Tue.Jan 30, 2024

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CAR-T for lupus: the ‘tip of the iceberg’ for cell therapy in autoimmune disease

Bio Pharma Dive

Since a landmark paper in 2022, drugmakers have begun nearly a dozen trials of cell therapies for lupus, with more set to start. Here’s why their efforts are worth watching.

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GSK seeks to extend RSV vaccine use in adults aged 50-59

Pharmaceutical Technology

The EMA has accepted GSK’s regulatory application seeking expansion of its RSVvaccine, Arexvy, to include adults aged 50 to 59 years.

Vaccine 264
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Non-opioid drug from Vertex cuts pain in major trial tests

Bio Pharma Dive

The company plans to soon ask the FDA for approval of the drug, which it has pitched as a safer alternative to addictive opioid painkillers.

Drugs 340
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Vertex aims for approval after Phase III win with non-opioid pain reliever

Pharmaceutical Technology

Vertex is planning to submit a new drug application to the FDA following the announcement of its Phase III programme meeting its primary endpoint.

Drugs 241
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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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Cour gets $105M, pharma help to ‘reprogram’ autoimmune disease

Bio Pharma Dive

Roche, Pfizer and Bristol Myers Squibb have all invested in the startup, which is using nanoparticle technology to retrain the body’s immune system.

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Aqemia wins $32.5m for generative AI-powered drug discovery platform

Pharmaceutical Technology

The funds secured by France-based biotech Aqemia, which partnered with Sanofi late last year, bring its Series A funding sum to $65m.

Drugs 147

More Trending

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International consortium identifies biomarkers for cardiovascular disease in diabetes

Pharma Times

Type 2 diabetes is estimated to affect 462 million people worldwide

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Gilead deepens investment in Arcus and TIGIT drugs

Bio Pharma Dive

The companies said the deal shows their “continued conviction in the TIGIT pathway,” an area of research that so far has not lived up to expectations.

Drugs 173
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Sanofi partners with Synthekine to develop IL-10 therapeutics

Pharmaceutical Technology

Synthekine will receive an upfront payment of $40 million for its preclinical cytokine engineering clinical expertise.

Engineer 130
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After 'bad launch' remark by CEO, Pfizer's RSV vaccine gains traction in Q4. How will it fare in latest round of GSK showdown?

Fierce Pharma

After 'bad launch' remark by CEO, Pfizer's RSV vaccine gains traction in Q4. How will it fare in latest round of GSK showdown?

Vaccine 126
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Setting up trials in APAC and Middle East can boost patient recruitment

Pharmaceutical Technology

Setting up trial sites in countries with unmet clinical needs can lead to higher patient recruitment, compared to established trial hubs.

Trials 130
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Amid strategic pivot, 2seventy bio plots comeback for BMS-partnered CAR-T Abecma

Fierce Pharma

2seventy Bio has traveled a difficult path ever since it spun out from bluebird bio to work on cancer cell therapies. | 2seventy Bio has traveled a difficult path ever since it spun out from bluebird bio to work on cancer cell therapies. Now, the company is splitting in two once again, passing its R&D programs to Regeneron and going all-in on its Bristol Myers Squibb-partnered CAR-T Abecma.

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Transient expression of RNA for CAR T-cell therapies: An emerging opportunity for lipid nanoparticles

Pharmaceutical Technology

By enabling mRNA delivery for transient protein expression, lipid nanoparticles could address key challenges facing CAR T-cell therapies.

RNA 130
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People with chest pain more likely to develop heart and circulatory diseases

Pharma Times

Around one million adults in the UK visit their GP every year due to chest pain

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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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MHRA approves Napp Pharmaceuticals’ Rezzayo for invasive candidiasis

Pharmaceutical Technology

The UK MHRA has approved Napp Pharmaceuticals' new antifungal treatment for invasive candidiasis, Rezzayo (rezafungin).

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First human subject receives a Neuralink brain implant

pharmaphorum

Elon Musk’s Neuralink company has said it has implanted its wireless brain implant device into a human being for the first time

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FDA approves Takeda’s GAMMAGARD LIQUID to treat CIDP

Pharmaceutical Technology

The FDA has approved Takeda’s GAMMAGARD LIQUID for the treatment of adults with chronic inflammatory demyelinating polyneuropathy.

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Digital prescriptions added to NHS App

pharmaphorum

From today, a new feature added to the NHS App used in the UK will allow millions of people to submit and view prescriptions, in a bid to save time for patients and doctors. The digital prescription function, which does away with the need for paper scrip, was put through its paces in a pilot trial last year involving a million users of the app, now being used by three-quarters of the UK population or around 33.5 million people.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Gilead and Arcus Biosciences expand oncology partnership deal

Pharmaceutical Technology

Gilead Sciences and Arcus Biosciences have expanded their oncology partnership agreement and announced an equity investment.

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US bill paints some Chinese biotechs as security threats

pharmaphorum

Legislation filed in the US is seeking to block Chinese biotech companies from federal contracts on the grounds they are a national security concern

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Revolutionizing Patent Landscaping: A Human-Supervised AI Approach to Identify Tech Clusters

Drug Patent Watch

The recent paper published in PLOS ONE presents a novel approach for efficiently retrieving a substantial number of patents related to specific technologies. The authors enhance an automated patent landscaping… The post Revolutionizing Patent Landscaping: A Human-Supervised AI Approach to Identify Tech Clusters appeared first on DrugPatentWatch - Make Better Decisions.

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The future of pharmacovigilance – beginning the shift to AI-driven processes

pharmaphorum

Explore the future of pharmacovigilance as we begin to shift towards AI-driven processes. Learn about the advancements in AI models, the role of GenAI, and how experts are leveraging these technologies to improve drug safety and monitoring.

Drugs 111
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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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ICER would contribute to Medicare price negotiations under one condition, new president says

Fierce Pharma

With the Inflation Reduction Act's Medicare price negotiations moving ahead (PDF) rapidly, one party n | The price-negotiation component of the Inflation Reduction Act appears right up ICER’s alley. But the watchdog’s new president says there’s a condition that needs to be met for the organization to regularly contribute to the process.

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Getting down to the nitty gritty of actively creating healthier societies

pharmaphorum

In a new episode of the pharmaphorum podcast, host Nicole Raleigh speaks with Stuart Cooper, CEO of Adelphi Group, about Anthropy – a yearly event that aims to spark innovation and foster fresh thinking among diverse leaders – and about creating healthier societies, about biopharma’s role in that, including implementation of preventative methods in ameliorating global health.

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FDA rejects Defender Pharma's motion sickness nasal gel candidate

Fierce Pharma

A nasal gel version of the motion sickness drug scopolamine has failed to make the grade with the FDA. The U.S. | A nasal gel version of the motion sickness drug scopolamine has failed to make the grade with the FDA. The U.S. regulator has sent a complete response letter to Defender Pharmaceuticals, rejecting DPI-396 for the prevention of nausea and vomiting induced by motion.

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Vertex scores double win with non-opioid pain drug

pharmaphorum

Vertex Pharma says its much-anticipated non-opioid painkiller, VX-548, clears two phase 3 trials en route to an FDA filing later this year

Drugs 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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Stevanto Group tackling flexible drug containment packages and filling solutions

Outsourcing Pharma

Two new offerings have been unveiled by drug delivery and solutions provider, Stevanto Group S.p.A.

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How to achieve patient centricity in clinical trial listings

Antidote

Facilitating medical research relies on patient participation, yet research protocols often overlook the patient perspective. Improving patient centricity in clinical trials demands prioritizing the patient experience.

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Treatment approved for Hong Kong's second most common cancer

Outsourcing Pharma

With colorectal cancer (MRC) being the second biggest cancer type in Hong Kong, it is positive news that Hutchmed has received marketing approval for its Elunate (fruquintinib) small molecule treatment.

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Merck inks research deal with Culmination Bio to leverage ‘powerful’ patient data platform

BioPharma Reporter

Merck has signed a R&D collaboration deal with data and technology company Culmination Bio, a spinoff from Intermountain Health.

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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.