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.

Patients 131
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New Amgen immunotherapy could treat common solid tumour

European Pharmaceutical Review

Amgen’s new immunotherapeutic agent Tarlatamab has been shown in a Phase II trial to provide sustained anti-tumour activity in 40 percent of the small cell lung cancer patients. The international DeLLphi-301study was investigated as a new anti-cancer treatment option for patients previously considered to be beyond treatment. Results from the trial were published in the New England Journal of Medicine.

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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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Novo Nordisk to expand French production facilities

European Pharmaceutical Review

Novo Nordisk is investing over €2.1 billion (16 billion Danish kroner) to expand its production site in Chartres, France, supporting manufacture of its products for serious chronic diseases. Novo Nordisk’s multi-billion facility expansion This financial commitment will greatly strengthen manufacturing capacity, more than doubling the site’s footprint.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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NHS urges individuals to take up cervical screening invitations

PharmaTimes

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

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Vertex scores European cystic fibrosis medicine approval

European Pharmaceutical Review

The European Commission has granted a label expansion of the combination treatment KAFTRIO ® (ivacaftor/tezacaftor/elexacaftor) with ivacaftor, for children aged two to five years old with cystic fibrosis. The treatment from Vertex Pharmaceuticals is indicated for individuals who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator ( CYSTIC FIBROSISTR ) gene.

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Lithuania Set to Become Home to Largest Biotech City

PharmaTech

The largest biotech hub is set to be built in Lithuania by Northway Group.

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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.

Pharma 81
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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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Holiday Gift Ideas for Pharmacists and Pharmacy Technicians

Pharmacy Times

For pharmacists and pharmacy technicians, who work diligently to ensure our health and well-being, choosing the perfect holiday gift can be a thoughtful way to express gratitude and brighten their season.

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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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Sosei to regain rights to IBD drug after GSK discontinues programme

Pharmaceutical Technology

The Sosei Heptares oral IBD drug was first licensed to GSK in 2020 and is currently in Phase I clinical development.

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Addressing Burnout: When the Body Says ‘Enough’

Pharmacy Times

In part 2 of this series, trauma-informed pharmacist Helen Sairany, PharmD, MBA, discusses the physical manifestations of burnout.

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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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Why We Were Not Properly Winterized for RSV Season

PharmaTech

Looking at the role that RSV and pediatric medical practices play in drug shortages.

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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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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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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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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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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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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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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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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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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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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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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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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.