February, 2023

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J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries

Fierce Pharma

J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries mbayer Fri, 02/03/2023 - 09:29

Pharma 363
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GoodRx Illegally Sold Users’ Data to Google & Facebook, FTC Says

MedCity News

GoodRx failed to notify users that it sold their personal health information to Google, Facebook and other tech companies, the FTC claimed. The agency filed an order that prohibits GoodRx from sharing its users’ data with third parties for advertising purposes and requires the company to pay a $1.5 million penalty. GoodRx agreed to pay the settlement but did not admit to wrongdoing.

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Medicinal cannabis: the route to good manufacturing practice registration

European Pharmaceutical Review

The UK medicinal cannabis sector has witnessed important regulatory advances in recent years. After the substance became legal in the UK in 2018, pharmaceutical companies have faced numerous obstacles to attain a fairer position in the industry. Crucially, January 2023 marked a key moment: the Medicines and Healthcare products Regulatory Agency (MHRA) granted Celadon Pharmaceuticals the first good manufacturing practice (GMP) registration since legalisation in 2018 for high Δ9-tetrahydrocannabin

Medicine 128
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Tiny Patch for Cardiac Ultrasound Imaging

Medgadget

Engineers at the University of California San Diego have developed a wearable ultrasound system for cardiac imaging. The postage stamp-sized patch can be worn on the skin of the chest and uses AI and ultrasound waves to perform advanced imaging of the heart. The technology can even be worn to perform cardiac ultrasound imaging during exercise. Each patch can be worn for up to 24 hours, and provides information on how much blood the heart is pumping, a key metric in detecting and appraising a var

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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HIV vaccines suffer setbacks but new approaches could turn the tide

Pharmaceutical Technology

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections. This marks the second time one of Janssen’s HIV vaccines failed after another showed disappointing results in the Phase IIb Imbokodo trial in August 2021.

Medicine 117
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ChatGPT AI-Generated Content Dangerous for Healthcare?

Healthcare Success

ChatGPT is an artificial intelligence chatbot that can have human-like conversations, translate, and provide users with information. It can also write good content. Like, really good. And now that Google has openly stated, “Appropriate use of AI or automation is not against our guidelines,” it begs the question: Should we use it to produce healthcare content?

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Healthcare is Moving to the Home. Are Health Plans Ready?

MedCity News

The future of healthcare means more home-based care. By taking steps now to embrace this shift, health plans will set the pace for supporting patients in the place where they most want to receive care.

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First successful CAR-T treatment for muscle inflammation

European Pharmaceutical Review

University Hospital Erlangen in Germany is the first in the world to use chimeric antigen receptor (CAR) T-cells to successfully treat a patient suffering from a severe case of muscle inflammation (myositis). The researchers noted that risk of developing a very severe form of the autoimmune inflammatory disease is high. The patient who received the CAR T treatment was diagnosed with anti-synthetase syndrome.

Medicine 128
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3D Bioengineered Skin Grafts Fit Complex Anatomy

Medgadget

Researchers at Columbia University’s Irving Medical Center have developed a method to create three-dimensional bioengineered skin grafts. To date, bioengineered skin is typically created in flat sheets. However, these are difficult to fit to complex anatomy, such as the hand, and so these researchers have designed a more sophisticated technique that combines laser scanning, 3D printing, and cell culture to create seamless three dimensional skin grafts.

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GenScript ProBio and RVAC partner for Covid-19 vaccine pDNA

Pharmaceutical Technology

GenScript ProBio has announced a strategic collaboration with RVAC Medicines to manufacture GMP-grade plasmid DNA (pDNA) for the latter’s RVM-V001, an mRNA Covid-19 vaccine candidate. Under the agreement, GenScript ProBio will offer GMP plasmid manufacturing service for the RVM-V001 programme. This collaboration is expected to help expedite the clinical manufacturing of RVM-V001 and future mRNA-based vaccines that target infectious diseases such as Clostriodioides difficile infection (CDI) and R

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How Machine Learning Drives Clinical Trial Efficiency

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.

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What the latest DEA Proposed Rule Means for Telemedicine Prescribing of Controlled Substances

Nixon Gwilt Law

Late Friday (February 24, 2023), the US Drug Enforcement Agency (DEA) released a proposed rule to make permanent some of the flexibilities allowed during the Public Health Emergency (PHE) for telemedicine companies whose providers prescribe controlled substances. Keep reading this timely post to find out: What these proposed changes are; How they will impact your telemedicine business; and Where (and how) stakeholders can weigh in on the DEA’s proposal in the 30-day comment period.

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GSK was warned repeatedly about Zantac impurity but played down risks: Bloomberg

Fierce Pharma

GSK was warned repeatedly about Zantac impurity but played down risks: Bloomberg esagonowsky Wed, 02/15/2023 - 09:02

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All Generations Find Telehealth Beneficial, New CVS Health Data Shows

MedCity News

A new CVS Health survey found that 76% of adults agree that telehealth is more convenient than other healthcare options. Additionally, 75% agree that it is more flexible, 75% believe that it is easier to schedule appointments and 77% said that it is quicker to provide care. The percentages varied slightly by generation, although a vast majority of each age group still said they agreed with these characteristics for telehealth.

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Brian Fox is bringing ‘fresh eyes’ to ad agency Klick

PharmaVoice

Why the recently appointed president of commercial solutions sees near limitless potential to expand Klick’s footprint across the life sciences — and how generative AI is playing a role.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Ingestible Sensor Reveals Gastric Motility

Medgadget

Researchers at MIT have developed an ingestible sensor that can reveal gastrointestinal motility issues, such as gastroparesis and gastroesophageal reflux disease. The technology is intended for use as an easy at-home method to diagnose such issues, which typically require more invasive and inconvenient procedures, such as endoscopy or X-ray imaging.

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4D Molecular’s Fabry gene therapy program on FDA clinical hold

Pharmaceutical Technology

4D Molecular Therapeutics (4DMT), the California-based biotechnology company focused on developing gene therapies for rare and large market diseases, has had the FDA place a clinical hold onto its Fabry disease (FD) gene therapy program (4D-310). 4DMT had paused enrollment of patients to two of its trials for 4D-310 last month following a significant adverse event where three patients experienced kidney issues; however, these were treated and resolved in a four-week period. 4DMT has stated that

FDA 105
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European Pharmaceutical Review Issue 1 2023

European Pharmaceutical Review

Included in this issue of European Pharmaceutical Review : FOREWORD Accelerating drug development David Elder, David P Elder Consultancy RAMAN SPECTROSCOPY Shining a light on Raman for microbiological analysis Tim Sandle, Bio Products Laboratory LIMS Overcoming barriers to capturing data in a laboratory Samantha Kanza, University of Southampton ENVIRONMENTAL MONITORING Endotoxin trends: sustainability, automation and beyond Miriam Guest, AstraZeneca UK REGULATORY INSIGHT UPC opt-out – a strateg

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Pfizer CEO's texts with European Commission chief trigger new NYT lawsuit

Fierce Pharma

Pfizer CEO's texts with European Commission chief trigger new NYT lawsuit kdunleavy Tue, 02/14/2023 - 10:29

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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Healthcare and Gen X: 4 Things Marketers Need to Get Right

MedCity News

Gen X is at the height of its spending potential. Its U.S. population of 65 million has saved a collective $13 trillion and owns 29% of the nation’s household wealth (versus just 6.4% owned by millennials).

Marketing 134
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ReCor Medical Announces Two Concurrent JAMA Network Publications of Study Results on the Paradise Ultrasound Renal Denervation System for the Treatment of Hypertension

Legacy MEDSearch

ReCor Medical, Inc. (“ReCor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced that primary endpoint results from the RADIANCE II pivotal trial were published in the Journal of the American Medical Association (JAMA). Study results showed that the Paradise Ultrasound Renal Denervation (uRDN) System successfully reduced blood pressure compared to sham.

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Wearable Device Senses When Vocal Fatigue Sets in

Medgadget

Researchers at Northwestern University have developed a wearable that can detect when someone is talking or singing, and tallies this information up to provide a warning when the wearer might be at risk of vocal fatigue. Overusing your voice in a short space of time can lead to vocal fatigue and even injury. This technology is useful for patients with vocal disorders, but also for people who rely on their voices a lot, such as singers, politicians, and teachers.

Leads 108
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UK MHRA approves Takeda’s dengue vaccine Qdenga

Pharmaceutical Technology

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]). The vaccine candidate has been approved for active immunisation against the infection in people from four years of age. Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes.

Safety 105
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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Analytical platform could advance mRNA medicine QC

European Pharmaceutical Review

Tokyo researchers have developed a new analytical platform based on liquid chromatography, mass spectrometry and software analysis that quantifies the structure of messenger RNA (mRNA)-based medicines. The method is an important innovation for quality control ( QC) in production lines. The platform can elucidate mRNA sequences while quantifying ‘capping’ at one end of the molecule and the integrity of the tail on the other, all vital in mRNA pharmaceuticals.

Medicine 100
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FDA turns down Cytokinetics’ once-promising heart failure drug omecamtiv

Fierce Pharma

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

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HHS Aims To Reduce Prescription Drug Costs Through 3 New Models

MedCity News

The U.S. Department of Health & Human Services announced three models Tuesday that will be tested by the CMS Innovation Center and aim to lower prescription drug costs. The models, which include access to $2 generic drugs, build on the Inflation Reduction Act of 2022.

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Survey Finds 57% of U.S. Physicians Have Changed Their Perception of a Medication as a Result of Info on Social Media

PharmExec

Sermo and LiveWorld survey of 50+ pharma marketers and 200+ physicians finds that social media plays a major role in influencing perceptions of medications, prescribing Habits, ongoing medical education and professional networking.

Media 98
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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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Automated Feeding Platform to Study Mosquito Disease Transmission

Medgadget

A team at Rice University has developed an automated feeding platform for mosquitoes that allows researchers to test different types of repellent and investigate mosquito-borne disease transmission. Traditionally, such mosquito research would require human volunteers or animal subjects for the mosquitos to feed on, but this is obviously inconvenient and a little distasteful.

Medicine 108
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US FDA approves GSK’s Jesduvroq to treat anaemia of CKD

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). It is claimed to be the only HIF-PHI approved in the country that offers a new oral treatment option for adult patients on dialysis with anaemia of CKD.

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Astellas and Bayer announce management changes

European Pharmaceutical Review

Changes to management for Big Pharma companies Astellas and Bayer AG have been announced for 2023. Astellas Astellas Pharma Inc. has approved changes of its Representative Director, President and CEO and its management structure. Effective April 1, 2023, Naoki Okamura and Kenji Yasukawa will hold the following positions: Naoki Okamura is currently Representative Director, Executive Vice President of Astellas.

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Vertex pricing under fire—again—as activists press 4 governments for Trikafta generics

Fierce Pharma

Vertex pricing under fire—again—as activists press 4 governments for Trikafta generics fkansteiner Tue, 02/07/2023 - 10:08

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.