XTalks

DECEMBER 9, 2024

The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway for drugs and biologics targeting serious or life-threatening conditions. This guidance focuses on improved accountability, earlier confirmatory studies and greater clarity on novel endpoints.

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Clinical Trials Clinical Trials Compliance Trials 105

pharmaphorum

JANUARY 4, 2024

Amplifying the patient voice is essential for the success of clinical trials. Learn why it is crucial for patient engagement, recruitment, and overall trial success, and how it can address challenges such as transportation and financial barriers.

Clinical Trials 131

Clinical Trials Clinical Trials Trials 131

Bio Pharma Dive

JANUARY 2, 2024

A non-addictive pain pill faces its definitive test, while study results in ALS, a rare heart disease and lung cancer could have far-reaching implications.

Clinical Trials 358

Clinical Trials Clinical Trials Trials 358

Antidote

JANUARY 5, 2024

Though clinical trial patient recruitment is an integral part of the medical research process, it is often one of the most difficult aspects of conducting a study. There are various reasons for this challenge, and among them is the widespread existence of misconceptions about participating in research that many patients may see as a barrier to entry.

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Clinical Trials Clinical Trials Trials Research 124

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

Medicine

ACRP blog

OCTOBER 10, 2024

The increased accessibility of generative artificial intelligence (Gen AI) models like OpenAI’s ChatGPT and DALL-E has captured the popular imagination. You’d be hard-pressed now to find any leadership team in any sector that isn’t at least considering ways to leverage Gen AI. The technology uses patterns learned from data to create new content. Most industries have applied it to routine back office or administrative tasks, such as note-taking, helping to increase the efficiency of everyday pr

Clinical Trials 69

Clinical Trials Clinical Trials Trials Life Science 69

Rethinking Clinical Trials

NOVEMBER 21, 2024

In a new commentary, members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core explore the potential of pragmatic trials to improve demographic representativeness and health equity in clinical research. The article, “Untapped Potential? Representativeness in Pragmatic Clinical Trials,” was published online ahead of print in JAMA.

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Trials Clinical Trials Clinical Trials Doctors 316

Bio Pharma Dive

OCTOBER 16, 2024

The results provide the first clinical evidence of RNA editing, a burgeoning field that's drawn interest from biotechs and pharmaceutical companies alike.

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RNA Trials 358

Bio Pharma Dive

OCTOBER 4, 2024

An experimental Alzheimer’s therapy from Cassava Sciences is still being tested in two Phase 3 studies, even as the company has come under regulatory scrutiny.

Trials 360

Trials 360

Bio Pharma Dive

OCTOBER 22, 2024

Early study data from Wave Life Sciences suggests how editing RNA may yield viable medicines. Large and small drugmakers say such results are just the start.

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RNA Life Science Medicine 354

Bio Pharma Dive

NOVEMBER 6, 2024

Pioneers like Alnylam Pharmaceuticals have led the RNA interference field for years. Now, a crop of young biotechs is building on that foundation by taking the drugmaking technology in new directions.

RNA 348

RNA 348

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Clinical Supply

Bio Pharma Dive

AUGUST 29, 2024

Far fewer venture funding rounds were closed by cell and gene therapy developers over the first six months of 2024 than in prior years. Experts say there are several factors.

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Gene Therapy Gene Development 357

Bio Pharma Dive

NOVEMBER 18, 2024

The agency's openness to a targeted pivotal study shows it’s still willing to consider accelerated clearance for Duchenne gene therapies despite questions about their effectiveness.

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Gene Therapy Gene 336

Pharmaceutical Technology

MAY 1, 2024

AstraZeneca has maintained that while the vaccine may, in “very rare” cases, cause TTS, the casual mechanism for this effect remains unknown.

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Vaccination Vaccine 364

Bio Pharma Dive

SEPTEMBER 4, 2024

Over the past 10 years, PD1-blocking medicines have transformed cancer care. But the steady expansion of their use has slowed and, despite much trying, pharmaceutical companies have largely failed to top the drugs’ successes.

Drugs 351

Drugs Medicine 351

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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

Clinical Trials

Bio Pharma Dive

OCTOBER 17, 2024

Vyalev’s clearance is the second victory for AbbVie in Parkinson’s this year, following an April readout for a drug acquired through its Cerevel buyout.

Drugs 340

Drugs 340

Bio Pharma Dive

MAY 7, 2024

Pfizer said the patient, a young boy who was treated earlier last year, had died suddenly. The company is working with trial researchers to investigate further.

Gene Therapy 360

Gene Therapy Gene Trials Research 360

Bio Pharma Dive

NOVEMBER 15, 2024

At an event hosted by BioPharma Dive, drugmaker executives and investors discussed the importance of focus, smart spending and maintaining lines of sight to the clinic.

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Bio Pharma Dive

MAY 16, 2024

The biotech, tentatively named Hercules CM Newco, has rights to three incretin drugs discovered by Jiangsu Hengrui Pharmaceuticals, two of which are in clinical testing.

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Licensing Licensing Drugs 356

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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.

Clinical Trials

Pharmaceutical Technology

JANUARY 29, 2024

At the JP Morgan Healthcare conference, Merck (MSD) indicated its eagerness to continue to establish its place in the immunological space.

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Bio Pharma Dive

DECEMBER 4, 2024

Results from the head-to-head study showed treatment with Zepbound resulted in 47% greater relative weight loss than Wegovy, a finding that could advantage Lilly in the companies’ market competition.

Drug Trials 317

Drug Trials Trials Drugs Marketing 317

Bio Pharma Dive

NOVEMBER 11, 2024

Negative drug results cost AbbVie billions of dollars in market value and convinced analysts that Bristol Myers had placed a better bet in buying Karuna Therapeutics.

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Drugs Marketing 328

Pharmaceutical Technology

FEBRUARY 29, 2024

India’s Tata Institute has developed a tablet combining resveratrol and copper that has the potential to prevent the recurrence of cancer.

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Development 358

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

Clinical Research

Bio Pharma Dive

SEPTEMBER 8, 2024

Study results provide much-anticipated details to Summit’s claim earlier this year that its drug “decisively beat” Merck’s dominant immunotherapy.

Drugs 340

Drugs 340

Bio Pharma Dive

JUNE 17, 2024

One expert described trial results presented at EULAR last week as “unprecedented.” But reports of relapses in some patients drew questions about the therapies’ ultimate potential.

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Trials 349

Pharmaceutical Technology

FEBRUARY 12, 2024

The UK MHRA has granted approval for a variation in licence of Pfizer-BioNTech’s Comirnaty XBB.1.5 vaccine targeting Omicron variant.

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Vaccination Vaccine 357

Pharmaceutical Technology

JULY 22, 2024

As the use of AI soared across healthcare, NVIDIA fit the bill in providing the necessary technology – and its stock tells the same story.

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Marketing 344

Advertiser: FourKites

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

Research

Bio Pharma Dive

JUNE 27, 2024

A growing cohort of biotechs, from Biohaven to Neurocrine to Jazz, hope research on ion channels will bring them new drugs and big business — much like it has done for Vertex.

Medicine 345

Medicine Drugs Research 345

Bio Pharma Dive

NOVEMBER 21, 2024

Howard Chang will take over as chief scientific officer and senior VP of research as the biotech searches for more ways to overcome the looming loss of exclusivity for some of its top-selling medicines.

Scientist 319

Scientist Medicine Research 319

Bio Pharma Dive

SEPTEMBER 26, 2024

In testing, Cobenfy eased schizophrenia symptoms without some of the disruptive side effects typical of existing drugs. The results have been met with excitement, as well as caution.

Drugs 334

Drugs 334

Bio Pharma Dive

JANUARY 30, 2024

Since a landmark paper in 2022, drugmakers have begun nearly a dozen trials of cell therapies for lupus, with more set to start. Here’s why their efforts are worth watching.

Trials 354

Trials 354

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

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