Bio Pharma Dive
OCTOBER 18, 2024
European regulators have for the fourth time issued a negative opinion on PTC's Translarna. Elsewhere, Amylyx read out data and Leqembi hit a roadblock in Australia.
Pharmaceutical Technology
OCTOBER 18, 2024
An 800% increase in licensing deal values indicates growing confidence in mRNA technology, but some vaccine producers are facing lawsuits.
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Bio Pharma Dive
OCTOBER 18, 2024
Detailed data from a Phase 2b/3 study of Merck’s treatment clesrovimab should support the company’s efforts to win approval by the 2025-2026 season.
Pharmaceutical Technology
OCTOBER 18, 2024
Late-stage pipeline products could drive combined sales of approximately $171.4 million by 2033 in the 8MM.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
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
OCTOBER 18, 2024
The antibody drug conjugate didn’t help patients live longer in a confirmatory trial, prompting a review of its conditional approval in that indication.
Pharmaceutical Technology
OCTOBER 18, 2024
An FDA AdCom in September recommended against full approval for Ocaliva by a 13-1 vote for the treatment of primary biliary cholangitis.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
OCTOBER 18, 2024
A Phase IIb/III trial with infants entering their first respiratory syncytial virus (RSV) season met its primary endpoints.
Bio Pharma Dive
OCTOBER 18, 2024
The financially struggling healthcare giant also pulled its earnings guidance, citing increased medical cost pressures in its health benefits unit.
Pharmaceutical Technology
OCTOBER 18, 2024
The expanded approval intensifies the rivalry with Jazz Pharmaceuticals, which has previously attempted to block Lumryz’s path to market.
Fierce Pharma
OCTOBER 18, 2024
After falling short in a confirmatory clinical trial, Gilead Sciences has decided to withdraw Trodelvy as a bladder cancer treatment in the U.S. | After falling short in a confirmatory clinical trial, Gilead Sciences has decided to withdraw Trodelvy as a bladder cancer treatment in the U.S.
Pharmaceutical Technology
OCTOBER 18, 2024
TheracosBio has entered a partnership with BAMCO Africa to deliver BRENZAVVY (bexagliflozin) to patients in sub-Saharan Africa.
Fierce Pharma
OCTOBER 18, 2024
Novo Holdings is encountering more resistance as it aims to close its $16.5 billion acquisition of pharma manufacturing giant Catalent by the end of the year. | A dozen consumer groups and trade unions penned a letter to Lina Khan, chair of the U.S. Federal Trade Commission, urging the antitrust agency to block Novo Holdings’ proposed $16.5 billion buyout of CDMO giant Catalent.
Pharmaceutical Technology
OCTOBER 18, 2024
Sanofi and Orano Group subsidiary Orano Med have announced a partnership to enhance the development of next-generation RLTs.
pharmaphorum
OCTOBER 18, 2024
Jörg Möller's sojourn as CEO of BenevolentAI has come to an abrupt end, as the firm names co-founder Ken Mulvany as executive chair
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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
OCTOBER 18, 2024
A potential three-year framework agreement between the Greek government and the pharmaceutical industry, starting at the beginning of 2025, has been the focus of recent discussions between the Ministry of Health (MoH) and associations representing the pharmaceutical industry in Greece.
pharmaphorum
OCTOBER 18, 2024
AbbVie has finally claimed FDA approval for its 24-hour Parkinson's therapy Vyalev, 18 months after the US regulator turned it down
Pharmaceutical Technology
OCTOBER 18, 2024
The US FDA has approved AbbVie's VYALEV to treat motor fluctuations in adults with advanced Parkinson's disease (PD).
pharmaphorum
OCTOBER 18, 2024
MSD reveals the data that could unlock filings for clesrovimab, a rival to Sanofi and AstraZeneca's Beyfortus for preventing infant RSV infections
Fierce Pharma
OCTOBER 18, 2024
After hitting a wall with the FDA last year, Novo Nordisk has picked up backing from European drug reviewers for its novel hemophilia treatment concizumab. | Novo Nordisk received good news from European drug reviewers on its hemophilia treatment, while PTC Therapeutics' Duchenne Muscular Dystrophy therapy was again recommended for rejection upon a re-examination.
XTalks
OCTOBER 18, 2024
The US Food and Drug Administration (FDA) has approved Itovebi (inavolisib) for the treatment of adults with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation. This approval addresses a significant need for patients with endocrine-resistant breast cancer, where disease progression remains a challenge.
Fierce Pharma
OCTOBER 18, 2024
After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy. | Astellas' Vyloy won an FDA approval to treat gastric or gastroesophageal junction adenocarcinoma patients whose tumors are CLDN18.2 positive. The drug was rejected earlier this year thanks to observations raised during the agency's inspection of a third-party manufacturing facility.
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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.
pharmaphorum
OCTOBER 18, 2024
Sanofi invests €300m in Orano Med's lead-based radioligandsSanofi has firmed up its position in the red-hot area of radiopharmaceuticals for cancer with the purchase of a €300 million ($325 million) stake in Orano Med, a subsidiary of French nuclear fuel company Orano.The transaction builds on a three-way partnership between Sanofi, Orano Med, and RadioMedix – signed in September with a €100 million upfront payment – to develop a radioligand therapy (RLT) for rare neuroendocrine tumours (NETs) c
Pharmaceutical Commerce
OCTOBER 18, 2024
With great power comes great responsibility. In this case, tackling these obstacles is vital to making sure that the positives of GLP-1s are not outweighed by the downfalls of improper waste disposal.
Intouch Solutions
OCTOBER 18, 2024
As we stand at the intersection of creativity and technology, a common question arises: Will generative AI (GenAI) make creatives obsolete? The answer that echoed through the Miami Beach Convention Center at Adobe MAX 2024 was a firm no. From stage to stage, the resounding sentiment was that GenAI isn’t here to replace creativity; it’s here to elevate it.
Pharmaceutical Commerce
OCTOBER 18, 2024
The latest news for pharma industry insiders.
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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
Trialfacts
OCTOBER 18, 2024
Contents About the Study Why Participate? Your Rights Who Can Participate? More Study Details Location Research Centre: Austin Health, University of Melbourne Location: Heidelberg VIC 3084, Australia Lead Researcher: Professor Richard Kanaan HREC: This study has been reviewed and approved by the Austin Health Human Research Ethics Committee (HREC/94244/Austin-2023) About the Study Feeling overwhelmed by Debilitating Symptom Complexes Attributed to Ticks (DSCATT)?
Fierce Pharma
OCTOBER 18, 2024
Nancy McGee, VP & GM U.S. Patient Support Services, IQVIAJennifer Millard, VP U.S. Integrated Patient Support Services, IQVIA | The 2025 Medicare Part D redesign will eliminate the “donut hole” and reduce out-of-pocket costs. Patient support is crucial for a smooth transition and better patient outcomes.
Antidote
OCTOBER 18, 2024
Improving health literacy for more equitable access to clinical trial research Low health literacy is a major concern in healthcare. Statistics show that nearly 88% of Americans struggle with health literacy , and this issue is not evenly distributed across the population. Older adults, racial and ethnic minorities, non-native English speakers, low-income individuals, and those with limited education are more likely to face challenges in this area, leading to worse health outcomes and heightened
WCG Clinical
OCTOBER 18, 2024
There have been several revolutionary advancements in the field of neurological imaging. These have included the invention of Computed Tomography (CT) and Magnetic Resonance Imaging (MRI), as well as the introduction of intravenous contrast enhancement. These techniques are the foundation of noninvasive neurological imaging and have advanced patient clinical care and research.
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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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