Fierce Pharma

SEPTEMBER 29, 2023

After a former human resources officer blew the whistle on alleged manufacturing shortfalls at Eli Lilly’s massive Branchburg, New Jersey, production plant, the parties have been engaged in settlem | After a former human resources officer blew the whistle on alleged manufacturing shortfalls at Eli Lilly’s massive Branchburg, New Jersey, production plant, the parties have been engaged in settlement talks.

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Manufacturing 303

MedCity News

SEPTEMBER 29, 2023

It makes sense that when care navigation prioritizes the patient and better links them to care by reducing barriers and smoothing out the road to seeing a provider, the patient experiences better outcomes. Better outcomes also translates to fewer hospital readmissions, saving money for both patients and their employers.

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Patients 110

Fierce Pharma

SEPTEMBER 29, 2023

After establishing Venclexta as a treatment for chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML), AbbVie and Roche were hoping to demonstrate the med's promise in a subset of mul | Despite the trial missing its primary endpoint of progression-free survival, the companies will soon discuss the "potential favorable trends" with health authorities.

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Medgadget

SEPTEMBER 29, 2023

CraniUS , a medtech company based in Baltimore, has developed the NeuroPASS drug delivery system. The technology is designed to deliver drugs to the brain, and it can bypass the blood-brain barrier. This layer of specialized endothelium significantly restricts which drug molecules can enter the brain, normally greatly limiting treatment options for patients with brain-based disease.

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Medicine Distribution Specialization Medical 106

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Fierce Pharma

SEPTEMBER 29, 2023

A proposed restriction on the use of fluorinated substances in Europe would have an “irredeemable impact” on the continent’s life sciences sector, the European Federation of Pharmaceutical Industri | A proposed restriction on the use of fluorinated substances in Europe would have an “irredeemable impact” on the continent’s life sciences sector, the European Federation of Pharmaceutical Industries and Associations (EFPIA) warns.

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Manufacturing Pharmaceutical 249

MedCity News

SEPTEMBER 29, 2023

Midi Health’s Series A funding round was led by Google Ventures. In total, Midi Health has raised $40 million, including from Felicis, Semper Virens, Icon, 25M and Operator Collective. The company offers virtual care for those going through perimenopause or menopause.

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MedCity News

SEPTEMBER 29, 2023

Preliminary weight loss and safety data for Structure Therapeutics’ drug candidate suggest it’s competitive with other oral GLP-1 targeting contenders from big pharma companies. The data are from a small study and a short time frame, but Structure was able to leverage the encouraging preliminary results into a private placement of securities.

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Competition Safety Pharma Biopharma 105

European Pharmaceutical Review

SEPTEMBER 29, 2023

Janssen Pharmaceutical Companies of Johnson & Johnson’s Phase III MARIPOSA study is the first to show a clinically meaningful benefit in a chemotherapy-free regimen compared to the small molecule treatment TAGRISSO ® ( osimertinib ). This is based on positive topline results for Rybrevant ® (amivantamab-vmjw) in combination with lazertinib, as first-line anti-cancer treatment in locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC).

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Pharmaceutical Safety Patients 104

MedCity News

SEPTEMBER 29, 2023

Right now, manufacturers are thriving. Hospitals are failing. And patients are suffering. We must stop this trend in its tracks by becoming better stewards of hospital resources and supply chains.

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Manufacturing Patients 99

Pharmaceutical Technology

SEPTEMBER 29, 2023

Karuna Therapeutics has announced the submission of a NDA to the FDA for KarXT (xanomeline-trospium) for the treatment of schizophrenia.

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FDA 111

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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.

Safety

European Pharmaceutical Review

SEPTEMBER 29, 2023

A paper published in the IEEE Sensors Journal has demonstrated 100 percent inline pharmaceutical packaging content verification by combining standard diffuse reflectance MOEMS-EC-QCL spectroscopy with artificial intelligence (AI). It described how a quantum cascade laser (QCL)-based blister-verification sensor with verification via backscattering mid-infrared (IR) spectroscopy substance chemical identification can support blistering machines to achieve a better inline content verification.

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Pharmaceutical Medicine Medical 95

Medgadget

SEPTEMBER 29, 2023

Researchers at Pohang University of Science & Technology in South Korea have developed a durable strain sensor that can detect complex body movements. The technology will be useful for patients undergoing physical rehabilitation, allowing physical therapists to assess their movements in significant detail and measure progress. Conventional strain sensors are often affected by heat and humidity, making them less durable as a wearable, and they typically detect only biaxial strain, providing l

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Electronics Manufacturing Patients Medical 94

European Pharmaceutical Review

SEPTEMBER 29, 2023

The US Food and Drug Administration (FDA) has approved Exxua (gepirone hydrochloride extended-release tablets) for adults with major depressive disorder ( MDD ). Oral selective serotonin (5HT) 1a receptor agonist Exxua is the first approved antidepressant with a novel mechanism of action that selectively targets the serotonin 1A receptor, a key regulator of mood and emotion.

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FDA Food and Drug Administration Medicine Food 93

Medgadget

SEPTEMBER 29, 2023

Researchers at Oxford University have developed a tiny battery that can power small implantable devices, such as drug delivery technologies. The new battery is inspired by the ionic gradients that electric eels use to generate electricity. It involves tiny droplets of a conductive hydrogel that are placed near each other. Each droplet has a different ionic concentration, meaning that ions will flow from high concentration droplets to low concentration droplets.

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Networking Safety Medicine Medical 92

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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

Distribution

MedCity News

SEPTEMBER 29, 2023

CEO of Alignment Health joins the Payer’s Place and details how the growth of Medicare Advantage will only help patients in the future.

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Patients Healthcare Healthcare 99

PharmaTimes

SEPTEMBER 29, 2023

FlyPharma Europe is an event for the pharma logistics industry, connecting professionals from across the globe - News - PharmaTimes

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Pharma 99

Pharmaceutical Commerce

SEPTEMBER 29, 2023

A reflection on my time with Pharma Commerce thus far, and a plan of action for moving the brand forward.

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Pharma 104

PharmaTimes

SEPTEMBER 29, 2023

Review raises concerns about approach taken by the DHSC regarding changes to Statutory Scheme - News - PharmaTimes

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Medicine 101

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Safety

Pharmaceutical Technology

SEPTEMBER 29, 2023

At the industry crossroads of healthcare and pharmaceuticals at the Life Sciences Baltics 2023 conference, all signs pointed towards an AI-based future.

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Healthcare Healthcare Pharmaceutical 59

Clarify Health

SEPTEMBER 29, 2023

With an eye toward curbing healthcare costs while improving quality, many organizations are investing in Centers of Excellence (CoEs). Healthcare Centers of Excellence are recognized for their commitment to quality, expertise, and the pursuit of the best possible outcomes for patients. They often play a critical role in advancing medical knowledge and improving patient care in specialized areas of healthcare.

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Networking Healthcare Healthcare Competition 52

Pharmaceutical Technology

SEPTEMBER 29, 2023

India is known as the 'pharmacy of the world', producing a substantial quantity of generic drugs globally. However, its lax regulatory oversight has resulted in persistent drug recalls and scandals that have stained the country’s manufacturing reputation.

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Pharma Manufacturing 52

Legacy MEDSearch

SEPTEMBER 29, 2023

ReGelTec, Inc. , announced that the U.S. Food and Drug Administration has approved an IDE for the company’s pivotal study to support premarket approval of its HYDRAFIL® System. The HYDRAFIL System contains an injectable polymer that is implanted percutaneously via a needle to augment the native disc in a procedure performed under local anesthesia at an outpatient surgery center.

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FDA Food and Drug Administration Recruitment Medical 52

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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.

Specialization

PharmaTech

SEPTEMBER 29, 2023

The contract is part of US Department of Health and Human Services’ ‘Project NextGen’ initiative, aimed at pushing forward new and stronger COVID-19 vaccines and therapies.

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Pharmaceutical Technology

SEPTEMBER 29, 2023

The stem cell startup aims to bolster immune systems of patients born without a thymus or with poor thymic function by restoring T cell development.

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Patients 52

PharmaTech

SEPTEMBER 29, 2023

Under the partnership, Sartorius will leverage SPARTA Biodiscovery’s technology to accelerate development of nanoparticles used for drug delivery.

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Pharmacy Times

SEPTEMBER 29, 2023

Ruben A. Mesa, MD, FACP, discusses the results of the SIMPLIFY-1 and MOMENTUM trials and how the data led to the approval of momelotinib to treat intermediate or high-risk myelofibrosis in adult patients with anemia.

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Leads FDA Patients 58

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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

Leads

Pharmaceutical Technology

SEPTEMBER 29, 2023

Pharmaceutical Technology has listed some of the leading providers of washing, disinfection and sterilisation in the pharmaceutical industry.

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Leads Pharmaceutical 52

Pharmacy Times

SEPTEMBER 29, 2023

The most persuasive reason for industry-academia collaboration is the many opportunities it opens for pharmacy students who may not have considered all the ways they can use their PharmD to serve the cause of humankind.

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Pharmaceutical Technology

SEPTEMBER 29, 2023

BARDA in the US has awarded a $168m Project NextGen grant to ModeX Therapeutics to develop anti-viral therapies.

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Pharmaceutical Commerce

SEPTEMBER 29, 2023

Jason Cook uncovers ways in which pharma companies can plan for weather-related challenges that may arise.

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Pharma 59

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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.

Management