Bio Pharma Dive
OCTOBER 18, 2021
Though the study's primary goal was missed, Biogen claimed there were some signs its drug, tofersen, could slow the disease's progression. The company is now engaging with regulators to discuss tofersen's future.
World of DTC Marketing
OCTOBER 21, 2021
SUMMARY: Medicare spent nearly $600 million over a three-year period to pay for four cancer drugs with no clinical benefit an analysis published Monday by JAMA Internal Medicine found. More than $170 million of this spending was for products voluntarily withdrawn by their manufacturers after clinical trials showed that they did not improve overall survival in people with various types of cancer.
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Camargo
OCTOBER 20, 2021
As pharmaceutical science and innovation advance, breakthrough combination products frequently emerge that provide patients with therapeutics comprised of two or more constituents. Combination products can be either two or more active pharmaceutical molecules, combined to address different aspects of a health condition, or the combination of a medical device and a small or large molecule product.
Pharma Times
OCTOBER 18, 2021
Dupilumab (also known as Dupixent) will be available to patients through injections
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
Bio Pharma Dive
OCTOBER 19, 2021
A closely watched competitor to Merck's molnupiravir failed a Phase 2 study, prompting its makers to change their strategy in a move that could delay an answer on the drug's efficacy until late next year.
NY Times
OCTOBER 21, 2021
The company said that in a study, boosters cut down the number of breakthrough infections among fully vaccinated people by more than 95 percent.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
OCTOBER 18, 2021
Interstitial lung disease (ILD) is a termed used to describe a collection of over 200 lung disorders
Bio Pharma Dive
OCTOBER 19, 2021
The drugmaker plans to switch over to a commercial business model late next year or early in 2023, said Jennifer Taubert, head of J&J's pharma division.
NY Times
OCTOBER 18, 2021
The agency may act this week, when it is expected to authorize booster shots for recipients of the Moderna and Johnson & Johnson vaccines.
pharmaphorum
OCTOBER 19, 2021
A new poll of clinical trial sponsors has found that around nine out of 10 of them are running decentralised trials with the help of digital technologies, a big increase on pre-COVID-19 levels. The survey by Veeva Systems found a big increase in the adoption of technologies that enabled remote trials during COVID-19, with increased use of tools such as remote monitoring, electronic data collection and consent forms, and web portals for studies.
Pharma Mirror
OCTOBER 22, 2021
ADELAIDE, AUS, Oct 19, 2021 – (ACN Newswire) – Agilex Biolabs, the Australian regulated bioanalytical and toxicology laboratory facilities for clinical trials is presenting a new webinar entitled “Getting it right! Considerations for Immuno-oncology and Vaccine Studies and the Bioanalytical Tools used” in partnership with Outsourcing Clinical Trials (OCT).
Bio Pharma Dive
OCTOBER 21, 2021
The biotech won EU approval for two gene therapies, Zynteglo and Syksona, both of which it's now said it will pull from market after difficulties negotiating reimbursement.
Pharma Times
OCTOBER 21, 2021
Givlaari uses ‘gene silencing’ RNA interference technology, to target the production of pathogenic compounds in people AHP
pharmaphorum
OCTOBER 22, 2021
The FDA has approved an artificial intelligence-based test for early detection of dementia that can be carried out on an iPad in five minutes. The CognICA Integrated Cognitive Assessment (ICA) test developed by London, UK-based company Cognetivity Neurosciences has been approved by the FDA as an alternative to traditional pen-and-paper tests with some key advantages, according to its developer.
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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
Pharma Mirror
OCTOBER 22, 2021
New Delhi, India, More than 50 per cent of the world’s hip fractures are expected to occur in the Asia Pacific by the year 2050. In a strong effort to stem the tide, and to promote quality care in osteoporosis, the Asia Pacific Consortium on Osteoporosis (APCO) has launched a world-first, interactive, educational osteoporosis resource – the APCO Health Care Professional (HCP) Peer to Peer Educational Modules – today, to mark World Osteoporosis Day (Wednesday, October 20).
Bio Pharma Dive
OCTOBER 19, 2021
Following discussions with the FDA, the companies plan to submit zuranolone for approval in major depressive disorder and postpartum depression over the next roughly year and a half.
Pharma Times
OCTOBER 20, 2021
Lucid-PSYCH is a psychoactive compound potentially viable for the treatment of major depressive disorders
pharmaphorum
OCTOBER 19, 2021
The work of the UK’s HTA body, the National Institute for Health and Care Excellence (NICE), is often heatedly debated, and this time it’s for holding back a clinical guideline. Leela Barham looks into the controversy. Updating a previous clinical guideline. NICE began their work to update a 2007 clinical guideline on Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in January 2018.
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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.
Pharma Mirror
OCTOBER 22, 2021
TOKYO, Hitachi, Ltd. (TSE: 6501), Tohoku University and Kyoto University have become the world’s first (1) to establish technology for the highly efficient and high-quality production of actinium-225 (225Ac), a substance required for a form of radiation therapy known as targeted alpha therapy (TAT). TAT is a new cancer therapy which combines a substance that emits alpha particles which destroy cancer cells with a compound that selectively accumulates in cancer cells.
Bio Pharma Dive
OCTOBER 19, 2021
Drugs from Vertex can effectively treat the lung disease in as much as 90% of patients. Gene therapy could be a solution for the remaining 10%, but the path forward is challenging.
Outsourcing Pharma
OCTOBER 19, 2021
To fully reap the benefits of tech advances, a company leader advises, a life-sciences firm must embrace change and connection throughout the operation.
pharmaphorum
OCTOBER 21, 2021
Twitter has been used by health professionals for over a decade to share medical knowledge and education. Until late-2018 they had only 140 characters to do this, increasing to 280 at that time. There have been some collaborative ways to have meaningful interactions on the platform including Twitter journal clubs. Four ways HCPs are using Twitter for medical education.
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.
Pharma Mirror
OCTOBER 21, 2021
Post-workout protein intake has numerous benefits. For a long time, fitness experts and nutritionists have recommended taking protein after your workout. Though the health benefits of pre-workout protein intake are in question, the post-workout protein intake helps recover muscle after intense exercise. A pre-training shake is a drink that you can consume before any workout or physical activity to improve the body’s performance.
Bio Pharma Dive
OCTOBER 21, 2021
A third dose was 96% effective in preventing COVID-19 compared to a placebo in a Phase 3 trial of previously vaccinated adults. Missing details, however, leave some questions unanswered.
Pharma Times
OCTOBER 19, 2021
Results are 'unprecedented' according to company
pharmaphorum
OCTOBER 18, 2021
Roche has claimed an earlier-than-expected FDA approval for its checkpoint inhibitor Tecentriq in non-small cell lung cancer (NSCLC), giving the drug a lead in early-stage cases that can be treated with surgery. The US regulator has cleared Tecentriq (atezolizumab) as adjuvant treatment after surgery and platinum-based chemotherapy in patients with tumours in which 1% or more cells express the PD-L1 biomarker, to try to stop the cancer recurring.
BioSpace
OCTOBER 18, 2021
While it has yet to reach clinical trials, preclinical results with the company’s specially-tailored adeno-associated virus have been fortuitously auspicious.
Bio Pharma Dive
OCTOBER 18, 2021
The company hopes a "streamlined" sales force can turn around a drug launch that's failed to meet expectations amid tough competition from rival medicines.
Pharma Times
OCTOBER 22, 2021
EUA amendments 'based on the available data and information'
pharmaphorum
OCTOBER 21, 2021
Analysts were predicting sales of Biogen’s recently approved Alzheimer’s therapy Aduhelm may start to gather a little momentum in the third quarter, but the drug seems to be going into reverse. As it turned out, Aduhelm (aducanumab) made just $300,000 in the three-month period from July to September, against analysts’ estimates of $12 million, suggesting that few patients are being treated with the $56,000 a year therapy.
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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.
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