Fri.Apr 19, 2024

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AskBio’s AB-1002 gene therapy receives FDA fast-track status

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted fast-track designation to Bayer subsidiary Asklepios BioPharmaceutical’s (AskBio) investigational gene therapy AB-1002, aimed at treating congestive heart failure (CHF).

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Cerevel Parkinson’s data adds lustre to AbbVie acquisition

pharmaphorum

Cerevel's first phase 3 trial of Parkinson's drug tavapadon is positive - good news for AbbVie which is trying to buy the biotech for $8.

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FDA approves Takeda’s ENTYVIO SC for Crohn’s disease

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Takeda’s ENTYVIO subcutaneous (SC) administration as a maintenance therapy to treat adults with moderately to severely active Crohn's disease (CD).

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CureVac and MD Anderson Cancer Center partner to develop new cancer vaccines

Pharma Times

Both will develop cancer vaccine candidates in selected haematological and solid tumour indications

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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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NIH team develops AI tool to predict cancer drug response

Pharmaceutical Technology

Researchers at the National Cancer Institute, a unit of the National Institutes of Health (NIH) in the US, have developed an AI tool that can predict drug responses in cancer treatment.

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New clinical trial aims to investigate skin patches to spot lung transplant rejection

Pharma Times

Involving 152 patients, the SENTINEL trial aims to cut lung transplant rejection by up to 50%

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Reuters Pharma USA 2024 – Serena Goodwin

pharmaphorum

Stay updated on the latest STEM Healthcare news from Reuters Pharma USA 2024, featuring insights from global account lead at STEM, Serena Goodwin on the impact of AI in healthcare.

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Clinical trial packaging services in contract manufacturing for the pharmaceutical industry

Pharmaceutical Technology

Pharmaceutical Technology Has Listed Some of the Leading Providers of Clinical Trial Packaging Services. Download For Free Here.

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This week in drug discovery (15-19 April) 

Drug Discovery World

News round-up for 15-19 April by DDW Digital Content Editor Diana Spencer. The headline news this week all concerns clinical trials for new drugs that could have a significant impact on future patient treatment, including trials testing therapeutics for ALS, cystic fibrosis, gonorrhoea, TB and Parkinson’s. The top stories: Drug candidate for ALS patients authorised for Phase II trial Axoltis Pharma has received authorisation from ANSM, the French agency for the safety of health products, to laun

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Evotec and Variant Bio forge antifibrotic drug discovery partnership

Pharmaceutical Technology

Evotec has entered a partnership agreement with Variant Bio aimed at detecting a treatment for ailments caused by fibrosis.

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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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'The Top Line': Winning formulas for the best biotech and drug names

Fierce Pharma

This week on “The Top Line,” we're joined by Fierce Biotech Senior Editor Annalee Armstrong and Fierce Pharma Marketing Senior Editor Ben Adams. | This week on "The Top Line," we are joined by Annalee Armstrong, Senior Editor at Fierce Biotech, and Ben Adams, Senior Editor of Fierce Pharma Marketing, to discuss Fierce's take on March Madness.

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Pharmaceutical compliance management software for the pharmaceutical industry

Pharmaceutical Technology

Pharmaceutical Compliance Management Software Is Designed to Enhance Patient Safety. Download the Free Buyer’s Guide Here.

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Fierce Pharma Asia—Leqembi's cost to Medicare; Takeda's $1.2B-plus Kumquat deal; Fujifilm Diosynth's reorg

Fierce Pharma

Medicare's spending projection on the Alzheimer's drug Leqembi is way higher than Eisai's own estimates. Takeda signed an immuno-oncology deal potentially worth more than $1.2 billion. | Medicare's spending projection on the Alzheimer's drug Leqembi is way higher than Eisai's own estimates. Takeda signed an immuno-oncology deal potentially worth more than $1.2 billion.

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Vox Pop Pharma - companies keen to find alternatives to animal testing - read their views

Outsourcing Pharma

Earlier this week, Charles River Laboratories International, Inc. revealed its Alternative Methods Advancement Project (AMAP), which it said is a strong initiative aimed at changing drug discovery and development by exploring alternatives to animal testing.

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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.

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Gene therapy proved to be safe in patients with Parkinson’s disease

Drug Discovery World

Askbio’s AB-1005 (also known as AAV2-GDNF), an investigational gene therapy for the treatment of Parkinson’s disease, was well tolerated with no serious adverse events in a Phase Ib clinical trial. The data were presented at the American Academy of Neurology 2024 Annual Meeting in Denver, Colorado, USA. Based on the safety and efficacy results, a Phase II trial (REGENERATE PD) has been developed and is expected to begin enrolling in the US, EU, and UK later this year.

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Hyundai Bio plans trials of antiviral for dengue fever

pharmaphorum

Hyundai Bioscience is preparing to start clinical trials of what it hopes could become the first antiviral treatment for dengue fever

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Partnership to speed up cell therapy delivery

Drug Discovery World

Autolomous and BioCentriq have collaborated to digitise and accelerate process development and manufacturing activities for cell therapy. Autolomous’ software platform is designed to materially affect the cell and gene therapy sector. BioCentriq will leverage the autoloMATE platform to streamline its process development operations and enhance client experience.

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Experimental AI predicts whether cancer drugs will work

pharmaphorum

Researchers in the US have developed an artificial intelligence tool that can predict how a patient will respond to cancer treatment

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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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Pharma Pulse 4/19/24: The Real Cost of State Drug Importation Programs, Millions in Africa Will Miss HPV Shots After Merck Production Problem & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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FDA clears Roche’s Alecensa for adjuvant use in NSCLC

pharmaphorum

Roche's Alecenesa has become the first ALK inhibitor to be approved by the FDA for adjuvant use in early-stage, ALK+ NSCLC

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