Point radiopharma drug results disappoint in prostate cancer study
Bio Pharma Dive
DECEMBER 18, 2023
While the study met its goal, the drug’s benefit was less than analysts had predicted, an outcome that could hasten a planned takeover by Eli Lilly.
Mon.Dec 18, 2023
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Vertex secures CHMP nod for Casgevy approval in Europe
Pharmaceutical Technology
DECEMBER 18, 2023
Following US and UK approvals, the EMA’s CHMP has recommended conditional approval for Casgevy, with a decision expected in Q1 2024.
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Pivotal Life Sciences reloads with $389M, hunting for deals in a downturn
Bio Pharma Dive
DECEMBER 18, 2023
The firm is tracking startups that launched during the biotechnology sector’s peak a few years ago but now need fresh funds to move their programs forward, one of its investors said.
Novo Nordisk Foundation sets up airborne infection vaccine initiative
Pharmaceutical Technology
DECEMBER 18, 2023
The Novo Nordisk Foundation has invested Dkr1.8bn in the initiative to develop vaccines for various airborne infection diseases.
A Dentist Reveals What Happens to Your Teeth as You Get Older
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 18, 2023
A healthy smile helps us live long, well and happy lives. But just like our bodies, our teeth succumb to age-related changes. So what happens to teeth as you age? And what can you do to ensure your smile lasts the distance? [link] First, what are teeth made of?
Foundation behind Novo Nordisk to invest $260M in vaccine R&D
Bio Pharma Dive
DECEMBER 18, 2023
The newly established initiative, which consists of a research center and an accelerator, will focus on developing vaccines for tuberculosis, influenza and group A streptococcus.
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Structure shares sink as obesity pill misses expectations in small study
Bio Pharma Dive
DECEMBER 18, 2023
Results from a Phase 2 trial fell short of what’s been seen with a similar Eli Lilly medicine, causing the closely watched biotech’s shares to plummet.
Magazine: Advancing islet transplantation for type 1 diabetes
Pharmaceutical Technology
DECEMBER 18, 2023
In this issue: Diabetes researchers oppose the regulation of islet transplantation as a biologic in the US, why haemophilia gene therapies are so expensive, how AI will help with trial recruitment.
Illumina to part with Grail, ending battle with regulators
Bio Pharma Dive
DECEMBER 18, 2023
Activist investor Carl Icahn, who is suing the company over its acquisition of Grail, continued to push for the removal of several board members in a letter to fellow shareholders.
December 18, 2023: Ethics Consultation Documents Now Available for ARBOR-Telehealth and I CAN DO Surgical ACP
Rethinking Clinical Trials
DECEMBER 18, 2023
Ethics and regulatory onboarding documentation for 2 of the NIH Pragmatic Trials Collaboratory's newest trials is now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the ARBOR-Telehealth and I CAN DO Surgical ACP studies. The consultations took place by video conference and included representation from the studies' principal investigators, members of the NIH Collaboratory's Ethics and Regu
The New Age of Decentralized Clinical Trials
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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
Experts prefer whole genome sequencing as viable option to identify & characterize bacteria as concerns of AMR escalate
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 18, 2023
As antimicrobial resistance (AMR) poses a growing threat to global public health, challenging the effectiveness of antibiotics and other antimicrobial drugs, medical experts suggest whole genome sequencing as a viable option to identify and characterize the bacteria, viruses, fungi or parasites, along with their transmission pattern.
FDA backs Astellas-Pfizer’s Padcev with Keytruda for urothelial cancer
Pharmaceutical Technology
DECEMBER 18, 2023
The US FDA approved Astellas Pharma-Pfizer’s Padcev plus Merck’s (MSD) Keytruda to treat locally advanced or metastatic urothelial cancer.
Dissemination & Implementation in Embedded Pragmatic Trials: Raising the Bar for Real-World Research: AcademyHealth (December 2023)
Rethinking Clinical Trials
DECEMBER 18, 2023
December 10, 2023 : The NIH Pragmatic Trials Collaboratory hosted a Workshop at the 2023 AcademyHealth 16th Annual Conference on the Science of Dissemination and Implementation in Health. This training workshop introduces concepts in the design, conduct, and implementation of embedded pragmatic clinical trials (ePCTs), and provides firsthand ePCT experiences and case studies from the NIH Pragmatic Trials Collaboratory Demonstration Projects.
Biocytogen and Ona enter cancer ADC development deal
Pharmaceutical Technology
DECEMBER 18, 2023
Biocytogen Pharmaceuticals and Ona Therapeutics signed an antibody agreement to develop antibody-drug conjugates for solid tumours.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
To fight rare diseases, win the data battle first
pharmaphorum
DECEMBER 18, 2023
To effectively combat rare diseases, it is essential to prioritise the collection and analysis of data. This article explores how pharmaceutical companies are leveraging AI and focusing on orphan drugs to tackle rare diseases.
Pivotal bioVenture raises the stakes in biotech and pharmaceutical support
Pharmaceutical Technology
DECEMBER 18, 2023
The latest $389m pledge follows an initial investment of $300m in 2017 that was raised to fund early-stage life-science startups.
Cognitive decline in early Alzheimer’s could stem from serotonin loss
Pharma Times
DECEMBER 18, 2023
MCI patients had 25% lower levels of serotonin compared to healthy patients Researchers from Johns Hopkins Medicine have suggested that serotonin loss in parts of the brain may play a role in cognitive decline in the early stages of Alzheimer’s disease (AD). Published in the Journal of Alzheimer’s Disease , the study was supported by other contributing scientists from the Johns Hopkins University School of Medicine and the Johns Hopkins Bloomberg School of Public Health.
CymaBay seeks FDA approval for primary biliary cholangitis therapy
Pharmaceutical Technology
DECEMBER 18, 2023
CymaBay Therapeutics has filed a new drug application (NDA) with the FDA seeking approval for seladelpar for PBC management.
The New Age of Decentralized Clinical Trials
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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.
Gene therapy could reduce seizures in childhood epilepsy
Drug Discovery World
DECEMBER 18, 2023
University College London (UCL) researchers have developed a new gene therapy to cure focal cortical dysplasia, which a new study shows can significantly reduce seizures in mice. Focal cortical dysplasia is caused by areas of the brain that have developed abnormally and is among the most common causes of drug-resistant epilepsy in children. Epilepsy in focal cortical dysplasia is associated with comorbidities, including learning disabilities.
EMA CHMP recommends Takeda’s Hyqvia for CIDP treatment
Pharmaceutical Technology
DECEMBER 18, 2023
The EMA CHMP recommended granting approval for Takeda’s Hyqvia for chronic inflammatory demyelinating polyneuropathy.
New patent expiration for Glaxosmithkline drug VENTOLIN HFA
Drug Patent Watch
DECEMBER 18, 2023
Annual Drug Patent Expirations for VENTOLIN+HFA Ventolin Hfa is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from nine suppliers. There are two patents… The post New patent expiration for Glaxosmithkline drug VENTOLIN HFA appeared first on DrugPatentWatch - Make Better Decisions.
Illumina to divest Grail after two years of lawsuits
Pharmaceutical Technology
DECEMBER 18, 2023
Illumina aims to finalise the terms of this divestiture by the end of the second quarter of 2024.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
Charles River snags clearance to produce Vertex and CRISPR's Casgevy from Tennessee plant
Fierce Pharma
DECEMBER 18, 2023
Following a string of approvals in the United States and beyond, Vertex Pharmaceuticals continues to build out its manufacturing network for the world’s first CRISPR-based gene therapy, Casgevy.
Cognitive decline in early Alzheimer’s could stem from serotonin loss
Pharma Times
DECEMBER 18, 2023
MCI patients had 25% lower levels of serotonin compared to healthy patients - News - PharmaTimes
CHMP backs Biogen’s Skyclarys for Friedreich’s ataxia
pharmaphorum
DECEMBER 18, 2023
Biogen’s Skyclarys is on course to becoming the first approved medicine for the inherited neurological disease Friedreich’s ataxia (FA) in the EU after it was recommended by the EMA’s human medicines committee.
Digital health collaboration to trial AI-powered X-rays for lung cancer detection
Pharma Times
DECEMBER 18, 2023
Earlier diagnosis could increase patient survival rates by five years or more - News - PharmaTimes
How Machine Learning Drives Clinical Trial Efficiency
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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.
UK approves treatment for hot flushes during the menopause
Outsourcing Pharma
DECEMBER 18, 2023
Astellasâ drug fezolinetant (Veoza) has been approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the prevention of hot flashes during the menopause.
Welireg Wins FDA Approval for Advanced Renal Cell Carcinoma, the Second for the Merck Drug
XTalks
DECEMBER 18, 2023
Merck received its second US Food and Drug Administration (FDA) approval for its cancer pill Welireg (belzutifan). The oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor was first approved in August 2021 for von Hippel-Lindau (VHL), a rare hereditary disease that causes tumor growth in different organs, particularly the kidney. Last week, the drug received its second FDA approval for adults with advanced renal cell carcinoma who have relapsed or have refractory disease following treatment
FDA approval expands Welireg to patients with renal cell carcinoma
Outsourcing Pharma
DECEMBER 18, 2023
The oral treatment belzutifan, developed by MSD (known as Merck in the US) and branded as Welireg, has received the green light from the US Food and Drug Administration (FDA) for the treatment of an advanced form of renal cell carcinoma (RCC).
GSK tees up AstraZeneca rivalry with positive Jemperli-Zejula readout in endometrial cancer
Fierce Pharma
DECEMBER 18, 2023
On a mission to grow in oncology, GSK has more positive data to report in endometrial cancer. | GSK has more positive data to report in endometrial cancer as the company's PD-1/PARP combination turned in a trial win. The combination could represent a threat to a rival therapy at AstraZeneca.
Accelerating Clinical Supply Through Integrated Drug Development
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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.
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