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 263
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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.

Vaccine 306
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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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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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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 262
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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

More Trending

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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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Balancing phase-appropriate needs with commercial readiness in viral vector manufacturing

Bio Pharma Dive

The MilliporeSigma viral vector team has unlocked unique insights and workflows that can guide innovators through steps they might not even realize they needed to take.

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New paediatric blood test to prevent sudden death from hereditary heart condition

Pharma Times

Hypertrophic cardiomyopathy is a rare condition that affects up to 1,000 children in the UK

Research 144
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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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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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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Boehringer and Zealand intensify GLP1-RA MASH race

Pharmaceutical Technology

Boehringer and Zealand have shared new data that builds on previously announced results with survodutide in MASH.

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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 119
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Monthly IV version of Leqembi set for FDA review by next year

Pharmaceutical Technology

Eisai and Biogen eye expanded regimen options for thire Alzheimer’s disease drug, as experts debate the reach of Eli Lilly’s donanemab.

Drugs 130
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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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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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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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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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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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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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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Crucial Insights on Patent Litigation Strategies in Pharma Industry

Drug Patent Watch

In the “Patent Effect” podcast, Mustafa introduces his guest, Hakan Yum, the IP Director of Exrain Pharma, based in Sweden.

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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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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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GSK, attempting to stage Blenrep comeback, bids adieu to combo studies with SpringWorks' Ogsiveo

Fierce Pharma

Despite the recent approval of SpringWorks Therapeutics’ Ogsiveo, GSK is calling it quits on prior plans to wed the Pfizer spinout’s drug with its withdrawn cancer med Blenrep. | SpringWorks has received a notice of termination on an amended collaboration and licensing deal with GSK from 2022. Under the updated pact, GSK and SpringWorks were working together to develop and potentially market combinations of Blenrep and Ogsiveo in multiple myeloma.

Licensing 111
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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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Last places on FDA START rare disease programme filled

pharmaphorum

The last three slots for projects that will be included in the FDA’s new programme to accelerate the development of therapies for rare diseases have been taken by Moderna, Myrtelle, and Calico Life Sciences.

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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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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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Dana-Farber Cancer Institute and OncoHost partner for renal cell carcinoma research

Pharma Times

Accounting for 4% of all cases, kidney cancer is currently the sixth most common cancer diagnosed in the UK

Research 109
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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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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.

Vaccine 108
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Moderna applies for review of updated Covid-19 vaccine

Pharmaceutical Technology

Moderna has filed an application with the US FDA to review its updated Spikevax formula, designed to combat the SARS-CoV-2 variant JN.1.

Vaccine 130
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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.