Bio Pharma Dive
NOVEMBER 15, 2021
Luxturna, approved four years ago as the first gene therapy for an inherited disease in the U.S., is improving sight and quality of life for several of the patients who received it.
World of DTC Marketing
NOVEMBER 16, 2021
SUMMARY: Omnichannel marketing employs the simultaneous implementation of channels across personal, non-personal, and media and addresses the integrated needs of multiple stakeholders – consumers/patients, healthcare professionals, and payers. Sounds good but is that the answer? There is no doubt that healthcare is the middle of an evolution not seen in over 30 years.
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pharmaphorum
NOVEMBER 16, 2021
An artificial intelligence algorithm developed by GE Healthcare that helps with the placement of endotracheal tubes (ETTs) has been approved by the FDA. The new tool – part of GE’s Critical Care Suite 2.0 – helps bedside staff and radiologists assess patients before intubation – for example prior to ventilation in patients with critical COVID-19 – and make sure their ETTs are positioned correctly.
BioPharma Reporter
NOVEMBER 18, 2021
Biogen says it is disappointed with feedback received from a European Medicines Agency committee on its aducanumab Marketing Authorization Application: but pledges to continue to engage with the regulator as it considers its next steps.
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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
NOVEMBER 17, 2021
A European Medicines Agency panel tasked with reviewing drugs voted against the biotech's controversial Alzheimer's medicine, signaling an approval is unlikely next month
World of DTC Marketing
NOVEMBER 15, 2021
SUMMARY: Physicians are tired and overwhelmed with medical information on new drugs. They don’t have the time to sit in the office and search for more information, and they feel that pharma is giving them “too much” information. An exciting development presented itself. A client launched an Oncology drug based on extensive research with physicians, but the results were not that good during a post-launch evaluation.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioPharma Reporter
NOVEMBER 18, 2021
The European Medicines Agency (EMA) could issue an opinion on Novavaxâ Conditional Marketing Authorization for its COVID-19 vaccine âwithin weeksâ.
Bio Pharma Dive
NOVEMBER 19, 2021
The decision comes as at least 10 states have already begun opening up booster dose eligibility, with cases remaining at high levels across the country.
World of DTC Marketing
NOVEMBER 18, 2021
SUMMARY: AbbVie continues to profit from Americans by repeatedly raising U.S. prices on its widely-used Humira rheumatoid arthritis drug while cutting the price abroad. AbbVie exploits the U.S. patent system to fend off competitors and increased the price of Humira to $77,000 for a year’s supply, while the price of its cancer drug Imbruvica was raised to $181,529 per year.
pharmaphorum
NOVEMBER 16, 2021
Moderna is already riding high on the strength of its mRNA-based COVID-19 vaccine, but the broader potential of its technology has been shown in a new AstraZeneca-partnered candidate for heart failure. At the American Heart Association (AHA) congress, the two partners presented results from the phase 2a EPICCURE trial that showed that injecting their AZD8601 candidate directly into the heart muscle of patients undergoing coronary artery bypass graft (CABG) surgery seemed to improve heart functio
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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
BioPharma Reporter
NOVEMBER 15, 2021
Pfizer and BioNTech have completed long-range drone deliveries of their mRNA COVID-19 vaccine: with partner Zipline claiming to be the first to deliver vaccines in this way at a national scale.
Bio Pharma Dive
NOVEMBER 17, 2021
Chroma Medicine's launch is the latest step in a decadeslong quest by drugmakers to capitalize on research into epigenetics, a way of controlling gene expression without altering DNA.
BioSpace
NOVEMBER 18, 2021
BioNTech is on the Fast Track. This morning, the company announced it received Fast Track Designation from the U.S. Food and Drug Administration for its cancer immunotherapy candidate.
pharmaphorum
NOVEMBER 19, 2021
US company Respira Labs has developed a device worn on the chest that uses tiny speakers and microphones to project sound into the lungs and listen for signals that could indicate serious lung diseases. The Sylvee wearable uses an artificial intelligence (AI) algorithm to interpret sounds that may indicate trapped air in the lungs, which can be a sign of ill health, using acoustic resonance – similar to the way an ultrasound machine creates visual images.
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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.
BioPharma Reporter
NOVEMBER 16, 2021
CRISPR Therapeutics and ViaCyte, Inc. have received the green light from Health Canada for their Clinical Trial Application for VCTX210: an allogeneic, gene-edited, immune-evasive, stem cell-derived therapy for the treatment of type 1 diabetes (T1D).
Bio Pharma Dive
NOVEMBER 15, 2021
While CMS is still weighing whether to authorize wide coverage of Biogen's pricey Alzheimer's drug, administrators are planning to build reserves in case costs skyrocket.
Pharma Times
NOVEMBER 15, 2021
Those eligible will have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
pharmaphorum
NOVEMBER 15, 2021
Patients with sickle cell disease are facing racism in the NHS that is putting their lives a risk, claims a new report. . The All-Party Parliamentary Group (APPG) document – entitled No One’s Listening and partnered with the Sickle Cell Society – found “serious care failings” in acute services and evidence of attitudes underpinned by racism in the care of people with SCD, a red blood cell disorder that mainly affects black people.
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
NOVEMBER 18, 2021
In a Bloomberg News survey of 25 large insurers, none described the drug as “medically necessary,” and said Aduhelm was still experimental.
Bio Pharma Dive
NOVEMBER 18, 2021
The biotech will pay $725 million to opt into rights on four experimental medicines developed by Arcus, including ones that could challenge Merck's Keytruda in lung cancer.
Pharma Times
NOVEMBER 18, 2021
The UKHSA have said that deferring the vaccine dose could help to reduce even further the small risk of heart inflammation following vaccination
pharmaphorum
NOVEMBER 16, 2021
Biogen’s chief medical officer Al Sandrock has announced he will retire at the end of the year, ending a 23-year career at the biotech. The architect of many of Biogen’s biggest-selling drugs, Sandrock is bowing out as Biogen is still struggling with the rollout of its controversial new Alzheimer’s disease therapy Aduhelm (aducanumab).
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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
NOVEMBER 17, 2021
Merck’s Keytruda (pembrolizumab) keeps expanding the indications for which it’s approved. The company announced today that the FDA had approved the anti-PD-1 therapy for adjuvant treatment of renal cell carcinoma.
Bio Pharma Dive
NOVEMBER 16, 2021
Study results released earlier this month showed the pill, when given soon after symptoms start, dramatically reduced the risk of COVID-19 hospitalization or death.
Pharma Times
NOVEMBER 16, 2021
The data was obtained by a Freedom of Information request, according to The Independent
pharmaphorum
NOVEMBER 15, 2021
Johnson & Johnson’s SGLT2 inhibitor Invokana has been shown to have a significant effect on heart failure symptoms in a clinical trial that relied entirely on remote monitoring of symptoms using a smartphone app. The real-world CHIEF-HF study is said to be the first fully “decentralised, mobile, indication-seeking clinical study” with no need for patients to visit clinic, according to J&J’s pharma division Janssen.
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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.
BioSpace
NOVEMBER 14, 2021
Between the numerous COVID-19 vaccines and several new antiviral drugs, it would appear that the tools to end the COVID-19 pandemic are within reach. Here’s a look at some of the top stories.
Bio Pharma Dive
NOVEMBER 16, 2021
Sandrock championed the controversial Alzheimer's drug, and was integral to the development of several other of Biogen's most important medicines during his 24 years at the biotech.
Pharma Times
NOVEMBER 17, 2021
This deal will see more patients having access to treatment which could prevent 21,700 strokes and 5,400 deaths
pharmaphorum
NOVEMBER 18, 2021
Merck & Co has chalked up another win in drive to move PD-1 inhibitor Keytruda earlier in the treatment pathway for cancer, after the FDA greenlit use of the drug as post-surgery (adjuvant) therapy for renal cell carcinoma (RCC). The checkpoint inhibitor has been approved for use after surgery in patients with RCC – the most common form of kidney cancer – who are at intermediate-high or high risk of the disease recurring.
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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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