Bio Pharma Dive
SEPTEMBER 4, 2024
Over the past 10 years, PD1-blocking medicines have transformed cancer care. But the steady expansion of their use has slowed and, despite much trying, pharmaceutical companies have largely failed to top the drugs’ successes.
Pharmaceutical Technology
SEPTEMBER 4, 2024
Actimed says S-oxprenolol shares a similar pharmacology to its lead product S-pindolol, which is being studied in cachexia.
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Bio Pharma Dive
SEPTEMBER 4, 2024
The funding comes amid a slowdown in venture investment for gene and cell therapy startups, and will support development of multiple solid tumor programs.
Pharmaceutical Technology
SEPTEMBER 4, 2024
Merck has gained EC approval for KEYTRUDA plus Padcev for adults with unresectable or metastatic urothelial carcinoma.
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
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!
Bio Pharma Dive
SEPTEMBER 4, 2024
The biotech is putting Voxzogo, its drug for skeletal disorders, at the center of plans to grow revenue the rest of this decade and beyond.
Pharmaceutical Technology
SEPTEMBER 4, 2024
Pfizer Ignite will support Acepodia in developing its pipeline cancer therapeutic candidates.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
SEPTEMBER 4, 2024
By integrating the best practices from decentralized trials, CROs can optimize efficiencies and streamline site-based operations, ensuring that site-centric trials remain effective and innovative.
Bio Pharma Dive
SEPTEMBER 4, 2024
A new dose regimen of Biogen's spinal muscular atrophy drug appeared promising, while Denali Therapeutics and Regenxbio charted plans for drug approval applications.
Pharmaceutical Technology
SEPTEMBER 4, 2024
The US Food and Drug Administration (FDA) has granted fast track designation to Innovent Biologics' IBI363 for treating melanoma.
Rethinking Clinical Trials
SEPTEMBER 4, 2024
The National Center for Complementary and Integrative Health (NCCIH), with support from the Helping to End Addiction Long-term ® Initiative, or NIH HEAL Initiative ® , published a notice of funding opportunity for pragmatic clinical trials within the infrastructure of the NIH-DOD-VA Pain Management Collaboratory (PMC). Read the full notice of funding opportunity (RFA-AT-24-011).
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
Pharmaceutical Technology
SEPTEMBER 4, 2024
ProKidney is prioritising one of two clinical studies evaluating rilparencel, to bring the cell therapy to the US market quicker.
Fierce Pharma
SEPTEMBER 4, 2024
Over the last decade, three blockbuster drugs—Biogen’s Spinraza, Roche’s Evrysdi and Novartis’ gene therapy Zolgensma—have transformed the treatment landscape for spinal muscular atrophy (SMA). | Biogen revealed that a portion of its phase 2/3 DEVOTE study met its primary endpoint, as a higher dose of Spinraza improved the motor function of treatment-naive infants with spinal muscular atrophy.
Pharmaceutical Technology
SEPTEMBER 4, 2024
Despite the best efforts of pharmaceutical manufacturers and regulators to improve the security and traceability of drug products, counterfeits continue…
pharmaphorum
SEPTEMBER 4, 2024
Digital skills: Why private clinics need effective communication lines to bridge the growing digital divide Mike.
Pharmaceutical Technology
SEPTEMBER 4, 2024
The Phase II/III fosgonimeton study was started after efficacy signals were noted in a subgroup analysis from an earlier Phase II trial.
Bio Pharma Dive
SEPTEMBER 4, 2024
Acquisitions of late-stage VC startups have been rare, a fact Pitchbook attributed to “ongoing price gaps between buyers and sellers.
Pharmaceutical Technology
SEPTEMBER 4, 2024
Between 2012 and 2021, outsourcing propensity for FDA NDA injectables approvals averaged 40%, according to GlobalData’s Contract Injectable Packaging Trends…
XTalks
SEPTEMBER 4, 2024
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is bringing together the agency’s artificial intelligence (AI)-based activities into one domain by establishing an AI council. CDER Director Patrizia Cavazzoni announced that the AI council would consolidate the FDA’s three existing AI groups — the CDER AI Steering Committee, AI Policy Working Group and CDER AI Community of Practice.
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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
Pharmaceutical Technology
SEPTEMBER 4, 2024
Azurity Pharmaceuticals’ Nymalize oral solution in a 30mg/5ml prefilled ENFit syringe has received US FDA approval.
ACRP blog
SEPTEMBER 4, 2024
Clinical trials provide the scientific foundation for justifying the safety and efficacy of drugs, biologics, and devices—but are laborious, expensive, and risky. Only 10% of drugs entering clinical trials receive U.S. Food and Drug Administration (FDA) approval, while common reasons for trial failure include poor patient selection, recruitment challenges, and complex study designs.{1} The pharmaceutical industry has begun leveraging artificial intelligence (AI) to streamline numerous aspects of
Pharmaceutical Technology
SEPTEMBER 4, 2024
Primrose Bio has entered a partnership with ExPLoRNA Therapeutics aimed at advancing the development and marketing of mRNA medicines.
pharmaphorum
SEPTEMBER 4, 2024
Data from a phase 2 trial of Roche's oral BTK inhibitor fenebrutinib have shown "near-complete suppression" of disease activity and disability progression in relapsing multiple sclerosis (MS).The full results of the FENopta open-label extension study are due to be reported in full at the ECTRIMS congress in Copenhagen later this month, but top-line findings include that 99% of patients treated with fenebrutinib were free of T1 gadolinium-enhancing lesions, markers of active inflammation, at 48 w
Pharmaceutical Commerce
SEPTEMBER 4, 2024
The latest news for pharma industry insiders.
Fierce Pharma
SEPTEMBER 4, 2024
Several months after its parent company unveiled new labs and office space to unite cell and gene therapy research on the West Coast, Astellas Gene Therapies is turning out the lights at a Californ | Several months after its parent company unveiled new labs and office space to unite cell and gene therapy research on the West Coast, Astellas Gene Therapies is turning out the lights at a California production plant.
pharmaphorum
SEPTEMBER 4, 2024
Regeneron signs up for access to a study run by Koneksa exploring the use of digital biomarkers to track patients with Parkinson's.
Fierce Pharma
SEPTEMBER 4, 2024
With a shortage of ADHD drugs persisting, the DEA has raised production limits on Takeda’s Vyvanse and its generic versions by 24%, the agency said.
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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.
pharmaphorum
SEPTEMBER 4, 2024
Swiss startup Haya Therapeutics has formed a $1bn partnership with Eli Lilly to look for new therapies for obesity in non-coding DNA
Drug Patent Watch
SEPTEMBER 4, 2024
Optimizing API manufacturing is crucial for ensuring the consistent production of high-quality APIs. The pharmaceutical industry has learned valuable lessons from various strategies and technologies that have significantly improved the efficiency, precision, and sustainability of API manufacturing processes. De-risking involves minimizing the uncertainty and unknowns in an API strategy.
pharmaphorum
SEPTEMBER 4, 2024
Novartis' Fabhalta is first oral monotherapy for paroxysmal nocturnal haemoglobinuria cleared by NICE for NHS use.
Fierce Pharma
SEPTEMBER 4, 2024
In his nine months as CEO, BioMarin’s new chief Alexander Hardy has so far overseen shakeups in the company’s leadership team, a slimdown of its R&D program and decisive action on the future of | The company's game plan includes five new indications for dwarfism drug Voxzogo through 2031, which could represent a $5 billion opportunity covering a patient population of 420,000.
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