pharmaphorum

DECEMBER 22, 2022

The life sciences industry is flexing towards innovation in new areas, faster than ever before, and increasing patient care in astonishing ways. Decentralised oncology trials, for example, have shown actual predictive outcome value. We can now measure patient activity, steps, and movement continuously and in real time, which serves as a new potential indicator of treatment effectiveness. 1 And, digital therapeutics have emerged as an effective treatment for chronic diseases, including mental ill

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Bio Pharma Dive

DECEMBER 19, 2022

The OK caps a long development journey for the treatment, which was previously turned back by the agency. Ferring doesn’t expect it to be available until the second half of next year, however.

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Gene Therapy FDA Approval Gene Development 352

Pharmaceutical Technology

DECEMBER 21, 2022

Moderna and the UK government have entered a ten-year strategic collaboration to build a messenger ribonucleic acid (mRNA) research, development and manufacturing facility in the country. The latest development comes after the parties announced an agreement in principle in June this year. This Moderna Innovation and Technology Centre (MITC) is expected to offer access to a locally produced future mRNA vaccine portfolio against respiratory viruses, subject to regulatory evaluation and licensure.

Gene Therapy 351

Gene Therapy Vaccination Vaccine Manufacturing 351

STAT News

DECEMBER 20, 2022

Lots of people struggle to get enough sleep — and the responsibility for fixing the problem tends to fall on the individual. Experts offer advice like reducing screen time, exercising more, or just going to bed earlier in the evening. But many restless nights can’t be solved with blackout curtains, ear plugs, or other typical suggestions.

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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

Medical Xpress

DECEMBER 20, 2022

Using machine learning and clinical data from electronic health records, researchers at the Icahn School of Medicine at Mount Sinai in New York constructed an in silico, or computer-derived, marker for coronary artery disease (CAD) to better measure clinically important characterizations of the disease.

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Development Medicine Research Cardiology 145

Bio Pharma Dive

DECEMBER 21, 2022

Lynparza’s authorization in first-line prostate cancer comes days after U.S. regulators delayed a decision on the same indication, a potential sign of the FDA’s concerns around PARP blockers.

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Regulation Drugs 315

pharmaphorum

DECEMBER 19, 2022

A collaboration between academic centres in the UK has won government funding for a digital approach to dysfunctional breathing or dyspnoea, a symptom that affects around 10% of the population. The Engineering and Physical Sciences Research Council (EPSRC) has set aside £400,000 (almost $490,000) for the project, which will help fund work at the Universities of Plymouth, Salford and Stirling, and the Glasgow School of Art.

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Engineer Development Research 145

Medical Xpress

DECEMBER 20, 2022

Probiotic bacteria usually found in fermented foods, such as yogurt, sourdough bread, and miso soup, might help dispel the embarrassment of persistent bad breath (halitosis), finds a pooled data analysis of the available evidence, published in the open access journal BMJ Open.

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Bacteria 145

Bio Pharma Dive

DECEMBER 19, 2022

Removal of the partial study suspension, which the agency imposed last December after a case of persistent anemia, helps clear the way for Bluebird to submit an approval application early next year.

Gene Therapy 300

Gene Therapy Gene 300

Pharmaceutical Technology

DECEMBER 18, 2022

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting variation to the marketing authorization (MA) for Moderna ’s Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214) booster for usage in children aged six to 11 years. The 0.25mL dose of the booster vaccine could potentially be used in the European Union (EU) following authorisation in these children a minimum of three months following a previous Covid-19 vaccination.

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Gene Therapy Vaccination Vaccine Clinical Trials 304

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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

NPR Health - Shots

DECEMBER 17, 2022

Dark chocolate bars tested by Consumer Reports exceeded California's daily maximum allowable dose levels for lead or cadmium. But a toxicologist says eaten in moderation, it's nothing to worry about.

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STAT News

DECEMBER 22, 2022

Sepsis, a deadly overreaction of the immune system to infection, has befuddled clinicians and researchers for decades. Covid-19 made things worse. The early signs and symptoms of sepsis mimic those of both Covid-19 and influenza: fever, chills, dry cough, shortness of breath, fatigue, muscle or body aches, sore throat, nasal congestion, runny nose, and more.

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Research Drugs Development 137

Bio Pharma Dive

DECEMBER 20, 2022

The proposed bill would strengthen rules around confirmatory testing, help speed product withdrawals and set up a panel of agency officials to better coordinate policy.

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Production Drugs 306

Pharmaceutical Technology

DECEMBER 22, 2022

Fentanyl is a powerful opioid (a narcotic analgesic that is at least partly synthetic) that is being trafficked in increasing quantities from Mexico to the US by cartels. The Drug Enforcement Administration (DEA) recently announced that it had seized 10,000 pounds of illicit fentanyl in 2022 and pointed out that this volume represented enough fentanyl to kill every American.

Drugs 264

Drugs Manufacturing Production Marketing 264

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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

NPR Health - Shots

DECEMBER 19, 2022

American Sirens author Kevin Hazzard tells the story Freedom House, a neighborhood nonprofit that, with the help of a pioneering physician, trained some of the nation's first paramedics.

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Medicine 141

STAT News

DECEMBER 20, 2022

Americans have been warned — again — about lax attention to routine vaccinations. This time the warning comes from measles , an age-old, vaccine-preventable disease, with an outbreak in central Ohio among nearly 80 children and counting, almost all of them unvaccinated against measles. Once well-controlled in the U.S., which has maintained “measles elimination status” for almost 20 years, this disease may no longer be a rarity as millions of children in the U.S. are m

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Vaccination Vaccine 135

Bio Pharma Dive

DECEMBER 21, 2022

The pharma dosed the first patient in a Phase 2 study testing a treatment it hopes could compete with closely-watched weight-loss drugs from Lilly, Novo Nordisk and Amgen.

Drugs 300

Drugs 300

Pharmaceutical Technology

DECEMBER 19, 2022

Sanofi has extended the partnership with Innate Pharma for natural killer (NK) cell therapeutics in oncology. With the latest development, Sanofi will licence a NK cell engager programme that acts on B7H3 from the antibody-based NK cell engager therapeutics (ANKET) platform of Innate. Under the latest licence deal, Sanofi will make an upfront payment of $26.4m (€25m) to Innate.

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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

NPR Health - Shots

DECEMBER 22, 2022

After decades of wondering, an NPR reporter finally figures out how her husband's family dog knew when the school bus would arrive everyday. She did some digging — and now it all makes scents.

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STAT News

DECEMBER 23, 2022

Flu activity across the United States continues to decline, though it remains at high levels in most parts of the country, the Centers for Disease Control and Prevention reported Friday in its weekly influenza update for the week ending Dec. 17. The percentage of people seeking medical care for influenza-like illness dropped for the third straight week, and hospitalizations due to flu declined for the second week in a row.

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Bio Pharma Dive

DECEMBER 19, 2022

The company said its experimental drug helped patients with the fatty liver disease while also improving fibrosis. One analyst called the readout a “major win” for Madrigal and the NASH field.

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Drugs 278

Medical Xpress

DECEMBER 20, 2022

People aged 95 and over still want to be part of society and enjoy a level of independence, despite having a more limited interaction with the world, a new study shows.

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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

NPR Health - Shots

DECEMBER 23, 2022

Dusty camps of displaced people have sprung up on the outskirts of cities. They ran from their homes because of drought, famine and fighting that involves the militant group al-Shabaab.

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STAT News

DECEMBER 21, 2022

This is part of a series of snapshots from post-Roe America. H e loved peaches. He loved ice cream. He loved blueberry waffles, evenly gridded, which she’d pulled from the crinkly package in the freezer and popped in the toaster to eat on her way to work. L. knew all this from the way he moved, the way he made her sick. His name was Kai. He was due on December 18.

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Packaging Packaging 124

Bio Pharma Dive

DECEMBER 22, 2022

The pharma will pay the Chinese drugmaker $175 million for access to seven preclinical antibody-drug conjugates, deepening ties established this year.

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Drugs Antibody 300

Medical Xpress

DECEMBER 20, 2022

A new perspective article published in The Lancet Diabetes & Endocrinology has highlighted that screening and treatment of osteoporosis lags behind other diseases, resulting in significant morbidity, mortality, and economic costs.

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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

NPR Health - Shots

DECEMBER 21, 2022

An examination of billing policies and practices at more than 500 hospitals across the country shows widespread reliance on aggressive collection tactics.

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STAT News

DECEMBER 21, 2022

Even as the United States has made commitments to health as a human right and reversing health disparities and has invested significantly in orphan diseases, it continues to overlook sickle cell disease (SCD), the most common inherited blood disorder worldwide, which affects more than 100,000 Americans , most of whom are Black or Hispanic American. As hematologists who take care of people with sickle cell disease , it’s disheartening to see this condition receive only a fraction of the at

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Bio Pharma Dive

DECEMBER 19, 2022

Glofitimab, part of a long-standing collaboration between the two companies that’s resulted in Rituxan and Ocrevus, will be the responsibility of Roche, which will pay out royalties.

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Development Drugs 268

pharmaphorum

DECEMBER 22, 2022

Construction will start early next year of a new manufacturing centre in the UK with the capacity to produce 250 million vaccine doses per year, the centrepiece of a 10-year alliance between the government and US biotech Moderna. The government said today it has finalised the partnership – agreed in principle earlier this year and estimated to be worth in the region of $1.2 billion – although it is not revealing the financial details, as these are “commercially sensitive.” The overar

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Vaccination Vaccine Life Science Manufacturing 122

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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