FDA denies expanded approval for Alnylam RNA drug
Bio Pharma Dive
OCTOBER 9, 2023
The agency rejected Alnylam’s application for approval of its medicine patisiran in people with a rare heart condition, setting back the company’s plans.
Mon.Oct 09, 2023
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GSK and Zhifei sign deal for shingles vaccine in China
Pharmaceutical Technology
OCTOBER 9, 2023
GSK and Chongqing Zhifei have signed an exclusive agreement for co-promoting the former’s shingles vaccine, Shingrix, in China.
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GSK partners with Chinese pharma to expand Shingrix sales
Bio Pharma Dive
OCTOBER 9, 2023
The purchase agreement with Chongqing Zhifei Biological Products is part of GSK’s plan to double sales of the shingles vaccine by 2026.
Want to Cut Heart Disease Risk? Here’s How Many Flights of Stairs to Climb Daily
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 9, 2023
Getting up at least 50 steps a day is associated with a more than 20 percent cut in the risk of cardiovascular disease, new research shows – so you may only need to climb five flights of stairs per day to significantly boost your heart health.
Islet transplantation for type 1 diabetes: Do regulators have it right?
Pharmaceutical Technology
OCTOBER 9, 2023
Diabetes researchers oppose the regulation of islet transplantation as a biologic, following the approval of CellTrans’ Lantidra.
October 9, 2023: Registration Opens for Pragmatic Trials Workshop at AcademyHealth Dissemination & Implementation Conference
Rethinking Clinical Trials
OCTOBER 9, 2023
The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 16th Annual Conference on the Science of Dissemination and Implementation in Health in Arlington, Virginia. The workshop, “Dissemination & Implementation in Embedded Pragmatic Trials: Raising the Bar for Real-World Research,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a particular focus on methods relevant to health
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Taiwan keen to partner with India in smart hospitals & cell based therapies for cancer: TAITRA chairman
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 9, 2023
With Maharashtra alone accounting for 65% of India’s data centre capacity and having a favourable start-up and investment ecosystem, Taiwan is keen to partner with Indian businesses in Maharashtra and India for setting up Smart Hospitals with the help of technologies like Artificial Intelligence (AI), said James Huang, Chairman, Taiwan External Trade Development Council (TAITRA) […]
UK pharma industry hits out at plans to rework statutory payment scheme
Pharmaceutical Technology
OCTOBER 9, 2023
More than 20 pharmaceutical companies across the UK have hit out against a proposed measure in the UK's regulation of medicines.
Using real-world data to improve patient access to oncology therapies
Bio Pharma Dive
OCTOBER 9, 2023
Oncology manufacturers can improve access by using claims, labs, pathway and policy data to address misalignment.
BMS signs agreement to buy Mirati Therapeutics for $5.8bn
Pharmaceutical Technology
OCTOBER 9, 2023
Bristol Myers Squibb (BMS) signed a definitive agreement to acquire all outstanding shares of Mirati Therapeutics for $5.8bn.
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
Gates Foundation spends $40M to boost mRNA vaccine production in Africa and beyond
Fierce Pharma
OCTOBER 9, 2023
Following similar initiatives to bolster mRNA vaccine production and access in Africa, the Bill & Melinda Gates Foundation is providing new funding to a clutch of drugmakers. | Following similar initiatives to bolster mRNA vaccine production and access in Africa, the Bill & Melinda Gates Foundation is providing new funding to a clutch of drugmakers.
Novartis expands Cosentyx reach for rheumatic diseases with IV version approval
Pharmaceutical Technology
OCTOBER 9, 2023
The approval marks the first intravenous (IV) formulation treatment in adults with rheumatic diseases in six years.
Reviving an R&D Pipeline
Drug Patent Watch
OCTOBER 9, 2023
The article titled “Reviving an R&D Pipeline: A Step Change in the Phase II Success Rate” discusses Pfizer’s efforts to improve its research and development (R&D) productivity. The pharmaceutical industry… The post Reviving an R&D Pipeline appeared first on DrugPatentWatch - Make Better Decisions.
AstronauTx wins £48m in funding for developing Alzheimer’s therapies
Pharmaceutical Technology
OCTOBER 9, 2023
The Series A funds will help advance a pipeline, which includes drugs that provide both symptomatic and disease-modifying benefits.
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
Non-viral gene therapy shows early efficacy in lung cancer
Drug Discovery World
OCTOBER 9, 2023
Positive Phase I trial data indicates that Reqorsa (quaratusugene ozeplasmid) has shown early efficacy for the treatment of non-small cell lung cancer (NSCLC). The data will be presented at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston. Developed by gene therapy company Genprex, Reqorsa is a non-viral gene therapy that leads to expression of the TUSC2 tumour suppressor gene in cancers.
Signal: LimmaTech raises $37m for antimicrobial resistance research
Pharmaceutical Technology
OCTOBER 9, 2023
Limmatech, a GSK spinoff focused on combatting antimicrobial resistance, had sought series A funding seven years after foundation.
GSK strikes $3B Shingrix partnership with China powerhouse Zhifei. Is a deal for RSV shot next?
Fierce Pharma
OCTOBER 9, 2023
GSK has forged a partnership with vaccine powerhouse Chongqing | GSK has forged a partnership with vaccine powerhouse Chongqing Zhifei Biological Products to distribute Shingrix in China. Zhifei will pay £2.5 billion ($3.05 billion) for exclusive rights to distribute the shingles shot in China from 2024 through 2026. The deal could be a precursor to similar arrangement between the companies for GSK’s new respiratory syncytial virus (RSV) vaccine Arexvy, the London-based drugmaker said.
Janssen seeks approval from EMA for NSCLC combo therapy
Pharmaceutical Technology
OCTOBER 9, 2023
Janssen has submitted an application seeking approval from the EMA for the NSCLC combo therapy, RYBREVANT plus chemotherapy.
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.
H1 launches new AI tool with 'power to be pharma's most impactful LLM'
Outsourcing Pharma
OCTOBER 9, 2023
A new generative artificial intelligence (AI) tool has been launched by H1, a global healthcare data company and will have a 'profound impact on clinical trial diversity'.
Amgen acquires Horizon Therapeutics for $27.8bn
Pharmaceutical Technology
OCTOBER 9, 2023
Amgen has acquired Horizon Therapeutics in a deal valued at $27.8bn following approval from the US Federal Trade Commission.
Positive opinion on Calliditas' Alport Syndrome drug from EMA
Outsourcing Pharma
OCTOBER 9, 2023
Calliditas Therapeutics AB announced on Friday (October 5) that the European Medicines Agency (EMA) has issued a positive opinion on the companyâs drug, setanaxib in Alport Syndrome (AS).
Alnylam abandons plans for RNAi drug Onpattro after FDA hits the brakes
Pharmaceutical Technology
OCTOBER 9, 2023
The FDA CRL cited insufficient evidence to approve the use of Onpattro for treating cardiomyopathy of ATTR amyloidosis.
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.
NCI and Medidata extend partnership by five years to support critical oncology research
Outsourcing Pharma
OCTOBER 9, 2023
A 15-year partnership between Medidata, a Dassault SystÃmes company, and the National Cancer Institute (NCI) has been extended by five years. The NCI is part of the National Institutes of Health.
Ultimovacs bags orphan drug tag for mesothelioma vaccine
Pharmaceutical Technology
OCTOBER 9, 2023
The FDA decision follows a similar designation for the vaccine UV1 against malignant melanoma in December 2021.
New University of Bristol study to aid strep A vaccine development
Pharma Times
OCTOBER 9, 2023
The study will offer new insights into the immune system's response to iGAS - News - PharmaTimes
Phastar's net-zero target approved by the Science Based Targets initiative (SBTi)
Outsourcing Pharma
OCTOBER 9, 2023
Contract research organization (CRO), Phastar, has had its net-zero target approved by SBTi which it hopes to achieve by adopting stringent sustainability standards.
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.
Elligo Health Research expands Study Marketplace with Syneos Health
Pharma Times
OCTOBER 9, 2023
The agreement builds on the companies’s existing partnership - News - PharmaTimes
Merck Touts Keytruda Phase III NSCLC Survival Data Ahead of FDA Decision
BioSpace
OCTOBER 9, 2023
The pharma giant’s anti-PD-1 therapy met its dual primary endpoint of overall survival as a treatment regimen for non-small cell lung cancer patients, as the FDA’s Oct. 16 PDUFA date looms.
Pharma marketing: Getting personalized with Fingerpaint Group
Fierce Pharma
OCTOBER 9, 2023
Marketers operating in every sector are seeking ways to offer personalized, high-quality experiences to their target audiences. | How much influence will AI exert over pharma marketing? Is it a silver bullet solution to productivity and personalization challenges? Fingerpaint Group’s Paul Hagopian sits down with Fierce Pharma to discuss what has become a hotly contested topic.
Akero’s Phase IIb NASH Data Disappoints, Sends Stock Plummeting
BioSpace
OCTOBER 9, 2023
Both low and high doses of Akero Therapeutics’ lead candidate efruxifermin failed to significantly outperform placebo at improving liver fibrosis without worsening non-alcoholic steatohepatitis.
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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