.7bn (£9.7bn) per year.

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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