Hyloris wins painkiller approval amidst amplified anti-opioid efforts
Pharmaceutical Technology
OCTOBER 18, 2023
The FDA approved Hyloris’s non-opioid painkiller as the agency increases efforts to mitigate an opioid crisis.
Wed.Oct 18, 2023
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BrainStorm, after setbacks, withdraws approval application for ALS drug
Bio Pharma Dive
OCTOBER 18, 2023
A panel of FDA advisers last month found BrainStorm’s data unconvincing. The company now says a Phase 3b study will be needed for its NurOwn cell therapy to have a shot at an approval.
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Lisata receives orphan drug designation for pancreatic cancer therapy
Pharmaceutical Technology
OCTOBER 18, 2023
Lisata has received orphan drug designation from the EMA's Committee for Orphan Medicinal Products for LSTA1 to treat pancreatic cancer.
Ultragenyx to spin out new company around Alzheimer’s gene therapy
Bio Pharma Dive
OCTOBER 18, 2023
CEO Emil Kakkis says the company's findings are too exciting to ignore, but the “high-risk, high-return” venture needs to be pursued outside the organization.
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
Ardelyx wins FDA approval for phosphate absorption inhibitor
Pharmaceutical Technology
OCTOBER 18, 2023
The company also secured $50m in debt financing to support the commercial launch of Xphozah in November 2023.
Antidepressants Can Take Weeks to Work, And We Finally Know Why
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 18, 2023
The most widely prescribed class of antidepressant has – at long last – been shown to increase connections in the human brain. The discovery offers a plausible biological explanation for the medication’s delayed treatment response and could help develop new targeted treatments.
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NIPER underscores applications of AI in pharma research to enable faster, cost-effective drug discovery
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 18, 2023
The National Institute of Pharmaceutical Education and Research (NIPER) has underlined indispensability of artificial intelligence in pharmaceutical research. The applications of AI have enabled faster, more cost-effective, and data-driven approaches across the drug discovery and development lifecycle.
Intellia cleared by FDA to start Phase 3 test of gene editing treatment
Bio Pharma Dive
OCTOBER 18, 2023
Developed with Regeneron, Intellia’s treatment is designed to inactivate a gene to treat an inherited disease called transthyretin amyloidosis.
October 18, 2023: In This Friday’s PCT Grand Rounds, Ending Hepatitis C in the United States
Rethinking Clinical Trials
OCTOBER 18, 2023
In this Friday’s PCT Grand Rounds, Rachael Fleurence of the NIH and Joshua Sharfstein of Johns Hopkins University will present “A National Initiative to Eliminate Hepatitis C in the United States – Why This Matters to Clinical Trialists.” The Grand Rounds session will be held on Friday, October 20, 2023, at 1:00 pm eastern. Fleurence is a senior advisor at the NIH.
After long journey, Ardelyx gets FDA OK for kidney disease drug
Bio Pharma Dive
OCTOBER 18, 2023
The biotech plans to hire additional sales staff to support the U.S. launch of Xphozah, which had been rejected by the FDA two years ago.
Kura aims for FDA approval with positive pivotal data for tipifarnib
Pharmaceutical Technology
OCTOBER 18, 2023
The data from the Phase II trial showed the efficacy of tipifarnib in patients with head and neck squamous cell carcinoma.
NICE recommends Roche’s Columvi for advanced lymphoma in UK
Pharma Times
OCTOBER 18, 2023
Around 700 people in the UK could benefit from the new treatment - News - PharmaTimes
Lack of in-person contact is key patient concern when HCPs use AI
Pharmaceutical Technology
OCTOBER 18, 2023
Concerns have arisen that innovative technologies such as artificial intelligence (AI) could have a damaging effect on HCP relationships
UKRI awards £10m in funding to tackle antimicrobial resistance
Pharma Times
OCTOBER 18, 2023
UK researchers can apply to receive a share of £3m to set up transdisciplinary networks - News - PharmaTimes
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
ESMO: Seagen, Astellas and Merck knock it out of the park with Padcev-Keytruda combo in bladder cancer
Fierce Pharma
OCTOBER 18, 2023
Editor's Note: Please check back on Oct. 22 when the full data of EV-302 are presented at ESMO 2023. | The results are in for a phase 3 bladder cancer trial assessing the combination of Seagen and Astellas' Padcev, plus Merck's Keytruda, versus standard of care chemotherapy. The figures indicate that the combo can be transformative in the indication.
Sage Therapeutics wins orphan drug designation for Huntington’s treatment
Pharmaceutical Technology
OCTOBER 18, 2023
Sage Therapeutics’ SAGE-718 has been awarded the orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of Huntington’s Disease.
Pfizer settles gender pay discrimination allegations at NYC headquarters
Fierce Pharma
OCTOBER 18, 2023
Pfizer will cough up $2 million to settle allegations from the U.S. Department of Labor that it underpaid certain women who were employed at the company’s New York City headquarters. | The accusations centered on the company's compensation of 86 female employees in 2015 and 2016. Under the settlement with the Department of Labor, the company must also set aside $500,000 for potential future salary adjustments.
Mirum’s plans to expand Livmarli’s market get hit as FDA pushes approval date
Pharmaceutical Technology
OCTOBER 18, 2023
The FDA has pushed Livmarli’s PDUFA date to 13 March 2024, citing an information request deemed a major amendment.
Grand Rounds October 13, 2023: Incorporating Social Determinants of Health Into PCORnet (Keith Marsolo, PhD)
Rethinking Clinical Trials
OCTOBER 18, 2023
Speaker Keith Marsolo, PhD Associate Professor Department of Population Health Sciences Duke University School of Medicine Slides Keywords PCORnet, Common Data Model, EHR, Social Determinants of Health Key Points There are many different definitions of social determinants of health. The World Health Organization defines social determinants of health as non-medical factors that influence health outcomes and conditions in which people are born, grow, work, live, and age, and the wider set of force
Monte Rosa and Roche partner for development of MGDs
Pharmaceutical Technology
OCTOBER 18, 2023
Monte Rosa Therapeutics and Roche have signed an agreement for the development of MGDs to target cancer and neurological diseases.
UCB's approval spree rolls on with FDA nod for Zilbrysq, its 2nd drug for myasthenia gravis
Fierce Pharma
OCTOBER 18, 2023
UCB is on an approval roll. | UCB is on an approval roll. Within hours of each other, the Brussels-based company has scored FDA green lights for plaque psoriasis treatment Bimzelx and for generalized myasthenia gravis (gMG) drug Zilbrysq. Not only that, the Zilbrysq endorsement is UCB’s second in the indication this year, coming on top of the FDA signing off on UCB’s Rystiggo in June.
Gilead and Assembly Biosciences partner to develop antiviral therapies
Pharmaceutical Technology
OCTOBER 18, 2023
Gilead Sciences has entered a partnership with Assembly Biosciences to advance the research and development of new antiviral therapies.
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.
Medical drone delivery set for global take off
pharmaphorum
OCTOBER 18, 2023
Medical drone delivery set for global take off Mike.
Prevymis wins CHMP nod for CMV disease in kidney transplant patients
Pharmaceutical Technology
OCTOBER 18, 2023
The positive opinion expands the antiviral drug’s use to CMV-positive donors and CMV-negative kidney transplant patients at high risk of CMV infection
Seagen wins future royalties in Enhertu patent dispute
pharmaphorum
OCTOBER 18, 2023
Seagen wins future royalties in Enhertu patent dispute Phil.
The Evolution of Innovation: Realizing the Therapeutic Benefits of Cannabinoids
Fierce Pharma
OCTOBER 18, 2023
By Robert Iannone, M.D., M.S.C.E.
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
Evident Vascular raises $35m, and other digital financings
pharmaphorum
OCTOBER 18, 2023
Evident Vascular raises $35m, and other digital financings Phil.
UCB's blockbuster hopeful Bimzelx overcomes manufacturing hurdles to win FDA nod
Fierce Pharma
OCTOBER 18, 2023
UCB has been “eagerly awaiting” an FDA approval for its psoriasis therapy Bimzelx (bimekizumab) after manufacturing problems resulted in a rejection last May. Now, the wait is over. | The FDA rejected the drug last May after conducting an inspection at UCB's Belgian manufacturing plant. That followed a prior delay due to COVID-related inspection hold ups.
Balancing the health ecosystem: Putting the patient first
pharmaphorum
OCTOBER 18, 2023
Balancing the health ecosystem: Putting the patient first Mike.
After launch limitations, Johnson & Johnson exec touts manufacturing progress on CAR-T drug Carvykti
Fierce Pharma
OCTOBER 18, 2023
After launch limitations, Johnson & Johnson exec touts manufacturing progress on CAR-T drug Carvykti fkansteiner Wed, 10/18/2023 - 14:44
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.
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