Fierce Pharma

SEPTEMBER 5, 2023

Add Novartis to the list of biopharma giants that have filed lawsuits against the U.S. government as a reaction to the Inflation Reduction Act (IRA). | Add Novartis to the list of biopharma giants that have filed lawsuits against the U.S. government as a reaction to the Inflation Reduction Act. The case was filed Friday in New Jersey federal court, three days after the CMS revealed that Novartis’ heart failure treatment Entresto was among 10 drugs subject to price negotiations in 2026.

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Biopharma Government 274

MedCity News

SEPTEMBER 5, 2023

CMS released a proposed rule to establish staffing standards among the nation’s nursing homes. Reactions have been mixed — but mainly negative. Long-term care facilities say that they can neither find nor afford more workers. On the other hand, some lawmakers argue the proposed rule doesn’t do enough to protect care quality for patients. As for labor unions, they seem generally happy with the rule.

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Patients Healthcare Healthcare 113

Fierce Pharma

SEPTEMBER 5, 2023

As the Federal Trade Commission (FTC) scrutinizes Pfizer’s $43 billion Seagen buyout, the antibody-drug conjugate (ADC) specialist has notched a phase 3 win that could broaden its cervical cancer a | The drug boosted overall survival, progression-free survival and objective response rates in patients with recurrent or metastatic cervical cancer who had disease progression on or after a front-line therapy.

Patients 238

Patients 238

MedCity News

SEPTEMBER 5, 2023

Novartis became the seventh drugmaker to legally challenge the White House’s Medicare drug pricing negotiation program. The company filed its lawsuit three days after HHS announced the first 10 drugs that were selected for the program — its heart failure medication Entresto was one on the list. HHS can expect to face more lawsuits from the manufacturers of the 10 drugs it named last week, experts have warned.

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Manufacturing Medical Biopharma 108

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Fierce Pharma

SEPTEMBER 5, 2023

Despite scoring a number of federal contracts in recent years, it’s lights out for government-backed rescue autoinjector maker AktiVax. | AktiVax, also known as Aktiv Pharma Group, informed the state of Colorado that “the company must shut down substantially all of its operations,” citing “unexpected circumstances.” In turn, the company is mothballing three manufacturing facilities and laying off around 70 employees.

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Government Manufacturing Pharma 216

MedCity News

SEPTEMBER 5, 2023

Peanut allergy therapy Palforzia, which Nestlé acquired in a multi-billion dollar deal, has been sold to allergy product company Stallergenes Greer. Palforzia was the first FDA-approved drug for peanut allergy, but its sales were hampered by the Covid-19 pandemic.

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Food FDA Sales Biopharma 104

MedCity News

SEPTEMBER 5, 2023

The current dual-system model is inefficient, wasteful, and inconvenient. There is a clear need to integrate workers’ comp and medical benefits programs to cut down on costs and alleviate the hassle of dealing with separate care silos. It’s possible, and its time has come.

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Medical Insurance 104

Fierce Pharma

SEPTEMBER 5, 2023

After lackluster sales dampened the initial enthusiasm that came with a $2.1 billion acquisition, Nestlé has finally found a new owner for its peanut allergy drug Palforzia. | After lackluster sales dampened the initial enthusiasm that came with a $2.1 billion acquisition, Nestlé has finally found a new owner for its peanut allergy drug Palforzia.

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Sales 187

Pharmaceutical Technology

SEPTEMBER 5, 2023

Nestlé has sold its peanut allergy drug Palforzia to Swiss biopharma Stallergenes Greer harma, concluding a year-long strategic review.

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Biopharma 119

Fierce Pharma

SEPTEMBER 5, 2023

One year after Vifor Pharma officially joined the fold at CSL thanks to an M&A deal, the iron deficiency specialist is shedding 85 staffers based in California. | A year after Vifor Pharma joined CSL under an M&A deal, the company has cut 85 employees based out of Vifor's Redwood City location in California.

Pharma 154

Pharma 154

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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

MedCity News

SEPTEMBER 5, 2023

A webinar sponsored by AVIA Health and SeamlessMD will discuss the latest trends in remote monitoring and how to extend these benefits beyond chronic conditions all while using fewer staff resources.

Patients 100

Patients 100

PharmaVoice

SEPTEMBER 5, 2023

Leaked data for Roche’s immunotherapy appeared positive, but some experts aren’t convinced it’ll make an impact for cancer patients.

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Patients 105

MedCity News

SEPTEMBER 5, 2023

Startup Star Therapeutics will use the Series B funding to support clinical development of a drug candidate for von Willebrand disease, a bleeding disorder. The capital will also support the formation of new biotech subsidiaries developing antibodies with therapeutic applications in hematology and immunology.

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Biopharma Pharma 92

European Pharmaceutical Review

SEPTEMBER 5, 2023

Novo Nordisk’s semaglutide injection Wegovy ® is now available as a treatment for obesity in the UK. The pharmaceutical company stated it believed that the launch of Wegovy will help provide an additional option to support people living with obesity in the UK. The semaglutide injection is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management.

Medicine 89

Medicine Food Management Pharmaceutical 89

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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

PharmaVoice

SEPTEMBER 5, 2023

Explore four modern tech capabilities designed to help decrease cycle times, improve processes and compliance and mitigate site burdens.

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European Pharmaceutical Review

SEPTEMBER 5, 2023

The UK government is investing £5.5 million to establish a Medicines Manufacturing Skills Centre of Excellence. The centre will help the UK life sciences sector to have the right talent to drive innovation to support the UK in its response to future health emergencies. It will build on existing infrastructure and best practice, and deliver sustainable, end-to-end training provision.

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Medicine Manufacturing Biopharma Pharmaceutical manufacturing 86

PharmaTimes

SEPTEMBER 5, 2023

Candidate ESO-101 will treat participating patients across five European countries - News - PharmaTimes

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Recruitment Patients 110

European Pharmaceutical Review

SEPTEMBER 5, 2023

Potential of real-time measurement through miniaturisation of a process analytical technology (PAT) technique has been reported in a Biotechnology and Bioengineering paper. A micromixer was able to effectively detect aggregation in offline measurement-validated samples. The authors described how a PAT fluorescent dye (FD)-based microfluidic sensor was successfully implemented in an integrated downstream process.

Pharmaceutical 83

Pharmaceutical 83

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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.

Safety

PharmaTimes

SEPTEMBER 5, 2023

The funding will boost the University of Nottingham spinout’s development of bone regeneration treatment - News - PharmaTimes

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Pharmaceutical Technology

SEPTEMBER 5, 2023

A new set of European Society of Cardiology (ESC) guidelines was shared at the 2023 ESC conference in Amsterdam, Netherlands.

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Management 98

European Pharmaceutical Review

SEPTEMBER 5, 2023

It is now five years since the first reports of N -nitrosodimethylamine (NDMA) contamination in valsartan active pharmaceutical ingredient (API). Over that time-period the issue has morphed from an API contamination issue of sartans (and other APIs), into concerns about API-related nitrosamines in drug products, ie, nitrosamine drug substance‑related impurities (NDSRIs).

Pharmaceutical 79

Pharmaceutical Medicine Consulting Safety 79

Pharmaceutical Technology

SEPTEMBER 5, 2023

The UK MHRA has granted marketing authorisation for AbbVie’s Aquipta (atogepant) for the prophylaxis of migraine in adults.

Marketing 98

Marketing 98

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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 5, 2023

Advanced analytical tools generate more data in today’s labs than ever before.

Management 105

Management 105

Spotio

SEPTEMBER 5, 2023

If you’re in outside sales, you probably spend a significant amount of your time in the field, knocking on doors, and meeting with potential customers face to face. It’s a great way to make sales—unless your door knocking game is subpar. Fortunately, there are plenty of door knocking apps you can use to improve your efforts in this area.

Prospecting 52

Prospecting Sales CRM Leads 52

Evolve Your Success

SEPTEMBER 5, 2023

With time-saving AI tools, doctors can save time on tasks like medical reports and focus on what truly matters – superior patient care. For this Special Labor Day episode, we’re going to dive into the cutting-edge world of AI revolutionizing healthcare, specifically in the field of gastrointestinal medicine. Our guest, Ibraz Shaikh , takes us on a captivating journey through the corridors of a medical software company at the forefront of this groundbreaking transformation.

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Medical Medical sales Doctors Sales 52

Clarify Health

SEPTEMBER 5, 2023

Payers are constantly looking to improve member outcomes while lowering costs. Optimizing provider networks is the number one way to do so. Provider networks are the primary tool for health plans to attract and retain new members while optimizing returns. Members often compare networks when choosing a Medicare Advantage or employer-sponsored health plan to see how much it will cost them in premiums, which physicians and specialists are in-network, and if there are any add-on benefits.

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Networking Healthcare Provider Healthcare Healthcare 52

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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

PharmaTech

SEPTEMBER 5, 2023

Both companies have a focus to developing and commercializing treatments for rare diseases with a strong focus on patients and supporting communities with little to no existing therapeutic options.

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Patients 52

Legacy MEDSearch

SEPTEMBER 5, 2023

Techsomed Ltd., a medical software innovator dedicated to enhancing clinical impact in ablation therapy, announced today that it has received 510(k) clearance from the USA Food and Drug Administration (FDA) for its VisAble.IO software intended to assist physicians in planning liver ablation procedures, and confirming ablation zones, with the goal of increasing treatment precision.

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FDA Food and Drug Administration Physicians Recruitment 52

Pharmaceutical Technology

SEPTEMBER 5, 2023

The Nordics are a well-known powerhouse of pharmaceutical innovation and production. But what opportunities do the region’s own pharma markets offer industry players, and what do marketing authorisation holders need to know when bringing new medicines to these countries?

Pharmaceutical 52

Pharmaceutical Medicine Pharma Marketing 52

Clarivate

SEPTEMBER 5, 2023

At Clarivate, we work hard to deliver the best user experience for of our solutions. So it’s especially gratifying to be recognized for excellence by the most important judges of all: the IP professionals who rely on our products every day. That’s why we’re so excited about the recent user accolades for our IPfolio® IP management solution. Awards and reviews IPfolio received a number of Summer 2023 award badges from G2, a respected source of peer reviews from more than 80 million software users

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CRM Professional Services Management Specialization 52

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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.

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