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

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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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GSK’s Depemokimab Significantly Reduces Asthma Exacerbations

Pharmaceutical Commerce

A pooled analysis of the SWIFT-1 and SWIFT-2 trials found 54% reduction in exacerbation rates over 52 weeks in patients with severe asthma with type 2 inflammation treated with depemokimab.

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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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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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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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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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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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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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Sanofi Jumps Into Radiopharmaceuticals, Paying €100M for Therapy That Could Rival a Novartis Drug

MedCity News

Sanofi is licensing a RadioMedix radiopharmaceutical in development for neuroendocrine tumors. The French pharmaceutical giant is responsible for global commercialization of the therapy, a potential competitor to the Novartis radiopharmaceutical Lutathera. The post Sanofi Jumps Into Radiopharmaceuticals, Paying €100M for Therapy That Could Rival a Novartis Drug 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 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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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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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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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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Syneos Health Communications takes the crown at PM Society Digital Awards

pharmaphorum

The PM Society Digital Awards 2024, an annual event in the healthcare marketing industry sponsored by Twist Health, held its 15th ceremony at The Brewery in London on 12th September.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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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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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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Medicare drug pricing negotiations: What comes next?

pharmaphorum

Explore the ins and outs of Medicare drug pricing negotiations with Alice Valder Curran on this insightful podcast. Learn more about what comes next in this crucial healthcare sector.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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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Why Digital Health Startups Should Start Thinking About Their Reimbursement Pathway Earlier

MedCity News

Some of the most difficult processes for digital health startups to navigate are those related to reimbursement and coding. Startups will often need to create entirely new codes for their products, so they should start thinking about this sooner rather than later, experts said at a recent conference. The post Why Digital Health Startups Should Start Thinking About Their Reimbursement Pathway Earlier 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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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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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First bird flu case with no known animal contact seen in US

pharmaphorum

CDC reports the first-ever US case of an H5 strain of avian influenza without a known occupational exposure to sick or infected animals

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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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The New Role of Engagement: Surfacing Insights at the Point of Care and Beyond

MedCity News

By surfacing conversational, behavioral, and environmental insights at the point of care — and enabling data-driven operational decisions — AI has the power to transform individual patient experiences and drive systemic improvements in care quality and efficiency. The post The New Role of Engagement: Surfacing Insights at the Point of Care and Beyond 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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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

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.