Pharmaceutical Technology

MARCH 10, 2023

On 10 March, the National Health Service Blood and Transplant (NHSBT) opened a new Clinical Biotechnology Centre (CBC) with the aim of improving the UK’s ability to develop and manufacture cell and gene therapies. A £9.3 million ($11 million) grant is being used to build the facility in Bristol where therapies for currently incurable diseases, such as some forms of cancer, sickle cell disease, and cystic fibrosis can be manufactured.

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Bio Pharma Dive

MARCH 10, 2023

The medicine, a nasal spray for migraines to be sold as Zavzpret, was a key part of Pfizer’s roughly $12 billion buyout of Biohaven last year.

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Pharmaceutical Technology

MARCH 10, 2023

The US Food and Drug Administration (FDA) has granted approval for Pfizer ’s Zavzpret (zavegepant) for the acute treatment of migraine in adult patients with or without aura. Zavzpret is claimed to be the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray approved to treat migraine. It is a third-generation, selective and structurally unique, small molecule CGRP receptor antagonist and is currently under clinical development with oral and intranasal formulation

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Bio Pharma Dive

MARCH 10, 2023

The positive vote comes despite doubts from FDA scientists and increases the chance that Polivy could soon be approved as a first-line treatment alongside a drug regimen called R-CHOP.

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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

MARCH 10, 2023

Freeze drying is a crucial technique to prolong the shelf life of pharmaceutical products. Also known as lyophilisation, the technique stabilises and preserves sensitive products such as biologics, and diagnostic kits, in a permanently storable state. Pharmaceutical and biotechnology industries widely use freeze-drying systems to protect vaccines, antibodies, antibiotics such as penicillin, blood plasma, proteins, enzymes, hormones, viruses, and bacteria from heat and minimise their biological a

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STAT News

MARCH 10, 2023

Silicon Valley Bank, which does business with roughly half of the nation’s tech and biotech companies, failed on Friday. Now, as federal regulators step in to clean up SVB’s mess, biotech startups are left wondering: What happens to their money, and who’s going to finance the industry? On Friday morning, the Federal Deposit Insurance Corporation took control of SVB and is presiding over a sale of the firm’s assets to cover clients’ deposits.

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NPR Health - Shots

MARCH 10, 2023

Close to 40% of surveyed Americans, a record high, put off medical care last year because of finances. Americans are delaying or skipping doctor's visits, dental and vision care, and medications.

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Doctors Doctor 140

Pharmaceutical Technology

MARCH 10, 2023

Lebanon’s ongoing economic crisis and changes in pricing strategies have caused monumental price hikes that impact market access. In Lebanon, the battle for access to medicines rages on and is further heightened by dramatic decreases to the healthcare budget last year. Consequentially, the five-year average price trend in Lebanon for all medicines has increased to 1,123%.

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STAT News

MARCH 10, 2023

For graduating medical students hoping to secure a residency training position — and that’s virtually all of them — Match Day is the most anticipated day of the year. The Match is the culmination of medical school, application preparation, interviews, and recruitment events. It’s like a traditional job search but without the room for negotiation since it is based on an algorithm that announces job placement once a year, on the third Friday of March, for all participat

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NPR Health - Shots

MARCH 10, 2023

While supporting some of the state's most restrictive LGBTQ laws, Tenn. Lt. Gov. Randy McNally admitted to regularly commenting on nearly naked online photos of a gay man with heart and fire emojis.

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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

MARCH 10, 2023

The enzyme TBK1 is an important component of the innate immune system that plays a critical role in the defense against viruses. Upon mutation-induced loss of TBK1 function, patients show an increased susceptibility to viral infections. Strikingly, if TBK1 is not expressed at all, this clinical effect is not seen.

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NPR Health - Shots

MARCH 10, 2023

Three years ago, the novel coronavirus swept the world. Here are 24 quotes and 13 photos that sum up the reaction in the weeks before the World Health Organization's declaration of a global pandemic.

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Medical Xpress

MARCH 10, 2023

A study conducted by the Centers for Disease Control and Prevention (CDC) from 2009 to 2017 determined that approximately 1 in 44 children ages 3-17 are diagnosed with some form of autism spectrum disorder (ASD). Research also has established that children with ASD have an increased risk of obesity, and obesity has been linked to increased risks for cardiometabolic disorders such as diabetes and dyslipidemia (high level of cholesterol or fat in the blood).

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Research 111

Fierce Pharma

MARCH 10, 2023

Pfizer hopes to nose out competition with approval for new migraine nasal spray Zavzpret kdunleavy Fri, 03/10/2023 - 10:22

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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

Medical Xpress

MARCH 10, 2023

For most people, respiratory syncytial virus (RSV) is about as dangerous as the common cold. But for children younger than six months old, and for people whose immune defenses have been weakened by age, disease, chemotherapy or transplantation, RSV can be fatal.

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NPR Health - Shots

MARCH 10, 2023

Monkeys using stones to crack open nuts generate many stone flakes accidentally that look exactly like the ones archaeologists have long thought early humans made intentionally as tools. Oops. (Image credit: Lydia V.

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Advarra

MARCH 10, 2023

Having a one in four chance of developing sickle cell disease (SCD) is uniquely, and overwhelmingly, familiar to the African American population. Considered a rare disease, research in finding better therapies – and possibly even a cure – for SCD may be competing for funding with conditions impacting broader populations. SCD’s significant impact on African Americans also means it predominantly impacts a minority community historically underserved by clinical research.

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STAT News

MARCH 10, 2023

By law, Medicare will have to take a medication’s efficacy and its research and development costs into account when it starts to negotiate drug prices — but recent research shows pharma companies ignore those factors when they pick prices for their products. Two recent studies aimed to quantify how much R&D costs impact a drug’s price, and how much a drug’s effectiveness correlates with its price — factors that might, in theory, help justify a sizable price

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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

Medical Xpress

MARCH 10, 2023

Pregnant persons should dim the lights in their home and turn off or at least dim their screens (computer monitors and smartphones) a few hours before bedtime to reduce the risk of gestational diabetes mellitus, a new Northwestern Medicine study shows.

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STAT News

MARCH 10, 2023

Ever since the Food and Drug Administration approved osimertinib for some early-stage lung cancer patients to take after surgery, clinicians have debated whether the evidence suggested the drug was worth the cost. The initial results of the phase 3 trial testing the drug were “phenomenal,” said Sandeep Patel, a medical oncologist at the University of California, San Diego.

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Drugs Trials 98

Medical Xpress

MARCH 10, 2023

Pulmonary fibrosis is a devastating disease characterized by progressive scarring in the lungs, killing up to half of patients within five years of a diagnosis. Little is known about whether there are differences in how the condition affects individuals of different ethnicities.

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STAT News

MARCH 10, 2023

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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Clinical Development Development 98

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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

Drug Discovery World

MARCH 10, 2023

Cancer Research UK and UCB have agreed a clinical development collaboration to advance two of UCB’s investigational oncology antibody candidates through clinical trials. The collaboration focuses on the development of two investigational antibody candidates, UCB6114 and UCB4594, by bringing together the oncology-focused translational research and clinical development capabilities of Cancer Research UK, and UCB’s antibody discovery expertise.

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Medical Xpress

MARCH 10, 2023

Like many consumers, you may be on a quest for healthier food options and willing to try something new or a new take on a familiar food. If you're diagnosed with celiac disease, you may be looking for gluten-free alternatives. Or maybe you're on the hunt for lower carbohydrate choices.

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STAT News

MARCH 10, 2023

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 rather abbreviated this time around due to a Woodstock-like gathering for health journos. However, we do hope to hang with our short person and promenade with the official mascot upon our return.

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Medical Xpress

MARCH 10, 2023

Atrial fibrillation (AFib) not only causes shortness of breath and palpitations but puts patients at increased risk of stroke. When medication or other treatments fail to relieve symptoms, cardiologists increasingly perform catheter ablation, which uses small burns or freezing to break up the electrical signals inside the heart responsible for the chaotic beats.

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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

Fierce Pharma

MARCH 10, 2023

FDA calls expert hearing for Intercept’s high-profile NASH application for Ocaliva aliu Fri, 03/10/2023 - 10:49

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Medical Xpress

MARCH 10, 2023

March is National Kidney Month, which makes this a good time to learn more about the difference between two kidney disorders—kidney cysts and polycystic kidney disease.

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Pharma Times

MARCH 10, 2023

Positive results emerge from AEGEAN phase 3 trial for patients with resectable non-small cell lung cancer

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Medical Xpress

MARCH 10, 2023

While closing your eyes for a few minutes during your busy day may seem like a good idea, it's important to consider the effects napping may bring.

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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