October, 2024

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How Generative AI Will Find a Place in the Pharma Industry Now and in the Years to Come

MedCity News

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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Novartis, Apellis drop dueling datasets as they race for approval in rare form of kidney disease

Fierce Pharma

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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The 2024 PharmaVoice 100

PharmaVoice

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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Community Pharmacies in Crisis: Navigating the Challenges and Closures

Pharmaceutical Commerce

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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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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Innovating allergy drug delivery with a needle-free alternative

European Pharmaceutical Review

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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Novo joins Lilly in asking FDA for ban on GLP-1 compounding

pharmaphorum

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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Big Pharma's layoff wave in New Jersey rolls on with hundreds of J&J cuts, 57 at Bayer

Fierce Pharma

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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On the front lines of the superbug war, new treatments can’t arrive soon enough

PharmaVoice

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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Direct to Patient Healthcare

Healthcare Success

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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Next-gen Virtual Tools for Education & Learning in the Life Sciences

Impetus Digital

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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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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Lilly pledges £279m to UK for biotech hub and obesity plan

pharmaphorum

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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‘You Almost Have to Be Doing It’: Why Scott Gottlieb Thinks All Doctors Will Use LLMs Soon

MedCity News

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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FDA removes Novo's Wegovy from shortage list, marking end of semaglutide supply rout in US

Fierce Pharma

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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‘It’s been hard to watch.’ A noted epidemiologist talks H5N1 and the U.S.’s fragmented response

PharmaVoice

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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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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CPHI Milan 2024: What Does the Future Pharma Workforce Look Like?

PharmaTech

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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Cell and gene therapy approvals drive paradigm change in manufacturing

Pharmaceutical Technology

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

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Otsuka eyes early filing of IgAN drug after phase 3 readout

pharmaphorum

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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What’s Next for Psychedelic Medicines?

MedCity News

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

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Starboard wants to hold Pfizer leadership 'accountable' for overpaid M&A deals, poor return on R&D investment

Fierce Pharma

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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AlphaFold’s Nobel Prize is ‘the dawn of a new era’ in mapping drug development potential

PharmaVoice

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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What Does the FDA's Recent Update of the Nitrosamine Guidance Convey?

PharmaTech

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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mRNA licensing agreements surge 800% amid GSK lawsuits

Pharmaceutical Technology

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

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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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Lilly touts new Kisunla regimen that reduces side effects

pharmaphorum

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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The Convergence of Digital Health and Life Sciences

MedCity News

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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Astellas nabs class-first FDA approval for CLDN18.2 gastric cancer med Vyloy

Fierce Pharma

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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Want to launch a blockbuster? An AstraZeneca exec breaks it down.

PharmaVoice

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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Facing Potential Drug Shortages, FDA Delays Enforcement of DSCSA Compliance Deadline, with Stipulations

Pharmaceutical Commerce

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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NUHS’s CD7 CAR-T cell therapy shows promise for leukaemia

Pharmaceutical Technology

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

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Gilead, MSD say HIV combo could be weekly, oral HIV drug

pharmaphorum

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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4 Things That Worry FDA Commissioner Robert Califf

MedCity News

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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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A