Pfizer cleared to restart hemophilia gene therapy trial
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.
Sat.Apr 30, 2022 - Fri.May 06, 2022
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Our healthcare system is really screwed up
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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How patient-on-a-chip tech could be the future of drug discovery
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.
DrugPatentWatch named “Best of the Web” by Genetic Engineering News
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.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
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
Biogen CEO to step down as company pulls back from Alzheimer's drug
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.
Biogen: It’s a cruel business world
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.
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Oramed hits oral insulin clinical trial milestone
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.
FDA rejects two China-developed cancer drugs
Bio Pharma Dive
MAY 2, 2022
The regulator cited concerns around single-country trials in turning back Hutchmed's pancreatic cancer treatment, while manufacturing issues held up Junshi and Coherus' throat cancer medicine.
Byondis and Medac link up to commercialise trastuzumab duocarmazine
Pharma Times
MAY 3, 2022
Byondis and Medac have entered into a license and collaboration agreement for form of targeted chemotherapy
UK study finds evidence for brain fog after severe COVID
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.
How Whipnotic is Revolutionizing Whipped Cream
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.
FDA places stricter limits on J&J's COVID-19 vaccine after review of rare side effect
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.
Farxiga demonstrates success in preserved ejection fraction trial
Pharma Times
MAY 5, 2022
DELIVER represents the largest ever trial to address heart failure with preserved ejection fraction
Studying inequities throughout the pandemic
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
The New Age of Decentralized Clinical Trials
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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
Clinical Data Management Experts Share Insights on Modern Digital Clinical Trials
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.
Vertex surprised by FDA halt of diabetes cell therapy study
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.
Isla Visual Record for Surveillance to aid post-surgery wound assessment
Pharma Times
MAY 4, 2022
Platform will enable patients to monitor and share updates of their post-surgical wound healing
Which pharmaceutical companies have the most drug patents in Ireland?
Drug Patent Watch
MAY 6, 2022
This chart shows the pharmaceutical companies with the most patents in Ireland. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is…. The post Which pharmaceutical companies have the most drug patents in Ireland? appeared first on DrugPatentWatch - Make Better Decisions.
How Machine Learning Drives Clinical Trial Efficiency
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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.
The Paleo Diet Launches a Paleo Certification Program for Food Packaging
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.
Ionis, AstraZeneca change a key trial, fueling more questions about a genetic heart disease
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.
WHO recommends Veklury for high-risk patients
Pharma Times
MAY 6, 2022
WHO have stated that Veklury recommendation is being updated following compelling new evidence of hospital reductions
The Give Back: Introducing the New Intouch Philanthropy Program
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.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
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.
Camzyos Secures FDA Approval for Obstructive HCM, Bristol Myers Eyes it as its Next Big Cardiac Drug
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.
Spero to lay off 75% of workforce, change strategy after FDA challenges study results
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.
Novartis Kymriah receives EC approval for lymphoma treatment
Pharma Times
MAY 4, 2022
Approval for Kymriah follows a positive CHMP opinion and is applicable to all 27 EU member states
4 Reasons Why You Shouldn’t Ignore CDISC Data Standards
pharmaphorum
MAY 5, 2022
A quick recap: Who are CDISC and what do they do? The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organization that aims to maximise the impact of clinical research data by establishing and promoting the use of data standards. Basically, these standards make clinical data easier to understand and interpret. “We develop and advance data standards of the highest quality to transform incompatible formats, inconsistent methodologies, and diverse perspectives into a power
Qelbree: The First FDA-approved Nonstimulant ADHD Drug for Adults in 20 Years
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.
Biogen, having scrapped Aduhelm, tries to convince investors of turnaround plan
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.
Idorsia’s Quviviq approved for adults with chronic insomnia disorder
Pharma Times
MAY 3, 2022
The EC’s decision on the insomnia treatment was supported by phase 3 trial results
Idorsia is first to EU market with orexin insomnia drug
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.
The New Age of Decentralized Clinical Trials
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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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