Tue.Jun 11, 2024

article thumbnail

Europe taps CSL Seqirus to produce bird flu vaccines for pandemic preparedness efforts

Fierce Pharma

Right after signing on to help with bird flu pandemic preparedness efforts in the U.S., CSL Seqirus has agreed to do the same in Europe through a vaccine supply pact. | The vaccine maker will deliver 665,000 doses of its avian flu-matched pre-pandemic vaccine. Under a 4-year contract, authorities can purchase up to 40 million doses.

333
333
article thumbnail

Ipsen, Genfit Drug That Missed in MASH Wins FDA Approval in a Much Rarer Liver Disease

MedCity News

Iqirvo failed as a treatment for the fatty liver disease MASH, but the drug is now FDA approved in primary biliary cholangitis. An Intercept Pharmaceuticals drug already treats this rare liver disease and Gilead Sciences is poised to compete with its PBC drug approaching an FDA decision this summer. The post Ipsen, Genfit Drug That Missed in MASH Wins FDA Approval in a Much Rarer Liver Disease appeared first on MedCity News.

FDA 116
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

After M&A stretch, Pfizer CEO says company needs 'breathing period' from large deals

Fierce Pharma

Amid a recent biopharma M&A resurgence, one major player plans to stay out of the waters after making multiple recent splashes. | Though not for lack of business development capacity, Pfizer is currently taking a large dealmaking “breathing period,” CEO Albert Bourla told investors this week at Goldman Sachs’ 2024 annual Global Healthcare Conference in Miami.

Biopharma 301
article thumbnail

Lilly’s Alzheimer’s drug set to join Leqembi after FDA vote

pharmaphorum

An FDA advisory committee has delivered a strong endorsement to Eli Lilly’s Alzheimer’s disease therapy donanemab, voting unanimously that the safety and efficacy of the amyloid-busting drug support its approval. The independent advisors on the Peripheral and Central Nervous System Drugs Advisory Committee voted by 11 to zero that donanemab’s benefits outweigh its risks, and by the same margin that the data submitted by Lilly to support its efficacy was convincing.

FDA 111
article thumbnail

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

article thumbnail

Gilead forks over $40M to settle thousands of claims in web of litigation over alleged delay of safer HIV meds

Fierce Pharma

As Gilead Sciences awaits the progression of California state litigation over its alleged delay of safer HIV drugs, the company is biding its time with a proposed $40 million settlement t | More than 2,000 plaintiffs accused the HIV drugmaker of purposely waiting to launch safer TAF-based meds in the early 2000s in order to maximize profits from its older TDF-based products.

275
275
article thumbnail

Report: MA Beneficiaries Spend $2,500 Less on Healthcare Than Traditional Medicare Beneficiaries

MedCity News

A report conducted by ATI Advisory and commissioned by Better Medicare Alliance found that Medicare Advantage beneficiaries have lower healthcare spending than fee-for-service Medicare enrollees. This is true across racial and ethnic groups, according to the report. The post Report: MA Beneficiaries Spend $2,500 Less on Healthcare Than Traditional Medicare Beneficiaries appeared first on MedCity News.

More Trending

article thumbnail

Navigating the Tricky Climate of Health Tech Funding

MedCity News

Getting would-be investors—and the right kind of investors—to notice and care about your company requires a robust strategy. The post Navigating the Tricky Climate of Health Tech Funding appeared first on MedCity News.

107
107
article thumbnail

Ipsen, Genfit gain FDA approval for Iqirvo in liver disorder, teeing up Intercept showdown

Fierce Pharma

Once hyped as a potential blockbuster medicine for metabolic-associated steatohepatitis (MASH), Ipsen and Genfit’s elafibranor has found its calling as a treatment for a lower-profile liver disorde | Once hyped as a potential blockbuster medicine for metabolic-associated steatohepatitis (MASH), Ipsen and Genfit’s elafibranor has found its calling as a treatment for a lower-profile liver disorder.

Medicine 226
article thumbnail

FDA clears Ipsen’s primary biliary cholangitis drug

pharmaphorum

Ipsen has been given accelerated approval by the FDA for Iqirvo, which becomes the dual PPAR alpha/delta agonist for rare cholestatic liver disease primary biliary cholangitis (PBC).

FDA 103
article thumbnail

Ahead of UK election, life sciences trade group pushes politicians to boost local industry

Fierce Pharma

As the U.K. braces for a potential government shake-up ahead of its general election next month, the country’s premier biopharma trade organization is throwing down the gauntlet. | The Association of the British Pharmaceutical Industry is challenging U.K. political parties to blueprint their plans to unlock the nation’s healthcare industry potential, according to a press release issued Monday.

Biopharma 204
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

How Regulatory Ambiguity is Impeding Healthcare Innovation

MedCity News

America should be a global leader in healthcare. Instead, we rank last among our peers, and outmoded regulations are holding us back. The post How Regulatory Ambiguity is Impeding Healthcare Innovation appeared first on MedCity News.

article thumbnail

UK pharma industry delivers election ‘wish list’

pharmaphorum

The Association of the British Pharmaceutical Industry (ABPI) is calling on political parties contesting the general election to spell out their plans to nurture and drive growth in the life sciences sector and deliver for patients.

Pharma 100
article thumbnail

How Good Referral Pathways Impact Vascular and Overall Health

MedCity News

As with so many other conditions, in vascular health, patients often need to be seen within a few days or weeks, but current referral systems drag on for many weeks and months. The post How Good Referral Pathways Impact Vascular and Overall Health appeared first on MedCity News.

article thumbnail

EU orders bird flu vaccine supplies from CSL Seqirus

pharmaphorum

CSL Seqirus will provide 665,000 doses of bird flu vaccine to the European Commission to protect at-risk workers and guard against a potential outbreak

103
103
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

AstraZeneca Tagrisso sNDA gains FDA priority review for lung cancer

Pharmaceutical Technology

AstraZeneca's sNDA for Tagrisso has obtained FDA priority review for unresectable, Stage III EGFRm non-small cell lung cancer.

FDA 111
article thumbnail

Purity, potency, and safety – affordably – in stem cell therapy

pharmaphorum

In a new episode of the pharmaphorum podcast, web editor Nicole Raleigh discusses stem cell therapy, and accessibility to and affordability of such treatment, with Rafael R Carazo Salas, founder and CEO of CellVoyant, an AI-first biotechnology company spun out from the University of Bristol.

Safety 94
article thumbnail

Mount Sinai Medical Center Taps HealthSnap to Improve Chronic Conditions Management

MedCity News

South Florida-based Mount Sinai Medical Center announced a new remote patient monitoring and chronic care management partnership with HealthSnap, a Miami-based virtual care management platform. The partnership is aimed at improving outcomes among the health system’s Medicare population. The post Mount Sinai Medical Center Taps HealthSnap to Improve Chronic Conditions Management appeared first on MedCity News.

article thumbnail

GSK et al file appeal to Delaware Zantac order

pharmaphorum

GSK and other drugmakers have lost no time in filing an appeal to a Delaware court’s decision to allow more than 70,000 Zantac-related lawsuits to go ahead. Just over a week ago, Judge Vivian Medinilla of Delaware Superior Court issued an order ruling that cases claiming Zantac (ranitidine) could cause cancer were “admissible”, sparking a sell-off in GSK shares that wiped billions off its market cap.

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

A "Dashboard of Zero" for your Sales Pipeline

Clear Pivot

One of the best ways to find aging deals in your sales pipeline is to build a report that specifically highlights them. Here's how we do that in HubSpot.

article thumbnail

ALZpath licenses Alzheimer’s diagnosis tech to Roche

pharmaphorum

Diagnostics giant Roche is putting its weight behind a biomarker for Alzheimer’s disease developed by ALZpath.

102
102
article thumbnail

What Is Schema Markup for Healthcare & Why Is It Crucial for Modern SEO?

Healthcare Success

Schema markup is one of the levers that search engine optimization (SEO) specialists can leverage. Yet, it is surprisingly underutilized, making it an opportune way to increase your healthcare organization’s visibility on search engine results pages (SERPs). According to SEMRush, 92% of the top 10 results in Google Search incorporate schema markup. Although correlation does not equal causation, Google has mentioned in their documentation the importance of the correct schema to help improve their

article thumbnail

LucyTx announces additional $12.5m research funding for neurological diseases

PharmaTimes

Alzheimer’s and Parkinson’s disease are responsible for more than 30 million cases globally

90
article thumbnail

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

article thumbnail

Amphastar Pharmaceuticals gets grant for medication container assembly with cap and hold down members

Pharmaceutical Technology

Discover how Amphastar Pharmaceuticals' patented medication delivery system prevents premature discharge during storage. Secure, moisture-controlled storage for medication devices.

Medical 52
article thumbnail

US researchers develop AI liquid biopsy test to help identify lung cancer earlier

PharmaTimes

The leading cause of cancer globally accounts for an estimated 1.

Leads 90
article thumbnail

CCC Becomes a Founding Member of the Leiden Institute for FAIR and Equitable Science

Copyright Clearance Center

CCC joined forces with other industry stakeholders to launch the Leiden Institute for FAIR and Equitable Science (LIFES). In recognition of the challenges that exist with data reuse within the global research community, LIFES is a joint effort by an international public-private partnership of eleven academic and private organizations to build a wide and diverse network of public and private members that want to incorporate FAIR data principles (Findable, Accessible, Interoperable, Reusable) and

article thumbnail

Calcium+Company Announces New Chief Creative Officer, Bruno Brasileiro

PM360

Calcium+Company, a leading mid-sized diversified health communications group, is pleased to announce the promotion of Bruno Brasileiro from Executive Creative Director to Chief Creative Officer, based in the New York office. Brasileiro is an award-winning creative leader with more than 20 years of experience working in a variety of therapeutic categories and for a wide range of leading consumer and pharmaceutical clients.

Leads 52
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

AI in Pharmaceutical Training: From Pilots to Full Rollouts

Quantified

The pharmaceutical industry is changing fast, driven by AI. This technology is transforming how training teams work. Our recent webinar, “From Hype to Results: Practical Strategies for AI Enablement of the Field Force,” featured insights from Shawn Moran of ZS and Hallie Lynch from Quantified. Here’s a summary of the key points and a call to action to watch the full recording.

article thumbnail

Purdue Pharma gets grant for tamper resistant opioid analgesic extended release dosage form

Pharmaceutical Technology

Discover Purdue Pharma's innovative tamper-resistant opioid analgesic dosage form with extended release properties. Learn about the patented solid oral form designed for controlled drug release and enhanced safety in medication administration.

Pharma 52
article thumbnail

What Crucial Skill Sets are Global Biopharmas Asking Premier Executive Recruitment Firms to Search for in Top Talent?

PharmExec

A Q&A with Egon Zehnder’s Sergio Della Zassa about what biopharma executives and search firms are looking for in terms of table stakes skill sets and “unicorn” experiences from top talent in the field.

article thumbnail

Kineta gets grant for compounds for treating proteostasis dysfunction

Pharmaceutical Technology

Discover Kineta Inc's groundbreaking patent for compounds targeting proteostasis dysfunction. Learn about the specific chemical structures, pharmaceutical compositions, and methods for treating various conditions, including cancer symptoms. US Patent Publication Number: US11958873B2.

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.