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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Pharmaceutical Technology

MARCH 16, 2023

Earlier this week, the Florida Senate advanced a bill to restrict gender-affirming care for transgender minors. The bill is one of many that are currently being discussed in different states. Many politicians have cited doubts about the potential “harm” caused by puberty blockers and hormone therapies associated with gender-affirming care and concerns about incorrect treatment as major factors.

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Drugs Hormones Trials FDA Approval 360

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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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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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.

Trials

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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Pharmaceutical Technology

MARCH 17, 2023

As the field of digital therapeutics continues to broaden, specific uses in mental health and neurology are increasingly making headway for patients and on the market. At the same time, experts are saying developers in the field need to double down on securing clinical data to allow for its continued maturation. Companies are testing the use of digital platforms along with pharmacological treatments.

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STAT News

MARCH 16, 2023

Experts have long understood that a new polio vaccine developed to try to minimize the risks associated with the oral polio vaccine made by Albert Sabin might also cause the problem it was created to sidestep. It’s now clear that theoretical risk is a real one. The Global Polio Eradication Initiative announced Thursday that six children in the Democratic Republic of the Congo and one in Burundi have been paralyzed by viruses from the new vaccine, which is referred to as novel oral polio v

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NPR Health - Shots

MARCH 17, 2023

For the first time in decades, Democrats run the show in Michigan, passing legislative priorities they've been after for years: repealing a 1931 abortion law, repealing right-to-work and more.

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Pharmaceutical Technology

MARCH 17, 2023

Pharmanovia and Aeterna Zentaris have entered an exclusive licensing agreement for the latter’s medicine Ghryvelin (macimorelin). Under the deal, Pharmanovia will acquire the exclusive rights and license to commercialise Ghryvelin in the EEA and the UK from Consilient Health. Ghryvelin is used for the diagnosis of Adult Growth Hormone Deficiency (AGHD), a rare and serious condition, as well as for Childhood Onset Growth Hormone Deficiency (CGHD), if approved.

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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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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 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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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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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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Advertiser: FourKites

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

Research

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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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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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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Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

Sales

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 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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Pharmaceutical Technology

MARCH 17, 2023

Over the last twenty years, there has been a major rise in risk sharing agreements in the pharmaceutical space, said Alex Watt, GlobalData’s principal research analyst, at a recent webinar on the same topic. These agreements have been particularly propelled by the recent rise in inflationary pressures and pharmaceutical market instability, pushing healthcare systems to find new ways to reduce risks associated with new drugs.

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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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Advertiser: Aggregage

New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!

Vaccination

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 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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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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Bio Pharma Dive

MARCH 17, 2023

The combination drug didn’t help patients any more than chemotherapy, but Merck will continue the trial to test it together with chemo.

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Trials Drugs 321

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 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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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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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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STAT News

MARCH 17, 2023

The already beleaguered U.S. health care system is facing a new and costly threat that will affect patient care and ultimately may lead to hospital closures : paying for and processing a torrent of medical record requests. While the news media in 2022 focused on hospitals’ billions of dollars of losses , negative operating margins, and other daunting post-pandemic challenges , a set of costly modifications to the HIPAA Privacy Rule proposed by the Department of Health and Human Services m

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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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