Wed.Jun 08, 2022

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Astellas, despite recent setbacks, opens $100M gene therapy plant

Bio Pharma Dive

The opening of the plant, which could create more than 200 new jobs, comes on the heels of several significant issues with the company’s most advanced gene therapy program.

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CPHI China opens for international partnering after China rises in CPHI Index

Pharma Mirror

Shanghai/Amsterdam: CPHI & P-MEC China opens its online international partnering platform as pharmaceutical and biopharmaceutical industries in the country report strong underlying conditions and see increases in all categories of the most recent CPHI Pharma Index [1] – an annual score of each country’s pharma industry strength – with its overall score rising by 7.2%, the largest increase of any nation.

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Moderna says 'bivalent' booster sparks stronger immune response against omicron

Bio Pharma Dive

The biotech claims study results could position its reformulated vaccine as a booster in the fall, though it’s unclear how well the shot can prevent sickness caused by omicron or newer strains of the variant.

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Novotech Sponsors Endpoints ASCO 2022 Expert Panel on Accelerating Oncology Clinical Trials in China

Pharma Mirror

SYDNEY, Novotech, the leading Asia Pacific biotech specialist CRO which has recently expanded its services to the US, is sponsoring the Endpoints ASCO 22 “Accelerating clinical development in China and the US” Register here [link] JUNE 711:00am – 11:45am ET (1:00 – 1:45 local time)Novotech Booth at ASCO #14115 The virtual session will cover the latest on the clinical trial landscape and infrastructure in China and includes Novotech’s DCT partner, Obvio Health, on DC

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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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Apple adds medication tracking to iPhone and Apple Watch

pharmaphorum

Owners of an iPhone or Apple Watch have a new health feature, an app called Medications, that will help them manage and track their use of medicines. The new tool works as a component of Apple’s Health app and will let users add drugs or other health products like vitamins and supplements to a personal list – either by scanning a label or finding the product in a directory – and create custom schedules for them.

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Westminster Drug Project and Gilead Sciences join forces to take on hepatitis C

Pharma Times

The companies have partnered for a second time to support sector-wide efforts to eliminate hepatitis C virus in drug and alcohol services

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More Trending

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Abbott makes progress with wearable for diabetic ketoacidosis

pharmaphorum

Abbott is already a big player in the wearable glucose-monitoring sector, and has started working on a new device that will measure both glucose and ketones, potentially serving as a warning system for a life-threatening complication of diabetes known as ketoacidosis. The system – which already has a breakthrough device designation from the FDA – will take the form of a small patch-like device similar to Abbott’s FreeStyle Libre 3 device (pictured above), and a prototype version is already

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Ensysce’s Novel Opioid Appears Impervious to Abuse

BioSpace

Ensysce Biosciences is developing solutions that make opioids safer, and virtually impossible to abuse. BioSpace spoke with CEO Lynn Kirkpatrick about the company's novel technology.

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Sleep tracking and the potential for digital endpoints

pharmaphorum

Sleep and its importance to health is becoming a greater focus of research. With more research being published, the public is becoming more aware of sleep’s functions and there are a number of apps and devices that now allow users to gauge the quality of their rest. Ben Hargreaves uncovers why this interest in sleep could be more than a fad and might actually play a key role in research and clinical studies in the future.

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Riabni, the Biosimilar to Rituxan Gets FDA Approval for Rheumatoid Arthritis

XTalks

Amgen’s Riabni, a CD20-directed cytolytic antibody and biosimilar to Rituxan, got approval from the FDA on Monday for adults with moderate to severe rheumatoid arthritis. Rheumatoid arthritis (RA) is one of the most prominent systemic autoimmune diseases and affects about 1.5 million Americans. There are hereditary, environmental and lifestyle factors that are suggested to play a role in the triggering the disease.

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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.

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Innovation Passport  awarded Alnylam and its hypertension therapy

Pharma Times

The company received the Innovation Passport in the UK for zilebesiran, an investigational treatment of hypertension

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Lessons from the past: How cold-water corals respond to global warming

Scienmag

Cold-water corals, and the species Lophelia pertusa in particular, are the architects of complex reef structures. They build the foundations of important habitats for deep-sea organisms that find protection as well as food within the structures. Coral reefs, however, react very sensitively to changing conditions. These include warming of the ocean waters, acidification, declining oxygen […].

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Degron Therapeutics Launches into Sizzling Hot Protein Degradation Space

BioSpace

Degron Therapeutics, based in Shanghai, announced Thursday that it has secured $22 million in Series A financing for its unique molecular glue-based targeted protein degradation platform GlueXplorer.

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The “glass obstacle course” facing women in marine science

Scienmag

Major change is needed to counteract the lack of gender equality in marine science, according to new research from The Australian National University (ANU). Credit: Tracey Nearmy / The Australian National University Major change is needed to counteract the lack of gender equality in marine science, according to new research from The Australian National University […].

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The New Age of Decentralized Clinical Trials

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.

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All Aboard! Takeda’s Dengue Fever Vaccine Holds Up Over 4.5 Years

BioSpace

Takeda announced results from its Phase III clinical trial on TAK-003, its dengue fever vaccine candidate, at the Northern European Conference of Travel Medicine.

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The largest ever series of phage therapy case studies shows a success rate of more than half

Scienmag

The number of reported cases using viruses to treat deadly Mycobacterium infections just went up by a factor of five. In a new study, a team led by researchers from the University of Pittsburgh and the University of California San Diego report 20 new case studies on the use of the experimental treatment, showing the […].

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Game Day for bluebird bio: FDA to Assess First Lentiviral Vectors

BioSpace

Bluebird bio faces a two-day crucible as the U.S. Food and Drug Administration’s Cell, Tissue and Gene Therapies Advisory Committee will give two lentiviral vector gene therapies a thumbs up or down.

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New CDC study details county-level distribution of seven diseases spread by blacklegged ticks

Scienmag

Annapolis, MD; June 8, 2022—As surveillance for ticks and the disease-causing germs they spread improves, so does Americans’ access to knowledge about where the risk of tickborne disease is greatest. Credit: Susan Ellis, Bugwood.org Annapolis, MD; June 8, 2022—As surveillance for ticks and the disease-causing germs they spread improves, so does Americans’ access to knowledge […].

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Accelerating Clinical Supply Through Integrated Drug Development

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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AbbVie, Biohaven, Teva and Satsuma Tackle Migraine at AHS

BioSpace

The annual meeting of the American Headache Society (AHS) is being held in Denver, Colorado from June 9-12. Here’s a look at just some of the wide-ranging research being presented.

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New LLU study associates intake of dairy milk with greater risk of prostate cancer

Scienmag

Men with higher intakes of dairy foods, especially milk, face a significantly higher risk of prostate cancer compared to men with lower intakes, according to a new study conducted by researchers at Loma Linda University Health. The study found no such associations between increased prostate cancer risk and intake of non-dairy calcium, suggesting substances other […].

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Precision Announces Promising Data on Potential Allogeneic CAR T Pioneer

BioSpace

Precision BioSciences' clinical program exploring allogeneic CAR T therapy may well produce a market pioneer after initial data showed its ability to deliver a 100% overall response rate.

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PCR test for Okinawa mozuku could increase yields and lead to climate-tolerant strains

Scienmag

A simple PCR test could be used to improve cultivation of the edible brown seaweed, Okinawa mozuku, and even aid attempts at generating heat-tolerant strains, reported scientists from the Okinawa Institute of Science and Technology Graduate University (OIST). The PCR test, described in a new study published June 9, 2022, in Phycological Research, detects nine […].

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How Machine Learning Drives Clinical Trial Efficiency

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.

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Building in resilience can protect against disruption: Rockwell

Outsourcing Pharma

An expert from Rockwell Automation explains how integrating flexibility, using advanced technology, can help pharma manufacturing operations weather a storm.

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Swim Across America provides grant funding that helps lead to 100% cancer remission

Scienmag

The New England Journal of Medicine published a paper on June 5 that 12 patients completed a phase 2 clinical trial for advanced rectal cancer and showed a 100% clinical complete response to dostarlimab, an immunotherapy treatment produced by GlaxoSmithKline. The clinical trial was conducted at Memorial Sloan Kettering with early-stage grant funding from Swim […].

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Forbion Closes $500M Growth Fund to Boost Late-Stage European Companies

BioSpace

???????The Forbion Growth Opportunities Fund II will invest mainly in later-stage biopharmaceutical firms in Europe, focusing on marketing treatments for diseases with high unmet needs.

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NASA’s Webb telescope: Engineered to endure micrometeoroid impacts

Scienmag

Micrometeoroid strikes are an unavoidable aspect of operating any spacecraft, which routinely sustain many impacts over the course of long and productive science missions in space. Between May 23 and 25, NASA’s James Webb Space Telescope sustained an impact to one of its primary mirror segments. After initial assessments, the team found the telescope is […].

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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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Novartis’ Sandoz Launches Biosimilars Awareness Campaign to Improve Biosimilars Adoption Worldwide

XTalks

Novartis’ biosimilars and generics drug division Sandoz has announced a new global campaign called ‘Act4Biosimilars’ to help raise awareness about biosimilars and increase their adoption by at least 30 percent in over 30 countries by the year 2030. In a press release , the company says the goal of the Act4Biosimilars campaign is to help “address global health inequity and inequality” by increasing access to advanced medicines like biosimilars.

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Rapid-fire fast radio burst shows hot space between galaxies

Scienmag

ITHACA, N.Y. – A recently discovered, rare and persistent rapid-fire fast radio burst source – sending out an occasional and informative cosmic ping from more than 3.5 billion light years away – helps to reveal the secrets of the broiling hot space between the galaxies. That’s according to an international team of astronomers who published […].

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Actor Greg Grunberg Discusses New Series: "The Care Giver"

BioSpace

Greg Grunberg, who has appeared in multiple Star Wars projects, has partnered with Jazz Pharmaceuticals to bring "The Care Giver", a video web series, to life.

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FTC launches probe into pharmacy benefit management sector

pharmaphorum

Longstanding claims that one of the reasons for high drug prices in the US is the actions of pharmacy benefit management (PBM) companies – the middlemen in the supply chain – are being formally investigated by the Federal Trade Commission (FTC). The FTC has asked the six largest PBMs operating in the US market – CVS Caremark, Express Scripts, OptumRx, Humana, Prime Therapeutics and MedImpact Healthcare Systems – to hand over detailed records about their business practices over the last five year

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.