Mon.Jul 01, 2024

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Regulatory tracker: Sandoz, Samsung Bioepis gain FDA approval for biosimilar to J&J's Stelara

Fierce Pharma

Welcome to Fierce Pharma's regulatory tracker for the second half of 2024. | In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning.

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What Degree is Best For Medical Sales?

David Bagga

Medical Device Sales Academy What Degree is Best For Medical Sales? The healthcare industry, a significant driver of the economy and a key player in improving people’s lives, is poised for continued growth. This expansion is fueled by the increasing demand for healthcare services and tools, driven by an aging population and prevalent illnesses.

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Trending Sources

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After Gilead and J&J lawsuits, distributor Safe Chain sees its owners charged with wire fraud, conspiracy

Fierce Pharma

In yet another legal development surrounding counterfeit HIV drugs, a Florida court has handed down an indictment for the owners of a wholesale distributor that allegedly bought and redistribu | The wholesaler Safe Chain allegedly purchased $90 million of misbranded, diverted and adulterated HIV meds, according to U.S. authorities. The indictment of the company's three owners follows separate lawsuits from Gilead and Johnson & Johnson.

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AstraZeneca files rival to Pemgarda for COVID PrEP

pharmaphorum

AstraZeneca may have exited the COVID-19 vaccine market, but it is still hoping to protect vulnerable patients with its antibody sipavibart for pre-exposure prophylaxis (PrEP).The drugmaker said this morning that an application for sipavibart (AZD3152) has been accepted for review by the EMA as PrEP for immunocompromised patients who often do not respond adequately to vaccination alone and remain at high risk of serious outcomes from COVID-19.

Marketing 113
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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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GSK takes another Zantac personal injury case off its plate with settlement in Illinois

Fierce Pharma

GSK scratched another Zantac lawsuit off the list with a confidential settlement in Illinois as it continues to work through the mountain of personal injury litigation related to the heartburn pill | Following a win and a separate dismissal in Illinois, GSK agreed to a confidential settlement to resolve prostate cancer claims put forward by plaintiff Martin Gross.

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UK’s antibiotic subscription funding model – a route to market sustainability?

Pharmaceutical Technology

On 8 May, the UK was the world's first government to formally implement a new model for the funding and support of novel antibiotic commercialisation.

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More Trending

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CHMP meeting highlights – June 2024

European Pharmaceutical Review

At its recent June meeting, the EMA’s human medicines committee (CHMP) recommended 10 medicines for approval. Recommendations for regulatory approval The committee saw a need to give a marketing authorisation to Balversa (erdafitinib) as a treatment for adults with unresectable or metastatic urothelial carcinoma. In its meeting, the CHMP gave a positive opinion for the first nasally administered emergency treatment for allergic reactions.

Medicine 106
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As former BMS CEO Giovanni Caforio plots move to Novartis, will noncompete issues come into play?

Fierce Pharma

Fierce Pharma explored the status of the industry's noncompete clauses with experts to learn whether an intercompany transition at the highest levels can proceed without a hitch.

Pharma 184
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The Role of AI in Empowering Early Lung Cancer Detection & Transforming Patient Outcomes

MedCity News

AI-powered solutions for opportunistic lung cancer detection using routine chest X-rays offer hope for improved early diagnosis and survival rates. The post The Role of AI in Empowering Early Lung Cancer Detection & Transforming Patient Outcomes appeared first on MedCity News.

Patients 108
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Leveraging data and AI for clinical trial success

pharmaphorum

Over 90% of experimental therapies that reach human trials fail to make it to market. In today’s pharmaphorum podcast, Orr Inbar, co-founder and CEO of QuantHealth, a Tel Aviv-based AI-powered clinical trial design company, discusses how advances in data and AI can help. This includes cost-effectiveness. Ever a ‘game’ of risk-and-reward, leveraging data and technology can increase clinical trial success rates, bringing down the failure rate some 20%, potentially.

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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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One Conversation Could Be All It Takes to Identify Chronic Kidney Disease

MedCity News

No one should ever learn about CKD after their kidneys have already failed. The post One Conversation Could Be All It Takes to Identify Chronic Kidney Disease appeared first on MedCity News.

Patients 106
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Lilly builds in radiopharma with $140m Radionetics deal

pharmaphorum

Eli Lilly has lined up another deal in the radiopharmaceutical sector, paying $140 million to partner drugs developed by Radionetics Oncology and taking an option on buying the company outright for $1 billion.Radionetics is working on small-molecule drugs that target G protein-coupled receptors (GPCRs), a fertile source of drug targets for the pharma industry and the target of around a third of all marketed drugs but according to the company is a “largely unexplored” class for radiopharma.

Pharma 93
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K Health’s Latest Funding Round Brings the Primary Care AI Startup to $380M Raised

MedCity News

K Health closed a $50 million equity funding round, which brought its total fundraising amount to $380 million and propelled the startup to a $900 million valuation. The company, which was founded in 2016, uses AI to educate patients about their symptoms and connect them to primary care. The post K Health’s Latest Funding Round Brings the Primary Care AI Startup to $380M Raised appeared first on MedCity News.

Education 101
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France agrees to fund experimental glioblastoma therapy

pharmaphorum

France's HAS agrees to fund treatment with Carthera's ultrasound device for French subjects enrolled in a glioblastoma trial.

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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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5 Funding Announcements from Payer/Employer Companies In June

MedCity News

Here is a list of some of the biggest funding rounds in the payer/employer space that were announced in June. The post 5 Funding Announcements from Payer/Employer Companies In June appeared first on MedCity News.

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NeuroSense says ALS drug extends survival

pharmaphorum

NeuroSense Tx reports 12-month data with its amyotrophic lateral sclerosis therapy PrimeC, including a 43% improvement in survival

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How to Market Sensitive Healthcare Topics: A Guide

Healthcare Success

When my wife Clara met her new workout trainer, he asked, “What can I help you with?” She replied with a smile, “menopause.” She elaborated, “My doctor helps me with hormone therapy, and I work out five days a week at a boot camp. But I feel stuck with the way I look and feel. I want to lose fat, build muscle, and feel healthier.” When she shared this story with me, we laughed and remarked on how far things have come in recent years.

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Eli Lilly Puts $1B on the Line to Expand its Cancer Radiopharmaceuticals Prospects

MedCity News

Eli Lilly is paying $140 million for the exclusive right to buy Radionetics Oncology for the price of $1 billion. The clinical-stage startup, a Crinetics Pharmaceuticals spinout, develops radiopharmaceuticals that target GPCRs overexpressed by solid tumors. The post Eli Lilly Puts $1B on the Line to Expand its Cancer Radiopharmaceuticals Prospects appeared first on MedCity News.

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

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First Nasal Adrenaline Spray Among EMA Approvals in June

PharmaTech

EMA’s CHMP gave positive opinions on a nasal delivery for epinephrine and for a first-in-class medicine to treat pulmonary arterial hypertension, among others, including a biosimilar for treatment of autoimmune diseases.

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Risk adjusted net present value: What is the current valuation of Pfizer’s Atirmociclib?

Pharmaceutical Technology

Atirmociclib is a small molecule commercialized by Pfizer, with a leading Phase III program in Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer).

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ICL granted £150,000 to explore link between breast cancer and breastfeeding

PharmaTimes

Breast cancer is the most common cancer in the UK, accounting for 15% of all cancers

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Maximizing Your Content Investment

Eversana Intouch

Repurposing content is a smart strategy that can enhance your content marketing efforts without breaking the bank. Specifically in pharmaceutical marketing, effective content repurposing can streamline efforts, maintain compliance and enhance brand engagement. In this POV, EVERSANA INTOUCH’s content strategy experts, Carrie Bolin and Jesse Brown, dive into the benefits and practical steps for effective content repurposing for your brand.

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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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University of Liverpool launches new biotech spin-out company Galytx

PharmaTimes

The biotech company will develop novel therapeutic drugs for the treatment of fatal diseases

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Risk adjusted net present value: What is the current valuation of Vertex Pharmaceuticals’s Suzetrigine?

Pharmaceutical Technology

Suzetrigine is a small molecule commercialized by Vertex Pharmaceuticals, with a leading Phase III program in Post-Operative Pain.

Leads 75
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J&J adds another string to nipocalimab bow with gMG data

pharmaphorum

Johnson & Johnson has reported new phase 3 data with its FcRn blocker nipocalimab in generalised myasthenia gravis (gMG), pointing to data that it says differentiates it from other drugs in the class.The results from the Vivacity-MG3 study, presented at the European Academy of Neurology (EAN), show an improvement with nipocalimab compared to placebo on activities of daily living scores that have not been seen with other FcRn inhibitors, according to J&J.

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Risk adjusted net present value: What is the current valuation of Atai Life Sciences’s RL-007?

Pharmaceutical Technology

RL-007 is a small molecule commercialized by Atai Life Sciences, with a leading Phase II program in Diabetic Neuropathic Pain.

Leads 75
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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AI’s Promise in Delivering on Patient-Centricity

PharmExec

How pharmaceutical companies can utilize AI at key stages of the treatment journey to enhance patient-centric engagement by increasing empathy and humanity in patient interactions.

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TauRx seeks UK MHRA approval for Alzheimer’s treatment

Pharmaceutical Technology

TauRx Pharmaceuticals has filed an application with the UK MHRA seeking approval for hydromethylthionine mesylate (HMTM) to treat Alzheimer’s.

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The IRA will lower U.S. drug spending, CMS finds — but not for awhile

PharmaVoice

As the first 10 drugs undergo price negotiations with the U.S. government, the latest spending projections reveal soon-to-be-implemented price caps will have an impact by 2027.

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Risk adjusted net present value: What is the current valuation of Pfizer’s Osivelotor?

Pharmaceutical Technology

Osivelotor is a small molecule commercialized by Pfizer, with a leading Phase III program in Sickle Cell Disease.

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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