Wed.Feb 21, 2024

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NEJM paper fills in details on ‘remarkable’ CAR-T result in autoimmune disease

Bio Pharma Dive

The full results spotlight cell therapy’s potential to treat lupus and other inflammatory conditions, but also the problems drug developers must solve first.

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Would You Recognize a Seizure? Here’s How to Help as a Bystander.

AuroBlog - Aurous Healthcare Clinical Trials blog

Approximately 1 in 26 people develop epilepsy, a condition in which someone experiences recurring and unprovoked seizures. But experiencing a seizure does not always mean a person has epilepsy. Seizures can be provoked by acute head injuries, alcohol withdrawal and high blood sugar, among other things.

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Behind the new kind of cell therapy that just won FDA approval

Bio Pharma Dive

One expert views Amtagvi’s approval as a catalyst for further investment in TIL therapies, akin to how Kymriah’s 2017 clearance buoyed CAR-T treatment.

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Will smart tech revolutionise drug delivery for ulcerative colitis patients?

Pharmaceutical Technology

Biora’s new smart pill represents a new treatment modality that may increase the efficacy of therapeutics for ulcerative colitis

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Running Decentralized Trials at Scale: Planning for Success

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.

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Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Worldwide Clinical Trials

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure.

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United Therapeutics, in unusual step, sues FDA over rival’s drug application

Bio Pharma Dive

The biotech alleges that the agency is letting competitor Liquidia sidestep the rules by accepting an amendment to an application that’s involved in a patent dispute.

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More Trending

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Vir, in midst of restructuring, loses its chief medical officer

Bio Pharma Dive

The departure of Phil Pang, who played a key role in developing Vir’s COVID-19 antibody, comes amid a broader company restructuring.

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Elicio’s vaccine shows promise as potential cancer treatment in phase 1 trial

Pharma Times

Results showed robust responses in patients with pancreatic and colorectal cancer

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Bavarian Nordic terminates cancer vaccine work

Bio Pharma Dive

The Danish company scrapped a vaccine in Phase 1 testing and will exit oncology altogether, focusing instead on infectious disease research.

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Researchers launch global iSPY network to research Strep A infections

Pharma Times

A streptococcal bacterial infections are estimated to affect around 50 million people worldwide

Research 134
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2022 Research: The Rapid Rise of Ocean Freight Visibility

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.

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Bavarian Nordic’s revenue soars post-mpox outbreaks

Pharmaceutical Technology

Bavarian Nordic reported a preliminary revenue of $1bn for 2023, driven by sales of JYNNEOS, its moneypox/smallpox vaccine.

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February 21, 2024: In This Week’s PCT Grand Rounds, Virtual Monitoring in Decentralized Clinical Trials

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Adrian Hernandez and Christopher Lindsell of Duke University will present “Virtual Vigilance: Monitoring of Decentralized Clinical Trials.” The Grand Rounds session will be held on Friday, February 23, 2024, at 1:00 pm eastern. Hernandez is the executive director of the Duke Clinical Research Institute (DCRI) and professor of medicine and vice dean in the Duke University School of Medicine.

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MHRA bans OTC sale of codeine after recreational abuse reports

Pharmaceutical Technology

Codeine linctus has been reclassified from a pharmacy-only medicine to a prescription-only medicine in the UK.

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Clinical research is about trial and error

pharmaphorum

Clinical research involves trial and error as part of the drug development process. Learn more about how to optimise drug trials and the important role of participants in clinical research.

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

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

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PepGen earns FDA fast track designation for myotonic dystrophy type 1 candidate

Pharmaceutical Technology

A Phase I trial studying the therapy is underway after an FDA clinical hold was lifted last year, with initial data expected in 2024.

Trials 130
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The evolution of clinical research: embracing new delivery models in the UK

pharmaphorum

Explore the evolution of clinical research in the UK, including the role of NIHR and Direct Delivery Teams in embracing new delivery models. Join our informative webinar to learn more.

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Polpharma looks to challenge Takeda’s Entyvio in IBD

Pharmaceutical Technology

Polpharma’s biosimilar candidate PB106 showed non-inferiority to the reference therapy Takeda’s Entyvo in a Phase III trial.

Trials 130
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Novavax dodges COVID vaccine refund by settling Gavi arbitration for up to $400M

Fierce Pharma

On the heels of a turbulent 2023 in which Novavax’s very existence was at stake, the beleaguered vaccine maker has new reason to be optimistic about the future. | Novavax has reached a settlement with Gavi, the Vaccine Alliance ending arbitration tied to a 2021 advance purchase agreement around its prototype COVID-19 vaccine NVX-CoV2373. Had Novavax lost the arbitration, the company might have had to refund nearly $700 million.

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Genezen to license CSL’s lentiviral vector production system

Pharmaceutical Technology

Contract development and manufacturing organisation Genezen has announced plans to license CSL’s Cytegrity lentivirus production system.

Licensing 130
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Long-Acting Injectable Cabenuva Found More Effective Than Daily ART at Suppressing HIV in Patients With Adherence Challenges

Pharmaceutical Commerce

Cabenuva (cabotegravir + rilpivirine) showed superior efficacy in maintaining viral load suppression in patients with HIV compared with standard of care daily oral antiretroviral treatment.

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WuXi ATU gains approval for Amtagvi manufacturing at US site

Pharmaceutical Technology

WuXi ATU received FDA approval to commence the analytical examination and production of Iovance’s Amtagvi at its Philadelphia site.

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Mobile ADHD awareness game launches in Germany

pharmaphorum

Attention-deficit hyperactivity disorder (ADHD) in adults is not well understood and highly underdiagnosed, but the developers of a mobile game designed to raise awareness hope to shine a light on the struggles of people struggling with the condition.

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FDA approves new dose regimen for J&J multiple myeloma treatment

Pharmaceutical Technology

The US FDA has approved Johnson & Johnson’s (J&J) reduced dosing frequency of TECVAYLI for relapsed or refractory multiple myeloma.

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United sues FDA to try to block rival’s drug application

pharmaphorum

United sues FDA for allowing a marketing application for a competitor to its top-seller Tyvaso, filed by Liquidia, that sidesteps established procedures

Drugs 111
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BMS’ KRAZATI sNDA to treat colorectal cancer gains priority review

Pharmaceutical Technology

Bristol Myers Squibb (BMS) reported FDA acceptance of the sNDA for KRAZATI plus cetuximab to treat colorectal cancer for priority review.

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Digital health firms DarioHealth and Twill merge

pharmaphorum

DarioHealth has bought fellow digital health company Twill in a move that combines their chronic disease and mental health platforms.

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From Prinicpal to Univo IRB, Julie Blasingim on a mission to revolutionize research ethics

Outsourcing Pharma

This week Univo IRB was announced as the new company name for Principal IRB.

Research 105
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Biologics Development in Immunology and Inflammation — Featuring Amir Reichman, CEO of Scinai Immunotherapeutics – Xtalks Life Science Podcast Ep. 147

XTalks

This episode features an interview with Amir Reichman, CEO of Scinai Immunotherapeutics , a biopharma company focused on developing cutting-edge biological treatments within the inflammation and immunology (I&I) sector, with a primary focus on addressing autoimmune and infectious diseases. Scinai Immunotherapeutics is working on developing nanosized antibodies from alpacas, known as VHH-antibodies or NanoAbs, which show promise as improved biological therapies for various illnesses.

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RAPT hit by FDA clinical hold on eczema, asthma drug

pharmaphorum

RAPT Therapeutics shares fell sharply after the FDA placed a clinical hold on oral CCR4 antagonist zelnecirnon in atopic dermatitis and asthma.

Drugs 105
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Novo Nordisk, Eli Lilly lead industrywide sales surge in Q4

Fierce Pharma

In a year that started with more than two-thirds of biopharma companies posting | While Novo Nordisk and Eli Lilly continued to be the biopharma industry growth leaders in the fourth quarter of 2023, many other drugmakers also delivered big gains, including Daiichi Sankyo, Amgen, Teva, GSK and Novartis.

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Psilocybin by Filament Health for Treatment Resistant Depression: Likelihood of Approval

Pharmaceutical Technology

Psilocybin is under clinical development by Filament Health and currently in Phase I for Treatment Resistant Depression.

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Surprise! Thanks to the IRA, Part D Plans Will Prefer High-List, High-Rebate Drugs

Drug Channels

Like many of you, I have believed that the Inflation Reduction Act of 2022 (IRA) will encourage Medicare Part D plans to adopt low-list-price products over their high-list/high-rebate counterparts, thereby popping the gross-to-net bubble. Actually, maybe not. Below, I explain why the IRA will encourage Part D plans to prefer high-list, high-rebate specialty drugs , even as the government and manufacturers will prefer a low-list-price version.

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Squaric acid dibutyl ester by Squarex Pharmaceutical for Herpes Labialis (Oral Herpes): Likelihood of Approval

Pharmaceutical Technology

Squaric acid dibutyl ester is under clinical development by Squarex Pharmaceutical and currently in Phase I for Herpes Labialis (Oral Herpes).

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Novo, Novartis, BMS and J&J win judge's blessing to combine arguments in upcoming IRA hearing

Fierce Pharma

Four major drugmakers are joining forces as they prepare to battle certain aspects of the Inflation Reduction Act (IRA) in court next month. | A federal judge in New Jersey agreed to let Bristol Myers Squibb, Novo Nordisk, Novartis and J&J present oral arguments together in their bid to challenge the government's new Medicare negotiations framework.

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