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.
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AI will continue to attract investment in near future in the healthcare industry
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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As biotech retreats, gene therapy companies retrench and redraw plans
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.
2022 in review: Regulation starts to catch up with AI in pharma
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.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
What to make of Eisai and Biogen’s latest Alzheimer’s drug data
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.
In surprise result, Alzheimer’s drug from Eisai, Biogen shows benefit in large trial
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.
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‘One needs to feel safe’: Racism can put sleep — and its health benefits — out of reach
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.
Developing a digital marker for coronary artery disease
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.
UK digital health project aims to tackle dysfunctional breathing
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.
Long-COVID personalized medicine enters Phase 2 trial
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.
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
Bridging the Translational Gap between Alzheimer’s Advances and Patients
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.
NervGen Pharma sets sights on trial for spinal-cord injury treatment
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.
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.”.
Early cell therapy successes start to turn the tide in lupus
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.
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.
AstraZeneca withdraws US COVID vaccine application, shifts focus to antibody treatments
Fierce Pharma
NOVEMBER 10, 2022
AstraZeneca withdraws US COVID vaccine application, shifts focus to antibody treatments. aliu. Thu, 11/10/2022 - 09:02.
Building a biotech in a downturn: 3 lessons from VCs and startup CEOs
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.
COVID spreading faster than ever in China. 800 million could be infected this winter
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.
Opinion: Hospice care needs saving
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.
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.
Adults who neglect COVID-19 health recommendations may also neglect basic road safety, study finds
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.
Meet Florence, WHO’s AI-powered digital health worker
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.
Brain cancer vaccine succeeds at prolonging survival in Phase 3 trial
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.
Well-Versed Sharkey Ready to Take GeoVax from Buyer to Seller
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.
2022 Research: The Rapid Rise of Ocean Freight Visibility
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.
ALS drug approved by FDA in closely watched decision, marking win for patients, developer
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.
Bluebird gene therapy approved by FDA for rare blood disease
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.
Alnylam drug succeeds in key heart disease study, boosting company
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.
‘In vivo’ cell therapy: expanding beyond CAR-T
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.
An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space
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
CAR-T pioneer Carl June on founding biotech startups and cell therapy’s next act
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.
A Versant-backed biotech emerges to take on ‘overlooked’ cancer targets
Bio Pharma Dive
OCTOBER 6, 2022
Nested Therapeutics touts a deep bench of scientific leaders and advisers, including Kevan Shokat, whose work drugging KRAS — a cancer-related gene once thought to be undruggable — helped lead to the development of Amgen’s Lumakras.
Pfizer study results show Paxlovid benefit less clear in lower-risk patients
Bio Pharma Dive
JUNE 15, 2022
A closely watched study missed its goal, failing to prove the antiviral pill’s benefit in a broader population than the high-risk individuals for which it’s currently cleared.
'The music stopped': Biotech rout leaves drug startups grounded as demand slumps for IPOs
Bio Pharma Dive
FEBRUARY 6, 2022
For the first time in years, biotechs no longer have an easy path onto Wall Street, a market reversal that could change what the next generation of young drugmakers looks like.
Mandatory COVID Vaccination Policy Template
Advertiser: Aggregage
New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!
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