Sat.Mar 23, 2024 - Fri.Mar 29, 2024

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Leveraging Digital Tools to Optimize Manufacturing Processes

Pharmaceutical Commerce

In this Pharmaceutical Commerce video interview, Barry Heavey, Life Sciences Supply Chain Lead, Accenture, discusses how companies can leverage digital tools like artificial intelligence and machine learning to optimize manufacturing processes and ensure efficient production.

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BioNTech hit with 'notice of default' from NIH in COVID-19 vaccine royalty dispute

Fierce Pharma

Even as Germany's BioNTech deals with ongoing declines of its revenue and share price, it's facing another serious concern: U.S. | Even as Germany's BioNTech deals with ongoing declines of its revenue and share price, it's facing another serious concern: U.S. officials are pressing the company to pay royalties linked to the commercialization of its lucrative Pfizer-partnered COVID-19 vaccine.

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Nanoscope preps filing for retinitis pigmentosa gene therapy

pharmaphorum

Nanoscope Therapeutics is on the brink of filing for FDA approval of what could be the first gene therapy for incurable eye disease retinitis pigmentosa (RP) that can be used regardless of underlying genetic mutations.

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Merck Drug for Heart and Lung Disorder Wins a First-in-Class FDA Approval

MedCity News

Merck drug Winrevair is the first in a new class of pulmonary arterial hypertension therapies that address a key signaling pathway behind the disease. The drug comes from Merck’s $11.5 billion acquisition of Acceleron Pharma.

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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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Next-gen Moderna COVID-19 vaccine shows promise

European Pharmaceutical Review

Moderna’s next-generation COVID-19 vaccine mRNA-1283 demonstrated a higher immune response against SARS-CoV-2, interim results from the company’s Phase III trial show. These findings were based on data comparing the treatment to mRNA-1273.222 (Spikevax ® ), Moderna’s licensed vaccine for the condition. “We are excited to announce our fourth infectious disease vaccine programme with positive Phase III data,” stated Stéphane Bancel, Chief Executive Officer of Moderna. “mRNA

Safety 110
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In banner year, Lilly rewards CEO David Ricks with 24% boost in total pay to $26.6M

Fierce Pharma

In 2023, Eli Lilly CEO David Ricks received a 24% boost in pay from $21.4 million to $26.6 million. The increase coincides with the company's booming sales.

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How Can Digital Health Startups Stand Out In Today’s Landscape?

MedCity News

During a recent panel, Flare Capital Partners’ Michael Greeley and Mount Sinai’s Robbie Freeman shared some attributes that they think stand out among digital health startups that have found success in today’s environment.

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Who’s getting left behind in the weight loss bonanza?

PharmaVoice

As the new weight loss drugs take the world by storm, companies in other areas are battening the hatches for when slimmer patients need fewer medical interventions.

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Merck scores key FDA approval for pulmonary arterial hypertension drug Winrevair

Fierce Pharma

After three years, the crown jewel of Merck’s $11.5 billion acqu | After three years, the crown jewel of Merck’s $11.5 billion acquisition of Acceleron is ready to pay dividends. With the FDA’s approval of Winrevair (sotatercept) to treat pulmonary arterial hypertension (PAH), Merck is set to launch the first disease-modifying treatment for the condition.

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Novo Nordisk agrees $1.1bn takeover of RNA biotech Cardior

pharmaphorum

Novo Nordisk has agreed to buy Cardior Pharmaceuticals for $1.1 billion, adding expertise in RNA therapeutics and a heart failure therapy in mid-stage trials.

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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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AbbVie Gets Another Ulcerative Colitis Contender via $137M Landos Acquisition

MedCity News

AbbVie is acquiring Landos Biopharma, whose lead drug is a small molecule that takes a novel approach to treating ulcerative colitis. Preliminary proof-of-concept data from a Phase 2 study are expected later this year.

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The Rising Tide of Biopharma Manufacturing Costs

Pharmaceutical Commerce

In this Pharmaceutical Commerce video interview, Barry Heavey, Life Sciences Supply Chain Lead, Accenture, discusses the specific factors contributing to rising manufacturing costs.

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With Merck's key PAH approval on tap, Johnson & Johnson wins nod for combo tablet

Fierce Pharma

With the FDA expected this week to approve a first-in-class treatment from Merck for pulmonary arterial hypertension (PAH), Johnson & Johnson has beaten its New Jersey rival to the punch with a | With the FDA expected this week to approve a first-in-class treatment from Merck for pulmonary arterial hypertension (PAH), Johnson & Johnson has beaten its New Jersey rival to the punch with a nod from the U.S. regulator for its newest PAH treatment.

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Brainomix AI shows its worth in AZ pulmonary fibrosis trial

pharmaphorum

Brainomix's e-Lung AI can accurately identify idiopathic pulmonary fibrosis patients most likely to progress and could inform the clinical trial design for new therapies

Patients 111
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Boundless Bio’s ‘BOLD’ IPO Reels In $100M for a New Kind of Cancer Drug

MedCity News

Cancer drug developer Boundless Bio is a pioneer in therapies that target extrachromosomal DNA. The IPO cash will support its pipeline, including a lead program on track to report preliminary data later this year.

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Are Adults With Diabetes Who Switch to High-Deductible Health Plans at Greater Risk for Complications?

Pharmaceutical Commerce

A study of patients with the long-term conditions who are required to switch to high-deductible health plans could potentially be more likely to experience diabetes complications than those who stay in standard insurance plans.

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Intelligence officials warned lawmakers WuXi AppTec furnished China with client's intellectual property: Reuters

Fierce Pharma

An alleged development in the national security crackdown against WuXi AppTec and a handful of other Chinese companies in the U.S. | An alleged development in the national security crackdown against WuXi AppTec and a handful of other Chinese companies in the U.S. suggests intelligence officials and lawmakers may have good reason to be concerned about the CDMO’s potential political ties to its home country.

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FDA turns down Regeneron bispecific blood cancer antibody

pharmaphorum

FDA has turned down a pair of marketing applications for Regeneron’s CD20xCD3 bispecific antibody odronextamab to treat two common forms of non-Hodgkin lymphoma

FDA 108
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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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Novocure’s Electrical Cancer Therapy Shows It Can Treat Tumors in the Brain

MedCity News

Novocure said its “Tumor Treating Fields” met the main goal of a pivotal study enrolling non-small cell lung cancer patients with brain metastases. However, results for the electricty-based treatment fell short of statistical significance on several secondary endpoints.

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Novel LAI antipsychotic approved in EU

European Pharmaceutical Review

The first once-every-two-months long-acting injectable (LAI) antipsychotic approved by the European Commission (EC) is authorised as maintenance treatment for adults with schizophrenia in the EU. The European Commission’s decision for this formulation of Abilify Maintena ® 960mg (aripiprazole) is applicable to all EU Member States, in addition to Iceland, Norway and Liechtenstein.

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Caring Cross, Brazil's Fiocruz team up to produce cell and gene therapies at a fraction of their cost in the US

Fierce Pharma

Maryland non-profit Caring Cross has unveiled a partnership with the Brazilian government that's designed to provide access to advanced cell and gene therapies for diseases like leukemia, lymphoma | Maryland nonprofit Caring Cross has unveiled a partnership with the Brazilian government which is designed to provide access to advanced CAR-T and gene therapies for diseases like leukemia, lymphoma and HIV infection—and in the process provide a manufacturing model that demonstrates how to reduc

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Medical Sales Rep Recruitment: Implementing an effective selection process for better results.

MaBiCo

Medical Sales Rep Recruitment: Implementing an effective selection process for better results. For most organizations, recruiting plays a pivotal role in driving sales effectiveness, even though it remains one of the most challenging aspects to execute effectively. Several sales leaders think their companies have mastered recruitment, while others may consider it as less important compared to other SFE (sales force effectiveness) drivers.

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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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Nearly Half of RN Vacancies in 2023 Were Agency Staffing Positions: Three Takeaways for Employers

MedCity News

It’s a complex, multifaceted problem that no magic bullet will solve — but more visibility into the data behind hiring and salaries for RNs may help. Here’s a look at how.

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Quality risk management in radiopharmaceutical production

European Pharmaceutical Review

A paper published in Applied Sciences has described a quality risk assessment methodology for application in sterile PET radiopharmaceutical production under Good Manufacturing Practice (GMP) regulations. According to research highlighted in the paper, applying quality standards such as GMP and ISO 9001 “guarantees the quality and safety of a radiopharmaceutical and contributes to optimising the performance and efficacy of the entire production process.

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Bristol Myers Squibb's versatile Zeposia doesn't make the grade in Crohn's disease trial

Fierce Pharma

Bristol Myers Squibb’s Zeposia (ozanimod) has attracted attention as a treatment for an unusual duo of diseases—multiple sclerosis (MS) and ulcerative colitis (UC). | Bristol Myers Squibb’s Zeposia has attracted attention as a treatment for an odd pair of unrelated diseases—multiple sclerosis (MS) and ulcerative colitis (UC). But the approval roll for the sphingosine 1-phosphate (S1P) receptor modulator may be over.

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Nuvation Bio nears commercial stage with AnHeart buy

pharmaphorum

Nuvation Bio speeds up its path to becoming a commercial-stage biotech with a deal to acquire AnHeart Therapeutics and its late-stage lung cancer therapy taletrectinib

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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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Novo Nordisk Expands Cardio Reach by Buying Heart Drugs Biotech Cardior

MedCity News

Novo Nordisk’s strategy to grow beyond metabolic diseases includes expanding into adjacent areas such as cardiovascular disease. Acquiring Cardio Pharmaceuticals adds a novel RNA-based therapy that is a potential heart failure treatment.

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Strong growth for Sweden’s pharmaceutical exports

European Pharmaceutical Review

According to SwedenBIO, Sweden‘s life sciences industry is witnessing a continued increase in export values. Based on statistics from Statistics Sweden, at SEK 152.5 billion, exports of pharmaceuticals reached a total of 7.3 percent of Sweden’s total export value. SwedenBIO highlighted that this is an almost 10 percent increase since 2022. Value of Swedish pharmaceutical exports Swedish pharmaceuticals exports are currently “significantly larger” than exports of iron and steel.

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After Amgen's stumble, BMS touts KRAS confirmatory trial win for newly bought Krazati

Fierce Pharma

Bristol Myers Squibb looks on track to overtake Amgen as the KRAS leader in lung cancer after following up its rival’s FDA setback with a positive confirmatory trial readout. | Bristol Myers Squibb looks on track to overtake Amgen as the KRAS leader in lung cancer after following up its rival’s FDA setback with a positive confirmatory trial readout.

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Nanoscope Therapeutics exhibits positive top-line Phase IIb results for MCO-010

Pharmaceutical Technology

Nanoscope Therapeutics released promising top-line results for its RESTORE trial, which is studying the gene therapy MCO-010 in patients with retinitis pigmentosa (RP).

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time