Bio Pharma Dive
MAY 31, 2023
The biotech, best known for its success developing migraine medicines, will seek approval of a treatment that failed a Phase 3 trial but showed signs of a positive effect.
Pharmaceutical Technology
MAY 31, 2023
XtalPi has made a partnership deal with US-based Eli Lilly to leverage artificial intelligence (AI) for drug discovery. XtalPi will receive $250m in upfront and milestone payments. The two companies will use XtalPi’s integrated AI capabilities and robotics platform for the de novo [without consideration of previous instances] design and delivery of drug candidates for an undisclosed target.
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Bio Pharma Dive
MAY 31, 2023
The shot’s clearance comes several weeks after the regulator made GSK’s Arexvy the first vaccine for RSV in the U.S.
Pharmaceutical Technology
MAY 31, 2023
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a new drug application (NDA) for its investigational single-tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) to the US Food and Drug Administration (FDA), to treat pulmonary arterial hypertension (PAH). The company is seeking approval for the combination therapy for the long-term treatment of PAH in adult patients with World Health Organisation functional class II-III.
Speaker: Brian Richardson, Brian Richardson, Founder and CEO of Richardson Consulting Group
Let’s face it—most ethics and compliance training programs aren’t winning awards for engagement. But that doesn’t mean they can’t be effective, captivating, and maybe even enjoyable! Join learning design expert Brian Richardson for a dynamic session on how to breathe new life into your ethics and compliance training. We'll explore innovative strategies to bring traditionally dry topics to life, making them resonate with learners and drive tangible change.
Bio Pharma Dive
MAY 31, 2023
The medicine, licensed from biotech ImmuNext in 2017, is one of two later-stage MS drug prospects in the French drugmaker’s portfolio.
Pharmaceutical Technology
MAY 31, 2023
The Danish CRISPR biotech SNIPR BIOME has released the first glimpse at the safety profile for SNIPR001, a gene therapy intended to target antibiotic resistance. Interim clinical results from a Phase I trial have demonstrated SNIPR001’s safety in healthy volunteers. Additionally, E.Coli was detected in a dose-dependent manner in feces, suggesting the therapy’s proof-of-principle targetin and removing the bacteria, including antibiotic-resistant strains.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
MAY 31, 2023
Stealth BioTherapeutics has made an exclusive licensing agreement with Pharmanovia for the commercialisation of its elamipretide to treat Barth syndrome. Pharmanovia will hold exclusive rights for the commercialisation of elamipretide in the EU, other European countries including Switzerland, Norway, Iceland and the UK, and the Middle East and northern Africa region.
Pharma Times
MAY 31, 2023
The neurological disease affects approximately 2.
Pharmaceutical Technology
MAY 31, 2023
The University of Sydney and Australian company Pharos Therapeutics have reached an agreement to leverage artificial intelligence (AI) to progress drug discoveries for the treatment of cancer and rare diseases. The university and Pharos have drawn up a memorandum of understanding (MoU) to use AI technology to identify potential compounds for the rapid development of treatments.
Fierce Pharma
MAY 31, 2023
FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy kdunleavy Wed, 05/31/2023 - 13:02
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Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness
Pharma Times
MAY 31, 2023
The inflammatory form of arthritis is estimated to affect nearly 38 million people worldwide
Pharmaceutical Technology
MAY 31, 2023
ZNA-1041 is under clinical development by F. Hoffmann-La Roche and currently in Phase I for Solid Tumor. According to GlobalData, Phase I drugs for Solid Tumor have a 54% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how ZNA-1041’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Rethinking Clinical Trials
MAY 31, 2023
Dr. John Alexander In this Friday’s PCT Grand Rounds, John Alexander of Duke University will present “PROACT Xa and the Wizard of Oz: Behind the Curtain of a Pragmatic Decentralized Clinical Trial.” The Grand Rounds session will be held on Friday, June 2, 2023, at 1:00 pm eastern. PROACT Xa was a prospective, randomized clinical trial conducted to determine whether apixaban was noninferior to warfarin in preventing valve thrombosis or valve-related thromboembolism in patients w
Pharmaceutical Technology
MAY 31, 2023
BBT-401 is under clinical development by Bridge Biotherapeutics and currently in Phase II for Ulcerative Colitis. According to GlobalData, Phase II drugs for Ulcerative Colitis have a 44% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how BBT-401’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Speaker: Amie Phillips Pablo, VP, Corporate Compliance & Privacy Officer at Novo Nordisk
In today’s complex healthcare environment, navigating third-party relationships has become even more challenging—whether it’s vendor relationships, employee activities, or patient-facing interactions. Left unmanaged, these conflicts can compromise trust, regulatory compliance, and even organizational reputation. So, how can healthcare teams stay ahead?
Pharma Mirror
MAY 31, 2023
In the face of increasing global health challenges, the development and production of vaccines have become paramount. One critical aspect is the ability to scale up manufacturing processes to meet the growing demand for viral vector-based vaccines. In this article, we will explore the efforts being made by innovative biotechnology companies to develop scalable and cost-effective manufacturing methods.
Pharmaceutical Technology
MAY 31, 2023
Following a rocky and somewhat controversial road to securing a US Food and Drug Administration (FDA) approval, Amylyx’s amyotrophic lateral sclerosis (ALS) drug is likely to hit another regulatory snag in Europe. AMX0035, marketed as Relyvrio in the US and Abrioza in Canada, is currently awaiting approval on its marketing authorisation application (MAA) from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
Fierce Pharma
MAY 31, 2023
After a yearslong investigation involving politicians and medical professionals alike, Novartis is looking to close the books on its Greek bribery imbroglio. | After an investigation that dates back to 2017, four former Novartis executives and a Greek politician were cleared of bribery charges. But 15 doctors were charged for their alleged involvement.
Pharmaceutical Technology
MAY 31, 2023
C4 Therapeutics has entered an exclusive licensing agreement with Betta Pharmaceuticals to develop and commercialise CFT8919 across the greater China region. The agreement will cover the Hong Kong special administrative region (SAR), the Macau SAR and Taiwan. It is expected to accelerate the development of CFT8919 in important international markets.
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Rethinking Clinical Trials
MAY 31, 2023
Save the date! The NIH Pragmatic Trials Collaboratory will host a virtual workshop June 20-21, 2023, to explore the critical cycle of evidence generation to decision by health system leaders to implement the findings of pragmatic clinical trials (PCTs) conducted within health care systems. The workshop, Getting the Right Evidence to Decision-Makers Faster , will kick off on Tuesday, June 20, at 11:00 a.m.
Pharmaceutical Technology
MAY 31, 2023
The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s new drug application (NDA) for repotrectinib for priority review. Repotrectinib is a tyrosine kinase inhibitor (TKI) intended to treat patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Its favourable properties for penetrating the human brain increase intracranial activity.
ProRelix Research
MAY 31, 2023
Introduction: Clinical trials are a crucial component of the pharmaceutical and medical research industry, aimed at evaluating the safety and effectiveness of new drugs, treatments, or medical devices before they […] The post Successful Clinical Trial With ProRelix Research: Phase 1, 2, 3 & 4 Clinical Trial Services at … appeared first on ProRelix Research.
Pharmaceutical Technology
MAY 31, 2023
Nadofaragene firadenovec is under clinical development by Ferring International Center and currently in Phase III for Malignant Pleural Mesothelioma. According to GlobalData, Phase III drugs for Malignant Pleural Mesothelioma have a 50% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Nadofaragene firadenovec’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmark
Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
pharmaphorum
MAY 31, 2023
Sanofi scores in MS with CD40 antibody frexalimab Phil.
Pharmaceutical Technology
MAY 31, 2023
ATRN-119 is under clinical development by Aprea Therapeutics and currently in Phase II for Solid Tumor. According to GlobalData, Phase II drugs for Solid Tumor have a 10% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how ATRN-119’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
pharmaphorum
MAY 31, 2023
ASCO 2023 preview: Prioritising the exploration of patient differences to enhance cancer care and research Mike.
Pharmaceutical Technology
MAY 31, 2023
Setanaxib is under clinical development by Calliditas Therapeutics and currently in Phase III for Primary Biliary Cholangitis (Primary Biliary Cirrhosis). According to GlobalData, Phase III drugs for Primary Biliary Cholangitis (Primary Biliary Cirrhosis) have a 25% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration.
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
pharmaphorum
MAY 31, 2023
PM Society’s ‘Securing Market Access to Medicines for England, Ireland, Scotland & Wales’ – part one Mike.
Pharmaceutical Technology
MAY 31, 2023
Decoy-20 is under clinical development by Indaptus Therapeutics and currently in Phase I for Hepatocellular Carcinoma. According to GlobalData, Phase I drugs for Hepatocellular Carcinoma have an 81% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Decoy-20’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
XTalks
MAY 31, 2023
An initial public offering (IPO) is the process through which a privately held company offers its shares to the public for the first time, transforming into a publicly traded company. In the biotech industry, a biotech IPO refers to a specific case where a biotechnology company goes public and lists its shares on a stock exchange. This allows the company to raise funds from public investors.
Outsourcing Pharma
MAY 31, 2023
A small molecule drug candidate from Algiax Pharmaceuticals can reduce excitability of neurons in relation to chronic pain, dampening signal and reducing pain, a study shows.
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