Tue.Nov 08, 2022

article thumbnail

Moderna’s Spikevax carries higher risk of myocarditis than Pfizer's Comirnaty, study says

Fierce Pharma

Moderna’s Spikevax carries higher risk of myocarditis than Pfizer's Comirnaty, study says. zbecker. Tue, 11/08/2022 - 11:03.

312
312
article thumbnail

A Culture of Quality: The Catalyst to Accelerate Innovation

PharmExec

Why enabling a shared culture of quality across an organization is key to maintaining pharma’s recent pace of innovation wins—while inspiring new levels of confidence.

128
128
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Neurotech's vision loss cell therapy implant hits primary goals in phase 3 trials

Fierce Pharma

Neurotech's vision loss cell therapy implant hits primary goals in phase 3 trials. ntaylor. Tue, 11/08/2022 - 06:28.

258
258
article thumbnail

Pandemic Planning Is Incomplete Without Health Equity at Its Core

MedCity News

It is more urgent than ever to take the necessary steps to ensure the needs of Latino communities are included in future public health planning to avoid repeating mistakes that led to unnecessary suffering.

103
103
article thumbnail

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.

article thumbnail

Take 2: Teva refiles for approval of long-acting schizophrenia drug months after FDA rejection

Fierce Pharma

Take 2: Teva refiles for approval of long-acting schizophrenia drug months after FDA rejection. ntaylor. Tue, 11/08/2022 - 06:14.

FDA 226
article thumbnail

Why digital transformation is essential to get value from R&D data

Pharma IQ

Pharma IQ looks at the benefits of moving to a digital lab.

Pharma 130

More Trending

article thumbnail

Pandemic boost to decentralised trials is here to stay

pharmaphorum

Due to the pandemic, decentralised trial solutions made the shift from an emerging trend to a crucial element of drug development. Ben Hargreaves examines the latest research suggesting that this transition looks set to become a permanent feature of trials in the years to come. The pharmaceutical industry’s role in developing effective vaccines against COVID-19 was a major benefit to the industry.

Patients 119
article thumbnail

Sublingual psychedelic startup nets $60M for depression trials

Fierce Pharma

Sublingual psychedelic startup nets $60M for depression trials. ntaylor. Tue, 11/08/2022 - 06:20.

235
235
article thumbnail

KFF: 77% of Women Are In Favor of Over-the-counter Birth Control Pills

MedCity News

The main factor behind why women want over-the-counter birth control pills is convenience, the survey found. Of those who are unlikely to use over-the-counter birth control pills — or are unsure if they would —most said it’s because they don’t currently use birth control pills or don’t plan to in the future.

98
article thumbnail

Plotting a Fulgent future, diagnostic business inks $100M deal to reunite with drug delivery sibling

Fierce Pharma

Plotting a Fulgent future, diagnostic business inks $100M deal to reunite with drug delivery sibling. ntaylor. Tue, 11/08/2022 - 07:59.

192
192
article thumbnail

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.

article thumbnail

With Secreted Proteins Map, Juvena Finds Path to $41M for New Regenerative Meds

MedCity News

Juvena Therapeutics is developing secreted protein drugs built on new knowledge gleaned from proprietary technology that maps these proteins and the tissues in the body where they offer a regenerative effect. The startup’s lead program is in development for the muscle disorder myotonic dystrophy type 1.

Leads 98
article thumbnail

J&J vet Mammen wanted board influence to be Biogen's next CEO, but chairman said no: Stat

Fierce Pharma

J&J vet Mammen wanted board influence to be Biogen's next CEO, but chairman said no: Stat. aliu. Tue, 11/08/2022 - 09:36.

130
130
article thumbnail

Walgreens expands presence in primary care through VillageMD’s $8.9B purchase of Summit Health

MedCity News

The combined organization will have more than 680 provider locations in 26 markets. With CVS Health and Amazon both making major acquisitions, the Summit Health deal was both offensive and defensive for Walgreens, one expert said.

article thumbnail

NICE backs use of MSD’s KEYTRUDA for triple-negative breast cancer

pharmaphorum

For the first time, patients in England with triple-negative breast cancer (TNBC) will be able to access immunotherapy at an earlier stage of their treatment journey, as Merck & Co/MSD’s KEYTRUDA is granted the go-ahead for use in patients with high-risk early-stage or locally advanced TBNC. The National Institute for Health and Care Excellence (NICE) has recommended the use of KEYTRUDA (pembrolizumab) as an option with chemotherapy for neoadjuvant, and alone as adjuvant treatment afte

Patients 109
article thumbnail

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.

article thumbnail

A Preview of Healthcare Startups at HLTH 2022 [Sponsored]

MedCity News

Startups will be plentiful at the upcoming HLTH conference at the Venetian Expo in Las Vegas November 13-16. Here’s a glimpse of some of the healthcare pain points they’re addressing.

article thumbnail

The Women’s Edge and The Boston Globe Again Name CCC to Top 100 Women-Led Businesses in Massachusetts

Copyright Clearance Center

November 8, 2022 – Danvers, Mass. – The Women’s Edge (formerly The Commonwealth Institute) together with its partner The Boston Globe , announced CCC , a leader in advancing copyright, accelerating knowledge, and powering Innovation, was named to the 22 nd annual Top 100 Women-Led Businesses in Massachusetts list. “The organizations on this year’s diverse list are driving innovation across the country, from increased manufacturing capacity to breakthroughs in clinical care and therapeutics

article thumbnail

Hospitals Should Be Wary of Using Meta Pixel & Other Third-Party Analytics Tools

MedCity News

ECRI recently issued an alert warning hospitals about the cybersecurity risks associated with the use of third-party analytics tools, such as Meta Pixel, Google Analytics and Adobe Analytics. When providers install these tools on their websites and patient portals, they may be exposing patient data — which tech companies can use to target medical-related ads to consumers as they browse the Internet.

Medical 97
article thumbnail

Smartphone and Cheap Earbuds for Accessible Newborn Hearing Test

Medgadget

Researchers at the University of Washington have developed a low-cost hearing test for newborns. Traditionally, the equipment for such testing is quite expensive. As newborns cannot let us know if they can hear something, the test is based on creating a noise within the ear canal and then listening to the vibrations created by the specialized hair cells within.

article thumbnail

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.

article thumbnail

Express Scripts must pay state AG $3.2M for allegedly overcharging for prescriptions

MedCity News

Following an investigation, the AG claimed Express Scripts, “billed and obtained payment for prescription drugs from payers of workers’ compensation claims in excess of amounts permitted by Massachusetts laws and regulations,” according to court documents. .

article thumbnail

Improved Membrane Coating for Anti-Cancer Nanoparticles

Medgadget

Scientists at the University of Eastern Finland have developed a technique that lets them improve the coating of nanoparticles when using cell membranes. Cell membranes offer a lot of benefits as a coating for synthetic nanoparticles, including shielding from the immune system, prolonged circulation times and improved tumor accumulation. However, current approaches to coating nanoparticles with cell membranes often result in an incomplete covering.

article thumbnail

Sanofi Inks Another AI Alliance, This Time Partnering With Insilico Medicine

MedCity News

Sanofi will use Insilico Medicine’s tech to advance drug development candidates up to six new targets. Disease indications were not disclosed, but the pharmaceutical giant said the new agreement will boost its drug discovery research in China.

article thumbnail

Whole-Person Care: Are We Ready? The Intersection of Pharma and Digital Therapeutics

PharmExec

Senior leaders focused on the advancement of digital medicine and health meet to discuss the importance of these tools for life sciences companies, payers, and others in harnessing a healthcare future that will be increasingly dominated by holistic treatment and delivery.

Pharma 83
article thumbnail

The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

article thumbnail

3 Measures Children’s Hospitals Need to Survive in 2023

MedCity News

In order to provide quality pediatric care, children’s hospitals need more government support, Children’s Hospital Association CEO Mark Wietecha argued in a recent letter to Congress. He recommended Congress enact 12-month continuous eligibility for children covered by Medicaid or CHIP, allocate more money to pediatric physician training, and enhance Medicaid’s low reimbursement rates for pediatric care.

article thumbnail

Chasing that ‘Time magazine cover potential’

PharmaVoice

Rami Elghandour was already retired. Then CAR-T specialist Arcellx lured him back into the industry to try to change the world.

98
article thumbnail

Time and Place Are of the Essence: Building Relationships With Patients for Better Health Outcomes

MedCity News

We now know that the once widely accepted approach in which physicians were believed to “always know best” and as a result dictated their orders to unquestioning patients is suboptimal medical care. In its place, healthcare is beginning to evolve to a more patient-centered, holistic model.

article thumbnail

While CAR-T wait times remain ‘heartbreaking,’ researchers push for innovations that could help

PharmaVoice

Facing an unprecedented manufacturing bottleneck, a new coalition is aiming to create the next generation of CAR-T therapies.

article thumbnail

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

article thumbnail

Developing Your Medical Sales Career

MedReps

When it comes to medical sales, there’s one place every sales rep wants to go: up. They envision themselves as the leader of their team, the manager in charge of the whole sales group or even the company’s CEO. Of course, it’s impossible to work your way up the ladder unless you’ve proven yourself as a reliable salesperson who can meet their targets and make their customers happy.

article thumbnail

Digital Biomarkers Could Reshape CNS Diagnosis, Treatment

PharmExec

AI drives new signal-detection efforts in Alzheimer’s and ALS.

122
122
article thumbnail

Working Together to Overcome Obstacles and the Sales Tools that Reps Need with Kevin Dunbrack at McCarthy & Sons

Map My Customers

One-on-one sales coaching between the manager and rep is a necessity. And one under-utilized methodology is the ride along. Managers often see it as just a last resort for struggling reps. Reps dread them. But they can be a gold mine for real, productive coaching. That’s the topic of the latest Field Sales Leadership Guide podcast by Map My Customers.

article thumbnail

Lilly preps for rollout of its connected diabetes system

pharmaphorum

After years of preparation, Eli Lilly is on the brink of launching a fully connected and personalised diabetes management platform, underpinned by digital technologies. The Tempo system brings together a pre-filled insulin pen, the TempoSmart app and a recently-approved Smart Button device that stores and transfers insulin dose-related data from the pen, and can link with compatible devices.

article thumbnail

Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.