pharmaphorum
OCTOBER 24, 2021
Roche’s Genentech unit has won FDA approval for Susvimo, an implant for eyesight-robbing disease wet age-related macular degeneration (AMD) that gives patients an alternative to regular injections into the eye. Susvimo has the same active ingredient as Roche’s big-selling therapy Lucentis (ranibizumab), a VEGF inhibitor administered once a month that has been approved by the FDA since 2006 for wet AMD.
BioSpace
OCTOBER 24, 2021
This is after the company shared positive results from its Phase III trial on Imfinzi, increasing the chances for survival in BTC patients when combined with standard-of-care chemotherapy regimens.
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Scienmag
OCTOBER 24, 2021
AUGUSTA, Ga. (Oct. 25, 2021) – Dr. Satish S.C. Rao, J. Harold Harrison, MD, Distinguished University Chair in Gastroenterology and founding director of the Digestive Health Center at the Medical College of Georgia and Augusta University Health, has been named the inaugural recipient of the American College of Gastroenterology’s Distinguished Mentorship and Teaching Award.
BioSpace
OCTOBER 24, 2021
The ongoing criminal trial of Holmes revealed Elizabeth Holmes and Theranos issued marketing materials to future partner Walgreens that included the use of Pfizer’s corporate logo.
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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
JAMA Internal Medicine
OCTOBER 24, 2021
This quasi-experimental study examines whether offering an incentive cash card to adults who receive or drive someone to receive their first dose of COVID-19 vaccine raises vaccination rates.
BioSpace
OCTOBER 24, 2021
C2i Genomics plans to make sophisticated AI-informed cancer diagnostics and tumor monitoring available throughout the world, regardless of where patients or clinical trials are located.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
OCTOBER 24, 2021
Researchers found improvements in the study's co-primary endpoints in patient-reported measures of esophageal inflammation and difficulty swallowing.
Scienmag
OCTOBER 24, 2021
Collectively clocking in at nearly 60 trillion particles, a newly released set of cosmological simulations is by far the biggest ever produced. Credit: The AbacusSummit Team; layout and design by Lucy Reading-Ikkanda/Simons Foundation Collectively clocking in at nearly 60 trillion particles, a newly released set of cosmological simulations is by far the biggest ever produced. […].
BioSpace
OCTOBER 24, 2021
Merck entered into collaborations with three different companies as it continues to assess Keytruda in combination with experimental drugs in different cancer indications.
Scienmag
OCTOBER 24, 2021
Niigata, Japan – Oral malignancies represent the seventh most common cancer worldwide. Many diagnosed patients relapse, despite radical resection of the primary oral squamous cell carcinoma (OSCC) lesion. Therefore, understanding the local invasion mechanism is warranted in developing more effective therapeutic approaches, and identifying markers that predict poor prognosis.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
BioSpace
OCTOBER 24, 2021
?The two Phase III studies are part of the ILLUMINATE clinical trial, which looks into the action of doravirine/islatravir (DOR/ISL) on HIV-1.
Drug Patent Watch
OCTOBER 24, 2021
Annual Drug Patent Expirations for GLUMETZA Glumetza is a drug marketed by Santarus Inc and is included in one NDA. It is available from two suppliers. There are three patents…. The post New patent expiration for Santarus Inc drug GLUMETZA appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
OCTOBER 24, 2021
Sio Gene Therapies had a few big announcements last week, including a Fast Track Designation from the U.S. Food and Drug Administration and the reorganization of its R&D group.
Drug Patent Watch
OCTOBER 24, 2021
Annual Drug Patent Expirations for INVOKAMET+XR Invokamet Xr is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There are six…. The post New patent expiration for Janssen Pharms drug INVOKAMET XR appeared first on DrugPatentWatch - Make Better Decisions.
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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.
BioSpace
OCTOBER 24, 2021
Novartis announced the CANOPY-1 Phase III trial of canakinumab failed to meet its primary endpoints when combined with Merck’s checkpoint inhibitor Keytruda (pembrolizumab).
Drug Patent Watch
OCTOBER 24, 2021
Annual Drug Patent Expirations for GRALISE Gralise is a drug marketed by Almatica and is included in one NDA. It is available from two suppliers. There are six patents protecting…. The post New patent expiration for Almatica drug GRALISE appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
OCTOBER 24, 2021
The U.S. Food and Drug Administration posted analyses of the Pfizer-BioNTech COVID-19 vaccine in children ages 5 to 11 years old ahead of Tuesday’s vaccines advisory committee meeting.
JAMA Internal Medicine
OCTOBER 24, 2021
This Patient Page summarizes prevention techniques for people who are afraid of falling and likely to fall.
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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.
BioSpace
OCTOBER 24, 2021
Xipere was approved for suprachoroidal use for the treatment of macular edema associated with uveitis, a form of eye inflammation.
BioTech 365
OCTOBER 24, 2021
Silver Bullet Therapeutics Launches OrthoFuzIon® Bone Screw System at DKOU German Congress of Orthopedics and Traumatology Silver Bullet Therapeutics Launches OrthoFuzIon® Bone Screw System at DKOU German Congress of Orthopedics and Traumatology Recent CE Mark Clearance Includes Reduction of Infection … Continue reading →
BioSpace
OCTOBER 24, 2021
The U.S. FDA has a busy period at the end of October heading into the first week of November.
BioTech 365
OCTOBER 24, 2021
Roche launches comprehensive genomic profiling kit to expand access to personalised cancer research Roche launches comprehensive genomic profiling kit to expand access to personalised cancer research The AVENIO Tumor Tissue Comprehensive Genomic Profiling (CGP) Kit is the first jointly-developed product … Continue reading →
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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.
BioSpace
OCTOBER 24, 2021
Bristol Myers Squibb is reportedly courting Canada's Aurinia Pharmaceuticals to strike a buyout deal.
BioTech 365
OCTOBER 24, 2021
Second Dupixent® (dupilumab) Phase 3 eosinophilic esophagitis trial to demonstrate significant disease improvements, underscoring role of type 2 inflammation in this complex disease Second Dupixent® (dupilumab) Phase 3 eosinophilic esophagitis trial to demonstrate significant disease improvements, underscoring role of type … Continue reading →
BioSpace
OCTOBER 24, 2021
Janssen reported analyses in which STELARA is showing promising results as a first-line therapy for Crohn’s Disease (CD) and Ulcerative Colitis (UC).
BioTech 365
OCTOBER 24, 2021
ERYTECH Announces Results from TRYbeCA-1 Phase 3 Trial of Eryaspase in Patients with Second-line Advanced Pancreatic Cancer ERYTECH Announces Results from TRYbeCA-1 Phase 3 Trial of Eryaspase in Patients with Second-line Advanced Pancreatic Cancer ERYTECH Announces Results from TRYbeCA-1 Phase … Continue reading →
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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.
BioSpace
OCTOBER 24, 2021
Colon cancer research has been making strides lately. Here’s everything you need to know.
BioTech 365
OCTOBER 24, 2021
Beckley Psytech Announces First Cohort Dosed in Phase 1 Clinical Trial Assessing Safety and Tolerability of Intranasal 5-MeO-DMT Beckley Psytech Announces First Cohort Dosed in Phase 1 Clinical Trial Assessing Safety and Tolerability of Intranasal 5-MeO-DMT Phase 1 trial is … Continue reading →
BioSpace
OCTOBER 24, 2021
It was yet another busy week for clinical trial news. Here’s a look.
BioTech 365
OCTOBER 24, 2021
Phathom Pharmaceuticals Announces New Data at ACG 2021 Annual Scientific Meeting Phathom Pharmaceuticals Announces New Data at ACG 2021 Annual Scientific Meeting Data from Phase 3 PHALCON-HP trial highlighted in oral presentation and recognized with the ACG Governors Award for … Continue reading →
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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