Pharmaceutical Technology

FEBRUARY 23, 2023

Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption ( Applied Biopharmaceutics and Pharmacokinetics, Shargel, Wu-Pong and Yu, 5th Edition ). Quotient Sciences helps biotech and pharma customers in the development and optimization of drug products.

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Bio Pharma Dive

FEBRUARY 21, 2023

There comes a time when companies with platforms need to focus on their most advanced prospects, Morrison said, rather than sink all of their funds into building the technology.

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NPR Health - Shots

FEBRUARY 20, 2023

Florida's medical boards have voted to ban gender-affirming care for transgender youth. Families with trans children and medical providers who care for them are worried about the impact.

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STAT News

FEBRUARY 21, 2023

A bedrock of the U.S. mental health system — a nine-item questionnaire used to spot depression — began not with a doctor, but with a marketing man. Howard Kroplick, now 73 years old and living on Long Island, is obsessed with antique racing cars and, in his storied career in the pharmaceutical industry, crucially urged Pfizer to avoid the word “impotence” when promoting Viagra.

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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

FEBRUARY 23, 2023

GenScript ProBio has announced a strategic collaboration with RVAC Medicines to manufacture GMP-grade plasmid DNA (pDNA) for the latter’s RVM-V001, an mRNA Covid-19 vaccine candidate. Under the agreement, GenScript ProBio will offer GMP plasmid manufacturing service for the RVM-V001 programme. This collaboration is expected to help expedite the clinical manufacturing of RVM-V001 and future mRNA-based vaccines that target infectious diseases such as Clostriodioides difficile infection (CDI) and R

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Bio Pharma Dive

FEBRUARY 21, 2023

The proposed model could help state Medicaid agencies explore different kinds of outcomes-based payment schemes, but may come too late to prepare for the first sickle cell gene therapy.

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Medical Xpress

FEBRUARY 24, 2023

Researchers from the University of Cincinnati examined the post-treatment journals kept by participants in a 2014 smoking cessation study that found psychedelics were effective in helping some people quit smoking for years.

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Pharmaceutical Technology

FEBRUARY 22, 2023

Amgen could be the winner of a high-stakes patent spat with Sanofi as tensions run high weeks before the March 27 US Supreme Court hearing. While some courts were previously on Sanofi’s side, it is possible that Amgen’s case could win this time, some legal experts say. However, Sanofi’s side also has significant support, highlighting the dispute’s contentious nature.

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Bio Pharma Dive

FEBRUARY 21, 2023

Many current top-selling products will lose patent protection by the end of the decade, putting pressure on companies to replace lost revenue with new medicines.

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NPR Health - Shots

FEBRUARY 21, 2023

Petitions for compassionate release soared in the pandemic, but federal judges denied most requests. This week officials will review guidelines aimed at freeing imprisoned people who pose no threat.

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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

FEBRUARY 23, 2023

More children and adolescents are identifying as transgender and offered medical treatment, especially in the US. But some providers and European authorities are urging caution because of a lack of strong evidence.

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Pharmaceutical Technology

FEBRUARY 22, 2023

The US Food and Drug Administration (FDA) has granted Fast Track designation for Biohaven ’s new anti-myostatin adnectin, taldefgrobep alfa, to treat spinal muscular atrophy (SMA). The new myostatin-targeting biologic investigational agent has been designed for specific binding to myostatin (GDF-8) to reduce overall levels of myostatin. It also works as a receptor antagonist to block myostatin signalling in skeletal muscles.

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Bio Pharma Dive

FEBRUARY 23, 2023

Sanofi and its development partner, Sobi, claim the drug’s once-a-week dosing, and its effect on blood-clotting protein levels, will help it compete in the crowded market for hemophilia A treatments.

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NPR Health - Shots

FEBRUARY 23, 2023

That's what epidemiologist Jenny Cresswell of the World Health Organization said of death rate data in a new report she authored — "equivalent to almost 800 deaths a day or a death every 2 minutes.

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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

Medical Xpress

FEBRUARY 18, 2023

COVID-19 infections can cause potentially life-threatening heart issues. Studies suggest that people with COVID-19 are 55% more likely to suffer a major adverse cardiovascular event, including heart attack, stroke and death, than those without COVID-19. They're also more likely to have other heart issues, like arrhythmias (abnormal heart rhythms) and myocarditis (inflammation of the heart muscle).

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Pharmaceutical Technology

FEBRUARY 20, 2023

The US Food and Drug Administration (FDA) has granted approval for Apellis Pharmaceuticals’ Syfovre (pegcetacoplan injection) to treat geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD). Syfovre has been approved for use in people with GA with or without subfoveal involvement and offers dosing flexibility with a regimen of every 25 to 60 days for patients and physicians.

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Bio Pharma Dive

FEBRUARY 23, 2023

Graphite Bio and Sangamo are stopping work on their respective sickle cell gene therapies, while Intellia revealed partner Novartis ended development of its genetic treatment for the blood disease.

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NPR Health - Shots

FEBRUARY 21, 2023

As fentanyl deaths soar, political pressure is growing to stop Mexican cartels that smuggle the drug. Experts on drug trafficking say trying to lock down the Mexican border is an impossible goal.

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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

FEBRUARY 24, 2023

A classic warning in public health goes like this: “A society that spends so much on health care that it cannot or will not spend adequately on other health enhancing activities may actually be reducing the health of its population.” No nation is as guilty of this practice as the United States, with its extremely high health expenditures alongside abysmal population-level health outcomes.

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Pharmaceutical Technology

FEBRUARY 21, 2023

Pfizer and BioNTech’s Covid-19 vaccine, Comirnaty, had a phenomenal year with forecast sales of $37bn in 2022. Comirnaty is expected to maintain the sales dominance it saw during the Covid-19 pandemic going into the future, with the average annual sales forecast rising by 19% between H1 and H2 2022, according to GlobalData’s Coronavirus Disease 2019 (Covid-19) Sector Forecast: H2 2022 Global Analyst Consensus Sales Forecast report.

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Bio Pharma Dive

FEBRUARY 23, 2023

Eisai and Biogen have data showing Leqembi slows cognitive decline, but CMS won’t budge until FDA converts its approval from accelerated to full.

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Drugs 278

NPR Health - Shots

FEBRUARY 22, 2023

Archaeologists have discovered evidence of a rare type of skull surgery dating back to the Bronze Age that's similar to a procedure still being used today. (Image credit: Kalisher et al.

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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

STAT News

FEBRUARY 22, 2023

Moderna is aiming to build a gene editing franchise powered by some of the same technologies used in its COVID-19 vaccines. The Cambridge biotech company announced Wednesday that it will partner with Life Edit Therapeutics to develop potentially permanent treatments for rare genetic diseases and other conditions. Life Edit is the North Carolina subsidiary of ElevateBio, a cell and gene therapy manufacturing firm in Waltham.

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BioPharma Reporter

FEBRUARY 21, 2023

The Danish-US biotech Hemab Therapeutics bags $135m to finance the clinical development of prophylactic treatments for genetic bleeding disorders including Glanzmann thrombasthenia and von Willebrand disease.

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Bio Pharma Dive

FEBRUARY 22, 2023

The messenger RNA specialist said Wednesday it is teaming up with Life Edit Therapeutics to develop therapies that can modify genes “in vivo.

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NPR Health - Shots

FEBRUARY 21, 2023

Reckitt says despite contamination fears, the recalled formula tested negative for Cronobacter, which can cause rare but deadly infections in infants. Here's how to identify and prevent them. (Image credit: U.S.

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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

STAT News

FEBRUARY 24, 2023

As a health policy wonk and health economist who has worked in pharmaceutical companies in the United States, Latin America, and Europe, I’ve seen vast volumes of data generated, gathered, aggregated, analyzed, shared, and resold by health care companies and organizations. In my studies with the world’s top medical statistics experts at the University of Oxford’s Centre for Evidence Based Medicine, I’ve also seen how flawed many datasets are, missing critical data pie

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Fierce Pharma

FEBRUARY 24, 2023

Moderna pays US government $400M 'catch-up payment' under new COVID-19 vaccine license esagonowsky Fri, 02/24/2023 - 09:18

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Bio Pharma Dive

FEBRUARY 24, 2023

Weeks after the Swiss drugmaker wrote off Gavreto’s accounting value, the biotech will regain responsibility for its commercialization.

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NPR Health - Shots

FEBRUARY 20, 2023

The bottles of Starbucks' vanilla Frappuccinos may contain pieces of glass, the Food and Drug Administration said. (Image credit: Gene J.

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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