March, 2024

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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 Pfizer struggling in 2023, CEO Bourla hit with 35% pay cut to $21.6M

Fierce Pharma

Pfizer knew 2023 was going to be a challenging year of transition. But even the drugmaker was surprised by the plummeting demand for its COVID-19 products, missing badly on its 2023 guidance. | After a difficult year for Pfizer, in which its share price fell by 44%, CEO Albert Bourla’s compensation fell by 35% from $33 million in 2022 to $21.6 million in 2023.

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Should the DOJ Break Up UnitedHealth Group?

MedCity News

The U.S. Department of Justice has reportedly recently launched an antitrust investigation of UnitedHealth Group, which begs the question of whether the healthcare giant should be broken up. Experts have varying opinions.

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Cannabinoids show promise in acute migraine clinical trial

pharmaphorum

Inhaled cannabinoids have been shown to perform better than placebo in providing pain relief for people suffering from acute migraine in a clinical trial

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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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What’s next for AAV gene therapies in 2024?

Pharmaceutical Technology

Upcoming regulatory events for pipeline AAV gene therapies, with a focus on neuromuscular and blood disorders, are setting high expectations for the space in 2024.

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Patient centricity for tailor-made healthcare

European Pharmaceutical Review

Can you tell us a bit about yourself and your role at Pfizer? I’m a pharmacist with an MBA and PhD. My PhD thesis is about considerations in the production and purchasing of drugs. I joined Pfizer in January 2023 as a health access specialist, after working at Clalit Health Services in Israel for almost 20 years. At Clalit, which is the second largest healthcare provider in the world, I worked in several management positions and gained a broad understanding of the needs and constraints of a heal

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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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Google Cloud Releases New Clinical Generative AI Tools at HIMSS24

MedCity News

At HIMSS, Google Cloud announced new AI features designed to assist providers, payers and any other healthcare organizations seeking to make better use of their clinical data.

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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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Oncology emerges as dominant therapy area for CRISPR technology

Pharmaceutical Technology

In late 2023, the Medicines and Healthcare products Regulatory Agency approved Vertex’s Casgevy, which became the inaugural clustered regularly interspaced short palindromic repeats (CRISPR)-based drug for the haematological indications beta thalassemia and sickle cell disease (SCD).

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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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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

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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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FDA approves first MASH drug: Madrigal's Rezdiffra breaks ground in notorious biopharma graveyard

Fierce Pharma

The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended, as the FDA has approved the first drug for the fatty liver disease. | The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended. The FDA has approved Madrigal's resmetirom under the brand name Rezdiffra as the first drug for the fatty liver disease.

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AliveCor Isn’t Backing Down from Apple, Its ‘Bully’

MedCity News

AliveCor CEO Priya Abani argues that Apple has made a habit of taking intellectual property from smaller medical device firms in order to improve the functionalities its Apple Watch. She also believes that Apple has been able to avoid taking accountability for this by “bombarding” smaller companies with litigation it knows they won’t be able to afford — a claim that medical IP lawyers have backed up.

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

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Lilly’s Alzheimer’s drug delayed as FDA seeks adcomm

pharmaphorum

The FDA has said it will seek the advice of independent advisors before it concludes its review of Eli Lilly’s amyloid-targeting Alzheimer’s disease therapy donanemab, delaying its review of the drug. Lilly said the US regulator “wants to further understand topics related to evaluating the safety and efficacy of donanemab,” which includes the safety and efficacy results of its pivotal TRAILBLAZER-ALZ 2 study.

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Akums introduces Hydroxyurea oral suspension for sickle cell disease

Pharmaceutical Technology

Akums Drugs and Pharmaceuticals has introduced Hydroxyurea oral suspension, a room temperature-stable drug for treating sickle cell disease.

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How Important Is Sales Forecasting Accuracy On Your Sales Team?

Integrity Solutions

As a sales leader have you looked at your forecast and asked questions like these: “Do we have enough opportunities in our forecast to confidently make our goal this quarter/year?” “We may have enough opportunities, but are they large enough in terms of projected revenue? What is our go-get?” “Are we progressing these opportunities through our pipeline process towards close?

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FDA approves innovative gene therapy for MLD

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved gene therapy Lenmeldy (atidarsagene autotemcel) as the first treatment for children with early-onset metachromatic leukodystrophy (MLD). Following a patient receiving chemotherapy, the autologous hematopoietic stem cell-based gene therapy is administered as a personalised, one-time, single-dose infusion.

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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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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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AstraZeneca Loses Lawsuit Challenging Drug Price Negotiation by Medicare

MedCity News

A federal judge disagreed with AstraZeneca’s claims that the Inflation Reduction Act causes harm by disincentivizing innovation and violates its constitutional rights to due process. Blockbuster AstraZeneca drug Farxiga is one of 10 medications selected for the Medicare drug price negotiation program created by the law.

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Surprise Enhertu rejection follows NICE process change

pharmaphorum

NICE has rejected the use of AstraZeneca and Daiichi Sankyo’s Enhertu as an NHS treatment for advanced HER2-low breast cancer, a decision that the companies have described as “devastating”.

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The Case for Domestic Sourcing to Establish Reliable Pharmaceutical Supply Chains in the United States

Pharmaceutical Commerce

Reliance on foreign imports means that disruptions in the supply chain can profoundly impact the ability of individuals in the United States to get access to the medications they need.

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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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SXSW 2024 Insights: Why the Greatest Risk a Brand Can Take Is Being Ordinary, Part 1

Eversana Intouch

Our team is on the ground at SXSW 2024, and as we navigate through the bustling streets of downtown Austin, Texas — where the magic of immersive brand experiences dress the streets — we can’t help but feel the pulse of innovation surrounding us. In this blog, Hattie Stearns, Senior Director, Experience Design & Innovation, delves into several key trends and insights from Day 1 of the conference, including the importance of building authentic immersive experiences that enable human connection

Marketing 105
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Novartis acquisition to address inflammation-driven diseases

European Pharmaceutical Review

Under a new deal, Novartis has agreed to acquire US-based biopharma company IFM Therapeutics, for a total of up to $835 million. As part of this new agreement, Novartis has exercised its option to acquire all outstanding capital stock of IFM Due, a subsidiary company of IFM. Therefore, under the acquisition, Novartis has full rights to IFM Due’s portfolio of small molecule Stimulator of Interferon Genes (STING) antagonists, IFM confirmed.

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Novo's obesity superstar Wegovy wins FDA nod to cut cardio risks in key label expansion

Fierce Pharma

Novo Nordisk’s fast-growing weight loss med Wegovy just added a new cardiovascular FDA approval to its label, likely enabling the med's superstar status to reach new levels. | The drug is the first weight loss treatment to win FDA approval to reduce the risk of severe cardiovascular outcomes, giving it an edge over rival Zepbound from Eli Lilly.

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How Marketing Fueled the Opioid Overdose Crisis and What We Can Learn From It

MedCity News

Given the link established across studies between marketing practices and the opioid overdose crisis, a few strategic steps can form a path forward for clinicians and policymakers.

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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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Japan clears first CLDN18.2 drug, Astellas’ Vyloy

pharmaphorum

Astellas has become the first drugmaker to bring a claudin 18.2 (CLDN18.2) targeted therapy to regulatory approval, getting a green light in Japan for Vyloy as a treatment for stomach cancer. The Ministry of Health, Labour and Welfare (MHLW) has cleared Vyloy (zolbetuximab) for use in combination with chemotherapy for patients with HER2-negative CLDN18.2-positive advanced or recurrent gastric cancer that cannot be treated with surgery.

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PAP 2024: John Hoffman Discusses the Health Equity Spotlight Panel

Pharmaceutical Commerce

In an interview with Pharma Commerce Associate Editor Don Tracy, John Hoffman, Principal, Advocate for Success, LLC talks about his 'Health Equity Spotlight' panel and advocacy accomplishments.

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Cellares Innovates With Automated Cell and Gene Therapy Platform

PharmaTech

Cellares CEO Fabian Gerlinghaus shares how an automated, closed-production platform with a small footprint can dramatically impact cost savings and scalability for cell and gene therapies.

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Lonza to acquire major biologics manufacturing facility

European Pharmaceutical Review

Lonza has agreed to acquire one of the world’s largest biologics manufacturing sites (by volume), for a total of $1.2 billion from Roche. The acquisition of the manufacturing facility will significantly increase Lonza’s capacity of the manufacture of large-scale biologics, to meet demand for commercial mammalian contract manufacturing. At present, the Genentech Vacaville facility in the US has a total bioreactor capacity of around 330,000 litres.

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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