Thu.Sep 14, 2023

article thumbnail

FDA, manufacturers make progress in resolving key cancer drug shortages: White House

Fierce Pharma

While there's certainly more work to do, the U.S. | Efforts from regulators and manufacturers have brought the U.S. supply of cisplatin back to nearly 100% of pre-shortage levels, according to the White House. The moves are “greatly alleviating the shortages of carboplatin,” too, the White House said.

article thumbnail

Senators Introduce Bipartisan Bill To Impose Harsher Penalties On Those Who Assault Healthcare Staff

MedCity News

This week, senators introduced a bipartisan bill that would make it a federal crime to assault hospital workers. Even though nearly 40 states have passed laws to intensify penalties for violent acts committed against healthcare personnel, there is currently no federal law protecting hospital employees from assault or intimidation.

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 Kenvue spinoff, J&J says it's 'uniting' Janssen and medtech segments under one brand

Fierce Pharma

Alongside a new logo reveal Thursday, Johnson & Johnson unveiled some major changes to its corporate persona. | J&J is uniting its medtech and pharmaceutical arms so that they will be “more connected to the Johnson & Johnson brand," the company said. Over time, Janssen is slated to become Johnson & Johnson Innovate Medicine, while the company’s medical technology segment will continue to run with the J&J MedTech moniker.

Medicine 269
article thumbnail

How Health Tech is Squashing AI Biases and Leveling the Playing Field in Healthcare

MedCity News

By making large amounts of diverse data widely available, healthcare institutions can feel confident about the evaluation, creation, and validation of algorithms as they’re transitioned from ideation to use.

article thumbnail

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

article thumbnail

Fierce Pharma Asia—Otsuka's gene therapy deal; Astellas' $354M plant; Exelixis and Insilico's AI drug pact

Fierce Pharma

Otsuka teamed up with Shape Therapeutics in an eye disease gene therapy deal potentially worth $1.5 billion. Astellas will build its third Irish manufacturing facility. | Otsuka teamed up with Shape Therapeutics in an eye disease gene therapy deal potentially worth $1.5 billion. Astellas will build its third Irish manufacturing facility for $354 million.

article thumbnail

While Auto vs. Allo Cell Therapy Debate Continues, VCs Look for ‘Next Shiny Thing’

MedCity News

Allogeneic cell therapy hasn’t caught up to autologous cell therapy yet, and the disappointing data so far has soured the entire allogeneic field for at least one venture capitalist. The cell therapy debate was one of the topics covered during a panel discussion at the Biopharm America conference.

Biopharma 111

More Trending

article thumbnail

GoodRx, MedImpact Launch Medication Savings Solution

MedCity News

MedImpact and GoodRx are teaming up to lower costs for MedImpact members. When eligible MedImpact members refill a generic prescription, the companies’ savings solution will compare the member’s benefit to GoodRx’s price and will automatically apply the lowest one.

article thumbnail

AZ's Alexion inks $125M deal to resolve investor lawsuit over Soliris sales tactics

Fierce Pharma

Nearly seven years have passed since Alexion’s then-CEO and CFO stepped down amid an investigation into improper sales practices. | Alexion has reached a $125 million deal to settle a class action lawsuit brought by investors who lost money during a stock plunge caused by allegations about the company's sales practices for Soliris.

Sales 182
article thumbnail

Avoiding Commercialization Pitfalls for CGTs

PharmExec

Lung-I Cheng, vice president of cell and gene therapy (CGT), Cencora (formerly AmerisourceBergen), discusses CGT commercialization strategies, common knowledge gaps, and what he wishes companies knew about commercialization strategies.

105
105
article thumbnail

Accelerating Alzheimer's therapy innovation: A new horizon in blood-based biomarkers

Fierce Pharma

By Dr Michael K Racke, Medical Director of Neurology, Quest Diagnostics | The escalating global challenge of Alzheimer's Disease (AD) demands new approaches to detection, diagnosis, and treatment. Dr. Racke will delve into recent advancements in the AD diagnostic landscape.

Medical 130
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

AstraZeneca partnership to pioneer UK’s first commercial biomethane supply

European Pharmaceutical Review

Under a new agreement, AstraZeneca is set to establish the first unsubsidised industrial-scale supply of biomethane. The pharmaceutical firm is investing greatly in its existing infrastructure to facilitate the shift to renewable gas and support a transition to 100 percent renewable energy. This includes its Macclesfield campus, the UK’s largest pharma manufacturing site.

article thumbnail

A possible mutiny at Abcam? Founder and former CEO says he'll vote against Danaher sale, assembles 'shadow board'

Fierce Pharma

A possible mutiny at Abcam?

Sales 244
article thumbnail

Brain Computer Interface Decodes Speech and Facial Expressions

Medgadget

Researchers at the University of California San Francisco have developed a brain computer interface that can lets someone with severe paralysis communicate with both speech and facial expressions, in the form of a digital avatar. The breakthrough advances what has been possible, with previous brain computer interface systems providing speech only, and allows people to communicate more completely, encompassing facial expressions, which are an important aspect of natural communication.

article thumbnail

Otsuka Collaborates with ShapeTX for Development of AAV Gene Therapies

PharmaTech

The companies are collaborating to apply ShapeTX’s AAVid capsid discovery platform and transgene engineering technology in addition to Otsuka’s expertise in genetic payload design and ophthalmology to develop novel treatment options for eye diseases.

article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Pfizer’s migraine medicine recommended by NICE

European Pharmaceutical Review

Rimegepant (Vydura) is the “first and only NICE-recommended medicine that can help alleviate the misery of acute migraines, and may be considered a step-change in treatment,” shared Helen Knight, Director of medicines evaluation at the National Institute for Health and Care Excellence (NICE). Made by Pfizer, Rimegepant (Vydura), is recommended in NICE final draft guidance for adults who have tried at least two triptans but failed to achieve adequate relief with these medicines.

article thumbnail

Highly Precise Pressure Sensor for Laparoscopic or Robotic Surgical Tools

Medgadget

Researchers at the National University of Singapore have developed a highly sensitive pressure sensor that can provide haptic feedback for surgeons using laparoscopic tools or for use in robotic grippers as part of robotic surgical systems. The technology is inspired by the surface of the lotus leaf, which is extremely sensitive to the pressure exerted by tiny drops of water and will repel them.

article thumbnail

Digital Medicine in Pharma: A Marketers’ Guide for Launch, Promotion and Life Cycle Management

Eversana Intouch

Digital medicine is emerging as a revolutionary field that can transform the entire spectrum of healthcare, from proactive prevention to effective treatment of diverse medical conditions. Unlike traditional pharmaceutical medications, digital medicine products need to speak to the clinical, economic and technological benefits to differentiate themselves from competitors.

article thumbnail

Providers & Payers Need to Learn How to Play Nice Sooner Rather Than Later

MedCity News

Even though providers and payers don’t always get along, they need to come together now more than ever. In the post-pandemic landscape, the healthcare industry won’t be able to maintain care quality and protect patient access without strong collaboration between these two parties, health system leaders said during a virtual panel.

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

UKRI report reveals impact of COVID-19 research and innovation funding

PharmaTimes

The report highlights steps needed to ensure future pandemics are handled effectively - News - PharmaTimes

105
105
article thumbnail

The Hidden Superpower: Why Everyone Should Harness The Art of Selling

Contrarian Sales Techniques

The Universal Truth Have you ever heard someone say, "I could never be in sales!"? It’s a sentiment many echo. Admittedly, the idea of selling for a living isn’t everyone's cup of tea. However, whether you're in the boardroom or at a family dinner, life often throws curveballs that require a bit of sales finesse. And here's the kicker: if you can master the art of selling, in many ways, you’re set for life.

article thumbnail

UK government invests £200m to boost NHS resilience this winter

PharmaTimes

The funding will reduce waiting lists and ease the demand on the NHS during Winter - News - PharmaTimes

article thumbnail

Astellas to build drug production facility in Ireland

Pharmaceutical Technology

Astellas Pharma is submitting a planning application for the construction of a new drug production facility in Ireland.

Pharma 69
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

Core Values Series: Growth

Penrod

Over the last few months, you’ve learned lots about our core values! We have one more in store for you: Growth. Our five Core Values are: Accountability Flexibility Growth Grit Teamwork We define Growth as “Deliberate pursuit of improvement both on the individual and team level. We are all equally responsible for growth.” We’ve seen our folks display Growth by: Taking on new responsibilities and owning their success Stepping outside their comfort zone to learn something new Requesting, giving, a

52
article thumbnail

Beacon Biosignals Receives FDA Clearance for AI-Assisted Sleep Monitoring Device Dreem 3S

Legacy MEDSearch

Beacon Biosignals is thrilled to announce the milestone achievement of FDA 510(k) Clearance for the Dreem 3S, an advanced wearable headband with integrated machine learning algorithms to capture electroencephalogram (EEG) data from the brain to monitor sleep architecture and aid in the diagnosis of disturbed sleep. FDA Clearance marks it as equivalent to in-lab polysomnography for the assessment of sleep staging.

FDA 52
article thumbnail

Maximizing Efficiency: The Advantages of Contract Employees with Rep-Lite

Rep-Lite

In today’s rapidly changing business landscape, adaptability and efficiency are paramount. One solution that has gained immense popularity is the use of contract employees. They bring a range of benefits to the table, and when you partner with Rep-Lite , these advantages become even more pronounced. In this blog, we explore the numerous benefits of contract employees and how Rep-Lite can help you leverage these advantages to enhance your workforce.

article thumbnail

Improving health equity in Europe’s small countries: How can we remove the barriers to access?

Pharmaceutical Technology

Ensuring equitable access to medicines is a key challenge for many governments, particularly those of smaller nations. Pharmaceutical Technology reviews the data and explores European initiatives to improve the situation.

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

Accelerate Your Success: The Advantages of Speed-to-Hiring with Rep-Lite

Rep-Lite

In the fast-paced world of business, speed can make all the difference, especially when it comes to hiring. Open positions represent opportunities, and the faster you can fill them, the sooner your organization can reap the benefits. This blog explores the numerous advantages of speed-to-hiring and how partnering with Rep-Lite can help you achieve your recruitment goals with efficiency and excellence.

article thumbnail

Colorcon Launches New Titanium Dioxide Free Moisture Protection Coating for Pharmaceutical Tablets

PharmaTech

Colorcon provides customers with Opadry complete film coating systems, which intends to help reduce complexity with delivering high-quality products and ingredients.

article thumbnail

FDA accepts Madrigal’s liver disease therapy NDA for review

Pharmaceutical Technology

The US FDA has accepted Madrigal Pharmaceuticals’ new drug application (NDA) for liver disease therapy resmetirom for review.

FDA 59
article thumbnail

O.G. Ice-T teams up with Sanofi in horror-themed flu vax ad

PharmaVoice

The French pharma’s latest vaccine campaign aims to raise awareness about the flu’s complications for marginalized groups.

Pharma 52
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.