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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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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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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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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How Enterprise Architecture is Reshaping Modern Medicine

Pharma IQ

Discover how Enterprise Architecture is transforming healthcare operations, enhancing patient care, and addressing technical debt in the industry.

Medicine 130
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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.

More Trending

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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.

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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

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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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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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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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Insilico Medicine reports positive results for idiopathic pulmonary fibrosis therapy

PharmaTimes

ISM001-055 shows promise in improving lung function among patients

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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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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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Biogen shows its IgAN hand with felzartamab data

pharmaphorum

Biogen has revealed encouraging phase 2 results with its anti-CD38 antibody felzartamab in rare kidney disease IgA nephropathy (IgAN), which it hopes could join a series of first-in-class therapies for the disorder.Data reported at the Kidney Week 2024 congress in San Diego showed that felzartamab was able to achieve "substantial" reductions in proteinuria and stabilised kidney function in the 54-subject IGNAZ study that extended for 18 months after the last dose of the antibody.

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

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Where Big Pharma’s campaign cash is flowing in this election

PharmaVoice

Big Pharma CEOs are hedging all bets by supporting both sides of the aisle in the 2024 election.

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It's a monster MASH for Madrigal as Rezdiffra has caught on in a flash

Fierce Pharma

Forget about the “bumpiness” analysts expected from Madrigal Pharmaceuticals’ launch of potentia | Forget about the “bumpiness” analysts expected from Madrigal Pharmaceuticals’ launch of potential blockbuster Rezdiffra. In its second full quarter on the market, the fatty liver disease drug racked up sales of $62 million, which routed Wall Street's expectations and triggered a 16% surge in Madrigal's share price.

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After prior trial flop, EyePoint's Duravyu bounces back with promising data in DME

Fierce Pharma

Earlier this year, EyePoint Pharmaceuticals’ drug-device combo Duravyu missed the mark in a non-proliferative diabetic retinopathy (NPDR) study, raising doubts about the product’s potential in seve | EyePoint released new diabetic macular edema data Monday that a Mizuho Securities analyst described as "very promising." The trial win provides a needed turnaround for the company's lead candidate Duravyu, which failed a study in non-proliferative diabetic retinopathy earlier this yea

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Pfizer lays off 75 more workers in North Carolina in wake of late-stage DMD trial fail

Fierce Pharma

Pfizer has told 75 employees in Sanford, North Carolina, that their positions have been eliminated. | Pfizer has told 75 employees in Sanford, North Carolina, that their positions have been eliminated. The layoffs come three months after the company axed 150 positions in Sanford following a high-profile phase 3 trial failure for its Duchenne muscular dystrophy gene therapy candidate.

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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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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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AstraZeneca heads to regulators after Airsupra asthma trial stops early thanks to 'overwhelming efficacy'

Fierce Pharma

After winning a first-in-class nod for its two-drug inhaler Airsupra l | After winning a first-in-class nod for its two-drug inhaler Airsupra last January, AstraZeneca is bolstering the rescue treatment’s clinical package with new data showing it can cut the risk of asthma exacerbations regardless of patients’ disease severity.

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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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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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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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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.

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After prior rejection, Iterum nabs long-sought FDA nod for oral UTI drug Orlynvah

Fierce Pharma

Despite recent concerns from the FDA about potential off-label use and antimicrobial resistance, Dublin-based Iterum Therapeutics has scored a green light for its oral antibiotic sulopenem. | Iterum's Orlynvah was approved by the FDA Friday to treat certain uncomplicated urinary tract infections (uUTIs) in adult women who have limited or no alternative antibacterial treatment options.

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Novo plots US, EU approval filings after oral semaglutide shows cardio benefits in certain diabetes patients

Fierce Pharma

As Novo Nordisk’s injectable diabetes-obesity duo Ozempic and Wegovy grab all the limelight, an oral version of the semaglutide drug showed it can provide heart-related benefits, too. | As Novo Nordisk’s injectable diabetes-obesity duo Ozempic and Wegovy grab all the limelight, an oral version of the semaglutide drug showed it can provide heart-related benefits, too.

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Baxter to import 18,000 tons of IV product by year-end as hurricane recovery efforts continue in NC

Fierce Pharma

As recovery efforts at the North Carolina plant hit by Hurricane Helene move at an “encouraging pace,” Baxter International is laying out new details on a sweeping importation plan to help critical | Baxter has said the first IV product shipments cleared by the FDA for temporary importation are set to arrive in the U.S. this weekend. By the end of the year, the company expects nearly 18,000 tons of product from Europe and Asia to reach The States.

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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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Gilead strikes licensing deals with 6 generics makers to boost access to long-acting HIV PrEP med

Fierce Pharma

Gilead Sciences is wasting no time in promoting worldwide access to its twice-yearly pre-exposure prophylaxis (PrEP) HIV candidate lenacapavir. | The company will allow six generic manufacturers to make and sell its long-acting PrEP drug, lenacapivir, in 120 resource-limited countries.

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Aspen Neuroscience, underway with Parkinson's cell therapy trial, bolsters manufacturing with new San Diego facility

Fierce Pharma

Aspen Neuroscience, underway with Parkinson's cell therapy trial, bolsters manufacturing with new San Diego facility fkansteiner Wed, 10/02/2024 - 07:31

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Compounders sue FDA for removing Eli Lilly's tirzepatide from shortage list

Fierce Pharma

With an estimated 2 million people in the United States taking copycat vers | A compounding industry group has sued the FDA, claiming its action to remove Eli Lilly’s Mounjaro and Zepbound from its drug shortage list is a “reckless and arbitrary decision—lacking any semblance of lawful process.” In declaring the end of the shortage, the FDA has halted the ability of compounding pharmacies to manufacture the in-demand products.

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J&J's Erleada prevails over Astellas, Pfizer’s Xtandi in real-world prostate cancer study

Fierce Pharma

While they were both approved several years back to treat the same two types of prostate cancer, Astellas and Pfizer’s Xtandi has held a larger slice of the market than Johnson & Johnson’s riva | A real-world, head-to-head study of two androgen receptor pathway inhibiting (ARPI) prostate cancer drugs indicates that Johnson & Johnson’s Erleada provides an edge in overall survival versus Astellas and Pfizer’s Xtandi.

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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