Tue.Jun 11, 2024

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Ipsen drug for rare liver disease approved by FDA

Bio Pharma Dive

The medicine will join Intercept’s Ocaliva as a treatment option for primary biliary cholangitis. Another drug, from the now Gilead-owned CymaBay, could be cleared for the condition by August.

Drugs 290
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AstraZeneca Tagrisso sNDA gains FDA priority review for lung cancer

Pharmaceutical Technology

AstraZeneca's sNDA for Tagrisso has obtained FDA priority review for unresectable, Stage III EGFRm non-small cell lung cancer.

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ADCs are in focus. Here’s where AstraZeneca, AbbVie hope to take the field next.

Bio Pharma Dive

Newer components and drug combinations could expand use of the targeted cancer medicines, according to company executives.

Medicine 278
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June 11, 2024: Many Older Participants in Acupuncture Research Have Prior Acupuncture Experience, BackInAction Data Suggest

Rethinking Clinical Trials

Dr. Andrea Cook and Dr. Lynn DeBar, principal investigators of BackInAction Many older adults who participate in acupuncture research may have prior experience with acupuncture, according to an analysis of data from the BackInAction trial. The finding has implications for the design and conduct of future pragmatic clinical trials involving acupuncture.

Research 147
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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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Donanemab approval would fuel growth of amyloid-blocking Alzheimer’s drugs, analysts say

Bio Pharma Dive

After an FDA panel backed the experimental Lilly drug, Wall Street analysts see its likely clearance as benefiting Eisai and Biogen’s rival Leqembi.

Drugs 182
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Kyowa Kirin invests $530m in new US biologics manufacturing facility

Pharmaceutical Technology

Kyowa Kirin has received approval from its board of directors to invest $530m to establish a new biologics plant in Sanford, NC, US.

More Trending

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Tailor-made Solution for Collagenase

Pharma Mirror

By Michael von Papen, Chief Expert at Pharmatec GmbH – a Syntegon Company When a leading global collagenase manufacturer wants to renew and optimize a system at the heart of its production, technical expertise, and engineering competence is paramount. Moreover, cooperation within the project team needs to be well organized. Nordmark and Pharmatec, a subsidiary of Syntegon, have shown how this helps to master even unexpected challenges during the construction of a new filtration and concent

Engineer 130
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AstraZeneca champions early kidney disease diagnosis with modelling data

Pharmaceutical Technology

Early diagnosis of chronic kidney disease has both economic and environmental benefits, according to AstraZeneca’s Mina Makar.

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After M&A stretch, Pfizer CEO says company needs 'breathing period' from large deals

Fierce Pharma

Amid a recent biopharma M&A resurgence, one major player plans to stay out of the waters after making multiple recent splashes. | Though not for lack of business development capacity, Pfizer is currently taking a large dealmaking “breathing period,” CEO Albert Bourla told investors this week at Goldman Sachs’ 2024 annual Global Healthcare Conference in Miami.

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J&J-backed Bright Peak secures $90m to advance immunoconjugate programme

Pharmaceutical Technology

The funds will be used to advance PD1-IL18 immunoconjugate BPT567 into early-stage trials for solid tumours.

Trials 130
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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3rd to 7th June – This week in clinical trials

pharmaphorum

Get the latest updates on clinical trials from 3rd to 7th June involving companies like uniQure, Takeda, Otsuka, CatalYm, Agios, and Transgene. Stay informed on the latest developments in the field.

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UK clinical trial sector must address subpar timelines, say experts

Pharmaceutical Technology

Experts highlighted the need to address a gap in UK regulatory timelines compared to international standards.

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US researchers develop AI liquid biopsy test to help identify lung cancer earlier

Pharma Times

The leading cause of cancer globally accounts for an estimated 1.

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Tacalyx extends seed funding round to raise over €14m

Pharmaceutical Technology

Cancer-focused biotech Tacalyx has extended its seed financing round to raise over €14m ($15.03m).

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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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LucyTx announces additional $12.5m research funding for neurological diseases

Pharma Times

Alzheimer’s and Parkinson’s disease are responsible for more than 30 million cases globally

Research 119
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Ultragenyx Pharmaceutical gets grant for method of protecting aav viral particles during heat inactivation

Pharmaceutical Technology

Protect AAV viral particles with Ultragenyx's patented heat inactivation method. Learn how specific buffers preserve genomic integrity and biological activity.

Genome 130
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Gilead forks over $40M to settle thousands of claims in web of litigation over alleged delay of safer HIV meds

Fierce Pharma

As Gilead Sciences awaits the progression of California state litigation over its alleged delay of safer HIV drugs, the company is biding its time with a proposed $40 million settlement t | More than 2,000 plaintiffs accused the HIV drugmaker of purposely waiting to launch safer TAF-based meds in the early 2000s in order to maximize profits from its older TDF-based products.

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Purdue Pharma gets grant for tamper resistant opioid analgesic extended release dosage form

Pharmaceutical Technology

Discover Purdue Pharma's innovative tamper-resistant opioid analgesic dosage form with extended release properties. Learn about the patented solid oral form designed for controlled drug release and enhanced safety in medication administration.

Drugs 130
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA wants to make the home a healthcare hub

pharmaphorum

The FDA is exploring ways to transform the home into a healthcare hub, bringing healthcare services closer to individuals. This article discusses the potential impact of this trend on the future of healthcare.

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Kineta gets grant for compounds for treating proteostasis dysfunction

Pharmaceutical Technology

Discover Kineta Inc's groundbreaking patent for compounds targeting proteostasis dysfunction. Learn about the specific chemical structures, pharmaceutical compositions, and methods for treating various conditions, including cancer symptoms. US Patent Publication Number: US11958873B2.

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Lilly’s Alzheimer’s drug set to join Leqembi after FDA vote

pharmaphorum

An FDA advisory committee has delivered a strong endorsement to Eli Lilly’s Alzheimer’s disease therapy donanemab, voting unanimously that the safety and efficacy of the amyloid-busting drug support its approval. The independent advisors on the Peripheral and Central Nervous System Drugs Advisory Committee voted by 11 to zero that donanemab’s benefits outweigh its risks, and by the same margin that the data submitted by Lilly to support its efficacy was convincing.

Drugs 115
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United Laboratories International gets grant for method for removing contaminant material from oil and gas equipment

Pharmaceutical Technology

Discover a patented method for removing contaminant material from oil and gas industrial equipment using a unique solvent composition. Learn more about this innovative approach in the recently granted patent US11946021B2.

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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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Don’t sweat an FDA sIRB mandate in clinical research – It’s good news for everyone

pharmaphorum

The FDA's Single Institutional Review Board (sIRB) mandate is good news for clinical research. Learn more about how this mandate benefits everyone involved in the clinical research process.

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Syros Pharmaceuticals gets grant for CDK7 inhibitors for treating cancer and other diseases

Pharmaceutical Technology

Discover how Syros Pharmaceuticals' patented compounds inhibit CDK7, inducing cellular apoptosis and treating diseases like cancer and ALS.

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FDA clears Ipsen’s primary biliary cholangitis drug

pharmaphorum

Ipsen has been given accelerated approval by the FDA for Iqirvo, which becomes the dual PPAR alpha/delta agonist for rare cholestatic liver disease primary biliary cholangitis (PBC).

Drugs 114
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Silence Therapeutics gets grant for compound for rna interference therapy in treating liver disease

Pharmaceutical Technology

Discover the groundbreaking patent by Silence Therapeutics Plc for a compound revolutionizing RNA interference therapy. Learn how formula (II) is paving the way for targeted treatment of liver disease and genetic disorders.

RNA 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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EU orders bird flu vaccine supplies from CSL Seqirus

pharmaphorum

CSL Seqirus will provide 665,000 doses of bird flu vaccine to the European Commission to protect at-risk workers and guard against a potential outbreak

Vaccine 114
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BioMarin Pharmaceutical gets grant for treatment of adolescent PKU patients using avpal variant

Pharmaceutical Technology

Reduce blood phenylalanine levels in adolescents with PKU using AvPAL variants. A detailed patent outlines a method involving weekly doses over 50 weeks for subjects aged 12-17, with dosage adjustments for optimal results.

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Ipsen, Genfit gain FDA approval for Iqirvo in liver disorder, teeing up Intercept showdown

Fierce Pharma

Once hyped as a potential blockbuster medicine for metabolic-associated steatohepatitis (MASH), Ipsen and Genfit’s elafibranor has found its calling as a treatment for a lower-profile liver disorde | Once hyped as a potential blockbuster medicine for metabolic-associated steatohepatitis (MASH), Ipsen and Genfit’s elafibranor has found its calling as a treatment for a lower-profile liver disorder.

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Piramal Enterprises gets grant for pharmaceutical kit for cancer treatment with CDK and antioxidant

Pharmaceutical Technology

Discover the groundbreaking patent by Piramal Enterprises Ltd for a pharmaceutical kit combining CDK and antioxidant enzyme inhibitors to revolutionize cancer treatment. Learn more about this innovative therapy now!

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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.