Fri.Nov 24, 2023

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Health Canada approves Jazz’s cannabis derived seizure therapy

Pharmaceutical Technology

Epidiolex has been approved as an adjunct therapy for seizures associated with three rare forms of epilepsy in patients aged two and older.

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Successful clinical trial for re-engineered Covid vaccine 

Drug Discovery World

The University of Queensland’s re-engineered clamp platform has produced a vaccine that is equally safe and virus-neutralising as an approved Covid vaccine considered among the best in its class. The pivotal proof-of-concept testing clears the way to progress the Clamp2 technology in a range of research programmes. Project leader, Associate Professor Keith Chappell, said the preliminary clinical trial results were an ‘exciting reward’ for the team’s continued dedication and the community’s wi

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Bayer expands German manufacturing facilities to fulfill supply demand

Pharmaceutical Technology

Bayer announced the launch of a Berlin, Germany-based manufacturing facility to meet future demands from the US, China and Europe.

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NHS urges individuals to take up cervical screening invitations

Pharma Times

Around 3,200 new cases of cervical cancer are diagnosed in the UK every year - News - PharmaTimes

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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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Vertex obtains EC approval for combination therapy to treat CF

Pharmaceutical Technology

Vertex Pharmaceuticals has obtained approval from EC) for the label expansion of Kaftrio plus ivacaftor to treat children with CF.

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Study suggests cognitive decline could be linked to hippocampus shrinkage

Pharma Times

The findings could benefit patients living with neurodegenerative conditions - News - PharmaTimes

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More Trending

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Postum: A Time-Honored Coffee Alternative

XTalks

In the world of hot beverages, Postum occupies a unique place. Originating as a coffee alternative, this drink has carved out a niche among those seeking a caffeine-free option. To understand its enduring appeal, let’s delve into its history, ingredients and its status in today’s beverage market. The Birth of Postum Postum was born out of necessity.

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Johnson & Johnson sees highest patent filings and grants during August in Q3 2023

Pharmaceutical Technology

Access and buy GlobalData’s databook on the latest filings and grants activity for Johnson & Johnson here.

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Calliditas Therapeutics' partner Everest Medicines' announces kidney drug approval

Outsourcing Pharma

Calliditas Therapeutics AB announced today (November 24) that its partner Everest Medicines has revealed that China's National Medical Products Administration (NMPA) has approved Nefecon.

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F. Hoffmann-La Roche sees highest patent filings and grants during August in Q3 2023

Pharmaceutical Technology

Access and buy GlobalData’s databook on the latest filings and grants activity for F. Hoffmann-La Roche here.

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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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Progress for Johnson & Johnson's lung cancer drug as extension submitted to EMA

Outsourcing Pharma

The Janssen Pharmaceutical Companies of Johnson & Johnson announced last week (November 23) the submission of a type 2 extension of indication application to the European Medicines Agency (EMA).

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Bristol-Myers Squibb sees highest patent filings and grants during August in Q3 2023

Pharmaceutical Technology

Access and buy GlobalData’s databook on the latest filings and grants activity for Bristol-Myers Squibb here.

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International Health Partners' Christmas campaign: Working with pharma for patients worldwide

pharmaphorum

International Health Partners' Christmas campaign: Working with pharma for patients worldwide Nicole.

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What’s in a name: Agencies struggle to keep up with expanding drug space 

Pharmaceutical Technology

With more approved drugs coming through than ever before, the need to avoid confusing names to ensure patient safety is important.

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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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How to optimise commercial-scale ATMP manufacturing through automation

pharmaphorum

How to optimise commercial-scale ATMP manufacturing through automation Mike.

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Novo Nordisk expands site to manufacture GLP-1 drugs

Pharmaceutical Technology

The expansion comes as Novo is trying to maintain strong growth in T2D after the launch of Eli Lilly’s Zepbound this month.

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New patent for Abbvie drug RINVOQ

Drug Patent Watch

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

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Novartis sees highest patent filings and grants during August in Q3 2023

Pharmaceutical Technology

Access and buy GlobalData’s databook on the latest filings and grants activity for Novartis here.

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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.

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New patent for Antares Pharma drug XYOSTED (AUTOINJECTOR)

Drug Patent Watch

Annual Drug Patent Expirations for XYOSTED+%28AUTOINJECTOR%29 Xyosted (autoinjector) is a drug marketed by Antares Pharma Inc and is included in one NDA. It is available from one supplier. There are… The post New patent for Antares Pharma drug XYOSTED (AUTOINJECTOR) appeared first on DrugPatentWatch - Make Better Decisions.

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China’s NMPA approves ArkBio’s RSV neutralising antibody drug

Pharmaceutical Technology

China’s NMPA has approved ArkBio IND application for its respiratory syncytial virus (RSV) neutralising antibody, AK0610.

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The value of mission-orientated research in biopharma R&D 

Drug Discovery World

Patrick Speedie , Co-Founder & Co-CEO of  IN-PART , explores why a global approach is needed for the best science to prosper and the lessons industry can take from the Covid-19 pandemic.   The Covid-19 pandemic unequivocally demonstrated the power of industry-academia collaboration, with the fastest ever development, testing and approval of a life-saving vaccine.

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Ellipses receives orphan drug designation for selective RET inhibitor

Pharmaceutical Technology

Ellipses Pharma has secured ODD from the US FDA for its next generation EP0031/A400, to potentially treat solid tumours.

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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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Progress for Johnson & Johnson's lung cancer drug as extension submitted to EMA

Outsourcing Pharma

The Janssen Pharmaceutical Companies of Johnson & Johnson announced last week (November 23) the submission of a type 2 extension of indication application to the European Medicines Agency (EMA).

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Amgen sees highest patent filings and grants during July in Q3 2023

Pharmaceutical Technology

Access and buy GlobalData’s databook on the latest filings and grants activity for Amgen here.

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Combination therapy recommended for NHS use for advanced biliary tract cancer 

Drug Discovery World

AstraZeneca has announced that the National Institute for Health and Care Excellence (NICE) has recommended Imfinzi (durvalumab) in combination with gemcitabine and cisplatin (chemotherapy) for NHS use in England and Wales for the first-line treatment of adults with locally advanced, unresectable, or metastatic biliary tract cancer (BTC). 1 There remains a significant unmet need for new treatment options in BTC, a group of rare and aggressive cancers that occur in the bile ducts and gallbladder,

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Lupin introduces triple combination Vilfuro-G in India for COPD

Pharmaceutical Technology

Lupin has introduced the fixed-dose triple combination drug (FDC), Vilfuro-G, to manage chronic COPD in India.

Drugs 130
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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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NHS Confederation, ABPI say break down barriers to partnerships and change the lives of millions

pharmaphorum

NHS Confederation, ABPI say break down barriers to partnerships and change the lives of millions Nicole.

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Which pharmaceutical drugs have the most drug patents in Croatia?

Drug Patent Watch

This chart shows the drugs with the most patents in Croatia. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.… The post Which pharmaceutical drugs have the most drug patents in Croatia? appeared first on DrugPatentWatch - Make Better Decisions.

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Intellectual property: Striking the balance

pharmaphorum

Intellectual property: Striking the balance Mike.

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