Mon.Nov 11, 2024

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Managing Drug Patent Portfolios Effectively

Drug Patent Watch

Effective management of drug patent portfolios is crucial for pharmaceutical companies to maintain market exclusivity, protect revenue streams, and drive innovation. A robust patent strategy aligned with business goals is essential for maximizing value and staying competitive in the pharmaceutical landscape.

Drugs 88
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On Wall Street, ‘flat out’ failure of AbbVie schizophrenia drug leaves analysts stunned

Bio Pharma Dive

Negative drug results cost AbbVie billions of dollars in market value and convinced analysts that Bristol Myers had placed a better bet in buying Karuna Therapeutics.

Drugs 323
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Autolus secures FDA approval for CAR-T cell therapy use in ALL  

Pharmaceutical Technology

Aucatzyl is the first CAR-T cell therapy approved by the FDA with no requirement for a risk evaluation mitigation strategy (REMS) programme.

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FDA approves new CAR-T competitor to Gilead’s Tecartus

Bio Pharma Dive

Developer Autolus set a list price of $525,000 for its new cell therapy, which it will sell for a type of leukemia under the brand name Aucatzyl.

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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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Pharmaceutical Technology Excellence Awards 2024: BostonGene 

Pharmaceutical Technology

BostonGene is a winner in four categories in the 2024 Pharmaceutical Technology Excellence Awards.

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FDA lifts pause on Novavax flu vaccine trials

Bio Pharma Dive

After an investigation, the agency concluded that a case of muscle weakness in one of Novavax’s trials was actually ALS and unrelated to vaccination.

More Trending

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AbbVie’s $9B bet collapses as closely watched schizophrenia drug fails studies

Bio Pharma Dive

Shares in AbbVie slumped Monday after the company disclosed its psychiatric medicine emraclidine didn’t best placebo in two Phase 2 trials.

Medicine 154
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There’s a Critical Thing We Can Do to Keep Alzheimer’s Symptoms at Bay

AuroBlog - Aurous Healthcare Clinical Trials blog

PET scans were used to measure protein levels in the brain. (JohnnyGreig/Getty Images) Deep sleep could be key to forestalling slow declines in brain health that may one day lead to Alzheimer’s disease, the most common form of dementia.

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Cigna confirms it is not pursuing Humana acquisition

Bio Pharma Dive

The formal denial comes after Cigna CEO David Cordani tried to push back on persistent speculation of a Humana merger earlier this fall.

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AlloVir and Kalaris enter merger to advance retinal disease therapies

Pharmaceutical Technology

AlloVir has entered into a definitive agreement for the acquisition of the complete outstanding shares of Kalaris Therapeutics, to create a new entity focused on developing therapies for retinal diseases.

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

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Thinking inside the box: How SmartLabs is driving new collaborations to support the life science industry in global innovation hubs

Bio Pharma Dive

Seamlessly scale and adapt to match the rapid pace and complexity of modern science.

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Gamma delta T cells explained: The next medical breakthrough?

Pharmaceutical Technology

We explore the immense potential of gamma delta T cells, and the challenges in sourcing and scaling up sufficient volumes to treat patients.

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7 steps to selecting the right global central lab

Bio Pharma Dive

Unlock global clinical trial success with seamless sample logistics and standardized testing.

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FDA delays priority review of Neurotech’s eye cell therapy implant

Pharmaceutical Technology

The US regulatory agency has pushed the PDUFA date by three months to 18 March 2025 to “allow for more time to review additional data”.

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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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Fueling accelerated drug development in autoimmune diseases with a modality-agnostic approach

Bio Pharma Dive

Innovation-without-borders philosophy seeks to bring forward only the most promising therapies.

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How to adapt to choppy waters in biotech ecosystem

Pharmaceutical Technology

At the Outsourcing in Clinical Trials Conference in New England, experts shared ways to operate in a difficult clinical trials ecosystem.

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Scottish medicines consortium approves CAR T-cell therapy for blood cancer

Pharma Times

First car t-cell therapy accepted for second-line treatment in Scotland

Medicine 127
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Dizal seeks FDA approval for NSCLC treatment sunvozertinib

Pharmaceutical Technology

Dizal has submitted sunvozertinib’s new drug application (NDA) to the US Food and Drug Administration (FDA) aiming to secure approval for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (exon20ins) mutations.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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AI tool spots long COVID in electronic health records

pharmaphorum

Mass General Brigham researchers have developed an AI that can spot hidden cases of long COVID from electronic health records

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SMC recommends Yselty for treating uterine fibroids

Pharma Times

New treatment option approved for women in Scotland

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The evolving role of AI in drug submission and approval: An expert perspective

pharmaphorum

Discover an expert perspective on how artificial intelligence is transforming the drug submission and approval process in the pharmaceutical industry. Explore the evolving role of AI in drug development.

Drugs 114
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World AMR Awareness Week 2024: New Antimicrobial Resistance Research

XTalks

World Antimicrobial Resistance Awareness Week 2024, observed from November 18 to 24, 2024, centers on the theme “Educate. Advocate. Act now.” This theme addresses antimicrobial resistance (AMR), a critical issue where bacteria, viruses, fungi and parasites develop resistance to treatments, making infections harder — or sometimes impossible — to treat effectively.

Research 104
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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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Autolus readies its CAR-T Aucatzyl to go after heavy hitter competition following FDA nod

Fierce Pharma

Watch out, Gilead and Novartis: there's a new CAR-T in town. | Autolus' Aucatzyl has become the first CAR-T approved by the FDA without a REMS mandate. And the company is ready to hit the ground running, facing Gilead and Novartis as its competitors.

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Autolus bags FDA approval for leukaemia cell therapy

pharmaphorum

Autolus gets its first product approval, an FDA green light for anti-CD19 CAR-T Aucatzyl for B-cell acute lymphoblastic leukaemia

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LogiPharma Europe to Celebrate 25 Years

Pharmaceutical Commerce

The conference returns to Lyon, France and promises a timely and relevant agenda that attendees will resonate with.

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Advantage BMS as AbbVie drug fails schizophrenia trials

pharmaphorum

AbbVie's $8.7bn play for Cerevel looks like a poor bet as its lead schizophrenia drug flunks two phase 2 trials, but which rival stands to benefit?

Trials 86
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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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Pharma Pulse 11/11/24: Advertising/Marketing Trends to Expect in Q1 of 2025, Understanding the Burnout Crisis & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Unicycive eyes June FDA verdict for hyperphosphataemia drug

pharmaphorum

FDA starts review of Unicycive's drug for hyperphosphataemia in patients with chronic kidney disease on dialysis, aiming to improve on onerous phosphate binder therapy

Drugs 83
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High Blood Pressure Research Study Seeks Healthy Individuals!

Trialfacts

Contents About the Study Why Participate? Your Rights Who Can Participate? More Study Details Study Location Research Center: Dynocardia, Inc Location: 1188 Centre Street, Second Floor, Newton Center, 02459 Lead Researcher: Mohan Thanikachalam, MD IRB: This study has been reviewed and approved by the WCG Institutional Review Board About the Study Are you generally healthy?

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Building Supply Chain Visibility

Pharmaceutical Commerce

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jonathan Colehower, managing director, global operations & supply chain practice at UST, offers his observations as to how stakeholders are building out their networks.

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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.