MedCity News

OCTOBER 20, 2024

Pharmaceutical and biotech companies are using generative AI to predict drug-target interactions, optimize lead compounds, and generate novel molecular structures. During the recent MedCity News INVEST Digital Health conference, a panel discussed these applications and more. The post How Generative AI Will Find a Place in the Pharma Industry Now and in the Years to Come appeared first on MedCity News.

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Fierce Pharma

OCTOBER 28, 2024

Novartis and Apellis Pharmaceuticals have rolled out detailed data on iptacopan and pegcetacoplan, respectively, as they race for the prize in a type of rare kidney disease. | Novartis and Apellis dropped new data on their respective meds, iptacopan and pegcetacoplan, in the rare kidney disease C3 glomerulopathy. While Apellis' drug seems to have an efficacy edge based on a cross-trial comparison, Novartis may have gotten the jump by filing for approvals ahead of its competitor.

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PharmaVoice

OCTOBER 8, 2024

This year’s PharmaVoice 100 encompasses the industry’s ongoing revolutions and leaders who are not only navigating these changes, but at times, forging new paths for others to follow.

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Pharmaceutical Commerce

OCTOBER 31, 2024

With today's pharmacy landscape shaken by unprecedented and wider disruption to healthcare support and delivery, community and independent entities strive to remain an integral cog in the mix.

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Sales Management

European Pharmaceutical Review

OCTOBER 17, 2024

In August 2024, the European Commission approved EURneffy (adrenaline nasal spray) in the EU as the first needle-free emergency option to treat anaphylaxis. This decision was granted a couple of weeks following approval by the US and Drug Administration (FDA). What are the main advantages of EURneffy over similar treatments? EURneffy was determined by the European Medicines Agency (EMA) to be interchangeable with injection products given it provides the comparable exposures to epinephrine (adren

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pharmaphorum

OCTOBER 23, 2024

Novo Nordisk has asked the FDA to stop compounding pharmacies making cheaper versions of its semaglutide-based therapies for obesity and diabetes, saying the drug is too complex to be made safely by these manufacturers.

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Fierce Pharma

OCTOBER 1, 2024

Johnson & Johnson is laying off 231 employees in New Jersey and Bayer is cutting 57 positions in the state, according to separate Worker Adjustment and Retraining Notification (WARN)

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PharmaVoice

OCTOBER 28, 2024

As antimicrobial resistance rises, researchers are running out of time to fight each new wave of superbugs. And the funding isn’t enough.

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Healthcare Success

OCTOBER 17, 2024

Struggling with burnout while maintaining high-quality healthcare services that patients love? Tune in to our latest podcast as Lee Aase, founder of HELPCare, LLC, shares how he transitioned from his pioneering social media work at Mayo Clinic to lead an innovative membership-based direct-to-patient healthcare business. This podcast is a must-listen for healthcare leaders and primary care practitioners seeking innovative ways to enhance patient access, optimize care delivery, and address challen

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Impetus Digital

OCTOBER 29, 2024

Pharma-exclusive Webinar: Next-gen Virtual Tools for Education & Learning in the Life Sciences About the webinar Join us for one of three webinar sessions, tailored exclusively for Pharma leaders. Between November 18–20, we will delve into the future of educational tools in the life sciences industry. Our expert speakers will unveil the latest virtual tools that are reshaping how professionals engage with and educate HCPs, patients, and internal teams.

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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

Patients

pharmaphorum

OCTOBER 14, 2024

Eli Lilly may invest $364m in the UK and work with the government to tackle serious public health challenges including obesity.

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Government 142

MedCity News

OCTOBER 29, 2024

Large language models will soon become a much bigger part of doctors’ clinical workflows, former FDA Commissioner Scott Gottlieb said Tuesday at the 3rd Annual Summit on the Future of Rural Health Care. The post ‘You Almost Have to Be Doing It’: Why Scott Gottlieb Thinks All Doctors Will Use LLMs Soon appeared first on MedCity News.

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Fierce Pharma

OCTOBER 31, 2024

Less than a month after the FDA removed Eli Lilly’s tirzepatide from its shortage list, the agency has done the same for Novo Nordisk’s rival GLP-1 semaglutide, potentially signaling the end of a d | The FDA this week revised its shortage list to note that the.25 mg starter dose of Novo’s semaglutide-based obesity med Wegovy is now available in the U.S.

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PharmaVoice

OCTOBER 9, 2024

Katelyn Jetelina, well known for her newsletter “Your Local Epidemiologist,” digs into the H5N1 outbreak, the public health response and what’s next for vaccinations.

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PharmaTech

OCTOBER 10, 2024

Five speakers discussed the impact of the COVID-19 pandemic, the rise of artificial intelligence, more women in leadership tracks in the industry, and various emerging technologies.

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Pharmaceutical Technology

OCTOBER 14, 2024

Trends in gene therapy approvals in recent years are rapidly shaping the future of manufacturing capabilities in the pharmaceutical industry.

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pharmaphorum

OCTOBER 22, 2024

Otsuka is hoping to file for approval of its anti-APRIL antibody sibeprenlimab as a treatment for kidney disorder IgA nephropathy (IgAN) after the drug hit the target in a phase 3 trial.The Japanese drugmaker said that interim results from the 530-patient VISIONARY study showed that sibeprenlimab achieved a statistically significant and clinically meaningful reduction in 24-hour urine protein-to-creatine ratio (uPCR) – a measure of how well the kidneys are working – after nine months of treatmen

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MedCity News

OCTOBER 30, 2024

After the FDA delayed the approval of MDMA-assisted therapy for PTSD, there’s still a way forward for psychedelic medicines, experts said at HLTH. The post What’s Next for Psychedelic Medicines? appeared first on MedCity News.

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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.

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Fierce Pharma

OCTOBER 22, 2024

Activist investor Starboard Value is baring its teeth at Pfizer management, more openly going after CEO Albert Bourla’s job. | Activist investor Starboard Value is baring its teeth at Pfizer management, more openly going after CEO Albert Bourla’s job in a new presentation.

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Management 325

PharmaVoice

OCTOBER 15, 2024

A Nobel Prize in chemistry for Google’s DeepMind protein-structure mapping is the tip of the iceberg for advances in drug discovery and development.

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PharmaTech

OCTOBER 23, 2024

This article presents an overview of FDA’s recent update to the guidance document, Control of Nitrosamine Impurities in Human Drugs.

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FDA 111

Pharmaceutical Technology

OCTOBER 18, 2024

An 800% increase in licensing deal values indicates growing confidence in mRNA technology, but some vaccine producers are facing lawsuits.

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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

OCTOBER 30, 2024

Eli Lilly says a new starting dose regimen for its Alzheimer's disease therapy Kisunla reduces the risk of side effects that have stood in the way of approvals and reimbursement decisions for drugs in its class.Simply shifting one vial of the anti-amyloid antibody from the first infusion to the third infusion of the titration phase of dosing – the period used to achieve therapeutic levels in the body – is enough to lower the incidence of a potentially serious side effect known as ARIA-E, accordi

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Side effects 103

MedCity News

OCTOBER 24, 2024

Despite the challenges of interoperability, regulatory compliance, technology adoption, and data privacy, the benefits of digital health are undeniable. Collaboration between policymakers, clinicians, IT developers, and patients, can help overcome these obstacles. The post The Convergence of Digital Health and Life Sciences appeared first on MedCity News.

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Fierce Pharma

OCTOBER 18, 2024

After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy. | Astellas' Vyloy won an FDA approval to treat gastric or gastroesophageal junction adenocarcinoma patients whose tumors are CLDN18.2 positive. The drug was rejected earlier this year thanks to observations raised during the agency's inspection of a third-party manufacturing facility.

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PharmaVoice

OCTOBER 16, 2024

Even drugs with “blockbuster potential” often fall short of expectations. Here’s what can help a new medication pass the $1 billion mark.

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Medical 115

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Pharmaceutical Commerce

OCTOBER 11, 2024

The now-11-year odyssey to track drugs by item through the supply chain will be under a regulatory exemption for up to two years.

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FDA 111

Pharmaceutical Technology

OCTOBER 7, 2024

The CD7 CAR)-T cell therapy has demonstrated potential in treating patients with relapsed or refractory T-cell leukaemia.

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Patients 121

pharmaphorum

OCTOBER 21, 2024

An antiretroviral combination developed by Gilead and MSD suppressed HIV with a single weekly oral dose in a phase 2 trial reported at IDWeek 2024

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MedCity News

OCTOBER 24, 2024

This week at HLTH, FDA Commissioner Robert Califf discussed the current state of healthcare AI. He talked about some of the qualms he has, such as his worry that AI is worsening health inequities and his concern that providers aren’t capable of validating AI tools’ effectiveness. The post 4 Things That Worry FDA Commissioner Robert Califf appeared first on MedCity News.

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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