Mon.Dec 11, 2023

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How Clario is improving clinical trials: 'Therapies that hold immense promise may never see the light of day'

BioPharma Reporter

Dr. Michael OâNeal, chief medical officer at Clario, believes that many drugs ultimately fail due to common operational and data challenges that could, and should, be corrected.

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Humira leads ICER’s latest list of ‘unsupported’ price hikes

Bio Pharma Dive

AbbVie’s blockbuster medicine topped a list of treatments that, combined, elevated U.S. healthcare spending by $1.3 billion in 2022, according to the price watchdog’s latest yearly report.

Medicine 288
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Quality and sustainability: The balancing act for pharma manufacturing  

Pharmaceutical Technology

Trends in sustainability and quality assurance were key themes discussed at the recent CPHI Europe 2023 meeting, although the data reveals a lack of implementation of sustainable solutions.

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ASH23: Pharma branding, Editas’ high bar and clinical trial diversity

Bio Pharma Dive

Editas had the tall task Monday of convincing ASH attendees its gene therapy for sickle cell disease could improve on Casgevy and Lyfgenia.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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First gene therapies for sickle cell disease secure FDA approval

Pharmaceutical Technology

The FDA has approved Vertex/CRISPR’s Casgevy and bluebird bio’s Lyfgenia gene therapies for the red blood cell disorder.

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Profitable growth is on the horizon

Bio Pharma Dive

A return to profitable growth is on the horizon—organizations that take advantage of the following key trends can thrive in 2024 and beyond.

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More Trending

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Life sciences leaders invest in process mining to accelerate digital transformation

Bio Pharma Dive

Research from Everest Group shows how life sciences leaders are investing in process mining to speed time-to-market, improve regulatory compliance and drive innovation.

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How to improve patient engagement and retention rates with mobile nurse visits

Pharmaceutical Technology

We analyse dropout data and speak to DCT expert, Ellen Weiss, to explore the power of mobile visits in improving patient engagement and retention rates.

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Top 10 Fastest Growing Medical Device Companies in 2023

XTalks

Medical device companies continue to maintain a crucial role in enhancing patient care and diagnostic precision in 2023. Through the utilization of their state-of-the-art technology and substantial investments in research and development (R&D), these med tech/medical device companies persist in driving industry innovation beyond the pandemic, thereby laying the foundation for a more streamlined approach against diseases in the future.

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Novo Holding-backed Danish startup raises €23m in Series A

Pharmaceutical Technology

The funding will advance Hoba’s lead candidate HB-086 to Phase I clinical trial for chemotherapy induced neuropathic 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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UKHSA urges individuals from ethnic minority groups to get vaccinated

Pharma Times

New data highlights the inequalities in emergency hospital rates and vaccinations - News - PharmaTimes

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Ferring signs microbiome R&D partnership deal with PharmaBiome

Pharmaceutical Technology

Ferring Pharmaceuticals has signed an R&D partnership agreement with PharmaBiome to develop microbiome-based therapies in gastroenterology.

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BMS Inks Potential $8.4B Deal for SystImmune’s ADC for Lung, Breast Cancer

BioSpace

Bristol Myers Squibb has bought the rights to develop and commercialize SystImmune’s potentially first-in-class, bi-specific antibody-drug conjugate for lung and breast cancer as well as other solid tumors.

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Signal: CAR-T study suggests cell therapy can treat autoimmune diseases

Pharmaceutical Technology

A study shared at ASH saw lupus and sclerosis patients make marked recoveries through CAR-T therapy initally targeted at blood cancers.

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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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NHS rolls out online GP registration to over 2,000 practices

Pharma Times

Around 2,100 GP surgeries had enrolled into the digital service by the end of November - News - PharmaTimes

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FDA grants approval for Astellas Pharma’s antifungal therapy Cresemba

Pharmaceutical Technology

The US FDA has granted approval for Astellas Pharma’s Cresemba to treat children with invasive aspergillosis and invasive mucormycosis.

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Merck's first ever AI solution has more than 60 billion possibilities for successful drug properties

Outsourcing Pharma

Science and technology giant, Merck, has launched its first software-as-a-service (SaaS) platform that it says bridges the gap between virtual molecule design and real-world manufacturability.

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Novartis gears up for label expansion for Kisqali with Phase III results

Pharmaceutical Technology

Novartis is seeking approval for Kisqali as a treatment of early breast cancer, with an FDA application planned by the end of 2023.

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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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Tome Biosciences Launches with $213M in Funding, Targets ‘New Era’ of Genomic Medicines

BioSpace

Backed by ARCH Venture Partners and Fujifilm, as well as technology licensed from MIT, Tome is looking to create curative cell and integrative gene therapies.

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Nona Biosciences and Evive enter antibody discovery deal

Pharmaceutical Technology

Nona Biosciences has entered a partnership deal with biopharmaceutical company Evive Biotech to discover antibodies.

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Sanofi Drops Acquisition of Maze’s Pompe Disease Drug After FTC Challenge

BioSpace

Following the regulator’s administrative complaint and threat of a lawsuit in federal court, Sanofi has decided to terminate its licensing deal with Maze Therapeutics to avoid a long litigation process.

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Astellas Pharma's treatment for hot flashes and night sweats approved

Outsourcing Pharma

A treatment option to reduce the number and intensity of hot flashes and night sweats associated with menopause has been approved by the European Commission (EC).

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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.

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AstraZeneca Buys into RSV Vaccine Market with Potential $1.1B Icosavax Purchase

BioSpace

With the acquisition, AstraZeneca will gain access to Icosavax’s investigational combination vaccine IVX-A12, which is being developed for respiratory syncytial virus and human metapneumovirus in older adults.

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As ICER places a spotlight on pharma's price hikes, J&J, Roche and more hit back

Fierce Pharma

After many years of tracking the pharmaceutical industry’s pricing tactics, the Institute for Clinical and Economic Review (ICER) is once again placing a spotlight on the price increases that end u | The Institute for Clinical and Economic Review (ICER)’s fifth annual report on unsupported price increases (UPI) puts Humira in the top spot of offenders.

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Pfizer’s $43B Seagen Buy Clears Regulatory Hurdles, Plans Dec 14 Closing

BioSpace

The companies have received all required regulatory approvals to complete the deal, the largest for the sector in the past three years and the biggest for the hot antibody-drug conjugate market.

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Hope for multiple myeloma patients who have exhausted standard-of-care therapies

Outsourcing Pharma

Last-line multiple myeloma patients, who have exhauster other treatment options have been responding to oral drug inobrodib in combination with pomalidomide and dexamethasone (pom and dex).

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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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Novartis’ Iptacopan Aces Phase III Study in Ultra-Rare Kidney Disease Days After FDA Approval

BioSpace

The trial demonstrated that C3G glomerulopathy patients treated with the oral factor B inhibitor saw a significant reduction in protein in their urine. The results come days after iptacopan won the FDA’s green light for a rare blood disease.

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Predictive genetic testing offers the greatest promise and ethical challenge of our time

pharmaphorum

Predictive genetic testing offers the greatest promise and ethical challenge of our time Mike.

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ASH: Abecma’s survival data show why FDA wanted expert meeting on the Bristol Myers cell therapy

Fierce Pharma

ASH: Abecma’s survival data show why FDA wanted expert meeting on the Bristol Myers cell therapy aliu Mon, 12/11/2023 - 14:51

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Trade & Channel Strategies 2023: Aligning Patient Access

Pharmaceutical Commerce

Panel uncovers ways to handle the increasing complexities and risks surrounding commercialization.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.