pharmaphorum

JANUARY 17, 2023

Late last year, pharmaphorum spoke with AstraZeneca’s Ben Challis, VP and head of translational science and experimental medicine, cardiovascular, renal, and metabolism (CVRM), together with Magnus Jörnten-Karlsson, executive director of Unify. Unify, launched in December 2020, is AstraZeneca’s patient app and clinical trial support tool. Already, it is operating at scale across the company, used in more than 28 countries and available in 62 languages.

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Bio Pharma Dive

JANUARY 18, 2023

The result from the nearly 4,000-person trial is the latest setback in a long-running effort to develop a safe and effective shot for HIV infections.

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Pharmaceutical Technology

JANUARY 16, 2023

While the biopharmaceutical industry has been impacted and pressured by various factors such as the Covid-19 pandemic, inflation, the Ukraine-Russia war, ongoing supply chain issues, and a challenging economic environment, collaboration between pharma companies and emerging technologies providers continues to grow, especially in the research and development (R&D) field, offering some resilience in times of geopolitical and economic disruptions.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 17, 2023

To reduce the harmful health effects of sitting, take a 5-minute light walk every half-hour. That’s the key finding of a new study that my colleagues and I published in the journal Medicine & Science in Sports & Exercise. We asked 11 healthy middle-aged and older adults to sit in our lab for 8 hours […].

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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

Pharma Times

JANUARY 16, 2023

MHRA approval relates to the company’s midlands-based drug development facilities

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Bio Pharma Dive

JANUARY 17, 2023

In a conversation at the J.P. Morgan Healthcare conference, the longtime Biogen executive discussed his hesitance to jump back into an executive role and why an opportunity to run Voyager Therapeutics drew him in.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 16, 2023

There’s a lot of dietary advice out there, but the science that links food and health isn’t always clear-cut. A new study on the topic is one of the most comprehensive to date and has identified four eating patterns associated with lower mortality risk. Analyzing the eating patterns of 119,315 people over 36 years, researchers […].

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STAT News

JANUARY 18, 2023

Yet another experimental HIV vaccine has failed. The National Institute of Allergy and Infectious Diseases reported Wednesday that a Phase 3 clinical trial of a vaccine was stopped because the vaccine was ineffective at preventing HIV infection. The vaccine was being developed by Janssen, the vaccine division of Johnson & Johnson.

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Bio Pharma Dive

JANUARY 19, 2023

“What we’re experiencing now is the aftershock of the party that went on for the last three years,” said Ovid CEO Jeremy Levin in a BioPharma Dive panel that included former Sage head Jeff Jonas and biotech entrepreneur Greg Verdine.

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Pharmaceutical Technology

JANUARY 17, 2023

Spain’s Hospital Universitario 12 de Octubre researchers, along with the Josep Carreras Leukaemia Research Institute, have developed a new cell therapy based on STAb cells to treat a type of leukaemia. The Spanish Association Against Cancer (AECC) provided funding for the new STAb therapy development. It could be used for T-Cell Acute Lymphoblastic Leukaemia (T-ALL) treatment in patients for whom bone marrow transplantation and chemotherapy failed to work.

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Clinical Supply

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 19, 2023

Taking into account the four main components of regulator, industry, trade and patient/consumer in a medicine value supply chain, the Drugs and Cosmetics (D&C) Rules, 1945 and D&C Act, 1940 needs an urgent revamp as there is no clause of compensation for ADRs in patients, according to drug regulatory experts.

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STAT News

JANUARY 18, 2023

With a few clicks, Daniel added the chemical to his online cart and ordered it. In less than a week, a vial containing white powder arrived at his house. He used a syringe to measure out sterile water and eject it into the vial to dissolve the powder. Then, with a different syringe, he drew up about a quarter of a milliliter of the solution and injected it into his lower abdomen.

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Bio Pharma Dive

JANUARY 20, 2023

The drugmaker had sought an accelerated approval based on promising data from a small mid-stage trial. Results from a larger study are due in the second quarter.

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Pharmaceutical Technology

JANUARY 19, 2023

The US Food and Drug Administration (FDA) has granted Fast Track designation for Avidity Biosciences’ AOC 1020 to treat facioscapulohumeral muscular dystrophy (FSHD). AOC 1020 has been designed for the treatment of the underlying cause of FSHD, which is caused by the abnormal expression of a gene known as double homeobox 4 or DUX4. This DUX4 protein abnormal expression leads to modifications in gene expression in muscle cells which are associated with progressive muscle function loss in FSHD pat

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Clinical Trials

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 18, 2023

Indian healthcare sector is now looking at the government for working capital and preferential funding support. This is because there are no incentives to stimulate the establishment of smaller hospitals and nursing homes in rural regions, making it difficult for firms to establish chains of smaller hospitals.

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Pharma Times

JANUARY 18, 2023

Therapy is the first oral MET inhibitor treatment option for certain advanced NSCLC adult patients

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Bio Pharma Dive

JANUARY 20, 2023

Analysts argue the FDA’s choice to decline accelerated approval for donanemab, while surprising, is not the main factor that will determine whether it eventually becomes a commercial success.

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Pharmaceutical Technology

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Luye Pharma Group’s Rykindo (risperidone) as an extended-release injectable suspension to treat schizophrenia in adult patients. Rykindo has also been approved as a single agent or as adjunctive therapy to lithium or valproate to treat bipolar I disorder in these patients. Developed using Luye Pharma’s microsphere technology platform, Rykindo is a bi-weekly long-acting risperidone injection.

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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

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 17, 2023

The 72nd Indian Pharmaceutical Congress (IPC), to be held in Nagpur from January 20 to 22, will be attended by over 10,000 delegates from India and 150 from abroad. The number of delegates registered from foreign countries has crossed one hundred and it is expected that it will cross 150 by January 20. We are trying […].

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Pharma Times

JANUARY 19, 2023

Therapy is among the first to receive a positive draft recommendation under streamlined pilot process

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Bio Pharma Dive

JANUARY 20, 2023

The regulator’s decision ends a seven-month study pause that followed a report of one participant experiencing mild symptoms of peripheral neuropathy.

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Pharmaceutical Technology

JANUARY 19, 2023

Sun Pharmaceutical Industries has signed a definitive agreement to buy all outstanding shares of Concert Pharmaceuticals, in a deal valued at $576m. Under the deal terms, the company will buy all shares of Concert common stock through a tender offer for $8.00 per share in cash upfront payment. Additionally, the stockholders of Concert will receive a contingent value right (CVR), based on the net sales milestones of deuruxolitinib, entitling them to up to $3.50 per share of common stock in cash.

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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

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 16, 2023

The Ministry of Fisheries, Animal Husbandry and Dairying has changed the name of the committee controls and monitors the experiments on animals from the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), to the Committee for Control and Supervision of Experiments on Animals (CCSEA). The change in name simplifies and […].

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STAT News

JANUARY 19, 2023

Today’s teens and tweens have never known a world without social media. There are still a lot of open questions about how sites like TikTok and Instagram may shape their development — and stories focusing on the potential negative impacts of social media tend to dominate the news. But a recent study published in JAMA Pediatrics is the latest in a growing body of research that suggests the relationship that young people have with social media is too complicated to be categorized as

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Bio Pharma Dive

JANUARY 20, 2023

The China-based drugmaker hopes Brukinsa’s survival data will help its drug compete with Imbruvica and Calquence.

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Pharmaceutical Technology

JANUARY 19, 2023

The Korean Ministry of Food and Drug Safety (KMFDS) has granted expanded approval to Novavax partner SK bioscience for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use as a booster dose in adults aged 18 and above. The latest move follows the recommendation for the Covid-19 vaccine to be used as an adult booster dose from the Korean Centers for Disease Control and Prevention in September last year.

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Pharma Times

JANUARY 18, 2023

Unrelenting pressure caused by strikes, flu and COVID-19 may be keeping NHS in vicious cycle

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Fierce Pharma

JANUARY 20, 2023

JPM23: Pfizer, Moderna and more look to combine COVID and flu vaccine markets zbecker Fri, 01/20/2023 - 14:48

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Bio Pharma Dive

JANUARY 17, 2023

Elicio’s combination with Angion Biomedica comes months after it abandoned a new stock offering, and is the latest example of how the IPO slowdown has shifted startups’ plans.

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Pharmaceutical Technology

JANUARY 17, 2023

Orphagen Pharmaceuticals has received a rare pediatric disease designation (RPDD) for OR-449 from the US Food and Drug Administration (FDA) to treat paediatric adrenocortical carcinoma (ACC). OR-449 is a first-in-class, orally bioavailable, potent and selective small molecule antagonist of the orphan nuclear receptor steroidogenic factor-1 (SF-1, NR5A1).

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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