Pharmaceutical Technology

FEBRUARY 9, 2023

Teva Pharmaceutical Industries has reported $3.9bn revenue in the fourth quarter (Q4) of 2022, representing a 5% decline in US dollars or a 1% increase in local currency terms, from $4.1bn in the same quarter of the previous year. During the quarter, higher revenues from Anda, generic products in the Europe segment, AJOVY and AUSTEDO were partially offset by fewer revenues from COPAXONE, generic products and certain respiratory products in the North America segment.

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Production 242

Bio Pharma Dive

FEBRUARY 9, 2023

While 2022 revenue came in slightly below analyst expectations, the pharma’s forecast puts within reach a sales target set nearly a decade ago by CEO Pascal Soriot.

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Sales 240

Pharmaceutical Technology

FEBRUARY 9, 2023

ReviR Therapeutics has signed a research collaboration and option-to-license agreement with Asieris Pharmaceuticals to discover new oncology therapeutics. The collaboration is aimed at discovering and developing new advanced treatments for genitourinary (GU) tumours as well as other related serious diseases using ReviR’s RNA-targeted technologies.

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Bio Pharma Dive

FEBRUARY 9, 2023

Intarcia, which once held a multibillion-dollar valuation, deflated following the FDA’s 2017 and 2020 rejections of its drug-device combination for diabetes.

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Drugs 242

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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

Rethinking Clinical Trials

FEBRUARY 9, 2023

We are pleased to announce that our workshop, “Changing Trials for Changing Times: Essentials of Embedded Pragmatic Clinical Trials,” will be available virtually and at no charge to all HCSRN Annual Conference registrants and all HCSRN members on the day preceding the conference in Denver. (This offering does not affect HCSRN Annual Conference programming, which will remain in person.

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Trials Clinical Trials Clinical Trials Research 130

Bio Pharma Dive

FEBRUARY 9, 2023

Mineralys, which is developing a hypertension drug, followed closely behind Structure Therapeutics in pricing an IPO, suggesting an opening investment window.

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Marketing Development Drugs 245

Bio Pharma Dive

FEBRUARY 9, 2023

The negative results for Galapagos’ drug filgotinib in a Crohn’s disease study follows a series of clinical disappointments for the company.

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Drugs 130

NPR Health - Shots

FEBRUARY 9, 2023

The Florida High School Athletic Association's board of directors has voted to remove questions about athletes' menstrual history from a required health form for participation in school sports.

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Pharmaceutical Technology

FEBRUARY 9, 2023

Buntanetap tartrate is under clinical development by Annovis Bio and currently in Phase III for Parkinson’s Disease. According to GlobalData, Phase III drugs for Parkinson’s Disease have a 46% phase transition success rate (PTSR) indication benchmark for progressing into Filing rejected/Withdrawn. GlobalData’s report assesses how Buntanetap tartrate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

Clinical Trials 100

Clinical Trials Clinical Trials Drugs Development 100

NPR Health - Shots

FEBRUARY 9, 2023

At many U.S. hospitals, children and teens are stuck in the emergency department for days or weeks because psychiatric beds are full. Massachussets has a simple, yet promising solution.

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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

Pharmaceutical Technology

FEBRUARY 9, 2023

Buntanetap tartrate is under clinical development by Annovis Bio and currently in Phase III for Alzheimer’s Disease. According to GlobalData, Phase III drugs for Alzheimer’s Disease have a 9% phase transition success rate (PTSR) indication benchmark for progressing into Filing rejected/Withdrawn. GlobalData’s report assesses how Buntanetap tartrate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

Clinical Trials 100

Clinical Trials Clinical Trials Drugs Development 100

NPR Health - Shots

FEBRUARY 9, 2023

Homosexuality was considered a mental disorder and "sexual deviation" until 1973 — months after Silverstein gave a presentation challenging the classification.

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Pharmaceutical Technology

FEBRUARY 9, 2023

Ibutamoren mesylate is under clinical development by Lumos Pharma and currently in Phase II for Growth Hormone Deficiency. According to GlobalData, Phase II drugs for Growth Hormone Deficiency have a 63% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Ibutamoren mesylate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

Hormones 100

Hormones Clinical Trials Clinical Trials Drugs 100

NPR Health - Shots

FEBRUARY 9, 2023

Drugmakers will be required to pay Medicare back for price increases that outpace inflation. The industry is expected to put up a fight over implementation.

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Drugs 136

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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

Pharmaceutical Technology

FEBRUARY 9, 2023

Ibutamoren mesylate is under clinical development by Lumos Pharma and currently in Phase I for Turner Syndrome. According to GlobalData, Phase I drugs for Turner Syndrome have a 100% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Ibutamoren mesylate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Hormones Clinical Trials Clinical Trials Genetics 100

Rethinking Clinical Trials

FEBRUARY 9, 2023

                                           Speakers Alex C. Spyropoulos, MD, FACP, FCCP, FRCPC Professor of Medicine – The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Professor – Institute of Health System Science – The Feinstein Institutes for Medical Research System Director – Anticoagulation and Clinical Thrombosis Services Northwell Health at Lenox Hill Hospital Jeffrey Solomon, BFA Senior Director, Usability Lab Feinstein Inst

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Clinical Trials Clinical Trials Trials Development 130

STAT News

FEBRUARY 9, 2023

Fungus-caused infections — real ones, not the ones sparking the zombie apocalypse on the popular show “The Last of Us” — pose a growing threat in the United States and around the world. Mississippi has become the latest state to report residents infected with Candida auris, a highly contagious fungus that thrives in hospitals and nursing homes.

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Nurses 122

NPR Health - Shots

FEBRUARY 9, 2023

Filmmaker Laura Poitras and Goldin discuss their Oscar-nominated documentary about efforts to remove the Sackler family name from prominent museums amid the opioid epidemic.

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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 9, 2023

Researchers who believe genomics can transform human health love to recount success stories. They’ll tell you about the 3-month-old boy whose heart was failing until researchers pinpointed what was ailing him. Or the baby girl who could have had a life-threatening reaction to anesthesia had researchers not sequenced her DNA ahead of time. But a new study focuses on a much more somber set of stories: those of infants who died with genetic diseases and who in some cases could have been trea

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Genetic Disease DNA Genetics Genome 119

Pharmaceutical Commerce

FEBRUARY 9, 2023

As the range of treatment options for rheumatoid arthritis (RA) continues to grow and biosimilars are poised to enter the arena, the need for expert strategies to improve therapy selection and address the access, affordability, and adherence challenges patients face is coming into sharper focus.

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STAT News

FEBRUARY 9, 2023

The Philips respiratory machine recall is a no-win situation for patients and doctors. But for the medical device giant’s longtime rivals and new competitors, business is looking up. “We think it will be difficult for Philips to regain all the share that they had,” said Margaret Kaczor, an analyst with William Blair who follows ResMed among other companies.

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Doctors Doctor 105

Medical Xpress

FEBRUARY 9, 2023

A single oral dose of the antibiotic azithromycin can reduce the risk of postpartum sepsis and death among women who deliver vaginally by one-third, according to a large multi-country clinical trial, called A-PLUS. Only 1.6% of women in the study who received azithromycin during labor developed sepsis or died within six weeks after delivery, compared to 2.4% of those who received placebo.

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Clinical Trials Clinical Trials Trials 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

STAT News

FEBRUARY 9, 2023

An inexpensive and easy-to-deliver intervention — a single dose of the antibiotic azithromycin — could sharply reduce the number of pregnant people in low- and middle-income countries who develop the life-threatening condition sepsis in childbirth, a study published Thursday reported. The results of an international trial , published in the New England Journal of Medicine, showed that administration of the antibiotic during labor cut the risk of the mother developing sepsis by abou

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Medicine Development Trials Drugs 98

Medical Xpress

FEBRUARY 9, 2023

Biochemist Jon Jacobs has analyzed the blood of patients with diseases and conditions such as Ebola, cancer, tuberculosis, hepatitis, diabetes, Lyme disease, brain injury and influenza.

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Protein 98

STAT News

FEBRUARY 9, 2023

WASHINGTON — Cigarette giant Reynolds American is calling on the Food and Drug Administration to crack down on manufacturers of disposable e-cigarettes, like Puff Bar and Elf Bar, which are increasingly being used by young people. The company, which also makes Vuse e-cigarettes, submitted a formal “citizen petition” to the FDA earlier this week calling on the agency to adopt an enforcement policy specifically targeted at disposable competitors to its products.

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Manufacturing Production Drugs 98

Medical Xpress

FEBRUARY 9, 2023

In animals, a process of programmed cell death called apoptosis ensures cells die when they should. An opposing force, governed by inhibitor of apoptosis proteins (IAPs), guards against excessive cell death. Together these competing cellular programs help maintain a balance between unchecked cell growth, such as cancer, and excess cell death, as seen in degenerative disease.

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Protein Research 98

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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

STAT News

FEBRUARY 9, 2023

When breast oncologists see new patients, one of their hopes is that the patient doesn’t have triple-negative breast cancer. The subtype is considered particularly dangerous, as it tends to grow and spread more aggressively than other types, and it has fewer effective treatment options. But a small new study suggests that help might come from an engineered virus.

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Engineer Medicine Trials Research 98

XTalks

FEBRUARY 9, 2023

Leading clinical trials technology platform provider Medable announced a new partnership with Nova Scotia Health Innovation Hub for a two-year pilot study to improve oncology trial access for patients in rural Nova Scotia through Medable’s decentralized clinical trial (DCT) platform. Nova Scotia is Canada’s second smallest province by area. Almost 50 percent of Nova Scotians live in rural communities with a population less than 1,000.

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Clinical Trials Clinical Trials Trials Clinical Research 98

STAT News

FEBRUARY 9, 2023

WASHINGTON — The Senate Judiciary Committee on Thursday passed legislation to prevent drug companies from gaming the patent system to delay competition from cheaper generics, but members in both parties said they still have concerns about the reforms. The measure also seeks to curb a practice of filing dozens of patents on drugs to forestall competition from generic drugs and biosimilars by restricting the number of patents that patent holders can contest.

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Drugs Generic Drugs 98

Medical Xpress

FEBRUARY 9, 2023

Arsenic contamination is a significant threat to human health in many parts of the world. Exposure to high levels of arsenic has been associated with a range of health problems such as diabetes, cognitive dysfunction, and certain types of cancer. In addition, arsenic exposure during pregnancy can cause miscarriages, reduced fetal growth and greater risk of health problems for children born in regions with high levels of arsenic.

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Contamination 98

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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