Mon.Jun 10, 2024

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Health economics and outcomes research: Biopharma and the shift to value-based care

Bio Pharma Dive

Of the changes sparked by value-based care, perhaps the most valuable for the biopharmaceutical industry to embrace is the use of health economics and outcomes research (HEOR) to better understand a product’s value.

Research 257
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Aligos Therapeutics gets grant for patent granted for compounds treating diseases and conditions

Pharmaceutical Technology

Discover the groundbreaking patent by Aligos Therapeutics for compounds targeting hepatitis B and D. Learn about the innovative methods for treatment and synthesis.

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Moderna says combination flu, COVID shot succeeds in study

Bio Pharma Dive

Positive results from the trial could position Moderna to bring the two-in-one vaccine to market in 2025.

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Risk adjusted net present value: What is the current valuation of Sensei Biotherapeutics’s SNS-101?

Pharmaceutical Technology

SNS-101 is a monoclonal antibody commercialized by Sensei Biotherapeutics, with a leading Phase II program in Non-Small Cell Lung Cancer.

Antibody 203
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Lilly Alzheimer’s drug gets unanimous backing of FDA panel

Bio Pharma Dive

The expert committee concluded donanemab’s benefits outweigh its risks, despite some concern over the drug’s safety.

Drugs 259
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Risk adjusted net present value: What is the current valuation of Pyxis Oncology’s PYX-201?

Pharmaceutical Technology

PYX-201 is a monoclonal antibody conjugated commercialized by Pyxis Oncology, with a leading Phase I program in Thyroid Cancer.

Antibody 203

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Shanghai Junshi Bioscience gets grant for isotope-enriched compounds for improving drug delivery and efficacy

Pharmaceutical Technology

Enhance drug effectiveness with isotope-enriched compounds! Discover how Shanghai Junshi Bioscience's patented technology improves therapeutic outcomes for PI3K mediated diseases.

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Alumis readies IPO to fund rival drug to Bristol Myers’ Sotyktu

Bio Pharma Dive

The offering will help fund Phase 3 tests of a drug the biotech claims could be more selective and potent than Bristol’s TYK2 inhibitor.

Drugs 169
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Kodiak Sciences gets grant for method of treating eye disorder with anti-VEGF antibody conjugate

Pharmaceutical Technology

Discover Kodiak Sciences Inc's innovative method for treating wet age-related macular degeneration with an anti-VEGF antibody conjugate. Patented approach offers extended therapeutic effects for at least 12 weeks, providing a less frequent treatment option.

Antibody 130
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What to know about endometrial cancer

Antidote

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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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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Ikena Oncology gets grant for cancer treatment method using compounds of formula i

Pharmaceutical Technology

Discover the groundbreaking patent by Ikena Oncology Inc for treating cancer with specific compounds and compositions. Learn about the innovative method targeting TEAD expression and YAP localization in various types of cancer.

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Psychedelic Therapies Could Soon Break Through Against Addiction

BioSpace

LSD, ketamine, ibogaine and related treatments are moving forward in clinical trials for substance use disorders, including alcohol use disorder and opioid use disorder.

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Sword Health gets grant for motion tracking system controlled by sound and electromagnetic waves

Pharmaceutical Technology

Revolutionize motion tracking with Sword Health Inc's patented method using sound and electromagnetic waves. Accurately track user motion with sensors, antennas, and microphones. Explore the innovative system outlined in US11960791B2 for precise tracking and user control.

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Moderna’s COVID-Flu Combo Shot Beats Separate Vaccines in Phase III Study

BioSpace

Moderna’s combination vaccine candidate for COVID-19 and influenza outperformed licensed vaccines in older adults, according to late-stage results reported on Monday.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Tenaya Therapeutics gets grant for compound for treating diseases by inhibiting HDAC6 activity

Pharmaceutical Technology

Discover the groundbreaking patent by Tenaya Therapeutics Inc for compounds inhibiting HDAC6 activity, offering potential treatments for various diseases. Explore the detailed chemical formula and structural insights in this comprehensive overview.

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Knock, Knock – FDA Issues Guidance on Best Processes and Practices During BIMO Inspections

FDA Law Blog

By Sarah Wicks & Anne K. Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In an effort to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance aimed at providing recommendations on how to handle inspections under FDA’s Bioresearch Monitoring (BIMO) program.

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Cue Biopharma gets grant for method of treating cancer with immune checkpoint inhibitor and protein

Pharmaceutical Technology

Discover Cue Biopharma Inc's innovative patent for treating cancer with immune checkpoint inhibitors and protein compositions targeting specific epitopes. Enhance cancer treatment efficacy with this groundbreaking approach.

Protein 130
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What can pharma companies do to quicken the pace of digital disruption?

pharmaphorum

Discover how pharmaceutical companies can leverage digital technologies to accelerate innovation and disrupt the industry. Learn about regulatory considerations and engagement with healthcare professionals (HCPs) for successful digital transformation.

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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.

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Vir Biotechnology gets grant for monoclonal antibody for treating staphylococcus aureus infection

Pharmaceutical Technology

Discover Vir Biotechnology's groundbreaking patent for a monoclonal antibody targeting Staphylococcus aureus infections. Learn how this innovative composition binds to key proteins for potential treatment.

Antibody 130
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Amyloid Remains a Key Target in Next-Generation Alzheimer’s Treatments

BioSpace

While more programs now involve candidates with different targets, experts say anti-amyloid therapies will remain a primary player in treating the memory-robbing disease.

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AbCellera Biologics gets grant for transgenic mouse with long HCDR3 immunoglobulin library production

Pharmaceutical Technology

Discover how AbCellera Biologics Inc's patented transgenic mouse with a unique LDH expression cassette revolutionizes immunoglobulin library production, enabling extended HCDR3 regions. Explore the groundbreaking genetic modifications enhancing antibody engineering.

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Lilly’s Tirzepatide Improves Liver Fibrosis in Phase II MASH Trial

BioSpace

Lilly’s tirzepatide achieved an absence of metabolic dysfunction-associated steatohepatitis without the worsening of fibrosis in more than 50% of patients in a mid-stage study, the company reported Saturday.

Trials 109
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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RAPT Therapeutics gets grant for inhibiting hematopoietic progenitor kinase 1 using pyrazole pyrimidine compounds

Pharmaceutical Technology

Discover the groundbreaking patent by RAPT Therapeutics Inc for pyrazole pyrimidine compounds targeting HPK1, offering hope for treating cancer and other diseases. Explore the wide-ranging potential of this innovative compound today!

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Scotland first UK nation to clear Mounjaro use for obesity

pharmaphorum

Scotland has become the first country in the UK to back NHS use of Eli Lilly’s obesity therapy Mounjaro, with a lower BMI threshold than draft NICE guidance

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Four key trends in the clinical trial supply chain

Pharmaceutical Technology

Clinical trial supply chains have experienced significant changes in recent years. We identify the four key trends.

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GSK notches another Zantac win as plaintiff drops case in Illinois

Fierce Pharma

As the year rolls on, GSK continues to knock out personal injury lawsuits in the long-running legal saga over whether the popular heartburn medication Zantac can cause cancer. | Plaintiff Eugenia Kasza, who alleged her use of Zantac caused her to develop breast cancer, has voluntarily dismissed her case against GSK. The case was set to start trial in Illinois state court on Monday.

Trials 106
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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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FDA committee unanimously backs Lilly’s donanemab bid for Alzheimer’s

Pharmaceutical Technology

All eleven members of an FDA advisory committee voted yes in favour of approving Lilly’s donanemab for the treatment of Alzheimer’s disease.

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SMC recommends first injectable bispecific for aggressive blood cancer

BioPharma Reporter

AbbVie has announced that the Scottish Medicines Consortium (SMC) has approved Tepkinly (epcoritamab) for adults with diffuse large B-cell lymphoma (DLBCL) who have not responded to or have relapsed after at least two prior treatments.

Medicine 105
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Ipsen extends Marengo partnership with $1.2bn T cell research deal

Pharmaceutical Technology

Ipsen has expanded its ongoing oncology research partnership with Marengo Therapeutics to advance precision precision T cell engagers (TCE).

Research 130
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Pfizer’s Paxlovid Ineffective Against Long COVID Using 15-Day Regimen: Study

BioSpace

While a prolonged, 15-day regimen of Paxlovid is safe, it appears to be ineffective at lowering the symptoms of long COVID, according to results of a Phase II trial funded by Pfizer and conducted by Stanford Medicine.

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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.