Tue.Feb 20, 2024

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Iovance, with approval of ‘TIL’ cell therapy, readies for complex launch

Bio Pharma Dive

The biotech set a price of roughly $515,000 per patient for its therapy Amtagvi, the first to be approved based on a decades-old technique of using tumor-infiltrating lymphocytes.

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IISc and BFI team up to maximise translational research projects

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian Institute of Science (IISc) and Blockchain For Impact (BFI) have teamed up to maximise translational research projects where the latter aims to allocate US$1 million. The collaboration, under the BFI-Biome Virtual Network Programme, will see BFI to support various research projects at the IISc.

Research 242
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Xolair amplifies reach after FDA approval for treating food allergies 

Pharmaceutical Technology

Xolair is the first FDA-approved drug to reduce allergic reactions in people with one or more food allergies, as per Roche’s announcement.

Allergies 236
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New ‘Prosthetic’ Hacks The Brain to Recall Specific Memories

AuroBlog - Aurous Healthcare Clinical Trials blog

Neuroscientists have ‘hacked’ the brain’s memory pathways with a new prosthetic system that could help improve the recollection of specific memories.

Research 222
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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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FDA puts hold on Rapt trials of drug for eczema, asthma

Bio Pharma Dive

Rapt reported one case of liver failure in a study participant who received the biotech’s drug, which is seen by analysts as a possible competitor to Dupixent.

Drugs 162
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Ultimovacs bags EMA orphan drug status for cancer vaccine

Pharmaceutical Technology

Following FDA orphan designation in 2023, the company is eligible for market exclusivity in mesothelioma for both regions.

Vaccine 147

More Trending

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Benzalkonium Chloride: How to overcome analytical challenges

Pharmaceutical Technology

We explore the challenges when conducting analytical testing of the popular preservative Benzalkonium Chloride.

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Here are 7 practical ways asynchronous advisory programs can make an impact in 2024

Bio Pharma Dive

Can asynchronous advisory programs can add distinct value to your strategic mix? Yes! Here's how.

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Singapore HSA accepts AffaMed’s NDA for ocular treatment

Pharmaceutical Technology

The Singapore HSA has accepted the new drug application (NDA) for AffaMed Therapeutics’ DEXTENZA to treat ocular inflammation and pain.

Drugs 130
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AbbVie’s Cerevel deal hits an uncommon roadblock

Bio Pharma Dive

A “second request” from the Federal Trade Commission could protract the timing of AbbVie’s proposed acquisition, which is slated to close around the middle of the year.

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

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US FDA accepts review of argenx’s VYVGART Hytrulo for CIDP

Pharmaceutical Technology

The US FDA has accepted for priority review argenx's sBLA for VYVGART Hytrulo to treat chronic inflammatory demyelinating polyneuropathy.

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Rick Gonzalez, longtime AbbVie CEO, to step down in July

Bio Pharma Dive

The veteran executive, who guided AbbVie through its separation from Abbott Laboratories, will be succeeded by Chief Operating Officer Robert Michael.

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Pfizer’s VELSIPITY receives EC approval for ulcerative colitis

Pharmaceutical Technology

Pfizer has obtained marketing authorisation from the European Commission (EC) for VELSIPITY to treat ulcerative colitis (UC).

Marketing 130
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Daiichi Sankyo plots €1B expansion to beef up antibody-drug conjugate production in Germany

Fierce Pharma

After laying out plans to absorb a pair of production subsidiaries in October, Japan’s Daiichi Sankyo is doubling down on its quest to dominate the red-hot antibody-drug conjugate (ADC) field. | Aiming to beef up development and manufacturing of antibody-drug conjugates, Daiichi Sankyo is plugging roughly €1 billion ($1.08 billion) into an expansion of its production facility in Pfaffenhofen an der Ilm, Germany.

Antibody 129
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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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AstraZeneca completes Icosavax acquisition for $1.1bn

Pharmaceutical Technology

AstraZeneca has concluded the acquisition of clinical-stage biopharmaceutical company Icosavax in a $1.1bn deal.

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AstraZeneca gets new Tagrisso OK as drug succeeds in another trial

Bio Pharma Dive

The FDA approved the targeted therapy together with chemo for first-line metastatic lung cancer, while fresh trial results supported earlier use.

Trials 124
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Researchers develop nanogel to deliver anti-inflammatory drugs for spinal cord injury

Pharma Times

The nanogels, in combination with rolipram, contributed to the recovery of injured tissue

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Touting commercial and R&D progress, AstraZeneca hikes CEO Pascal Soriot's pay to nearly £17M

Fierce Pharma

AstraZeneca, having surpassed its long-term $45 billion revenue goal last year, has handsomely rewarded its chief executive. | AstraZeneca CEO Pascal Soriot’s compensation package makes him the current top contender for 2023’s highest-paid pharma CEO in Europe. Still, as in years past, not everyone is pleased with Soriot’s 2023 windfall.

Packaging 119
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA starts review of Argenx drug in rare disease CIDP

pharmaphorum

The FDA has said it plans to deliver a decision in June on the use of Argenx’ Vyvgart Hytrulo in rare autoimmune disease chronic inflammatory demyelinating polyneuropathy (CIDP).

Drugs 116
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Another tough decision for Bayer as it plans to slash dividend by 95% to reduce debt

Fierce Pharma

Since he took over as CEO at Bayer nine months ago, Bill Anderson had had to make tough decisions to try to get the floundering conglomerate back on track. | Bayer plans to cut its investor dividends to help reduce the company’s debt. Over three years, Bayer intends to pay out the legal minimum. For 2023, that comes to €0.11 per share compared to the €2.40 the company paid out per share in 2022.

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Pfizer’s ulcerative colitis drug Velsipity gets EU okay

pharmaphorum

The European Commission has approved Pfizer’s S1P receptor modulator Velsipity as a treatment for ulcerative colitis (UC), raising the pressure on Bristol-Myers Squibb’s first-to-market Zeposia.

Drugs 115
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AbbVie CEO telegraphs retirement and prepares to pass baton to long-time deputy Robert Michael

Fierce Pharma

On AbbVie’s latest earnings call, analysts were curious whether long-time CEO Richard Gonzalez was weighing a succession plan now that Humira’s loss of U.S. exclusivity has passed. | Robert Michael, AbbVie’s current president and chief operating officer, has been tapped by the company’s board of directors to take over Richard Gonzalez’s CEO post on July 1.

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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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Bayer takes novel deep vein thrombosis drug into phase 2

pharmaphorum

Bayer takes anti-alpha2 antiplasmin antibody BAY3018250 into phase 2 as a deep vein thrombosis treatment, hoping to improve on thrombolytics.

Antibody 115
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New initiative to improve patient retention in paediatric clinical trials

Pharma Times

The new programme will engage with children and young people under the age of 18 years

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Bioptimus is born with $35m for foundation model for biology

pharmaphorum

Google DeepMind and Owkin scientists have joined forces to create Bioptimus, an AI startup that aims to develop a foundation model for biology

Scientist 115
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Patients with treatment-resistant depression sought for trial of psychedelic drug

Outsourcing Pharma

Some forms of depression cannot be cured by current treatments including antidepressants or going to psychological counselling or psychotherapy.

Trials 103
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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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Patient feedback is creating next-gen drug delivery devices

pharmaphorum

Patient feedback is driving innovation in next-generation drug delivery devices, improving patient adherence and experience. Learn how these advancements are shaping the future of healthcare.

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FDA Accepts Biologics License Application for Datopotamab Deruxtecan

Pharmaceutical Commerce

The agency will make its final decision surrounding the locally advanced or metastatic nonsquamous NSCLC drug —based on results from the TROPION-Lung01 Phase III trial—by Q4 2024.

Licensing 101
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How transparent is the VPAG?

pharmaphorum

Learn about the transparency of the Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG) regarding medicines pricing and the Association of the British Pharmaceutical Industry (ABPI). Explore how these factors impact the pharmaceutical industry.

Branding 105
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Grand Rounds February 16, 2024: Clinical Implications of the MINT Trial: p=0.07 (Jeffrey Carson, MD, MACP)

Rethinking Clinical Trials

             Speaker Jeffrey Carson, MD, MACP Principal Investigator and Study Chair MINT Trial Provost-New Brunswick, Rutgers Biomedical Health Sciences Distinguished Professor of Medicine Richard C. Reynolds, M.D. Chair in General Internal Medicine Rutgers, Robert Wood Johnson Medical School Keywords Transfusion; MI; MINT; Anemia; Clinical trials Key Points Anemia is common in patients with acute MI.

Trials 100
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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.