Medicine, Packaging and Regulation - Clinical Research Informer

EHDS regulation will depend on strong patient confidence

Pharmaceutical Technology

JUNE 25, 2025

European residents must be fully informed to properly trust the incoming European Health Data Space (EHDS) regulation if it is to succeed, experts have concluded. The European Commission (EC) faces a March 2027 deadline to adopt several key implementing acts, which will lay out detailed rules for putting the regulation into practice.

Regulation

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Revolution Medicines partners Royalty Pharma on $2bn funding

Pharmaceutical Technology

JUNE 25, 2025

Revolution Medicines has partnered Royalty Pharma for $2bn in flexible funding to support the independent worldwide development and commercialisation strategy of its renin-angiotensin system (RAS) oncogene (ON) inhibitors. Can pharma tariffs “Make America Manufacture Again”? Credit: SmartPhotoLab/Shutterstock.

Medicine

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UK enacts law to decentralise manufacture of personalised treatments

Pharmaceutical Technology

JULY 23, 2025

EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? The UK Government has passed legislation to decentralise the manufacture of personalised medicines, allowing them to be prepared in facilities closer to the patient.

Manufacturing

Manufacturing Gene Therapy Gene Medicine

RFK Jr looks to alter rare disease regulation by fast-tracking drug approvals

Pharmaceutical Technology

JUNE 6, 2025

Can pharma tariffs “Make America Manufacture Again”? Robert Barrie June 6, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook US health secretary Robert F Kennedy Jr. wants to ensure the ensuing the US does not lag behind other countries in drug development. Give your business an edge with our leading industry insights.

Regulation

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BeOne Medicines Gains CHMP Backing for BRUKINSA Tablet Formulation

The Pharma Data

JUNE 25, 2025

BeOne Medicines Receives Positive CHMP Opinion for New Film-Coated Tablet Formulation of BRUKINSA® (zanubrutinib), Paving the Way for European Market Approval BeOne Medicines Ltd. We look forward to a potential approval later this year and remain committed to delivering our impactful medicines to more patients in the region.”

Medicine

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Single-Cell Insights into PTSD Brain Changes

Scienmag

JUNE 19, 2025

One of the most revealing aspects of the study is the downregulation of the somatostatin (SST) gene itself across interneurons in the dorsolateral prefrontal cortex (DLPFC), a critical hub for executive function and emotional regulation. Modulating these signaling pathways could restore inhibitory balance and ameliorate PTSD symptoms.

Research

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Bharat Biotech acquires licence for GSK’s Shigella vaccine development

Pharmaceutical Technology

JUNE 13, 2025

Can pharma tariffs “Make America Manufacture Again”? Give your business an edge with our leading industry insights.

Vaccination

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How AI and machine learning are transforming drug discovery

Pharmaceutical Technology

JUNE 26, 2025

While regulators are responding by establishing guidelines and promoting collaboration with industry stakeholders, challenges remain, particularly regarding ethical implications of AI technologies in healthcare. Can pharma tariffs “Make America Manufacture Again”?

Drugs

Drugs Clinical Trials Clinical Trials Life Science

Scientists Unveil Previously Unknown Organelle Within Human Cells

Scienmag

JUNE 25, 2025

This tiny but indispensable structure, coined the “hemifusome,” was identified through cutting-edge cryo-electron tomography techniques by a collaborative team of researchers at the University of Virginia School of Medicine and the National Institutes of Health. Is the hemifusome involved in signaling cascades beyond cargo transport?

Scientist

Scientist Genetics Genetic Disease Medicine

Draig secures $140m for neuropsychiatric disorder therapies

Pharmaceutical Technology

JUNE 19, 2025

By GlobalData Learn more about Strategic Intelligence Draig was established through a partnership between Cardiff University’s Medicines Discovery Institute and SV Health Investors. Can pharma tariffs “Make America Manufacture Again”? Stay proactive with real-time data and expert analysis.

Clinical Trials

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Alzheimer’s R&D resurgence driven by $16.8bn in acquisitions in 2025YTD

Pharmaceutical Technology

JUNE 25, 2025

Can pharma tariffs “Make America Manufacture Again”? Give your business an edge with our leading industry insights.

Clinical Trials

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Vutrisiran marks first silencer approved for ATTR-CM

Pharmaceutical Technology

JUNE 12, 2025

However, few medicines are approved for ATTR-wt. GlobalData estimates that vutrisiran’s entrance into the ATTR-wt market will change the treatment paradigm, with the newly approved medicine likely to steal the majority of the patient share from competitors. Can pharma tariffs “Make America Manufacture Again”?

Clinical Trials

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Advancing Rare Disease Trials: Innovation, Partnerships and a Patient Focus

XTalks

APRIL 15, 2025

The challenge with gene therapy is that our healthcare systems in the US and globally are not set up for expensive, lifelong medicines like this, Cherednichenko explains. Since obtaining large datasets for rare diseases is inherently challenging, regulators often seek more information to support their decisions.

Trials

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Pharmaceutical Technology Excellence Awards 2025: i3 Membrane

Pharmaceutical Technology

JUNE 24, 2025

Can pharma tariffs “Make America Manufacture Again”?

Manufacturing

Manufacturing Clinical Trials Clinical Trials Gene Therapy

Genomics to roll out predictive clinical test across UK

Pharmaceutical Technology

JUNE 18, 2025

With the launch, Genomics claims its test is the first product in the country to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) and carry the UK Conformity Assessed (UKCA) mark, combining genetic testing and clinical data to enable prediction and prevention.

Genomics

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Quantum leap or quantum hype: the role of quantum computing in protein modelling

Pharmaceutical Technology

JULY 21, 2025

EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? From understanding disease development and progression to designing ligands with optimal binding affinity, structural biology underpins modern medicinal chemistry. Don’t let policy changes catch you off guard.

Protein

Protein Clinical Trials Clinical Trials Manufacturing

CNS innovator oligonucleotide licensing value up 339% from £2bn in 2024

Pharmaceutical Technology

JUNE 19, 2025

Oligonucleotides are short synthetic strands of DNA or RNA used in precision medicine to bind selectively to disease-causing genetic sequences as targeted therapeutics in the treatment of complex diseases. Can pharma tariffs “Make America Manufacture Again”? billion from 2021 to 2025 year-to-date.

Licensing

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EU’s Pharma Package falls short of Europe’s goal of global competitiveness

Pharmaceutical Technology

JULY 1, 2025

Experts praise the reforms to rare disease and antimicrobial research, but they worry that some provisions in the EU Pharma Package may harm innovation on the continent, contrary to its stated objectives. How will RFK Jr’s American dream for vaccines play out?

Pharma Packaging

Pharma Packaging Packaging Packaging Manufacturing

Medera and Novoheart collaborate on mini-heart models for HLHS

Pharmaceutical Technology

JUNE 25, 2025

Medera and its subsidiary Novoheart have collaborated with scientists at the University of California San Diego School of Medicine and Mayo Clinic to develop mini-heart models for hypoplastic left heart syndrome (HLHS). Can pharma tariffs “Make America Manufacture Again”? Credit: shisu_ka/Shutterstock.

Clinical Trials

Clinical Trials Clinical Trials Manufacturing Gene Therapy

Eli Lilly and Eisai’s Alzheimer’s drugs denied NHS use due to high costs

Pharmaceutical Technology

JUNE 19, 2025

Robert Barrie June 19, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Both Kisunla and Leqembi are both approved by the Medicines and Healthcare products Regulatory Agency (MHRA), meaning they will still be available privately. Can pharma tariffs “Make America Manufacture Again”?

Drugs

Drugs Clinical Trials Clinical Trials Manufacturing

FDA approves Sanofi and Regeneron’s Dupixent for bullous pemphigoid

Pharmaceutical Technology

JUNE 25, 2025

By addressing two central drivers of the underlying type 2 inflammation that contributes to bullous pemphigoid, Dupixent is the first targeted medicine to allow patients the potential to achieve sustained remission and reduce itch. Can pharma tariffs “Make America Manufacture Again”?

FDA Approval

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GE HealthCare’s PET imaging agent gains Alzheimer’s label expansion

Pharmaceutical Technology

JUNE 25, 2025

Can pharma tariffs “Make America Manufacture Again”? Give your business an edge with our leading industry insights.

Clinical Trials

Clinical Trials Clinical Trials Marketing Manufacturing

The Future of Autonomous Deliveries: Integrating Drones and Self-Driving Vehicles

Roots Analysis

MAY 28, 2025

Drone delivery, one such rapidly emerging area, is gaining a lot of market traction Introduction to Autonomous Deliveries Autonomous delivery refers to the use of self-driving delivery vehicles, drones or robots to transport goods, packages or products to your doorstep, without any human intervention.

Packaging

Packaging Packaging Marketing Production

Tisento’s MELAS treatment receives fast track status from FDA

Pharmaceutical Technology

JUNE 18, 2025

Tisento Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for its investigational oral medicine, zagociguat, for mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes (MELAS), a rare mitochondrial disease. Can pharma tariffs “Make America Manufacture Again”?

Clinical Trials

Clinical Trials Clinical Trials Manufacturing Trials

Juvenescence enhances AI drug discovery with Ro5 acquisition

Pharmaceutical Technology

JUNE 6, 2025

Can pharma tariffs “Make America Manufacture Again”? Give your business an edge with our leading industry insights.

Drugs

Drugs Clinical Trials Clinical Trials Life Science

The rise of GLP-1 drugs: Transforming weight loss treatment

Bio Pharma Dive

JUNE 23, 2025

Understanding GLP-1 drugs GLP-1, or glucagon-like peptide-1 receptor modulators, mimic natural hormones that regulate insulin and appetite. As these therapies develop, they exemplify the dynamic interplay between medicine, technology, and society’s evolving health needs.

Gene Therapy

Gene Therapy Drugs Gene Life Science

DoH – Abu Dhabi and Sanofi link for vaccine development

Pharmaceutical Technology

JUNE 20, 2025

Sanofi recently agreed to purchase Blueprint Medicines at an equity valuation of $9.1bn in a strategic move to strengthen its portfolio in the immunology domain with the addition of therapies for rare diseases. Can pharma tariffs “Make America Manufacture Again”? Sign up for our daily news round-up!

Vaccination

Vaccination Vaccine Development Manufacturing

SpliceBio secures $135m for gene therapy development

Pharmaceutical Technology

JUNE 12, 2025

SB-007 has received clearance from the Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) to enter clinical development. Can pharma tariffs “Make America Manufacture Again”? GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate?

Gene Therapy

Gene Therapy Gene Development Clinical Trials

Enterome to advance EO2463 immunotherapy with $19m funding

Pharmaceutical Technology

JUNE 12, 2025

Can pharma tariffs “Make America Manufacture Again”? Give your business an edge with our leading industry insights.

Clinical Trials

Clinical Trials Clinical Trials Trials Manufacturing

Navigating uncertainty: the future of vaccine oversight amid CDC firings

Pharmaceutical Technology

JUNE 25, 2025

Find out more Kennedy defended his choices, stating that the new committee members are dedicated to evidence-based medicine and will demand rigorous safety and efficacy data before making new vaccine recommendations. Can pharma tariffs “Make America Manufacture Again”? Give your business an edge with our leading industry insights.

Vaccination

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Mosanna Therapeutics gains $80m to advance OSA nasal spray

Pharmaceutical Technology

JUNE 10, 2025

Can pharma tariffs “Make America Manufacture Again”? Give your business an edge with our leading industry insights.

Clinical Trials

Clinical Trials Clinical Trials Life Science Manufacturing

Actio gains $66m to advance small molecule therapeutics pipeline

Pharmaceutical Technology

JUNE 19, 2025

The US regulator has granted orphan drug, fast track and rare paediatric drug designations to the therapy. Can pharma tariffs “Make America Manufacture Again”? Actio is progressing this therapy through the healthy volunteer phase of a Phase I trial and aims to move into a Phase Ib trial in individuals with TRPV4+ CMT2C in 2026.

Clinical Trials

Clinical Trials Clinical Trials Manufacturing Trials

EC authorises Sydnexis’ paediatric myopia treatment

Pharmaceutical Technology

JUNE 6, 2025

Following a positive opinion received in April 2025 from the European Medicines Agency’s Committee for Medicinal Products for Human Use, Japan-based eye health company Santen obtained the rights to commercialise the therapy under the brand name Ryjunea in Europe and the Middle East and Africa region.

Clinical Trials

Clinical Trials Clinical Trials Manufacturing Trials

Harbour BioMed partners Otsuka on new T-cell therapy

Pharmaceutical Technology

JUNE 23, 2025

Can pharma tariffs “Make America Manufacture Again”? Give your business an edge with our leading industry insights.

Gene Therapy

Gene Therapy Manufacturing Clinical Trials Clinical Trials

Gilead eyes Kymera’s ‘adhesive’ cancer drug in $750m deal

Pharmaceutical Technology

JUNE 25, 2025

Can pharma tariffs “Make America Manufacture Again”? Give your business an edge with our leading industry insights.

Drugs

Drugs Clinical Trials Clinical Trials Protein

BioOrbit eyes 2026 for pre-clinical trials of space manufactured protein crystals

Pharmaceutical Technology

JUNE 19, 2025

After that, it will be about compliance and regulation, as we must ensure that all our processes adhere to pharma regulations. Regulation has not been done in a space environment before, so we recognise we’ve got some hurdles to jump through, but these conversations are starting and that is exciting.”

Clinical Trials

Clinical Trials Clinical Trials Manufacturing Protein

The European Market Access Lag: 2021–2024

Pharmaceutical Technology

JUNE 9, 2025

Analysis includes innovative medicines with approved indications or indication extensions that were reimbursed since 2021. Factors assessed include the ratio of approved medicines to those that are reimbursed, volume of products reimbursed per year, and time to pricing and reimbursement. Patient profiles were counted distinctly.

Marketing

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FDA approves label updates for BMS’ CAR T cell therapies

Pharmaceutical Technology

JUNE 27, 2025

Give your business an edge with our leading industry insights.

FDA Approval

FDA Approval Gene Therapy Clinical Trials Clinical Trials

EC approves argenx’s efgartigimod alfa for CIDP treatment

Pharmaceutical Technology

JUNE 23, 2025

Can pharma tariffs “Make America Manufacture Again”? Give your business an edge with our leading industry insights.

Manufacturing

Manufacturing Clinical Trials Clinical Trials Marketing

Lisata collaborates with GATC Health on drug development

Pharmaceutical Technology

JUNE 18, 2025

Can pharma tariffs “Make America Manufacture Again”? Give your business an edge with our leading industry insights.

Development

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Ethris and Thermo Fisher partner on mRNA solutions

Pharmaceutical Technology

JUNE 16, 2025

The partnership aims to accelerate the progression of candidate mRNA medicines from research to clinical proof-of-concept. Can pharma tariffs “Make America Manufacture Again”? Go deeper with GlobalData Reports NPVM: Moderna Incs mRNA-1010 Reports NPVM: Moderna Incs mRNA-1647 Data Insights The gold standard of business intelligence.

Manufacturing

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Novo Nordisk signs $812m research deal with Deep Apple for non-GLP-1 drugs

Pharmaceutical Technology

JUNE 12, 2025

Novo Nordisk is developing a range of potential oral medicines for cardiometabolic diseases across modalities and targets, as we know that people living with these diseases have different needs and preferences,” said Jacob Sten Petersen, senior vice president of diabetes, obesity and MASH therapeutic area at Novo Nordisk.

Research

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