XTalks
AUGUST 26, 2024
Supermarket baby food is often a critical aspect of early childhood development. Yet, many products in the US baby food aisle fall short of nutritional standards. A recent study published in the journal Nutrients highlights significant concerns, revealing that many baby foods contain excessive amounts of sugar and salt, coupled with misleading marketing claims.
Bio Pharma Dive
AUGUST 26, 2024
The buzzy startup, which had raised over $200 million in venture funding, is letting go of much of its workforce, according to a state regulatory notice.
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AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 26, 2024
(iprogressman/Getty Images) Consuming too much caffeine is definitely bad for your health, and there may be good reasons why some people want to quit it altogether. But if you despair at the idea of giving up your morning coffee, fear not.
Bio Pharma Dive
AUGUST 26, 2024
Build-to-buy arrangements can give pharmaceutical companies an option to acquire a startup’s assets later, as with Novartis’ deal with the Versant-backed Borealis Biosciences.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 26, 2024
The amended provisions under the Jan Vishwas (Amendment of Provisions) Act, 2023, notified by the Central Government last year for removal of stringent punishments such as imprisonment from some of the Sections of The Pharmacy Act, 1948, will come into force from December 31, 2024.
Bio Pharma Dive
AUGUST 26, 2024
Regulators in Europe granted approval based on remission rates, while the FDA sought more progress in confirmatory trials when it rejected Ordspono.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
AUGUST 26, 2024
Through effective collaboration, partnerships can accelerate the development of lifesaving therapies and improve patient outcomes.
Pharmaceutical Technology
AUGUST 26, 2024
The European Commission (EC) has approved Janssen's BALVERSA as a treatment for adults with unresectable or metastatic urothelial carcinoma.
Bio Pharma Dive
AUGUST 26, 2024
CROs are vital in supporting biotech with R&D. How can that relationship go from transactional to partnership?
Pharmaceutical Technology
AUGUST 26, 2024
Invenra received rare pediatric disease designation (RPDD) and orphan drug designation (ODD) from the FDA for INV724 to treat neuroblastoma.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Bio Pharma Dive
AUGUST 26, 2024
Imagine the power of combining CTCs, cell-free DNA and cell-free RNA.
Pharmaceutical Technology
AUGUST 26, 2024
The European Commission (EC) has approved Celltrion's SteQeyma, a biosimilar to Stelara, for treating chronic inflammatory conditions.
Fierce Pharma
AUGUST 26, 2024
Restructuring seems to be the name of the game for many large drugmakers these days, and Belgium-based UCB is no except | Belgium’s UCB is selling off its mature neurology and allergy business—plus a manufacturing plant—in mainland China. The deal will see local healthcare asset manager CBC Group and Abu Dhabi-based investment firm Mubadala pay UCB $680 million.
Pharmaceutical Technology
AUGUST 26, 2024
China has granted approval for GenFleet Therapeutics’ fulzerasib for advanced non-small cell lung cancer (NSCLC).
pharmaphorum
AUGUST 26, 2024
A US government agency has hit back at a plan by Johnson & Johnson to change the way it pays discounts on drugs to hospitals in the controversial 340B programme
FDA Law Blog
AUGUST 26, 2024
By Larry K. Houck — Who says nothing happens in Washington, D.C., in August? The Drug Enforcement Administration (“DEA”) will announce Thursday in the Federal Register that it will hold a hearing on the proposed rescheduling of marijuana to schedule III at DEA Headquarters in Arlington, Virginia on December 2, 2024. DEA received over 43,500 public comments in response to the agency’s Notice of Proposed Rulemaking in the Federal Register on May 21, 2024.
Fierce Pharma
AUGUST 26, 2024
Even as Johnson & Johnson prepares to weather the impact of negotiated Medicare drug prices on two of its | The new rebate model would require eligible hospitals to submit rebate claims after paying full price for the drugs, as opposed to upfront discounts.
Cloudbyz
AUGUST 26, 2024
Implementing a Clinical Trial Management System (CTMS) is a critical step for any life sciences organization aiming to enhance the efficiency, compliance, and oversight of their clinical trials. However, a successful CTMS implementation goes beyond merely choosing the right software. It requires a well-planned and meticulously executed strategy that aligns with your organization’s unique needs and goals.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Fierce Pharma
AUGUST 26, 2024
When CVS Caremark removed AbbVie’s Humira from its national commercial formularies back in April, biosimilar prescriptions picked up at a whirlwind pace. | Following CVS Caremark's lead, Cigna's pharmacy benefit manager unit will nix Humira from formularies in favor of Humira biosimilars from Boehringer Ingelheim, Teva and Sandoz.
Drug Patent Watch
AUGUST 26, 2024
The pharmaceutical industry has increasingly relied on Contract Development and Manufacturing Organizations (CDMOs) to support the development and commercialization of drugs. CDMOs offer a range of services, from drug development to manufacturing, allowing pharmaceutical companies to focus on their core competencies.
Fierce Pharma
AUGUST 26, 2024
Breast cancer treatments have evolved dramatically over the years, so Kyowa Kirin has decided to stop selling a decades-old drug in the U.S. | Breast cancer treatments have evolved dramatically over the years, so Kyowa Kirin has decided to stop selling a decades-old drug in the U.S.
XTalks
AUGUST 26, 2024
The US Food and Drug Administration (FDA) has approved Niktimvo (axatilimab-csfr) for the treatment of chronic graft-versus-host disease (GVHD) in adult and pediatric patients weighing 40 kg or more. This approval, granted under the FDA’s Priority Review process, is intended for patients who have failed at least two prior lines of systemic therapy.
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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
Fierce Pharma
AUGUST 26, 2024
Five months after the FDA rejected Regeneron’s bid for acc | Five months after the FDA rejected Regeneron’s bid for accelerated approval of its T-cell engager odronextamab because of the immaturity of its confirmatory trial, the European Union has signed off on the treatment for two types of blood cancers. The European Commission also approved SIFI's first-of-its-kind Akantior for a rare corneal infection disorder.
XTalks
AUGUST 26, 2024
The presence of lead in food remains a critical concern for the US Food and Drug Administration (FDA). Lead, a toxic metal, can enter the food supply through environmental contamination during the growing, raising or processing of foods. In this episode of the Xtalks Food Podcast, Sydney talks about how lead contamination in food can arise and what the FDA is doing to monitor lead levels.
Fierce Pharma
AUGUST 26, 2024
In this week's episode of "The Top Line," we look at factors driving the continuing decli | In this week's episode of "The Top Line," we look at factors driving the continuing decline of flu vaccination rates in the U.S. and beyond.
Cloudbyz
AUGUST 26, 2024
The clinical research industry is in the midst of a digital revolution, with Clinical Trial Management Software (CTMS) at the forefront of this transformation. Over the years, CTMS has evolved from basic, on-premises legacy systems to sophisticated, cloud-based platforms that offer unprecedented capabilities in managing clinical trials. This evolution is driven by the need for greater efficiency, real-time data access, scalability, and cost-effectiveness in an increasingly complex and globalized
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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.
pharmaphorum
AUGUST 26, 2024
Changing Faces – Agency, consultancy, and investor hires from July 2024: Stay updated on the latest hires at EVERSANA, Ogilvy Health, Skarbek, and more in the industry.
Pharmaceutical Commerce
AUGUST 26, 2024
Chris Williams expands on the services that a third-party logistics (3PL) partner should offer, while sharing ways to alleviate standard supply chain issues.
pharmaphorum
AUGUST 26, 2024
Siemens Healthineers has agreed a $224m deal to buy the diagnostic arm of Novartis' AAA radiopharmaceuticals unit
Roots Analysis
AUGUST 26, 2024
In today’s global landscape, sustainability has emerged as a pivotal concern across various sectors including the pharmaceutical packaging industry. With mounting pressure to reduce the degrading impact on the environment posed due to conventional packaging materials, stakeholders engaged in the pharmaceutical sector have been compelled to reevaluate traditional practices and step into the sustainable packaging companies.
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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.
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