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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Trials Clinical Trials Clinical Trials Doctors 315

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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Pharmaceutical Technology

JULY 1, 2024

On 8 May, the UK was the world's first government to formally implement a new model for the funding and support of novel antibiotic commercialisation.

Marketing 299

Marketing 299

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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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.

Development 137

Development 137

pharmaphorum

JULY 23, 2024

Agilent has boosted its contract development and manufacturing organisation (CDMO) capacity with a $925 million deal to buy Biovectra, a Canadian provider of fill-and-finish services and active pharmaceutical ingredients (APIs).It's a statement of intent from Agilent, whose primary business is lab instrumentation and equipment, suggesting that it intends to grow the outsourcing side of its business, which is currently focused on the production of oligonucleotide and peptide medicines.

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Manufacturing Medicine Production Development 111

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.

Medicine 317

Medicine Trials Drugs 317

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.

Marketing 272

Marketing 272

Fierce Pharma

JULY 8, 2024

Is Eli Lilly’s Mounjaro or Novo Nordisk’s Ozempic more effective in helping patients lose weight? | Is Eli Lilly’s Mounjaro or Novo Nordisk’s Ozempic more effective in helping patients lose weight? While a head-to-head trial pitting the two treatments remains ongoing, new evidence shows that Lilly’s tirzepatide may be the superior weight loss product.

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Production Trials 135

BioSpace

JULY 23, 2024

AstraZeneca is proposing to use Imfinzi for resectable non-small cell lung cancer in the perioperative setting—both before and after surgical resection of the tumor. However, ahead of Thursday’s advisory committee meeting, FDA staffers have expressed concerns.

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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

pharmaphorum

JULY 11, 2024

The US Senate has come together to pass a bill that aims to prevent pharma companies from filing multiple patents around biologic drugs as a way to delay biosimilar competitors.Lawmakers unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S-150), which is part of a lengthening list of measures being taken by Congress to curb the prices of medicines in the US.

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Pharma Companies Medicine Drugs 122

Antidote

JULY 11, 2024

When determining which clinical trial is the right fit , many factors must be considered. The site location, the number of required visits, and the length of the study are all important considerations, but before any of this, it is vital to consider the study's inclusion and exclusion criteria.

Clinical Trials 114

Clinical Trials Clinical Trials Trials 114

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.

Drugs 293

Drugs Trials 293

Pharmaceutical Technology

JULY 2, 2024

The EMA has accepted AstraZeneca's MAA for sipavibart as Covid-19 pre-exposure prophylaxis (prevention) in immunocompromised patients.

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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

Fierce Pharma

JULY 22, 2024

As lawmakers and industry groups seek to get a handle on U.S. | As lawmakers and industry groups seek to get a handle on U.S. drug shortages, a new white paper from German market analytics firm QYOBO supports the thesis that disproportionately low prices for generic medicines can make it difficult for drugmakers to keep supplies afloat.

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Medicine Marketing Drugs 118

BioSpace

JULY 12, 2024

The Senate on Thursday unanimously passed a bill aimed at limiting the number of patents drugmakers can introduce and making it easier for generic and biosimilar competitors to enter the market.

Marketing 116

Marketing 116

pharmaphorum

JULY 24, 2024

The top three pharmacy benefit managers in the US felt the heat at a hearing of the House Oversight Committee, as lawmakers grilled executives over their business practices and accused them of monopolising the supply chain.

Pharmacy 108

Pharmacy Drugs 108

Antidote

JULY 15, 2024

Obesity, a condition that impacts 2 out of 5 adults in the United States , has become a significant health concern, both due to the impacts it has on individuals with the condition and the effect it can have on the overall medical system. It is estimated that obesity is responsible for nearly $1.73 billion in excess treatment costs annually, compounded by the fact that individuals with obesity are far more likely to have other conditions such as hypertension, diabetes, and osteoarthritis.

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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

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.

Clinical Trials 337

Clinical Trials Clinical Trials Trials Drugs 337

Pharmaceutical Technology

JULY 23, 2024

Johnson & Johnson is seeking approval for SPRAVATO for treatment-resistant depression with the submission of an sNDA to the US FDA.

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Fierce Pharma

JULY 15, 2024

It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become increasingly popular in recent years. | It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become increasingly popular in recent years. Now, the FDA is proposing to work directly with industry through a series of facility tours that could enable both sides to learn something from each other.

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Gene Therapy Gene Regulation Manufacturing 131

BioSpace

JULY 9, 2024

Following a disappointing readout last year, uniQure on Tuesday posted promising Phase I/II data for its investigational gene therapy AMT-130 and nabbed the first-ever Regenerative Medicine Advanced Therapy designation from the FDA in Huntington’s disease.

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Gene Therapy Gene Medicine 113

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

pharmaphorum

JULY 25, 2024

Ipsen has signed yet another portfolio-expanding deal – its fifth of the year so far – claiming rights outside the US to a drug for common brain cancer glioma from Day One Biopharmaceuticals.

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Licensing Licensing Drugs 105

Drug Discovery World

JULY 11, 2024

Evotec and Pfizer have entered into a multi-year research collaboration, initially focused on early discovery research for metabolic and infectious diseases. The research will be carried out at Evotec’s sites in France, including Campus Curie in Toulouse with capabilities spanning high throughput screening, in vitro and in vivo biology, proteomics and metabolomics.

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In-Vivo In-Vitro Genome Genomics 111

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

Pharmaceutical Technology

JULY 8, 2024

Myricx Bio has secured £90m ($114m) in its Series A financing round to propel its NMTi-ADC therapeutics into the clinical development stage.

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Development Clinical Development 264

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

Sales

Fierce Pharma

JULY 2, 2024

After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy—and a competitor to Eisai and Bioge | After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy, a competitor to Eisai and Biogen’s Leqembi, a full approval.

Drugs 138

Drugs 138

BioSpace

JULY 8, 2024

The blood plasma medicines manufacturer is considering a buyout offer from the founding family and asset manager Brookfield, which would delist the company from the Spanish and Nasdaq markets.

Manufacturing 109

Manufacturing Medicine Marketing 109

pharmaphorum

JULY 12, 2024

A new payment policy proposal released by the Centers for Medicare and Medicaid Services (CMS) this week covers digital tools used for behavioural health, which could be a boost for the digital health sector.The Medicare Physician Fee Schedule (PFS) sets out the method of payment, rates, and codes for healthcare providers participating in Medicare, and is often used by the administration as an instrument to encourage some forms of healthcare intervention.

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Behavioural Health 119

Pharmaceutical Commerce

JULY 19, 2024

FDA to review one-year results for Susvimo showing non-inferior visual acuity gains in diabetic macular edema and in the Diabetic Retinopathy Severity Scale for Diabetic Retinopathy.

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