Sat.Sep 07, 2024 - Fri.Sep 13, 2024

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With another phase 3 win, Gilead races toward 2025 launch for long-acting PrEP drug

Fierce Pharma

Gilead Sciences is no stranger to making history in HIV. | In a study of more than 3,000 participants, Gilead's twice-yearly lenacapavir delivered a 96% reduction in HIV infections compared with background HIV incidence.

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300+ Provider Organizations Urge Feds to Prevent Leaked DEA Rule From Going into Effect

MedCity News

More than 330 provider organizations signed letters this week urging the White House and Congress to extend a pandemic-era telehealth prescribing flexibility. Failure to extend this policy would cause millions of Americans to lose access to treatment, they argued. The post 300+ Provider Organizations Urge Feds to Prevent Leaked DEA Rule From Going into Effect appeared first on MedCity News.

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Digital Solution Implementation

Pharmaceutical Commerce

In the second part of her interview with Pharma Commerce Editor Nicholas Saraceno, Meghan Mullooly, Archbow Consulting’s Vice President, offers advice to pharma manufacturers for successfully applying digital solutions to their patient support programs.

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Lilly $1.8 billion investment to bolster Irish manufacturing

European Pharmaceutical Review

Eli Lilly and Company is planning to invest a total of $1.8 billion in two manufacturing sites in Ireland , boosting its medicine production worldwide. Edgardo Hernandez , Executive Vice President and President of Lilly Manufacturing Operations, explained that the company ’s new investments will enhance production of medicines for diabetes, obesity and Alzheimer’s.

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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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Akeso, Summit's PD-1 bispecific crushes Merck's Keytruda in study, signaling potential new standard in lung cancer

Fierce Pharma

The Keytruda-beating data from Akeso and Summit’s ivonescimab that oncology industry watchers had been awaiting are here. | The Keytruda-beating data from Akeso and Summit’s ivonescimab that oncology industry watchers had been awaiting are here. The China-only data are impressive, signaling the PD-1/VEGF bispecific antibody’s potential as a new standard of care in non-small cell lung cancer.

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The Human Touch: Why Human Transcriptionists Still Outperform AI in Healthcare

MedCity News

While AI continues to advance, the healthcare industry requires a level of accuracy, understanding, and confidentiality that only well-trained human transcriptionists can consistently provide. The post The Human Touch: Why Human Transcriptionists Still Outperform AI in Healthcare appeared first on MedCity News.

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Driving economic growth in UK with commercial clinical trials

European Pharmaceutical Review

A report from Frontier Economics has highlighted the major benefit industry clinical trials have had on UK’s economy. For instance, it has supported its growth and the job market, the research showed. Of the 65,000 jobs generated, 21,000 individuals were employed directly by the pharmaceutical industry to deliver trials, according to the data. While industry clinical trials in the UK have reduced , the Association of the British Pharmaceutical Industry (ABPI) stated that if the activity assumes

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After delay, Roche's Tecentriq Hybreza wins first FDA approval for a subcutaneous PD-L1 drug

Fierce Pharma

It’s better late than never for an FDA approval for the first subcutaneous PD-L1 inhibitor, which was doled out to Roche’s Tecentriq Hybreza after manufacturing delays derailed the company's initia | The under-the-skin formulation trims administration time down to seven minutes compared to the 30 to 60 minutes needed for intravenous Tecentriq.

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Rural Healthcare Goes Beyond Care: Targeting SDOH to Improve Health Outcomes

MedCity News

As poverty, food insecurity, inadequate housing, and complex comorbidities persist, it is essential that rural healthcare leaders have tools and systems in place to address the health of their neighbors. The post Rural Healthcare Goes Beyond Care: Targeting SDOH to Improve Health Outcomes appeared first on MedCity News.

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Prodrugs and patents: Enhancing therapy adherence and reducing side effects 

Pharmaceutical Technology

As the approval date for Bristol Myers Squibb’s schizophrenia drug KarXT looms, a prodrug approach emerges to potentially address dosing challenges.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Innovative medicine production site inaugurated in France

European Pharmaceutical Review

Sanofi has inaugurated a new production unit in France which utilises a world-first modular concept. The site, Modulus, located in Neuville-sur-Saône (Rhône-Alpes), is supported by an investment of nearly €500 million and will produce Sanofi’s next vaccines and biologic drugs. Modulus can adapt to manufacture up to four vaccines simultaneously. Notably, reconfiguration of the technological platform (live attenuated viral vaccines, recombinant protein or messenger RNA vaccines, as well as treatme

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Roche doubles down with another subcutaneous FDA nod, this one for MS star Ocrevus

Fierce Pharma

When Roche's Genentech gained approval for Ocrevus in 2017, the first-in- | The day after Roche gained an FDA approval for its subcutaneous version of cancer drug Tecentriq, the company also scored with a U.S. nod for its under-the-skin formulation of mega-blockbuster multiple sclerosis drug Ocrevus. The approval gives patients a more convenient injected way to receive Ocrevus as opposed to the infused formulation.

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The Apple AirPods Pro Have a New Hearing Feature, Yet the Biggest Impact May be to Protect Us All From Noise

MedCity News

Apple’s new Loud Sound Reduction capability scans the environment 46,000 times a second for sudden peaks in sound, reducing them to a safe level. The post The Apple AirPods Pro Have a New Hearing Feature, Yet the Biggest Impact May be to Protect Us All From Noise appeared first on MedCity News.

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Meet MILTON, AZ's AI that can predict 1,000+ diseases

pharmaphorum

A machine-learning tool developed by AstraZeneca and trained on UK Biobank data, called MILTON, can predict over 1,000 diseases, before diagnosis

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Addressing Key Challenges in U.S. Healthcare System

Referral MD

The U.S. healthcare system faces several key challenges that significantly affect providers and patients, making it harder to deliver high-quality care while managing costs. Rising healthcare expenses strain providers and complicate patient access to affordable treatments. Simultaneously, the patient experience is becoming a major focus as healthcare organizations strive to meet the growing expectations of consumer-driven care.

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ESMO: AZ, Daiichi build case for Enhertu in breast cancer patients with brain metastases

Fierce Pharma

Daiichi Sankyo and AstraZeneca are padding the case for their antibody-drug conjugate Enhertu with new data demonstrating the medicine’s worth in patients whose cancer has spread to the b | To bolster Enhertu's case in HER2-positive breast cancer, AstraZeneca and Daiichi Sankyo have rolled out positive data for the antibody-drug conjugate in patients who have brain metastases.

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A Closer Look at FIT Tests – A Primer on the Various Options for Colorectal Cancer Screening

MedCity News

As we confront the sobering statistics and growing impact of colorectal cancer, it’s clear that more education about the various options for testing is needed to increase screening rates across the U.S. The post A Closer Look at FIT Tests – A Primer on the Various Options for Colorectal Cancer Screening appeared first on MedCity News.

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Starmer says no extra NHS funding without big reforms

pharmaphorum

Keir Starmer has promised the biggest 'reimagining' of the NHS in its history but said there will be no more funding without sweeping reforms

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How Machine Learning Drives Clinical Trial Efficiency

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.

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A decade of cancer immunotherapy: Keytruda, Opdivo and the drugs that changed oncology

PharmaVoice

Over the past 10 years, PD1-blocking medicines have transformed cancer care. But the steady expansion of their use has slowed and, despite much trying, pharmaceutical companies have largely failed to top the drugs’ successes.

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After BIOSECURE Act passes in House, targeted Chinese companies say they're 'deeply' concerned

Fierce Pharma

After much anticipation and concern, the BIOSECURE Act—which would prevent U.S. companies from working with certain Chinese biotech service providers—has passed a key threshold. | Late Monday, the U.S. House of Representatives voted 306-81 in favor of the BIOSECURE Act, which was introduced in January and seeks to halt federal contracts with five named Chinese life-sci companies: WuXi AppTec, WuXi Biologics, BGI Group, MGI and Complete Genomics.

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Our Next Generations’ Health Depends on the Oral Health of Moms

MedCity News

This starts with viewing specialties such as oral health, maternal health, endocrinology, and cardiology — among others — as interconnected practices, not as separate areas. It also requires combining education, innovation, and investment to truly see — and feel — positive change and interconnected care The post Our Next Generations’ Health Depends on the Oral Health of Moms appeared first on MedCity News.

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Into the unknown: How quickly can vaccines be developed for Disease X

Pharmaceutical Technology

R&D frameworks are in place for the next pandemic-causing pathogen, but ways to derisk development are unclear.

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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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Apple AirPods get FDA okay for use as OTC hearing aids

pharmaphorum

It's known that excessive use of earbuds at high volumes can cause hearing loss, so somewhat ironic that the FDA has just authorised software that can turn Apple AirPods into hearing aids.The green light is for Hearing Aid Feature (HAF), an app compatible with Apple's AirPods Pro earbuds that amplifies sounds and can be used for people aged 18 and over with perceived mild to moderate hearing impairment.

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ESMO: Even after unique trial win, Incyte CEO views PD-1 drug Zynyz as pipeline aide

Fierce Pharma

Incyte’s late PD-1 entrant Zynyz has chalked up a unique clinical win. | Incyte’s late PD-1 entrant Zynyz has chalked up a unique clinical win. Yet company CEO Hervé Hoppenot views the antibody molecule not necessarily as a major revenue driver but as an aide to the company’s oncology pipeline.

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These Are 2 of The Biggest Issues with Healthcare AI, According to an FDA Reviewer

MedCity News

As the FDA continues its work to ensure that AI is deployed safely within healthcare, there are a couple prevalent issues that frequently pop up, said Luke Ralston, one of the agency’s reviewers. The post These Are 2 of The Biggest Issues with Healthcare AI, According to an FDA Reviewer appeared first on MedCity News.

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Pharma Pulse 9/12/24: AI Will Force a Transformation of Tech Infrastructure, Obesity Drug Market to be Worth $200 Billion by 2031 & more

Pharmaceutical Commerce

Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.

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How to Stay Competitive in the Evolving State of Martech

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

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Lilly ramps up Irish manufacturing investment by $1bn

pharmaphorum

Eli Lilly has added $1 billion to its investment plan for a new manufacturing facility in Ireland that will be used to produce its Alzheimer's therapy donanemab.The facility at a business park in Raheen, Limerick, was first announced in 2022 and this is the second time that Lilly has opted to double its investment in the site, taking the total above $2 billion and reinforcing the company's close ties to Ireland's pharma manufacturing sector.

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ESMO: GSK's Zejula misses survival goal in first-line ovarian cancer, as Pharma&'s combo disappoints

Fierce Pharma

In a rough day for PARP inhibitors in ovarian cancer, GSK’s Zejula didn’t deliver a life extension benefit in the final analysis of a phase 3 trial. | In a rough day for PARP inhibitors in ovarian cancer, GSK’s Zejula didn’t deliver a life extension benefit in the final analysis of a phase 3 trial. Another study showed that Pharma&’s attempt to enhance its Rubraca with Bristol Myers Squibb’s Opdivo seriously backfired.

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Highmark Covers AppliedVR’s Product for Chronic Low Back Pain

MedCity News

More than 4 million Highmark commercial members now have access to AppliedVR’s RelieVRx as a covered therapeutic. The post Highmark Covers AppliedVR’s Product for Chronic Low Back Pain appeared first on MedCity News.

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FDA approves Roche’s Tecentriq Hybreza for cancer

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Roche's Tecentriq Hybreza, a subcutaneous anti-PD-(L)1 cancer immunotherapy.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time