Tue.May 28, 2024

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ASCO 2024: J&J’s early radioligand prostate cancer trial reports four patient deaths

Pharmaceutical Technology

Nearly 37% of subjects experienced serious treatment-emergent adverse events, with thrombocytopenia and interstitial lung disease (ILD) being notable events.

Trials 130
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This Protein Could Help Us Unravel The Mystery of Alzheimer’s

AuroBlog - Aurous Healthcare Clinical Trials blog

There are a lot of connected, moving biological parts in our brains, which makes the study of brain diseases particularly challenging. Now new research has shed light on a key brain process potentially involved in Alzheimer’s disease.

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QUT team receives US DoD funding for Parkinson’s treatment

Pharmaceutical Technology

Scientists of QUT have secured A$4m ($2.65m) grant from the US DoD for developing new treatments for Parkinson's disease.

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Agios cashes in on cancer drug again with $905M Royalty Pharma deal

Bio Pharma Dive

The deal involves royalties for a brain cancer drug Agios previously sold off and that Royalty Pharma thinks could generate more than $1 billion in U.S. sales.

Drugs 200
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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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Indian pharma deploys new-gen air solutions to meet the stringent standards set by revised Schedule M

AuroBlog - Aurous Healthcare Clinical Trials blog

Indian pharmaceutical industry is adapting to the revised Schedule M guidelines by considering the deployment of new-generation quality air solutions. This is because air moisture is a critical factor in pharmaceutical manufacturing processes, as it can affect the quality and stability of medications.

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Insmed shares double as lung drug data convince Wall Street

Bio Pharma Dive

After reporting positive clinical trial results for its drug brensocatib, Insmed plans to later this year file for U.S. approval in bronchiectasis that’s not associated with cystic fibrosis.

Drugs 173

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Roche’s Sabry retires; Duchenne drug fails confirmatory test

Bio Pharma Dive

The veteran executive will be replaced by Boris Zaïtra. Elsewhere, Nippon Shinyaku shared negative Phase 3 data and Merck unveiled new breast cancer results for Keytruda.

Drugs 173
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May 28, 2024: Program Leadership Attends Annual Steering Committee Meeting to Tackle Challenges, Share Lessons From Pragmatic Trials

Rethinking Clinical Trials

Drs. Kevin Weinfurt, Lesley Curtis, and Adrian Hernandez, co–principal investigators of the Coordinating Center Leaders of the NIH Pragmatic Trials Collaboratory met in Bethesda, Maryland, on May 9 and 10 for the program’s 2024 Annual Steering Committee Meeting—an opportunity to network and hold rich discussions on key issues related to pragmatic research.

Trials 147
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The future of medicine: AI’s role in uncovering new drugs

Bio Pharma Dive

Artificial intelligence (AI) has sparked a revolution in the pharmaceutical industry, reshaping the way we approach complex biological challenges.

Medicine 173
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Takeda, amid restructuring campaign, plots 641 layoffs at two Massachusetts sites

Fierce Pharma

A recently announced $900 million restructuring drive is already making waves at Takeda, wi | From early July to March 2025, the Japanese drugmaker will cut 495 staffers at its Cambridge location and 146 in Lexington, Massachusetts. Takeda is the largest life sciences employer in the state.

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

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J&J gains another bispecific antibody with $1.25B skin drug buy

Bio Pharma Dive

The deal is J&J’s second this month involving bispecific antibodies, which the company has prioritized to build its immune and cancer drug pipeline.

Antibody 140
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Data breach at pharma partner Cencora puts sensitive patient information at risk

Fierce Pharma

A data breach at drug distributor Cencora has left sensitive information vulnerable, with patients on medicines from a dozen drugmakers potentially affected. | The potentially compromised data included patient information such as names and addresses, Cencora disclosed in letters to patients who may have been affected.

Medicine 130
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Restructuring for Resilience: How Biotech Leaders Can Navigate the New Landscape

Pharma Mirror

By Justin Kozak, Executive VP & Life Sciences Lead, Founder Shield The tide is turning in the once-booming biotech industry. Funding slowdowns and heightened competition are forcing companies to re-evaluate their strategies. Restructuring, including mergers and acquisitions (M&As) as well as workforce adjustments, has become a common theme. In this shifting environment, proactive risk management and strategic planning are crucial for biotech leaders.

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Vasomune wins FDA fast track designation for lung condition treatment

Pharmaceutical Technology

Currently in a Phase IIa study, AV-001 is being co-developed with AnGes for the prevention and treatment of ARDS in pneumonia.

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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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LifeArc and ALS TDI announce partnership to develop new clinical tools for ALS and MND

Pharma Times

The project will validate two minimally invasive biomarkers for ALS: MMP-9 and TIMP-1

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How logistics service providers add value for pharma companies

Pharmaceutical Technology

Logistics service providers (LSPs) can help pharma companies achieve their supply chain goals

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MRC awards two medical research units at University of Cambridge £30m in funding

Pharma Times

The MRC BRC and the MDU will use the funding and cutting-edge research to improve public health until March 2029

Research 123
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J&J expands atopic dermatitis scope with $1.25bn Numab antibody purchase

Pharmaceutical Technology

J&J has made its second dermatology deal this month, adding Numab’s bispecific antibody NM26 to its growing atopic dermatitis drug portfolio.

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

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AI is coming and regulators are getting prepared

pharmaphorum

The rise of AI is shaking up the healthcare industry. Learn how the MHRA is working to ensure the safe and effective use of AI in drugs and medical devices.

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Biotech’s road to recovery with 46% increase in Q1 venture funding

Pharmaceutical Technology

Investor optimism in biotech has increased due to the expected lowering of interest rates as inflation slows.

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Why Should Companies Use Digital Endpoints Across Clinical Development?

XTalks

The traditional clinical trials model is facing scrutiny. Marked by high costs ranging from $1 billion to $2 billion, lengthy timelines extending five to ten years and success rates falling below ten percent, there is a pressing need for reform. These daunting figures highlight the necessity for innovative solutions that can accelerate the journey of new drugs from the lab to patients.

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ASCO 2024: Rakuten’s photoimmunotherapy and Keytruda combo shows efficacy in HNSCC

Pharmaceutical Technology

A Phase III trial evaluating Rakuten’s photoimmunotherapy in combination with Keytruda in recurrent HNSCC is planned for H2 this year.

Trials 130
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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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Japan's Asahi Kasei puts up $1.06B offer to buy out Tarpeyo maker Calliditas

Fierce Pharma

Bolstered by a full FDA approval for its primary immunoglobulin A nephropathy (IgAN) treatment Tarpeyo, Calliditas has earned the attention of Japanese chemical giant Asahi Kasei. | Asahi Kasei has made a cash offer to acquire Calliditas in a deal worth 11.16 billion Swedish crowns ($1.06 billion), the companies announced Tuesday. Asahi’s bid represents a 74% premium to Calliditas' prior closing price.

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Helsinn and Angelini Pharma renew AULIN and MESULID distribution deal

Pharmaceutical Technology

Helsinn Group has renewed an agreement with Angelini Pharma for the commercialisation of AULIN and MESULID.

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Ex-Jazz, Sunesis exec Swisher takes over at NodThera

pharmaphorum

NLRP3-focused biotech NodThera has named former Jazz Pharma and Sunesis executive Dan Swisher as its new CEO.

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Asahi Kasei offers to buy Sweden’s Calliditas for $1.04bn

Pharmaceutical Technology

Asahi Kasei has made a public cash offer for the acquisition of all shares in Calliditas for a total deal value of $1.04bn.

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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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Trial readout sets up filings for Insmed bronchiectasis drug

pharmaphorum

Shares in Insmed double as phase 3 trial sets up filings for brensocatib, aiming to become the first approved drug for bronchiectasis

Trials 113
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NS Pharma's Duchenne therapy Viltepso fails confirmatory trial

Fierce Pharma

Since NS Pharma launched its Duchenne muscular dystrophy (DMD) drug Viltepso (viltolarsen) in 2020, sales have steadily

Sales 110
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Who Will the Next “Big Pharma” Players Be?

BioSpace

As AstraZeneca looks to climb toward the top of biopharma companies by revenue by the end of the decade, smaller companies are looking to join the ranks of the unofficial Big Pharma club.

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CG Oncology Reveals Promising Results from Phase II CORE-001 Clinical Trial for the Treatment of BCG-Unresponsive High-Risk Non-Muscle Invasive Bladder Cancer

Pharmaceutical Commerce

Results from the CORE-001 clinical trial are expected to be presented at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting.

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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.