October, 2024

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3rd time's the charm: AbbVie scores FDA nod for continuous Parkinson's disease therapy Vyalev

Fierce Pharma

AbbVie made history in 2015 with its Parkinson’s disease infusion pump therapy Duopa, kicking off a trend of delivery system innovation in the space as drugmakers sought to avoid the common pitfall | The 24-hour Parkinson's disease therapy crossed the FDA finish line after an initial manufacturing-related rejection last year and another snub in June.

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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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Video: Why the FTC’s Lawsuit Against PBMs May Have Some Legs

MedCity News

Months before the FTC sued the three largest pharmacy benefit managers, the CEO of Blue Shield of California battled its PBM – CVS Caremark – to bring a lower cost prostate cancer drug to its members. The post Video: Why the FTC’s Lawsuit Against PBMs May Have Some Legs appeared first on MedCity News.

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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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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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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.

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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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‘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.

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First Do No Harm: Support Legislative Efforts to Combat the Adverse Drug Event Epidemic 

MedCity News

The Hippocratic oath can’t stop with direct patient care; the healthcare industry and its key stakeholders must address persistent public health problems systematically. We have the tools to reduce medication harm by half or more; it is long past time to make this a public health priority. The post First Do No Harm: Support Legislative Efforts to Combat the Adverse Drug Event Epidemic appeared first on MedCity News.

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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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First real-world study reveals encouraging efficacy for cell therapy

European Pharmaceutical Review

New results from a first-of-its-kind study reports that a CAR-T cell therapy provided similar efficacy and safety to relapsed or refractory multiple myeloma patients administered with the treatment in clinical trials. For example, of the 236 patients who received infusions of ciltacabtagene autoleucel (cilta-cel), data shows that 89 percent responded to the treatment.

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

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AAPS PharmSci 360 2024: Drug Delivery in Early Development

PharmaTech

Pharmaceutical Technology sat down with Erica Schlesinger, vice president of technical development at Serán Bioscience, to talk about her upcoming presentation at AAPS PharmSci 360 2024, “High Dose Subcutaneous Delivery of Protein Therapeutics.

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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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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.

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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.

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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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Pfizer rounds out haemophilia portfolio with FDA approval

pharmaphorum

Pfizer’s anti-TFPI antibody marstacimab has been approved by the FDA to treat haemophilia, becoming the pharma group’s second new therapy for the blood disorder this year.Marstacimab will be launched as Hympavzi to treat haemophilia A without factor VIII inhibitors and haemophilia B without factor IX inhibitors in patients aged 12 and older and is the first drug in the anti-TFPI class to be approved in the US.

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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.

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EMA publishes EU strategy to 2028

European Pharmaceutical Review

A draft joint EU network strategy to 2028 has been published by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA). This is updated strategy replaces the original five-year strategy, which was developed to cover from 2021 to 2025 (EMANS 2025). Revised strategy – adapting to change The draft strategy covers the following focus areas up to 2028: Accessibility to support pathways for medicine access in the EU Leveraging data, digitalisation and artificial intelligen

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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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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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Wave sees RNA editing validation in early trial results

PharmaVoice

The results provide the first clinical evidence of RNA editing, a burgeoning field that's drawn interest from biotechs and pharmaceutical companies alike.

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Can AI Reduce Healthcare Disparities? Health Execs Debate

MedCity News

During the Reuters Total Health conference, two healthcare leaders debated whether AI has the potential to reduce healthcare disparities. One argued that the technology is not there yet, while the other argued that it’s about how people use AI. The post Can AI Reduce Healthcare Disparities? Health Execs Debate appeared first on MedCity News.

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Amgen to face investor lawsuit over $10.7bn tax liability disclosure

pharmaphorum

A federal judge in New York has ruled that Amgen must answer to claims of misleading investors about billions owed to US tax authorities, allowing a securities-fraud class action to proceed against the pharmaceutical giant.

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Healing begins with research: Promising development program on stem cells in rare diseases

Pharmaceutical Technology

RHEACELL has been researching ABCB5-positive stem cell therapies for patients with severe immune and inflammation-related diseases for which there are currently no adequate treatment options. Positive feedback from the regulatory authorities on the study program now gives reason to hope that those affected will be able to benefit from this new approach to regenerative medicine in the near future.

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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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EMA Denies Authorization of Duchenne Muscular Dystrophy Treatment, Again

PharmaTech

The agency has reconfirmed its recommendation to not give positive opinion to Translarna (ataluren) after a reexamination of the available data.

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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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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.

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How A Physician Group Is Using AI to Save Clinicians 3+ Hours Per Day on Documentation

MedCity News

Alpine Physician Partners — which operates primary care organizations in several states — is implementing Ambience Healthcare’s documentation and coding tool after a successful pilot. Before adopting Ambience’s tool, Alpine clinicians spent 4.7 hours on charting per day, but now that time has dropped down to 1.2 hours per day. The post How A Physician Group Is Using AI to Save Clinicians 3+ Hours Per Day on Documentation appeared first on MedCity News.

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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

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NIH study backs Bavarian Nordic mpox jab for adolescents

pharmaphorum

NIH study finds Bavarian Nordic's mpox vaccine is effective in adolescents, a particularly vulnerable group amid the ongoing outbreak

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NUHS’s CD7 CAR-T cell therapy shows promise for leukaemia

Pharmaceutical Technology

The CD7 CAR)-T cell therapy has demonstrated potential in treating patients with relapsed or refractory T-cell leukaemia.

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Enhancing intestinal drug delivery with Quality by Design

European Pharmaceutical Review

A study has reported an approach for optimising metronidazole colonic delivery systems, to increase their potential efficacy when treating diverticulitis. Researchers developed intestinal colon-coated sustained-release matrix metronidazole tablets, using a Quality by Design (QbD) approach. Arévalo-Pérez et al. noted that metronidazole is a synthetic nitroimidazole and has activity against anaerobic bacteria.

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US' top IV fluid maker Baxter voices uncertainty about recovery timeline at NC facility hit by Helene

Fierce Pharma

After announcing the closure of its biggest manufacturing site Sunday due to flooding caused by Hurricane Helene, Baxter International—the U.S.’ top supplier of hospital IV fluids—is laying out det | While progress is already being made after Hurricane Helene, which resulted in water “permeating” Baxter’s large IV fluid production plant in North Carolina, the company cautioned that it does not yet have a timeline for when operations will be back online.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time