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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Development Drugs Bioavailability In-Vivo 246

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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Drugs 321

Pharma Times

FEBRUARY 21, 2023

Final draft guidance from NICE ensures people at highest risk will have access to COVID-19 therapies

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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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Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Medicine

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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Vaccine Vaccination Gene Therapy Manufacturing 289

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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Pharma Times

FEBRUARY 21, 2023

Boost for effected patients as HEMGENIX receives green light from European Commission

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Gene Therapy Gene 144

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

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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Gene Therapy Gene 312

NPR Health - Shots

FEBRUARY 18, 2023

A large study found that cutting down on alcohol is a good idea. People who quit drinking also had increased risk of dementia, but researchers cautioned about drawing conclusions from that.

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Research 145

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Clinical Supply

Pharma Times

FEBRUARY 23, 2023

Phase 1/2 research shows that treatment could be very effective against Fabry disease

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Research 140

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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Clinical Trials Clinical Trials Genetics Protein 246

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 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

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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Marketing Doctor Doctors Drugs 139

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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FDA Approval Trials Drugs 246

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 290

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 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

Pharma Times

FEBRUARY 23, 2023

Next phase of Newel Health’s digital therapeutics solution for Parkinson’s disease gains vital grant

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Pharmaceutical Technology

FEBRUARY 20, 2023

Many have turned their attention to frontotemporal dementia (FTD) as the family of famed action star Bruce Willis announced his diagnosis last week. While there is no cure to this neurodegenerative condition, academics and companies are pushing through with research that could help patients and their families. Different approaches that are studied include antisense oligonucleotides (ASOs), and gene therapies, which are in early clinical trials.

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Development Gene Therapy Protein Gene 246

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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Gene Therapy Gene Development Genetics 264

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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Research 134

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

Pharma Times

FEBRUARY 24, 2023

Africa-based trials for blood test which detects risk of disease progression are due to begin

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Trials 130

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 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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Rethinking Clinical Trials

FEBRUARY 24, 2023

The National Institute on Drug Abuse (NIDA) invites primary care clinical and research teams to take part in a new Challenge competition funding opportunity, “Substance Use Prevention Services in Primary Care!” With this Challenge, NIDA is seeking better understanding of how primary care providers can implement substance use prevention interventions in their clinical settings.

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Clinical Trials Clinical Trials Research Drugs 130

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Clinical Supply

Worldwide Clinical Trials

FEBRUARY 22, 2023

Rare Disease Day on February 28th is a chance for rare disease communities to come together as one and join in conversation with stakeholders searching for treatments, raising money to support research, and changing the way healthcare and governments interact with patients. With so many important discussions happening this year between stakeholders, it is impossible to be a part of them all.

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Clinical Trials Clinical Trials Trials Research 130

Pharmaceutical Technology

FEBRUARY 23, 2023

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Artificial Intelligence in Pharmaceuticals: In-silico

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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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Drugs 246

Rethinking Clinical Trials

FEBRUARY 23, 2023

February 20, 2023 : The NIH Pragmatic Trials Collaboratory hosted a Pre-Conference Workshop, “Changing Trials for Changing Times: Essentials of Embedded Pragmatic Clinical Trials Workshop,” at the Health Care Systems Research Network 2023 Annual Conference. This training workshop introduces concepts in the design, conduct, and implementation of embedded pragmatic clinical trials (ePCTs) and provides firsthand ePCT experiences and case studies from the NIH Pragmatic Trials Collaboratory Demonstra

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Clinical Trials Clinical Trials Trials Research 130

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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