Sat.Nov 26, 2022 - Fri.Dec 02, 2022

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Steps to building a more patient-centric industry

pharmaphorum

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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What to make of Eisai and Biogen’s latest Alzheimer’s drug data

Bio Pharma Dive

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.

Drugs 359
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NHS expedites rollout of Bayer’s darolutamide for prostate cancer

Pharmaceutical Technology

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+: Alzheimer’s researchers try out an unfamiliar sensation: optimism

STAT News

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

Research 145
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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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Twitter will no longer enforce its COVID misinformation policy

NPR Health - Shots

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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FDA approves first microbiota-based treatment

Bio Pharma Dive

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.

More Trending

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After three years in prison, ‘CRISPR babies’ scientist is attempting a comeback

STAT News

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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NYC Mayor Adams faces backlash for move to involuntarily hospitalize homeless people

NPR Health - Shots

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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Pfizer, Roivant set up new company around inflammation drug

Bio Pharma Dive

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.

Drugs 316
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Expanding ketamine’s horizons to treat rare neurological disorders

Pharmaceutical Technology

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.

Research 275
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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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STAT+: Detailed data on Alzheimer’s therapy from Eisai, Biogen hold up to scientific scrutiny

STAT News

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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Medical bills remain inaccessible for many visually impaired Americans

NPR Health - Shots

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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Sana reshuffles drug pipeline, becoming latest biotech to cut staff

Bio Pharma Dive

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.

Drugs 339
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C4XD and AstraZeneca enter $402m deal to develop respiratory disease therapy

Pharmaceutical Technology

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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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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Good social relations promote active and healthy aging in Europe, finds researcher

Medical Xpress

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.

Doctors 142
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Thousands of toddler sippy cups and bottles are recalled over lead poisoning risk

NPR Health - Shots

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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FDA lifts pause on Beam plans to test base editing cancer therapy

Bio Pharma Dive

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

Gene 316
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Current pipeline developments could bring new hope for patients with PPMS

Pharmaceutical Technology

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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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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Opinion: Congress: Close the gap between funding for nutrition research and the toll diet-related disease takes on Americans

STAT News

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.

Research 141
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The chase is on: Regulators are slowly cracking down on vapes aimed at teens

NPR Health - Shots

The advent of vaping revived nicotine addiction among young people after a dramatic decline. The FDA seems poised to at last yank some products aimed at teens from the market. Will it work? (Image credit: Helen H.

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Gene editing startup iECURE returns to investors for fresh funding

Bio Pharma Dive

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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UK Government to fund research into new obesity treatments

Pharmaceutical Technology

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.

Research 227
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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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Opinion: Breakthrough Therapies Act: Good idea, wrong solution

STAT News

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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Study: Alzheimer's drug shows modest success slowing declines in memory, thinking

NPR Health - Shots

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.

Drugs 138
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Rigel wins US approval of rival drug to Servier leukemia treatment

Bio Pharma Dive

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.

Medicine 315
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India’s CDSCO approves Bharat Biotech’s intra-nasal vaccine for Covid-19

Pharmaceutical Technology

India’s Central Drugs Standard Control Organisation (CDSCO) has granted approval for Bharat Biotech’s BBV154 vaccine for treating Covid-19. BBV154 is claimed to be the first intra-nasal vaccine for Covid-19 in the world. It has been approved for restricted use in emergencies for people aged 18 and above in India for the first two-dose schedule and homologous booster doses.

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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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STAT+: AAM’s Dan Leonard, president of generic drug lobby, ousted

STAT News

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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Steroid injections worsen knee arthritis, according to two new studies

Medical Xpress

Two studies comparing injections commonly used to relieve the pain of knee osteoarthritis found that corticosteroid injections were associated with the progression of the disease. Results of both studies were presented today at the annual meeting of the Radiological Society of North America (RSNA).

Radiology 126
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Axsome says drug eased Alzheimer’s symptom in positive study

Bio Pharma Dive

Shares of the New York-based biotech rose by a third Monday morning, as fresh clinical trial results showed its drug AXS-05 both delayed and prevented the recurrence of Alzheimer’s agitation.

Drugs 286
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Xinjiang loosens some restrictions after anti-lockdown protests

NPR Health - Shots

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

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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.