October, 2024

article thumbnail

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.

Pharma 125
article thumbnail

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

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.

145
145
article thumbnail

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.

article thumbnail

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

article thumbnail

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

article thumbnail

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.

More Trending

article thumbnail

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.

article thumbnail

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.

142
142
article thumbnail

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

article thumbnail

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.

Pharma 109
article thumbnail

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.

article thumbnail

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.

FDA 112
article thumbnail

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.

Medicine 121
article thumbnail

GSK takes mRNA patent fight to Moderna, suing over vaccines for COVID and RSV

Fierce Pharma

Nearly six months after lodging a similar complaint against Pfizer and BioNTech over the partners’ COVID shot Comirnaty, GSK is targeting Moderna in a pair of lawsuits alleging the Massachusetts-ba | GSK is targeting Moderna in a pair of lawsuits claiming the mRNA specialist violated multiple patents with its vaccines Spikevax and mRESVIA. In the complaints, GSK says it hopes to recover a “reasonable royalty” tied to Moderna’s vaccine sales, plus damages.

Sales 326
article thumbnail

‘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.

122
122
article thumbnail

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

article thumbnail

Prior Authorization: Why It’s Essential in Healthcare

Referral MD

Prior authorization is a crucial healthcare topic related to the relationship between a patient, their healthcare provider, and the insurance company. This blog will outline everything you need to know about prior authorization , its definition, and its importance to healthcare. What is prior authorization? A patient’s physician or healthcare provider can decide what treatment the patient needs.

article thumbnail

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.

111
111
article thumbnail

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

Patients 109
article thumbnail

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.

FDA 124
article thumbnail

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.

article thumbnail

In boon for Pfizer and Merck, CDC panel backs expanded use of pneumococcal vaccines

Fierce Pharma

With an expanded recommendation from the Center for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP), pneumococcal conjugate vaccines (PCV) from Pfizer and | The CDC's immunization committee voted to expand the recommendation for pneumococcal conjugate vaccines, including both Pfizer’s Prevnar 20 and Merck’s newer Capvaxive.

315
315
article thumbnail

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.

116
116
article thumbnail

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.

FDA 111
article thumbnail

Pharma companies must adapt to keep pace with AI developments, say experts

Pharmaceutical Technology

At the Outsourcing in Clinical Trials Conference, key opinion leaders shared predictions for workflow changes due to AI.

Pharma 115
article thumbnail

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

article thumbnail

Sanofi invests €300m in Orano Med's lead-based radioligands

pharmaphorum

Sanofi invests €300m in Orano Med's lead-based radioligandsSanofi has firmed up its position in the red-hot area of radiopharmaceuticals for cancer with the purchase of a €300 million ($325 million) stake in Orano Med, a subsidiary of French nuclear fuel company Orano.The transaction builds on a three-way partnership between Sanofi, Orano Med, and RadioMedix – signed in September with a €100 million upfront payment – to develop a radioligand therapy (RLT) for rare neuroendocrine tumours (NETs) c

Leads 110
article thumbnail

Wearable Tumor-Zapping Medical Device Wins FDA Approval for Lung Cancer

MedCity News

The FDA approved Novocure medical device Optune Luna as a treatment for advanced cases of non-small cell lung cancer. The wearable technology delivers electrical fields that kill cancer cells. The post Wearable Tumor-Zapping Medical Device Wins FDA Approval for Lung Cancer appeared first on MedCity News.

Medical 128
article thumbnail

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.

FDA 319
article thumbnail

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.

Medical 115
article thumbnail

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.

article thumbnail

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.

FDA 111
article thumbnail

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.

article thumbnail

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

article thumbnail

CGMs Aren’t Just for People with Diabetes Anymore, Dexcom COO Says

MedCity News

This week at HLTH, Dexcom COO Jake Leach discussed Stelo, his company’s new product. Stelo is an over-the-counter continuous glucose monitor meant for all adults who don’t take insulin. The post CGMs Aren’t Just for People with Diabetes Anymore, Dexcom COO Says appeared first on MedCity News.

Medical 123
article thumbnail

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