FDA panel backs Bluebird gene therapy despite safety risks
Bio Pharma Dive
JUNE 9, 2022
Advisers to the agency voted 15-0 in support of the rare disease treatment eli-cel, which was linked to a bone marrow cancer in three study participants.
Sat.Jun 04, 2022 - Fri.Jun 10, 2022
344 
Monday Healthcare Headlines
World of DTC Marketing
JUNE 6, 2022
Medicare Advantage plans are endangering the lives of older adults and people with disabilities. The HHS Office of the Inspector General (OIG), which works to fight waste, fraud, and abuse, recently issued a devastating report showing that these corporate health plans, which contract with the government to deliver Medicare benefits, are denying large amounts of care inappropriately. .
Join 21,000+
Insiders
Sign Up for our Newsletter
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
A Cancer Trial’s Unexpected Result: Remission in Every Patient
NY Times
JUNE 5, 2022
The study was small, and experts say it needs to be replicated. But for 18 people with rectal cancer, the outcome led to “happy tears.”.
How celebrity investor Mark Cuban is tackling out-of-control drug prices
pharmaphorum
JUNE 6, 2022
American entrepreneur and investor Mark Cuban tells us why he and his partners launched the Mark Cuban Cost Plus Drug Company (MCCPDC), a public-benefit corporation and online pharmacy that provides patients access to medications at a lower cost. . US drug prices have soared over the last several decades, causing, at times, financial hardship for patients and their families, so Cuban says he developed MCCPDC with a simple mission – “to be the low-cost provider of medications to patients.”.
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
ASCO 2022: Gilead's tough weekend, bispecific progress and 'gamma delta' cell therapy
Bio Pharma Dive
JUNE 6, 2022
The biotech's highly anticipated breast cancer data were upstaged by a rival, while presentations from Roche, J&J and Adicet Bio highlighted emerging alternatives to CAR-T treatment.
Moderna takes mRNA influenza candidate into Phase 3 trials
BioPharma Reporter
JUNE 7, 2022
Moderna has dosed the first participants in a Phase 3 study of the companyâs seasonal influenza vaccine candidate, mRNA-1010.
Sign up to get articles personalized to your interests!
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
More Trending
Four things you need to know about FDA regulations and digital health
pharmaphorum
JUNE 10, 2022
If you work in pharma, the chances are you’re no stranger to the United States Food and Drug Administration, or FDA, which regulates pharmaceuticals. But if you’re becoming more involved with the world of digital health, as many pharma companies are these days, you may find that your old FDA knowledge isn’t much help in knowing what will be required of you.
Immatics and Editas join up to bring CRISPR to 'gamma delta' cell therapy
Bio Pharma Dive
JUNE 7, 2022
The two biotechs will use gene editing to make prospective treatments more potent, adding to a recent flurry of activity involving the fast-emerging form of cellular immunotherapy.
CPHI China opens for international partnering after China rises in CPHI Index
Pharma Mirror
JUNE 8, 2022
Shanghai/Amsterdam: CPHI & P-MEC China opens its online international partnering platform as pharmaceutical and biopharmaceutical industries in the country report strong underlying conditions and see increases in all categories of the most recent CPHI Pharma Index [1] – an annual score of each country’s pharma industry strength – with its overall score rising by 7.2%, the largest increase of any nation.
?“This [clinical] trial has given our family hope”: A story of cancer survivorship
Worldwide Clinical Trials
JUNE 7, 2022
In her own words, a daughter shares how a career in cancer research helped support her mother’s courageous battle with late-stage ovarian cancer. By Cathy Purvis, MBA; Site Activation Manager, Oncology and Rare Disease, Worldwide Clinical Trials. I landed in oncology thanks to the luck of the draw. This area happened to be where I was assigned when first starting in Site Activation.
How digital is transforming the commercial leader’s role in biopharma
pharmaphorum
JUNE 10, 2022
Pharma’s evolving role in patient care. The digital revolution has already reshaped the commercial engine of biopharma companies. Pharma’s digital initiatives now routinely enable new channels that educate and market to patients, physician engagement that is more efficient and effective, and novel payment mechanisms and distribution models that improve access to therapies.
FTC to investigate CVS Caremark, others in probe of PBM business practices
Bio Pharma Dive
JUNE 7, 2022
The decision to launch an inquiry reversed a vote earlier this year, when FTC commissioners had deadlocked over whether to look into the drug pricing middlemen.
Novotech Sponsors Endpoints ASCO 2022 Expert Panel on Accelerating Oncology Clinical Trials in China
Pharma Mirror
JUNE 8, 2022
SYDNEY, Novotech, the leading Asia Pacific biotech specialist CRO which has recently expanded its services to the US, is sponsoring the Endpoints ASCO 22 “Accelerating clinical development in China and the US” Register here [link] JUNE 711:00am – 11:45am ET (1:00 – 1:45 local time)Novotech Booth at ASCO #14115 The virtual session will cover the latest on the clinical trial landscape and infrastructure in China and includes Novotech’s DCT partner, Obvio Health, on DC
Bachem and Eli Lilly link up to advance oligonucleotide products
Pharma Times
JUNE 7, 2022
The agreement will see the two companies expand current oligonucleotide technologies
The New Age of Decentralized Clinical Trials
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Apple adds medication tracking to iPhone and Apple Watch
pharmaphorum
JUNE 8, 2022
Owners of an iPhone or Apple Watch have a new health feature, an app called Medications, that will help them manage and track their use of medicines. The new tool works as a component of Apple’s Health app and will let users add drugs or other health products like vitamins and supplements to a personal list – either by scanning a label or finding the product in a directory – and create custom schedules for them.
'Dramatic' study results for AstraZeneca, Daiichi drug suggest new way to treat aggressive breast cancer
Bio Pharma Dive
JUNE 5, 2022
A quarter century after Roche's Herceptin became an option for HER2-positive breast cancer, positive study results for Enhertu could push doctors to consider a new classification of "HER2 low" disease.
CDCDB: A large and continuously updated drug combination database
Drug Patent Watch
JUNE 7, 2022
This article was originally published by Guy Shtar, Louise Azulay, Omer Nizri, Lior Rokach & Bracha Shapira in Scientific Data volume 9, Article number: 263 under a Creative Commons Attribution…. The post CDCDB: A large and continuously updated drug combination database appeared first on DrugPatentWatch - Make Better Decisions.
Takeda’s dengue vaccine candidate delivers continued protection
Pharma Times
JUNE 9, 2022
Vital dengue vaccine offers over four years’ protection following successful clinical trial
How Machine Learning Drives Clinical Trial Efficiency
Advertisement
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.
Eversana aims athletes’ mental coaching at pharma sales reps
pharmaphorum
JUNE 6, 2022
Eversana’s suite of commercialisation tools for pharma companies will soon have a new component – cognitive behavioural training tools designed to improve the performance of sales representatives. The addition to the company’s portfolio – which already spans services like patient support, digital engagement, dispensing and distribution, and data/analytics – has arrived on the back of an alliance with business and wellness coaching specialist Limitless Minds.
Forbion raises $500M to back growing biotechs amid industry slump
Bio Pharma Dive
JUNE 10, 2022
The European venture firm’s latest fund will open up a new source of investment at a time companies are struggling to go public or hold their value.
Can the industry elevate the success rate of cancer trials?
Outsourcing Pharma
JUNE 7, 2022
During the upcoming BIO International Convention, experts from CerFlux, the MD Anderson Cancer Center, and Aga Khan University will weigh in with insights.
Westminster Drug Project and Gilead Sciences join forces to take on hepatitis C
Pharma Times
JUNE 8, 2022
The companies have partnered for a second time to support sector-wide efforts to eliminate hepatitis C virus in drug and alcohol services
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.
Praxis wields the axe as lead depression drug fails
pharmaphorum
JUNE 6, 2022
Shares in Praxis Precision Medicines were in freefall today after the company’s efforts to develop a new therapy for major depressive disorder (MDD) ended in failure, forcing a restructuring and staff cuts. The selloff followed the announcement of the phase 2/3 Aria study results with PRAX-114 as a monotherapy for MDD, which showed the GABA positive allosteric modulator was unable to show a significant benefit on any of the study’s primary and secondary endpoints.
GSK claims first positive Phase 3 result for an RSV vaccine
Bio Pharma Dive
JUNE 10, 2022
The British drugmaker now plans to seek approval of what could be the first preventive shot for the common lung infection. However, Pfizer, Johnson & Johnson and Moderna are close behind.
Small Study of GSK Rectal Cancer Drug Yields "Unheard of" Results
BioSpace
JUNE 5, 2022
In a small study of 14 rectal cancer patients, researchers at Memorial Sloan Kettering Cancer Center published results where 100% of the 12 patients who completed treatment went into remission.
Daiichi Sankyo and AstraZeneca’s Enhertu delivers promising trial results
Pharma Times
JUNE 6, 2022
Enhertu reduced the risk of disease progression or death compared to chemotherapy in certain patients with metastatic breast cancer
Controlling Diabetes: Advances & Adherence
Pharmaceutical Commerce
JUNE 10, 2022
Proper control of type 1 and 2 diabetes can greatly reduce the personal impact and economic burden of this pervasive public health condition. To that end, stakeholders are exploring many parallel routes to help individuals and society maintain the upper hand, as the toll of diabetes continues to skyrocket.
FDA advisers offer unanimous support to second Bluebird gene therapy
Bio Pharma Dive
JUNE 10, 2022
By a 13-0 vote, the panel agreed the benefits of Bluebird’s beta thalassemia treatment outweigh its risks, one day after reaching a similar conclusion for another of the company’s drugs.
Sanofi furthers its digital ambitions with Paris accelerator
pharmaphorum
JUNE 9, 2022
Sanofi has launched a new initiative in its drive to integrate digital technologies throughout its business, setting up an accelerator based in Paris that will serve as the lynchpin of the effort. The accelerator has been set up to “develop products and solutions that will support Sanofi’s mission to transform the practice of medicine with the use of digital, data and artificial intelligence (AI)”, said the drugmaker.
Vertex trial for hypoglycaemia therapy shows early promise
Pharma Times
JUNE 7, 2022
New data now reveals significant increases in the blood glucose time-in-range compared to baseline, following VX-880 dosage
The New Age of Decentralized Clinical Trials
Advertisement
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.
Let's personalize your content