Tue.Sep 26, 2023

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Intercept, after biotech rollercoaster ride, agrees to buyout by Alfasigma

Bio Pharma Dive

Once valued at more than $7 billion, the liver drug company couldn’t secure a long-sought FDA approval in NASH and last month said it would abandon that research.

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Ann Marie Hall, SR Clinical Trial Manager, Site Management, shares her story about why World Alzheimer’s month is so important to her.

Worldwide Clinical Trials

In September, as we observe World Alzheimer’s month and focus attention on how far we have come in raising awareness of the disease and research being done to find more effective treatments, I think back to when my grandmother was first diagnosed and how heart wrenching it was to watch her loose herself over the years. When my mother was diagnosed, it was not a surprise, as I had already been witnessing those early changes and knew what was coming.

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Immunovant data show potential for autoimmune disease drug

Bio Pharma Dive

Much anticipated clinical trial data for Immunovant’s experimental FcRn inhibitor could catalyze business development decisions for its parent, Roivant Sciences.

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The competitive edge: Unlocking the full potential of autoinjectors through comprehensive in-house manufacturing

Pharmaceutical Technology

To optimise autoinjector combination product development, it is crucial for pharma and biotech to partner with device companies that have in-house control over the whole device manufacturing process.

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

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Novo Nordisk, Evotec partner in metabolic disease drug discovery pact

Bio Pharma Dive

Hunting for more metabolic disease drugs, Novo plans to work with Evotec to shape early academic research into new development programs.

Drugs 152
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Novo Nordisk and Valo to develop cardiometabolic disease therapies

Pharmaceutical Technology

Novo Nordisk has signed an agreement with Valo Health for the discovery and development of new therapies to treat cardiometabolic diseases.

More Trending

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Signal: Big Pharma embraces AI as Novo Nordisk partners with AI start-up Valo in $2.7bn deal

Pharmaceutical Technology

Novo Nordisk A/S and Valo Health Inc. have partnered to use Valo's AI-powered human dataset to discover and develop new treatments.

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Psycheceutical Q&A: Could topical ketamine transform PTSD treatment?

BioPharma Reporter

Psychedelics have re-emerged in the world of medicine as promising treatments for various mental health conditions, particularly post-traumatic stress disorder (PTSD).

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Acesion wins €45m in Series B funding to develop atrial fibrillation therapy

Pharmaceutical Technology

The funding will support the clinical development of the oral SK ion channel inhibitor that was recently evaluated in a Phase II trial.

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Gilead Axes Phase III Magrolimab Trial Based on Disappointing Data

BioSpace

After picking up magrolimab in a $4.9 billion purchase of Forty Seven, a second Phase III study is being discontinued for the anti-CD47 antibody, this time in acute myeloid leukemia.

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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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Genmab receives EC approval for lymphoma therapy

Pharmaceutical Technology

Genmab has received marketing authorisation from the European Commission (EC) for TEPKINLY as a monotherapy to treat adults R/R DLBCL

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UKHSA reaches vaccine deal with CSL Seqirus

Pharma Times

Agreement will provide timely boost to pandemic preparedness against influenza - News - PharmaTimes

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Novartis confirms plans for spin-off of Sandoz business

Pharmaceutical Technology

Novartis has confirmed plans for the spin-off of generics and biosimilars business, Sandoz, following shareholder approval.

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AbbVie Terminates Caribou CAR-T Contract in Culling of Cancer Pipeline

BioSpace

Soon after cancelling its contract with I-Mab, AbbVie has now also turned its back on a partnership with Berkeley-based Caribou Biosciences that was focused on advancing allogeneic CAR-T therapeutics.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Coherus Biosciences gets hit with CRL for pegfilgrastim biosimilar injectable

Pharmaceutical Technology

Coherus has also announced the completion of study site inspections by the FDA for the checkpoint inhibitor toripalimab.

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Oxford Biodynamics launches prostate screening test

Pharma Times

EpiSwitch is designed for men with prostate cancer risk in the UK and is 94% accurate - News - PharmaTimes

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GSK receives Japanese approval of RSV vaccine for older patients

Pharmaceutical Technology

GSK has received approval from Japan’s MHLW for RSV vaccine Arexvy to prevent RSV disease in adults aged over 60 years

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AstraZeneca, BMS Reluctantly Agree to Medicare Drug Price Negotiation Program

BioSpace

Despite filing respective lawsuits challenging the program, AstraZeneca and Bristol Myers Squibb have decided to participate in the first round of price negotiations under the Inflation Reduction Act.

Drugs 109
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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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Sandoz scores European approval for Tysabri biosimilar

Pharmaceutical Technology

The Sandoz biosimilar, Tyruko, has been approved for all indications as the reference medication, Biogen’s Tysabri.

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WuXi debuts first vaccine CDMO site in China, where it plans to employ more than 500

Fierce Pharma

Amid a global expansion spree at WuXi Biologics, the company's immunization-focused subsidiary has christened its inaugural CDMO site in China. | WuXi Vaccines launched its first standalone vaccine contract manufacturing facility in Suzhou. With the plant, the company adds drug substance and drug product capacity for projects in various stages of development.

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FDA Adcomm Rejects BrainStorm’s ALS Therapy in Nearly Unanimous Vote

BioSpace

An FDA advisory committee voted 17-1 on Wednesday that BrainStorm Cell Therapeutics did not demonstrate substantial evidence of efficacy for NurOwn in mild to moderate amyotrophic lateral sclerosis.

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J&J, IBM face class-action lawsuit over patient data breach

Fierce Pharma

As if the talc product liability lawsuits weren’t enough headache for Johnson & Johnson, the New Jersey pharma is now facing another lawsuit from patients, this time about a recent data breach. | As if the talc product liability lawsuits weren’t enough headache for Johnson & Johnson, the New Jersey pharma is now facing another lawsuit from patients, this time about a recent data breach.

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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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Astellas Withdrew Its Inflation Reduction Act Lawsuit—Will Other Companies Follow?

BioSpace

While Astellas did not say why it withdrew its suit, it was the only company to file a legal complaint that wasn’t on the initial IRA drug price negotiations list and may not have had any grounds to sue.

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Merck KGaA's MilliporeSigma pumps €28M into 2 new mRNA production plants

Fierce Pharma

On a €1 billion quest to build a global mRNA network, Merck KGaA’s MilliporeSigma has rounded out its service offerings to include all key stages of mRNA development, manufacturing and commercializ | On a €1 billion quest to build a global mRNA network, Merck KGaA’s MilliporeSigma has rounded out its service offerings to include all key stages of mRNA development, manufacturing and commercialization.

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What clinical trial statistics tell us about the state of research today

Antidote

Recruiting patients for a clinical trial can be a challenging process. Studies show that many patients report having little or no knowledge of clinical trials , and sponsors and researchers often report having difficulties finding and enrolling patients in studies. However, once patients understand more about the medical research process, many individuals do want to participate in a clinical trial.

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Hires and retires: key appointments in pharma

BioPharma Reporter

BioPharma Reporter and Outsourcing Pharma is keeping you in the know with our most recent round-up of important appointments in the pharma industry - including Veranova, Matica Bio and Aldevron.

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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.

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Has Merck's Lagevrio fueled evolution of COVID variants? Researchers say it's possible

Fierce Pharma

As coronavirus concerns increase with the changing of the seasons, the most commonly used oral antiviral treatments are in the spotlight once again. | As coronavirus concerns increase with the changing of the seasons, the most commonly used oral antiviral treatments are in the spotlight once again.

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Alto Reports Positive Phase II PTSD Data After Mid-Stage MDD Win

BioSpace

Following promising results in major depressive disorder, Alto Neuroscience on Tuesday reported positive data for its investigational drug ALTO-100 in post-traumatic stress disorder.

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After 2 FDA rejections and restructuring drive, Intercept sells itself to Italy's Alfasigma

Fierce Pharma

It’s been an uphill battle for Intercept Pharmaceuticals in the three years since the FDA first nixed its attempt to bring Ocaliva to patients with nonalcoholic steatohepatitis (NASH)-related liver | The company inked the buyout at $19 per share after two FDA rejections for Ocaliva in nonalcoholic steatohepatitis-related liver fibrosis and a recent attempt at cutting costs.

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Novartis' ruxolitinab to treat rare blood cancer recommended for approval by NICE

Outsourcing Pharma

A rare and incurable blood cancer, associated with an overproduction of blood cells, that can lead to stroke or heart attack, will soon have access to a small molecule Novartis treatment for the condition.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.