Fierce Pharma

SEPTEMBER 28, 2023

Fabre-Kramer Pharmaceuticals' major depressive disorder (MDD) drug gepirone has been rejected by the FDA not once, not twice, but three times since the turn of the millennium. | Fabre-Kramer's Exxua suffered three prior FDA rejections before scoring an FDA approval for major depressive disorder last week. Its label doesn't include sexual dysfunction as an adverse reaction, which is rare among antidepressants.

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MedCity News

SEPTEMBER 26, 2023

Digital therapeutics will be one of the topics discussed at INVEST Digital Health scheduled for October 26 at Health Wildcatters headquarters in Pegasus Park in Dallas. Register today!

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Medicine 127

Medgadget

SEPTEMBER 26, 2023

Researchers at the University of Texas at Austin have developed an electroencephalogram (EEG) sensor that is incorporated into a virtual reality headset. The technology can measure brain activity while someone is undergoing an immersive virtual reality experience. The device may assist in enhancing medical virtual reality interventions, such as those used to treat post-traumatic stress disorder or phobias, by revealing brain activity during different tasks or experiences that help clinicians to

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Medical 119

Copyright Clearance Center

SEPTEMBER 28, 2023

September 28, 2023 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, announces the availability of AI-disambiguated data and enriched metadata, for researchers and institutions, within RightFind Navigate through a pilot for its customers. CCC also announces several powerful new features of the RightFind Suite.

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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 24, 2023

Syntax Bio’s technology platform uses CRISPR to direct stem cells to become a desired cell type in a process that’s more scalable and less expensive than current methods. The startup is raising a Series A round of financing to further demonstrate the potential of its technology.

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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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Fierce Pharma

SEPTEMBER 25, 2023

More than five years after an initial FDA approval, Novartis is touting positive trial results for its radiotherapy Lutathera as a first-line therapy against the rare cancer that killed Apple co-fo | More than five years after an initial FDA approval, Novartis is touting positive trial results for its radiotherapy Lutathera as a first-line therapy against the rare cancer that killed Apple co-founder Steve Jobs.

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FDA 279

MedCity News

SEPTEMBER 28, 2023

Sanofi dominates the market for therapies that treat Pompe disease, a rare enzyme deficiency. The FDA has approved an Amicus Therapeutics combination treatment for patients inadequately served by the Sanofi products.

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FDA Marketing Patients Biopharma 122

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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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

Medgadget

SEPTEMBER 26, 2023

Researchers at the University of California San Francisco have developed an implantable bioreactor that may pave the way for artificial kidneys. Dialysis and kidney transplants both have significant disadvantages for patients with kidney failure, and so scientists are trying to develop a lab created kidney that would not require harsh immunosuppression or a donor kidney.

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Patients Medicine 105

Fierce Pharma

SEPTEMBER 28, 2023

Slated for an FDA decision last October, Amicus Therapeutics’ Pompe disease bid was foiled by COVID-related travel restrictions. | Slated for an FDA decision last October, Amicus Therapeutics’ Pompe disease bid was foiled by COVID-related travel restrictions. Nearly a year later, the Philadelphia company has gained its long-awaited green light.

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FDA 272

MedCity News

SEPTEMBER 28, 2023

New York, Florida, Texas and Minnesota terminated Medicaid coverage for some enrollees for “unallowable or potentially unallowable reasons” during the Covid-19 public health emergency, according to a recent Office of Inspector General report.

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PharmaVoice

SEPTEMBER 26, 2023

From COTA’s large datasets and AI model assistants to a company guiding patients through cancer care, AI can help — but it’s a long way from human-free.

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Patients 105

Advertiser: ZoomInfo

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

Competition

PharmaTech

SEPTEMBER 28, 2023

Dosage forms are being shaped by numerous factors, with patient-centricity continuing to be an important driver of decisions in development.

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Patients 116

Fierce Pharma

SEPTEMBER 28, 2023

While GLP-1 drugs from Novo Nordisk and Eli Lilly are believed to be relatively free of serious side effects, a few problems have emerged as the treatments have gained wider and longer-term use.

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Side effects FDA 269

MedCity News

SEPTEMBER 26, 2023

Costco is partnering with Sesame to offer Costco Members discounted pricing on virtual health services, including primary care and mental health. But the move is a little different from other retailers like CVS Health and Walgreens.

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PharmaTimes

SEPTEMBER 28, 2023

Collaboration will enable teams across the organisation to increase clinical research innovation - News - PharmaTimes

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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.

FDA

European Pharmaceutical Review

SEPTEMBER 28, 2023

According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), more than 600 essential medicines are at risk if a proposed restriction on the use of fluorinated substances, per- and polyfluoroalkyl substances (PFAS) across pharmaceutical manufacturing in the EEA, is implemented. A total ban [of PFAS] would see medicines’ manufacturing in the EU grind to a halt in under three years” EFPIA stated that the EU chemical legislation under The Regulation on the regist

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Pharmaceutical manufacturing Manufacturing Pharmaceutical Medicine 97

Fierce Pharma

SEPTEMBER 25, 2023

After several diabetic patients received a sham version of Roche's Avastin and lost their sight, the Drug Regulatory Authority of Pakistan (DRAP) is halting the sale or distribution of the drug unt | Authorities in Pakistan are investigating the use of altered versions of Roche's Avastin after several diabetic patients who received a sham version of the drug lost their sight.

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MedCity News

SEPTEMBER 27, 2023

NurOwn, Brainstorm Cell Therapeutics’ experimental stem cell therapy for ALS, did not win the backing of an independent panel of FDA advisors. Many advisory committee members said they want to see more data from another clinical trial, the same guidance the FDA has given the biotech for nearly three years.

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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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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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European Pharmaceutical Review

SEPTEMBER 25, 2023

Nuclear magnetic resonance (NMR) relaxation techniques traditionally used in the food and chemical industries are becoming more relevant to pharmaceutical applications as well. The measured relaxation rate constants resulting from fast chemical exchange between water and exposed NH and OH protons on proteins can be selective to biologics. This has led to applications with biopharmaceutical formulations and protein investigations.

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Pharmaceutical Manufacturing Food Electronics 96

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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MedCity News

SEPTEMBER 26, 2023

Intercept Pharmaceuticals’ acquisition by Alfasigma comes three months after the FDA again rejected the biotech’s drug as a treatment for the fatty liver disease NASH. But Intercept still has rare liver disease assets, and Italy-based Alfasigma says acquiring the company will help it expand in gastroenterology and hepatology.

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Impetus Digital

SEPTEMBER 27, 2023

Authentic patient engagement and insight-gathering are becoming must-haves in Pharma. However, multiple obstacles remain before patient-centricity becomes more than a buzzword. In our latest playbook , we take a deep dive into the top barriers preventing cross-functional teams from wholeheartedly adopting patient-centric practices, along with how to overcome these obstacles.

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Patients Pharma 94

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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.

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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

Fierce Pharma

SEPTEMBER 26, 2023

Amid a global expansion spree at WuXi Biologics, the company's immunization-focused subsidiary has christened its inaugural CDMO site in China. | WuXi Vaccines launched its first standalone vaccine contract manufacturing facility in Suzhou. With the plant, the company adds drug substance and drug product capacity for projects in various stages of development.

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Manufacturing 253

MedCity News

SEPTEMBER 27, 2023

As a combined entity, Virgin Pulse and HealthComp will serve more than 1,000 self-insured employers and more than 20 million members. New Mountain Capital will be the majority owner.

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Insurance 116

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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Advertiser: ZoomInfo

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.

Marketing