Fri.Nov 17, 2023

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AstraZeneca’s first-in-class FDA approval for Truqap marred by surprise restriction

Fierce Pharma

After the landmark success of Enhertu in HER2-low breast cancer, AstraZeneca has blazed another trail in the world’s most common cancer type. | After the landmark success of Enhertu in HER2-low breast cancer, AstraZeneca has blazed another trail in the world’s most common cancer type. But an unexpected restriction has cast a dark cloud over the first-in-class approval.

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From Inequality to Empowerment: The Role of Automation Technologies in Healthcare

MedCity News

Automation can be a powerful tool to bring together all the pieces needed to provide optimal care that can be scattered across various systems and apps. Whether it’s to exchange patient data quickly and easily, identify communities in need of programs to address food inequity, or reduce no-shows by sending automatic reminders, using the right technology is an essential tool for achieving better patient care.

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AstraZeneca plans to exit 'beating heart' of Indian operations in Bangalore

Fierce Pharma

Amid a corporate review of AstraZeneca’s global manufacturing and supply network, the company’s Indian subsidiary is planning to close up shop at the “beating heart” of its India operations in Bang | AstraZeneca Pharma India will exit its production plant in Bangalore, India, “in due course,” the company said in a filing. AZ plans to find a buyer who can also serve as a contract manufacturer for the drugs produced there.

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Why Employers and Payers Should Offer Companionship Services, Per Papa’s CEO

MedCity News

A recent report from Papa, a companion care company, found that 22% of Medicare Advantage members are severely lonely. The findings give some insights into why employers and payers should offer companion support, according to Andrew Parker, founder and CEO of Papa.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA signs off on new uses for Astellas and Pfizer's Xtandi, Merck's Keytruda

Fierce Pharma

The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi. | The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi. Keytruda’s expansion is in stomach cancer. Xtandi’s new indication expands its already deep portfolio in the treatment of prostate cancer.

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Why Abbott Believes Its New Pacemaker Will Help It Capture More Market Share

MedCity News

Abbott’s new leadless pacemaker system has become commercially available and has begun being implanted in people at hospitals across the nation. Most people who need a pacemaker require pacing in two chambers of the heart, and the dual-chamber technology in Abbott’s new system allows these patients to have a leadless pacemaker.

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Looking Ahead to Regulatory Trends in Healthcare IT

MedCity News

The healthcare IT industry is in a state of constant evolution, with regulatory trends shaping the path forward. Continuous updates in certification regulations, the integration of emerging technologies, and data privacy concerns are just some of the challenges facing healthcare IT stakeholders.

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CDC rushes extra doses of Sanofi, AZ's Beyfortus to ease supply shortfall

Fierce Pharma

In response to a supply squeeze for Sanofi and AstraZeneca’s respiratory syncytial virus (RSV) antibody Beyfortus, the U.S. | Sanofi and AstraZeneca's highly anticipated infant RSV immunization ran into supply issues just a few months into its launch. In response, government officials are speeding more doses into distribution.

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AstraZeneca Cancer Drug Is First in Class, But FDA Nod Is Narrower Than Expected

MedCity News

The FDA approved AstraZeneca’s Truqap as a new treatment for advanced cases of breast cancer. The drug is the first in a new class of therapies addressing AKT genetic alterations.

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Micron Biomedical receives funds to produce needle-free vaccines

Pharmaceutical Technology

Micron Biomedical has received $23.6m in funding from the Bill & Melinda Gates Foundation for the bulk manufacturing of needle-free vaccines.

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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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??A startling drop in U.S. life expectancy — and how pharma could help turn the tide

PharmaVoice

The recently observed dip was particularly acute for men, who now live an average of 5.8 fewer years than women.

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Addressing Widespread Financial Insecurity in the Healthcare Industry

MedCity News

It’s not just our lowest-paid healthcare professionals who suffer from financial insecurity. From the hardworking custodian to the extremely specialized surgeon, all healthcare professionals should be offered the resources and means to keep up with inflation and financial concerns.

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NHS trials artificial intelligence system to prevent avoidable admissions

PharmaTimes

The AI system will identify those most at risk and reduce pressure on the NHS - News - PharmaTimes

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The Power of Centralized Distribution in the Face of DSCSA Compliance

Pharmaceutical Commerce

With new mandates right around the corner, there is an unwavering demand for pharma operations to perform at peak efficieny.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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EC approves lebrikizumab for atopic dermatitis

European Pharmaceutical Review

The European Commission has approved Ebglyss (lebrikizumab) for atopic dermatitis patients 12 years and older with a body weight of at least 40kg, who are candidates for systemic therapy. Almirall has licensed the rights to develop and commercialise lebrikizumab for the treatment of dermatology indications in Europe. The company said it will launch lebrikizumab in Germany, with further European rollout planned throughout 2024.

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Daiichi Sankyo signs agreement with Japan to supply Covid-19 vaccine

Pharmaceutical Technology

Daiichi Sankyo has signed an agreement with Japan's MHLW to deliver 1.4 million doses of its omicron-adapted mRNA vaccine for Covid-19.

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Q&A With Jade Shields, Vice President of Corporate Affairs at Ferring Pharmaceuticals

PharmExec

Shields discusses Ferring’s recent $5 million endowment to the American Society of Reproductive Medicine.

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Trial for novel CGRP migraine medicine gleans positive results

European Pharmaceutical Review

Results from AbbVie’s Phase III study, PRODROME , published in The Lancet showed that UBRELVY ® (ubrogepant) 100mg for acute treatment of migraine significantly reduced the likelihood of development of moderate or severe headache compared to placebo within 24 hours post-dose. This was demonstrated when the calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) was administered during the prodrome phase (ie, one to sixurs before the predicted onset of headache pain) of a migraine a

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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Analyzing Risks of Online Marketing for Teeth Whitening Products, Post-COVID

PharmExec

Heliyon study evaluates online information, labeling accuracy, and quantitative analysis of high peroxide content gels.

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Is it Time for a New Healthcare Brand – Or a Rebrand?

Healthcare Success

Have your products, services, or target audience evolved to the point where they no longer align with your brand? Has your health brand become lost in a sea of sameness? Do your marketing assets feel stale and out of touch with your audience? Did your business neglect to establish proper healthcare branding from the beginning? Whether your current branding isn’t servicing your business anymore or your brand has evolved beyond your existing branding—it’s time for a rebrand.

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StartUPDATES: New developments from healthcare startups

MedCity News

Check out news from Harmony Health Foundation, Gratia Health, Pathway, Fortuna Health, and more.

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New NIHR Research Delivery Network in England announced by DHSC

PharmaTimes

The University of Leeds and NHS organisations will host the network in 2024 - News - PharmaTimes

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Hachette Restructures

Copyright Clearance Center

The post Hachette Restructures appeared first on Copyright Clearance Center.

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Digital health company BehaVR hits the merger trail again

pharmaphorum

Digital health company BehaVR hits the merger trail again Phil.

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5 Best Roofing Sales Training Resources

Spotio

Looking to sell more roofs for your roofing business? Proven roofing sales training will help you (or your reps) connect with more customers and close more deals. The question is, which sales training for roofing companies is best? We aim to answer that for you in this article. Keep reading to learn about six specific programs you can use to take your roofing venture to the next level.

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FDA’s Janet Woodcock will step down early next year

pharmaphorum

FDA’s Janet Woodcock will step down early next year Phil.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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How to influence care decisions at the point of care

Clarify Health

In this video, Emily Roesing , Senior Director of Product at Clarify Health, discusses how to influence specialist referral and facility selection at the point of care. Transcript I have spent many years focused on finding solutions that will help both payers and providers tackle this question: How can we get patients to visit the best possible specialists and receive care at the right facilities?

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How To Make The Best First Impression With Your New Medical Distributor

Cesare Ferrari

Consider this: You worked hard to find and select a new commercial partner in an uncovered market. You and your new distributor invested time and resources to establish what both expect to be a long-term, profitable and fruitful commercial relationship. All the prerequisites are fulfilled, the distribution agreement is signed, and the regulatory departments are working together in harmony to register the products.

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FDA Approves Merck's Keytruda With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma

Pharmaceutical Commerce

Pembrolizumab (Keytruda) plus fluoropyrimidine- and platinum-containing chemotherapy for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction cancer approved by FDA after being found to lower the risk of metastasis or death.

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Xtandi Approved by FDA for Nonmetastatic Castration-Sensitive Prostate Cancer

PharmExec

Enzalutamide (Xtandi) from Astellas Pharma Inc. and Pfizer Inc. gets FDA approval to treat nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.