Wed.Dec 27, 2023

article thumbnail

Amgen's request for full approval of Lumakras in lung cancer denied by FDA

Fierce Pharma

Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. | Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. The California biopharma will now have to conduct an additional confirmatory trial to gain the coveted FDA nod.

FDA 313
article thumbnail

Cytokinetics Heart Drug’s Trial Data Look Competitive With BMS Med Camzyos

MedCity News

Cytokinetics drug aficamten met the main goal of a pivotal test in obstructive hypertrophic cardiomyopathy. If approved, the daily pill would compete against a Bristol Myers Squibb drug projected to become a blockbuster seller.

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

Pfizer's Hospira recall spree bleeds into 2024 with product pulls for multiple hospital drugs in shortage

Fierce Pharma

After a year plagued by recalls, Pfizer’s sterile injectables unit Hospira seems no closer to righting the ship over its glass-contamination woes. | After a year plagued by recalls, Pfizer’s sterile injectables unit Hospira seems no closer to righting the ship over its glass-contamination woes. Shortly before the holiday, Hospira announced two separate recalls over the potential presence of glass particulates in vials and syringes of certain hospital meds.

238
238
article thumbnail

How Clarivate works towards SDG 12: Responsible consumption and production

Clarivate

At Clarivate we put sustainability at the heart of our business goals. Environment, social and governance issues are at the core of our global culture, serving as guiding principles for every decision we make. Our sustainability report is full of real-life examples of how we help our customers, colleagues and communities, with transparent, data-driven results and real insights on where we need to focus moving forward.

article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Report: Nearly Half of Patients Miss Medical Bills Due to Communication Problems

MedCity News

About 45% of patients have missed or forgotten to pay medical bills because of challenges they experienced in communicating with their provider, a survey from Artera found. Another 43% of patients said that these communication issues negatively affected their health.

Medical 105
article thumbnail

AstraZeneca buys Chinese CAR-T biotech Gracell in a $1.2bn deal

Pharmaceutical Technology

The deal is worth approximately $1.2bn in combined upfront and potential contingent value payments and is expected to close in Q1 2024.

98

More Trending

article thumbnail

Ultragenyx Picks Andelyn Biosciences to Manufacture Novel Gene Therapy for Sanfilippo Syndrome

PharmaTech

Andelyn Biosciences has been selected by Ultragenyx to manufacture UX111, that company’s gene therapy for treating Sanfilippo Syndrome.

article thumbnail

Key Leadership Lessons for Biotech Executives from a Hospital Administrator

MedCity News

While it may appear that hospital administrators and biotech CEOs have quite dissimilar jobs because they face different challenges daily, this article attempts to conveys the value of some of the underlying principles that one can develop in the field of hospital administration, that may have some value in other healthcare fields and in other executive positions.

article thumbnail

BMS strikes again, with $4.1bn RayzeBio takeover bid

pharmaphorum

Bristol-Myers Squibb makes a foray into the radiopharmaceutical category with a $4.

98
article thumbnail

Unveiling the Future of Radiology: Key Trends from RSNA 2023

MedCity News

At RSNA, three major trends stood out: the integration of artificial intelligence (AI), a renewed focus on health equity, and a dedicated effort to enhance the patient experience.

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

Update: Apple Watches back on sale after appeal

pharmaphorum

Apple will appeal a decision by the USTR not to veto a ban on US imports of some of its smartwatches, found to violate patents held by wearables company Masimo

Sales 62
article thumbnail

How Can Hospitals Prepare for 2024’s Cyberthreats?

MedCity News

Many hospitals remain underprepared to protect themselves against cybercriminals’ barrage of increasingly sophisticated attacks, but there are a couple concrete steps they can take to build a stronger defense structure — like virtual patching and thinking twice about moving to the cloud.

article thumbnail

Top Marketing Stories of 2023

PharmExec

Pharma marketing teams had to deal with big changes in 2023.

article thumbnail

Strategic Outsourcing: Enhancing Medical Sales Recruitment Solutions

Rep-Lite

Medical sales reps are typically hired to sell and promote products like medical equipment and pharmaceutical drugs. Their customers include pharmacists, doctors, and nurses. Their role is crucial as they can answer questions, raise awareness, introduce a product, and offer advice when needed. However, organizations can outsource the recruitment and hiring process to medical staffing agencies instead of hiring themselves.

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

European Medicines Regulatory Network on Track to Meet Goals

PharmaTech

The midterm report of the European Medicines Agencies Network Strategy finds that the network has strengthened and is on track to achieve its objectives.

article thumbnail

Bristol Myers Squibb agrees to acquire RPT company RayzeBio for $4.1bn

Pharmaceutical Technology

Bristol Myers Squibb (BMS) has signed a definitive agreement for the acquisition of RayzeBio in a total equity value of nearly $4.1bn.

52
article thumbnail

“Change Because We Have To” – Scholarly Publishing in 2023

Copyright Clearance Center

Scholarly publishers and service providers are pulling and pushing at traditions, opening doors, and introducing innovations.

52
article thumbnail

ARTBIO divulges plans for proprietary isotope manufacturing technology

Pharmaceutical Technology

ARTBIO is developing a proprietary radiotherapy manufacturing technology to overcome distribution and supply chain challenges.

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

Top 3 Most-Read Supply Chain Logistics Pieces of the Year

Pharmaceutical Commerce

The most popular pieces pertaining to the supply chain featured ADMs, vaccine supply chains, and wholesalers.

52
article thumbnail

Our Top 5 Podcast Episodes of 2023

PharmExec

Our top five episodes of the year.

52
article thumbnail

Eligibility Factors in Multiple Myeloma Transplant

Pharmacy Times

Gabriel Hinojosa, PharmD, BCOP, analyzes eligibility factors and treatment shifts in multiple myeloma care, considering autologous stem cell transplant risks and evolving therapy approaches with daratumumab.

26
article thumbnail

Apple to appeal after US backs ban on watch imports

pharmaphorum

Apple has launched an appeal against a decision by the Biden administration not to veto a ban on imports into the US of some of its smartwatches, after a complaint that the devices violate patents held by Masimo on the use of wearables to measure blood oxygen levels.

76
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

Top 5 Pharmacy Times Reimbursement Articles of 2023

Pharmacy Times

From newsworthy moments to groundbreaking research, these were the most-read reimbursement-related articles on Pharmacy Times in 2023.

26
article thumbnail

Developing point-of-care CAR T manufacturing

European Pharmaceutical Review

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. 1 Following in vitro production from T cells collected from a patient’s leukapheresis procedure, the CAR T cells are infused back into the patient’s blood, where they proliferate and expand. The CAR T cells need to persist in the blood to expand and elicit maximal effect, and there is a correlation between expansion and persistence and response.

article thumbnail

Top 5 Pharmacy Times Pneumococcal Articles of 2023

Pharmacy Times

From newsworthy moments to groundbreaking research, these were the most-read pneumococcal-related articles on Pharmacy Times in 2023.

26
article thumbnail

Top 5 Pharmacy Times Skin Cancer Articles of 2023

Pharmacy Times

From newsworthy moments to groundbreaking research, these were the most-read skin cancer-related articles on Pharmacy Times in 2023.

26
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