Wed.Jan 10, 2024

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5 questions facing pharma in 2024

Bio Pharma Dive

Many drugmakers hope to compete in obesity, while others seek to win oncology’s next era. In the background, a contentious drug pricing law looms.

Drugs 288
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Vertex’s CASGEVY therapy gains approval in Saudi Arabia

Pharmaceutical Technology

Vertex Pharmaceuticals has announced the approval of CASGEVY (exagamglogene autotemcel [exa-cel]), the first CRISPR/Cas9 gene-edited therapy.

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January 10, 2024: In This Friday’s PCT Grand Rounds, a Lottery for Allocating Scarce COVID-19 Resources

Rethinking Clinical Trials

In this Friday's PCT Grand Rounds, Erin McCreary of the University of Pittsburgh will present "Design and Implementation of a Weighted Lottery to Equitably Allocate Scarce COVID-19 Resources." The Grand Rounds session will be held on Friday, January 12, 2024, at 1:00 pm eastern. McCreary is a clinical assistant professor of medicine at the University of Pittsburgh and the director of infectious diseases improvement and clinical research innovation at UPMC.

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A Crash Diet Could Be a Seriously Bad Idea For Weight Loss

AuroBlog - Aurous Healthcare Clinical Trials blog

Those trying to kick-start their weight loss or perhaps wanting to lose a few pounds before a big event or holiday may be tempted to try a crash diet.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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JPM24: Novartis’ head start, FTC fallout and Bluebird’s price defense

Bio Pharma Dive

Radiopharma drugmakers spoke with BioPharma Dive about chasing Novartis in the hot field, while investors debated the impact of a surprise FTC challenge.

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Biopharmaceutical drugs’ affordability driven by R&D cost and production complexity: Dr Tumbagi

AuroBlog - Aurous Healthcare Clinical Trials blog

Biopharmaceutical involves substantial investments in research, clinical trials, regulatory compliance, and manufacturing. Hence the affordability of these medicines are a complex issue, said Dr Amaresh Tumbagi, Karnataka additional drugs controller.

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Novavax: Creating tomorrow’s vaccines today

pharmaphorum

Novavax is a leading pharmaceutical company dedicated to creating protein-based vaccines for diseases like COVID-19 and malaria. Learn more about their innovative vaccine development process and their commitment to creating a healthier future.

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EMA approves Mitochon’s neurogenerative disease study  

Pharmaceutical Technology

The upcoming 14-day pilot study will investigate the safety and response of MP101 in patients with neurogenerative diseases.

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Biotech funding recovery predicted for 2024

Drug Discovery World

The biotech market is heading to recovery in 2024, following a marked downturn in investment in 2022 and 2023, according to healthcare industry professionals. A GlobalData survey ‘The State of the Biopharmaceutical Industry 2024’ found that more than 40% of the healthcare industry professionals surveyed globally expressed an optimistic or very optimistic sentiment on biotech funding starting to bounce back over the next 12 months.

Marketing 115
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BioArctic and Eisai’s Leqembi gains approval in China

Pharmaceutical Technology

BioArctic AB and Eisai have announced the approval of Leqembi in China for mild cognitive impairment associated with Alzheimer's disease.

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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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JP Morgan Week 2024 - Day 2

pharmaphorum

On Day 2 of the JP Morgan 2024 conference, there are exciting presentations from companies such as Daiichi-Sankyo, Recode Therapeutics, and Vir Biotech. The focus was on innovative advancements in healthcare and the contributions of women in the industry. Learn more about the highlights of this day.

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Alcon’s dry eye drug achieves primary endpoints in Phase III trials

Pharmaceutical Technology

Alcon plans to file for regulatory approval for its dry eye drug with the FDA in mid-2024 after Phase III studies met the primary endpoints.

Drugs 130
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Patient Perspectives: After a lung cancer diagnosis, turning to art and medical research

Antidote

One of the most important results of the work we do at Antidote is directly impacting the lives of patients — and getting to hear their stories is a constant reminder of why we do what we do.

Research 105
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Precision BioSciences and TG Therapeutics sign azer-cel licence deal

Pharmaceutical Technology

Precision BioSciences and TG Therapeutics concluded a licensing agreement for developing azercabtagene-zapreleucel for autoimmune diseases.

Licensing 130
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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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Evotec to advance drug discovery in collaboration with the Crohn’s & Colitis Foundation

Outsourcing Pharma

Evotecâs end-to-end integrated research and development platform will be able to advance drug discovery for two drug targets which is why it has joined forces with the Crohnâs & Colitis Foundation.

Drugs 105
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Venatorx and Menarini sign commercial deal for antibiotic

Pharmaceutical Technology

Venatorx and Menarini have signed an agreement for the commercialisation of the antibiotic cefepime-taniborbactam, in 96 countries.

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Life sciences real estate trends for 2024 and beyond

pharmaphorum

Explore the latest trends and projections in life sciences real estate, including the impact of digital health, the evolving needs of laboratory facilities, and the future of real estate in this sector. Stay ahead of the curve with insights into the industry's future.

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STADA and Alvotech’s win first EU-approval for Stelara biosimilar

Pharmaceutical Technology

STADA and Alvotech’s Uzpruvo gained an EU marketing authorisation, allowing it to be sold in the European Economic Area in 2024.

Marketing 130
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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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Interview: Grapevine's CEO on piecing together the puzzle for standardized data

Outsourcing Pharma

Clinical data management is a vital phase in clinical research, that should lead to the generation of high-quality, reliable, and statistically sound data from clinical trials.

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GSK acquires Aiolos Bio for $1.4bn to boost respiratory portfolio

Pharmaceutical Technology

GSK’s acquisition, which comes amid other big money moves in the pharma industry, aims to broaden its asthma drug range.

Drugs 130
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Fortrea, Advarra and Veeva form partnership to 'dramatically simplify' clinical trial process

Outsourcing Pharma

Global contract research organization (CRO), Fortrea today announced an industry partnership with founding members cloud solutions company Veeva Systems Inc., and provider of clinical research technology, Advarra.

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JPM24: Riding label expansions and launches, AZ plots course toward 'industry-leading growth' by 2030

Fierce Pharma

With a late-stage pipeline spanning more than 120 clinical trials and a firm grasp of five major disease areas, AstraZeneca appears confident heading into 2024. | In AZ's push to reach industry-leading growth by 2030, confidence is key, chief financial officer Aradhana Sarin said at the J.P. Morgan Healthcare Conference. Besides that goal, the company wants to be a top-3 player in its five disease areas of focus.

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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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Top 5 pharma marketing trends in 2024

pharmaphorum

Discover the top 5 pharma marketing trends to watch out for in 2024. From personalised marketing strategies to the power of video and omnichannel communication, explore how patient-centric approaches and generative AI are shaping the future of pharmaceutical marketing.

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MilliporeSigma and ACD/Labs in collaboration to 'shape the future of analytical testing'

Outsourcing Pharma

Informatics software developer supporting R&D, ACD/Labs, has formed a collaboration with MilliporeSigma, the US and Canada Life Science business of Merck KGaA.

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AbbVie launches pump-based Parkinson’s drug in EU

pharmaphorum

AbbVie has launched its Produodopa therapy for Parkinson’s disease onto the market in the EU, becoming the first and only 24-hour subcutaneous infusion therapy for the neurodegenerative disorder.

Drugs 98
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JPM24: BioMarin's new CEO Hardy says top priority is expansion of dwarfism drug Voxzogo

Fierce Pharma

In his first presentation as the new CEO of BioMarin, Alexander Hardy left no doubt about his mission for the rare and genetic disease specialist. | In his first presentation as the new CEO of BioMarin, Alexander Hardy left no doubt about his mission for the rare and genetic disease specialist. The top priority for the former Genentech CEO is to accelerate and maximize the commercial potential of dwarfism drug Voxzogo.

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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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JPM: Precision Bio continues offload of CAR-T rights

pharmaphorum

Precision BioSciences licenses non-cancer uses of its allogeneic CAR-T therapy azer-cel to TG Therapeutics as it pivots to in vivo applications of its gene-editing technology

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JPM24: After 'clearing the decks,' Alkermes ready to roll as pure-play neuroscience company

Fierce Pharma

Age 37 might be old for a “coming-out party,” but that’s the situation for Alkermes at this year’s J.P. Morgan Healthcare Conference, chief operating officer Blair Jackson said in an interview. | Age 37 might be old for a “coming-out party,” but that’s the situation for Alkermes at this year’s J.P. Morgan Healthcare Conference, said chief operating officer Blair Jackson.

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Ensuring R&D investments deliver maximum potential: Notable ways to enhance clinical development strategy and design

pharmaphorum

Ensuring R&D investments deliver maximum potential: Notable ways to enhance clinical development strategy and design Mike.

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Barinthus Bio announces $47m project to advance MERS coronavirus vaccine

Pharma Times

The partnership will advance VTP-500 from early development to phase 2 clinical trials

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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.