Mon.Jan 15, 2024

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MSD’s Keytruda wins expanded FDA combo approval in cervical cancer

Pharmaceutical Technology

MSD’s blockbuster immunotherapy, set to lose patent protection in 2028, secures third FDA approval in cervical cancer.

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CellVoyant secures £7.6 million seed funding to develop stem cell therapies with AI

BioPharma Reporter

CellVoyant, an AI-first biotechnology spin-out from the University of Bristol accelerating the development of novel cell therapies, has announced a Â7.6 million seed round.

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Basilea buys Spexis’ preclinical antibiotics programme for $2.3m

Pharmaceutical Technology

The acquired programme consists of antibiotics against gram-negative bacteria, including multidrug-resistant strains.

Bacteria 147
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Keytruda Granted Latest FDA Approval in Cervical Cancer

Pharmaceutical Commerce

FDA approves Keytruda (pembrolizumab) combined with chemoradiation for the treatment of patients with FIGO 2014 stage III to IVA cervical cancer, which is the 39th overall approved indication for the drug in the United States.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Amgen showcases exciting potential in the obesity space at JPM24

Pharmaceutical Technology

If new treatments are shown to maintain weight loss, they will become game changers within the obesity space.

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Merck continues to boost oncology pipeline through acquisitions

Drug Discovery World

Merck (MSD), through a subsidiary, has agreed to acquire immunotherapy company Harpoon Therapeutics for $680 million. The acquisition includes HPN328, an investigational delta-like ligand 3 (DLL3) targeting T-cell engager being evaluated in certain patients with small cell lung cancer and neuroendocrine tumours. The announcement follows the news that Merck agreed a deal with Inspirna for colorectal cancer drug ompenaclid (RGX-202).

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Aversa Fentanyl combines abuse-deterrent transdermal technology with fentanyl patch system

Outsourcing Pharma

Access to opioids such as fentanyl can lead to abuse but now two companies have signed an agreement to reduce the abuse potential while making sure they are still accessible to those who need them.

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PCM Trials acquires Netherlands-based Clinical Trial Service, becoming the most experienced independent provider of mobile visit services with the largest geographic coverage area in support of decentralized clinical trials (DCTs)

Pharmaceutical Technology

PCM Trials, a Denver, USA based leader in providing mobile research nurses for decentralized clinical trials, today announced the acquisition of Clinical Trial Service (CTS).

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British Columbia’s Safer Opioid Supply Policy and Opioid Outcomes

JAMA Internal Medicine

This cohort study examines the whether there were changes in opioid prescribing and opioid-related health outcomes after implementation of British Columbia’s Safer Opioid Supply policy.

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AI could revolutionise pharma compound synthesis

pharmaphorum

Researchers at the University of Cambridge and Pfizer have developed an AI-powered approach to make it easier to design and make pharma molecules

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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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Cormica Bradford expanding equipment range to update capabilities

Outsourcing Pharma

Cormica Bradford, a division of Cormica says it is proud to announce a significant expansion of its laboratory capabilities.

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Santhera debuts DMD drug Agamree in Germany

pharmaphorum

Santhera’s new treatment for Duchenne muscular dystrophy Agamree has been launched in its first market, Germany, following its EU approval last month.

Drugs 98
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SGD Pharma to grow significantly in 2024 with investments and in package manufacturing

Outsourcing Pharma

SGD Pharma has announced its goal to become the global market leader in primary pharmaceutical glass packaging.

Packaging 109
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As Novartis backs off, Amgen said to be after Cytokinetics

pharmaphorum

Speculation about a takeover play for Cytokinetics isn’t going away, with Amgen the latest company to be linked to the company and its highly-anticipated cardiovascular drug aficamten.

Drugs 89
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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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Cormica Bradford expanding equipment range to update capabilities

Outsourcing Pharma

Cormica Bradford, a division of Cormica says it is proud to announce a significant expansion of its laboratory capabilities.

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Keytruda breaks new ground in cervical cancer

pharmaphorum

MSD’s Keytruda has been cleared by the FDA as the first PD-1 inhibitor for newly diagnosed cervical cancer patients with less severe disease

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CellVoyant secures £7.6 million AI stem cell boost

Pharma Times

CellVoyant’s platform combines AI with live cell imaging

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German union will resist any plan to split up Bayer

pharmaphorum

Germany’s IG BCE trade union has pushed back against any break-up of Bayer, claiming it could put thousands of domestic jobs at risk

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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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Kanabo and City Dock Pharmacy team up

Pharma Times

Companies collaborate to launch walk-in pain clinic

Pharmacy 120
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True innovation in life sciences is only possible through a connected, pan-European approach

pharmaphorum

True innovation in life sciences is only possible through a connected, pan-European approach Mike.

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TRUFF: Elevating Hot Sauce With a Touch of Luxury

XTalks

As far as condiments go, few brands have managed to capture the hearts and taste buds of food enthusiasts quite like TRUFF. Known for infusing the luxury of truffles into everyday pantry staples, TRUFF recently unveiled its newest creation: the TRUFF Jalapeño Lime Hot Sauce. This vibrant green sauce, distinct in both flavor and color, marks a bold new chapter in the company’s innovative journey.

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Aversa Fentanyl combines abuse-deterrent transdermal technology with fentanyl patch system

Outsourcing Pharma

Access to opioids such as fentanyl can lead to abuse but now two companies have signed an agreement to reduce the abuse potential while making sure they are still accessible to those who need them.

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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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New patent expiration for Bausch And drug PROLENSA

Drug Patent Watch

Annual Drug Patent Expirations for PROLENSA Prolensa is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from two suppliers. There are nine… The post New patent expiration for Bausch And drug PROLENSA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
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New DDW Highlights podcast: 15 January 2024

Drug Discovery World

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. This week has seen a number of significant discoveries by researchers in academic institutions, in some cases in partnership with industry, emphasising the important role universities play in early-stage drug discovery.

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New patent for Bioxcel drug IGALMI

Drug Patent Watch

Annual Drug Patent Expirations for IGALMI Igalmi is a drug marketed by Bioxcel and is included in one NDA. It is available from one supplier. There are six patents protecting… The post New patent for Bioxcel drug IGALMI appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
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Six collaborations driving drug discovery innovation

Drug Discovery World

1. Amgen and NVIDIA Amgen has announced plans to advance drug discovery using NVIDIA’s DGX SuperPOD-powered insights from human datasets. The NVIDIA DGX SuperPOD will be installed at Amgen’s deCODE genetics’ headquarters in Reykjavik, Iceland and will be used to build a human diversity atlas for drug target and disease-specific biomarker discovery. “For more than a decade, Amgen has been preparing for this hinge moment we are seeing in the industry, powered by the union of technology and biotech

Drugs 59
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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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New patent expiration for Btcp Pharma drug LAZANDA

Drug Patent Watch

Annual Drug Patent Expirations for LAZANDA Lazanda is a drug marketed by Btcp Pharma and is included in one NDA. There are five patents protecting this drug. This drug has… The post New patent expiration for Btcp Pharma drug LAZANDA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
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Healthcare in the age of AI: How will artificial intelligence impact future decision-making?

pharmaphorum

Artificial intelligence (AI) is transforming the healthcare industry, particularly in decision-making and therapeutic advancements. Learn how AI will revolutionise healthcare and impact future decision-making processes in this informative article.

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New patent for Sumitomo Pharma drug ORGOVYX

Drug Patent Watch

Annual Drug Patent Expirations for ORGOVYX Orgovyx is a drug marketed by Sumitomo Pharma and is included in one NDA. It is available from one supplier. There are eight patents… The post New patent for Sumitomo Pharma drug ORGOVYX appeared first on DrugPatentWatch - Make Better Decisions.

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Orion buys stake in LegoChem amid pivot to cancer and pain

pharmaphorum

Orion buys stake in LegoChem amid pivot to cancer and pain Phil.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.