FDA Law Blog

MARCH 29, 2023

By Kalie E. Richardson — Early on March 29, 2023, FDA announced the landmark approval of Narcan (naloxone hydrochloride) Nasal Spray for use as a nonprescription opioid overdose reversal agent. I previously blogged on the February 15, 2023 Joint Meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) which unanimously agreed that the benefit-risk profile of Narcan Nasal Spray (NNS) is “supportive of its use as a n

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Bio Pharma Dive

MARCH 27, 2023

Not getting traction with your patient services program? Here’s why and what to do about it.

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Pharmaceutical Technology

MARCH 31, 2023

The European Medicines Agency (EMA) has recommended HIPRA’s Covid-19 vaccine , Bimervax, as a Covid-19 booster. Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March. Bimervax is a recombinant protein subunit vaccine, marketed by the Girona, Spain-based Hipra.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 27, 2023

It comes down to discipline. That’s according to MIT Professor Li-Huei Tsai, a neuroscientist who focuses on diseases like Alzheimer’s and directs The Picower Institute for Learning and Memory. She told Insider that the keys to maintaining healthy brain function and memory as you age are no secret.

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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

STAT News

MARCH 30, 2023

New evidence of the spillover of the avian flu virus, known as H5N1, to some mammals is again raising alarm bells, though for experts familiar with the virus, “ none of them ever stopped worrying about H5N1.” The recent death of a Cambodian girl from bird flu is a reminder that much is at stake. If H5N1 were to cross over to humans and ignite another pandemic, could the United States do it all over again?

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Bio Pharma Dive

MARCH 27, 2023

The medicine, a personalized stem cell treatment, will be reviewed by an FDA advisory committee sometime in the future, the company said.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 26, 2023

The Indian Council of Medical Research (ICMR) has released the draft consensus document for management of urinary bladder cancer.

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NPR Health - Shots

MARCH 31, 2023

A pediatric surgeon and his colleagues at Vanderbilt University Medical Center had prepared for a mass casualty event, but the victims of Monday's shooting had already died by the time they arrived.

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Bio Pharma Dive

MARCH 30, 2023

The veteran pharmaceutical executive was J&J’s head of R&D until his departure last August. He’s agreed to run FogPharma, a richly funded startup, and take over for founder Greg Verdine.

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Pharmaceutical Technology

MARCH 29, 2023

Viking Therapeutics has announced the start of a Phase I clinical study to evaluate its dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist VK2735. The trial, which is investigating healthy adults with a minimum body mass index of 30 kg/m2, will see VK2735 administered as an oral tablet once daily for 28 days.

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Clinical Supply

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 27, 2023

Eyestem will be submitting data for approval of phase 2a first-in-human study for its product named as Eyesight RPE to the Drugs Controller General of India (DCGI) for dry age-related macular degeneration (AMD).

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STAT News

MARCH 29, 2023

The Marburg outbreak in Equatorial Guinea continues to grow, the World Health Organization said Wednesday, as the global health agency stated that it knows of confirmed cases that the country has not yet reported. To date Equatorial Guinea has acknowledged nine laboratory-confirmed cases, seven of whom have died. In addition, 20 other people with links to the confirmed cases died without being tested; they are considered probable cases.

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Bio Pharma Dive

MARCH 27, 2023

A closely watched meeting showed the FDA’s own external advisers think that effects on this protein, known as neurofilament, could be enough to warrant conditional approval of certain drugs.

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Pharmaceutical Technology

MARCH 29, 2023

Regeneron Pharmaceuticals has collaborated with Sonoma Biotherapeutics to discover, develop and commercialise new regulatory T cell (Treg) therapies for autoimmune diseases. The partnership will combine the VelociSuite technologies of Regeneron with Sonoma Biotherapeutics’ pioneering approach to develop and produce gene modified Treg cell therapies.

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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

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 29, 2023

Indian healthcare providers and pharma companies pace up their efforts with early detection and research for new medicines to combat the spread of tuberculosis as drug resistance concerns emerge. TB is a significant public health threat, with an estimated 10 million annual cases. India shares the highest TB burden with 2.69 million cases and 4.

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NPR Health - Shots

MARCH 25, 2023

A decade after a landmark report on Americans' shorter lives, the problem has only gotten worse. Unlike other wealthy nations, U.S. life expectancy has not bounced back from the pandemic.

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Bio Pharma Dive

MARCH 28, 2023

The biotech is working on a dual-acting weight loss treatment that could compete with medicines from Novo Nordisk, Eli Lilly and others.

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Pharmaceutical Technology

MARCH 28, 2023

Vertex Pharmaceuticals has signed a new non-exclusive licensing agreement with CRISPR Therapeutics to expedite the development of its hypoimmune cell therapies to treat type 1 diabetes (T1D). Under the terms of the deal, the company will receive non-exclusive rights to CRISPR/Cas9, a gene-editing technology of CRISPR Therapeutics, for the development of potentially curative T1D cell therapies.

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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

MARCH 28, 2023

Indian pharma is now accelerating its pace towards interdisciplinary research for medicines to combat diseases. In this regard several collaborations for the integration of knowledge from different academic disciplines to address common complex problems that cannot be solved by any individual researcher from a single area of research are already underway.

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NPR Health - Shots

MARCH 31, 2023

The first outbreak this year was in Equatorial Guinea, which has seen 20 deaths already. Now there are cases reported in Tanzania as well for this infectious disease with a high fatality rate.

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Bio Pharma Dive

MARCH 31, 2023

After revising its calculations, CMS removed Gilead’s cancer cell therapies Yescarta and Tecartus, as well as 5 other medicines, from the first set of drugs subject to rebates under a provision of the IRA.

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Pharmaceutical Technology

MARCH 30, 2023

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research and the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) have launched the Lupus Research Alliance (LRA) in a bid to advance research for the condition. Lupus is a potentially life-threatening autoimmune disorder that disproportionately impacts women and communities of colour.

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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

STAT News

MARCH 28, 2023

A panel of experts that advises the World Health Organization on vaccine use suggested Tuesday that countries no longer need to consider offering additional Covid-19 boosters to people at medium or low risk of becoming seriously ill if they contract the SARS-CoV-2 virus. The Strategic Advisory Group of Experts on Immunization — which is known as the SAGE — said some countries may continue to offer boosters to people at medium and low risk, but those decisions should be made ba

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NPR Health - Shots

MARCH 30, 2023

Built largely with Western donations, the spa-like retreat provides soldiers with counseling, aromatherapy and more. But most soldiers are there for no more than a week.

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Bio Pharma Dive

MARCH 28, 2023

The pharma aims to use Bicycle's drugmaking technology to explore new ways of making the targeted radiation treatments.

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Pharma Times

MARCH 31, 2023

Collaboration comes after renewed focus on key therapeutic areas of immunology and oncology

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Clinical Supply

STAT News

MARCH 28, 2023

In the doctor’s offices of the future, artificial intelligence will be a fly on the wall, listening in and logging the sensitive conversations that happen every day between patients and their doctors. Gone will be the distracted doctor hunched over a keyboard, tapping, clicking, constantly playing catch-up with hours of extra work. That’s the vision pitched by a spate of new startups and major tech companies like Microsoft, which one year ago spent over $19 billion to acquire Nuanc

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Pharmaceutical Technology

MARCH 31, 2023

On March 30, ViiV Healthcare and Medicines Patent Pool (MPP), announced sublicensing agreements with the pharma manufacturers Aurobindo , Cipla and Viatris to produce generic forms of the long-acting cabotegravir used as pre-exposure prophylaxis (PrEP) for HIV. According to a press release, the selected pharma companies will be allowed to produce long acting cabotegravir in 90 countries.

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Bio Pharma Dive

MARCH 27, 2023

The former venture arm of GSK had several of its portfolio companies get acquired or go public in the past year, overcoming a tough environment for young biotechs.

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Rethinking Clinical Trials

MARCH 29, 2023

In this Friday’s PCT Grand Rounds, Jody Cioliono will present “Efficacy and Safety of a Quadruple Ultra-Low-Dose Treatment for Hypertension (QUARTET USA): Results From a Randomized Controlled Trial.” The Grand Rounds session will be held on Friday, March 31, 2023, at 1:00 pm eastern. The QUARTET USA trial tested a novel approach to lowering blood pressure compared with standard-dose monotherapy.

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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