KCL and McMaster University partner to advance nuclear medicine research
Pharma Times
APRIL 12, 2024
Both partners’ will leverage their nuclear research facilities and expertise to develop new health interventions
Fri.Apr 12, 2024
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Moderna pauses plans to build mRNA facility in Kenya
Pharmaceutical Technology
APRIL 12, 2024
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
APRIL 12, 2024
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.
UK charities condemn continued drug shortages
Pharmaceutical Technology
APRIL 12, 2024
As the UK tackles several drug shortages, UK charities and pharmacists called for urgent action to be taken.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Roche, Adaptimmune part ways on cell therapy research
Bio Pharma Dive
APRIL 12, 2024
The two companies have ended a collaboration that was struck in 2021 and focused on “off-the-shelf” cell therapies for cancer.
FDA approves AstraZeneca’s FASENRA for asthma in children
Pharmaceutical Technology
APRIL 12, 2024
The US FDA has granted approval for AstraZeneca's FASENRA in children aged six to 11 years with severe asthma and an eosinophilic phenotype.
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FDA approves new administration routes for Xcopri
Pharmaceutical Technology
APRIL 12, 2024
SK Life Sciences Xcopri (cenobamate) is approved as an oral suspension mixed with water for mouth administration or via a nasogastric tube.
AACR, Cancer Treatment and the Promise of Antibody-Drug Conjugates
BioSpace
APRIL 12, 2024
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.
Eliem Therapeutics agrees to acquire Tenet
Pharmaceutical Technology
APRIL 12, 2024
Eliem Therapeutics has announced an agreement for the acquisition of development-stage private biotechnology company Tenet Medicines.
AstraZeneca Expands Fasenra’s Label to Younger Children with Severe Asthma
BioSpace
APRIL 12, 2024
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.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Fujifilm invests $1.2bn ramping up North Carolina facility
Pharmaceutical Technology
APRIL 12, 2024
The site expansion is set to add 680 jobs to the site and expand Fujifilm’s contract research business and production capacity.
The case for adaptive EDI strategies in the UK
pharmaphorum
APRIL 12, 2024
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.
Novartis signs deal for Arvinas’ prostate cancer therapy
Pharmaceutical Technology
APRIL 12, 2024
Novartis has signed an exclusive strategic licence agreement for Arvinas’ ARV-766, a new treatment for prostate cancer.
Study suggests tumour microenvironments could predict cancer progression
Pharma Times
APRIL 12, 2024
NSCLC is the most common type of lung cancer and is responsible for up to 85% of all cases
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
Century secures $60m in stock sale and buys preclinical cell therapy biotech
Pharmaceutical Technology
APRIL 12, 2024
Century Therapeutics will pay $35m upfront and an additional $10m milestone payments to acquire Clade Therapeutics.
Changing Faces: Agency, consultancy, and investor hires from March 2024
pharmaphorum
APRIL 12, 2024
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.
Lilly Suffers Legal Loss in Tirzepatide Case Against Compounding Pharmacy
BioSpace
APRIL 12, 2024
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.
FDA advisers back new endpoint for myeloma approvals, paving way for faster introduction of new drugs
Fierce Pharma
APRIL 12, 2024
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.
The New Age of Decentralized Clinical Trials
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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.
EMA Finds No Link Between GLP-1 Drugs and Suicidal Thoughts, Self-Harm
BioSpace
APRIL 12, 2024
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.
Shareholders approve AstraZeneca's 2024 pay proposal for CEO Pascal Soriot despite proxy adviser discontent
Fierce Pharma
APRIL 12, 2024
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.
Fujifilm Pumps $1.2B into CDMO Capacity in North Carolina, Eyes 680 New Jobs by 2031
BioSpace
APRIL 12, 2024
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.
Candel wins FDA orphan drug designation for pancreatic cancer drug
Pharmaceutical Technology
APRIL 12, 2024
The FDA designation follows positive Phase II data announced recently.
Accelerating Clinical Supply Through Integrated Drug Development
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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.
Enlivex’s Stock Plummets 50% on Phase II Sepsis Results for Cell Therapy
BioSpace
APRIL 12, 2024
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.
Ex-broadcaster Paxman hands Parkinson’s wish list to UK PM
pharmaphorum
APRIL 12, 2024
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.
Selkirk Pharma says success hinges on ability to deliver on manufacturing promises
BioPharma Reporter
APRIL 12, 2024
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.
BioMarin’s Voxzogo shows promise in hypochondroplasia
pharmaphorum
APRIL 12, 2024
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
How Machine Learning Drives Clinical Trial Efficiency
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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.
With 9% pay hike, Merck CEO Davis entered $20M compensation club in 2023
Fierce Pharma
APRIL 12, 2024
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.
TORL rakes in $158m for ADCs, and other bio financings
pharmaphorum
APRIL 12, 2024
Our regular round-up of financings in the biotech sector features rounds for TORL BioTherapeutics, Nvelop Therapeutics, D3 Bio, and Century Therapeutics.
How Patient Engagement Can Reduce Brand Launch Risks
Drug Channels
APRIL 12, 2024
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.
AZ shareholders back CEO Soriot’s pay package, amid dissent
pharmaphorum
APRIL 12, 2024
Shareholders in AstraZeneca have voted to approve controversial increase in the salary and bonus package for CEO Pascal Soriot.
The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric
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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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