Fri.Apr 12, 2024

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KCL and McMaster University partner to advance nuclear medicine research

Pharma Times

Both partners’ will leverage their nuclear research facilities and expertise to develop new health interventions

Medicine 111
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Moderna pauses plans to build mRNA facility in Kenya

Pharmaceutical Technology

Moderna has announced the halt of its project to build a messenger ribonucleic acid (mRNA) manufacturing facility in Kenya.

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European regulator concludes no suicide link to obesity drugs

Bio Pharma Dive

The decision clears a concern hanging over GLP-1 medicines like Ozempic since reports of suicidal ideation and self-harm among people taking the drugs surfaced in July.

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UK charities condemn continued drug shortages

Pharmaceutical Technology

As the UK tackles several drug shortages, UK charities and pharmacists called for urgent action to be taken.

Drugs 195
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Roche, Adaptimmune part ways on cell therapy research

Bio Pharma Dive

The two companies have ended a collaboration that was struck in 2021 and focused on “off-the-shelf” cell therapies for cancer.

Research 183
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FDA approves AstraZeneca’s FASENRA for asthma in children

Pharmaceutical Technology

The US FDA has granted approval for AstraZeneca's FASENRA in children aged six to 11 years with severe asthma and an eosinophilic phenotype.

More Trending

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FDA approves new administration routes for Xcopri 

Pharmaceutical Technology

SK Life Sciences Xcopri (cenobamate) is approved as an oral suspension mixed with water for mouth administration or via a nasogastric tube.

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AACR, Cancer Treatment and the Promise of Antibody-Drug Conjugates

BioSpace

This week’s American Association for Cancer Research annual meeting drove home the importance of antibody-drug conjugates as an emerging class of potential anti-cancer therapeutics.

Antibody 136
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Eliem Therapeutics agrees to acquire Tenet

Pharmaceutical Technology

Eliem Therapeutics has announced an agreement for the acquisition of development-stage private biotechnology company Tenet Medicines.

Medicine 130
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AstraZeneca Expands Fasenra’s Label to Younger Children with Severe Asthma

BioSpace

The FDA on Thursday approved the label expansion of AstraZeneca’s Fasenra as an add-on maintenance treatment for severe eosinophilic asthma in patients six to 11 years of age.

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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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Fujifilm invests $1.2bn ramping up North Carolina facility

Pharmaceutical Technology

The site expansion is set to add 680 jobs to the site and expand Fujifilm’s contract research business and production capacity.

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The case for adaptive EDI strategies in the UK

pharmaphorum

Uncover the importance of adaptive EDI strategies in the UK through research and discussions on diversity. Explore the benefits and best practices in promoting a more inclusive workplace.

Research 117
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Novartis signs deal for Arvinas’ prostate cancer therapy

Pharmaceutical Technology

Novartis has signed an exclusive strategic licence agreement for Arvinas’ ARV-766, a new treatment for prostate cancer.

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Study suggests tumour microenvironments could predict cancer progression

Pharma Times

NSCLC is the most common type of lung cancer and is responsible for up to 85% of all cases

Research 154
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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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Century secures $60m in stock sale and buys preclinical cell therapy biotech

Pharmaceutical Technology

Century Therapeutics will pay $35m upfront and an additional $10m milestone payments to acquire Clade Therapeutics.

Sales 130
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Changing Faces: Agency, consultancy, and investor hires from March 2024

pharmaphorum

Stay up to date on the latest agency, consultancy, and investor hires from March 2024 with Changing Faces. Learn about Langland, 4BIO Capital, Jeito Capital and more.

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Lilly Suffers Legal Loss in Tirzepatide Case Against Compounding Pharmacy

BioSpace

Florida District Judge Roy Altman earlier this week ruled against Eli Lilly, finding that the drugmaker cannot use state law to block reformulated versions of its blockbuster weight-loss and diabetes medication tirzepatide.

Pharmacy 115
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Shareholders approve AstraZeneca's 2024 pay proposal for CEO Pascal Soriot despite proxy adviser discontent

Fierce Pharma

History is repeating for AstraZeneca CEO Pascal Soriot, who successfully dodged an executive pay revolt at the company’s annual meeting Thursday, echoing a similar situation that played out in 2021 | Out of more than 1.18 billion votes cast by AstraZeneca shareholders at the company's annual meeting this week, 64.43% of investors voted in favor of an updated pay policy that could see CEO Pascal Soriot earn upward of 18.7 million pounds sterling ($23.5 million) for his performance this year.

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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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EMA Finds No Link Between GLP-1 Drugs and Suicidal Thoughts, Self-Harm

BioSpace

The European Medicines Agency on Friday said it found no evidence linking GLP-1 receptor agonists with suicidal thoughts and actions, following a review of patients taking Novo Nordisk’s semaglutide and liraglutide, and Eli Lilly’s dulaglutide and AstraZeneca’s exenatide.

Medicine 115
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FDA advisers back new endpoint for myeloma approvals, paving way for faster introduction of new drugs

Fierce Pharma

After oncology experts reviewed arguments in favor of a surrogate endpoint to support multiple myeloma drug approvals, drug developers may soon have a new pathway in the R&D journey. | After oncology experts reviewed arguments in favor of a surrogate endpoint to support multiple myeloma drug approvals, drug developers may soon have a new pathway in the R&D journey.

Drugs 108
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Fujifilm Pumps $1.2B into CDMO Capacity in North Carolina, Eyes 680 New Jobs by 2031

BioSpace

The global contract development and manufacturing organization is investing $1.2 billion to boost production capabilities at its Holly Springs, North Carolina, site including mammalian cell culture bioreactors.

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Candel wins FDA orphan drug designation for pancreatic cancer drug

Pharmaceutical Technology

The FDA designation follows positive Phase II data announced recently.

Drugs 130
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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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Enlivex’s Stock Plummets 50% on Phase II Sepsis Results for Cell Therapy

BioSpace

Investors were disappointed in data from a mid-stage study of Enlivex Therapeutics’ Allocetra cell therapy for the treatment of sepsis. The Israeli company is considering a follow-on trial in sepsis caused by urinary tract infection.

Trials 107
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Ex-broadcaster Paxman hands Parkinson’s wish list to UK PM

pharmaphorum

To mark World Parkinson’s Day, former broadcaster Jeremy Paxman has delivered a list of recommendations for improving how the disease is managed in the UK to Prime Minister Rishi Sunak.

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With 9% pay hike, Merck CEO Davis entered $20M compensation club in 2023

Fierce Pharma

Merck CEO Robert Davis has cracked the $20-million mark in annual pay for the first time, putting him in an exclusive club of biopharma heavy hitters. | Merck CEO Robert Davis has cracked the $20-million mark in annual pay for the first time, putting him in an exclusive club of biopharma heavy hitters. Davis, 57, received a 9% bump in pay in 2023 to $20.3 million, according to the company’s proxy filing.

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BioMarin’s Voxzogo shows promise in hypochondroplasia

pharmaphorum

BioMarin’s Voxzogo has been shown to increase growth rates in children with hypochondroplasia, a genetic cause of very short stature, in a phase 2 trial

Genetics 111
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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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Selkirk Pharma says success hinges on ability to deliver on manufacturing promises

BioPharma Reporter

In the fast-paced domain of pharmaceutical contract development and manufacturing organizations (CDMOs), Selkirk Pharma believes it stands out as a beacon of innovation and reliability.

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TORL rakes in $158m for ADCs, and other bio financings

pharmaphorum

Our regular round-up of financings in the biotech sector features rounds for TORL BioTherapeutics, Nvelop Therapeutics, D3 Bio, and Century Therapeutics.

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How Patient Engagement Can Reduce Brand Launch Risks

Drug Channels

Today’s guest post comes from Jessica Lens, Chief Patient Experience Officer at CareMetx. Jessica discusses the challenges of patient nonadherence. She then outlines how manufacturers can build adherence into their patient services program to increase patient engagement. To learn more about enhancing patient engagement and adherence, download CareMetx's new report: Driving Brand Success: Minimize Risk and Capture Missed Value from Patient Engagement and Adherence.

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AZ shareholders back CEO Soriot’s pay package, amid dissent

pharmaphorum

Shareholders in AstraZeneca have voted to approve controversial increase in the salary and bonus package for CEO Pascal Soriot.

Packaging 104
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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.