Fierce Pharma

APRIL 22, 2024

As a closely watched readout from Alnylam Pharmaceuticals' Amvuttra in the rare heart disease transthyretin amyloid cardiomyopathy (ATTR-CM) is expected in a few weeks, experts suggested the RNA si | As an all-important readout from Alnylam’s Amvuttra in the rare heart disease ATTR-CM is expected in a few weeks, experts suggested that the RNA silencer may have a hard time challenging Pfizer’s tafamidis franchise despite a last-minute trial design change.

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Pharmaceutical 189

MedCity News

APRIL 22, 2024

The Commonwealth Fund recently launched the National Task Force on the Future Role of Employers in the U.S. Health System. In 2025, the task force will release a blueprint of actionable recommendations on how employers can improve their coverage. The post Why the Commonwealth Fund Created a Task Force for Employer-Sponsored Insurance appeared first on MedCity News.

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Insurance 99

Fierce Pharma

APRIL 17, 2024

One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis (MS) drug Ocrevus ahead of an FDA decision, the Swiss pharma said. | One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis drug Ocrevus ahead of an FDA decision, the Swiss pharma said.

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Pharmaceutical Technology

APRIL 22, 2024

Discover how BioMarin Pharmaceutical's patent for PAL variants offers a groundbreaking method to treat PKU in adolescents. Administering AvPAL variants weekly over 50 weeks effectively reduces blood phenylalanine levels.

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Pharmaceutical Patients 94

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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

pharmaphorum

APRIL 16, 2024

A smart sensor developed by Adherium has been cleared by the FDA for use with AstraZeneca's asthma inhaler Airsupra and Breztri for COPD.

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FDA 128

European Pharmaceutical Review

APRIL 22, 2024

The USP Microbiology Expert Committee is due to vote on the proposed Chapter <86> to approve bacterial endotoxin testing using non-animal derived reagents between 21 June and 1 July 2024. Jaap Venema , Chief Science Officer, USP shared with EPR that the chapter is helping to guide manufacturers how to the adopt these methods and provides “a path to wider adoption”.

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Manufacturing Pharmaceutical 88

MedCity News

APRIL 22, 2024

In this episode, we’re joined by John Auerbach, senior vice president of federal health at consulting firm ICF. He discusses rising preeclampsia rates and how stakeholders need to act. The post MedCity FemFwd: What Needs To Happen to Improve Preeclampsia Rates? appeared first on MedCity News.

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Consulting 96

Pharmaceutical Technology

APRIL 22, 2024

Health Canada has approved Merck’s KEYTRUDA (pembrolizumab), an anti-programmed cell death protein 1 (PD-1) therapy for use in combination with fluoropyrimidine- and platinum-containing-chemotherapy as a first-line treatment for adult gastric cancer patients.

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Patients 90

PharmaVoice

APRIL 19, 2024

Where Amylyx ultimately failed in ALS, it could prevail in a rare disease. The doctor leading this research explains why.

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Doctors Leads 119

LEVO Health

APRIL 18, 2024

At Levo Health, we’re always on the lookout for opportunities to push the boundaries of healthcare marketing and support innovations that can transform the industry. This year, we’re thrilled to take our commitment a step further by sponsoring the 2024 HealthTech|X Accelerator program hosted by Tampa Bay Wave. Tampa Bay Wave has a proven track record of fostering startup success, having supported 527 startups, collectively raising over $900 million in capital and creating more than 5

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Healthcare Healthcare Competition Training 98

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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

Fierce Pharma

APRIL 18, 2024

During a busy period of overhaul at Sanofi, the company is restructuring its U.S. vaccine commercial group. | During a busy period of overhaul at Sanofi, the company is restructuring its U.S. vaccine commercial group. A spokesperson said the company would offer affected employees a chance to apply for new roles, plus "outplacement services.

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MedCity News

APRIL 17, 2024

This week, the FTC ordered Cerebral to pay a $7 million fine, accusing the company of mishandling users’ sensitive health data and misleading consumers about cancellation policies. Experts agree that other virtual healthcare providers need to work on their legal and compliance strategies in order to avoid a similar fate. The post What Does the FTC’s $7M Fine Against Cerebral Mean for the Industry?

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Healthcare Provider Healthcare Healthcare 115

Pharmaceutical Technology

APRIL 18, 2024

Outrun Therapeutics announced its launch with $10m seed funding to advance a protein stabilisation pipeline focused on E3 ligase inhibitors.

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Integrity Solutions

APRIL 19, 2024

Mastering the human side of selling is key to sales success, but what does phrase that mean exactly? At its essence, humanizing the sales experience is really about personalization. It’s about asking questions from a place of genuine curiosity, listening, fully absorbing what you’re hearing and then being willing and able to pivot in whatever direction the customer’s answers take us.

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Sales Leads Prospecting Sales experience 93

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

pharmaphorum

APRIL 16, 2024

Boehringer Ingelheim says the strongest R&D pipeline in its history is set to deliver 25 new product launches between now and 2030

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Fierce Pharma

APRIL 17, 2024

In addition to their acclaimed efficacy against diabetes and obesity, GLP-1 drugs are gaining traction for their potential to treat a variety of other common disorders. | In addition to their acclaimed efficacy against diabetes and obesity, GLP-1 drugs are gaining traction for their potential to treat a variety of other common disorders. Now, two trials have shown that Eli Lilly’s weight loss product Zepbound (tirzepatide) can help patients overcome obstructive sleep apnea (OSA).

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Patients 281

MedCity News

APRIL 21, 2024

Questions about whether acetaminophen use during pregnancy can lead children to develop neurological problems have sparked scientific inquiry and litigation. Lawsuits are continuing, but a new National Institutes of Health-sponsored study has results that show no causal link between acetaminophen and neurodevelopmental disorders. The post NIH Study: Use of Popular Pain Reliever During Pregnancy Not Linked to Neuro Disorders in Kids appeared first on MedCity News.

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Leads Biopharma Pharma 99

Pharmaceutical Technology

APRIL 19, 2024

The US Food and Drug Administration (FDA) has granted fast-track designation to Bayer subsidiary Asklepios BioPharmaceutical’s (AskBio) investigational gene therapy AB-1002, aimed at treating congestive heart failure (CHF).

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Food and Drug Administration FDA Food 98

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

APRIL 19, 2024

The “accurate, precise, and robust” data obtained via the dew point chilled mirror method, means it is an “outstanding” approach for quantifying water activity status in tablets and capsules, according to a paper published in RPS Pharmacy and Pharmacology Reports. It has value for direct assessment to determine microbiological bioburden , stated Prada-Ramírez et al.

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Pharmaceutical products Pharmaceutical Pharmacology Leads 87

pharmaphorum

APRIL 17, 2024

Sage Therapeutics has suffered another disappointment after deciding that it will have to drop the Parkinson’s programme for key pipeline drug dalzanemdor after it showed no benefit in a phase 2 trial. The oral positive allosteric modulator (PAM) of the NMDA receptor is being investigated to see if it can counteract mild cognitive impairment in neurodegenerative disorders, and the PRECEDENT trial in Parkinson’s is the first major readout from the drug programme.

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Fierce Pharma

APRIL 16, 2024

Despite a pair of clinical misfires in 2023, argenx has stuck by the thesis that its star drug Vyvgart, also known as efgartigimod, could tackle a wide array of autoimmune diseases linked to immuno | Argenx is bolstering its case for Vyvgart’s CIDP potential and preparing for a possible launch later this year—all while the company continues to prove the medication’s worth in its inaugural generalized myasthenia gravis indication.

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MedCity News

APRIL 19, 2024

Ilant Health extended its seed round from $3 million to $5.5 million. The company garnered interest from LifeX Ventures, Celtic House Asia Partners and Cornucopian Capital. The post Ilant Health Raises Extended Seed Round of $5.5M for Obesity Management Platform appeared first on MedCity News.

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Management 107

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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

Pharmaceutical Technology

APRIL 18, 2024

Inflammation, cell metabolism and neuronal health are current key areas of focus for dementia researchers, according to Jane Osbourn, chief scientific officer (CSO) at Alchemab.

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Copyright Clearance Center

APRIL 16, 2024

In a publishing environment buffeted by digital disruption and calls for open access, university presses in 2024 must manage to remain relevant and sustainable even as their audiences grow.

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Management 94

pharmaphorum

APRIL 17, 2024

Drug shortages fuelled by Brexit are now the 'new normal' in the UK and worsened in 2023, says Nuffield Trust report.

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Medicine 108

Fierce Pharma

APRIL 19, 2024

Roche isn’t content with Alecensa being the best-selling ALK inhibitor in metastatic lung cancer. | Roche isn’t content with Alecensa being the best-selling ALK inhibitor in metastatic lung cancer. The Swiss pharma has now secured an FDA approval in the post-surgical setting as it continues to test the drug in additional patient populations.

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FDA Pharma Patients 246

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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

MedCity News

APRIL 18, 2024

Achieving strong cybersecurity is a vast, interconnected web that must incorporate the correct software, procedures, and workflows and take into account the human element across an entire organization. The post In the World of Interoperability, How to Meaningfully Strengthen Cybersecurity appeared first on MedCity News.

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Pharmaceutical Technology

APRIL 16, 2024

The price ceiling policy has been in place for more than 20 years, but it has neither been very successful nor free of consequences for pharma companies.

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Pharma Marketing 111

Copyright Clearance Center

APRIL 18, 2024

In a recent town hall webinar, The Heart of the Matter: Copy­right, AI Training and LLMs, CCC (Copyright Clearance Center) made the case that current artificial intelligence (AI) technology infringes copyrights, both in the way its underlying large language models (LLMs) are developed, or trained, and in the outputs it enables users to create.

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Training 83

pharmaphorum

APRIL 22, 2024

Ireland’s SynOx Therapeutics has completed a second-round financing, raising $75 million, as it prepares to take its drug for tenosynovial giant cell tumour (TGCT) into phase 3 trials. TGCT is a rare disease affecting the joints and tendons caused by overproduction of the protein CSF-1, which stimulates the proliferation of various cell types, inflammation, and destruction of the matrix of the joint.

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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.

Patients