Bio Pharma Dive
OCTOBER 16, 2023
There are many common reasons clinical trials fail, including failure to demonstrate efficacy, safety concerns, issues with inclusion and exclusion criteria and patient recruitment. Follow these five steps to increase the odds of clinical trial success.
BioSpace
OCTOBER 17, 2023
After the FDA released draft guidance on increasing diversity in clinical trials, companies have been left to figure out the details. Here’s what experts say is working.
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pharmaphorum
OCTOBER 19, 2023
How generative AI Is transforming healthcare Mike.
Bio Pharma Dive
OCTOBER 18, 2023
CEO Emil Kakkis says the company's findings are too exciting to ignore, but the “high-risk, high-return” venture needs to be pursued outside the organization.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 16, 2023
In the search for a treatment for Alzheimer’s disease, researchers have zeroed in on a protein with protective effects. A new study reveals how cholesterol and inflammation in different types of human brain cells interact with a protein called ABCA7, which regulates how molecules pass through cell membranes.
Pharmaceutical Technology
OCTOBER 17, 2023
In October 2023, Novo Nordisk announced that its trial studying Ozempic (semaglutide) in diabetic CKD patients, will come to a halt almost a year prior to its planned completion.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
OCTOBER 18, 2023
The FDA approved Hyloris’s non-opioid painkiller as the agency increases efforts to mitigate an opioid crisis.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 18, 2023
The most widely prescribed class of antidepressant has – at long last – been shown to increase connections in the human brain. The discovery offers a plausible biological explanation for the medication’s delayed treatment response and could help develop new targeted treatments.
Rethinking Clinical Trials
OCTOBER 18, 2023
In this Friday’s PCT Grand Rounds, Rachael Fleurence of the NIH and Joshua Sharfstein of Johns Hopkins University will present “A National Initiative to Eliminate Hepatitis C in the United States – Why This Matters to Clinical Trialists.” The Grand Rounds session will be held on Friday, October 20, 2023, at 1:00 pm eastern. Fleurence is a senior advisor at the NIH.
Bio Pharma Dive
OCTOBER 18, 2023
A panel of FDA advisers last month found BrainStorm’s data unconvincing. The company now says a Phase 3b study will be needed for its NurOwn cell therapy to have a shot at an approval.
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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
OCTOBER 18, 2023
Lisata has received orphan drug designation from the EMA's Committee for Orphan Medicinal Products for LSTA1 to treat pancreatic cancer.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 15, 2023
In a medical first, scientists have hindered the growth of bowel cancers in mice by harnessing immune cells in the large intestine. One of the most exciting new cancer treatments is immunotherapy, which works by training the body’s immune system to identify and destroy cancer cells.
Fierce Pharma
OCTOBER 16, 2023
As the coronavirus outbreak has shifted to the endemic phase, drugmakers have warned of a drop in demand for COVID-19 products, with the impact coming into focus during the fall vaccination season. | Pfizer has slashed its 2023 revenue projection by $9 billion because of declining demand for COVID products. The company now expects sales to reach between $58 billion and $61 billion, down from a prior range of $67 billion to $70 billion.
Bio Pharma Dive
OCTOBER 17, 2023
Nucleus RadioPharma, a contract developer and manufacturer, is expanding at a time when investment is pouring into the radiopharmaceutical drug field.
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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.
Pharmaceutical Technology
OCTOBER 17, 2023
As AI applications in drug manufacturing widen, Leucine’s digital twin of the shop floor helps automate compliance and improve safety.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 19, 2023
Everyone has a different tolerance for spicy food — some love the burn, while others can’t take the heat. But the scientific consensus on whether spicy food can have an effect — positive or negative — on your health is pretty mixed.
Fierce Pharma
OCTOBER 16, 2023
Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery. | Thanks to a new FDA approval for Merck's Keytruda, a continuous immunotherapy regimen around surgery is now available for patients with early-stage non-small cell lung cancer. The drug's label already includes an overall survival win from a key trial.
Bio Pharma Dive
OCTOBER 16, 2023
A few key meetings remain this year, like ESMO and ASH, while next year’s events are already being planned. Here’s a list of conferences to keep in mind.
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.
Pharmaceutical Technology
OCTOBER 16, 2023
Pfizer is launching a $3.5bn cost-saving programme and BioNTech expects 2023 revenues to decrease as demand for Covid treatments wanes.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 17, 2023
At least 10% of people infected with SARS-CoV-2, the virus that causes COVID, have symptoms that last more than four weeks after the infection.
Fierce Pharma
OCTOBER 17, 2023
If there’s one thing a wide swath of industry players can agree on, it’s that the FDA’s drug approval process represents the gold standard for drug regulation. | Influential trade group PhRMA—plus hundreds of drugmakers, leaders and investors—are urging the Supreme Court to overturn a restrictive ruling on the abortion pill mifepristone. In SCOTUS filings, the industry representatives said the ruling undermines the FDA's authority.
Bio Pharma Dive
OCTOBER 20, 2023
With the alliance, Merck joins Pfizer, AstraZeneca and Gilead in staking major bets on the potential for antibody-drug conjugates to reshape cancer treatment.
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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
Pharmaceutical Technology
OCTOBER 20, 2023
NVIDIA’s vice-president of healthcare, Kimberly Powell, discussed GenAI in pharma and the importance of partnerships.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 15, 2023
The Pharmacopoeial Discussion Group (PDG), with the Pharmacopoeia Commissions from US, Europe and Japan as members to harmonise pharmacopeial standards globally, has announced the Indian Pharmacopoeia Commission (IPC) as a PDG member.
BioSpace
OCTOBER 19, 2023
Seeking to deepen its immuno-oncology business, Merck has closed a deal potentially worth $22 billion across three of Daiichi Sankyo’s DXd antibody-drug conjugates for various solid tumor indications.
Bio Pharma Dive
OCTOBER 17, 2023
The Danish drugmaker's innovation hub in Boston has teamed up with the Broad Institute, Mass General Brigham, Harvard and Yale, expanding its research into cardiometabolic diseases.
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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.
Pharmaceutical Technology
OCTOBER 18, 2023
The company also secured $50m in debt financing to support the commercial launch of Xphozah in November 2023.
Fierce Pharma
OCTOBER 17, 2023
Editor's note: This is an evolving story. Please check back on Oct. 23 when the full data of MARIPOSA are presented at ESMO 2023. | A drug combination from Johnson & Johnson outperformed AstraZeneca’s Tagrisso in slowing the worsening of newly diagnosed lung cancer. But it’ll take more than a tumor progression win to dethrone the EGFR king.
BioSpace
OCTOBER 15, 2023
A revised Paxlovid supply agreement with the U.S. government has pushed Pfizer to launch a “cost realignment” program including layoffs, though it is still unclear how many employees will be affected.
Bio Pharma Dive
OCTOBER 17, 2023
One month after Roche’s Genentech inked a similar deal, the Swiss pharma is now paying $50 million to work with Monte Rosa on molecular glue medicines for cancer and neurological diseases.
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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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