Bio Pharma Dive
JUNE 7, 2021
With the decision, the agency cleared the way for what many predict will become a lucrative and highly sought-after option — though fierce debate continues over whether the medicine, Biogen's aducanumab, actually benefits patients' daily lives.
World of DTC Marketing
JUNE 6, 2021
SUMMARY: The media headlines promise weight loss for diabetes patients, but Norvo’s new drug is in the same class as other drugs and carries many warnings. Can diabetes patients really stay adherent to a drug for 63 weeks in which 85% of patients report GI side effects and will insurance cover the cost? The headlines read “FDA approves obesity drug that helped people cut weight 15%” But buyer beware.
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Camargo
JUNE 9, 2021
Camargo Research Group , Camargo’s managed nonclinical solution, has worked on more than 200 nonclinical programs since its inception in 2005, many of which include rare routes of administrations (ROAs) and use of uncommon animal species. We have collaborated with sponsors on many niche programs that have shone a light on both the creativity and the broad range of specialized capabilities needed for such complex development programs.
BioSpace
JUNE 9, 2021
An immunocompromised patient in South Africa became a veritable COVID-19 variant laboratory as the virus mutated more than 30 times in 216 days of her infection, according to recent, not-yet-peer-reviewed research paper published in medRxiv.
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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
Bio Pharma Dive
JUNE 9, 2021
Approval of Aduhelm sets a precedent that could enable some drugs, like Eli Lilly's drug donanemab, to advance quickly and cause other previously sidelined ones to get a second look.
World of DTC Marketing
JUNE 5, 2021
SUMMARY: Obesity has many causes, and while we would like to think the answer is as easy as people exercising more and eating less, it isn’t that simple. There is disagreement whether obesity is really considered a disease or a behavioral risk factor, similar to smoking, alcohol, and substance abuse that may lead to disease. Obesity is a multifactorial disease in which environmental conditions and several genes play an important role in developing this disease.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
JUNE 9, 2021
The MHRA has issued an EAMS scientific opinion opening the door to use of cipaglucosidase alfa with miglustat in eligible patients with Pompe disease
Bio Pharma Dive
JUNE 10, 2021
The biotech said its drug for alpha-1 antitrypsin deficiency wasn't potent enough to advance into further testing, but plans to move others into clinical trials next year.
World of DTC Marketing
JUNE 11, 2021
Key Points: Trust in the CDC and FDA has decreased dramatically during the COVID-19 pandemic among health care professionals, according to a new WebMD/Medscape poll. Out of nearly 450 U.S. doctors surveyed in the same time period, 77% said their trust in the CDC has decreased and 48% said their trust in the FDA has decreased. Health care professionals have been critical of these agencies’ decisions during the pandemic, with some concerned that their work has been politicized and now wit
pharmaphorum
JUNE 9, 2021
“Rarely does the answer come from the boardroom” – what can user experience teach us about building accessible digital health? No one should be left behind as the world embraces digital healthcare say leading user experience voices. The experts discussed the benefits and merits of co-creation during a session on bridging the digital divide, held during the recent Patient Experience Digital Summit.
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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 Times
JUNE 8, 2021
Tecentriq is indicated for adults with metastatic NSCLC if their tumours have PD-L1 expression on at least 50% of tumour cells or 10% of tumour-infiltrating immune cells
Bio Pharma Dive
JUNE 9, 2021
Though most of Merck's COVID-19 efforts have come up short, its antiviral pill could still have a role, as signaled by the U.S. government's sizable financial commitment.
BioSpace
JUNE 7, 2021
The first human case of a new strain of avian flu was diagnosed in China in late May. Chinese health authorities say there is a low risk of contagion. After China notoriously underreported COVID-19 mortality, can this new assurance be trusted?
pharmaphorum
JUNE 11, 2021
A digital therapeutic aimed at people with chronic lower back pain based on virtual reality (VR) has shown encouraging results in a clinical trial, helping patients manage the fear of movement that can reduce their activity and impede recovery. The therapy uses a VR headset to guide people with chronic pain through a series of cognitive behavioural therapy (CBT) exercises that are designed to help them overcome the fear of movement – also known as kinesiophobia.
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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.
XTalks
JUNE 8, 2021
Novartis’ Zolgensma (onasemnogene abeparvovec) gene therapy has been making significant strides as of late, including dosing of the first Spinal Muscular Atrophy (SMA) patient with the treatment in the UK last week. In addition, recent data from a Phase I trial has shown ‘remarkable’ long-term results of the gene therapy in children with the disease.
Bio Pharma Dive
JUNE 10, 2021
The FTC and its counterparts abroad are rethinking their approach to drugmaker acquisitions. Past scrutiny offers clues where they may look next.
BioPharma Reporter
JUNE 7, 2021
The virtual clinical development firmâs analysis of patient profiles reflects obesity is the most significant indicator for severity in those under 40.
pharmaphorum
JUNE 11, 2021
The development of vaccines for COVID-19 has been a masterclass in effective collaboration and applied digitisation in healthcare. However the increased complexity and involvement of different parties, exposes manufacturers to heightened threat levels. Abel Archundia discusses how COVID-19 has highlighted the importance of securing clinical trials against cyber threats.
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.
BioSpace
JUNE 6, 2021
In the field of drug discovery, one must always begin with the target, right? Not if you ask Cellarity, a quickly emerging biotech company revolutionizing the drug development space.
Bio Pharma Dive
JUNE 11, 2021
The latest results from the companies' trials give support to hopes that CRISPR gene editing could functionally cure sickle cell disease and beta thalassemia.
Pharma Times
JUNE 11, 2021
The approval is based on results from the Phase III VIALE-A study as well as the Phase Ib M14-358 clinical trial
pharmaphorum
JUNE 7, 2021
Novartis’ Kymriah has had the CAR-T therapy market for acute lymphoblastic leukaemia (ALL) to itself so far, but Gilead Sciences’ Kite subsidiary is now looming in the rear view mirror – armed with new data for its already-filed rival Tecartus. Results of the phase 1/2 ZUMA-3 trial of Tecartus (brexucabtagene autoleucel) reported at the ongoing ASCO conference revealed a 71% complete response rate with the CAR-T in heavily pre-treated adult patients with B-cell precursor ALL.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
BioSpace
JUNE 6, 2021
Grail presents its first data from the interventional PATHFINDER trial of Galleri, its multi-cancer early detection blood test. Galleri is now available in the U.S. by prescription.
Bio Pharma Dive
JUNE 8, 2021
Two near identical clinical trials of Aduhelm yielded conflicting results, dividing experts and even FDA staff. A third, confirmatory study is required, but Biogen has until 2029 to finish it.
Pharma Times
JUNE 10, 2021
Consortium will assess multiple process analytical technologies used in the cell and gene therapy industry
pharmaphorum
JUNE 8, 2021
Dr Jay Mei from Antengene tells us how the Asia Pacific region is opening up to innovative pharma companies, and gives tips for companies navigating this enormous market. Home to over 60% of the world’s population, Asia Pacific (APAC) is not a region the biopharma industry can afford to ignore. Dr Jay Mei, founder and CEO of Antengene, notes that the region has rich innovation resources but also urgent medical needs, leading to both opportunities and uncertainties for the industry.
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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.
Drug Patent Watch
JUNE 11, 2021
Annual Drug Patent Expirations for INJECTAFER Injectafer is a drug marketed by Am Regent and is included in one NDA. It is available from one supplier. There are five patents…. The post New patent for Am Regent drug INJECTAFER appeared first on DrugPatentWatch - Make Better Decisions.
Bio Pharma Dive
JUNE 8, 2021
Biogen priced its newly approved medicine Aduhelm at an average cost of $56,000 a year, adding affordability to other barriers patients may face.
XTalks
JUNE 10, 2021
As the foodservice sector recovers from the COVID-19 pandemic, the demand for vanilla is expected to boom in its various forms. According to a recent report from Aust and Hachmann, a Canadian vanilla producer, demand for industrial-grade vanilla should remain steady while black/gourmet vanilla will experience a strong recovery. . “Although prices have fallen dramatically in the past 12 months, the recent uptick in demand has helped to stabilize the market,” the report noted.
pharmaphorum
JUNE 11, 2021
The fallout over the FDA’s decision to approved Biogen’s Alzheimer’s therapy Aduhelm continues to be felt, with a third member of its advisory committee resigning in protest. . The latest to depart the FDA’s Peripheral and Central Nervous System Drugs panel is Aaron Kesselheim of Harvard Medical School, joining fellow committee members Joel Perlmutter and David Knopman who quit earlier this week.
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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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