Digital health tech: a solution to substance use disorders?
Pharmaceutical Technology
JULY 4, 2023
Substance use disorders leave people with long-term negative mental and physical health implications and can lead to death.
Sat.Jul 01, 2023 - Fri.Jul 07, 2023
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FDA grants Eisai’s Leqembi full approval, opening door to wider use of Alzheimer’s drug
Bio Pharma Dive
JULY 6, 2023
The broader approval is expected to push insurers, namely Medicare, to increase coverage of so-called amyloid-targeting therapies.
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7 factors that impact clinical trial patient recruitment
Antidote
JULY 7, 2023
Participating in a clinical trial is a significant decision for patients, and several factors can influence their decision to enroll. These factors include understanding the trial's details, goals, and logistics. Sponsors must understand what matters most to patients when designing protocols, and prioritizing patient-centric considerations is key to enhancing patient engagement and trial success.
Lifera, Sanofi and Arabio boost vaccine manufacture in Saudi Arabia
Pharmaceutical Technology
JULY 6, 2023
Lifera, Arabio and Sanofi have signed a memorandum of understanding (MOU) to bolster manufacturing of vaccines in Saudi Arabia.
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
‘Mixed’ results seed doubt about AstraZeneca, Daiichi’s next cancer drug
Bio Pharma Dive
JULY 5, 2023
The medicine delayed disease progression compared to chemotherapy in a closely watched lung cancer trial. But analysts questioned its effect size and safety, and AstraZeneca shares fell more than 8%.
Rationing strategies proliferate with cancer drugs in short supply
Pharmaceutical Technology
JULY 4, 2023
While drug shortages have been a major cause for concern over the past few years, medications to treat cancer are in particularly short supply.
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Moderna strikes deal worth up to $1B to develop, produce mRNA drugs in China: reports
Fierce Pharma
JULY 5, 2023
Despite political tensions between Washington and Beijing, foreign pharmaceutical investments are progressing in China. | In a deal that could be worth up to $1 billion, Massachusetts-based Moderna inked a memorandum of understanding, plus a land collaboration agreement, to research, develop and manufacture mRNA medicines in China.
Biosimilar clinical trials and study designs’ considerations
ProRelix Research
JULY 6, 2023
Biosimilar clinical trials and study designs’ Considerations The rising prevalence and large market share of biological products emphasize their importance as treatment options for several cancers and autoimmune diseases. In […] The post Biosimilar clinical trials and study designs’ considerations appeared first on ProRelix Research.
FDA rebuffs Amneal's Parkinson's prospect with $500M peak sales target
Fierce Pharma
JULY 5, 2023
Amneal Pharmaceuticals’ hopes for a midyear launch of its extended-release Parkinson’s disease prospect—and a shot at a potential $500 million peak sales opportunity in the U.S.—have been put on ic | The FDA has rebuffed Amneal’s application for IPX203, an oral formulation of carbidopa/levodopa, which leverages a unique delivery formula in a bid to increase “on” time without troublesome dyskinesia.
Eli Lilly’s retatrutide sets new record for weight loss in obesity space
Pharmaceutical Technology
JULY 3, 2023
Pipeline developments within the obesity space have recently garnered interest following recent results published on Eli Lilly’s retatrutide.
With new data, J&J steps forward in growing race for oral autoimmune drugs
Bio Pharma Dive
JULY 5, 2023
Phase 2 results show a pill the company is developing is competitive with other oral medicines in testing against psoriasis, among them the TYK2 inhibitors that have drawn significant industry interest.
July 6, 2023: NIH Pragmatic Trials Collaboratory Welcomes 2 New Demonstration Projects: BEST-ICU and Remote Tai Chi
Rethinking Clinical Trials
JULY 6, 2023
Dr. Michele Balas and Dr. Eduard Vasilevskis The NIH Pragmatic Trials Collaboratory is excited to add 2 new Demonstration Projects to its portfolio of innovative pragmatic clinical trials embedded in healthcare systems. BEST-ICU (or Behavioral Economic and Staffing Strategies to Increase Adoption of the ABCDEF Bundle in the ICU) is supported by the National Heart, Lung, and Blood Institute (NHLBI).
DigitalHealth.London’s Accelerator programme selects Aide
Pharma Times
JULY 3, 2023
Project aims to boost the adoption of technology across London’s NHS and help patients manage conditions - News - PharmaTimes
Incyte’s non-segmental vitiligo treatment approved in UK
Pharmaceutical Technology
JULY 5, 2023
Following FDA approival and CE marking for Incyte’s JAK-inhibiting cream Opzelura (ruxolitinib), the MHRA has followed suit in the UK.
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
Sarepta sells FDA fast pass earned from Duchenne gene therapy approval
Bio Pharma Dive
JULY 5, 2023
The deal enables Sarepta to quickly cash in on the clearance of Elevidys, with $102 million in new funds to help bankroll its drug research.
Bernie Sanders proposes price caps on drugs developed with federal funds
Fierce Pharma
JULY 6, 2023
After becoming chairman of the powerful Senate Health, Education, Labor and Pensions Committee earlier this year, Sen. | After becoming chairman of the powerful Senate Health, Education, Labor and Pensions Committee earlier this year, Sen. Bernie Sanders, I-Vermont—a longtime opponent of Big Pharma—has become even more ubiquitous in his efforts to reduce drug prices.
Driving Tomorrow’s Outcomes Through Clinical Research in Real-World Settings: Essentials of Embedded Pragmatic Clinical Trials: AcademyHealth (June 2023)
Rethinking Clinical Trials
JULY 5, 2023
June 23-24, 2023 : The NIH Pragmatic Trials Collaboratory hosted a Pre-Conference Workshop, “Changing Trials for Changing Times: Essentials of Embedded Pragmatic Clinical Trials Workshop,” at the Health Care Systems Research Network 2023 Annual Conference. This training workshop introduces concepts in the design, conduct, and implementation of embedded pragmatic clinical trials (ePCTs) and provides firsthand ePCT experiences and case studies from the NIH Pragmatic Trials Collaboratory Demonstrat
Abeona Therapeutics raises funds to launch cell therapy
Pharmaceutical Technology
JULY 4, 2023
Abeona Therapeutics has raised $25m from its current select investors to launch and commercialise its cell therapy, EB-101.
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.
What US trial sponsors should know about the GDPR
Bio Pharma Dive
JULY 3, 2023
What is the GDPR and why does it matter to your life sciences company. iliomad Health Data can help you maintain GDPR compliance.
Teva weighs sale of $2B API business as CEO Richard Francis embarks on 'Pivot to Growth' strategy: reports
Fierce Pharma
JULY 6, 2023
Less than two months into its "Pivot to Growth" strategy under a new CEO, Israeli-American generics giant Teva Pharmaceutical could be weighing a major shake-up of its key drug ingredients business | Teva is looking at strategic options for its active pharmaceutical ingredient unit, with a potential sale on the table, BNN Bloomberg and Benzinga have reported.
July 3, 2023: Report Shares Strategies for Addressing Bias and Lack of Generalizability of EHR Data
Rethinking Clinical Trials
JULY 3, 2023
Pragmatic research is vulnerable to biases due to differences in data capture and access to care for different subsets of the population, which, if left unaddressed, can propagate inequities in health and the healthcare system. In a new article published online ahead of print in JAMIA , the NIH Pragmatic Trials Collaboratory’s Demonstration Project teams reflect on the health equity challenges encountered by their trials and share the specific strategies they used to mitigate sources of po
Generative AI – beyond the hype
Pharmaceutical Technology
JULY 3, 2023
2023 started with a buzz around ChatGPT, and more generally around the immense potential that generative AI (GenAI) holds.
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.
Moderna, chasing GSK and Pfizer, brings RSV vaccine to regulators
Bio Pharma Dive
JULY 5, 2023
The vaccine has a chance to become Moderna’s second approved product and could help offset declining sales for its COVID-19 shot.
Novo Nordisk brings new round of lawsuits against compounded versions of Ozempic and Wegovy
Fierce Pharma
JULY 7, 2023
As demand skyrockets for GLP-1 drugs that can trigger significant weight loss, unauthorized versions of the treatments have started to fill pharmacies. | In late May, the FDA warned of illegal knockoffs of Novo Nordisk’s Ozempic and Wegovy. And now, the Danish company has filed its second wave of lawsuits against pharmacies in the U.S. that are producing the copycats.
Novavax COVID-19 vaccine produces immunity
Pharma Times
JULY 7, 2023
Second dose of treatment generates response among young people during Oxford University trial - News - PharmaTimes
Antidepressant prescriptions continue to steadily grow in England
Pharmaceutical Technology
JULY 7, 2023
As quarterly antidepressant prescriptions hit 22 million, the NHS looks to cut down patient reliance.
Brii buys further into VBI therapy, expanding hepatitis B partnership
Bio Pharma Dive
JULY 6, 2023
The deal comes three months after VBI cut costs and laid off staff in a restructuring meant to prioritize the two medicines Brii is interested in.
With full Alzheimer's approval in hand, Eisai and Biogen kick off Leqembi's launch in earnest
Fierce Pharma
JULY 6, 2023
It’s official: Roughly half a year after the FDA granted an accelerated nod to Eisai and Biogen’s new Alzheimer’s disease med lecanemab, the companies have converted that green light into a full-fl | With a full approval in hand, Leqembi has become the first treatment shown to reduce the rate of disease progression and slow cognitive and functional decline in adults with Alzheimer’s disease under the FDA's traditional approval pathway.
Teva reveals critical Ajovy data
Pharma Times
JULY 4, 2023
Therapy has been developed to reduce the frequency, duration and severity of migraine attacks - News - PharmaTimes
EMA-endorsed statement targets Covid-19 vaccine misinformation
Pharmaceutical Technology
JULY 6, 2023
The ICMRA says evidence from more than 13 billion global vaccine doses shows good safety amid “dangerous” false information.
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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