Bio Pharma Dive
OCTOBER 6, 2022
Nested Therapeutics touts a deep bench of scientific leaders and advisers, including Kevan Shokat, whose work drugging KRAS — a cancer-related gene once thought to be undruggable — helped lead to the development of Amgen’s Lumakras.
Pharmaceutical Technology
OCTOBER 7, 2022
Provention Bio and Sanofi US have signed a co-promotion agreement to launch the former’s lead investigational drug candidate, teplizumab for the delay in the onset of clinical type 1 diabetes (T1D). The agreement aids Provention in leveraging the capabilities and commercial resources of Sanofi to back teplizumab’s launch. The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk.
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AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 3, 2022
After 50 years of research, eminent Stanford University sleep researcher William Dement reportedly said the only solid explanation he knows for why we sleep is “because we get sleepy” Even though sleep may be, as one researcher put it, “the only major behavior in search of a function”, it clearly does matter for our health […].
NPR Health - Shots
OCTOBER 2, 2022
More than 1.2 million people struggled to put food on the table at some point last year in the Washington, D.C. region. Tens of millions more are struggling across the country.
Bio Pharma Dive
OCTOBER 3, 2022
Shares in LogicBio had lost nearly all their value since a 2018 IPO, bringing the company to the brink of Nasdaq delisting. The buyout deal represents a premium of over 600%.
Pharmaceutical Technology
OCTOBER 6, 2022
Pfizer has acquired all the outstanding shares of the common stock of biopharmaceutical firm Global Blood Therapeutics (GBT) in a deal worth nearly $5.4bn. The total enterprise value comprised debt and the net of cash acquired. With the latest acquisition, GBT became a wholly-owned Pfizer subsidiary. GBT discovers and develops life-changing therapies for ailments with an initial focus on sickle cell disease (SCD).
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
STAT News
OCTOBER 4, 2022
A little over a century ago, scientists working in laboratories discovered that microbes were the cause of many epidemics. Once they understood that, they began to put their faith more and more in laboratory science. This major transformation, called the bacteriological revolution, began in the 1880s. During this period, diphtheria was one of the leading causes of death among mostly poor children in New York City.
Bio Pharma Dive
OCTOBER 1, 2022
The resubmission has been long awaited after BioMarin’s original application was unexpectedly rejected by the FDA two years ago. The company expects a decision around the middle of next year.
Pharmaceutical Technology
OCTOBER 5, 2022
In 2010, two patients with end-stage refractory chronic lymphocytic leukaemia (CLL) were administered Novartis’ autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, Kymriah (tisagenlecleucel), as part of a Phase I trial. In March this year, it was reported that these two patients were still in remission, making this the longest known CLL remission after CAR-T therapy and demonstrating to the industry that long-term remission is indeed possible.
NPR Health - Shots
OCTOBER 1, 2022
In 2014, it was hard to miss the ALS Ice Bucket Challenge that set out to raise money to fund research for the disease. And it paid off. A new treatment was funded by $2.2 million of the funds raised.
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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
STAT News
OCTOBER 3, 2022
A Swedish scientist won the 2022 Nobel Prize in medicine or physiology on Monday for his groundbreaking research into the evolutionary history of humankind. Svante Pääbo, of the Max Planck Institute for Evolutionary Anthropology in Leipzig, Germany, accomplished something widely believed to be impossible: recovering and reading DNA from 40,000-year-old bones.
Bio Pharma Dive
OCTOBER 6, 2022
A new fast track designation allows Lilly to begin the process of seeking approval of tirzepatide for obesity, though the drug will need to succeed in a second trial to get to market.
Pharmaceutical Technology
OCTOBER 4, 2022
Pfizer has acquired commercial-stage biopharmaceutical firm Biohaven Pharmaceutical for $148.50 for each share or a total consideration of nearly $11.6bn in cash. In May, Pfizer entered a definitive agreement to acquire all outstanding shares of Biohaven which were not previously held by the former. . With the takeover, Biohaven became a wholly-owned Pfizer subsidiary.
NPR Health - Shots
OCTOBER 3, 2022
Planned Parenthood says it will provide abortions out of an RV-based clinic in southern Illinois by the end of the year. It will reduce travel time for some patients coming from surrounding states.
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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.
STAT News
OCTOBER 4, 2022
The press release issued by pharmaceutical companies Eisai and Biogen on Sept. 27 might someday be remembered as the beginning of a revolution in Alzheimer’s diagnosis and treatment. Years and years of failed Alzheimer’s trials created, and then fortified , doubts about whether drugs that attacked amyloid, a brain protein linked to Alzheimer’s disease, were a valid approach to its treatment.
Bio Pharma Dive
OCTOBER 3, 2022
Part of a $1 billion alliance the companies formed in 2020, the drug will be tested in a large study of patients who test positive for mutations in a gene called LRRK2.
Pharmaceutical Technology
OCTOBER 4, 2022
The type 2 diabetes (T2D) space recently witnessed a new approval: on 15 September, the European Commission (EC) authorised Eli Lilly’s Mounjaro (tirzepatide) for T2D patients. Mounjaro is a dual gastric inhibitory polypeptide (GIP)/glucagon-like peptide 1 (GLP-1) receptor agonist. This event is of paramount interest, and not only for T2D patients, as it could address vital unmet needs for other GIP/GLP-1 receptor agonist–treated diseases, including obesity.
NPR Health - Shots
OCTOBER 5, 2022
A study finds small but meaningful declines in personality traits that help us navigate social situations, trust others, think creatively, and act responsibly. Young people were especially affected.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
STAT News
OCTOBER 4, 2022
After years spent building a seemingly slapdash set of medical initiatives, Verily seems to have a game plan. The Alphabet life sciences spinout is doubling down on the business of evidence generation , trying to build the tools and technical infrastructure that will help pharma and digital health customers run the next generation of clinical trials.
Bio Pharma Dive
OCTOBER 7, 2022
The biotech believes the two Phase 2 trials initiated Thursday can support approval applications for what could be the first so-called allogeneic cancer cell therapy.
Pharmaceutical Technology
OCTOBER 3, 2022
The UK National Institute for Health and Care Excellence (NICE) has recommended zanubrutinib (Brukinsa) as an option to treat Waldenstrom’s macroglobulinaemia (WM) patients. With the latest development, zanubrutinib became the first WM drug to receive the recommendation for routine National Health Service (NHS) usage in England. The recommendation will also be applicable in Wales and Northern Ireland.
NPR Health - Shots
OCTOBER 1, 2022
Some flu experts are urging many people to get their shots earlier than usual this year because of the potential for an early, possibly severe flu season. But what's the best timing for you?
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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
STAT News
OCTOBER 6, 2022
The American Revolution had July 4. The allies had D-Day. And now U.S. patients, held down for decades by information hoarders, can rally around a new turning point, October 6, 2022 — the day they got their health data back. Under federal rules taking effect Thursday, health care organizations must give patients unfettered access to their full health records in digital format.
Bio Pharma Dive
OCTOBER 4, 2022
Chroma Medicine, which launched last year with $125 million in funding, has drawn several high-profile biotech leaders to it, including ex-Alnylam CEO John Maraganore and deal maven George Golumbeski.
Pharmaceutical Technology
OCTOBER 1, 2022
The US Food and Drug Administration (FDA) has granted approval for Amylyx Pharmaceuticals’ Relyvrio (sodium phenylbutyrate and taurursodiol) to treat adult patients with amyotrophic lateral sclerosis (ALS). Indicated for use as a monotherapy or along with currently approved therapies, Relyvrio can be administered orally by mixing a packet in eight ounces of water.
NPR Health - Shots
OCTOBER 4, 2022
A New York woman seeking to end a dangerous ectopic pregnancy in a fallopian tube finds the procedure more complicated and expensive than expected — even in a state with liberal abortion laws.
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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.
STAT News
OCTOBER 6, 2022
The United States is in a (relative) Covid-19 lull, with cases and hospitalizations falling as the wave driven by the BA.5 lineage of the Omicron variant recedes. But as if we needed a portent of an anticipated fall and winter wave , Covid is on the rise in some European countries. What’s different, at least for now, is that there’s not one variant pushing the wave.
Bio Pharma Dive
OCTOBER 4, 2022
AstraZeneca paved the way for PARPs in prostate cancer when it won an approval for Lynparza in advanced patients. Now Pfizer may have a combination treatment for earlier-stage disease.
Pharmaceutical Technology
OCTOBER 6, 2022
BioLink Life Sciences has received a contract worth $750,000 from the US Biomedical Advanced Research and Development Authority (BARDA) to develop Ramatroban for treating Covid-19 pneumonia patients in the hospital setting. A dual blocker of thromboxane and prostanoid receptors, Ramatroban showed efficacy in animal models of atherosclerosis, respiratory dysfunction, thrombosis and sepsis.
NPR Health - Shots
OCTOBER 1, 2022
U.S. overdose deaths have exceeded 100,000 a year, yet few hospitals are equipped to treat patients with addiction. A new kind of treatment team connect patients with help before they're discharged.
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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.
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