Bio Pharma Dive
MAY 3, 2022
Michel Vounatsos, Biogen's CEO since 2017, will be replaced as the company "substantially" eliminates the commercial workforce around Aduhelm, which has generated paltry sales in the face of resistance from insurers and doctors.
World of DTC Marketing
MAY 4, 2022
A 2015 Commonwealth Fund brie f showed that — before the major provisions of the Affordable Care Act were introduced — the United States had worse outcomes and spent more on health care, primarily because of greater use of medical technology and higher prices, compared to other high-income countries. The United States ranks last overall, despite spending far more of its gross domestic product on health care.
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pharmaphorum
MAY 4, 2022
Testing drug compounds on a chip designed to mimic human organs sounds closer to science fiction than reality, yet the technology already exists and is already being put to use. Ben Hargreaves discovers how the technology could provide more accurate safety predictions and even discover new treatments. The limits of animal models in drug discovery are well known.
BioPharma Reporter
MAY 5, 2022
Oramed Pharmaceuticals announced this week that it has enrolled 100% of the patients in the worldâs first Phase 3 study of oral insulin under FDA approved protocols.
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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
MAY 6, 2022
Due to potential issues in manufacturing, the pharma is halting deliveries of two cancer drugs, Lutathera and Pluvicto, in the U.S. and Canada, a setback for a business in which the company has invested heavily.
World of DTC Marketing
MAY 3, 2022
Biogen announced that CEO Michel Vounatsos is being replaced as the big biotech undergoes a restructuring of the pipeline. It’s long overdue but kind of like putting smoke detectors in a house that has burnt down. From the beginning, Aduhelm was doomed to fail. There was outrageous pricing along with data that, at best, was highly questionable.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Drug Patent Watch
MAY 2, 2022
DrugPatentWatch has been named to Genetic Engineering News‘ Best of the Web list. The review by Genetic Engineering News profile highlighted the “new training modules designed to help you find…. The post DrugPatentWatch named “Best of the Web” by Genetic Engineering News appeared first on DrugPatentWatch - Make Better Decisions.
Bio Pharma Dive
MAY 6, 2022
The agency is limiting use to adults who either can't or won't take another authorized vaccine after collecting more data on a rare and unusual clotting syndrome that has weighed on the shot's uptake.
BioPharma Reporter
MAY 4, 2022
An expert from Pharmatech Associates offers a glimpse into the evolution of CM and previews a lively discussion during the upcoming CPhI North America event.
pharmaphorum
MAY 4, 2022
Cognitive problems affecting memory and attention can be substantial and long-lasting in patients who suffer severe COVID-19 infections, according to a study by researchers in the UK. The study used computerised cognitive assessments to follow-up 46 people who were hospitalised with COVID-19 at the Addenbrooke’s Hospital in Cambridge over a three-month period in 2020, comparing the results with 460 matched control subjects.
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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
XTalks
MAY 3, 2022
Whipnotic is putting a new twist on whipped cream, using its patented technology to dispense a creamy whipped topping with flavor-infused swirls and all-natural colors. The New York-based startup delivers an entirely reimagined multi-sensory whipped cream experience, revolutionizing the relatively unchanged whipped cream market. . Whipnotic is the first swirled whipped cream that uses its patented technology to dispense an all-natural color and infused swirl with the press of the nozzle.
Bio Pharma Dive
MAY 3, 2022
While a voluntary pause in dosing new patients will remain in place, the FDA's decision puts the study back on track to deliver data in 2023.
BioPharma Reporter
MAY 3, 2022
Biogen will âsubstantially eliminateâ commercial infrastructure for Alzheimerâs drug Aduhelm and take additional cost-reduction measures, the company announced as it released its Q1 2022 results this morning.
pharmaphorum
MAY 3, 2022
Alain Labrique, PhD, professor and associate chair of research at Johns Hopkins Bloomberg School of Public Health (JHSPH) and chair of the World Health Organization (WHO) digital health guidelines development group discusses with us the ongoing research study, National Pandemic Pulse, he and his colleagues are performing in the US. Using comprehensive, repeat surveys deployed across the US population, Labrique and fellow researchers at JHSPH are measuring disparities and inequities due to COVID
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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
MAY 6, 2022
In this interview, Xtalks spoke with experts from eClinical Solutions , Katrina Rice, Chief Delivery Officer, Data Services; and Diane Lacroix, Vice President, Clinical Data Management, about clinical data management for modern day digital clinical trials. They discussed current challenges and solutions that life science companies and clinical development organizations have with the management of clinical data.
Bio Pharma Dive
MAY 2, 2022
The partners increased the size and length of a large, ongoing study in transthyretin amyloidosis cardiomyopathy, a decision that has implications Alnylam Pharmaceuticals, which is testing two of its drugs against the disease.
BioPharma Reporter
MAY 4, 2022
CPhI North America 2022 host city Philadelphia is set to become one of the worldâs biggest cell and gene therapy manufacturing hubs. But itâs just one of many centers of innovation that are helping drive the US pharma and biopharma industry.
Intouch Solutions
MAY 2, 2022
We’ve been thrilled to unveil a newly focused and funded project to Intouchers during Global Volunteer Month, and we’d love to tell you about it too. The Give Back is Intouch’s approach to – well – giving back. It’s a bigger, better philanthropy program than we’ve ever had before, supporting our efforts to make the world a better place, including the fight to overcome healthcare inequities and support social-justice initiatives.
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.
XTalks
MAY 5, 2022
The Paleo Diet LLC, the founding organization behind the corresponding lifestyle movement, has launched a new Paleo certification program. Based on the science from the researchers who established the framework of modern Paleolithic nutrition, the program aims to provide guidance for the food industry by codifying Paleo Diet standards and making them available to manufacturers, retailers and other partners.
Bio Pharma Dive
MAY 4, 2022
Agency statisticians took a different view of the Phase 3 results the biotech was relying on to support approval of a new antibiotic, an announcement that triggered the sector's latest restructuring.
Scienmag
MAY 3, 2022
HAMILTON, May 4, 2022 — McMaster University researchers who study the dynamics of infectious disease transmission have investigated the population-level consequences of a potentially significant––and unobvious––benefit of wearing masks. Credit: McMaster University, Hamilton, Ontario, Canada HAMILTON, May 4, 2022 — McMaster University researchers who study the dynamics of infectious disease transmission have investigated the population-level consequences of […].
pharmaphorum
MAY 3, 2022
Idorsia has become the first drugmaker in the EU to claim approval for a drug for chronic insomnia in the dual orexin receptor antagonist class, ahead of rival drugs from Merck & Co and Eisai. The new drug – Quviviq (daridorexant) – has been approved by the European Commission for adults who have been suffering insomnia for at least three months and are experiencing “considerable impact” on daytime functioning, according to the Swiss pharma company.
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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.
XTalks
MAY 5, 2022
Supernus Pharmaceuticals’ Qelbree was approved by the FDA on Friday. Qelbree is the newest nonstimulant ADHD drug for adults after two decades. Attention deficit hyperactivity disorder (ADHD) is one of the most established psychiatric disorders found in children and can be diagnosed at 3 years of age. The common symptoms of ADHD include lack of attention, hyperactivity and increased impulsivity.
Bio Pharma Dive
MAY 2, 2022
The regulator determined Vertex had "insufficient information" to test higher doses of the therapy, which showed promise in the first two patients treated.
Scienmag
MAY 5, 2022
Native species in California’s estuaries are expected to experience greater declines as invasive species interact with climate change, according to a study from the University of California, Davis. Credit: Ben Rubinoff, UC Davis Native species in California’s estuaries are expected to experience greater declines as invasive species interact with climate change, according to a study […].
BioPharma Reporter
MAY 6, 2022
CDMO Matica Bio has opened a new 45,000-square-foot facility dedicated to the production of viral vectors and cell-based products used in cell and gene therapies, vaccines, oncolytic therapies and other genetic medicines.
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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.
XTalks
MAY 4, 2022
Bristol Myers Squibb (BMS) was granted US Food and Drug Administration (FDA) approval for its highly awaited cardiac drug Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM). The FDA approved 2.5 mg, 5 mg, 10 mg and 15 mg capsules of Camzyos for adults with symptomatic New York Heart Association (NYHA) class II-III obstructive HCM to improve functional capacity and symptoms.
Bio Pharma Dive
MAY 4, 2022
Though executives claimed that inking deals and derisking research programs are priorities, analysts questioned whether any meaningful strategic changes will occur in the near term.
Scienmag
MAY 2, 2022
EMBARGOED: THIS ARTICLE IS EMBARGOED UNTIL MONDAY, MAY 2, 3:00 PM, US EST Credit: Greg Asner, Center for Global Discovery and Conservation Science EMBARGOED: THIS ARTICLE IS EMBARGOED UNTIL MONDAY, MAY 2, 3:00 PM, US EST As the world sees rising ocean temperatures, it will also see more cases of coral bleaching. When corals bleach, […].
pharmaphorum
MAY 6, 2022
Throughout my 30-year career, there have been many times it was obvious I stood out just because of my gender. I was often the only woman in the room, the meeting, or on the committee. Many colleagues had never worked with a woman leader before, let alone reported to a female boss. I’ve certainly faced barriers – sometimes literally. Exclusive behavior has many faces.
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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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