July, 2023

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Pfizer backs CRISPR biotech Caribou in latest cell therapy investment

Bio Pharma Dive

Five years after helping launch Allogene Therapeutics, Pfizer is backing another developer of “off-the-shelf” cell therapies in a deal that gives the drugmaker the chance to acquire a multiple myeloma treatment.

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Digital health tech: a solution to substance use disorders?

Pharmaceutical Technology

Substance use disorders leave people with long-term negative mental and physical health implications and can lead to death.

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Bernie Sanders proposes price caps on drugs developed with federal funds

Fierce Pharma

After becoming chairman of the powerful Senate Health, Education, Labor and Pensions Committee earlier this year, Sen. | After becoming chairman of the powerful Senate Health, Education, Labor and Pensions Committee earlier this year, Sen. Bernie Sanders, I-Vermont—a longtime opponent of Big Pharma—has become even more ubiquitous in his efforts to reduce drug prices.

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DigitalHealth.London’s Accelerator programme selects Aide

Pharma Times

Project aims to boost the adoption of technology across London’s NHS and help patients manage conditions - News - PharmaTimes

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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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Women in Science: How Charco Neurotech's Lucy Jung is 'restoring joy' for Parkinson's patients

BioPharma Reporter

Lucy Jung is the CEO and founder at Charco Neurotech, a medtech start-up which has developed the CEU1, a non-invasive wearable device for Parkinson's, that uses vibrotactile stimulation to reduce symptoms of slowness and stiffness resulting in improved movement. We spoke to her about her background, how she got involved in the Parkinson's space and her fascination for problem-solving.

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Biosimilar clinical trials and study designs’ considerations

ProRelix Research

Biosimilar clinical trials and study designs’ Considerations The rising prevalence and large market share of biological products emphasize their importance as treatment options for several cancers and autoimmune diseases. In […] The post Biosimilar clinical trials and study designs’ considerations appeared first on ProRelix Research.

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Eli Lilly’s retatrutide sets new record for weight loss in obesity space

Pharmaceutical Technology

Pipeline developments within the obesity space have recently garnered interest following recent results published on Eli Lilly’s retatrutide.

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Moderna mounts 2 new patent lawsuits against mRNA rivals Pfizer, BioNTech: report

Fierce Pharma

Caught in a litigation crossfire, Moderna has reportedly opened two new fronts in its COVID-19 vaccine patent war with Pfizer and BioNTech. | Moderna has lodged two new lawsuits at the High Court in Dublin, Ireland, and the Brussels Commercial Court in Belgium, Juve Patent first reported. This adds to a complex web of ongoing mRNA patent litigation.

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Complex road ahead, despite phase 3 progress, for Annovis’ buntanetap in Parkinson’s Disease

Outsourcing Pharma

Drugs like Annovis Bioâs buntanetap and prasinezumab have the potential to ârevolutionize the treatment of Parkinsonâs Diseaseâ says analytics company, GlobalData, an analytics company, but it is a complex road ahead.

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New patent expiration for Astrazeneca drug SYMBICORT

Drug Patent Watch

Annual Drug Patent Expirations for SYMBICORT Symbicort is a drug marketed by Astrazeneca and is included in one NDA. It is available from three suppliers. There are eleven patents protecting… The post New patent expiration for Astrazeneca drug SYMBICORT appeared first on DrugPatentWatch - Make Better Decisions.

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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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Pharmacovigilance (PV) Services at a Glance

ProRelix Research

Ensuring the safety and efficacy of new drugs, medical devices, and biological products does not end once the treatment is approved or is on the market but extends to the […] The post Pharmacovigilance (PV) Services at a Glance appeared first on ProRelix Research.

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European regulators probe suicide risk to Ozempic, other Novo drug Saxenda

Bio Pharma Dive

Three reports from Iceland spurred the EMA to evaluate whether certain Novo Nordisk drugs, including Ozempic, might cause thoughts of self harm.

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Rationing strategies proliferate with cancer drugs in short supply

Pharmaceutical Technology

While drug shortages have been a major cause for concern over the past few years, medications to treat cancer are in particularly short supply.

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Teva weighs sale of $2B API business as CEO Richard Francis embarks on 'Pivot to Growth' strategy: reports

Fierce Pharma

Less than two months into its "Pivot to Growth" strategy under a new CEO, Israeli-American generics giant Teva Pharmaceutical could be weighing a major shake-up of its key drug ingredients business | Teva is looking at strategic options for its active pharmaceutical ingredient unit, with a potential sale on the table, BNN Bloomberg and Benzinga have reported.

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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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Building Upon the Unique Perspective of Patient Advocacy Groups

ACRP blog

As leaders in the clinical research enterprise seek to expand the public’s understanding of clinical trials and their potential benefits for healthcare at the personal, community, and national levels, communications tactics cannot remain stuck at the one-on-one rate of physician referrals or patient recruiters reaching out to individual potential volunteers for real progress to be seen.

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What types of clinical research are there?

Antidote

Before any new therapy can be put on the market, it must be tested to ensure its safety and effectiveness, and the research for this process is done through clinical trials. Clinical trials evaluate new drugs, devices, packaging, and behaviors in order to determine if these potential therapies work for particular conditions or patient populations.

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Immunotherapy is here to stay

Drug Discovery World

DDW’s Megan Thomas spoke with Frédéric Triebel , the French immunologist/oncologist who is best known for his 1990 discovery of the LAG-3 immune control mechanism. Triebel shares insights from his career, expands on his experience with the company he founded, Immutep, and comments on the future of immuno-oncology (I-O). Background Lymphocyte-activation gene 3, or LAG-3, is a gene that provides the genetic information to make a cell surface molecule with biologic effects on T-cell function.

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BridgeBio explores path forward for muscular disease drug

Bio Pharma Dive

According to the company, FDA officials have signaled openness to using a surrogate endpoint for assessing accelerated approval of a treatment for limb-girdle muscular dystrophy.

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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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Lifera, Sanofi and Arabio boost vaccine manufacture in Saudi Arabia

Pharmaceutical Technology

Lifera, Arabio and Sanofi have signed a memorandum of understanding (MOU) to bolster manufacturing of vaccines in Saudi Arabia.

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Novo Nordisk's GLP-1 drugs under review in Europe after reports flag possible suicide risks

Fierce Pharma

Two cases of suicidal thoughts and one case of self-harm from users in Iceland of Novo Nordisk’s diabetes and obesity drugs have prompted the European Medicines Agency (EMA) to review the blockbust | Two cases of suicidal thoughts and one case of self-harm from users in Iceland of Novo Nordisk’s diabetes and obesity drugs have prompted the European Medicines Agency (EMA) to review the blockbuster products.

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How to Find the Best Digital Marketing Agency for Your Business 

Pharma Marketing Network

In today’s digital world, partnering with a competent and reliable digital marketing agency is crucial for businesses seeking to enhance their online presence, reach their target audience, and achieve their marketing goals. However, with countless agencies available, it can be overwhelming to find the right one that aligns with your business objectives.

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Ortho-Phthalates Retain FDA Approval for Food Packaging Despite Petitions

XTalks

Last week, the US Food and Drug Administration (FDA) stood by its decision, denying a petition asking it to reevaluate the use of eight ortho-phthalates in food-contacting packaging materials. The agency also declined demands to overturn five earlier approvals regarding five distinct ortho-phthalates, alleged to significantly risk human health by leaching into food and beverage products.

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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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Partnership could enhance antibody discovery for cancer research

Drug Discovery World

Cancer Research Horizons has signed a collaboration agreement to license the entire Twist Biopharma Solutions Library of Libraries. Under the terms of the agreement, Cancer Research Horizons will license Twist’s ‘Library of Libraries’, an collection of synthesised antibody libraries designed based on naturally occurring sequences that harness innovative structural and developability features to cover a wide range of antibody drug targets, for a period of five years.

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Novartis buys a preclinical biotech and its RNA drug technology

Bio Pharma Dive

For $500 million, Novartis will acquire DTx Pharma and its preclinical neurological disease drugs, marking the Swiss company’s latest investment in gene-silencing medicines.

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Incyte’s non-segmental vitiligo treatment approved in UK

Pharmaceutical Technology

Following FDA approival and CE marking for Incyte’s JAK-inhibiting cream Opzelura (ruxolitinib), the MHRA has followed suit in the UK.

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Novo Nordisk brings new round of lawsuits against compounded versions of Ozempic and Wegovy

Fierce Pharma

As demand skyrockets for GLP-1 drugs that can trigger significant weight loss, unauthorized versions of the treatments have started to fill pharmacies. | In late May, the FDA warned of illegal knockoffs of Novo Nordisk’s Ozempic and Wegovy. And now, the Danish company has filed its second wave of lawsuits against pharmacies in the U.S. that are producing the copycats.

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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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5 Strategies to Strengthen Relationships with HCPs

Pharma Marketing Network

Developing strong and meaningful relationships with Healthcare Professionals (HCPs) is vital for healthcare organizations, pharmaceutical companies, and medical device manufacturers alike. These partnerships not only improve patient outcomes but also foster mutual trust and collaboration. In this blog, we will explore five effective strategies to enhance your relationship-building efforts with HCPs and ultimately achieve better healthcare outcomes.

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Daiichi Sankyo’s Vanflyta (Quizartinib) Finally Gets US Approval for FLT3-ITD Positive AML

XTalks

The US Food and Drug Administration (FDA) has granted approval to Daiichi Sankyo’s Vanflyta (quizartinib) for newly diagnosed patients with FMS-like tyrosine kinase 3 receptor-internal tandem duplication ( FLT3 -ITD) positive acute myeloid leukemia (AML). FLT3 -ITD mutations occur in about a quarter of all AML cases. Vanflyta is the first and only FLT3 inhibitor approved in the US for FLT3 -ITD positive AML and across all three treatment phases: induction, consolidation and maintenance.

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Pharma Not the Only Ones Upset with PBM Practices

Pharmaceutical Commerce

The National Alliance of Healthcare Purchaser Coalitions releases resources for employers/health plan purchasers to offer insights on PBMs role in high prescription drug costs.

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AstraZeneca buys Pfizer’s early gene therapy work for up to $1B

Bio Pharma Dive

The British pharma is deepening its investment in genetic medicine through a deal for a group of Pfizer’s gene therapy delivery tools, while the New York giant cuts back.

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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.