Sat.Jun 12, 2021

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Alfa Laval makes ‘full-single-use’ cell harvesting possible amid industry challenges

Pharma Mirror

As growing strain on pharmaceutical technology necessitates more efficient practice, Alfa Laval has launched the CultureOne™, the industry’s first premium separator system for single-use cell culture processing. According to Bioplan Associates, single-use bioprocessing technologies now dominate the pre-commercial manufacturing space. However, Alfa Laval states many companies have not been able to make the transition to ‘full-single-use’ when harvesting proteins due to the lack of a single-use di

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New patent expiration for Xspire Pharma drug ZONTIVITY

Drug Patent Watch

Annual Drug Patent Expirations for ZONTIVITY Zontivity is a drug marketed by Xspire Pharma and is included in one NDA. It is available from one supplier. There are three patents…. The post New patent expiration for Xspire Pharma drug ZONTIVITY appeared first on DrugPatentWatch - Make Better Decisions.

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Radiotracer effective for detection and assessment of lung fibrosis

Scienmag

Credit: Image created by CA Ferreira et al., University of Wisconsin-Madison, Madison, WI. Reston, VA (Embargoed until 4:30 p.m. EDT, Saturday, June 12, 2021)–Positron emission tomography (PET) using a 68Ga-labeled fibroblast activation protein inhibitor (FAPI) can noninvasively identify and monitor pulmonary fibrosis, according to research presented at the Society of Nuclear Medicine and Molecular Imaging […].

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New patent expiration for Janssen R drug INTELENCE

Drug Patent Watch

Annual Drug Patent Expirations for INTELENCE Intelence is a drug marketed by Janssen R And D and is included in one NDA. It is available from one supplier. There is…. The post New patent expiration for Janssen R drug INTELENCE appeared first on DrugPatentWatch - Make Better Decisions.

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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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Westlake Hills TX Dental Bonding Cosmetic Dentistry Updated

BioTech 365

Westlake Hills TX Dental Bonding Cosmetic Dentistry Updated Westlake Hills TX Dental Bonding Cosmetic Dentistry Updated Westlake Hills Dental Arts has updated cosmetic dental bonding treatents.

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Protocol Amendments and What They Trigger In Clinical Research

Clinical Trial Gurus

In clinical research trials, protocol amendments are a very frequent occurrence. In this video I break down what cascade of events should occur from a regulatory and site training perspective whenever a new protocol amendment takes place.

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Core One Labs’ Biosynthesized Psilocybin Provisional Patent Imminent

BioTech 365

Core One Labs’ Biosynthesized Psilocybin Provisional Patent Imminent Core One Labs’ Biosynthesized Psilocybin Provisional Patent Imminent VANCOUVER, British Columbia, June 12, 2021 (GLOBE NEWSWIRE) — Core One Labs Inc.

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Which pharmaceutical drugs have the most drug patents in Chile?

Drug Patent Watch

This chart shows the drugs with the most patents in Chile. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.…. The post Which pharmaceutical drugs have the most drug patents in Chile? appeared first on DrugPatentWatch - Make Better Decisions.

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Incyte Announces Updated Data for Ruxolitinib Cream Accepted for Presentation at the 2021 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference

BioTech 365

Incyte Announces Updated Data for Ruxolitinib Cream Accepted for Presentation at the 2021 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference Incyte Announces Updated Data for Ruxolitinib Cream Accepted for Presentation at the 2021 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference — First … Continue reading →

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F.D.A. Still Lacks a Permanent Commissioner

NY Times

With the pandemic easing, the federal agency’s long-term agenda for drug approvals or new issues is languishing without a permanent commissioner.

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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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Celltrion Healthcare presents the first real-world data for Truxima® (biosimilar rituximab) in patients with diffuse large B-cell lymphoma at the EHA 2021 Virtual Congress

BioTech 365

Celltrion Healthcare presents the first real-world data for Truxima® (biosimilar rituximab) in patients with diffuse large B-cell lymphoma at the EHA 2021 Virtual Congress Celltrion Healthcare presents the first real-world data for Truxima® (biosimilar rituximab) in patients with diffuse large … Continue reading →

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Longer-term Data for Kite’s Yescarta® in Relapsed or Refractory Follicular Lymphoma Demonstrate Substantial Survival Improvement Over Current Therapies in Comparative Analysis

BioTech 365

Longer-term Data for Kite’s Yescarta® in Relapsed or Refractory Follicular Lymphoma Demonstrate Substantial Survival Improvement Over Current Therapies in Comparative Analysis Longer-term Data for Kite’s Yescarta® in Relapsed or Refractory Follicular Lymphoma Demonstrate Substantial Survival Improvement Over Current Therapies in … Continue reading →

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New Phase 3 Study Results Show IMBRUVICA® (ibrutinib)-Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia

BioTech 365

New Phase 3 Study Results Show IMBRUVICA® (ibrutinib)-Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia New Phase 3 Study Results Show IMBRUVICA® (ibrutinib)-Based Combination Regimen as an … Continue reading →

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 Janssen Announces Results from Phase 3 MAIA Study Showing Significant Overall Survival Benefits for Treatment with DARZALEX®? (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma Who are Transplant Ineligible

BioTech 365

Janssen Announces Results from Phase 3 MAIA Study Showing Significant Overall Survival Benefits for Treatment with DARZALEX®?

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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.