Bio Pharma Dive
SEPTEMBER 26, 2022
The request, if cleared, would make U.S. kids between 5 through 11 eligible to receive a "bivalent" shot targeting components of the omicron variants currently circulating.
Pharmaceutical Technology
SEPTEMBER 26, 2022
The European Commission (EC) has granted approval for AstraZeneca division Alexion’s Ultomiris (ravulizumab) as an add-on to standard therapy to treat generalised myasthenia gravis (gMG) in adults. The treatment is indicated for gMG patients who are anti-acetylcholine receptor (AChR) antibody-positive. In July, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) provided a positive opinion recommending a grant of marketing authorisation for Ultomiris.
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Bio Pharma Dive
SEPTEMBER 26, 2022
The startup, which launched last year with $315 million in funding and plans to advance a new form of gene editing, is one of the first big venture-backed biotechs in several months to seek an IPO.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 26, 2022
The National Medical Commission (NMC), the apex medical education regulatory body, has come out with draft Establishment of Medical College Regulations, (Amendment), 2022 ushering changes in rules for setting up medical institutes. The draft amendment regulations introduced changes in qualifying criteria for establishing medical colleges mentioned in ‘Establishment of Medical College Regulations, 1999.
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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
SEPTEMBER 26, 2022
Over the last 2 years, a greater spotlight has shone on inequalities in health care, and the greater need to improve health equity.
Pharmaceutical Technology
SEPTEMBER 26, 2022
Concept: Norway’s semiconductor company Nordic Semiconductor (Nordic) has launched an ultra-low power dual-band Wi-Fi 6 companion chip called nRF7002. The company intends to compete in the competitive Wi-Fi IoT market for sensors and other low-power devices with its Wi-Fi-capable chip. Nature of Disruption: When used in conjunction with Nordic's current products, the nRF7002 offers Wi-Fi 6 connectivity and Wi-Fi-based location using service set identifier (SSID) detection of local hubs.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
SEPTEMBER 26, 2022
The UK National Institute for Health and Care Excellence (NICE) has granted approval for Pfizer ’s palbociclib (Ibrance) in combination with anti-cancer therapy, fulvestrant, to treat advanced breast cancer patients. With the publication of the final draft guidance by the institute, the combination therapy will be offered for routine use in the National Health Service (NHS).
Bio Pharma Dive
SEPTEMBER 26, 2022
With supply and labor constraints creating backlogged custom-manufacturing schedules, developers have felt the pain in cost and speed to market.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 26, 2022
Eczema (or atopic dermatitis) affects millions of people, particularly children under the age of six. The chronic inflammatory skin disorder causes the skin to go red and dry and to start oozing and itching, making life very uncomfortable. There’s currently no cure for the condition, just ways of managing it – but an existing drug […].
Bio Pharma Dive
SEPTEMBER 26, 2022
While a long-rumored acquisition by Merck & Co. still hasn’t materialized, Seagen is forging ahead with a deal of its own, grabbing rights to a bispecific antibody drug from Lava Therapeutics.
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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
STAT News
SEPTEMBER 26, 2022
CAMBRIDGE, Mass. — The fluorescent orange sticker atop the white machine reads “BIOHAZARD,” but it’s a bit of a misnomer. Although Earth abounds with pathogens that can maim, kill, paralyze, and poison, the specimens inside this machine — being pipetted left and right behind glass for sequencing — are probably the most innocuous human viruses you will ever encounter.
Bio Pharma Dive
SEPTEMBER 26, 2022
The U.K. drugmaker now also stands to become the first big pharmaceutical company to have women in its top two roles, with the transition planned for May 2023.
NPR Health - Shots
SEPTEMBER 26, 2022
Prescribing medical abortions across state lines is now risky for doctors. "We're talking about something that's a protected right in one state and a felony in a sister state," says one legal scholar.
STAT News
SEPTEMBER 26, 2022
Here’s a scenario anyone who has done clinical research will recognize: A 32-year-old woman participating in a Phase 1 healthy-volunteer crossover clinical trial tested negative for pregnancy when she enrolled and agreed to use contraception during the course of the trial, as specified in the protocol. After completing the first phase of the trial, she checked in for the second phase, at which time the required pregnancy test was positive.
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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.
BioPharma Reporter
SEPTEMBER 26, 2022
The US National Institutes of Health plans to invest $130m in accelerating the widespread use of artificial intelligence (AI) by the biomedical and behavioral research communities through its Bridge2AI program.
STAT News
SEPTEMBER 26, 2022
Regulators in half a dozen European countries are now taking steps to enforce requirements that clinical trial sponsors make study results public, although three other countries have so far taken little to no action, a new analysis finds. Specifically, Austria, Belgium, Denmark, Finland, Germany, Sweden and the Netherlands are in varying stages of prompting sponsors to publicize results of their past clinical trials.
pharmaphorum
SEPTEMBER 26, 2022
Social health—the dynamic, real-time action people take to find meaningful connections and share information that impact the health journey—has dramatically shifted the ways in which healthcare marketers can, and should, reach their desired audiences. . Through Health Union’s unique and expansive Social Health Network of more than 100,000 patient leaders; and millions of engaged patients and caregivers across a growing portfolio of more than 40 condition specific online health communities, this
STAT News
SEPTEMBER 26, 2022
The health insurance industry is continuing its campaign to convince the public that Medicare Advantage saves taxpayers money, but experts say federal data still concludes the exact opposite — and that the program as currently designed is a drain on Medicare’s trust fund. America’s Health Insurance Plans, the industry’s primary lobbying group, funded a new report that was conducted by actuaries at Wakely Consulting Group.
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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.
pharmaphorum
SEPTEMBER 26, 2022
Pfizer and Sangamo have restarted recruitment of patients into their registration trial for haemophilia A gene therapy giroctocogene fitelparvovec, after the FDA lifted a clinical hold on the study. The phase 3 AFFINE trial was paused voluntarily by the two partners almost a year ago, and subsequently placed on hold by the FDA, after patients treated with the therapy produced higher than expected levels of Factor VIII – the clotting factor that giroctocogene fitelparvovec is designed to produce
STAT News
SEPTEMBER 26, 2022
In an effort to sway the Food and Drug Administration not to withdraw accelerated approval of Makena, a drug developed to prevent preterm birth that does no such thing, a pharmaceutical company owned by a private equity company is making the specious argument that the drug should be kept on the market because it may — the emphasis is mine — work in Black people.
Clinical Trial Podcast
SEPTEMBER 26, 2022
When a new drug or device undergoes “first in human” experience, the primary focus is on participant safety. How will the drug or device interact with the human body? And will this interaction be safe? To answer these two questions, regulatory authorities around the world require medical product manufacturers to conduct Phase I, also known as early phase clinical trials.
STAT News
SEPTEMBER 26, 2022
Good morning, everyone. Damian Garde here, filling in for Ed Silverman at the outset of yet another working week. Here’s hoping the travails of your day tend toward the painless. Below are a few items to get you started, and, as always, if you hear something curious, do let us know. … GSK appointed Julie Brown, formerly of Burberry, to serve as its chief financial officer, the company’s first female CFO, Bloomberg tells us.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
pharmaphorum
SEPTEMBER 26, 2022
Japan’s Daiichi Sankyo has claimed its first worldwide approval for Ezharmia, a first-in-class dual EZH1 and EZH2 inhibitor for the treatment of patients with relapsed or refractory adult T-cell leukaemia/lymphoma (ATL). The Ministry of Health, Labour and Welfare (MHLW) in Japan has cleared Ezharmia (valemetostat tosylate) based on the results of an open-label phase 2 trial which revealed a 48% overall response rate with the drug in previously-treated ATL patients.
Pharma Times
SEPTEMBER 26, 2022
The study will focus on checkpoint inhibitor refractory non-small cell lung cancer
NPR Health - Shots
SEPTEMBER 26, 2022
The White House is convening a day-long conference this week to review new proposals for tackling food insecurity and diet-related chronic disease.
Outsourcing Pharma
SEPTEMBER 26, 2022
Pfizer and CytoReason have been partnered on artificial intelligence and machine learning technologies for drug discovery and development since 2019. The latest deal brings the companies closer.
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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 Times
SEPTEMBER 26, 2022
Precision X affinity ligand will enable the efficient purification of the non-Fc fusion protein
Pharmaceutical Commerce
SEPTEMBER 26, 2022
New facility will focus on company’s temperature-controlled pallet shipper rental program.
Outsourcing Pharma
SEPTEMBER 26, 2022
Adding to broader action being taken across the industry, the company has signed an agreement with Enel for the supply of renewable energy credits covering its electricity needs across the US.
Pharmaceutical Commerce
SEPTEMBER 26, 2022
Following a decade of solid groundwork to modernize regulatory information management in life sciences, leading companies have now shifted their focus to how they might exploit this new digital landscape.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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