Rethinking Clinical Trials

JULY 23, 2024

In an invited commentary published this month in Circulation: Cardiovascular Quality and Outcomes , authors from the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core describe the recurring and emerging ethical issues in pragmatic clinical trials. Coauthors Caleigh Propes, Stephanie Morain, and Pearl O’Rourke discuss 3 key challenges facing pragmatic trials researchers: waivers and alterations of informed consent and their implications for transparency managing and resp

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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.

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Pharmaceutical Technology

JUNE 17, 2024

Novavax has sought US FDA approval for an updated JN.1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.

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FDA Approval Vaccination Vaccine 363

Fierce Pharma

JULY 15, 2024

While patent cliffs are looming for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a research note f | While patent cliffs loom for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a July 11 research note from Morgan Stanley.

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Production Research 141

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Clinical Supply

BioSpace

JULY 10, 2024

Investment in the development of new antimicrobials is falling rapidly, even as the global public health threat of antimicrobial resistance is growing increasingly severe worldwide.

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Development 137

BioPharma Reporter

APRIL 2, 2024

The FDA has agreed to permanently remove several social media posts urging people not to take ivermectin for the treatment of COVID-19, after a lawsuit brought by three doctors accused the regulatory body of interfering with their ability to practice medicine.

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Doctors Doctor Medicine Regulation 145

Outsourcing Pharma

MAY 30, 2024

In an intriguing interview with Cybinâs CEO, Doug Drysdale, OSP senior editor, Liza Laws found out how second-generation psychedelics could be the biggest breakthrough in psychiatry in 40 years.

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Clinical Development Development 133

Drug Discovery World

FEBRUARY 12, 2024

DDW’s Megan Thomas spoke to experts from the drug discovery industry about their predictions on what 2024 holds for our sector. This is part of a series of predictions based on different themes. Here, experts weigh in on the impact of artificial intelligence (AI), machine learning (ML) and automation in the sector. Updesh Dosanjh, Practice Leader for Pharmacovigilance Technology Solutions, IQVIA “In 2024, the traditional pain points of the pharmacovigilance (PV) space will not disappear.

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Pharma Times

MAY 23, 2024

High-grade gliomas are rare, malignant tumours which account for up to 12% of all childhood brain tumours

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Vaccination Vaccine Research 160

Antidote

JUNE 10, 2024

Also known as endometrial carcinoma or uterine cancer, endometrial cancer occurs when the cells that line the uterus begin growing uncontrollably. Though the mortality rates are relatively low due to the high rate of early detection, it is a cancer that impacts nearly 70,000 people every year.

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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

XTalks

JUNE 26, 2024

In this episode, Ayesha spoke with Alessio Travaglia, PhD, Director Neuroscience at the Foundation for the National Institutes of Health (FNIH) who also manages FNIH’s new Accelerating Medicines Partnership in Amyotrophic Lateral Sclerosis (AMP ALS) program, and Nadia Sethi, DDS, an ALS patient advocate who formerly served as Director of Community Outreach and Engagement at the ALS Therapy Development Institute.

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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 348

Pharmaceutical Technology

APRIL 24, 2024

Pfizer and its Germany partner BioNTech have urged London’s High Court to invalidate competitor Moderna's patents over technology instrumental in the Covid-19 vaccines development as the latest phase of a global legal fight that started yesterday (23 April), reported Reuters.

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Fierce Pharma

JUNE 20, 2024

For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. | For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. For Gilead, it serves as one of two pieces for a potential FDA filing. For GSK, it means a major competitor could be looming around the corner.

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Drugs Trials 144

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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

BioSpace

MARCH 25, 2024

The National Institutes of Health claims BioNTech is in default regarding alleged royalty payments the agency contends it is owed in connection with the company’s COVID-19 vaccine Comirnaty.

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Vaccination Vaccine 145

BioPharma Reporter

APRIL 9, 2024

Pfizer has been accused of âbringing discreditâ on the pharma industry after senior employees promoted its âunlicensedâ COVID-19 vaccine through social media at the height of the pandemic.

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Vaccination Vaccine 140

pharmaphorum

FEBRUARY 23, 2024

Explore the opportunities and challenges facing rare disease therapies developers, including the impact of Rare Disease Day, FDA regulations, and cutting-edge technologies like CRISPR gene therapy.

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Gene Therapy Development Regulation Gene 139

Bio Pharma Dive

JULY 18, 2024

The offering comes days after the publication of a paper showing what analysts said was early proof that “off-the-shelf” cell therapies can treat inflammatory diseases.

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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

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

Bio Pharma Dive

JUNE 21, 2024

Peter Marks’ decision to override the objections of agency staff and broaden use of Elevidys could have a “lasting impact” on gene therapy as well as the FDA, one analyst wrote.

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Gene Therapy Gene 334

Bio Pharma Dive

JULY 1, 2024

Study results are expected for a pair of closely watched obesity drugs, while key tests await for a high-priced AbbVie acquisition and one of 2023’s largest IPOs.

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Clinical Trials Clinical Trials Trials Drugs 337

Bio Pharma Dive

JULY 15, 2024

Updated results show the biotech's RAS inhibitor shrank pancreatic tumors in 20% to 25% of study participants, but with high rates of side effects like rash and nausea.

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Medicine Trials Drugs 317

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

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.

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Trials 353

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.

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Gene Therapy Gene Trials Research 360

Bio Pharma Dive

JUNE 6, 2024

The agency is seeking input from an advisory panel on whether donanemab is effective across different groups of Alzheimer's patients, and on an unusual dosing strategy used by Lilly.

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Drugs 333

Bio Pharma Dive

JULY 11, 2024

Far behind companies like Novo and Eli Lilly, Pfizer hopes the version of the drug, danuglipron, that it’s chosen to advance can break into the ultra-lucrative market for weight-loss medicines.

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Medicine Marketing Drugs 312

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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Bio Pharma Dive

JUNE 7, 2024

A vote against MDMA-assisted therapy set back a high-profile treatment. Proponents argue the panel offered few solutions to longstanding problems, making the path forward unclear.

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Bio Pharma Dive

JULY 22, 2024

The company plans to start a late-stage study next year, after a smaller trial found its drug offered “robust and consistent” benefits on communication, cognition and motor function.

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Drugs Trials 293

Bio Pharma Dive

APRIL 8, 2024

Recent biotech company acquisitions have put emerging schizophrenia treatments in focus. But many development hurdles still stand in the way of new medicines for the brain.

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Medicine Drugs Development 342

Bio Pharma Dive

JUNE 4, 2024

A group of independent experts wasn't convinced by clinical trial data from company Lykos Therapeutics, which is seeking FDA approval of MDMA-assisted treatment for post-traumatic stress disorder.

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Advertiser: Aggregage

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