Tue.Feb 01, 2022

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Sarepta reveals gene editing alliance with biotech exploring alternative delivery methods

Bio Pharma Dive

The collaboration with GenEdit, a South San Francisco startup developing new ways of delivering gene editing tools into the body, dates back to December 2020, but has recently begun to advance.

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A perfect storm for biotech stocks

World of DTC Marketing

According to STAT News “after a double-digit decline in 2021, the sector has fallen another 20% in the new year, erasing billions in value and leading even the most seasoned investors to question whether biotech has further to fall. Can small biotech companies survive? Many large pharmaceutical companies reported record performances in 2021, whether that’s a decade-high stock price or shares that outperformed the broader market as investors continued to pour money into companies maki

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The pipeline of new antibiotics is drying up. A bill in Congress aims to change that.

Bio Pharma Dive

Despite the growing threat of drug-resistant bacteria, few new antibiotics are reaching the market because of hurdles that biotech executives and experts say stand in the way.

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Coordinated conservation and restoration critical to save Asia’s threatened native trees

Scienmag

A new study has revealed that the rich native tree diversity in South and Southeast Asia is at risk of potential extinction. The region-wide and spatially explicit threat assessment focused on 63 socio-economically important native trees in Asia, showing that all species are highly vulnerable to at least one of the common threats in the […].

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Pfizer lures research chief from Roche, prompting high-level reshuffle

Bio Pharma Dive

William Pao led discovery and early development at the Swiss drugmaker, and will now head Pfizer's global efforts to launch new products.

Research 321
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BARDA scopes market as it looks to partner next-generation COVID-19 vaccine developers

BioPharma Reporter

US government agency, BARDA, is drawing on industry feedback to assist it in understanding the advanced developmental landscape of next-generation COVID-19 vaccines.

More Trending

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Global campaign aims to increase equity in cancer care

Outsourcing Pharma

On World Cancer Day, the Union for International Cancer Control is launching a three-year campaign with the goal to improve cancer care around the globe.

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6 Digital Health Takeaways From CES 2022 That Will Change Healthcare as We Know It

Intouch Solutions

Digital health investments skyrocketed in 2021, increasing 79% from 2020, according to a year-end report by CB Insights , a marketing intelligence firm. This growing digital transformation within the healthcare industry was highlighted at CES 2022, with one of the main-stage keynote presentations by Robert Ford, President and CEO of Abbott. Ford discussed his vision and the promise of healthcare technology: to bring care that’s more personal and precise, proactively manage health, detect disease

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Recipharm acquires Portuguese CDMO as it looks to grow its biologics business

BioPharma Reporter

Contract development and manufacturing organization (CDMO), Recipharm, has acquired GenIbet, a Portuguese CDMO, specializing in the manufacture of biological clinical trial material.

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Omicron BA.2 variant more transmissible, say UK and Danish studies

pharmaphorum

The new BA.2 subvariant of Omicron is around 50% more transmissible than the original BA.1 strain, and there is somewhat conflicting evidence on its ability to evade the protection from vaccines, according to new studies. BA.2 is now the dominant strain of the COVID-19 virus in Denmark, and scientists from the country’s Statens Serum Institute (SSI) have compared the two subvariants in more than 8,500 households including almost 18,000 people.

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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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New research links continents to key transitions in Earth’s oceans, atmosphere and climate

Scienmag

A new study led by University of Wisconsin Oshkosh geologist Timothy Paulsen and Michigan Tech geologist Chad Deering advances the understanding of the role that continents have played in the chemical evolution of Earth’s oceans, with implications for understanding atmospheric oxygenation and global climate oscillations. Credit: Timothy Paulsen, UW Oshkosh A new study led by […].

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Byannli authorised in Britain for schizophrenia treatment

Pharma Times

Market authorisation for twice yearly schizophrenia treatment which offers patients much-needed medication continuity

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Still Not Skyrocketing: New CMS Data Reinforce the Truth About U.S. Drug Spending

Drug Channels

The boffins at the Centers for Medicare & Medicaid Services (CMS) recently dropped the latest National Health Expenditure (NHE) data, which measures all U.S. spending on healthcare. (See links below.) These data provide our first official look at how the pandemic has affected U.S. healthcare spending. Today, I examine the key insights from these latest figures.

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Synthetic control arms in clinical trials: Making it happen

pharmaphorum

Across the industry, pharma companies are turning to AI and real-world data to address many of the challenges of running clinical trials. But what does it take to implement these innovations? Can the combined potential of new AI technologies and real-world patient data hold the key to overcoming the challenges in clinical trial design that have historically led to trial failure?

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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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UK plants flowering a month earlier due to climate change

Scienmag

Climate change is causing plants in the UK to flower a month earlier on average, which could have profound consequences for wildlife, agriculture and gardeners. Credit: Ulf Büntgen Climate change is causing plants in the UK to flower a month earlier on average, which could have profound consequences for wildlife, agriculture and gardeners. Using a […].

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Broadening horizons: positive CHMP opinion for expanding Ayvakyt

Pharma Times

Ayvakyt receives a positive opinion from the CHMP for the treatment of adults with advanced systemic mastocytosis

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Climate change has likely begun to suffocate the world’s fisheries

Scienmag

By 2080, around 70% of the world’s oceans could be suffocating from a lack of oxygen as a result of climate change, potentially impacting marine ecosystems worldwide, according to a new study. The new models find mid-ocean depths that support many fisheries worldwide are already losing oxygen at unnatural rates and passed a critical threshold […].

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Cytiva and NecstGen team up to accelerate development of cell and gene therapies

BioPharma Reporter

Cytiva and NecstGen have announced a strategic collaboration to accelerate the development of new cell and gene therapies globally.

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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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American Roentgen Ray Society awards 2022 ARRS Gold Medal to Edward Lee

Scienmag

Leesburg, VA, February 1, 2022—The American Roentgen Ray Society (ARRS) proudly announces that Edward Y. Lee, MD, MPH of Boston Children’s Hospital and Harvard Medical School has been awarded the 2022 ARRS Gold Medal. Credit: Dr. Edward Y. Lee, American Roentgen Ray Society (ARRS), American Journal of Roentgenology (AJR) Leesburg, VA, February 1, 2022—The American […].

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Rare and orphan conditions take center stage during webinar

Outsourcing Pharma

During OSPâs exclusive February 23 webinar Rare and Orphan Diseases, leading expertswill lend their unique experience and expertise to the important topic.

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New super-conductors could take data beyond zeroes and ones

Scienmag

DURHAM, N.C. – Remember flip-phones? Our smartphones may one day look just as obsolete thanks to spintronics, an incipient field of research promising to revolutionize the way our electronic devices send and receive signals. Credit: Ko et al. PNAS Feb. 4, 2022 DURHAM, N.C. – Remember flip-phones? Our smartphones may one day look just as […].

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Tribes Reach $590 Million Opioid Settlement With Johnson & Johnson

NY Times

Money from the tentative deal would go toward addiction and treatment and would be overseen by Native American tribal leaders.

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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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Picture warnings on sodas? A promising tool to fight childhood obesity

Scienmag

A study published in the journal PLOS Medicine is the first to examine in a realistic setting whether pictorial health warnings on sugary drinks — like juice and soda — influence which beverages parents buy for their children. The findings are promising: The warnings reduced parental purchases of sugary drinks for their kids by 17%. […].

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Real-World Evidence 2022: Rare Diseases and Innovative Therapies

pharmaphorum

Real-World Evidence 2022: Rare Diseases and Innovative Therapies (RWE 2022) will convene the full spectrum of stakeholders working in RWE in rare diseases and innovative therapies, including pharma and biotech, medical device companies, health technology assessors (HTAs), regulators, payers, academics, patient advocacy groups and service providers – to discuss how we accelerate RWE and regulatory approval in a post-COVID and post-Brexit world.

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Instability of brain activity during sleep and anesthesia underlies the pathobiology of Alzheimer’s disease

Scienmag

A new study at Tel Aviv University revealed a pathological brain activity that precedes the onset of Alzheimer’s first symptoms by many years: increased activity in the hippocampus during anesthesia and sleep, resulting from failure in the mechanism that stabilizes the neural network. The researchers believe that the discovery of this abnormal activity during specific […].

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How to accelerate mouse model generation without reducing quality

Drug Discovery World podcast

The latest DDW Sitting Down With sponsored podcast features Dominque Bröhl and Evert-Jan Uringa, Scientific Program Managers at Taconic Biosciences, who discuss how mouse model generation can be accelerated without any loss of quality. They offer insight into the latest developments, innovation and challenges in mouse model generation, how timelines can be accelerated without compromising on quality and explain more about Taconic’s involvement in this field.

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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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Virginia Tech professor lands two grants for the study of brain trauma

Scienmag

Michelle Theus, an associate professor of molecular and cellular neurobiology in the Department of Biomedical Sciences and Pathobiology within the Virginia-Maryland College of Veterinary Medicine, recently secured two grants totaling nearly $4.5 million from the National Institute of Health (NIH) for research related to traumatic brain injuries. Credit: Virginia Tech Michelle Theus, an associate professor […].

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Update: Mutual Recognition Agreement CH-EU

Pharma Business Blog

1) General background information. As a consequence of the failed MRA between CH and the EU, EU certificates (i.e., medicinal products with SQS certificate) which were issued by the respective Swiss body, shall no longer be recognized in the EU and an EU representative is required. Swiss Medtech companies have recently engaged national associations in order to take action against the so-called SQS ban by the EU Commission.

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€16 million for photonic quantum processors

Scienmag

— JOINT PRESS RELEASE OF THE UNIVERSITY OF STUTTGART AND JOHANNES GUTENBERG UNIVERSITY MAINZ — Credit: photo/©: Max Kovalenko / University of Stuttgart — JOINT PRESS RELEASE OF THE UNIVERSITY OF STUTTGART AND JOHANNES GUTENBERG UNIVERSITY MAINZ — Quantum computers will one day be able to solve problems at high speed that cannot be handled […].

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New patent expiration for Gilead Sciences drug BIKTARVY

Drug Patent Watch

Annual Drug Patent Expirations for BIKTARVY Biktarvy is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from two suppliers. There are thirteen…. The post New patent expiration for Gilead Sciences drug BIKTARVY appeared first on DrugPatentWatch - Make Better Decisions.

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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.