Wed.Jun 18, 2025

article thumbnail

FDA approves twice-yearly shot of Gilead drug for HIV prevention

BioPharma Drive: Drug Pricing

The clearance ushers in a closely-watched launch for Gilead, which aims to show a long-acting injection can upend a market dominated by oral medicines.

article thumbnail

AI sniffs earwax and detects Parkinson’s with 94% accuracy

Science Daily: Pharmacology News

Imagine diagnosing Parkinson s disease not with pricey scans or subjective checklists, but with a simple ear swab. Scientists in China have developed a promising early screening method that detects Parkinson s from subtle changes in the scent of ear wax yes, really. By analyzing specific volatile compounds in ear wax and feeding that data into an AI-powered olfactory system, they achieved 94% accuracy in identifying who had the disease.

Disease 226
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA to speed reviews for drugs supporting ‘national interests’

BioPharma Drive: Drug Pricing

A new pilot program announced by FDA Commissioner Martin Makary would award vouchers that could cut drug reviews to one or two months — but only for products that meet a special criteria.

FDA 232
article thumbnail

Eli Lilly to Buy Gene Therapy Firm Verve in $1 Billion Deal to Develop Heart Drug

Drugs.com

WEDNESDAY, June 18, 2025 — Drugmaker Eli Lilly plans to buy Verve Therapeutics, a gene-editing startup, for about $1 billion upfront. The deal gives Lilly a potential new treatment for heart disease, The Wall Street Journal reported. The.

Therapies 173
article thumbnail

Bridging Innovation & Patient Care: The Growing Role of AI

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!

article thumbnail

A startup banks $66M to pursue ‘inclusive precision medicine’

BioPharma Drive: Drug Pricing

With backers such as Regeneron’s venture arm, Actio Biosciences is working on medicines that counter a wide range of disease-causing genetic mutations in conditions like epilepsy and Charcot-Marie-Tooth disease.

Disease 147
article thumbnail

AI Boosts Skin Cancer Diagnoses, Study Says

Drugs.com

WEDNESDAY, June 18, 2025 — An experimental AI tool can help speed detection of melanoma and other skin diseases, a new study says. The tool, PanDerm, improved accuracy of skin cancer diagnoses by 11% when used by doctors, researchers reported.

Doctors 209

More Trending

article thumbnail

CDC Vaccine Expert Resigns After RFK Jr. Cuts Advisers

Drugs.com

WEDNESDAY, June 18, 2025 — A senior scientist at the U.S. Centers for Disease Control and Prevention (CDC) has resigned, warning that changes in leadership may weaken the country’s vaccine program. Dr. Fiona Havers, who led the.

Vaccine 260
article thumbnail

Open Targets Platform 25.06 has been released!

The Open Targets Blog

The latest release of the Platform — 25.06 — is now available at platform.opentargets.org. We’re trying something new: tomorrow at 3pm UK time,  join our walkthrough and Q&A session on LinkedIn. The team will showcase the new features and data in this release, and then will answer your questions about the release and the Platform.

article thumbnail

How Wildfires Might Increase Risk Of Flu, COVID-19

Drugs.com

WEDNESDAY, June 18, 2025 — Wildfires might inadvertently increase the risk of flu and COVID-19 outbreaks, a new study argues.Sky-choking wildfire smoke tends to drive people indoors, and infectious diseases are more likely to spread among those p.

Disease 233
article thumbnail

Draig, a brain drug startup, debuts with $140M to treat depression

BioPharma Drive: Drug Pricing

The funds will support Phase 2 testing of a drug the company believes to be able to safety home in on AMPA receptors, an emerging but unproven depression target.

Drugs 189
article thumbnail

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

article thumbnail

Infertility Tied To Heart Problems In Women

Drugs.com

WEDNESDAY, June 18, 2025 — Infertility appears linked to women’s risk of heart problems, an evidence review suggests. Women who are infertile have an increased risk of heart disease and stroke, with the risk highest among younger women.

Disease 147
article thumbnail

Scholar Rock drug preserves muscle in obesity trial

BioPharma Drive: Drug Pricing

While the results were an important proof point for so-called anti-myostatin drugs, Scholar Rock executives indicated the company may look for a partner in obesity while focusing on rare diseases.

Trials 162
article thumbnail

Talk Therapy Eases Depression, Anxiety In Stroke Survivors

Drugs.com

WEDNESDAY, June 18, 2025 — Talk therapy can help stroke survivors who are in the throes of depression or anxiety, a new study says. About half of patients (49%) fully recovered from a post-stroke mood disorder after participating in talk.

Therapies 138
article thumbnail

The Top 15 Specialty Pharmacies of 2024: How PBMs, Health Systems, and Independents Are Shaping the Market (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for Friday’s live video webinar: What’s Next for Retail Pharmacy: Data, Debate, and Disruption. I’ll be joined by special guest Antonio Ciaccia, CEO of 46brooklyn Research, and President of 3 Axis Advisors. Click here to see the original post from April 2025. Drug Channels Institute’s (DCI’s) latest analysis reveals that PBM-affiliated specialty pharmacies continue to dominate the dispensing of specialty drugs.

article thumbnail

How Machine Learning Drives Clinical Trial Efficiency

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.

article thumbnail

Tech Transfer Readiness: Big Responsibility, Greater Reward

thought leadership

So, you're thinking about Technology Transfers (i.e., TT or Tech Transfer)? This question may look familiar to you. That is because we asked this very question in the first installment of our Tech Transfer blog series Technology Transfer Projects: Assessing Need and Readiness. In that blog, we talked about identifying the need for a Tech Transfer as well as identifying if you are ready to lead your own Tech Transfer.

article thumbnail

LEVALBUTEROL TARTRATE

New Drug Approvals

LEVALBUTEROL TARTRATE Levosalbutamol cas 661464-94-4 4-[(1 R )-2-( tert -butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;(2 R ,3 R )-2,3-dihydroxybutanedioic acid 1,3-BENZENEDIMETHANOL, alpha(SUP 1)-(((1,1-DIMETHYLETHYL)AMINO)METHYL)-4-HYDROXY-, (alpha(SUP 1)R)-, (2R,3R)-2,3-DIHYDROXYBUTANEDIOATE (2:1) (SALT) MW 628.7, C30H48N2O12 Xopenex HFA Levosalbutamol tartrate ADS4I3E22M UNII-ADS4I3E22M Levosalbutamol tartrate(levalbuterol) is the R-enantiomer of the short-acting β2-adrenergic receptor

article thumbnail

Phase 3 Trial of Ifinatamab Deruxtecan Begins in Advanced Prostate Cancer

The Pharma Data

Phase 3 Trial Launches for Ifinatamab Deruxtecan in Advanced Prostate Cancer Patients Daiichi Sankyo and Merck have announced the initiation of IDeate-Prostate01 , a global Phase 3 clinical trial evaluating the investigational drug ifinatamab deruxtecan (I-DXd) in patients with metastatic castration-resistant prostate cancer (mCRPC) who have experienced disease progression during or following treatment with androgen receptor pathway inhibitors (ARPIs).

Trials 40
article thumbnail

How CDMOs Can Use Patent Data to Win More Pharmaceutical Clients

Drug Patent Watch

"Breaking the Patent Code: How CDMOs Can Unlock a Competitive Edge in the Pharmaceutical Market As the pharmaceutical landscape continues to evolve, Contract Development and Manufacturing Organizations (CDMOs) are under increasing pressure to differentiate themselves and attract high-value clients. But what sets the winners apart from the rest?

article thumbnail

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

article thumbnail

Merck Names Neoclease Winner of 2025 Biotech Grant

The Pharma Data

Merck Awards 2025 North American Advance Biotech Grant to Neoclease for AI-Driven Parkinson’s Gene Editing Therapy Merck, a global leader in science and technology, has officially named Neoclease as the recipient of its 2025 North American Advance Biotech Grant , recognizing the Boston-based biotech startup for its cutting-edge work in AI-designed gene-editing therapies, particularly targeting Parkinson’s disease.

Science 40
article thumbnail

FDA’s New Priority Voucher Pilot Program Has Landed: CNPV

FDA Law Blog: Drug Discovery

By Mark A. Tobolowsky & Michelle L. Butler & Deborah L. Livornese — After teasing a new rapid review pilot program for the past few weeks, on June 17, 2025, FDA officially announced the Commissioner’s National Priority Voucher (“CNPV”) program to expedite new drug and biologic (but not device or drug-device combination product) reviews. As described in the press release and accompanying FAQ , the CNPV program is designed to reduce review time to 1-2 months following final drug applicati

FDA 59
article thumbnail

Alnylam Promotes Pushkal Garg to Chief R&D Officer

The Pharma Data

Alnylam Elevates Dr. Pushkal Garg to Lead Unified Research and Development Organization, Signaling Strategic Expansion into Next Phase of RNAi Therapeutics Innovation Alnylam Pharmaceuticals , a global leader in RNA interference (RNAi) therapeutics, has announced the promotion of Pushkal Garg, M.D., to the role of Executive Vice President and Chief Research and Development Officer.

RNA 40
article thumbnail

FDA's Commissioner’s National Priority Voucher (CNPV) Pilot Program Overview

thought leadership

An inside look at FDA's new Commissioner's National Priority Voucher (CNPV) pilot program—what it is, why it matters, and how regulatory and development teams can leverage it to accelerate high-priority therapies.

FDA 40
article thumbnail

Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

article thumbnail

AbbVie: Atogepant Outperforms Topiramate in Phase 3 Migraine Study

The Pharma Data

AbbVie Reports Strong Phase 3 Results for Atogepant, Demonstrating Superiority Over Topiramate in Migraine Prevention AbbVie , a leading global biopharmaceutical company, has announced promising topline results from its pivotal Phase 3 TEMPLE clinical trial—a multicenter, randomized, double-blind, head-to-head study that evaluated the efficacy, safety, and tolerability of atogepant (branded as QULIPTA® in the U.S. and AQUIPTA® in the EU) compared to topiramate, a widely used anticonvulsant appro

article thumbnail

How Will US Policy Impact the Growth of UK Biotech?

Fierce BioTech

How Will US Policy Impact the Growth of UK Biotech? We spoke with 16 C-level executives from UK-based biotechs about recent US policies (such as MFN pricing) & the likely impact on the UK biotech sector.

Science 52
article thumbnail

Amgen to Present Phase 2 Maritide Data at ADA 85th Scientific Sessions

The Pharma Data

Amgen to Unveil Full Phase 2 MariTide Data and Cardiometabolic Research Highlights at ADA 2025 Scientific Sessions Amgen has announced that it will present comprehensive data from Part 1 of its Phase 2 clinical study for MariTide (maridebart cafraglutide), formerly known as AMG 133, at the upcoming 85th Scientific Sessions of the American Diabetes Association (ADA), set to take place from June 20 to 23, 2025, in Chicago.

article thumbnail

Why Inclusive Design Solutions Are important for Accessibility

Perficient: Drug Development

Accessibility is often viewed through the lens of accommodations , making modifications after barriers are identified. But true inclusion starts with design. Inclusive design solutions are key to ensuring accessibility is baked into products, spaces, and technology from the beginning , rather than being treated as an afterthought. By embracing inclusive design, we create equitable, flexible, and universally beneficial experiences that support a diverse range of users—including those with disabil

article thumbnail

Biogen Launches Phase 3 Pediatric Trial of Omaveloxolone for Friedreich Ataxia

The Pharma Data

Biogen Launches Global Phase 3 Pediatric Trial of Omaveloxolone for Friedreich Ataxia Biogen has officially launched its BRAVE study a pivotal, global Phase 3 clinical trial aimed at evaluating omaveloxolone in pediatric patients with Friedreich ataxia (FA). This significant development marks a critical step in extending treatment to a younger population suffering from this rare and progressive neuromuscular disorder.

Trials 40
article thumbnail

Mastering TypeScript: Your Ultimate Guide to Types, Inference & Compatibility

Perficient: Drug Development

In today’s world, TypeScript has become the go to choice for building robust but at the same time scalable applications. By combining various approaches for static type with dynamic capabilities of React, our hero enhances and improves productivity and responsibility. At the same time reduces the runtime errors. But to use TypeScript efficiently, we need to dive deeply into types, inference, compatibility and more.

article thumbnail

Protecting Europe's Critical Undersea Infrastructure Depends on Coordination and Collaboration

RAND: Drug Policy and Trends

In May, the Polish navy intercepted a suspicious vessel linked to Russia's 'shadow fleet' near a critical power cable. This incident highlights the vulnerability of Europe's undersea infrastructure. Protecting this vital network requires coordinated efforts from national navies, government departments, and private companies.

article thumbnail

Why playing it safe is slowing down drug discovery

Drug Target Review

In early-stage drug discovery, pressure is nothing new. Long timelines, strict regulation and scientific uncertainty are part of the job. However, when that pressure is compounded by political shifts, market volatility and rising expectations from the global pharmaceutical industry, the old ways of working start to crack. Nick Petschek is Managing Director – EMEA at Kotter , a change and transformation consultancy grounded in John Kotter’s 50 years of leadership research.

Drugs 52
article thumbnail

Navigating Regulatory Hurdles in Drug Development

DrugBank

Drug development is a complex and highly regulated process. Before a therapy can be approved for patient use, it must undergo extensive clinical testing and strictly adhere to regulatory guidelines. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global counterparts, set rigorous standards to ensure that drugs are safe, effective, and high-quality.

article thumbnail

Death by Nemawashi

RAND: Drug Policy and Trends

Delayed decisionmaking in Japan, driven by the need for consensus, poses significant risks to Taiwan's security and the U.S.-Japan alliance, and could allow China to capitalize on inaction in a crisis. The United States could mitigate the negative effects on operational timelines through preparation and adroit diplomacy.

40