Bio Pharma Dive
AUGUST 9, 2022
The CEO recently led Upstream through a $200 million financing that will support development of an inflammatory disease drug. “We have what investors probably want at this time,” she told BioPharma Dive.
Pharmaceutical Technology
AUGUST 9, 2022
Health Canada has accepted the New Drug Submission (NDS) of Endo International subsidiary Paladin Labs for cenobamate tablets as an adjunctive treatment to manage partial-onset seizures in adult epilepsy patients. The treatment is intended for such patients who are not well-controlled with standard therapy. The regulatory agency is anticipated to provide a decision on whether cenobamate tablets can be commercialised and sold in Canada under this NDS in the middle of next year.
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Bio Pharma Dive
AUGUST 9, 2022
Boston-based Cerevance uses samples of healthy and diseased human brain tissue to find new targets for central nervous system diseases.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 9, 2022
When babies in the African countries of Guinea Bissau and Uganda were given the tuberculosis vaccine, something remarkable happened. Instead of the vaccine only protecting against the target bacteria – Myocbacterium tuberculosis – the tuberculosis vaccine offered broad protection against a range of unrelated infections, including respiratory infections and serious complications such as sepsis.
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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
Bio Pharma Dive
AUGUST 9, 2022
The experimental vaccine is the most advanced candidate for the tick-borne disease and, if successful, would be the first to reach the market since withdrawal of GSK’s Lymerix.
Pharmaceutical Technology
AUGUST 9, 2022
Embracing environmental, social and governance (ESG) criteria is rising in importance as a driver of foreign direct investment (FDI) , with investors increasingly taking into account such criteria as part of their site selection decision. However, when it comes to responsible investing, there is more to it than simply ticking off the 'E', 'S' and 'G'.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
AUGUST 9, 2022
In the first half of 2022 the number of deals relating to healthtech decreased significantly by 28.7% from the same period in 2021. This marks an acceleration in growth from the 34.7% decrease in deals that occurred in H2 2021 relative to the same period a year earlier. GlobalData's deals database looks at mergers, acquisitions and venture capital and private equity investments taking place daily between thousands of companies across the world.
Bio Pharma Dive
AUGUST 9, 2022
The biotech now expects about $2 billion in revenue in 2022, less than half its previous estimates, after sales fell sharply in the second quarter.
Rethinking Clinical Trials
AUGUST 9, 2022
The Helping to End Addiction Long-Term Initiative?, or NIH HEAL Initiative?, is seeking applications for opioid misuse prevention research in community health centers. The funding opportunity announcement, RFA-DA-23-048: HEAL Initiative: Research Studies to Develop and Implement Interventions to Prevent Opioid Misuse in Community Health Centers , supports interdisciplinary teams to study the development, adaptation, and/or implementation of interventions to prevent misuse of opioids and other su
Bio Pharma Dive
AUGUST 9, 2022
Mathai Mammen is leaving to “pursue other opportunities,” J&J said in an abrupt announcement. William Hait, currently head of external innovation, will take Mammen’s place in the interim.
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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
Pharmaceutical Technology
AUGUST 9, 2022
Mentions of artificial intelligence within the filings of companies in the pharmaceutical industry fell 24% between the first and second quarters of 2022. In total, the frequency of sentences related to artificial intelligence between July 2021 and June 2022 was 400% higher than in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings.
NPR Health - Shots
AUGUST 9, 2022
Some object to paying for health insurance plans that cover preventive services that they say violate their religious beliefs, which could cause millions to lose access to care if the courts agree.
Pharmaceutical Technology
AUGUST 9, 2022
Life science group Sartorius has signed a definitive agreement for the acquisition of complete outstanding shares of UK-based company Albumedix from private investors in a deal valued at nearly $501.5m (£415m). Sartorius will carry out the takeover through its French-listed subgroup Sartorius Stedim Biotech. The acquisition of Albumedix is intended at bolstering the new advanced therapy solutions portfolio of Sartorius.
NPR Health - Shots
AUGUST 9, 2022
The Museum of Modern Art shows the colorful works of Frédéric Bruly Bouabré, a prolific artist from the Ivory Coast who documented his Bété culture — and even created a pictograph language.
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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.
Pharmaceutical Technology
AUGUST 9, 2022
Pfizer has signed a definitive agreement for the acquisition of all the outstanding shares of biopharmaceutical firm Global Blood Therapeutics (GBT) for a total enterprise value of nearly $5.4bn or $68.50 for each share in cash. GBT focuses on discovering, developing and delivering life-changing therapies, starting with sickle cell disease (SCD). The takeover of GBT complements and boosts Pfizer’s expertise in rare haematology.
STAT News
AUGUST 9, 2022
This story has been excerpted from the STAT Report “ The race for longevity: How scientists — and industry — are seeking to extend healthy lives.” Beating back the diseases of aging has become something of a pet project for many of Silicon Valley’s tech titans. Earlier this year, Altos Labs, a partial cellular reprogramming company, drew billions of dollars of investment, including from Jeff Bezos and Yuri Milner.
NPR Health - Shots
AUGUST 9, 2022
The actor said he suffered from hearing, vision and balance issues and that it took him an entire year to recover from the autoimmune condition that causes the swelling of blood vessels.
STAT News
AUGUST 9, 2022
You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences. Sign up to get this newsletter delivered in your inbox every Tuesday and Thursday.
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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.
NPR Health - Shots
AUGUST 9, 2022
There isn't currently a Lyme disease vaccine on the U.S. market. Researchers are hoping to change that.
STAT News
AUGUST 9, 2022
The U.S. heath secretary recently declared monkeypox as a public health emergency , paving the way for emergency use authorizations of additional vaccines or vaccine regimens to fight the disease. The same day, Food and Drug Administration Commissioner Robert Califf said that the U.S. government is seriously considering stretching the very limited supply of Bavarian Nordic’s Jynneos vaccine — the only vaccine licensed against monkeypox in the U.S.
NPR Health - Shots
AUGUST 9, 2022
NPR's Leila Fadel speaks with Kali Rubaii, an assistant professor at Purdue University, about the impact of U.S. military burn pits in Iraq on Iraqi civilians.
STAT News
AUGUST 9, 2022
Six years ago, an expert panel made a strong suggestion to the White House: set up a national system to care for patients with traumatic injuries, which lead to about 30,000 deaths every year. “In the civilian sector, where injury is the leading cause of death for Americans under age 46, as many as 1 in 5 deaths from traumatic injuries may be preventable with optimal trauma care,” the authors wrote.
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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.
NPR Health - Shots
AUGUST 9, 2022
NPR readers share their favorite tips on how to cope with heat without an air conditioner. Among the tips: take a shower with a sheet on, then wear it to bed.
STAT News
AUGUST 9, 2022
The $5.4 billion acquisition of Global Blood Therapeutics by Pfizer was sealed with a phone call and a commitment to reach patients with sickle cell disease wherever in the world they live. “When Albert called me, the first thing he said was, ‘You guys have really been amazing in what you’ve done in such a short period of time,’” said Ted Love, Global Blood’s CEO, recalling for me his conversation with Pfizer CEO Albert Bourla.
Drug Discovery World
AUGUST 9, 2022
Scientists have discovered how melanoma skin cancer cells invade new tissues in research they hope might lead to new treatments. . A team from The Institute of Cancer Research, London discovered that melanoma cells harness a gene usually used by growing nerves to escape from their immediate area and invade new tissues. . They found that melanoma cells use the gene ARHGEF9 to create ‘molecular drills’ which help them attach to, and punch holes through, surrounding cells and structures.?
STAT News
AUGUST 9, 2022
In recent years, many health care professionals have been confronting the challenging chapters of their institutions’ history, as societies more broadly grapple with how to deal with past institutional trauma. Whether it is problematic medical experiments; abuses of authority; systematic patterns of neglect, discrimination, or racism; or funders with questionable sources of wealth, many institutions now have to reckon with their past.
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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.
Antidote
AUGUST 9, 2022
At Antidote, we understand that it can be difficult for patients to discover how to participate in clinical trials — which is why creating a patient-centric user experience for our clinical trial search tools is one of our main priorities.
STAT News
AUGUST 9, 2022
Top of the morning to you. And a steamy one, it is. In fact, there is more steam rising from the grounds of the Pharmalot campus than from our ritual cup of stimulation. But this is to be expected at this time of year, yes? Although there is that small matter of climate change. In any event, there is work to be done. So as always, we have assembled a few items of interest for you.
Drug Channels
AUGUST 9, 2022
Over the weekend, the U.S. Senate passed a massive overhaul of the Medicare Part D program. If passed into law, these changes will have many unintended consequences , but will not address the warped incentives baked into our current rebate system. This makes it a good time to review the murky, little-seen economics of how commercial plan sponsors and payers access the billions of dollars in manufacturer rebates and fee that are negotiated by their pharmacy benefit managers (PBMs).
pharmaphorum
AUGUST 9, 2022
Magnetic resonance imaging (MRI) technology specialist Bot Image has won FDA approval for its artificial intelligence-powered software ProstatID, used for the detection and diagnosis of prostate cancer. The software is combined with traditional MRI scanning to improve the “accuracy and speed” of prostate cancer diagnosis by improving the diagnostic resolution of images, according to the company, which makes it available as a software-as-a-service (SaaS) to radiology departments.
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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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