Bio Pharma Dive
NOVEMBER 28, 2023
U.S. tax law changes enacted six years ago slashed large pharma companies' rates and saved them billions. Now, a push for an international floor could disrupt their R&D accounting.
Pharmaceutical Technology
NOVEMBER 28, 2023
The US Food and Drug Administration (FDA) has accepted to review Orexo’s new drug application (NDA) for opioid overdose medication, OX124.
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Bio Pharma Dive
NOVEMBER 28, 2023
The agency said the benefit of approved treatments like Gilead’s Yescarta still outweighs any such risk, but the alert could slow drugmaker efforts to develop the treatments for wider use.
Pharmaceutical Technology
NOVEMBER 28, 2023
The emergency use listing is based on non-clinical data where the vaccine demonstrated immune responses against variants in SARS-CoV-2.
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The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Bio Pharma Dive
NOVEMBER 28, 2023
Fresh off a $7 billion deal with Roche, the chief executive spoke with BioPharma Dive about this year’s “discordant combination” of major biotech achievements alongside market headwinds.
Pharmaceutical Technology
NOVEMBER 28, 2023
Venture financing for innovative radiopharmaceutical drugs witnessed an approximately 550% increase from $63m in 2017 to $408m in 2023 YTD (year-to-date) total deal value in the US.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
NOVEMBER 28, 2023
A Phase IIb/III trial studying the company’s immunotherapy izokibep, failed to achieve statistical significance for its primary endpoint
Bio Pharma Dive
NOVEMBER 28, 2023
The pharma has overhauled its pipeline this year, cutting R&D programs outside of its four main therapeutic areas.
Pharmaceutical Technology
NOVEMBER 28, 2023
Emergent’s Cyfendus was approved by the US FDA as a post-exposure prophylactic vaccine for anthrax in July.
Rethinking Clinical Trials
NOVEMBER 28, 2023
The workshop summary is now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Getting the Right Evidence to Decision-Makers Faster.” The 2-day workshop explored the critical cycle of evidence generation by researchers to decision-making by healthcare system leaders to implement the findings of pragmatic clinical trials conducted within healthcare systems.
Pharmaceutical Technology
NOVEMBER 28, 2023
Aldeyra has submitted new trial plans to the US FDA, and anticipates NDA resubmission for reproxalap in H1 2024.
Fierce Pharma
NOVEMBER 28, 2023
In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs. | In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs.
Pharmaceutical Technology
NOVEMBER 28, 2023
The agency has set a PDUFA date of 25 May 2024 for pz-cel, which if approved, Abeona would be eligible for a priority review voucher.
Fierce Pharma
NOVEMBER 28, 2023
As the pandemic eased earlier this year, officials in Poland became vocal critics of the financial obligations laid down by Pfizer’s large vaccine supply pact with the European Union. | As the pandemic eased earlier this year, officials in Poland became vocal critics of the financial obligations laid down by Pfizer’s large vaccine supply pact with the European Union.
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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
Pharmaceutical Technology
NOVEMBER 28, 2023
Japan’s MHLW has granted approval for Daiichi Sankyo’s Omicron XBB.1.5-adapted monovalent mRNA vaccine as a booster for Covid-19.
Fierce Pharma
NOVEMBER 28, 2023
Gilead Sciences' Kite Pharma cell therapy unit is undergoing a business review that will result in layoffs to about 7% of the organization’s workforce. | Gilead’s Kite Pharma cell therapy unit is undergoing a business review that will result in layoffs to about 7% of the organization’s workforce. In a letter sent to staff this week that was obtained by Fierce Biotech, Kite Pharma Executive Vice President Cindy Perettie previewed a “refreshed business strategy” that would better align the un
Pharma Times
NOVEMBER 28, 2023
Tafinlar and Mekinist led to a 56% overall response rate in children with BM-HGG - News - PharmaTimes
Pharmaceutical Technology
NOVEMBER 28, 2023
Opening the first day of the CTO Europe conference, experts set their sights on the impact of digital technologies on oncology trials.
Fierce Pharma
NOVEMBER 28, 2023
Novartis is getting more optimistic about its midterm sales potential, thanks to bullish estimates for some blockbuster drugs. | Novartis is getting more optimistic about its midterm sales potential, thanks to bullish estimates for some blockbuster drugs, including Entresto and Kisqali.
Pharmaceutical Technology
NOVEMBER 28, 2023
As per recommendations, Bayer will continue to investigate asundexian in a different Phase III trial with stroke patients.
Fierce Pharma
NOVEMBER 28, 2023
Armed with a full FDA approval after four years supplying its anthrax vaccine under a pre-emergency use authorization, Emergent BioSolutions is expanding its countermeasure supply pact with the Uni | Armed with a full FDA approval after four years supplying its anthrax vaccine under a pre-emergency use authorization, Emergent BioSolutions is expanding its countermeasure supply pact with the United States.
Pharmaceutical Technology
NOVEMBER 28, 2023
Boehringer Ingelheim has entered an agreement with IBM to leverage the latter’s foundation model technologies for antibody discovery.
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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.
Pharma Times
NOVEMBER 28, 2023
Around 3,000 new cases of mesothelioma are diagnosed in the US every year - News - PharmaTimes
Pharmaceutical Technology
NOVEMBER 28, 2023
The US Food and Drug Administration (FDA) has granted orphan drug designation for Arcturus Therapeutics’ ARCT-032 for cystic fibrosis.
pharmaphorum
NOVEMBER 28, 2023
Putting patients at the centre of innovation starts with clinical trial access Mike.
Fierce Pharma
NOVEMBER 28, 2023
Dermavant CEO Todd Zavodnick isn’t concerned with the slow uptake of the hyped plaque psoriasis drug Vtama. He points to another breakthrough treatment which took a while to catch on: Botox. | Dermavant CEO Todd Zavodnick isn’t concerned with the slow uptake of hyped plaque psoriasis drug Vtama. He points to another breakthrough treatment which took a while to catch on—Botox.
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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
pharmaphorum
NOVEMBER 28, 2023
Veeva Commercial Summit '23: The power of connectivity Mike.
Fierce Pharma
NOVEMBER 28, 2023
As drug shortages mount in the U.S. with little relief in sight, President Joe Biden has rolled out a slew of efforts to bolster the nation’s supply chains. | Monday, during the first meeting of the new White House Council on Supply Chain Resilience, President Biden unveiled nearly 30 actions to bolster production networks across industries. Among those actions, Biden intends to leverage the Defense Production Act (DPA) to make more essential medicines at home and thwart future drug shortages.
pharmaphorum
NOVEMBER 28, 2023
Reducing the stigma attached to psychedelics Mike.
BioSpace
NOVEMBER 28, 2023
The United States’ relatively high costs have become a political issue on both sides of the aisle. Here’s how international pharmaceutical prices stack up.
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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.
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