Thu.Dec 21, 2023

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Landmark Melanoma Vaccine Could Be Available in Just 2 Years

AuroBlog - Aurous Healthcare Clinical Trials blog

Moderna CEO Stephane Bancel told AFP his company’s experimental vaccine against melanoma could be available in as little as two years, in what would amount to a landmark step against the most serious form of skin cancer. Globally there were an estimated 325,000 new melanoma cases and 57 ,000 deaths from the disease in 2020.

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Genevoyager opens CDMO facility for gene therapy development

Pharmaceutical Technology

Genevoyager has announced the opening of contract development and manufacturing organisation facility to manufacture gene therapy products.

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J&J bets bigger on MeiraGTx’s eye gene therapy

Bio Pharma Dive

Ahead of a Phase 3 readout that could come next year, the pharma is paying $130 million in upfront and near-term cash for rights to the retinitis pigmentosa treatment that it didn’t already own.

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QCI introduces innovative solution ‘Quality Setu’ to streamline NABH complaints redressal process

AuroBlog - Aurous Healthcare Clinical Trials blog

In order to streamline the National Accreditation Board for Hospitals and Healthcare Providers (NABH) helpdesk and complaints redressal process, the Quality Council of India (QCI) and all its boards have introduced an innovative solution for addressing concerns promptly and transparently through “Quality Setu”.

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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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Sanofi scraps a top ADC prospect after study setback

Bio Pharma Dive

The drug, acquired via a deal with ImmunoGen, was the most advanced experimental medicine in the French pharma’s pipeline.

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Wearable technology to be offered to thousands with type 1 diabetes in UK

Pharma Times

The condition affects around 270,935 people in England and 16,090 people in Wales - News - PharmaTimes

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NHS expands home-testing kits to detect bowel cancer earlier

Pharma Times

Bowel cancer is currently the third most common type of cancer in England - News - PharmaTimes

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BioMarin strikes deal with Elliott, agrees to review business

Bio Pharma Dive

Under pressure from the activist investor, BioMarin will add more independent directors and set up an operational review committee.

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MEI Pharma files patent for a cancer treatment method using mitochondrial and bcl-2 inhibitors

Pharmaceutical Technology

Discover a groundbreaking method to treat cancer using a combination of mitochondrial and Bcl-2 inhibitors. Learn more about this patent's innovative approach.

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As Vertex and CRISPR build out Casgevy launch, doctor sees strong demand and warns of possible supply hitches

Fierce Pharma

As Vertex Pharmaceuticals and CRISPR Therapeutics lay the groundwork for the launch of their CRISPR-based gene-editing therapy Casgevy, one doctor who treats sickle cell disease patients is already | As Vertex Pharmaceuticals and CRISPR Therapeutics lay the groundwork for the launch of their world-first CRISPR-based gene therapy Casgevy, one doctor who treats sickle cell disease patients is already seeing strong demand.

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

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Diakine-DK210 (EGFR) by Deka Biosciences for Pancreatic Cancer: Likelihood of Approval

Pharmaceutical Technology

Diakine-DK210 (EGFR) is under clinical development by Deka Biosciences and currently in Phase I for Pancreatic Cancer.

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2024 forecast: Big Pharma reworks China strategy, and job cuts are part of it

Fierce Pharma

Big Pharma companies have often talked about the major opportunities that await in China. | Big Pharma companies have often talked about the major opportunities that await in China. But as price cuts play out and internal priorities shift, multinational companies are reworking their business models in the country.

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BI-1701963 by Boehringer Ingelheim International for Metastatic Colorectal Cancer: Likelihood of Approval

Pharmaceutical Technology

BI-1701963 is under clinical development by Boehringer Ingelheim International and currently in Phase II for Metastatic Colorectal Cancer.

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Court reverses Servier verdict on Mediator, ?orders payment of €430M

Fierce Pharma

Two years ago, with a favorable ruling and a slap-on-the | A favorable ruling two years ago had Servier hoping that its decades-long litigation surrounding weight-loss pill Mediator was finally over. But an appeal from prosecutors now leaves the company facing a hefty penalty.

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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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Sudo raises $116m to advance TYK2 programmes 

Pharmaceutical Technology

Sudo plans to advance two TYK2 candidates into clinical testing next year for the treatment of autoimmune and neurologic conditions.

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NICE backs digital technologies for COPD rehab

pharmaphorum

NICE backs NHS use of digital COPD rehab programmes, myCOPD and SPACE for COPD, as an alternative to face-to-face consultations

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FDA revamps EUA guidance for Covid-19 monoclonal antibodies

Pharmaceutical Technology

The FDA released an updated guidance for developing Covid-19 monoclonal antibody treatments for EUAs as variants evolve.

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BioMarin settles with activist investor Elliott, adds three new independent directors and review committee

Fierce Pharma

Along with a new CEO, BioMarin will head into 2024 with three new board directors and a new strategy review committee after settling with activist investor Elliott Investment Management. | Elliott Investment Management is one of BioMarin's largest investors with a stake worth more than $1 billion. The three new independent directors include a former Lilly exec and ImmunoGen's CEO.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Cadonilimab by Akeso for Transitional Cell Cancer (Urothelial Cell Cancer): Likelihood of Approval

Pharmaceutical Technology

Cadonilimab is under clinical development by Akeso and currently in Phase II for Transitional Cell Cancer (Urothelial Cell Cancer).

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Sanofi drops lung cancer ADC tusamitamab ravtansine

pharmaphorum

Sanofi ends development of CEACAM5-targeting ADC tusamitamab ravtansine after it fails a phase 3 trial in non-small cell lung cancer (NSCLC)

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Cadonilimab by Akeso for Small-Cell Lung Cancer: Likelihood of Approval

Pharmaceutical Technology

Cadonilimab is under clinical development by Akeso and currently in Phase II for Small-Cell Lung Cancer.

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With FDA approval, Ionis and AstraZeneca gear up to launch rare disease drug Wainua

Fierce Pharma

Ionis Pharmaceuticals and AstraZeneca are wrapping up the year with a much-anticipated present from the FDA: an approval for the companies’ transthyretin amyloidosis (ATTR) drug Wainua. | The approval in hereditary transthyretin-mediated amyloid polyneuropathy, which affects around 40,000 to 50,000 patients globally, sets the stage for a potential label expansion down the line to treat the broader transthyretin amyloid cardiomyopathy patient population.

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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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BT-8009 by Bicycle Therapeutics for Fallopian Tube Cancer: Likelihood of Approval

Pharmaceutical Technology

BT-8009 is under clinical development by Bicycle Therapeutics and currently in Phase II for Fallopian Tube Cancer.

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AI specialist Fauna grabs $494m Lilly obesity alliance

pharmaphorum

Lilly partners with Fauna Bio in $494m deal to see if a hibernating squirrel's genomics could unlock new obesity drug targets.

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FDA rejects MSD’s gefapixant for chronic cough

Pharmaceutical Technology

Despite approvals in Europe and Japan, the FDA rejected the oral drug, citing a lack of substantial evidence for treatment effectiveness.

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Let’s Talk Prostate Cancer calls for action by MEPs

pharmaphorum

An organisation representing the interests of patients with prostate cancer has published a manifesto ahead of the EU elections next year, calling for more screening for the disease in EU member states.

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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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Calliditas receives FDA approval for Tarpeyo to treat IgAN

Pharmaceutical Technology

Calliditas Therapeutics has received the US FDA approval for Tarpeyo to treat adult primary immunoglobulin A nephropathy (IgAN) patients.

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Indivior bags $111m contract from US for overdose therapy

pharmaphorum

Indivior has secured a $111 million BARDA supply contract in the US for its Opvee intranasal therapy for treating opioid overdose

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GSK signs licence deal for Hansoh Pharma’s cancer drug

Pharmaceutical Technology

GSK has signed an exclusive licence agreement for Hansoh Pharma’s B7-H3-targeting ADC, HS-20093, for potential treatment of solid tumours.

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Three Key Elements to Win the Gold – Advice From Award-Winning Creative Experts

Intouch Solutions

Recently, three of our creative leaders at EVERSANA INTOUCH had the honor of participating in a webinar hosted by Cannes Lions, exploring the theme of “Health and the Health-Conscious Consumer.” This insightful session featured Susan Perlbachs, Chief Creative Officer; Nick Capanear, Managing Director, Executive Creative Director; and Ivan Blotta, Group Creative Director, Head of Art.

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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.