Avrobio halts gene therapy research and considers a sale
Bio Pharma Dive
JULY 12, 2023
The decision to explore “strategic alternatives” comes about six weeks after the company sold its most advanced treatment to Novartis for nearly $90 million.
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Disturbing New Finding Links Cognitive Decline to Dental Hygiene
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 12, 2023
Researchers in Japan found a connection between tooth loss, gum disease, and shrinkage in a region of the brain involved in memory and Alzheimer’s disease called the hippocampus.
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EMA expands probe of possible suicide risk to popular weight loss, diabetes drugs
Bio Pharma Dive
JULY 12, 2023
The European drug regulator says it now has 150 reports of possible cases involving self-injury and suicidal thoughts among people taking GLP-1 medicines like Ozempic.
Imperial spinout wins £1.6m Innovate UK grant for NK cell therapies
Pharmaceutical Technology
JULY 12, 2023
Innovate UK’s New Cancer Therapeutics programme awarded the grant to the Imperial College spinout to support pre-clinical development.
Startup Tenpoint raises $70M to develop regenerative medicines for the eye
Bio Pharma Dive
JULY 12, 2023
Backed by F-Prime Capital and Sofinnova Partners, the company claims to have technology that could allow it replace eye cells destroyed in age-related and inherited ocular conditions.
EMA concern stirs over suicide risk with weight loss GLP-1RA drugs
Pharmaceutical Technology
JULY 12, 2023
The EMA is reviewing data on the potential effects of high-profile GLP-1RAs in causing suicidal thoughts and thoughts of self-harm.
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Cingulate prepares for FDA approval for its once-daily ADHD pill
Pharmaceutical Technology
JULY 12, 2023
To that end, the company presented positive top-line Phase III results for its once-daily stimulant for ADHD.
July 12, 2023: Workshop Materials Now Available From ‘Driving Tomorrow’s Outcomes Through Clinical Research in Real-World Settings’
Rethinking Clinical Trials
JULY 12, 2023
Complete materials are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Driving Tomorrow’s Outcomes Through Clinical Research in Real-World Settings. “ The 2-day workshop, held in June at the 2023 AcademyHealth Annual Research Meeting in Seattle, introduced concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a focus on methods relevant to health services researchers.
Illumina hit by EU with maximum fine for Grail acquisition
Bio Pharma Dive
JULY 12, 2023
The European Commission called Illumina’s closing of the deal without its approval an “unprecedented” move that undermines its system for regulating the competitive landscape.
July 12, 2023: In This Week’s PCT Grand Rounds, Lessons From the COORDINATE-Diabetes Trial
Rethinking Clinical Trials
JULY 12, 2023
Dr. Christopher Granger and Dr. Neha Pagidipati In this Friday’s PCT Grand Rounds, Christopher Granger and Neha Pagidipati of Duke University will present “Lessons From the COORDINATE-Diabetes Trial.” The Grand Rounds session will be held on Friday, July 14, 2023, at 1:00 pm eastern. The Coordinating Cardiology Clinics Randomized Trial of Interventions to Improve Outcomes (COORDINATE)–Diabetes was a cluster randomized trial assessing the effect of a multifaceted intervention of
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
Synlogic’s phenylketonuria therapy gains FDA fast track status
Pharmaceutical Technology
JULY 12, 2023
The US FDA has awarded fast track designation to clinical-stage biotechnology firm Synlogic’s labafenogene marselecobac for phenylketonuria.
India emerging as a preferred destination for CRAMS due to combination of factors: Experts
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 12, 2023
Indian pharmaceutical & nutraceutical companies are increasingly recognizing the advantages of outsourcing various aspects of their operations, intensifying their focus on this strategic approach to offer a competitive cost structure, which makes it an attractive destination for outsourcing, said Vivek Srivastava, senior vice president, innovation, business strategy and scientific affairs & Yuvraj Datta, director, manufacturing […]
Takeda withdraws BLA for dengue vaccine
Pharmaceutical Technology
JULY 12, 2023
Takeda has withdrawn the biologics licence application (BLA) submitted to the US FDA for TAK-003, a tetravalent dengue vaccine candidate.
Women in Science: Lisa Moneymaker and her 'atypical' journey in the pharma industry
BioPharma Reporter
JULY 12, 2023
Lisa Moneymaker is full of energy, enthusiasm, and wisdom. She is well-known on the pharma circuit and itâs easy to see why. She has been chief technology officer and chief product officer at Saama since October last year and feels passionately about women in science and women in general â and although her journey was without many challenges, she appreciates that is not the case for everyone.
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
Canada’s Solve FSHD provides $1.4m for rare muscle dystrophy therapy
Pharmaceutical Technology
JULY 12, 2023
Canada's Solve FSHD has awarded four grants to augment the understanding of facioscapulohumeral muscular dystrophy (FSHD).
Acasti appoints WuXi to oversee STRIVE-ON trial
Outsourcing Pharma
JULY 12, 2023
Acasti Pharma, a late-stage biopharma company with drug candidates addressing rare and orphan diseases, has selected WuXi Clinical Development to conduct its STRIVE-ON phase 3 safety trial for GTX-104, a novel injectable nimodipine formulation for intravenous infusion (IV) that addresses high, unmet medical needs for aneurysmal subarachnoid haemorrhage (aSAH).
Septerna raises $150m in Series B funding round
Pharmaceutical Technology
JULY 12, 2023
Septerna has raised $150m in a Series B funding round to develop its pipeline comprising new therapies that act on GPCRs.
Ora partners with North West London Clinical Trials Alliance to enhance ophthalmology treatments
Outsourcing Pharma
JULY 12, 2023
Ora, a clinical research organization (CRO) for ophthalmology pharmaceutical and device development, has partnered the North West London Clinical Trials Alliance, to improve the quality and access to clinical research in the region.
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.
Crossbow raises Series A funds to develop cancer antibodies
Pharmaceutical Technology
JULY 12, 2023
Crossbow Therapeutics has raised Series A funds worth $80m to develop a new class of antibody treatments for cancer.
Assessing the Accuracy of Pharmaceutical-Sponsored Health Information Online
Pharma Marketing Network
JULY 12, 2023
The internet is a vast resource of information on health and wellness. However, not all of this information is created equal. Some of it is accurate and reliable, while other information may be misleading or even harmful. This is especially true when it comes to pharmaceutical-sponsored health information. Pharmaceutical companies have a vested interest in promoting their products, so it’s important to be critical of any information they put out.
NHS doubles down on Netflix-style antibiotic subscription model
Pharmaceutical Technology
JULY 12, 2023
The NHS is set to expand a project to tackle antimicrobial resistance, following the success of a pilot.
Beyond the Pill: Creating Value with Patient-Centric Pharmaceutical Marketing
Pharma Marketing Network
JULY 12, 2023
The pharmaceutical industry is facing a number of challenges, including increasing competition, rising costs, and changing regulations. In order to succeed in this challenging environment, pharmaceutical companies need to adopt a patient-centric approach to marketing. Patient-centric pharmaceutical marketing is based on the understanding that patients are more than just consumers of drugs.
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.
Skyelarke makes public significant changes to SkyePay
Pharmaceutical Technology
JULY 12, 2023
The SkyePay system allows patients to receive payments for participating in clinical trials.
2SAN launches first FDA cleared at-home fertility test
Outsourcing Pharma
JULY 12, 2023
2San, a supplier of self-diagnostic tests, has partnered with Proov to distribute their proprietary at-home fertility tests in select Hy-Vee stores across eight states in the Midwest.
Stada expands its European treatment portfolio
Pharma Times
JULY 12, 2023
Company adds a number of additional brands from Sanofi following initial take overs in 2021 - News - PharmaTimes
Galmed uses AI to recruit underserved patients into clinical trials
Outsourcing Pharma
JULY 12, 2023
The Israeli company Galmed Pharmaceuticals is deploying artificial intelligence (AI) tools developed by the U.S. company OnKai to help carry out clinical trials of a rare disease treatment in communities that have low access to healthcare.
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.
TheracosBio teams with Mark Cuban's Cost Plus to launch Brenzavvy at bargain price
Fierce Pharma
JULY 12, 2023
As another SGLT2 diabetes drug hits the market, the obvious question is: How will it find a way to compete against formidable blockbusters Farxiga and Jardiance? | TheracosBio and Mark Cuban's online distributor Cost Plus Drug Company have partnered to provide newly approved SGLT2 inhibitor Brenzavvy at a major discount to competitors in the class, including AstraZeneca's Farxiga and Eli Lilly and Boehringer Ingelheim's Jardiance.
FDA Gives Alzheimer’s Drug Leqembi Full Approval. That Means Medicare Coverage But.
Pharmaceutical Commerce
JULY 12, 2023
Medicare-eligible patients need to be enrolled in registry to get Medicare coverage for the anti-beta amyloid drug that is priced to cost $26,500 a year.
Merck applies more pressure against IRA, asking for decision without trial in fight with US government
Fierce Pharma
JULY 12, 2023
Merck is bringing more heat in its battle against drug price negotiation provisions in the Inflation Reduction Act (IRA), filing Tuesday in federal court in Washington, D.C. | Merck is bringing more heat in its battle against drug price negotiation provisions in the Inflation Reduction Act (IRA), filing Tuesday for a decision without a trial. In its request for a summary judgment, Merck reiterated its claim that the drug price negotiation program violates the First and Fifth Amendments of the Co
World Courier Launches Pharma Logistics Station in the Midwest
Pharmaceutical Commerce
JULY 12, 2023
AmerisourceBergen’s new 34,000 square-foot plant in Chicago area will support shipments that require temperature storage/delivery as cold as cryogenic.
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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