Thu.May 09, 2024

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The growth of clinical trials in Africa

Pharmaceutical Technology

Clinical trials are growing across Africa as the immense potential of the continent starts to be realised. Sponsors and CROs are tapping into the unsaturated patient pools, more diverse populations, and competitive operations costs.

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Takeda targets ‘efficiency’ in restructuring, pipeline cuts

Bio Pharma Dive

The company is discontinuing an array of early drug programs, including several in oncology, as it prioritizes investment in six late-stage assets.

Drugs 237
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Anixa expands cancer vaccine collaboration with Cleveland Clinic

Pharmaceutical Technology

Anixa Biosciences has expanded its partnership with Cleveland Clinic to develop additional vaccines for cancers.

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Novo taps another Flagship startup in search for next obesity drugs

Bio Pharma Dive

The deal with Metaphore Biotechnologies is the third to emerge from a Flagship alliance that’s meant to boost the Danish drugmaker’s pipeline of weight loss medicines.

Medicine 186
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Higher CO2 Levels Have a Concerning Effect on Viruses Floating Through The Air

AuroBlog - Aurous Healthcare Clinical Trials blog

Virus containing droplets were suspended in the CELEBS experimental device for different durations before infectivity was tested. (Allen Haddrell/University of Bristol) Keeping CO2 levels low reduces infectious airborne viral loads, new research suggests.

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Royalty Pharma pays startup $525M for stake in Sanofi MS drug

Bio Pharma Dive

The deal gives the company milestone payments and royalties to a medicine, frexalimab, that Sanofi licensed from biotech ImmuNext and expects to be a future blockbuster.

Licensing 180

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Rakovina expands collaborations to leverage AI platform

Pharmaceutical Technology

Rakovina has expanded research collaborations with Pharma Inventor and the University of British Columbia to identify novel drug candidates.

Drugs 147
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Report warns economic instability has hit UK drug discovery

pharmaphorum

A UK report has said that inflation and geopolitical instability have led to a “dramatic drop” in investment in smaller companies developing new medicines, with a knock-on effect on the entire life sciences industry.

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Takeda tackles $900m restructuring plan after generics hurt annual profits

Pharmaceutical Technology

Workforce optimisation, R&D prioritisation and technology investments are on Takeda’s agenda.

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New metric predicts burden of participating in trials

pharmaphorum

A new metric developed by Phesi can predict the burden that clinical trials will impose on patients, allowing amendments that can improve the design, efficiency and cost

Trials 110
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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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Marinus parts ways with 20% of its workforce

Pharmaceutical Technology

Marinus expects to share data from the Phase III RAISE trial of IV ganaxolone for the treatment of status epilepticus later in the summer.

Trials 130
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Understanding the evolution of container closure integrity testing

pharmaphorum

How have drug container closure testing methods changed over time? This post explores the history and development of techniques to evaluate container integrity.

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Sobi’s Aspaveli obtains indication extension approval in Europe

Pharmaceutical Technology

Sobi gains approval for an indication extension from the European Commission for Aspaveli for adults with PNH who have haemolytic anaemia.

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LogiPharma Europe 2024: Delivering Agility in Supply Chains Through Building Multimodal Cold Chain Networks

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Cathy O'Brien, VP of Sales, UPS Healthcare discusses her masterclass on delivering agility in supply chains by building a multimodal cold chain network while also reducing risks at LogiPharma Europe 2024.

Sales 105
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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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UK research project secures EPSRC grant for medicine development

Pharmaceutical Technology

A research project between DMU and the University of Surrey received a grant to help reduce costs for companies in developing medicines.

Medicine 130
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Interview with Cally Edgren, Senior Director of Sustainability at Assent – Xtalks Food Podcast Ep. 158

XTalks

This episode of the Xtalks Food Podcast features an interview with Cally Edgren, a PFAS expert and the Senior Director of Sustainability at Assent, a leader in supply chain sustainability management solutions. Cally starts off by explaining what PFAS chemicals are and why they are so prevalent in the food industry. She delves into the details of a federal PFAS ban that was proposed in April and how it would impact businesses if passed.

Packaging 103
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GHIT Fund invests Y1.54bn in malaria and NTD drug projects

Pharmaceutical Technology

The GHIT Fund announced an investment of Y1.64bn ($10.8m) in four new projects aimed at developing drugs to treat malaria and NTDs.

Drugs 130
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AlphaFold 3 takes structure predictions well beyond proteins

pharmaphorum

Google DeepMind and Isomorphic Labs' newly launched AlphaFold 3 extends the power of the AI model to 'all life’s molecules'

Protein 115
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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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Acumen doses first patient in Phase II Alzheimer’s disease trial

Pharmaceutical Technology

Acumen Pharmaceuticals has dosed the first patient in the ALTITUDE-AD Phase II trial for its lead drug sabirnetug (ACU193).

Trials 130
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Oregon and Lantern collaborate to develop drug candidate for various cancer indications

Pharma Times

Anticancer drugs will be responsible for 90% of nearly 612,000 predicted US cancer deaths in 2024

Drugs 128
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Novo Holdings-backed Commit launches with $17.2m in seed funding

Pharmaceutical Technology

The Danish biotech, Commit Biologics, will focus on developing antibody therapies to treat cancer and autoimmune diseases.

Antibody 130
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Bespoke Gene Therapy Consortium Targets AAVs for Rare Diseases

BioSpace

Launched in 2021, the public-private consortium on Wednesday updated ASGCT attendees on its efforts to bring adeno-associated virus gene therapies to more rare disease patients.

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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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OneChain’s CAR T trial treats its first cortical T-cell ALL patient

Pharma Times

The subtype accounts for 20% of all T-cell leukaemias, a rare form of blood cancer which produces too many abnormal T-cells

Trials 109
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Novo Inks $600M Deal with Metaphore to Develop Next-Gen Obesity Drugs

BioSpace

As competition with Eli Lilly heats up, Novo Nordisk has partnered with Flagship’s Metaphore Biotechnologies to take biomimicry approach to GLP-1s.

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In gene therapy race, bluebird leads Vertex in activating treatment centers but trails in patient starts

Fierce Pharma

Five months out from their twin FDA approvals in sickle cell disease (SCD), who’s winning the race to treat patients with their respective gene therapies—bluebird bio or partners Vertex Pharmaceuti | Five months out from their twin FDA approvals in sickle cell disease (SCD), who’s winning the race to treat patients with their respective gene therapies—bluebird bio or partners Vertex Pharmaceuticals and CRISPR Therapeutics?

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Keytruda Strikes Out Again in Endometrial Cancer with Phase III Flop

BioSpace

After a combination with Eisai’s Lenvima failed to improve survival in advanced disease in December, adjuvant Keytruda plus chemotherapy missed the mark in newly diagnosed, high-risk patients.

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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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Pfizer puts 74 Swiss jobs on chopping block as it folds Seagen into its cancer operations

Fierce Pharma

After telegraphing more than a hundred potential layoffs in March in connection with plans to stop construction of a massive Seagen facility, Pfizer is plowing ahead with efforts to streamline its | Pfizer has proposed another round of staff reductions and role changes at legacy Seagen, this time hitting Seagen’s European headquarters in Switzerland, where 74 positions could be up for the chop.

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Report highlights challenges facing life sciences sector amid economic turbulence

Outsourcing Pharma

A collaborative report released today (May 9) by Medicines Discovery Catapult (MDC), sheds light on the challenges facing the life sciences sector amidst recent economic turbulence.

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Merck's Keytruda plus chemo comes up short as post-surgery therapy in newly diagnosed endometrial cancer

Fierce Pharma

While Merck & Co.’s Keytruda already boasts a pair of approvals to treat certain forms of endometrial cancer, a recent effort to prove the PD-1 inhibitor’s worth as a post-surgery add-on therap | While Merck & Co.’s Keytruda already boasts a pair of approvals to treat certain forms of endometrial cancer, a recent effort to prove the PD-1 inhibitor’s worth as a post-surgery add-on therapy in newly diagnosed patients has fallen short.

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Takeda Lowers Profit Outlook Amid Vyvanse Loss of Exclusivity, Eyes $900M Restructuring in 2024

BioSpace

Takeda saw a 57% drop in profit in its 2023 fiscal year and has lowered its outlook for the coming fiscal year, mostly driven by increasing generic competition for its ADHD treatment Vyvanse.

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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.