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.

Pharma 331
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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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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 119
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State of AI in Sales & Marketing 2025

AI adoption is reshaping sales and marketing. But is it delivering real results? We surveyed 1,000+ GTM professionals to find out. The data is clear: AI users report 47% higher productivity and an average of 12 hours saved per week. But leaders say mainstream AI tools still fall short on accuracy and business impact. Download the full report today to see how AI is being used — and where go-to-market professionals think there are gaps and opportunities.

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Building Rapport In Sales Is An Essential Selling Skill – Here’s Why

Integrity Solutions

Building rapport in sales is essential for establishing trust and fostering long-term relationships with clients. While technology has made it easier than ever for buyers to access information, B2B buyers in particular are looking for insights and advice from a salesperson they can trust and who they believe has their best interests in mind to help them make good decisions.

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More Trending

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Going In Reverse Is Faster Way Forward for Crescent Bio’s Cancer Immunotherapy

MedCity News

Crescent Biopharma is going public via a reverse merger with GlycoMimetics that will capitalize the combined company with $200 million. Crescent’s lead program is a bispecific antibody for cancer that replicates the properties of a Summit Therapeutics bispecific drug that recently trounced Merck’s blockbuster med Keytruda in a pivotal head-to-head study.

Biopharma 299
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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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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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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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The Intersection of AI and Sales: Personalization Without Compromise

Speaker: Jesse Hunter and Brynn Chadwick

Today’s buyers expect more than generic outreach–they want relevant, personalized interactions that address their specific needs. For sales teams managing hundreds or thousands of prospects, however, delivering this level of personalization without automation is nearly impossible. The key is integrating AI in a way that enhances customer engagement rather than making it feel robotic.

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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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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 284
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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.

Sales 252
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Biogen, Sage Therapeutics Drop Plans to Develop Partnered Drug in Major Depressive Disorder

MedCity News

The FDA had asked Biogen and Sage Therapeutics to provide more clinical data supporting Zurzuvae in major depressive disorder. Citing the time and expense of additional clinical trials, the partners decided against further development in this indication The post Biogen, Sage Therapeutics Drop Plans to Develop Partnered Drug in Major Depressive Disorder appeared first on MedCity News.

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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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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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AbbVie Adds Another Alzheimer’s Prospect With $1.4B Aliada Therapeutics Acquisition

MedCity News

Aliada brings AbbVie an early clinical Alzheimer’s disease drug candidate as well as the platform technology that produced it. Aliada licensed its brain delivery technology from Johnson & Johnson. The post AbbVie Adds Another Alzheimer’s Prospect With $1.4B Aliada Therapeutics Acquisition appeared first on MedCity News.

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Eli Lilly's tirzepatide products come up more than $1B short of expectations in Q3

Fierce Pharma

Sales of Eli Lilly’s diabetes and weight loss drugs fell far short of expectations in the third quarter, leading the juggernaut company to reduce its annual revenue guidance and triggering speculat | Sales of Eli Lilly’s diabetes and weight loss drugs fell far short of analyst expectations in the third quarter, leading the juggernaut company to reduce its annual revenue guidance and triggering speculation that skyrocketing demand for the blood sugar modulating treatments has maxed out.

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Seaport Therapeutics Secures $225M for New Kind of Depression Drug

MedCity News

Seaport Therapeutics’ Series B financing was one of the largest rounds of funding in our recap of biotech financing news, which spans startups developing drugs for neurological diseases, cancer, immunology, and more. The post Seaport Therapeutics Secures $225M for New Kind of Depression Drug appeared first on MedCity News.

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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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Novo Nordisk asks FDA to prevent compounders from making copycat versions of GLP-1 star semaglutide

Fierce Pharma

The war is on between compounding pharmacies making knockoff versions of popular weight loss drugs and pharma giants Novo Nordisk and Eli Lilly, who want to protect their right to sell their patent | Novo Nordisk has asked the FDA to prevent compounders from manufacturing copycat versions of its juggernaut diabetes and obesity treatments Ozempic and Wegovy, claiming the drugs are too complex to safely replicate.

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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

Leads 215
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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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Novartis falls short in legal effort to undo FDA approval of MSN's Entresto generic

Fierce Pharma

As a host of generics circle the gates, Novartis has lost another bid to waylay MSN Pharmaceuticals’ copycat of the Swiss pharma’s top-selling drug Entresto. | In a court decision filed in Washington, D.C., U.S. District Judge Dabney Friedrich rejected Novartis’ position that the FDA’s approval of MSN’s Entresto generic was unlawful. In issuing the decision, the judge upheld the green light that MSN won in July.

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

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UK's Labour Party unveils £520M innovative manufacturing fund as part of life-sci-heavy budget

Fierce Pharma

Biopharma production efforts are set to receive a big boost in the U.K. thanks to a new budget rolled out by the Labour Party following this summer’s general election. | As part of the new budget presented Wednesday by the U.K.’s Chancellor of the Exchequer, Rachel Reeves, the country is debuting a new capital grants vehicle known as the Life Sciences Innovative Manufacturing Fund.

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Astellas doesn't see eye to eye with Europe on geographic atrophy drug Izervay

Fierce Pharma

While Astellas’ Izervay and Apellis’ Syfovre battle for market share in geographic atrophy (GA) in the United States, both companies are struggling to reach patients in the indication in Europe.&nb | While Astellas’ Izervay and Apellis’ Syfovre battle for market share in geographic atrophy (GA) in the United States, both companies are struggling to reach patients in the indication in Europe.

Medicine 233
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Teva hands over $450M to resolve kickback lawsuits involving MS drug Copaxone and generics

Fierce Pharma

A little over four years after being sued by the United States, Teva is putting longstanding allegations that it paid kickbacks on a popular multiple sclerosis drug to bed. | Teva Pharmaceuticals USA and Teva Neuroscience have agreed to pay a combined $450 million to resolve claims that the company violated the United States' Anti-Kickback Statute and the False Claims Act, the U.S.

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Novartis' Pluvicto enters FDA orbit for expansion bid as agency requests 'flexibility'

Fierce Pharma

As expected, Novartis’ radioligand therapy Pluvicto crossed the blockbuster sales threshold with one quarter still left of 2024. | Novartis didn't use a priority review voucher for Pluvicto's key application in an earlier treatment setting of prostate cancer. The company made the decision in response to the FDA's request for "flexibility" in its review timeline, Novartis CEO Vas Narasimhan explained.

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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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Amgen pledges to launch Eylea biosim after legal win—but Regeneron stresses the fight's not over yet

Fierce Pharma

While Regeneron may have lost its latest bid to block the launch of Amgen’s Eylea biosimilar Pavblu, the New York-based pharma isn’t throwing in the towel just yet. | Amgen is preparing to launch its Eylea biosimilar, Pavblu, after another victory over Regeneron in court. That said, Regeneron is appealing the decision and stressed that it continues to believe Amgen's copycat infringes multiple Eylea patents.

Pharma 215
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CDMO Samsung Biologics bags $1.2B production contract, bringing total 2024 deal value to $3.3B+

Fierce Pharma

With multiple high-profile production pacts already in the books for 2024, CDMO Samsung Biologics has hooked another big one. | Following a string of high-profile deals, Samsung Biologics has locked down a $1.2 billion contract with an unnamed Asia-based pharmaceutical company that’s expected to run through December 2037. Samsung did not elaborate on the identity of its new partner or the types of drugs it will help produce under the accord.

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Bristol Myers partner Zai Lab plots KarXT filing in China after trial win

Fierce Pharma

After the recent FDA approval for the promising schizophrenia drug Cobenfy (xanomeline and trospium chloride), Bristol Myers Squibb and its partners are moving fast to expand the global reach of th | In a phase 3 bridging study run by Zai Lab in China, Bristol Myers Squibb's KarXT helped schizophrenia patients chart a 9.2-point total-score reduction on the Positive and Negative Syndrome Scale versus placebo at week 5, teeing up a forthcoming regulatory filing.

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