Wed.Sep 21, 2022

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Alzheimer’s Might Not Actually Be a Brain Disease, Expert Says

AuroBlog - Aurous Healthcare Clinical Trials blog

The pursuit of a cure for Alzheimer’s disease is becoming an increasingly competitive and contentious quest with recent years witnessing several important controversies. In July 2022, Science magazine reported that a key 2006 research paper, published in the prestigious journal Nature, which identified a subtype of brain protein called beta-amyloid as the cause of Alzheimer’s, […].

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Rocket agrees to acquire biotech firm Renovacor

Pharmaceutical Technology

Rocket Pharmaceuticals has entered a definitive agreement for the acquisition of biotechnology firm Renovacor in an all-stock equity deal worth nearly $53m, or $2.60 for each share. Renovacor focuses on offering precision treatments for genetic cardiovascular and mechanistically-related ailments. The most advanced programme of the company is adeno-associated virus (AAV)-based gene therapy, REN-001.

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September 21, 2022: In PCT Grand Rounds, Birth Outcomes of a Nurse Home Visiting Program in a Medicaid-Eligible Population

Rethinking Clinical Trials

Dr. Margarat McConnell. In this Friday’s PCT Grand Rounds, Dr. Margaret McConnell of the Harvard T.H. Chan School of Public Health will present “ Effect of an Intensive Nurse Home Visiting Program on Adverse Birth Outcomes in a Medicaid-Eligible Population.” The Grand Rounds session will be held on Friday, September 23, 2022, at 1:00 pm eastern.

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Industrial automation hiring levels in the pharmaceutical industry rose in August 2022

Pharmaceutical Technology

The proportion of pharmaceutical companies hiring for industrial automation related positions rose in August 2022 compared with the equivalent month last year, with 52% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 49.7% of companies who were hiring for industrial automation related jobs a year ago but a decrease compared to the figure of 58.3% in July 2022.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Parliamentary Committee recommends govt to bring DoP under ministry of health

AuroBlog - Aurous Healthcare Clinical Trials blog

The department-related Parliamentary Committee for ministry of health and family welfare, which has looked into the medical devices regulations and recommended the way forward, has sought the Central government to bring the Department of Pharmaceuticals (DoP) under the Ministry, for better coordination. It has also pitched an idea of setting up a department of medical […].

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STAT+: After early wins, CRISPR gene editing is about to get a lot harder

STAT News

The short history of CRISPR gene editing in humans has, with rare exception, been a history of triumphant progress: A patient apparently cured of sickle cell in 2019, six patients with toxic DNA knocked out of their liver last year, another six patients with a different strand of toxic liver DNA knocked out last week.   The next era of CRISPR may not be so smooth.

More Trending

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To stem overdoses, Canada is offering safer opioids. Advocates want the U.S. to do the same

STAT News

TORONTO — The Finks, married just a month earlier, sat down for their appointment, Kim dressed in head-to-toe pink and Chris in all black. He was taciturn, while she joked she couldn’t stop talking long enough to have her blood pressure taken. Jouvence Tshiyoyo Bukumba, a nurse, asked Kim, 46, about her cardiology appointment and Chris, 54, about his nerve pain.

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Genetically modified herpes combats advanced cancers

Pharma Times

A new genetically engineered virus has delivered a one-two punch in initial phase 1 trial

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Opinion: Termination is the safest course for some high-risk pregnancies. Dobbs decision threatens that care

STAT News

Ava was excited about her pregnancy. As her rheumatologists, we were anxious about it. Her death left a newborn without its mother, shattered a family, and may be a harbinger of what’s to come for pregnant people with serious medical conditions. Ava (not her real name) was a 28-year-old Hispanic woman with systemic lupus erythematosus, an autoimmune disease in which the immune system mistakenly attacks the body’s tissues and organs.

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Patient centricity is becoming business critical for pharma

pharmaphorum

New book sets the pharmaceutical industry on a course for bridging the patient centricity optimism gap. Bridging the gulf between patient centricity ambition and reality has never been more important for pharma – luckily, this seemingly insurmountable goal isn’t as far out of reach as many envision. That’s according to Sharon Suchotliff, patient centricity lead at consultancy firm ZS Associates, which has just published a book on the art of patient involvement.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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STAT+: Researchers show they can quickly turn CAR-T cells on and off, raising hopes for safer cancer treatments

STAT News

Researchers reported Wednesday that they could quickly and reliably turn CAR-T cells on and off in cancer patients, giving scientists an unprecedented level of control over this potent — but at times dangerous — oncology therapy. The findings, presented at the CAR-TCR Summit in Boston, come from an early-stage clinical trial by Scripps Research of patients with B cell cancers.

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Dispelling myths about memory loss for World Alzheimer's Day

Antidote

September 21 is World Alzheimer’s Day , a day of recognition aimed at increasing awareness of and understanding the issues faced by people living with Alzheimer’s. Though there are many conditions that can cause memory loss , Alzheimer’s is one of the most common — it is estimated that 5.4 million Americans are living with the condition , most of whom are over the age of 65.

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STAT+: Catalent is scolded by FDA for quality control issues at a plant that helps make Covid-19 vaccines

STAT News

Catalent, one of the largest contract manufacturers in the pharmaceutical industry, was cited by the U.S. Food and Drug Administration for a series of quality control failures at a facility in Bloomington, Ind., the same plant where the company helps produce two Covid-19 vaccines. The issues prompted the agency to delay distribution of Moderna booster shots, although their release has now reportedly been authorized.

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FDA seems poised to approve a new drug for ALS, but does it work?

NPR Health - Shots

In March, experts who advise the FDA questioned the efficacy of an experimental new drug for ALS. In September, they voted to approve it anyway.

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The New Age of Decentralized Clinical Trials

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.

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Opinion: Listen: Polio is back in the U.S. Two physicians offer ways to fight its spread

STAT News

Polio has exploded back into Americans’ consciousness after being out of the spotlight in the U.S. for half a century or so: In late summer, it paralyzed an adult in New York state, and the poliovirus has been detected in New York City’s wastewater. This week on the “First Opinion Podcast,” doctors Sallie Permar and Jay Varma make the case that pediatricians are the frontline for fending off this “old foe,” but they need help.

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AstraZeneca’s Tezspire approved in the EU for patients with severe asthma

Pharma Times

Tezspire is a maintenance therapy for patients with no phenotype or biomarker limitations

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STAT+: Pharmalittle: FDA scolds Catalent over quality control at plant making Covid shots; Novartis will ask SCOTUS to protect a key patent

STAT News

Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a delightful cup of stimulation. Our choice today is maple cinnamon French toast, a yummy concoction that has quickly become one of our favorites.

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White Bagging Update 2022: Hospitals Battle to Boost Buy-and-Bill

Drug Channels

The battle for control of the specialty patient continues. In 2022, specialty pharmacies—via white, brown, and clear bagging—now constitute a meaningful share of the distribution channels for provider-administered oncology drugs. However, buy-and-bill appears to have rebounded substantially at hospitals. As I explain below, this resurgence likely reflects the success of vertically-integrated hospital/specialty pharmacy/physician mega-systems against the large insurer/PBM/specialty pharmacy/provi

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Accelerating Clinical Supply Through Integrated Drug Development

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.

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13th PM Society Digital Awards – celebrating creative innovation

pharmaphorum

Although a tone of respectful sobriety lay over the PM Society Awards this year, as the nation’s citizens came from far and wide to London to pay their final respects to Her Majesty Queen Elizabeth II, Thursday 15 th September was, nonetheless, in equal measure an evening that paid serious homage to the best and brightest in creative digital innovation and its effectiveness within the healthcare arena.

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Building up Australia’s vaccine manufacturing capacity

BioPharma Reporter

Almost all of Australiaâs vaccines are imported: creating a potential crisis in a pandemic. As a result, the country is setting out its strategy for developing vaccine manufacturing capabilities.

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Is There a Coffee Shortage Brewing?

XTalks

Coffee inventories in South America are declining so severely that reserves are predicted to be extremely low, but can we expect a coffee shortage? Global coffee prices are increasing and will continue to do so amid market uncertainty driven by supply shortages in Brazil , the world’s largest coffee producer. Coffee prices have been volatile in recent months, but the situation is predicted to get even worse in the weeks ahead as Brazilian coffee exports hold on to their supplies to drive up pric

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Cancer Clinical Trials: USA Scenario and Study Designs

ProRelix Research

According to the World Health Organization (WHO), cancer is the leading cause of death worldwide, with a death rate of one in six in 2020 (1). Aside from the high […]. The post Cancer Clinical Trials: USA Scenario and Study Designs appeared first on ProRelix Research.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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POC study proves efficacy of zapnometinib in severe Covid-19

Drug Discovery World

A proof of concept (POC) study has shown the clinical benefit of zapnometinib in patients with severe Covid-19 and supports further evaluation in severe viral diseases. Atriva Therapeutics and investigators will continue to evaluate the RESPIRE data and will provide an update on the full dataset in due course. The POC / Phase IIa RESPIRE study (zapnometinib) in patients hospitalised with moderate-to-severe Covid-19 met its primary endpoint of improvement on the clinical severity status (CSS) sca

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New patent for Orexo Us drug ZUBSOLV

Drug Patent Watch

Annual Drug Patent Expirations for ZUBSOLV Zubsolv is a drug marketed by Orexo Us Inc and is included in one NDA. It is available from one supplier. There are nine…. The post New patent for Orexo Us drug ZUBSOLV appeared first on DrugPatentWatch - Make Better Decisions.

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EU approval for first oral treatment for lupus nephritis

Drug Discovery World

Otsuka Pharmaceutical’s Lupkynis (voclosporin) is the first oral treatment to be approved in Europe for the treatment of active lupus nephritis (LN) in adult patients. The drug has received approval from the European Commission (EC) in combination with mycophenolate mofetil (MMF) for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) LN.

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New patent for Vifor Fresenius drug VELPHORO

Drug Patent Watch

Annual Drug Patent Expirations for VELPHORO Velphoro is a drug marketed by Vifor Fresenius and is included in one NDA. It is available from one supplier. There are ten patents…. The post New patent for Vifor Fresenius drug VELPHORO appeared first on DrugPatentWatch - Make Better Decisions.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.

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How can automation help with the discovery of biologics and biosimilars?

Drug Discovery World

Zoe Hughes-Thomas, GSK, will be discussing the ways in which Automation Can Help With The Discovery of Biologics and Biosimilars at the new Tech Theatre at this year’s ELRIG Drug Discovery, supported by DDW. Hughes-Thomas is Associate Director, Head Medicine Design Automation, GSK. The Tech Theatre will feature a series of seminars focused on automation and technology for drug discovery. .

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New patent for Clarus drug JATENZO

Drug Patent Watch

Annual Drug Patent Expirations for JATENZO Jatenzo is a drug marketed by Clarus and is included in one NDA. It is available from one supplier. There are eight patents protecting…. The post New patent for Clarus drug JATENZO appeared first on DrugPatentWatch - Make Better Decisions.

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Discover the benefits of fragment-based drug discovery

Drug Discovery World

Register now to attend the free webinar, Introduction into Fragment Based Drug Discovery, hosted by DDW and supported by WuXi AppTec. The event will take place on Thursday, October 13 at 3PM BST, 4PM CET, 10AM EST, 7AM PDT. Fragment-based drug discovery (FBDD) is a method used for finding hit compounds as one strategy of hit identification (hit ID) in the drug discovery process.

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New patent for Alnylam Pharms drug OXLUMO

Drug Patent Watch

Annual Drug Patent Expirations for OXLUMO Oxlumo is a drug marketed by Alnylam Pharms Inc and is included in one NDA. There are twelve patents protecting this drug. This drug…. The post New patent for Alnylam Pharms drug OXLUMO appeared first on DrugPatentWatch - Make Better Decisions.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.