Thu.Apr 03, 2025

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Roche halts testing of Sarepta Duchenne gene therapy in Europe

Bio Pharma Dive

The Swiss drugmaker, which holds European rights to Elevidys, suspended three trials while researchers investigate the death of a young man who died following treatment.

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AZmed’s AZchest Receives Two FDA Clearances for AI-Powered Software Applications

XTalks

European AI med tech company AZmed received two new FDA clearances for its AI-powered chest X-ray tool, AZchest. The FDA approved AZchest applications to detect lung nodules and triage cases involving pneumothorax and pleural effusion. The applications offer radiologists improved interpretation and detection of these chest X-ray abnormalities. AZchest, a clinically validated AI radiology solution, automatically identifies, classifies and generates reports on key cardiac and pulmonary abnormaliti

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FDA misses approval deadline for Novavax’s COVID-19 vaccine

Bio Pharma Dive

The delayed decision comes amid a major organizational shakeup that included the departure of top vaccine official Peter Marks.

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AMMOI general secretary Dr Ramanathan elected as director board member of Ayushexcil

AuroBlog - Aurous Healthcare Clinical Trials blog

The Kerala based Ayurveda Medicine Manufacturers Organisation of India (AMMOI) has got a chair in the administrative committee of the Ayush Export Promotion Council (Ayushexcil ) with the election of its general secretary Dr. D Ramanathan as one of the board of directors.

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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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Biotech ‘megarounds’ hold steady as startups, VCs wait on IPOs

Bio Pharma Dive

More than three-quarters of private biotech investment tracked by BioPharma Dive between January and March was distributed via rounds worth at least $100 million, which experts believe reflects a strategic shift.

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Lilly’s Lepodisiran Achieves Over 90% Reduction in Heart Disease Marker in Phase II Trial

XTalks

Eli Lilly shared new Phase II trial data showing that its experimental siRNA therapy, lepodisiran, leads to reductions in levels of lipoprotein(a) (Lp(a)) a genetically inherited risk factor for heart disease in adults with elevated levels of the marker. In the Phase II ALPACA trial, a single 400 mg dose of lepodisiran led to an average decrease of 93.9% in Lp(a) levels over the 60- to 180-day period after treatment compared to placebo, meeting the trials primary endpoint.

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AI in Pharma Brand Planning: Insights from Our Latest Survey

Intouch Solutions

Artificial Intelligence (AI) is revolutionizing various industries, and pharma is no exception. However, despite its potential, more than half (55%) of pharma brand planning executives are concerned about their companys digital capabilities, especially generative AI. A recent article from Marketing & Pharma highlights the findings from EVERSANAs third-annual brand planning survey and the role AI plays in brand planning.

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IO360 Summit: Improving CAR-T cell therapy manufacture and accessibility

Pharmaceutical Technology

If preclinical findings were translated into the clinic, they could shorten the CAR-T generation lead time from two weeks to one day.

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Germany will reimburse haemophilia gene therapy Hemgenix

pharmaphorum

Germany has agreed to reimburse CSL Behring's haemophilia B gene therapy Hemgenix with a unique outcomes-based payment model

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Neurona raises $102m to advance cell therapy for drug-resistant epilepsy

Pharmaceutical Technology

Neurona will kick start a Phase III trial in H2 2025 investigating NRTX-1001 in patients with a type of drug-resistant epilepsy.

Drugs 130
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Elekta and Azra AI partner to advance cancer registry operations with AI

Pharma Times

Collaboration introduces automation to enhance efficiency

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Atsena closes $150m in Series C round to progress gene therapy

Pharmaceutical Technology

Atsena Therapeutics has completed an oversubscribed Series C financing round, raising $150m to support the advancement of ATSN-201.

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BeiGene abandons TIGIT antibody after lung cancer flop

pharmaphorum

BeiGene has decided to stop the development of its TIGIT-targeting drug ociperlimab in yet another setback for the drug class

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ABPI calls on UK Government to resolve “VPAG crisis”

Pharmaceutical Technology

UK Government drug sale clawbacks must be eased for pharma innovation to meet its ten-year plan, say industry representatives.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Novartis gets FDA nod for second of three IgAN drugs

pharmaphorum

Novartis has claimed accelerated approval in the US for Vanrafia, one of a trio of drugs it hopes will revolutionise the treatment of IgA nephropathy.

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Weight loss implants to increase compliance and cut admin burden for patients

Pharmaceutical Technology

Reduced frequency is very encouraging for patient compliance and could help those who dislike weekly injections and self-administration.

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PAP 2025: Establishing and Transitioning to a Foundation

Pharmaceutical Commerce

In the first part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Rachel Thorpe, executive director at the Otsuka Patient Assistance Foundation, describes the various conference sessions that she participated in.

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Astellas Pharma and JFCR partner for oncology research

Pharmaceutical Technology

Astellas Pharma has entered a strategic partnership with the JFCR to expedite research in translational and clinical oncology.

Research 130
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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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The Growing Role of DTC Healthcare

Pharmaceutical Commerce

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Colin Banas, MD, DrFirsts chief medical officer, explains the rise in patients turning to DTC platforms following insurance denials.

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The role of thin-layer chromatography (TLC) and high-performance liquid chromatography (HPLC) in modern pharmaceutical and herbal drug analysis

Pharmaceutical Technology

Thin-layer chromatography (TLC) is a valuable tool, particularly in the analysis of herbal medicines and traditional remedies.

Medicine 130
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Pharma Pulse 4/3/25: Analyzing the Theranos Appeals, Current CAR-T Therapy Trends in Managed Care & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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FDA grants accelerated approval to Novartis’ Vanrafia for IgAN

Pharmaceutical Technology

The FDA has granted accelerated approval to Novartis Vanrafia for adults with primary immunoglobulin A nephropathy (IgAN).

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Multiple studies of Sarepta's DMD therapy halted after death

pharmaphorum

Three studies of Sarepta's Elevidys Duchenne gene therapy have been placed on hold as the death of a 16-year-old boy is investigated

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Woman’s Brain Implant Turns Her Thoughts Into Speech in Real Time

AuroBlog - Aurous Healthcare Clinical Trials blog

(Mehau Kulyk/SPL/Getty Images) Nearly two decades after suffering a brainstem stroke at the age of 30 that left her unable to speak, a woman in the US regained the ability to turn her thoughts into words in real time thanks to a new brain-computer interface (BCI) process.

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IO360 summit: CAR-T cell therapy applications beyond blood cancer

Pharmaceutical Technology

Recent innovations include engineering CAR T-cells to overcome the immunosuppressive tumour microenvironment.

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Grand Rounds March 28, 2025: A Cross-Sectional Study of GPT-4–Based Plain Language Translation of Clinical Notes to Improve Patient Comprehension of Disease Course and Management (Anivarya Kumar, BA; Matthew Engelhard, MD, PhD)

Rethinking Clinical Trials

Speakers Anivarya Kumar, BA Fourth-Year Medical Student Duke University School of Medicine Matthew Engelhard, MD, PhD Assistant Professor, Department of Biostatistics & Bioinformatics Duke University School of Medicine Slides Keywords Health Literacy; Large Language Models; Artificial Intelligence; Electronic Health Records Key Points Limited health literacy (HL) has tangible effects on morbidity and mortality: its associated with higher rates of hospital admissions a

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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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Indian pharma prioritizes skilled workforce proficient in techy & regulatory compliance to meet evolving market needs

AuroBlog - Aurous Healthcare Clinical Trials blog

Indian pharmaceutical sector demands a highly skilled workforce proficient in technology, data science, and regulatory compliance. This is because as the global pharma and life sciences landscape evolves rapidly, hiring trends and talent retention strategies have emerged as key priorities.

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European Commission approves ustekinumab for paediatric Crohn’s disease

Pharma Times

Approval extends ustekinumabs use to younger patients

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While FDA Suffers Staffing Cuts, Nondelegation Case in SCOTUS Is Latest Legal Challenge to Curb Agency Powers

FDA Law Blog

By John W.M. Claud & JP Ellison Last June, the United States Supreme Court issued four landmark decisions that curbed executive agency powers. Those decisions are changing the way agencies, including FDA, exercise their rulemaking and enforcement authorities. Regardless your position on the correctness of the holdings or the reasoning behind them, Loper Bright , Jarkesy , EPA v.

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Oz confirmed by Senate to lead CMS

Bio Pharma Dive

Mehmet Oz, a physician and TV personality, takes office as HHS lays off thousands of staffers and Republicans float potential cuts to Medicaid.

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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