Pharmaceutical Technology

FEBRUARY 26, 2023

In the last decade, the idea of tapping into the gut has attracted much interest from investors and the public, but recent years have showed that a lot more work needs to be done before such treatments enter the mainstream. This is largely due to the FDA’s rigorous approach to the safety of microbiome therapeutics, which has manifested in clinical holds, resulting in delays that have dimmed the enthusiasm in the space in recent times.

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Bio Pharma Dive

FEBRUARY 27, 2023

Celgene veteran Scott Smith will take over for Michael Goettler on April 1 as the generic drugmaker prepares for a return to growth after divestitures and the addition of a new eye care division.

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Rethinking Clinical Trials

MARCH 1, 2023

In this Friday’s PCT Grand Rounds, Dr. Margaret Kuklinski and Dr. Stacy Sterling will present “Adoption, Implementation and Sustainment of Family-Focused Prevention in Health Care Systems: How Do We Get There?” Kuklinski and Sterling are the principal investigators of GGC4H , an NIH Pragmatic Trials Collaboratory Demonstration Project.

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STAT News

MARCH 3, 2023

The American College of Surgeons recently announced its new well-being initiative for surgeons. This wellness program has lofty goals: [The ACS] recognizes the need to foster well-being, resilience, and work-life integration for all surgeons, regardless of their career stage. Fostering the growth of both the surgical expertise and the person as a whole is paramount.

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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

MARCH 2, 2023

The US Food and Drug Administration (FDA) has approved Reata Pharmaceuticals ’ oral, once-daily medication SKYCLARYS (omaveloxolone) to treat Friedreich’s ataxia patients. SKYCLARYS is indicated to treat the ultra-rare, inherited neurodegenerative disorder in 16 years and above-aged adults and adolescents in the US. SKYCLARYS is the first approved treatment in Friedrich’s Ataxia and marks a milestone for drug development in this complex disease.

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Bio Pharma Dive

FEBRUARY 28, 2023

The biotech said the FDA was unconvinced by available study evidence and asked for data from an additional clinical trial, which the company currently does not plan to run.

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Fierce Pharma

MARCH 1, 2023

Pfizer, Viatris and more must face 'overarching conspiracy' claims in generic price-fixing suit aliu Wed, 03/01/2023 - 10:03

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Pharmaceutical Technology

MARCH 1, 2023

The US Food and Drug Administration (FDA) has granted approval for Regeneron Pharmaceuticals and Sanofi ’s Kevzara (sarilumab) to treat polymyalgia rheumatica (PMR) in adult patients. Kevzara has been approved as the first and only biologic indicated for PMR adult patients who did not respond to corticosteroids or who cannot tolerate corticosteroid taper.

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Bio Pharma Dive

MARCH 1, 2023

At a time when many startups have struggled to gain cash, the biotech has raised another $135 million to back its research, a new twist on genetic medicine.

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NPR Health - Shots

MARCH 1, 2023

Depending on where they lived, demands for repayment can drain the assets that a patient on Medicaid leaves behind after they die. Iowa aggressively collects "clawback" funds.

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STAT News

MARCH 2, 2023

The costs of obesity are projected to soar globally, in step with rising prevalence, according to a new report from the World Obesity Federation, the only group focused solely on tracking global obesity trends and a partner of the World Health Organization. Over half the world’s population will be either overweight or have obesity by 2035, the report projected, while the economic impact of a high BMI could reach $4.32 trillion annually, if current trends continue and policy inertia around

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Pharmaceutical Technology

MARCH 2, 2023

Merck has reported an increase in group net sales by 12.9% to €22.23bn in fiscal 2022 against €19.68bn in 2021. The growth in sales was driven by all regions and business sectors, particularly Life Science. Organically, the company generated an increase of 6.4% in group sales in fiscal 2022. Favourable foreign exchange effects of 6.1% resulted primarily from the development of the US dollar and the Chinese renminbi.

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Bio Pharma Dive

MARCH 2, 2023

The announcement, which follows recent regulatory setbacks for some of Intellia’s peers, is a “big win” for the gene editing field, according to one analyst.

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NPR Health - Shots

MARCH 1, 2023

Millions of people who depend on the Supplemental Nutrition Assistance Program known as SNAP will see a cut of $90 a month or more. Some recipients say it will make it harder to buy healthy food.

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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

Fierce Pharma

FEBRUARY 28, 2023

FDA turns down Cytokinetics’ once-promising heart failure drug omecamtiv kdunleavy Tue, 02/28/2023 - 18:55

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Pharmaceutical Technology

FEBRUARY 28, 2023

Breakthroughs in therapies containing monoclonal antibodies (mAbs) are showing ever-greater potential in treating a range of diseases, alongside biopharma manufacturers facing the challenge of keeping up with demand for production while controlling costs. At the height of the global pandemic, mAb therapies attracted headlines from their use in the fight against Covid-19, where they were used for the effective treatment of hospitalised patients suffering from the disease.

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Bio Pharma Dive

FEBRUARY 28, 2023

Aptinyx has joined a lengthy list of drugmakers looking to cut costs and explore strategic options after hitting setbacks in key clinical studies.

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NPR Health - Shots

FEBRUARY 28, 2023

Two U.S. intelligence agencies reportedly support the lab leak theory — with low-to-moderate confidence. No evidence has been shared. Scientists have strong evidence of animal spillover at a market.

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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 28, 2023

Welcome to STAT Madness, a bracket-style contest to find the best innovation in science and medicine. Click on each matchup for a short summary of each school’s pioneering research. Then pick your favorites. Help us crown a champ!

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Pharmaceutical Technology

FEBRUARY 28, 2023

The prevalence of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) continues to increase, compounded by risk factors such as advanced age, obesity, ethnicity, and type 2 diabetes mellitus (T2DM). As NAFLD progresses to NASH, the same factors also contribute to liver fibrogenesis (abnormal accumulation of fibrous tissue).

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Bio Pharma Dive

MARCH 3, 2023

An experimental medicine from Praxis Precision Medicines missed the main goal of a Phase 2b trial. But there were also some positive findings, which have encouraged the company to press forward.

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Medicine Trials Drugs 290

NPR Health - Shots

FEBRUARY 28, 2023

Billing experts and lawmakers are playing catch-up as providers get around new consumer protections, leaving patients like Danielle Laskey of Washington state with big bills for emergency care.

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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

Medical Xpress

FEBRUARY 25, 2023

Substance use disorder (SUD) is an extremely difficult disorder to overcome, and many individuals with SUD return to regular use after repeated attempts to quit.

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Pharmaceutical Technology

MARCH 1, 2023

Venture financing for early-stage innovator drugs for biotech companies based in the Asia-Pacific (APAC) region between 2018 to 2022 received three times less funding, at $23bn, than their US counterparts, at $72bn, according to GlobalData’s Pharma Intelligence Centre Deals Database. Although both regions experienced a surge in deal value and volume for early-stage venture financing for innovator drugs from 2020 to 2021, inflation and geopolitical factors such as the Russia-Ukraine war impacted

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Bio Pharma Dive

MARCH 1, 2023

The pharma company, along with its diabetes drug rivals Novo Nordisk and Sanofi, has long been under pressure over the high cost of insulin — scrutiny that has recently ramped up in the U.S.

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NPR Health - Shots

FEBRUARY 27, 2023

The federal agency that oversees Medicaid suggested Idaho wasn't trying hard enough to reach beneficiaries before letting their coverage lapse. Consumer advocates fear that could happen again.

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Pharma Times

FEBRUARY 28, 2023

Research into modified RNA messages could help treat diseases and develop new therapies

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Pharmaceutical Technology

FEBRUARY 28, 2023

KFA-115 is under clinical development by Novartis and currently in Phase I for Melanoma. According to GlobalData, Phase I drugs for Melanoma have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how KFA-115’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Bio Pharma Dive

FEBRUARY 27, 2023

Citing people familiar with the talks, The Wall Street Journal reported over the weekend that Pfizer is trying to acquire Seagen and its suite of cancer therapies in a deal that could be worth more than $30 billion.

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NPR Health - Shots

MARCH 3, 2023

Florida health officials are investigating the death and urging people to take precautions. Here's what to know if you're planning on breaking out your neti pot or swimming in a lake anytime soon.

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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