The people-first approach transforming eClinical processes
Pharmaceutical Technology
NOVEMBER 7, 2024
With the boom in eClinical solutions showing no signs of slowing, adding a “human at the center” perspective can help optimize data management
Thu.Nov 07, 2024
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Sarepta scraps a Duchenne drug as gene therapy sales rise
Bio Pharma Dive
NOVEMBER 7, 2024
Elevidys sales have increased since the FDA made a controversial choice to expand the therapy's use. Now, Sarepta is abandoning a successor to its drug Exondys 51, citing an “evolving" treatment landscape.
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EMA approves Sanofi/Regeneron’s Dupixent for young EoE patients
Pharmaceutical Technology
NOVEMBER 7, 2024
The EMA has granted approval for Sanofi/Regeneron’s Dupixent (dupilumab) to treat EoE in children as young as one.
Moderna earnings beat forecasts, but analysts question whether sales spike will last
Bio Pharma Dive
NOVEMBER 7, 2024
Sales of Moderna’s COVID-19 shot exceeded expectations, but the company’s launch of its new RSV vaccine has started slowly.
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
Minister for Science champions partnerships with private clinical sector in UK
Pharmaceutical Technology
NOVEMBER 7, 2024
Lord Vallance stated the government sees investment, innovation, and public-private partnership as crucial to UK healthcare.
New study to assess mpox vaccine in pregnant women and infants
Pharma Times
NOVEMBER 7, 2024
Trial to evaluate safety and efficacy of MVA-BN vaccine
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Elsevier backs Pistoia Alliance for AI in drug discovery
Pharma Times
NOVEMBER 7, 2024
New initiatives to tackle AI-related challenges in life sciences
Santen, Arctic Vision sign deal for ARVN001 to treat UME
Pharmaceutical Technology
NOVEMBER 7, 2024
Santen Pharmaceutical and Arctic Vision have signed a commercial collaboration agreement for the ARVN001to treat uveitic macular oedema.
Journey Medical’s Emrosi Wins FDA Approval for Rosacea, Could Rival Galderma’s Oracea
XTalks
NOVEMBER 7, 2024
Journey Medical Corporation, a leading biopharmaceutical company dedicated to the development and commercialization of innovative dermatology treatments, has announced that the US Food and Drug Administration (FDA) has approved Emrosi (minocycline hydrochloride extended release capsules, 40 mg), formerly referred to as DFD-29, for the treatment of rosacea.
Q3 2024 update: COVID-19 related private equity activity in the pharmaceutical industry
Pharmaceutical Technology
NOVEMBER 7, 2024
In the global pharmaceutical industry, there were two private equity deals announced in Q3 2024, worth a total value of $7.5m, according to GlobalData's Deals Database.
Sarepta pulls plug on Duchenne exon-skipping drug
pharmaphorum
NOVEMBER 7, 2024
Sarepta has halted development of vesleteplirsen, a follow-up to its Duchenne muscular dystrophy therapy Exondys 51.
Q3 2024 update: artificial intelligence related private equity activity in the pharmaceutical industry
Pharmaceutical Technology
NOVEMBER 7, 2024
In the global pharmaceutical industry, there were three private equity deals announced in Q3 2024, worth a total value of $4.2m, according to GlobalData's Deals Database.
Intra-Cellular’s Schizophrenia Drug Caplyta Shows Promising Trial Results for Relapse Prevention
XTalks
NOVEMBER 7, 2024
Intra-Cellular Therapies recently announced that its schizophrenia treatment, lumateperone (brand name Caplyta), has met the primary endpoint in a late-stage clinical trial. Caplyta is currently approved for the treatment of schizophrenia as well as bipolar I and bipolar II depression in adults. The randomized Study 304 clinical trial, a “withdrawal trial,” was conducted across multiple sites with the goal of assessing the efficacy, safety and tolerability of lumateperone 42 mg for the preventio
Private equity deals in pharmaceutical in Canada remained flat in Q3 2024
Pharmaceutical Technology
NOVEMBER 7, 2024
In Canada pharmaceutical industry, there were two private equity deals announced in Q3 2024, worth a total value of $4.2m, according to GlobalData's Deals Database.
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
More turbulence at Aurinia as autoimmune drugmaker lays off 45% of workforce
Fierce Pharma
NOVEMBER 7, 2024
After an activist investor revolted against the leadership team at Aurinia Pharmaceuticals, the CEO in question is resorting to restructuring. | After an activist investor revolted against the leadership team at Aurinia Pharmaceuticals, the CEO in question is resorting to restructuring, cutting the autoimmune disease biotech's workforce for a second time in less than a year.
Leading sales and marketing intent data, database and data enrichment providers and technology solutions for the pharmaceutical industry
Pharmaceutical Technology
NOVEMBER 7, 2024
Discover the top sales and marketing intelligence providers for the pharmaceutical industry, offering predictive insights and data enrichment to drive growth.
Webinar recap: Boosting recruitment and retention with SDOH data
pharmaphorum
NOVEMBER 7, 2024
Discover the key takeaways from a webinar focused on boosting recruitment and retention through Social Determinants of Health (SDOH) data. Learn how incorporating SDOH data can enhance your recruitment and retention strategies.
Vidac secures funding to advance skin cancer trials of novel ointment
Pharmaceutical Technology
NOVEMBER 7, 2024
Vidac will use the new funds to initiate a Phase IIb trial of its lead candidate VDA-1102 in patients with actinic keratosis.
Gilead's CAR-T sales stagnate as Trodelvy takes another impairment hit
Fierce Pharma
NOVEMBER 7, 2024
Despite a mission to become a dominant cancer drug player, Gilead Sciences has as of late been locked in on its bread-and-butter antirival franchise with an eye on the potential of its long-acting | Gilead's CAR-T therapies Yescarta and Tecartus have stayed relatively flat all year with its Yescarta facing a 1% decline over the third quarter due to competition.
GHO and Ampersand Capital to acquire Avid Bioservices
Pharmaceutical Technology
NOVEMBER 7, 2024
Funds managed by GHO Capital Partners and Ampersand Capital Partners have signed a definitive agreement to acquire Avid Bioservices.
Avid Bioservices to go private in $1.1bn private equity deal
pharmaphorum
NOVEMBER 7, 2024
Nasdaq-listed CDMO Avid Bioservices has agreed a $1.
Q3 2024 update: ecommerce related M&A activity in the pharmaceutical industry
Pharmaceutical Technology
NOVEMBER 7, 2024
In the global pharmaceutical industry, there were eight M&A deals announced in Q3 2024, worth a total value of $1.3bn, according to GlobalData's Deals Database.
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.
Blueprint's mastocytosis drug Ayvakit cleared for NHS use
pharmaphorum
NOVEMBER 7, 2024
NICE has recommended broad use of Blueprint Medicines' recently-approved therapy for rare blood disorder advanced systemic mastocytosis
Grand Rounds November 1, 2024: Congenital Heart Initiative: Redefining Outcomes and Navigation to Adult Centered Care (CHI-RON) Study (Thomas W. Carton, PhD, MS; Anitha S. John, MD, PhD)
Rethinking Clinical Trials
NOVEMBER 7, 2024
Speakers Anitha S. John, MD, PhD Medical Director Washington Adult Congenital Heart Program Professor of Pediatrics Children’s National Hospital George Washington University Thomas W. Carton, PhD, MS Chief Data and Strategy Officer Louisiana Public Health Institute Slides Keywords Adult Congenital Heart Disease; Registry; Patient Engagement Key Points The research team reviewed the current challenges in adult congenital heart disease (ACHD) clinical
Novo sheds kidney drug licensed for $1.3bn a year ago
pharmaphorum
NOVEMBER 7, 2024
Novo Nordisk has abandoned a drug it licensed from KBP Biosciences last year in a deal valued at up to $1.3 billion after it missed the mark in a chronic kidney disease (CKD) trial.The Danish group bought rights to ocedurenone, an oral non-steroidal mineralocorticoid receptor antagonist (nsMRA), from the Singapore biotech in October 2023 as a companion to its GLP-1-based therapies for reducing cardiovascular risk and kidney disease in people with diabetes and obesity.
Sparked by FDA expansion, Sarepta's Elevidys takes another leap in sales
Fierce Pharma
NOVEMBER 7, 2024
An FDA expansion of Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) Elevidys has sparked a new surge in sales for the gene therapy. | An FDA expansion of Sarepta Therapeutics’ Duchenne muscular dystrophy Elevidys has sparked a new surge in sales. The gene therapy's $181 million sales in the third quarter beat analysts' expectations as it made a 48% sequential leap.
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
Metrics for the UK’s VPAG: A work in progress
pharmaphorum
NOVEMBER 7, 2024
Discover the latest metrics and updates on the UK's VPAG (Voluntary scheme for branded medicines Pricing, Access and Growth) from NICE (National Institute for Health and Care Excellence). Stay informed on this work in progress.
Moderna disappoints in RSV debut, squares up with Pfizer in COVID-19 vaccine sales
Fierce Pharma
NOVEMBER 7, 2024
Days after Pfizer and BioNTech reported surprisingly strong sales of their updated COVID-19 vaccines, Moderna has done the same. | Days after Pfizer and BioNTech reported surprisingly strong sales of their updated COVID-19 vaccines, Moderna has done the same. But the Massachusetts biotech's RSV shot fell way short of expectations.
Novo Nordisk signs $285 million deal for a once-monthly GLP-1 receptor agonist
Outsourcing Pharma
NOVEMBER 7, 2024
Wegovy manufacturer Ascendis Pharma has been tasked with supporting the development of a once-monthly GLP-1 drug.
The Impact of Generic Drugs on Healthcare Costs
Drug Patent Watch
NOVEMBER 7, 2024
The rising cost of prescription drugs has become a significant public health concern, with millions of Americans struggling to afford their medications. One crucial factor in mitigating this issue is the increased use of generic drugs. Generic drugs have been instrumental in reducing healthcare costs, and their impact cannot be overstated.
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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