Tue.Sep 10, 2024

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Teva agrees to pay Baltimore City $80m for fuelling opioid epidemic

Pharmaceutical Technology

Baltimore opted out of a national settlement last year, instead pursuing its own claim against the opioid manufacturer.

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Scientists Reveal The Absolute Worst Thickness For a Paper Cut

AuroBlog - Aurous Healthcare Clinical Trials blog

(cookiecatagency/Getty Images) It’s happened to the best of us. There you are, minding your own business, sealing envelopes or replacing the printer ream, and tsssss ouch! A freshly minted paper cut, oozing ruby-red human juice, all over the clean white surface.

Scientist 190
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Investors are waking up to Centessa’s sleepiness drug

Bio Pharma Dive

A small, early study produced what one analyst called “highly compelling” results that lifted the company’s shares by as much as 15% Tuesday.

Drugs 196
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DoP to frame ‘Disposal Policy’ for safe removal of unused and expired drugs from household & sale premises

AuroBlog - Aurous Healthcare Clinical Trials blog

In order to avoid environmental hazards due to pharmaceutical products, the Department of Pharmaceuticals (DoP) is thinking of framing a ‘Disposal Policy’ for removing the unused and date-expired drugs from the sale premises and from the households.

Sales 151
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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House backs bill restricting China role in US biotech

Bio Pharma Dive

The Biosecure Act, which limits contracts with WuXi AppTec, WuXi Biologics and three other companies, still needs Senate support to advance.

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AstraZeneca/Daiichi’s ADC shows better survival for nonsquamous NSCLC patients

Pharmaceutical Technology

Datopotamab deruxtecan, developed under a collaboration between AstraZeneca and Daiichi Sankyo, elicited higher overall survival than chemotherapy.

More Trending

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EASD 2024: New developments in presymptomatic type 1 diabetes screening

Pharmaceutical Technology

The study involved over 3,600 participants, including FDRs of newly diagnosed type 1 diabetes patients in Denmark and children in Sweden.

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Bain closes $3B biotech fund amid flurry of startup buyouts

Bio Pharma Dive

The fund is Bain’s fourth and follows several recent acquisitions of some of its portfolio companies, among them Jnana Therapeutics and EyeBio.

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US bill passed to restrict business with Chinese biotech companies

Pharmaceutical Technology

The US House of Representatives has passed a bill to restrict business with certain Chinese biotech companies.

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Neuromuscular diseases in crosshairs in Forge Biologics gene therapy collaboration

BioPharma Reporter

Forge Biologics will help with the manufacturing of adeno-associated viruses (AAVs) in a collaboration with the non-profit Muscular Dystrophy Association (MDA) to develop gene therapies for neuromuscular diseases.

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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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EASD 2024: Eli Lilly releases Phase III data for once-weekly insulin in diabetes

Pharmaceutical Technology

Data from the two Phase III trials showed that efsitora induced HbA1C reductions similar to daily insulin in both type 1 and 2 diabetes.

Insulin 130
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Life sciences real estate is booming amid looming ‘patent cliff’, but what lies ahead?

pharmaphorum

Investment in life sciences real estate is booming as the industry faces the looming 'patent cliff' Learn about the current trends and what lies ahead for this sector.

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EASD24: Eli Lilly releases Phase III data for once-weekly insulin in diabetes

Pharmaceutical Technology

Data from the two Phase III trials showed that efsitora induced HbA1C reductions similar to daily insulin in both type 1 and 2 diabetes.

Insulin 130
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GSK’s Depemokimab Significantly Reduces Asthma Exacerbations

Pharmaceutical Commerce

A pooled analysis of the SWIFT-1 and SWIFT-2 trials found 54% reduction in exacerbation rates over 52 weeks in patients with severe asthma with type 2 inflammation treated with depemokimab.

Trials 105
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Moderna’s Laval facility gains Health Canada’s drug establishment licence

Pharmaceutical Technology

Moderna has announced that its Laval, Quebec manufacturing facility has received a drug establishment licence (DEL) from Health Canada

Drugs 130
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Ready-to-Use Boruzu (Bortezomib) from Amneal and Shilpa Approved by FDA

XTalks

Amneal Pharmaceuticals and Shilpa Medicare have announced US Food and Drug Administration (FDA) approval of Boruzu, a ready-to-use formulation of bortezomib for subcutaneous or intravenous (IV) administration. Boruzu, a proteasome inhibitor, offers a more efficient approach to treating multiple myeloma and mantle cell lymphoma by eliminating the reconstitution process required for Velcade, the current branded version of bortezomib.

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EASD 2024: Novel insights into maternal protection in T1D

Pharmaceutical Technology

At EASD 2024, meta-analysis results shed new light on the genetic transmission of type 1 diabetes (T1D) from parents to offspring.

Genetics 130
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Creyon Bio secures second patent for AI-powered oligonucleotide engineering

BioPharma Reporter

Creyon Bio Inc., a clinical-stage biotechnology company specializing in AI and machine learning-enabled oligonucleotide-based medicines (OBMs), recently announced the issuance of its second US patent.

Engineer 105
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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 closes Sanofi licence deal for T-cell engagers

Pharmaceutical Technology

Vir Biotechnology has concluded a deal with Sanofi, enabling access to multiple T-cell engages and the PRO-XTEN masking platform.

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After BIOSECURE Act passes in House, targeted Chinese companies say they're 'deeply' concerned

Fierce Pharma

After much anticipation and concern, the BIOSECURE Act—which would prevent U.S. companies from working with certain Chinese biotech service providers—has passed a key threshold. | Late Monday, the U.S. House of Representatives voted 306-81 in favor of the BIOSECURE Act, which was introduced in January and seeks to halt federal contracts with five named Chinese life-sci companies: WuXi AppTec, WuXi Biologics, BGI Group, MGI and Complete Genomics.

Genome 106
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Integrated Nanotherapeutics gains funds for new T1D treatment

Pharmaceutical Technology

Integrated Nanotherapeutics secured funds to propel the development of an immune tolerizing therapeutic for Type 1 diabetes.

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The future of regenerative medicine at Novo Nordisk Foundation

Drug Discovery World

Recently, the Novo Nordisk Foundation updated its strategy to include regenerative medicine. While regenerative medicine is not new to the Foundation, it is now an explicit part of the company’s strategy. DDW’s Megan Thomas caught up with Martin Ridderstråle, Senior Vice President and Head of Medical Science at the Novo Nordisk Foundation, to learn more about this strategic decision and the future of regenerative medicine at the Copenhagen-based charitable foundation.

Medicine 102
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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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T-cell targeting Candid Therapeutics launches with $370m

Pharmaceutical Technology

The new biotech has inherited two T cell engager antibodies as part of a three-way merger with Vignette and TRC 2004.

Antibody 130
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Therapy for aggressive brain cancer receives FDA clearance to start phase 1

BioPharma Reporter

Adaptin Bio has announced that the FDA has given the green light to start phase 1 clinical trials for its program APTN-101 targeting glioblastoma, the most common and aggressive form of brain cancer.

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Optimizing Partnerships for Generic Drug Development Success

Drug Patent Watch

The generic drug market has experienced significant growth over the past few decades, driven by the passage of the Hatch-Waxman Act in 1984 and subsequent legislation. Today, the market is more competitive than ever, with generic drugs accounting for over 90% of all prescriptions in the United States.

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Candid Therapeutics launches with $370m to tackle autoimmunity with T-cell engagers

BioPharma Reporter

The San Diego-based biotech company Candid Therapeutics has launched with a huge $370 million with the aim to develop T-cell engager therapies for autoimmune diseases.

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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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Phase 2 PREDICT-ILD imaging study commences in interstitial lung disease

Pharma Times

Molecular imaging agent 99mTc-maraciclatide to aid in disease prognostication

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WCLC: Bayer, Boehringer face off on HER2 cancers

pharmaphorum

Bayer and Boehringer present data on competing oral HER2 drugs at WCLC, as they run phase 3 trials in NSCLC with HER2 activations.

Trials 73
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APL and CurifyLabs partner to support patients with 3D printing medicine technology

Pharma Times

Critically ill individuals will benefit from futuristic tech

Medicine 121
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With Ads on Threads, Is It Time for an All-Meta Strategy?

Intouch Solutions

Before the end of 2024, Meta’s microblogging platform Threads will feature advertising. Why should you be interested? For one reason, Threads is far less controversial than the platform once known as Twitter, with a focus on proactive moderation, inclusive behavior and brand safety. For another, the entire Meta ecosystem offers cross-platform benefits for advertisers hoping to gain reach and engagement across Threads, Facebook, Instagram and WhatsApp.

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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.