Generative AI-focused biotech startup Evozyne raises $81m
Pharmaceutical Technology
SEPTEMBER 28, 2023
The company’s algorithms put proteins through millions of years of simulated evolution to identify potential functional candidates.
Sat.Sep 23, 2023 - Fri.Sep 29, 2023
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FDA staff hold ‘major concerns’ with Brainstorm ALS therapy, documents show
Bio Pharma Dive
SEPTEMBER 25, 2023
Agency scientists flagged numerous issues with Brainstorm’s stem cell treatment ahead of a high-profile Wednesday meeting of expert FDA advisers.
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Grand Rounds September 22, 2023: Integrating Community Health Workers into Team-Based, Early Childhood Preventative Care (Tumaini Rucker Coker, MD, MBA)
Rethinking Clinical Trials
SEPTEMBER 28, 2023
Speaker Tumaini Rucker Coker, MD, MBA Professor of Pediatrics Division Head for General Pediatrics University of Washington Department of Pediatrics Seattle Children’s Hospital Slides Keywords Pediatrics, Preventive Medicine, Community Health, Well Child Care Key Points There are 10 preventive care visits from ages 0-3, usually scheduled as 15-20 minute visits with a pediatrician.
AstraZeneca and SAS link up on AI and analytics
Pharma Times
SEPTEMBER 28, 2023
Collaboration will enable teams across the organisation to increase clinical research innovation - News - PharmaTimes
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
Karuna Therapeutics files for FDA approval for schizophrenia treatment
Pharmaceutical Technology
SEPTEMBER 29, 2023
Karuna Therapeutics has announced the submission of a NDA to the FDA for KarXT (xanomeline-trospium) for the treatment of schizophrenia.
PTC to lay off more staff following drug setback in Europe
Bio Pharma Dive
SEPTEMBER 29, 2023
The biotech is expanding cuts it announced a few months ago after the EMA decided against renewing a conditional clearance for its drug Translarna.
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NICE nod for Darzalex with lenalidomide and dexamethasone
Pharma Times
SEPTEMBER 25, 2023
Therapy has been developed to treat adult patients with newly diagnosed multiple myeloma - News - PharmaTimes
Generics expected to improve access for patients with idiopathic pulmonary fibrosis
Pharmaceutical Technology
SEPTEMBER 27, 2023
The idiopathic pulmonary fibrosis (IPF) market is underserved with just two licensed pharmaceutical treatments approved by the FDA in 2014.
Roche bets on Ionis RNA medicines with neuroscience deal
Bio Pharma Dive
SEPTEMBER 27, 2023
The Swiss drugmaker is restocking its pipeline by buying into preclinical Ionis medicines for Alzheimer’s and Huntington’s diseases.
Novartis targets first-line use for radiotherapy Lutathera with trial win in neuroendocrine tumors
Fierce Pharma
SEPTEMBER 25, 2023
More than five years after an initial FDA approval, Novartis is touting positive trial results for its radiotherapy Lutathera as a first-line therapy against the rare cancer that killed Apple co-fo | More than five years after an initial FDA approval, Novartis is touting positive trial results for its radiotherapy Lutathera as a first-line therapy against the rare cancer that killed Apple co-founder Steve Jobs.
Women in Life Science Denmark launches leadership drive
Pharma Times
SEPTEMBER 28, 2023
Initiative has been designed to support career advancement for women across the life sciences - News - PharmaTimes
Glenmark to market Winlevi in Europe and South Africa after Cosmo deal
Pharmaceutical Technology
SEPTEMBER 27, 2023
The popular acne treatment will soon be available in 15 EU countries in addition to UK and South Africa.
Eisai’s Alzheimer’s drug Leqembi approved in Japan
Bio Pharma Dive
SEPTEMBER 25, 2023
Eisai and Biogen’s anti-amyloid drug is still undergoing regulatory reviews in the EU, U.K. and elsewhere.
Decades-long regulatory odyssey ends with FDA nod for Fabre-Kramer's depression med Exxua
Fierce Pharma
SEPTEMBER 28, 2023
Fabre-Kramer Pharmaceuticals' major depressive disorder (MDD) drug gepirone has been rejected by the FDA not once, not twice, but three times since the turn of the millennium. | Fabre-Kramer's Exxua suffered three prior FDA rejections before scoring an FDA approval for major depressive disorder last week. Its label doesn't include sexual dysfunction as an adverse reaction, which is rare among antidepressants.
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
UKHSA reaches vaccine deal with CSL Seqirus
Pharma Times
SEPTEMBER 26, 2023
Agreement will provide timely boost to pandemic preparedness against influenza - News - PharmaTimes
New Alzheimer’s disease medication approved in Japan
Pharmaceutical Technology
SEPTEMBER 25, 2023
Eisai and BioArctic’s Leqembi is the only approved treatment that slows cognitive and functional decline in adults with Alzheimer’s.
ProQR sale of eye drugs comes undone over employment contracts
Bio Pharma Dive
SEPTEMBER 27, 2023
Laboratoires Théa terminated its planned purchase of ProQR’s sepofarsen after certain ProQR personnel opted against working for the French company.
NICE poised to reject AstraZeneca, Daiichi’s Enhertu in HER2-low breast cancer
Fierce Pharma
SEPTEMBER 27, 2023
NICE poised to reject AstraZeneca, Daiichi’s Enhertu in HER2-low breast cancer aliu Wed, 09/27/2023 - 10:40
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.
Portsmouth NHS Trust maternity team enhances patient experience
Pharma Times
SEPTEMBER 27, 2023
Patient waiting times to receive an appointment have reduced from 6-8 weeks to just 24 hours - News - PharmaTimes
AI is a pillar of tomorrow’s healthcare system, but limitations remain
Pharmaceutical Technology
SEPTEMBER 29, 2023
At the industry crossroads of healthcare and pharmaceuticals at the Life Sciences Baltics 2023 conference, all signs pointed towards an AI-based future.
BrainStorm’s ALS therapy not effective, FDA panel finds
Bio Pharma Dive
SEPTEMBER 27, 2023
Expert advisers to the agency voted 17-1 that Brainstorm's clinical trial data did not show the company's stem cell treatment was effective for treating ALS.
Ann Marie Hall, SR Clinical Trial Manager, Site Management, shares her story about why World Alzheimer’s month is so important to her.
Worldwide Clinical Trials
SEPTEMBER 26, 2023
In September, as we observe World Alzheimer’s month and focus attention on how far we have come in raising awareness of the disease and research being done to find more effective treatments, I think back to when my grandmother was first diagnosed and how heart wrenching it was to watch her loose herself over the years. When my mother was diagnosed, it was not a surprise, as I had already been witnessing those early changes and knew what was coming.
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.
NHS Confederation research supports investment in NHS services
Pharma Times
SEPTEMBER 27, 2023
Report shows that if the health service invests in community services hospital admissions will reduce - News - PharmaTimes
ModeX wins $168m BARDA contract to develop viral antibody therapies
Pharmaceutical Technology
SEPTEMBER 29, 2023
BARDA in the US has awarded a $168m Project NextGen grant to ModeX Therapeutics to develop anti-viral therapies.
Intercept, after biotech rollercoaster ride, agrees to buyout by Alfasigma
Bio Pharma Dive
SEPTEMBER 26, 2023
Once valued at more than $7 billion, the liver drug company couldn’t secure a long-sought FDA approval in NASH and last month said it would abandon that research.
Eli Lilly moves to settle with whistleblower who flagged alleged manufacturing shortfalls
Fierce Pharma
SEPTEMBER 29, 2023
After a former human resources officer blew the whistle on alleged manufacturing shortfalls at Eli Lilly’s massive Branchburg, New Jersey, production plant, the parties have been engaged in settlem | After a former human resources officer blew the whistle on alleged manufacturing shortfalls at Eli Lilly’s massive Branchburg, New Jersey, production plant, the parties have been engaged in settlement talks.
Oxford Biodynamics launches prostate screening test
Pharma Times
SEPTEMBER 26, 2023
EpiSwitch is designed for men with prostate cancer risk in the UK and is 94% accurate - News - PharmaTimes
Pharmaceutical Technology Excellence Awards 2023: Apprentice.io
Pharmaceutical Technology
SEPTEMBER 28, 2023
Apprentice provides cloud-based software solutions and is a Category Award Winner in the 2023 Pharmaceutical Technology Excellence Awards
Structure boosted by early data for experimental obesity drug
Bio Pharma Dive
SEPTEMBER 29, 2023
Shares in the biotech surged on Phase 1 trial results for an oral GLP-1 drug Structure is developing, reflecting investor enthusiasm for the weight loss medicines.
Post-pandemic reality hits digital health hard
pharmaphorum
SEPTEMBER 26, 2023
Post-pandemic reality hits digital health hard Mike.
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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