Sat.Nov 20, 2021 - Fri.Nov 26, 2021

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New Merck study results raise questions about its COVID-19 pill

Bio Pharma Dive

Final trial data for molnupiravir were less convincing than what Merck previously reported and could alter how the FDA views the drug, which will be evaluated at a meeting Tuesday.

Trials 357
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The current pricing of cancer treatments is unsustainable

World of DTC Marketing

SUMMARY: The U.S. needs to take substantial steps to address the high costs of cancer drugs. From 2009 to 2019, the median monthly treatment costs for new drugs at launch reached $11,755 in the U.S… Does the question become how much is a month(s) of other life worth? According to an analysis published by JAMA Oncology, prices for new drugs approved for use in the treatment of cancer in the United States more than doubled over the past decade.

Drugs 266
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Equal Parts Caregiver and Advocate: Clinical Trials from the Caregiver’s Point of View

Camargo

“There are only four kinds of people in the world: Those who have been caregivers, those who are currently caregivers, those who will be caregivers, and those who will need caregivers.”. ~ Roslyn Carter. Each November, National Family Caregiver Month recognizes and honors all those who have dedicated themselves to caring for ailing loved ones. It also helps raise awareness of the often-overwhelming issues they face, so that we can work together as a society to alleviate them.

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University of Glasgow reveals drug design for new Alzheimer’s treatments

Pharma Times

A team of scientists and pharmaceutical collaborators have discovered a ‘bench to bedside’ drug design, which will hopefully improve the future treatment of Alzheimer’s disease.

Drugs 160
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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Neurocrine stocks up on a biotech's psychiatric drugs

Bio Pharma Dive

A new deal with Sosei Heptares hands Neurocrine a "broad portfolio" of drugs for schizophrenia, dementia and other neuropsychiatric disorders.

Drugs 333
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Does CVS have a crystal ball into the future?

World of DTC Marketing

SUMMARY: CVS announced its plans to begin closing its doors –about 900 locations across the country. They know the future isn’t about selling 20 kinds of shampoos and vitamins. In the words of the company’s mission , its goal is to “make high-quality health and pharmacy services safe, affordable and easy to access.” Growth doesn’t mean getting more extensive; it means getting better.

Pharmacy 241

More Trending

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EMA approves Pfizer-BioNTech COVID-19 vaccine for young children

Pharma Times

The Food and Drug Administration (FDA) granted approval for emergency use of the Comirnaty vaccine in children in October 2021.

Vaccine 135
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Bluebird, after delays, gets speedy FDA review for beta thalassemia gene therapy

Bio Pharma Dive

The regulator will decide whether to approve Bluebird's treatment by next May, but its evaluation begins more than a year later than the biotech first hoped.

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Bonus BioGroup’s MesenCure Shows Promise Against COVID-19 Pneumonia

BioSpace

Bonus BioGroup’s product is back in the news again as its cell therapy promises to treat late-stage COVID-19.

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Telstar launches Usifroid global service platform for retrofitting & maintenance of freeze-dryers

Pharma Mirror

Terrassa (Barcelona) Telstar launches a new global service platform for retrofitting and maintenance of existing freeze-dryers, regardless of brand and model. Under Usifroid brand, this platform is specialized in providing a retrofitting and modernization service together with maintenance services and technical support to freeze-drying equipment for pharmaceutical production and research.

Branding 130
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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EC grant Trodelvy marketing authorisation for treatment of breast cancer

Pharma Times

With the latest approval from the EC, patients in Europe suffering from metastatic triple-negative breast cancer can now receive Gilead Science’s Trodlevy as part of their treatment.

Marketing 135
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AstraZeneca, after years of delays, opens UK hub meant to recharge drug research

Bio Pharma Dive

Formally unveiled five years after originally planned, the $1 billion headquarters will become the British drugmaker's second-largest R&D center by headcount.

Research 289
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New COVID variant ‘may sidestep vaccine protection’

pharmaphorum

A new variant of COVID-19 identified in Botswana with dozens of mutations is being watched closely, amid fears it could be resistant to the effect of currently-used vaccines. The B.1.1.529 variant has more mutations affecting the spike protein targeted by vaccines than any other strain identified to date, although it’s not yet clear if it is more or less transmissible.

Vaccine 116
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AI in Pharma and Biotech Market – Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2020 – 2030

Pharma Mirror

AI in Pharma and Biotech Market: Introduction Artificial Intelligence (AI) in pharma refers to the system of interconnected and automated technologies in the biotech industry that can function autonomously, with little or no human intervention. AI is an emerging technology that is being applied in numerous facets of the pharma sector, ranging from drug development to diagnosis and even patient care.

Marketing 130
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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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COVID-19 vaccines safe for pregnant women

Pharma Times

Data from the UK’s Health Security Agency (UKHSA) has revealed that COVID-19 vaccines are safe in pregnancy.

Vaccine 120
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With safety a concern, Merck, Gilead pause study of HIV drugs

Bio Pharma Dive

Out of an "abundance of caution," the companies halted enrollment in a trial evaluating the combination of Merck's islatravir and Gilead's lenacapavir.

Drugs 289
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Time for change: PhRMA survey shows insurance creates barriers to healthcare in US

pharmaphorum

Health insurance is not enough to provide the necessary affordable access to care for the US’ most vulnerable, finds new PhRMA report. For too many Americans, insurance coverage is not providing the health security it’s meant to. The Pharmaceutical Research and Manufacturers of America’s (PhRMA) first Patient Experience Survey (PES) has found that three in ten people with medical insurance still face financial barriers to accessing healthcare and prescription medicines.

Medicine 116
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How far away is help? Researchers map access to HIV care

Scienmag

In sub-Saharan Africa, 7 million people with HIV live more than 10 minutes from health care services and 1.5 million people with HIV live more than 60 minutes from a healthcare facility, according to a new study published this week in the open-access journal PLOS Global Public Health by Diego Cuadros of the University of […].

Research 111
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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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EMA supports molnupiravir prior to formal authorisation

Pharma Times

The oral antiviral drug is for the treatment of patients with COVID-19

Drugs 119
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Pfizer, BioNTech to seek full approval as COVID-19 vaccine efficacy holds up in young teens

Bio Pharma Dive

Four months after vaccination, no 12- to 15-year-olds in the companies' clinical trial developed COVID-19, compared to 30 who received a placebo.

Vaccine 264
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UK-wide whole genome sequencing for newborns is feasible – but there are some key questions to answer first

pharmaphorum

Genomics England, the Department of Health and Social Care’s genome-sequencing hub, has this year announced that support for whole genome sequencing (WGS) has reached a level at which its national rollout on the NHS may someday become a reality. The timing of this announcement is particularly opportune, as increasing knowledge and advances in WGS amongst scientists has resulted in the technology becoming increasingly affordable and effective, making its incorporation into the existing standardis

Genome 116
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Mix-and-match COVID-19 vaccines: New trial to add to growing body of research

BioPharma Reporter

A new clinical trial of heterologous â or âmix-and-matchâ â combinations of COVID-19 vaccines is set to start in Pakistan: seeking to add to research on the effectiveness of such combinations.

Vaccine 110
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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UK recognises Covaxin as valid COVID-19 vaccine for travel

Pharma Times

The approval of Covaxin follows the WHO Emergency Use Listing for the vaccine

Vaccine 117
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Nanomilling: an optimal solution for poorly soluble, challenging APIs

Bio Pharma Dive

A versatile technique to ensure your drug is ready on time for your first-in-human clinical trial.

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Re-envisioning mental health treatment using clinical VR

pharmaphorum

Skip Rizzo, PhD, research director for medical virtual reality at the University of Southern California’s Institute for Creative Technologies (USC ICT), tells us how its virtual reality (VR) therapy BRAVEMIND is changing PTSD treatment and how pharma can leverage clinical VR. “There’s a strong evidence base for VR applications in many areas, but it’s also breaking down barriers to care.

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Causes of Death Among Young Adults by Race and Ethnicity in Texas During the COVID-19 Pandemic, 2020

JAMA Internal Medicine

This cohort study examines mortality data from Texas, a racially and ethnically diverse state, to better understand excess mortality among adults aged 25 to 44 years during early months of the COVID-19 pandemic.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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PMEA 2021: A Celebration of Excellence in Patient Engagement

Pharma Times

After hosting a virtual ceremony in 2020, this year’s awards returned to the Royal Lancaster London hotel

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GSK dives into NASH, RNA interference with Arrowhead deal

Bio Pharma Dive

GSK has secured rights to a genetic medicine in early-stage human testing for NASH, a disease thought to affect millions of people and which has proven to be a tough target for drugmakers.

RNA 195
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FDA clears Takeda drug for post-transplant CMV infections

pharmaphorum

Takeda has scored the first-ever FDA approval of a treatment for refractory cytomegalovirus (CMV) infections in organ transplant patients, which can lead to an increased risk of complications and even death. Livtencity (maribavir) has been cleared for use in transplant patients aged 12 or over with CMV infections that do not respond to first-line treatment with current antiviral drugs for CMV, such as ganciclovir, valganciclovir, foscarnet and cidofovir.

Drugs 105
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Seizure Drug from Sagent Pharmaceuticals Recalled Over Faulty Seal

XTalks

Sagent Pharmaceuticals Inc. is recalling four lots of its injectable seizure medication levetiracetam over concerns of container closure integrity on vials of the drug product. According to the recall announcement that was posted by the US Food and Drug Administration (FDA), Sagent says the issue affects reserve sample vials that could lead to a non-sterile product.

Drugs 105
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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.