Wed.Nov 27, 2024

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Airways unbound: The biologic revolution in asthma treatment  

Pharmaceutical Technology

In recent years, the evolution of biologic therapies for severe asthma has paralleled advancements in other chronic conditions such as rheumatoid arthritis and psoriasis, where biologics have also transformed treatment paradigms.

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A Common Blood Pressure Drug Extends Lifespan And Slows Aging in Animals

AuroBlog - Aurous Healthcare Clinical Trials blog

The hypertension drug rilmenidine has been shown to slow down aging in worms, an effect that in humans could hypothetically help us live longer and keep us healthier in our latter years. Previous research has shown rilmenidine mimics the effects of caloric restriction on a cellular level.

Drugs 171
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Digital transformation expected to shorten drug development timelines

Pharmaceutical Technology

Pharmaceutical professionals expect digital solutions to solve drug development headaches, with AI already proving disruptive.

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How Intra-Cellular surprised Wall Street by breaking character

Bio Pharma Dive

The biotechnology company, which sees itself as "pretty conservative," recently put out an ambitious long-term revenue forecast for its schizophrenia and depression medicine Caplyta.

Medicine 173
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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 approves Medtronic InPen app, launching Smart MDI system with Simplera CGM

Pharmaceutical Technology

In an advancement for diabetes management, the US Food and Drug Administration (FDA) has granted clearance to Medtronic’s new InPen app, setting the stage for the launch of the company’s Smart MDI system integrated with the Simplera continuous glucose monitor (CGM).

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Kronos, Idorsia plan layoffs; PTC shelves ALS drug

Bio Pharma Dive

Kronos is cutting 83% of its workforce, while Idorsia is considering eliminating as many as 270 jobs. Elsewhere, PTC disclosed negative Phase 2 results for its ALS drug candidate utreloxastat.

Drugs 147

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Sarepta rebuilds drug pipeline with Arrowhead deal

Bio Pharma Dive

A broad licensing and research alliance will hand Sarepta four clinical-stage candidates, while Arrowhead receives $500 million in cash and another $325 million in equity investment.

Licensing 147
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Biotechnology to spur avenues in precision bio-therapeutics & bio-based chemicals

AuroBlog - Aurous Healthcare Clinical Trials blog

Union government is emphasising that the biotechnology sector’s thrust should be towards twin technologies. One is digital tech and the other is green tech which will help it transition towards sustainable development and foster low-carbon economy growth.

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Outlook Therapeutics stock craters as the wet AMD drug fails Phase III trial

Pharmaceutical Technology

The Norse Eight trial was part of the data requested by the FDA after the agency rejected the BLA for the company’s Lytenava last year.

Trials 130
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Kelun's Merck-partnered ADC snags first nod in China to kick off TROP2 fight with Gilead

Fierce Pharma

The competition among three TROP2 antibody-drug conjugates is ent | The competition among three TROP2 antibody-drug conjugates is entering a new stage as Kelun-Biotech’s Merck & Co.-partnered sacituzumab tirumotecan has become the second therapy in the class to win a marketing approval.

Antibody 121
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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EC approves Novartis’ Kisqali to treat early breast cancer

Pharmaceutical Technology

The EC has granted approval to Novartis' Kisqali (ribociclib) plus an aromatase inhibitor to treat early breast cancer patients.

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World AIDS Day 2024: Take the Rights Path

XTalks

World AIDS Day 2024 serves as a reminder of the ongoing fight against the human immunodeficiency virus, or HIV and acquired immunodeficiency syndrome, or AIDS. Marked each year on December 1, this day highlights progress in addressing one of the most significant public health challenges. This year’s theme , “Take the Rights Path to End AIDS,” emphasizes the importance of human rights in eradicating the epidemic.

Trials 102
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The race for approval: oral GLP-1R therapies in obesity

Pharmaceutical Technology

With expected sales for GLP1Rs in obesity estimated to surpass $126 billion by 2030, this drug category presents a lucrative market.

Sales 130
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Sanofi opens $590M modular vaccine, biologics plant in Singapore

Fierce Pharma

Two months after Sanofi completed construction in France of its innovative Modulus vaccine and biologics plant—which can be reconfigured within days during a pandemic—the drugmaker said it has

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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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Arrowhead and Sarepta link for rare genetic disease treatments

Pharmaceutical Technology

Arrowhead has entered a worldwide licensing and partnership agreement with Sarepta Therapeutics for rare genetic disease treatments.

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FDA oncology advisory committee to weigh Exelixis' Cabometyx in neuroendocrine tumors

Fierce Pharma

Before Exelexis’ Cabometyx can pass muster with the FDA in its hopeful neuroendocrine tumors indication next April, it will have to first face the agency’s Oncologic Drugs Advisory Committee ( | The agency's Oncologic Drugs Advisory Committee is set to discuss the treatment and its phase 3 CABINET study in March ahead of the FDA's planned decision date of April 2025.

Drugs 98
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BeiGene’s PD-1 drug approved in EU for first-line oesophageal cancer treatment

Pharmaceutical Technology

The EC has approved BeiGene’s PD-1 inhibitor Tevimbra in combination with chemotherapy to treat ESCC and G/GEJ adenocarcinoma.

Drugs 130
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Kisqali gets early breast cancer approval in Europe

pharmaphorum

Novartis' fast-growing breast cancer drug gets another growth driver as EU approves adjuvant use in patients with early-stage HR+, HER2- tumours.

HR 98
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA delays decision of Soleno’s Prader-Willi syndrome drug

Pharmaceutical Technology

The FDA has delayed its decision on Soleno Therapeutics investigational therapy for children with Prader-Willi syndrome.

Drugs 130
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With narcolepsy trial win, Axsome looks to revive former Pfizer antidepressant on the US market

Fierce Pharma

Once a controversial European depression treatment that never made it to the U.S. | The treatment, which was once a Pfizer antidepressant, reduced bouts of cataplexy and other narcolepsy symptoms in Axsome's ENCORE study.

Marketing 104
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Idorsia plans further job cuts and asset sale in latest cost-saving measures

Pharmaceutical Technology

Idorsia has extended its cash runway into 2025 via an exclusivity fee for global rights negotiations for Tryvio.

Sales 130
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Most life sciences CEOs expect to grow their head counts over the next 3 years: KPMG survey

Fierce Pharma

On a routine basis in recent years, headlines about layoffs in the biopharma industry have surfaced as companies large and small have been cutting costs and restructuring. | A survey of life sciences CEOs found that 94% plan to grow their workforce over the next three years, with 37% envisioning that the head count of their company will grow by at least 6%.

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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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Acadia signs agreement with Saniona to commercialise SAN711

Pharmaceutical Technology

Acadia Pharmaceuticals has secured an exclusive global licence from Saniona to develop and commercialise SAN711.

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Innovating Immunotherapeutics with Oncolytic Virus Therapy ft. Oncolytics Biotech’s CMO Dr. Thomas Heineman

XTalks

In this episode, Ayesha spoke with Thomas Heineman, MD, PhD, Chief Medical Officer at Oncolytics Biotech , a company developing an oncolytic virus cancer therapeutic that is currently in clinical trials for indications including metastatic breast cancer and pancreatic cancer. Oncolytics is developing a first-in-class, nonpathogenic oncolytic virus administered intravenously that activates, recruits and trains immune cells to identify and destroy cancer cells.

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Part 2 - Accelerating the Medical, Legal and regulatory (MLR) review leveraging AI

pharmaphorum

Learn how AI can accelerate the Medical, Legal, and Regulatory (MLR) review process. Discover strategies for leveraging AI to streamline and optimise MLR review in the medical, legal, and regulatory fields.

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Acute Leukemia Drug Revuforj Wins FDA Approval, Second Approval for Syndax this Year

XTalks

Syndax Pharmaceuticals’ Revuforj (revumenib) has won US Food and Drug Administration (FDA) approval for the treatment of relapsed or refractory (R/R) acute leukemia in patients aged one year and older who have a lysine methyltransferase 2A ( KMT2A, formerly MLL ) gene translocation. The approval marks the first menin inhibitor to receive FDA clearance, offering a novel therapeutic option for this challenging leukemia subtype.

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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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AI’s Role in Personalizing Life Sciences Digital Experiences

Pharmaceutical Commerce

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Chase Feiger, MD, co-founder, Ostro, discusses the value of AI technology when it comes to tackling digital commercialization challenges.

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Sanofi to Invest €40M to Expand Production of Thymoglobulin and Diabetes Drug Tzield at France Site

XTalks

Sanofi has announced a €40 million ($42.46 million) investment to enhance its biomanufacturing capabilities at the Lyon Gerland site in France. The initiative aims to bolster the production of Thymoglobulin (antithymocyte globulin [rabbit]), a treatment for kidney transplant rejection, and to localize the manufacturing of type 1 diabetes therapy Tzield (teplizumab).

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8th Gene Therapy Development Summit

pharmaphorum

The 8th Gene Therapy Development Summit organized by Hanson Wade is a premier event showcasing the latest advancements in gene therapy. Learn more about this highly anticipated event here.

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CTTI Leads Discussion on Digital Health Trials at ETH Digital Biomarkers Summit

CTTI (Clinical Trials Transformation Initiative)

In November 2024, Lindsay Kehoe, senior project manager at CTTI, presented at the Digital Biomarkers Summit held at ETH Zurich. The event gathered experts from academia, healthcare, and industry to discuss the transformative potential of wearable technologies in healthcare. Among the many topics covered, a key focus was the translation of digital innovations, such as wearable devices for sweat and breath, into clinical implementation to revolutionize healthcare.

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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.