Bluebird hit with another hold for sickle cell gene therapy
Bio Pharma Dive
DECEMBER 20, 2021
Study enrollment and treatment of sickle cell patients under 18 will be paused for safety reasons, another hurdle in a series of setbacks for the company.
Sat.Dec 18, 2021 - Fri.Dec 24, 2021
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Value-based healthcare can help reduce costs
World of DTC Marketing
DECEMBER 20, 2021
According to the Kaiser Family Foundation (KFF), in 2021, the average cost of employee health insurance premiums for family coverage increased by 4% from the previous year to $22,221. The average annual premiums for an individual’s plan also increased 4% to $7,739 this year. Why haven’t more employers addressed the rising costs of employee healthcare with value-based care?
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PDUFA VII: Implications for Developers of Cell and Gene Therapies
Camargo
DECEMBER 20, 2021
One of the biopharmaceutical industry’s most closely watched forthcoming regulatory developments is the FDA’s imminent reauthorization of the Prescription Drug User Fee Act (PDUFA). PDUFA VII , as the reauthorization is commonly known, will cover the fiscal years 2023-2027. Many of the advancements included in PDUFA VII are driven in large part by an increase in the development of innovative products such as cell and gene therapies.
Oxford and AstraZeneca aim to produce Omicron-targeted version of vaccine
Pharma Times
DECEMBER 22, 2021
Calls for booster vaccinations in order to combat the rising cases brought about by winter and the recent Omicron variant have intensified, in the midst of record case rates.
Bridging Innovation & Patient Care: The Growing Role of AI
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
US pauses distribution of Regeneron, Lilly antibodies over omicron concerns
Bio Pharma Dive
DECEMBER 23, 2021
The decision follows worrisome results in lab studies that indicated omicron can evade both drugs and leaves the U.S. with fewer treatments to respond to the variant's spread.
What Changes To Your Lifestyle Need To Be Done After Bariatric Surgery
Pharma Mirror
DECEMBER 24, 2021
Getting bariatric surgery is a lifesaver for many people. It can dramatically improve the quality of life of those that are having problems because of their obesity. It reduces and even eliminates diabetes in many people and seriously reduces the risk of heart disease. The weight loss can be dramatic as well. Starting almost immediately after the surgery, the pounds fall away with ease.
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AstraZeneca and Novavax say their vaccines are effective against Omicron
Pharma Times
DECEMBER 23, 2021
WHO officials remain cautious about claiming Omicron as a milder variant of the COVID-19 virus.
Novartis wins FDA approval for new heart drug, but faces uphill sales battle
Bio Pharma Dive
DECEMBER 22, 2021
Leqvio, which Novartis acquired for nearly $10 billion two years ago, arrives with high sales expectations. But uptake could be slow as insurers and doctors weigh the drug's safety and cost-effectiveness.
Deloitte: Artificial intelligence technology investments prove top priority for biopharma leaders
BioPharma Reporter
DECEMBER 22, 2021
The pandemic has focused biopharma industry minds on digital innovation, finds a Deloitte report.
Bias in artificial intelligence impacts drug development: AiCure
Outsourcing Pharma
DECEMBER 20, 2021
According to an expert from the clinical insights company, prejudice in AI can impact patient outcomes as well as the ability to develop effective treatments.
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
Cancer researchers across the UK partner in new trial to find drugs for rare cancers
Pharma Times
DECEMBER 21, 2021
The DETERMINE trial aims to discover whether existing ‘licensed’ drugs could also benefit patients with rare cancer types that the drug is not currently licensed for.
Moderna vaccine weaker against omicron, but third shot boosts protection
Bio Pharma Dive
DECEMBER 20, 2021
As a result of new laboratory data, the biotech company is deemphasizing more complex "multivalent" booster shots in favor of further study of its existing formulation and an omicron-specific version.
Sanofi buys US immuno-oncology biotech Amunix for $1 billion
pharmaphorum
DECEMBER 21, 2021
Sanofi has bolstered its immuno-oncology pipeline with a $1 billion agreement to acquire Amunix Pharma of the US – its fourth bolt-on deal of 2021. South San Francisco-based Amunix specialises in T-cell engager and cytokine-based treatments for solid tumours, and is planning to advance its lead programme AMX-818 – a cell-based therapy which targets HER2-expressing cancers – into the clinic next year.
Time to put patient voice first in cancer research: GRYT Health
Outsourcing Pharma
DECEMBER 21, 2021
The organization is working to give oncology professionals the chance to hear directly from patients about their unique experiences, concerns, and hopes.
Xeris Biopharma’s glucagon injection becomes available in UK
Pharma Times
DECEMBER 20, 2021
Tetris Pharma’s Ogluo is the first ready-to-use, pre-mixed and pre-measured glucagon injection.
Sanofi to buy cancer immunotherapy biotech for $1B
Bio Pharma Dive
DECEMBER 21, 2021
The French drugmaker is interested in Amunix Pharmaceuticals' technology, which could allow for more precise delivery of biologic drugs into cancerous tissue.
NICE backs Aimmune’s peanut allergy drug Palforzia for children
pharmaphorum
DECEMBER 23, 2021
Children in England with peanut allergies could be among the first in Europe to get access to Aimmune’s oral immunotherapy Palforzia, after the drugmaker agreed a supply deal with NHS England. The deal comes as cost-effectiveness watchdog NICE recommended Palforzia for NHS use in draft guidance published today which says the drug can be effective in inducing tolerance to peanuts and reducing the severity of allergic reactions, including potentially life-threatening anaphylaxis.
Dogs, VR, and rock stars: OSP’s favorite items of 2021
Outsourcing Pharma
DECEMBER 22, 2021
It has been a pleasure for the OSP team to connect with a long list of fascinating industry minds and share the stories; here are a few of our favorites.
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
CHMP recommend Saphnelo for systematic lupus erythematosus
Pharma Times
DECEMBER 21, 2021
With approval, Saphnelo would be the first available treatment for systematic lupus erythematosus in Europe in over ten years.
COVID-19 pill from Pfizer authorized by FDA in major pandemic milestone
Bio Pharma Dive
DECEMBER 22, 2021
Paxlovid is the first oral treatment for COVID-19, a potentially valuable new tool as the fast-spreading omicron variant fuels a sharp surge in cases across the U.S.
US health department backs 15 COVID-focused digital health startups
pharmaphorum
DECEMBER 22, 2021
A group of 15 digital health startups have joined a programme set up by the US federal government to address health inequality and mitigate the effects if the COVID-19 pandemic. The PandemicX accelerator, launched by the Department of Health and Human Services, is focused on “using digital tools and publicly accessible data to eliminate disparities and tackle drivers of inequity exacerbated by COVID-19.” Companies that have been invited to take part will get “curriculum, mentor
COVID-19 vaccine development: What the next wave of vaccines in 2022 could look like
BioPharma Reporter
DECEMBER 22, 2021
As 2021 draws to a close, we take a look at the COVID-19 vaccine development landscape and some of the candidates progressing through clinical trials.
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.
COVID-19 vaccine should be offered to vulnerable children aged five to 11-years-old
Pharma Times
DECEMBER 23, 2021
Government vaccine advisers have said vulnerable primary school children should be offered a low-dose of a COVID-19 vaccine.
Duchenne patient dies in Pfizer gene therapy study
Bio Pharma Dive
DECEMBER 21, 2021
The tragic news follows changes Pfizer recently made to the design of another study testing the therapy due to side effects seen in some participants.
Mydecine, Maya team up on digital tools for psychedelic drugs
pharmaphorum
DECEMBER 24, 2021
Psychedelic medicines developer Mydecine has joined forces with digital health company Maya to make digital tools that will be used alongside its drug candidates for mental health and addiction disorders. The aim is to develop the digital therapeutics (DTx) and new drug therapies in tandem, so that they can be co-prescribed by physicians and – at least in theory – improve the effectiveness of treatment.
Merck’s Covid Pill Is Authorized by F.D.A. for High-Risk Adults
NY Times
DECEMBER 23, 2021
The F.D.A. said the drug should be prescribed mainly when other treatments were “not accessible or clinically appropriate.”.
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.
Pfizer to provide UK with additional 2.5 treatment courses of Paxlovid
Pharma Times
DECEMBER 22, 2021
With authorisation, Pfizer’s oral antiviral candidate Paxlovid is an investigational SARS-CoV-2 protease inhibitor could be prescribed at the first sign of COVID-19 infection.
GSK's long-acting HIV shot approved for preventive use
Bio Pharma Dive
DECEMBER 21, 2021
The landmark FDA approval makes Apretude the first injectable treatment in the U.S. for HIV pre-exposure prophylaxis.
FDA sets out its stall on digital tools for remote clinical trials
pharmaphorum
DECEMBER 23, 2021
The FDA has published draft guidance on how digital health technologies (DHTs) like smart and wearable devices can be used to capture data remotely from patients in clinical trials – an approach that has come to the fore since the start of the pandemic. The new guidance sets out the regulator’s current thinking on how trial sponsors to incorporate DHTs in the design of studies of drugs or medical devices.
4D Pharma sees positive data from early stage asthma trial
BioPharma Reporter
DECEMBER 22, 2021
Live biotherapeutic product (LBP) developer, 4D Pharma, which has been NASDAQ listed since March this year, has announced positive topline results for the first part of its Phase I/II trial of an LBP strain for the treatment of asthma.
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