July, 2024

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UK’s antibiotic subscription funding model – a route to market sustainability?

Pharmaceutical Technology

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
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Artiva prices $167M IPO, riding optimism for autoimmune cell therapy

Bio Pharma Dive

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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July 23, 2024: Article From Ethics and Regulatory Core Highlights Key Challenges for Pragmatic Trials

Rethinking Clinical Trials

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

Trials 317
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Amgen, BMS and Merck have the most exposure as Big Pharma eyes $183B patent cliff: analyst

Fierce Pharma

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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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Why Is Antimicrobial Resistance Not Getting Much Attention from Biopharma?

BioSpace

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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Talk of the Towne episode 11: American Kidney Fund

Antidote

In the latest installment of Talk of the Towne, we sat down with Melanie Paris, M.A., MPH, the Senior Director of Strategic Partnerships and Kidney Disease Education at the American Kidney Fund (AKF). In the discussion, we got her insights into the types of kidney disease, treatment disparities, and the importance of clinical research in the field. She also shared many valuable resources for individuals and their loved ones living with kidney disease, which are linked here.

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10 clinical trials to watch in the second half of 2024

Bio Pharma Dive

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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Frontiers Health 2024: Connecting changemakers, cultivating health system change

pharmaphorum

Frontiers Health 2024 is a platform connecting innovators and changemakers in the life sciences industry to cultivate positive changes in health systems. Discover the latest trends and insights in healthcare innovation.

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Senate unanimously endorses legislation targeting pharma 'patent thickets'

Fierce Pharma

Even as pharma companies have yet to feel the full effects of the Inflation Reduction Act, Senate lawmakers have turned their attention to another facet of drug pricing with a bill meant to cr | The bill looks to limit the number of patents that companies can assert in litigation on individual products. It's intended to crack down on "patent thickets," which can delay and thwart generic competition.

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Study suggests targeting amyloid beta production could be promising in AD

Pharma Times

The neurodegenerative disease is currently the most common cause of dementia

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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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Rainwater Foundation, CurePSP, Aging Mind Foundation fund innovative tauopathy research

Outsourcing Pharma

The Rainwater Charitable Foundation (RCF), in collaboration with CurePSP and the Aging Mind Foundation (AMF), has announced the allocation of $2 million in grants to support groundbreaking research in primary tauopathies.

Research 111
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EMA fast-tracks review of AstraZeneca’s sipavibart to stop Covid

Pharmaceutical Technology

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

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Pfizer quits Duchenne gene therapy, lays off staff following study setback

Bio Pharma Dive

The company is letting go of 150 staffers alongside a decision to officially terminate the high-profile program, which was acquired in 2016.

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A symbiotic relationship for optimal AI-powered healthcare

pharmaphorum

Discover how OPEN Health and fusion's AI technology partnership is creating a symbiotic relationship that is revolutionising healthcare. Explore the benefits of this for optimal patient care.

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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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Game on: Lilly's Alzheimer's drug Kisunla, a challenger to Biogen and Eisai's Leqembi, gains full FDA nod

Fierce Pharma

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 137
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New study shows wearable trackers provide clinical use for heart disease patients

Pharma Times

Cardiovascular disease, including coronary heart disease, currently affects around seven million people in the UK

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How to get into a clinical trial? Understanding inclusion and exclusion criteria

Antidote

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.

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FDA launches new rare disease innovation hub

Pharmaceutical Technology

The new hub will act as a central point of connection and engagement for the rare disease community for FDA-related concerns.

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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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Revolution Medicines firms up Phase 3 trial plans with latest cancer drug data

Bio Pharma Dive

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 311
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Bill that would cut down ‘patent thickets’ clears Senate

pharmaphorum

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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Lilly's Mounjao triggers more weight loss than Novo Nordisk's Ozempic: study

Fierce Pharma

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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FDA fast-tracks first new fibromyalgia drug in 15 years

Drug Discovery World

The US Food and Drug Administration (FDA) has granted Fast Track designation to Tonix Pharmaceuticals’ Tonmya (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia. Tonmya is a non-opioid, centrally-acting analgesic drug under development for treating fibromyalgia, which is a common chronic pain condition affecting mostly women.

Drugs 106
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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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Leqselvi Can Achieve Nearly 90% Scalp Hair Coverage in Severe Alopecia Areata Patients

XTalks

The US Food and Drug Administration (FDA) has just approved Leqselvi (deuruxolitinib), a new oral medication by Sun Pharmaceutical Industries Limited, offering significant hope for those suffering from severe alopecia areata, a condition causing sudden hair loss. This approval marks a significant milestone, bringing new possibilities to the estimated 300,000 people in the US who deal with severe forms of this autoimmune disease.

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AstraZeneca’s Tagrisso gains approval in Canada for NSCLC

Pharmaceutical Technology

AstraZeneca has obtained Health Canada’s Notice of Compliance (NOC) for Tagrisso (osimertinib) to treat NSCLC.

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Pfizer thinks it found its obesity pill

Bio Pharma Dive

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.

Medicine 305
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UK partnership aims to support NHS use of depression app

pharmaphorum

Otsuka has teamed up with one of the innovation arms of the NHS to explore how a digital therapeutic (DTx) for major depressive disorder (MDD) could be deployed within the health service.The alliance with Health Innovation Oxford & Thames Valley (Oxford HIN) is focusing on Care for MDD, an app-based DTx that has been co-developed by Otsuka and digital health specialist Click Therapeutics.

Branding 115
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Bayer lops off 70 more employees at New Jersey headquarters

Fierce Pharma

Four months after Bayer handed pink slips to 90 staffers at its U.S. headquarters in Whippany, New Jersey, the company is laying off 70 more workers at the site. | Four months after Bayer handed pink slips to 90 staffers at its U.S. headquarters in Whippany, New Jersey, the company is laying off 70 more at the site, according to a state Worker Adjustment and Retraining Notification.

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Benefits of Drug Patent Licensing Agreements

Drug Patent Watch

The Power of Patent Licensing: Unlocking Innovation and Access to Medicines Patent licensing agreements have become a crucial tool in the pharmaceutical industry, allowing companies to collaborate and…

Licensing 105
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What is the medical definition of obesity?

Antidote

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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NHS rolls out “more convenient” Ocrevus injection for multiple sclerosis

Pharmaceutical Technology

The subcutaneous formulation of Roche’s blockbuster Ocrevus will cut hospital treatment time for patients.

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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.