August, 2023

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Sanofi appoints a venture investor to R&D head as executive team expands

Bio Pharma Dive

Houman Ashrafian, currently a scientific advisor at SV Health Investors, will fill the role left by John Reed, who oversaw the transformation of research and development during his five years at Sanofi.

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Clinical trials: How AI can help providers stay TMF inspection-ready

Pharmaceutical Technology

The clinical trials industry is facing a number of hurdles, but AI and digitalisation are being heralded as key to overcoming them, particularly when it comes to preparing for inspections and audits

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August 22, 2023: Distributed Research Network Shares Opportunities and Challenges for Pragmatic Research Embedded in Health Insurance Plans

Rethinking Clinical Trials

In an article published this month in Clinical Trials , researchers from the NIH Pragmatic Trials Collaboratory’s Distributed Research Network share opportunities for conducting pragmatic trials embedded in health insurance plans. “There are unique opportunities related to the design and conduct of pragmatic trials embedded in health insurance plans, which have longitudinal data on member/patient demographics, dates of coverage, and reimbursed medical care, including prescription drug dispensing

Research 245
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3 Key Takeaways from Psychedelic Science 2023

Worldwide Clinical Trials

As one of the more recent fields to emerge in the clinical space, psychedelics have gained significant traction as a potential treatment for various neuropsychiatric diseases. With so many exciting developments in the last few years, it’s critical for the psychedelic community to come together to reflect on our progress, share the latest discoveries, and discuss the future of psychedelic research.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Amid shortage, FDA clears several generics of Takeda's popular ADHD drug Vyvanse

Fierce Pharma

After 16 years on the market, Takeda's blockbuster attention-deficit/hyperactivity disorder (ADHD) med Vyvanse has finally reached its patent cliff. | After 16 years on the market, Takeda's blockbuster ADHD med Vyvanse has finally reached its patent cliff. And the FDA's approval of several generics comes amid a U.S. shortage of the drug.

Drugs 135
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Why participating in research can be a rewarding experience

Antidote

At the outset, many people may experience apprehension when considering joining a clinical trial. Opting to participate in a research study is a personal one — but it can also be quite gratifying. Various types of clinical studies play a pivotal role in ensuring the approval of life-saving medications and treatments. For this to happen, we need volunteers to take part.

Research 119

More Trending

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Pfizer’s first-ever bispecific antibody Elrexfio holds promise in multiple myeloma

Pharmaceutical Technology

The US Food and Drug Administration's recent accelerated approval of Pfizer's Elrexfio for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) has made a significant impact in the oncology community.

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BenevolentAI doses participants in BEN-8744 study

Pharma Times

The candidate is a peripherally restricted small-molecule PDE10 inhibitor to treat ulcerative colitis - News - PharmaTimes

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9 Ways Worldwide Optimizes Clinical Development for Your Biotech Growth Journey

Worldwide Clinical Trials

Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. At Worldwide, we understand the significance of this collaboration and are dedicated to becoming an extension of your team, providing personalized clinical development solutions that align with your corporate objectives and milestones.

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FDA turns down Outlook's ophthalmic version of Roche's Avastin over manufacturing, data shortfalls

Fierce Pharma

Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases. | Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases. Outlook Therapeutics has been trying to get an official approval for a reformulated version, but instead got a rejection letter.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Nestlé Tops List of Most Valuable Food Brands in 2023

XTalks

Food giant Nestlé has once again claimed the top spot on the list of the world’s most valuable food brands in Brand Finance’s “Food & Drink 2023” report. The report, which delves into brand strength, revenue and royalty rates to gauge brand worth, has consistently placed the Vevey, Switzerland-based brand as the most valuable food brand ever since its inception in 2015.

Branding 105
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Sage, reeling from depression drug decision, to lay off 40% of workforce

Bio Pharma Dive

Two founding executives are leaving Sage alongside a major restructuring announced weeks after the FDA approved the medicine, Zurzuvae, for much narrower use than the company had hoped.

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Artificial Intelligence related patent filings increased in the pharmaceutical industry in Q2 2023

Pharmaceutical Technology

The global pharmaceutical industry experienced a 52% decline in the number of artificial intelligence related patent applications in Q2 2023 compared with the previous quarter, according to GlobalData's Patent Analytics.

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UCB announces approval of Bimzelx

Pharma Times

The therapy is used to treat patients with psoriatic arthritis and axial spondyloarthritis - News - PharmaTimes

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How Machine Learning Drives Clinical Trial Efficiency

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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Pharma maintains high level of trust from UK public and doctors

Drug Discovery World

The pharmaceutical industry continues to maintain strong levels of public trust and favourability in the UK, according to data from the Association of the British Pharmaceutical Industry (ABPI). Opinions showed consistent recognition of the sector’s support for the NHS, with 67% of respondents saying the industry is committed to developing new medicines to meet patient needs.

Doctors 98
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Johnson & Johnson slashes price of tuberculosis drug Sirturo after relinquishing patent protections

Fierce Pharma

Seven weeks after saying it would allow generic competition for drug-resistant tuberculosis (TB) treatment Sirturo (bedaquiline) in low- and middle-income countries (LMICs), Johnson & Johnson h | Seven weeks after saying it would allow generic competition for drug-resistant tuberculosis (TB) treatment Sirturo (bedaquiline) in low- and middle-income countries (LMICs), Johnson & Johnson has slashed its own drug's price by 55% to $130 for a six-month course.

Drugs 110
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Fourteen HP&M Attorneys Recognized by Best Lawyers® in 2024 in America

FDA Law Blog

Hyman, Phelps & McNamara, P.C. (“HP&M”) is is proud to announce that 14 of the Firm’s attorneys have been selected to the 2024 edition of The Best Lawyers in America®. Newly recognized this year are attorneys Josephine M. Torrente (FDA Law), Michelle L. Butler (FDA Law), Sara W. Koblitz (FDA Law), Allyson B. Mullen (FDA Law), and Anne K. Walsh (FDA Law), as well as McKenzie E.

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Medicare names first 10 drugs for price negotiations

Bio Pharma Dive

The list includes the top-selling blood thinners Eliquis and Xarelto, as well as the arthritis drug Enbrel and heart failure medicine Entresto.

Drugs 294
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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Artificial Intelligence related patent filings increased in the pharmaceutical industry in Q2 2023

Pharmaceutical Technology

The global pharmaceutical industry experienced a 52% decline in the number of artificial intelligence related patent applications in Q2 2023 compared with the previous quarter, according to GlobalData's Patent Analytics.

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Partnership aims to boost mental health research

Pharma Times

The University of Strathclyde, the NHS and New York University join forces to increase knowledge - News - PharmaTimes

Research 120
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Meet the researcher: Giusy Di Conza

Drug Discovery World

DDW’s Megan Thomas looks at a day in the life of Giusy Di Conza , Head of Research at iOnctura. MT: Where do you work, and can you tell us what you’re working on at the moment? GDC : I’m Head of Research for a young, dynamic biotech called iOnctura. We are pioneering research into new biological mechanisms for established drug targets. Whereas traditionally biotechs have studied the effect of a drug on a singular pathway, we are focused on targets that are involved in multiple independent tumour

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Amid Medicare negotiation battle, lawmakers push for answers on insulin prices and patent reform

Fierce Pharma

It was a year ago this month that President Joe Biden signed the Inflation Reduction Act. | It was a year ago this month that President Joe Biden signed the Inflation Reduction Act. While the landmark bill introduces several pricing measures, Democrats on Capitol Hill are still pursuing ways to rein in the pharma industry. They are pressing insulin manufacturers on their plans to cut prices.

Insulin 107
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2022 Research: The Rapid Rise of Ocean Freight Visibility

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.

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MenuTrinfo’s ‘Certified Free From’ Label: An Assurance in Allergen-Free Dining

XTalks

In the US, the primary agency responsible for regulating allergen labeling on food products is the US Food and Drug Administration (FDA). The FDA established the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), which requires that food labels clearly identify the food source names of any ingredients that contain any protein derived from the nine most common food allergens.

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Apellis finds faulty needles in probe of rare eye drug side effects

Bio Pharma Dive

The company doesn’t know if the needles have caused retinal vasculitis in some people receiving its geographic atrophy drug Syfovre, but is no longer recommending their use.

Drugs 246
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CVS Health enters biosimilar fray with launch of new subsidiary

Pharmaceutical Technology

The newly-launched business, called Corvardis, is already targeting the Humira biosimilar landscape with Hyrimoz via a planned Sandoz-partnered launch in Q1 2024.

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FDA, CTTI Convening Virtual Public Workshop on Enhancing Clinical Study Diversity

CTTI (Clinical Trials Transformation Initiative)

The U.S. Food and Drug Administration (FDA), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is convening a virtual public workshop to solicit input on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups.

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

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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Draft ICH E6(R3) Guideline for GCP Presents Opportunity for Input from Stakeholders in DCTs

ACRP blog

The latest regulatory guidance addressing elements of decentralized clinical trials (DCTs) is the draft ICH E6(R3) Good Clinical Practice (GCP) guideline from the International Council for Harmonization (ICH). Much like recent guidances proposed by the U.S. Food and Drug Administration (FDA) and regulatory authorities in other nations, the ICH document outlines regulators’ expectations on how DCTs should be conducted, and with its addition to the list, stakeholders in digital, hybrid, and fully

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Johnson & Johnson's spinoff of Kenvue provides $13.2B in potential M&A firepower

Fierce Pharma

Last month, during a quarterly conference call—as Johnson & Johnson considered its future beyond the separation of its consumer health unit—Chief Financial Officer Joe Wolk described the compan | Last month, during a quarterly conference call—as Johnson & Johnson considered its future beyond separation of its consumer health unit—Chief Financial Officer Joe Wolk described the company’s appetite for M&A as “voracious.

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ModifyHealth is Leading the ‘Food as Medicine’ Industry with New Meal Plans

XTalks

ModifyHealth , a leader in the burgeoning food as medicine industry, recently released four new meal plan offerings catering to a variety of dietary needs in the US. These new plans were thoughtfully introduced in response to the increasing demand from consumers managing specific medical conditions including celiac disease, type 2 diabetes, high blood pressure, polycystic ovarian syndrome (PCOS) and beyond.

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HIV cell therapy startup Addimmune heads to Wall Street via blank-check merger

Bio Pharma Dive

The deal will help fund a cell-based treatment that completed Phase 1 testing last year and is designed to provide a “functional cure” for patients with HIV infections.

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The New Age of Decentralized Clinical Trials

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.