FDA Law Blog

MARCH 13, 2023

By Larry J. Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision ab

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Bio Pharma Dive

MARCH 14, 2023

“A generation of founders is now scarred,” one biotech CEO said, as small drugmakers grapple with the longer-lasting effects of SVB’s stunning collapse.

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Containment 312

Pharmaceutical Technology

MARCH 14, 2023

The National Health Surveillance Agency (ANVISA) in Brazil has granted approval for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003). The vaccine has received approval for preventing dengue disease in people aged four years to 60 years. Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes and is designed to provide protection against any of these.

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Rethinking Clinical Trials

MARCH 15, 2023

IMPACt-LBP, an NIH Pragmatic Trials Collaboratory Demonstration Project, enrolled its first study participant this week. Congratulations to the IMPACt-LBP study team for reaching this important project milestone! Dr. Christine Goertz, Dr. Adam Goode, Dr. Jon Lurie, and Dr. Rishi Chakraborty Co-led by investigators at Duke University and Dartmouth University, IMPACt-LBP is a cluster randomized trial of a multidisciplinary collaborative team approach for low back pain versus usual care.

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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

NPR Health - Shots

MARCH 14, 2023

Researchers say Mexican pharmacies that cater to U.S. tourists and medical travelers are selling medications that look safe but are laced with deadly fentanyl and methamphetamines.

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Bio Pharma Dive

MARCH 17, 2023

The regulator will convene a panel of advisers to consult on an approval decision for the biotech’s Duchenne treatment, a change from just a few weeks ago when Sarepta had said a meeting wouldn’t be held.

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STAT News

MARCH 13, 2023

An algorithm, not a doctor, predicted a rapid recovery for Frances Walter, an 85-year-old Wisconsin woman with a shattered left shoulder and an allergy to pain medicine. In 16.6 days, it estimated, she would be ready to leave her nursing home. On the 17th day, her Medicare Advantage insurer, Security Health Plan, followed the algorithm and cut off payment for her care, concluding she was ready to return to the apartment where she lived alone.

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NPR Health - Shots

MARCH 16, 2023

A Mississippi woman's life has been transformed by a treatment for sickle cell disease with the gene-editing technique CRISPR. All her symptoms from a disease once thought incurable have disappeared.

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Bio Pharma Dive

MARCH 15, 2023

Novartis joined venture investor Sofinnova in leading an $85 million investment in the startup that also involved Pfizer, Eli Lilly and Bristol Myers Squibb.

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Pharmaceutical Technology

MARCH 16, 2023

Talem Therapeutics, a subsidiary of Immunoprecise Antibodies, has entered a multi-target artificial intelligence (AI)-driven antibody discovery collaboration with Libera Bio. The partnership will use nanotechnology, which was proven in vivo, for providing antibodies inside tumour cells and provides a potential solution to address the medical challenge.

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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

STAT News

MARCH 17, 2023

ST. LOUIS — It’s been eight months since Kirsten Bibbins-Domingo, a general internist, cardiovascular researcher, and epidemiologist became the 17th editor in chief of the Journal of the American Medical Association and its network of journals. Bibbins-Domingo, who previously worked at the University of California, San Francisco, was named this week as a member of the 2023 STATUS List of people making a difference in health care and life sciences.

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NPR Health - Shots

MARCH 11, 2023

A bipartisan group of senators wants to make daylight saving time permanent. But sleep experts say standard time is better, because it saves morning light and is more in sync with our natural rhythms.

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Bio Pharma Dive

MARCH 13, 2023

The bank’s failure caused some companies to question whether they could pay employees, while forcing many others to take steps to calm nervous investors.

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Pharmaceutical Technology

MARCH 17, 2023

The Lung Cancer Research Foundation (LCRF) has announced a new research partnership with Daiichi Sankyo and AstraZeneca. This collaboration is intended to fund up to three research grants that are focused on antibody-drug conjugates (ADCs) for improving the outcomes for lung cancer patients. ADCs are designed for targeting cancer cells specifically and selectively provide a highly potent payload that may limit healthy cells’ damage.

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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

MARCH 15, 2023

In the summer and fall of 2021, West Nile virus spread rapidly through Arizona’s Maricopa County and other areas of the state. The outbreak, with more than 1,700 cases reported and 127 deaths. was the largest in the United States since the mosquito-borne virus first emerged in this country in 1999. But with the nation facing a far larger public health crisis with the Covid-19 pandemic, it went almost unnoticed.

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NPR Health - Shots

MARCH 15, 2023

After years of high rates, the country hit a new high during the pandemic, far exceeding rates in other developed nations. Black women are at especially high risk.

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Development 145

Bio Pharma Dive

MARCH 15, 2023

Tang Capital’s Concentra Biosciences is offering Jounce investors a competing bid to the biotech’s planned reverse merger with Redx Pharma.

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Pharmaceutical Technology

MARCH 16, 2023

Global biopharmaceutical firm UCB has entered an early drug discovery collaboration with Aitia. The collaboration is aimed at discovering and validating new drug targets and drug candidates that are linked to clinical endpoints causally in Huntington’s disease, a debilitating genetic disorder. It will combine the use of new drug targets for Huntington’s disease from Aitia’s Gemini Digital Twins with the expertise of UCB in preclinical model systems and drug research in neurodeg

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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 17, 2023

Around 4:30 p.m. last Friday, Ketamine Wellness Centers CEO Kevin Nicholson sent an email: In 30 minutes, the company would no longer be in business, he said. The message went out to some patients and to all of the employees of his company’s clinics across nine states — what had, up until moments before, been one of the largest ketamine clinic chains in the country.

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NPR Health - Shots

MARCH 12, 2023

Law enforcement organizations are promoting a new film about children being exploited into sharing sexual images and videos. But many of the film's key claims lack context.

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Bio Pharma Dive

MARCH 14, 2023

Responding to policy changes and pressure over high drug costs, the pharma is reducing the sticker price of four branded diabetes medicines by up to 75%.

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Medical Xpress

MARCH 16, 2023

In science, findings generated from studying small animals often are generalized and applied to humans, which are orders of magnitude larger. New research, which was led by Shirley Ryan AbilityLab and is published in the Journal of Physiology, not only is the first to directly measure human muscle contractile properties; it also is the first to show that extrapolating such information to humans based on animal measurements generates incorrect predictions.

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Research 105

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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

STAT News

MARCH 17, 2023

Moderna CEO Stéphane Bancel is starting to reap gargantuan gains from the stock he first got when he started with the company a decade ago, although nearly all of this chunk of his fortune remains earmarked for unknown charities. Bancel made $398 million in 2022 based on the actual realized gains of stock that was exercised and sold, according to STAT’s calculations from Moderna’s annual compensation disclosure filed this week.

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NPR Health - Shots

MARCH 14, 2023

The Danish drugmaker's move follows a similar announcement by rival Eli Lilly earlier this month. More than 8 million Americans use insulin, according to the American Diabetes Association.

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Insulin 131

Bio Pharma Dive

MARCH 14, 2023

The agency’s decision on Eisai and Biogen’s new drug contrasts with a stringent Medicare policy that limits coverage to patients in clinical trials.

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Medical Xpress

MARCH 16, 2023

Elite male soccer players were 1.5 times more likely to develop neurodegenerative disease than population controls, according to an observational study published in The Lancet Public Health journal.

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Development 105

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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

MARCH 16, 2023

Are you six months out from your Covid-19 bivalent booster and wondering when you’ll be able to get another shot? If you live in the United Kingdom or Canada, you already have your answer. The Canadian and U.K. governments, acting on recommendations from expert committees, plan to offer spring booster shots for people at highest risk of getting severely sick from Covid.

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NPR Health - Shots

MARCH 13, 2023

New evidence shows bempedoic acid works to lower cholesterol and reduce the risk of heart attacks, without the muscle pain that some people suffer when taking statins. (Image credit: Digital Vision.

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Bio Pharma Dive

MARCH 14, 2023

The regulator’s review of the planned $43 billion deal could reveal how it plans to apply a new philosophy toward drugmaker mergers.

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Medical Xpress

MARCH 17, 2023

A study examining the mental health-oral health association cross-sectionally and longitudinally was presented at the 52nd Annual Meeting & Exhibition of the AADOCR, held in conjunction with the 47th Annual Meeting of the CADR. The AADOCR/CADR Annual Meeting & Exhibition took place at the Oregon Convention Center in Portland on March 15-18, 2023.

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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.

Clinical Trials