Fierce Pharma
AUGUST 11, 2023
It’s been a rough summer for pharmaceutical companies trying to resolve lawsuits by declaring bankruptcy. | The Supreme Court has halted Purdue Pharma’s $6-billion bankruptcy settlement, which granted the company’s former owners—the Sackler family—immunity from civil suits related to the opioid crisis.
PharmExec
AUGUST 11, 2023
How pharma medical affairs and commercial teams are synchronizing their capabilities to boost omnichannel marketing strategies and better understand customer engagement needs.
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Fierce Pharma
AUGUST 11, 2023
Amylyx Pharmaceuticals’ amyotrophic lateral sclerosis (ALS) drug Relyvrio continues to wow Wall Street. | Amylyx’s amyotrophic lateral sclerosis drug Relyvrio continues to wow Wall Street. The drug brought in $98.2 million revenue in the second quarter, handily beating analysts’ consensus estimates of below $92 million.
PharmExec
AUGUST 11, 2023
From public defender to spearheading the adoption of innovative drugs, Wendy Short Bartie, senior VP and general manager for the hematology and cell therapy division at Bristol Myers Squibb, has remained a steadfast patient advocate—working to fulfill unmet medical needs and bring treatments to as many people as possible.
Fierce Pharma
AUGUST 11, 2023
Less than a month after the family of Henrietta Lacks reached a settlement with Thermo Fisher over its use of Lacks’ cells, another drugmaker stands accused of profiting from a racist medical syste | Less than a month after the family of Henrietta Lacks reached a settlement with Thermo Fisher over its use of Lacks’ cells, another drugmaker stands accused of profiting from a racist medical system.
MedCity News
AUGUST 11, 2023
Ceribell Inc., based in Sunnyvale, California, has developed a point-of-care EEG system that provides real-time seizure monitoring and alerting, which helps in the rapid and precise treatment of patients with suspected non-convulsive seizures. The FDA-cleared Ceribell ClarityPro software uses a machine-learning model to analyze EEG signals and generate bedside alerts.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
AUGUST 11, 2023
The healthcare AI space will be an exciting one to watch over the next couple years, as investment dollars flow to startups and providers launch more AI pilots. Two of the most interesting trends to watch will be the use cases that healthcare organizations prioritize when deploying generative AI models, as well as M&A activity within the healthcare AI field, a CB Insights analyst declared during a recent webinar.
Fierce Pharma
AUGUST 11, 2023
Since Pfizer’s smoking cessation drug Chantix was recalled in 2021, Endo's subsidiary Par Pharmaceuticals has been the only one to market the product. | Endo alleges that Zydus Pharmaceuticals infringed upon its Chantix patent, asserting that there is no alternative method for producing the drug without the impurities that led to the removal of Pfizer's original product from the market.
PharmExec
AUGUST 11, 2023
Life sciences executives who are confronted by too many choices in launching their environmental, social, and governance programs can leverage these two foundational tools to hone in on the set of issues, actions, and disclosures they should prioritize to create value.
MedCity News
AUGUST 11, 2023
An AI-driven app called juli improved symptoms of asthma and depression, two randomized controlled trials found. The app takes in data from electronic medical records, smartphones, wearable devices, the environment and patient questionnaires to provide personalized health recommendations.
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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.
European Pharmaceutical Review
AUGUST 11, 2023
The European Commission has revoked the conditional marketing authorisation (MA) for Novartis’ sickle cell medicine crizanlizumab in the European Union (EU) and EEA. The decision follows a May recommendation from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP). Crizanlizumab is a once-a-month, humanised monoclonal antibody infusion, indicated for the prevention of recurrent vaso‑occlusive crises (pain crises) in sickle cell disease patients aged 16 yea
MedCity News
AUGUST 11, 2023
While greater operational efficiency and cost control are essential to the success of VBC initiatives, so too is patient engagement. Care coordination and care management are far more difficult – and far less likely to achieve optimal outcomes – without patients who are fully engaged with their providers.
PharmExec
AUGUST 11, 2023
Now with a seat at the table, growing accountability, and evolving competencies, medical affairs can use its far-reaching influence to change pharma for the better.
MedCity News
AUGUST 11, 2023
CMS’ Enhancing Oncology Model and Cancer Moonshot are the forcing functions to achieve value-based care in oncology. In the spirit of working together to improve lives, this is a MUST for physicians to consider–before they get left behind.
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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
Pharmaceutical Technology
AUGUST 11, 2023
The latest tag adds to three fast track designations for Reqorsa, with the company initiating a Phase I/II trial in Q4 2023.
PharmExec
AUGUST 11, 2023
Continued approval to be based on verification and description of clinical benefit in confirmatory trials.
Pharmaceutical Technology
AUGUST 11, 2023
Following the business expansion in 2022, Clinigen announced the divestment of four of its cancer therapies.
Pharmaceutical Commerce
AUGUST 11, 2023
MIT’s Barbara Wixom, PhD, outlines the importance of data-powered research in producing financial success.
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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.
PharmaTimes
AUGUST 11, 2023
Highly selective inhibitor therapy treats patients with chronic spontaneous urticaria - News - PharmaTimes
PharmExec
AUGUST 11, 2023
Collaboration intends to inspire creativity in healthcare and pharma industries.
PharmaTimes
AUGUST 11, 2023
Data supports further exploration of candidate as a rapid-acting anti-depressant for home use - News - PharmaTimes
Pharmaceutical Technology
AUGUST 11, 2023
Absci, in collaboration with Caltech, has received a grant from the Bill & Melinda Gates Foundation to advance HIV therapeutic vaccine.
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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.
PharmaTech
AUGUST 11, 2023
The guidance can help both applicants and manufacturers limit the mutagenic and carcinogenic potential of NDSRIs.
Pharmaceutical Technology
AUGUST 11, 2023
City of Hope researchers are developing a chimeric antigen receptor (CAR) T cell therapy for the treatment of recurrent ovarian cancer.
PharmExec
AUGUST 11, 2023
Joint venture to combine artificial intelligence with biosciences’ dataset to identify novel therapy targets.
Pharmaceutical Technology
AUGUST 11, 2023
Oxurion has received €1m ($1.09m) in funding from Atlas as part of a subscription agreement with Atlas totalling up to €20.8m ($25m).
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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
Pharmaceutical Commerce
AUGUST 11, 2023
Citing growth as contributing factor, SaaS provider plans on relocating to a biopharma hub in Waltham, MA.
Pharmaceutical Technology
AUGUST 11, 2023
The US Food and Drug Administration (FDA) has accepted Astellas Pharma’s supplemental New Drug Application (sNDA) for CRESEMBA.
Pharmacy Times
AUGUST 11, 2023
Jennifer Chesak, author of The Psilocybin Handbook for Women, discusses how estrogen can affect binding at the serotonin receptor sites, causing psilocybin to impact women’s bodies differently.
Pharmaceutical Technology
AUGUST 11, 2023
In June, Sutro received a $140m payment from Blackstone Life Sciences as part of the Vaxcyte product licensing agreement.
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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.
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