FDA approves first gene therapy for hemophilia B
Bio Pharma Dive
NOVEMBER 22, 2022
The treatment, which is for the less common “B” form of the bleeding disorder, will be sold in the U.S. by maker CSL for $3.5 million.
Bio Pharma Dive
NOVEMBER 22, 2022
The treatment, which is for the less common “B” form of the bleeding disorder, will be sold in the U.S. by maker CSL for $3.5 million.
Pharmaceutical Technology
NOVEMBER 25, 2022
Artificial intelligence (AI) was seen as one of the top current investment priorities and was thought to continue to attract investment in the healthcare sector in the upcoming two years, according to GlobalData's latest report ‘Digital Transformation and Emerging Technology in the Healthcare Industry - 2022 Edition’. In this survey-based report tracker, digital media was prioritised as a top current investment target, with 53% of surveyed respondents confirming that their companies are currentl
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Bio Pharma Dive
MARCH 24, 2022
At least nine biotechs working in cell or gene therapy have announced layoffs, cost cuts or restructured their research since December — restructurings that have coincided with a stock market downturn.
Pharmaceutical Technology
DECEMBER 21, 2022
Artificial intelligence (AI) continued to stay in the news with several high-profile deals this year, as the pharmaceutical industry readily took to adopting AI models to improve drug discovery. But as the field grows in leaps and bounds, many authorities have prioritised the release of new guidelines, frameworks, and regulations to keep pace with these advances.
Bio Pharma Dive
NOVEMBER 29, 2022
At a medical conference, the companies detailed clinical trial results that could help support approval of their drug, lecanemab. However, some doctors aren’t yet convinced the medicine’s risks are worth its potential benefits.
Bio Pharma Dive
SEPTEMBER 28, 2022
The companies said the drug, called lecanemab, met all of its goals in the Phase 3 study. The data are a significant finding and provide stronger support for a much-debated hypothesis for treating Alzheimer’s.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
STAT News
DECEMBER 20, 2022
Lots of people struggle to get enough sleep — and the responsibility for fixing the problem tends to fall on the individual. Experts offer advice like reducing screen time, exercising more, or just going to bed earlier in the evening. But many restless nights can’t be solved with blackout curtains, ear plugs, or other typical suggestions.
Medical Xpress
DECEMBER 20, 2022
Using machine learning and clinical data from electronic health records, researchers at the Icahn School of Medicine at Mount Sinai in New York constructed an in silico, or computer-derived, marker for coronary artery disease (CAD) to better measure clinically important characterizations of the disease.
pharmaphorum
DECEMBER 19, 2022
A collaboration between academic centres in the UK has won government funding for a digital approach to dysfunctional breathing or dyspnoea, a symptom that affects around 10% of the population. The Engineering and Physical Sciences Research Council (EPSRC) has set aside £400,000 (almost $490,000) for the project, which will help fund work at the Universities of Plymouth, Salford and Stirling, and the Glasgow School of Art.
BioPharma Reporter
NOVEMBER 22, 2022
GeNeuro has recruited the first patients in a Phase 2 trial evaluating temelimab against long-COVID: assessing the efficacy of the treatment for improving cognitive impairment and fatigue.
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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
BioSpace
OCTOBER 26, 2022
With diagnostics for Alzheimer's already approved and therapeutics in late-stage clinical trials, the next hurdle is to translate these advances into clinical practice. The Davos Alzheimer's Collaborative is working on it.
Outsourcing Pharma
JANUARY 12, 2022
The company plans to launch a Phase Ib/II study of its compound NVG-291 in collaboration with researchers at Northwestern Universityâs Shirley Ryan AbilityLab.
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.”.
Pharmaceutical Technology
NOVEMBER 14, 2022
In a field dominated by antibodies and small molecules, two cell-therapy based approaches have come under the spotlight for showing early signs of efficacy in treating lupus. In September, a group from Friedrich Alexander University Erlangen-Nuremberg reported that five patients with lupus achieved remission after an infusion of autologous chimeric antigen receptor (CAR)-T cells led to a deep depletion of B cells.
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Fierce Pharma
NOVEMBER 10, 2022
AstraZeneca withdraws US COVID vaccine application, shifts focus to antibody treatments. aliu. Thu, 11/10/2022 - 09:02.
Bio Pharma Dive
SEPTEMBER 30, 2022
The drug, which will be sold as Relyvrio, showed modest benefits in function and survival in testing. It also became the latest test of the FDA's flexibility toward new therapies for neurological disorders.
NPR Health - Shots
DECEMBER 15, 2022
Scientists predict China will see the largest COVID surge of the pandemic this winter, with hundreds of millions of people infected. But some experts say that it could have been even worse.
STAT News
DECEMBER 14, 2022
Hospice in America is gravely ill. An extensive investigation jointly published by The New Yorker and ProPublica documented outright fraud, predatory practices, and flagrant mistreatment by specific publicly traded and private equity-owned hospice companies.
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.
Medical Xpress
DECEMBER 12, 2022
Reasons underlying hesitancy to get vaccinated against COVID-19 may be associated with increased risks of traffic accidents according to a new study in The American Journal of Medicine. Researchers found that adults who neglect these health recommendations may also neglect basic road safety. They recommend that greater awareness might encourage more COVID-19 vaccination.
pharmaphorum
OCTOBER 6, 2022
An artificial intelligence-powered digital health worker has been unveiled by the World Health Organisation (WHO) as its latest tool for disseminating reliable health information to the public. Originally developed by New Zealand tech company Soul Machines with support of the Qatar Ministry of Health, the first version of the virtual health worker was used to combat misinformation about the pandemic.
BioPharma Reporter
NOVEMBER 21, 2022
A Phase 3 trial for Northwest Biotherapeuticsâs DCVax-L vaccine extended survival in patients with gliobastoma for many months, or in some cases, years: according to new data.
BioSpace
JULY 11, 2022
Partnering is an important way to grow a business, and John Sharkey, Ph.D., newly-hired VP of business development for GeoVax, is well-positioned to identify strong partners.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Outsourcing Pharma
MAY 18, 2022
An expert from the AI-focused technology company shares insights as to how it can be harnessed to better interpret, and even predict, patient behavior.
Pharma Times
OCTOBER 4, 2022
Treatment involves adult patients with severe alopecia areata
Pharmaceutical Technology
AUGUST 4, 2022
Soaring patient numbers are stretching hospital capacity across the globe, forcing healthcare providers and their partners to think laterally about how to meet the demand without doubling their resources. Smarter diagnostic tools and more sophisticated remote- and self-care models will have an increasingly important role to play, as long as any advances are seen to deliver excellent outcomes and a better patient experience.
Bio Pharma Dive
NOVEMBER 3, 2022
In a panel discussion hosted by BioPharma Dive, venture capitalists and CEOs discussed how startups can navigate a challenging market as well as possible ripple effects from the new U.S. drug pricing law.
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
Bio Pharma Dive
AUGUST 17, 2022
The regulator cleared the biotech’s medicine Zynteglo for transfusion-dependent beta thalassemia, giving patients a powerful new treatment option. But it will come at a very high cost of $2.8 million in the U.S.
Bio Pharma Dive
AUGUST 3, 2022
The success of Alnylam's treatment in a trial known as APOLLO-B could pave the way for the biotech to reach consistent profitability, should the FDA sign off on a planned approval application.
Bio Pharma Dive
OCTOBER 18, 2022
At least five startups have emerged with new ways to genetically modify immune cells within the body, an approach that, if successful, could widen the field of CAR-T treatment.
Bio Pharma Dive
OCTOBER 18, 2022
The University of Pennsylvania immunologist and inventor of Kymriah spoke with BioPharma Dive about working with pharma, starting companies and the future of the cell therapy field.
Advertiser: Aggregage
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