Perficient: Drug Development

OCTOBER 3, 2023

Physician blogs are a great way to get your physicians’ messages out to the public. Blog articles that include your physicians’ bylines and consumer-friendly, understandable language help position your team of physicians as thought-leaders in their fields of expertise.

Doctors 52

Doctors Clinical Trials Marketing Engineering 52

FDA Law Blog: Drug Discovery

JANUARY 30, 2025

Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance). This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials. Tobolowsky & Charles G. Raver & James E.

FDA 105

FDA Trials Disease Drugs 105

National Institute on Drug Abuse: Nora's Blog

MARCH 6, 2025

Advancing reduction of drug use as an endpoint in addiction treatment trials astewart Thu, 03/06/2025 - 09:59 Nora's Blog March 18, 2025 Image Getty Images/ SolStock This blog was also published in the American Society of Addiction Medicine (ASAM) Weekly on March 18, 2025.&

Treatment 69

Treatment Trials Clinical Trials Drugs 69

Antidote

AUGUST 30, 2023

Various types of clinical studies play a pivotal role in ensuring the approval of life-saving medications and treatments. In this blog, we’re examining why participating in a clinical trial can be a rewarding experience for patients, and provide guidance on how potential volunteers can discover relevant studies.

Research 119

Research Clinical Trials Trials Treatment 119

The Premier Consulting Blog

NOVEMBER 6, 2024

Inhaled combination products (ICP) have emerged as a significant advancement in the treatment of respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), and other pulmonary conditions. What regulatory division governs ICPs? ICPs are subject to rigorous regulatory scrutiny due to their complexity.

Production 52

Production FDA Compliance Disease 52

Collaborative Drug

SEPTEMBER 23, 2024

AUC represents the total response of a system to varying levels of a drug or treatment and can serve as a powerful curve quality control metric. AUC calculation: Area Under the Curve is now available as a default calculated parameter on all dose response (Hill Equation) protocols.

Treatment 278

Treatment Drugs 278

Crown Bioscience

MARCH 3, 2025

These differences not only shape tumor behavior but also impact the efficacy of therapeutic strategies, highlighting the need for tailored approaches in cancer treatment. Understanding and leveraging this variability through advanced models like co-culture systems is critical for developing effective, type-specific therapies.

Drugs 52

Drugs Therapies Treatment Research 52

Common Sense for Drug Policy Blog

JULY 21, 2023

Residential Treatment Compared With Outpatient Treatment Coupled With MOUD "Residential treatment is often considered the highest intensity of treatment for individuals with OUD [ 40 ], and may by particularly important for those with unstable housing, co-morbid mental health conditions, or high medical need [ 41 ].

Treatment 52

Treatment Hospitals Research 52

Common Sense for Drug Policy Blog

APRIL 21, 2024

Agonist Treatment for Cannabis Use Disorder "Cannabinoid agonist treatment is unlikely to be an approach relevant to all cannabis users seeking treatment, as evidenced by the large numbers of individuals who did not complete the study screening process, and the modest 12-week treatment retention rates.

Treatment 52

Treatment Clinical Trials International Therapies 52

National Institute on Drug Abuse: Nora's Blog

FEBRUARY 1, 2024

50 years after founding, NIDA urges following science to move beyond stigma area Thu, 02/01/2024 - 11:20 Nora's Blog February 1, 2024 Image NIDA Image In 2024, NIDA celebrates its 50th anniversary. There was little in the way of effective prevention, and the only drug addiction treatment available was methadone.

Science 122

Science FDA Approval Treatment Research 122

Common Sense for Drug Policy Blog

DECEMBER 16, 2023

Treatment for Methamphetamine Use "Methamphetamine is a highly addictive psychostimulant with evidence of neurotoxic properties ( 1 – 3 ) and is consistently ranked as one of the most harmful illicit substances—both to the person using and to society ( 4 , 5 ). 33.8) ( 18 )." 33.8) ( 18 )." Psychiatry 14:1123424. doi: 10.3389/fpsyt.2023.1123424

Treatment 52

Treatment Therapies Research Drugs 52

Common Sense for Drug Policy Blog

NOVEMBER 29, 2023

Receipt of Opioid Use Disorder Treatments Prior to Fatal Overdoses and Comparison to No Treatment "The findings revealed that exposures to MOUD, even if not continued throughout the six-month exposure period was associated with reduced risk of a fatal poisoning compared to non-MOUD forms of treatment and no treatment exposure.

Treatment 52

Treatment Drugs 52

Common Sense for Drug Policy Blog

MAY 8, 2024

Regardless of region, jail jurisdiction size, locality, or opioid overdose death rate, larger percentages of jail jurisdictions initiated behavioral or psychological treatment for OUD than initiated or continued MAT. "In Opioid Use Disorder Screening and Treatment in Local Jails, 2019. In states with 24.0 In states with fewer than 10.0

Treatment 52

Treatment 52

Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

Drug Development 52

Drug Development Treatment FDA Approval Drugs 52

National Institute on Drug Abuse: Nora's Blog

AUGUST 28, 2024

Over the past two decades, substance use treatment admissions have increased among people aged 50 and over. Chronic pain is prevalent among older adults, and treatment for pain is less effective in this age group than it is in younger people; it negatively impacts quality of life and is a risk factor for cognitive decline and premature death.

Treatment 110

Treatment Research Disease Drugs 110

National Institute on Drug Abuse: Nora's Blog

OCTOBER 6, 2023

The power of protective layers: Employers advancing whole-person health mfleming Fri, 10/06/2023 - 17:56 Nora's Blog October 11, 2023 This blog was originally posted on LinkedIn.com. Stigma against people with substance use disorders can keep them from seeking treatment.

Treatment 92

Treatment Drugs Disease Research 92

FDA Law Blog: Drug Discovery

JULY 17, 2024

In December 2023, FDA established the Genetic Metabolic Diseases Advisory Committee (also called “GeMDAC,” which we blogged about here ) to advise FDA regarding treatments for genetic metabolic diseases (i.e., those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

FDA 105

FDA Disease Clinical Pharmacology Science 105

Common Sense for Drug Policy Blog

DECEMBER 20, 2023

Emergence of Methadone Maintenance Treatment in the US "Methadone emerged as a maintenance treatment modality for heroin dependence in the mid-1960s. Mark Parrino, added that opioid treatment programs (OTPs) came into existence because of a rejection by the medical community to treat this particular patient population. "By

Treatment 52

Treatment Regulations Engineering FDA 52

Common Sense for Drug Policy Blog

JANUARY 3, 2024

Syringe Service Program Use and Substance Use Treatment "In this study, there was no indication that needle-exchange use was associated with increasing drug use. Our analysis also suggested that among heroin injectors, needle-exchange participation was wholly compatible with the goals of drug treatment. 1981 , Robins 1980 ).

Treatment 52

Treatment Drugs 52

Common Sense for Drug Policy Blog

JANUARY 9, 2024

SUD Treatment for Young People: Limited Availability and Costly "Using the Substance Abuse and Mental Health Services Administration’s treatment locator and search engine advertising data, we identified 160 residential addiction treatment facilities that treated adolescents with opioid use disorder as of December 2022.

Treatment 52

Treatment Engineering 52

Common Sense for Drug Policy Blog

MAY 8, 2024

Opioid Use Disorder Screening and Treatment in Local Jails in the US "At midyear 2019, fewer than two-thirds (63%) of local jail jurisdictions conducted opioid use disorder (OUD) screenings at intake and more than half (54%) of jail jurisdictions provided inmates medications to treat opioid withdrawal (figure 1). Maruschak, Todd D.

Treatment 52

Treatment 52

FDA Law Blog: Biosimilars

DECEMBER 4, 2023

A prescription not issued in the usual course of professional treatment or in legitimate, authorized research is not a prescription within the meaning of the CSA and the pharmacist knowingly filling it, along with the prescriber issuing it, is subject to penalties. 21 U.S.C. § 829; 21 C.F.R. Complaint ¶ 58. Complaint ¶ 59.

Pharmacy 139

Pharmacy Government Treatment Compliance 139

National Institute on Drug Abuse: Nora's Blog

SEPTEMBER 25, 2024

BRAIN at 10: A View from the National Institute on Drug Abuse mfleming Wed, 09/25/2024 - 19:31 Nora's Blog October 1, 2024 By Nora Volkow, MD, Director, and Rita Valentino, Ph.D., Director, Division of Neuroscience and Behavior, NIDA This blog was originally posted on the The BRAIN Blog.

Drugs 100

Drugs Science Research Regulations 100

NIOSH Science Blog: Drugs

MAY 17, 2023

While there are treatment options, many patients will succumb to the disease, with a 5-year relative survival rate of 12%, per the American Cancer Society and the Surveillance, Epidemiology, and End Results Program. It was created to assist researchers and healthcare professionals better understand and treat malignant mesothelioma.

Treatment 52

Treatment Research Disease 52

National Institute on Drug Abuse: Nora's Blog

JULY 22, 2024

To address the fentanyl crisis, greater access to methadone Is needed area Mon, 07/22/2024 - 12:43 Nora's Blog July 29, 2024 By Nora D. Almost all (99%) of those retained in treatment achieved remission. Methadone may even be preferable for patients considered to be at high risk for leaving OUD treatment and overdosing on fentanyl.

Pharmacy 78

Pharmacy Treatment Community Pharmacies Trials 78

Alta Sciences

NOVEMBER 4, 2024

This blog explores the process required for manufacturing a highly potent API for an ophthalmic indication, based on a case study involving loteprednol etabonate, a topical corticosteroid used to treat eye inflammations. When handling loteprednol etabonate, additional containment strategies were applied to reduce aerosolization.

Engineering 52

Engineering Production Compliance Laboratories 52

Cytel

JUNE 18, 2024

ECAs have significant potential to save resources and accelerate access to innovative treatment. In a previous blog , our experts took a deep dive into the concept of ECAs, their acceptable use cases, and the current regulatory guidance.

Trials 59

Trials Treatment Clinical Development 59

PPD

JULY 29, 2024

This blog presents examples that demonstrate how AI can be used throughout the drug development process, with a specific focus on patient enrollment. Predicting clinical outcomes helps identify participants who would likely respond better to treatment and who might be at a higher risk.

Clinical Research 98

Clinical Research Clinical Trials Research Trials 98

Common Sense for Drug Policy Blog

OCTOBER 7, 2023

Given that the median duration of prison stay was only 16 days, excess risk of infection-related hospitalization after release may also reflect people seeking treatment outside prison for infections that initially developed before or during incarceration ( Lloyd et al., 2014 ; Joudrey et al., dwf_admin Sat, 10/07/2023 - 14:42 Source Thomas D.

Hospitals 52

Hospitals Treatment International Drugs 52

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies 119

Therapies FDA FDA Approval Treatment 119

National Institute on Drug Abuse: Nora's Blog

NOVEMBER 4, 2024

Improving community engagement in addiction science mfleming Mon, 11/04/2024 - 19:11 Nora's Blog November 12, 2024 Image ©Getty Images/ MStudioImages Medical research can sometimes become disconnected from the interests and needs of the people it is intended to serve.

Science 85

Science Research Treatment Drugs 85

FDA Law Blog: Biosimilars

JUNE 12, 2024

Gibbs — It’s been over a year and a half since Over-the-Counter (“OTC”) hearing aids became legal, and it’s not clear that they’ve made the difference in hearing loss treatment that Congress anticipated. (FDA Koblitz & Jeffrey N. FDA once estimated that OTC hearing aids would save patients over $3000.)

FDA 111

FDA Regulations Treatment Licensing 111

Eye on FDA

JULY 19, 2021

It has been a regular feature of the blog to give a read on what FDA has been talking about, at least through the form of press releases. It is not always an easy task because the nature of FDA’s practice in this respect has evolved over time. Apologies for the misfire, but hopefully we are working more smoothly now.

FDA 93

FDA Vaccine Treatment Drugs 93

addgene Blog

MAY 4, 2023

The “cause of disease” often requires understanding the disease genetics and the “treatment” usually requires drugs. In this blog we will review how CRISPR technology has brought drug and genetic screens together and expedited the drug discovery pipeline.

Drugs 52

Drugs Disease Treatment 52

Common Sense for Drug Policy Blog

JANUARY 4, 2024

Cost Benefit Analysis of Opioid Treatment, Syringe Service Programs, and Test & Treat "Although model projections can only provide estimates of health benefits and costs, such analyses can provide intuition around critical mechanisms and assumptions to inform decision making.

Treatment 52

Treatment Therapies Drugs 52

Drug Patent Watch

FEBRUARY 26, 2025

Unlocking the Secrets to Patenting Drug Combinations: Strategies and Challenges As a pharmaceutical professional, you know how crucial it is to stay ahead of the curve when it comes to patenting innovative treatments. In our latest blog post, we dive into the strategies and challenges of patenting drug combinations.

Drugs 40

Drugs Production Regulations Therapies 40

PPD

AUGUST 7, 2024

Clinical trials are the backbone of medical research, enabling the development of new treatments and therapies that can improve patient outcomes. In this blog, we will delve into the world of clinical trial contact center services and explore how they enhance the entire trial process, from recruitment to post-trial follow-up.

Clinical Trials 97

Clinical Trials Trials Compliance Clinical Research 97