Fierce Pharma

JULY 2, 2024

After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy—and a competitor to Eisai and Bioge | After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy, a competitor to Eisai and Biogen’s Leqembi, a full approval.

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FDA 347

David Bagga

JULY 1, 2024

Medical Device Sales Academy What Degree is Best For Medical Sales? The healthcare industry, a significant driver of the economy and a key player in improving people’s lives, is poised for continued growth. This expansion is fueled by the increasing demand for healthcare services and tools, driven by an aging population and prevalent illnesses.

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Medical sales Medical Sales Healthcare 130

European Pharmaceutical Review

JULY 4, 2024

Altering the conditions that T cells are grown in can improve CAR T-cell therapy, US researchers have found. Discovered by chance, their new method has potential to treat solid cancer tumours more efficiently, according to the findings. Putting T cells on a keto diet [putting our T cells on a three-day ‘keto’ diet] showed reduced maturity at the end of the manufacturing process.

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MedCity News

JULY 2, 2024

Eli Lilly’s Kisunla is now FDA approved for treating patients in the early stages of Alzheimer’s disease. In addition to slowing cognitive decline and disease progression, clinical trial results showed that amyloid beta plaques were reduced to the point where some patients could stop taking the infused therapy. The post Eli Lilly Alzheimer’s Drug Lands FDA Approval, Introducing Competition to Eisai’s Leqembi appeared first on MedCity News.

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Competition FDA Patients Biopharma 125

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Fierce Pharma

JULY 2, 2024

With four contract modifications totaling more than $250 million, the government is leveling up its agreements with long-time medical countermeasures supplier Emergent BioSolutions. | The drugmaker will supply its anthrax vaccine Cyfendus, its smallpox vaccine and two other drugs to help bolster the U.S. government's medical countermeasures stockpile.

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Medical Government 278

Pharmaceutical Technology

JULY 1, 2024

On 8 May, the UK was the world's first government to formally implement a new model for the funding and support of novel antibiotic commercialisation.

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Marketing Government 119

MedCity News

JULY 2, 2024

The Supreme Court made several recent decisions that impact healthcare, including overturning the Chevron deference and upholding access to the abortion pill mifepristone. The post 3 Recent Supreme Court Decisions that Affect Healthcare appeared first on MedCity News.

Healthcare 120

Healthcare Healthcare 120

Fierce Pharma

JULY 2, 2024

Even as the BIOSECURE Act charts an uncertain path through the legislative process, the draft bill has already seriously harmed the U.S. | Even as the BIOSECURE Act works its way through the legislative process, the draft bill has already caused a slide in U.S. life sciences companies' confidence in Chinese partners, a new survey has found.

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Biopharma 278

European Pharmaceutical Review

JULY 1, 2024

At its recent June meeting, the EMA’s human medicines committee (CHMP) recommended 10 medicines for approval. Recommendations for regulatory approval The committee saw a need to give a marketing authorisation to Balversa (erdafitinib) as a treatment for adults with unresectable or metastatic urothelial carcinoma. In its meeting, the CHMP gave a positive opinion for the first nasally administered emergency treatment for allergic reactions.

Medicine 106

Medicine Marketing Pharmaceutical 106

pharmaphorum

JULY 2, 2024

Sobi starts rolling application for refractory gout drug SEL-212 in the US, hoping to take on Amgen’s Krystexxa in the market.

FDA 132

FDA Marketing 132

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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

JULY 2, 2024

Primary care physicians are generally pretty optimistic about AI’s potential to make care delivery more efficient, according to new survey results. In the past few years, automated dictation and scribing tools were the AI technologies that have been most impactful for primary care providers. The post Why Are Primary Care Physicians Optimistic About AI?

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Physicians 120

Fierce Pharma

JULY 2, 2024

In recent months, frequent pharma critic Sen. | As the November U.S. elections near, it's clear that drug pricing will remain an important topic for voters and politicians. In a Tuesday op-ed, President Joe Biden and Sen. Bernie Sanders placed a spotlight on Novo Nordisk and Eli Lilly's drug pricing.

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Pharma 283

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. 1 For use as prescription drugs, a botanical product must be approved by the FDA: to date, only two h

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Marketing Food and Drug Administration Medicine Prescription 104

Pharmaceutical Technology

JULY 2, 2024

The EMA has accepted AstraZeneca's MAA for sipavibart as Covid-19 pre-exposure prophylaxis (prevention) in immunocompromised patients.

Patients 116

Patients 116

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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

MedCity News

JUNE 30, 2024

By being aware of the latest schemes, health plan leaders can ensure their members have appropriate access to care while preventing bad actors from exploiting telehealth policies established during the pandemic. The post Mental Health Fraud Schemes: How to Protect Your Plan appeared first on MedCity News.

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Fierce Pharma

JULY 3, 2024

After more than a decade with no treatment advances for chronic obstructive pulmonary disease (COPD), two have been approved by regulators on either side of the Atlantic within a week. | After more than a decade with no treatment advances for chronic obstructive pulmonary disease (COPD), two have been approved by regulators on either side of the Atlantic within a week.

Medicine 283

Medicine Patients 283

Spotio

JULY 3, 2024

Every sales department wants to close more deals. Fortunately, there’s an easy way to make this happen: implement a proven sales methodology that will enable your sales team to be more effective. Don’t believe us? Try this stat on for size: 90% of companies that follow a guided sales process rank as high performing. In other words, you’ll find more success if there’s a method to your madness.

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Sales Sales process Prospecting Consulting 98

pharmaphorum

JULY 2, 2024

The field of muscle stem cell research has been tangibly developing over the decades and in today’s pharmaphorum podcast wed editor Nicole Raleigh speaks with Dr Michael Rudnicki, co-founder and CSO of Satellos Biosciences, a company dedicated to developing novel therapeutics based on this science for those who live with Duchenne muscular dystrophy (DMD) and other degenerative muscle diseases.

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Medicine 107

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

MedCity News

JULY 3, 2024

Finding a payment technology solution that is specifically designed for alternative payment models like capitation helps payers and providers achieve financial sustainability in a value-based system. The post Capitation Technology Drives Financial Viability in Value-Based Care Models appeared first on MedCity News.

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Fierce Pharma

JULY 2, 2024

In a major win for Johnson & Johnson and Legend Biotech, their star CAR-T therapy Carvykti showed it can prolong the lives of patients with previously treated multiple myeloma. | In a major win for J&J and Legend, their star CAR-T therapy Carvykti showed it can prolong the lives of patients with previously treated multiple myeloma.

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Patients 266

Pharmaceutical Technology

JULY 2, 2024

Eisai has announced the termination of a deal with Bristol Myers Squibb to jointly develop and commercialise farletuzumab ecteribulin (FZEC).

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pharmaphorum

JULY 3, 2024

Beacon Therapeutics raises $170m for a pivotal trial of its gene therapy for X-linked retinitis pigmentosa, an inherited cause of blindness

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MedCity News

JUNE 30, 2024

Health plans must take a consistent, thoughtful approach to sustaining their business by managing costs without compromising member access to quality healthcare. The post Four Strategies Medicare Advantage Plans Can Implement to Mitigate Financial Pressures appeared first on MedCity News.

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Healthcare Healthcare Management 113

Fierce Pharma

JULY 1, 2024

Welcome to Fierce Pharma's regulatory tracker for the second half of 2024. | In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning.

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Pharma FDA Marketing 266

Pharmaceutical Technology

JULY 5, 2024

Fucaso, a BCMA CAR T-cell therapy, is co-developed by Innovent and IASO Bio and was approved to treat multiple myeloma in China last month.

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pharmaphorum

JULY 3, 2024

GSK has upgraded its longstanding alliance with CureVac on mRNA-based vaccines for respiratory infections, paying €400 million ($429 million) upfront for global rights to its influenza and COVID-19 jabs.

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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

MedCity News

JULY 2, 2024

BARDA is contributing funding for a Phase 3 clinical test of a Moderna messenger RNA vaccine that could protect against the strains of bird flu virus now spreading in U.S. dairy cows. The Moderna vaccine is currently in Phase 1/2 testing. The post Moderna Gets $176M From BARDA for Key Test of Bird Flu Vaccine appeared first on MedCity News.

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Biopharma Pharma 117

Fierce Pharma

JULY 2, 2024

The world’s first injectable immune checkpoint inhibitor likely won’t make it to the U.S. | The world’s first injectable immune checkpoint inhibitor likely won’t make it to the U.S. anytime soon, after the China-approved drug flunked a pivotal trial in a rare cancer, forcing its stateside developer Tracon to explore strategic alternatives.

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Pharmaceutical Technology

JULY 5, 2024

Approval is based on positive data from the Phase III FLAURA2 trial where Tagrisso plus chemotherapy showed PFS of 24.4 months.

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pharmaphorum

JULY 3, 2024

Eli Lilly finally has FDA approval for its amyloid-busting Alzheimer’s disease therapy donanemab and will launch it at a cost it claims could deliver savings compared to a rival therapy from Eisai/Biogen.

FDA 100

FDA 100

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.

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