Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. When developing biologics, sponsors must manage several scientific considerations specific to large molecule products, including biochemical characterization studies to confirm structural identity, biological activity studies to confirm potency, and mechanism of action maintenance.

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BioPharma Reporter

DECEMBER 13, 2021

Memo Therapeutics AG will receive CHF 10.5m (US $11.4m) from the Swiss government to clinically develop a SARS-CoV-2 antibody against COVID-19, allowing it to start Phase 1 studies in Q1, 2022.

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Antibody Clinical Trials Clinical Trials Clinical Development 143

Outsourcing Pharma

DECEMBER 13, 2021

The pharmaceutical company currently has several promising treatments in development for gastroenterological, dermatological, and cardiological conditions.

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Cardiology Dermatology Development Regulation 145

pharmaphorum

DECEMBER 13, 2021

UCB has the positive result it was hoping for in its phase 3 trial of anti-neonatal FC receptor (FcRn) antibody rozanolixizumab for autoimmune disease generalised myasthenia gravis (gMG), setting up regulatory filings next year. The MycarinG study met its primary endpoint, demonstrating a “statistically significant and clinically meaningful” improvement from baseline in the myasthenia gravis-activities of daily living (MG-ADL) score, said the Belgian drugmaker.

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Drugs Antibody Trials Marketing 130

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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

Pharma Times

DECEMBER 13, 2021

A team at The Institute of Cancer Research (ICR), London and the Clinical Trials Research Unit (CTRU) at the University of Leeds adopted a new high-speed trial methodology.

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Clinical Trials Clinical Trials Trials Drugs 114

NY Times

DECEMBER 13, 2021

Some laboratory studies suggest that molnupiravir can insert errors in DNA, which could in theory harm a developing fetus, sperm cells or children.

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XTalks

DECEMBER 13, 2021

The ongoing COVID-19 pandemic, which began in early 2020, has led to irreversible changes in consumer behavior , especially when it comes to their food and beverage purchasing habits. As stay-at-home orders and lockdowns were enforced in many cities and countries around the world, consumers formed new preferences, habits and expectations. Many of those new habits, however, were formed out of necessity rather than choice.

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Pharma Times

DECEMBER 13, 2021

The approval from the European Commission (EC) is based on the results of five clinical studies, involving over 2,800 patients.

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pharmaphorum

DECEMBER 13, 2021

A pair of trials have suggested that CAR-T therapies could offer an improved option for patients with large B cell lymphoma (LBCL) who have relapsed after or haven’t responded to first-line treatment. The results of the ZUMA-7 and TRANSFORM trials, reported at the American Society of Haematology (ASH) congress, could see Gilead Sciences’ Yescarta (axicabtagene ciloleucel) and Bristol-Myers Squibb’s Breyanzi (lisocabtagene maraleucel) move up the treatment pathway for this type

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Trials Clinical Trials Clinical Trials Marketing 97

Scienmag

DECEMBER 13, 2021

Philadelphia, December 13, 2021 – In a new study in The Journal of Molecular Diagnostics, published by Elsevier, investigators report on the design and testing of a breathalyzer, known as the Bubbler, that relies on viral RNA detection to diagnose SARS-CoV-2. Its name is derived from the bubbling sound that occurs when the patient exhales […].

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RNA Scientist Development Medicine 96

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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

BioPharma Reporter

DECEMBER 13, 2021

Oxford Biomedica plc has announced an extended commercial supply agreement with Novartis for the manufacture of lentiviral vectors for several Novartis CAR-T products.

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Manufacturing Production Development 98

Scienmag

DECEMBER 13, 2021

Laser beams can do more than just heat things up; they can cool them down too. That is nothing new for physicists who have devoted themselves to precision spectroscopy and the development of optical atomic clocks. But what is new is the extremely low temperature that researchers at the QUEST Institute at the Physikalisch-Technische Bundesanstalt […].

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Outsourcing Pharma

DECEMBER 13, 2021

The pharma firm has gifted $1m USD to form a scholarship fund for students headed toward careers in clinical research, with the aim of increasing diversity.

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Research Clinical Research Clinical Development Development 102

Scienmag

DECEMBER 13, 2021

Cancer chemotherapy has undergone a paradigm shift in recent years with traditional treatments like broad-spectrum cytotoxic agents being complemented or replaced by drugs that target specific genes believed to drive the onset and progression of the disease. Credit: Georgia Tech Cancer chemotherapy has undergone a paradigm shift in recent years with traditional treatments like broad-spectrum […].

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Gene Gene Therapy Drugs Medicine 93

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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

Drug Channels

DECEMBER 13, 2021

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Drug Channels Outlook 2022. Click here to see the original post and comments from August 2021. The generic prescription market is being disrupted—but not by the big, bad spaceman from Seattle. Instead, consider how GoodRx is affecting patients, payers, and PBMs.

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Pharmacy Drugs Marketing Generic Drugs 87

Scienmag

DECEMBER 13, 2021

Which came first, MHC class I or MHC class II? For decades, it has been debated which of these two similar classes came first in evolution. Now, Keiichiro Hashimoto and his group at Fujita Health University, Japan, in collaboration with European research groups, have provided an answer to this question in a new article in […].

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Research 93

Pfizer

DECEMBER 13, 2021

Shot of a Lifetime: How Two Pfizer Manufacturing Plants Upscaled to Produce the COVID-19 Vaccine in Record Time. Anonymous (not verified). Mon, 12/13/2021 - 11:40. Shot of a Lifetime: How Two Pfizer Manufacturing Plants Upscaled to Produce the COVID-19 Vaccine in Record Time. After Pfizer and BioNtech signed a letter of intent in March 2020 to work together on a vaccine, two Pfizer facilities were swiftly selected for developing the processes and manufacturing the product at an industrial scale.

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Manufacturing Vaccination Vaccine Production 52

Scienmag

DECEMBER 13, 2021

The brain is a remarkably complex and adaptable organ. However, adaptability decreases with age: as new connections between nerve cells in the brain form less easily, the brain’s plasticity decreases. If there is an injury to the central nervous system such as after a stroke, the brain needs to compensate for this by reorganising itself. […].

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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

Roots Analysis

DECEMBER 13, 2021

Earlier, approaches used for blood collection were invasive, time consuming and needed a healthcare expert. However, in recent years, the methods for blood collection are evolving at a rapid pace. According to research study, 69% of participant were found to take part more likely in clinical trials, if they are able to provide self-collected sample (at-home blood collection).

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Engineer Clinical Trials Clinical Trials Protein 52

Scienmag

DECEMBER 13, 2021

A new study found that during the early months of the COVID-19 pandemic people living with HIV were less likely to die from COVID than persons without HIV. Hospitalized patients with HIV and COVID were less likely to require mechanical ventilation and were less likely to die, according to the study published in AIDS Patient […].

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FDA Law Blog

DECEMBER 13, 2021

By Sophia R. Gaulkin & Riëtte van Laack — On December 6, 2021, FDA published a proposed rule to reorganize and amend the highly criticized agricultural water provisions of the Produce Safety Rule (PSR). This marks the Agency’s latest effort to balance public health protections with covered farms’ persistent concerns that the current provisions are overly complex, difficult to implement, and ill-suited to address the diversity of water uses and sources in the produce industry.

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Scienmag

DECEMBER 13, 2021

The processor is the brain of a computer – an often-quoted phrase. But processors work fundamentally differently than the human brain. Transistors perform logic operations by means of electronic signals. In contrast, the brain works with nerve cells, so-called neurons, which are connected via biological conductive paths, so-called synapses. At a higher level, this signaling […].

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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

BioTech 365

DECEMBER 13, 2021

Same Day Dental Crowns Newmarket Auckland Update By Parnell Dentist Same Day Dental Crowns Newmarket Auckland Update By Parnell Dentist Auckland Family Dental Parnell (09-379 0709) updated its dental crowns treatments for patients in Parnell, Remuera, Newmarket with cracked, broken, … Continue reading →

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Scienmag

DECEMBER 13, 2021

ORLANDO, Dec. 2021 – A team from UCF has developed the world’s first optical oscilloscope, an instrument that is able to measure the electric field of light. The device converts light oscillations into electrical signals, much like hospital monitorsconvert a patient’s heartbeat into electrical oscillation. Credit: University of Central Florida ORLANDO, Dec. 2021 – A team from UCF has developed the world’s first optical oscilloscope, an instrument that is able to measure the electric field of lig

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Development 88

Drug Patent Watch

DECEMBER 13, 2021

Annual Drug Patent Expirations for EVEKEO+ODT Evekeo Odt is a drug marketed by Arbor Pharms Llc and is included in one NDA. It is available from one supplier. There are…. The post New patent for Arbor Pharms drug EVEKEO ODT appeared first on DrugPatentWatch - Make Better Decisions.

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Scienmag

DECEMBER 13, 2021

Spin waves, a change in electron spin that propagates through a material, could fundamentally change how devices store and carry information. These waves, also known as magnons, don’t scatter or couple with other particles. Under the right conditions, they can even act like a superfluid, moving through a material with zero energy loss. Credit: (Credit: […].

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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

BioPharma Reporter

DECEMBER 13, 2021

This month saw BioCina officially open its new biologics manufacturing facility in Adelaide, Australia, flagging it as the only TGA, EMA, Health Canada and US-FDA approved commercial facility of its kind in the country.

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Scienmag

DECEMBER 13, 2021

Range anxiety with electric commercial vehicles is real, since running out of battery can have serious consequences. Researchers at Chalmers University of Technology, Sweden, have developed tools to help electric delivery-vehicles navigate strategically to use as little energy as possible. The secret lies in looking beyond just the distance travelled, and instead focusing on overall […].

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pharmaphorum

DECEMBER 13, 2021

The UK government has said it will step up its COVID-19 booster vaccination dramatically, with everyone in England aged over 18 offered a third dose before the end of the month. Westminster has promised additional support for the devolved administrations in Scotland, Wales and Northern Ireland to step up the booster campaign, and Scotland has already said it intends to match England’s target.

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Vaccination Vaccine 52

Scienmag

DECEMBER 13, 2021

Can your personality affect your job performance? It depends on the job, according to a new study by management and psychology researchers. Credit: University of Arkansas Can your personality affect your job performance? It depends on the job, according to a new study by management and psychology researchers. “Although past studies made statements about the […].

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Research 85

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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