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By Larry J. Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision ab
“A generation of founders is now scarred,” one biotech CEO said, as small drugmakers grapple with the longer-lasting effects of SVB’s stunning collapse.
The National Health Surveillance Agency (ANVISA) in Brazil has granted approval for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003). The vaccine has received approval for preventing dengue disease in people aged four years to 60 years. Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes and is designed to provide protection against any of these.
IMPACt-LBP, an NIH Pragmatic Trials Collaboratory Demonstration Project, enrolled its first study participant this week. Congratulations to the IMPACt-LBP study team for reaching this important project milestone! Dr. Christine Goertz, Dr. Adam Goode, Dr. Jon Lurie, and Dr. Rishi Chakraborty Co-led by investigators at Duke University and Dartmouth University, IMPACt-LBP is a cluster randomized trial of a multidisciplinary collaborative team approach for low back pain versus usual care.
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
The US Food and Drug Administration has approved a fast-acting nasal spray from Pfizer designed to treat migraines, the US pharmaceutical giant said Friday. Pfizer said it expected the drug, marketed under the name Zavzpret, to be available in pharmacies in July 2023.
Novartis joined venture investor Sofinnova in leading an $85 million investment in the startup that also involved Pfizer, Eli Lilly and Bristol Myers Squibb.
As the field of digital therapeutics continues to broaden, specific uses in mental health and neurology are increasingly making headway for patients and on the market. At the same time, experts are saying developers in the field need to double down on securing clinical data to allow for its continued maturation. Companies are testing the use of digital platforms along with pharmacological treatments.
As the field of digital therapeutics continues to broaden, specific uses in mental health and neurology are increasingly making headway for patients and on the market. At the same time, experts are saying developers in the field need to double down on securing clinical data to allow for its continued maturation. Companies are testing the use of digital platforms along with pharmacological treatments.
Researchers have developed a blood test to determine a person’s risk of developing anxiety, while also providing insight into its current severity and best course of treatment.
The bank’s failure caused some companies to question whether they could pay employees, while forcing many others to take steps to calm nervous investors.
Pharmanovia and Aeterna Zentaris have entered an exclusive licensing agreement for the latter’s medicine Ghryvelin (macimorelin). Under the deal, Pharmanovia will acquire the exclusive rights and license to commercialise Ghryvelin in the EEA and the UK from Consilient Health. Ghryvelin is used for the diagnosis of Adult Growth Hormone Deficiency (AGHD), a rare and serious condition, as well as for Childhood Onset Growth Hormone Deficiency (CGHD), if approved.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
After years of high rates, the country hit a new high during the pandemic, far exceeding rates in other developed nations. Black women are at especially high risk.
If you needed another reminder of just how important quality sleep is to our health and well-being, a new study has linked three specific sleep problems with a change in risk of developing dementia.
Talem Therapeutics, a subsidiary of Immunoprecise Antibodies, has entered a multi-target artificial intelligence (AI)-driven antibody discovery collaboration with Libera Bio. The partnership will use nanotechnology, which was proven in vivo, for providing antibodies inside tumour cells and provides a potential solution to address the medical challenge.
An algorithm, not a doctor, predicted a rapid recovery for Frances Walter, an 85-year-old Wisconsin woman with a shattered left shoulder and an allergy to pain medicine. In 16.6 days, it estimated, she would be ready to leave her nursing home. On the 17th day, her Medicare Advantage insurer, Security Health Plan, followed the algorithm and cut off payment for her care, concluding she was ready to return to the apartment where she lived alone.
The Indian Pharmacopoeia Commission (IPC) will run a series of skill development programmes (SDPs) on pharmacovigilance (PV) of medical products in May, August and November 2023. One SDP is scheduled between May 15 and May 19 with the other two scheduled between August 7 and August 11 and between November 20 and November 24, 2023.
The regulator will convene a panel of advisers to consult on an approval decision for the biotech’s Duchenne treatment, a change from just a few weeks ago when Sarepta had said a meeting wouldn’t be held.
The Lung Cancer Research Foundation (LCRF) has announced a new research partnership with Daiichi Sankyo and AstraZeneca. This collaboration is intended to fund up to three research grants that are focused on antibody-drug conjugates (ADCs) for improving the outcomes for lung cancer patients. ADCs are designed for targeting cancer cells specifically and selectively provide a highly potent payload that may limit healthy cells’ damage.
A Mississippi woman's life has been transformed by a treatment for sickle cell disease with the gene-editing technique CRISPR. All her symptoms from a disease once thought incurable have disappeared.
The Indian Institute of Science (IISc) researchers from the Department of Organic Chemistry (DOC) and Materials Research Centre (MRC) have shown that surface modifications of two-dimensional molybdenum disulphide (2D-MoS) nanosheets can make them highly effective for applications like delivering drugs to diseased cells.
Responding to policy changes and pressure over high drug costs, the pharma is reducing the sticker price of four branded diabetes medicines by up to 75%.
Global biopharmaceutical firm UCB has entered an early drug discovery collaboration with Aitia. The collaboration is aimed at discovering and validating new drug targets and drug candidates that are linked to clinical endpoints causally in Huntington’s disease, a debilitating genetic disorder. It will combine the use of new drug targets for Huntington’s disease from Aitia’s Gemini Digital Twins with the expertise of UCB in preclinical model systems and drug research in neurodeg
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.
Researchers say Mexican pharmacies that cater to U.S. tourists and medical travelers are selling medications that look safe but are laced with deadly fentanyl and methamphetamines.
The Central Drugs Standard Control Organisation (CDSCO) has approved two more Medical Device Testing Laboratories (MDTL) to carry out tests or evaluation of a medical device on behalf of the manufacturers under the provisions of the Medical Devices Rules (MDR), 2017.
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Immuno-oncology in Pharmaceuticals: Photodynamic canc
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.
A bipartisan group of senators wants to make daylight saving time permanent. But sleep experts say standard time is better, because it saves morning light and is more in sync with our natural rhythms.
The Subject Expert Committee (SEC), which advises the drug regulator on the approval of drugs and clinical trials of antimicrobial and antiviral drugs, has recommended waiver of phase III clinical trial on Emcure Pharmaceuticals’ application for manufacturing and marketing of HIV drug doravirine 100 mg and its bulk drug in the country.
The US Food and Drug Administration (FDA) has granted approval for Acadia Pharmaceuticals ’ Daybue (trofinetide) to treat Rett syndrome in adult and paediatric patients aged two years and above. Trofinetide is a synthetic version of the tripeptide glycine-proline-glutamate (GPE) naturally occurring molecule. It increased the branching of dendrites and synaptic plasticity signals in animal trials.
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