Pharmaceutical Technology

OCTOBER 31, 2022

The investigational ophthalmic formulation of bevacizumab, ONS-5010 is currently being developed as an intravitreal injection to treat wet AMD and other retinal diseases. The regulator has set 29 August 2023 as a Prescription Drug User Fee Act (PDUFA) goal date.

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FDA Approval Pharmacy Licensing Licensing 147

pharmaphorum

DECEMBER 21, 2021

During the course of the webinar, Keefer explained how specialty sites, with deep knowledge on one or certain groups of Rare Diseases, are crucial for further progress in drug development to progress the number of treatments available to Rare Disease patients and to provide support to those individuals. Headway being made.

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Development Genome Genomics Drugs 98

FDA Law Blog

SEPTEMBER 30, 2021

This time, “David” consists of a cast of seven compounding pharmacies and their amicus curiae supporters. Section 503A’s language requires FDA to promulgate a MOU to “address” the “distribution” of “inordinate amounts” of compounded drugs interstate and that it “shall issue regulations” to do so. By Karla L.

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Pharmacy Drugs Production Regulation 98

Pharmaceutical Technology

JANUARY 2, 2023

Danicamtiv is under clinical development by Bristol-Myers Squibb and currently in the Phase I and Phase II in clinical pathway. Danicamtiv overview Danicamtiv (MYK-491, DCM-1) is under development for the treatment of dilated cardiomyopathy (DCM), atrial fibrillation and systolic heart failure.

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Drugs Development Production Pharmacy 100

FDA Law Blog

MAY 31, 2021

Kirschenbaum — The past two weeks have seen two noteworthy developments relating to CMS’s Medicaid Drug Rebate Program (MDRP) regulations. In December 2020, CMS published a final rule making several changes to the MDRP regulations. CMS Proposes to Extend Effective Dates of Two MDRP Regulations. Virgin Islands).

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Development Drugs Manufacturing Regulation 52

World of DTC Marketing

FEBRUARY 28, 2021

SUMMARY: Pharma companies, like J&J, have received criticism for engaging in illegal activities, such as providing kickbacks and bribes, knowingly shipping adulterated or contaminated drugs to pharmacies, and marketing drugs for unapproved uses. So should we forget all that because they developed a COVID vaccine? The answer is NO.

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Vaccination Vaccine Contamination Compliance 180

Pharmaceutical Technology

MAY 25, 2023

Consequences of non-adherence A World Health Organisation (WHO) report on medication non‐adherence [1] shows that among people with chronic diseases in developed countries, adherence is estimated to be as low as 40%–60%. For more information on Huma’s regulated platform download the paper below. [1]

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Medicine Doctor Doctors Regulation 130

Pharmaceutical Technology

SEPTEMBER 15, 2022

The information contained within the download document is useful for pharmaceutical executives, drug development officers, product marketing managers, marketing executives, medical representatives, senior procurement executives, pharma packaging development specialists, and any other individual involved in pharmaceutical commercial packaging.

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Packaging Packaging Marketing Containment 130

Pharma in Brief

OCTOBER 26, 2023

The PMPRB has not had a full set of guidelines since July 1, 2022, when amendments to the Patented Medicines Regulations came into force. The Board previously indicated that the second stage of consultation, focused on the development of new guidelines, will take place in 2024.

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Medicine Drugs Pharmacy Regulation 52

Pharmaceutical Technology

JULY 25, 2022

For example, JAK inhibitors are oral drugs that feature a certain complexity, says Jonathan Watanabe, PhD, professor of Clinical Pharmacy at the University of California, Irvine. The FDA knows that developing specialty generics, particularly generic injectable products, can be challenging. The only way forward for generics producers.

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Drugs Manufacturing Production Marketing 298

The Pharma Data

NOVEMBER 9, 2020

Psilocybin, mescaline, LSD, MDMA, DMT and other psychedelic compounds added to exclusive dealing agreement for the development of psychedelic-based therapeutics. Dr. Löbenberg with respect to exclusive commercial development rights under his cannabis licences and to related intellectual property. The Company and Prof.

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Development Drugs Drug Delivery Production 40

The Pharma Data

OCTOBER 27, 2021

GSK Consumer Healthcare today unveils a three-year programme to support the pharmacy profession with additional practical resources, mental health provisions and proposed policy changes as part of its new report Standing with Pharmacists in the Age of Self-Care.

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Pharmacy Scientist Development Branding 52

FDA Law Blog

JANUARY 22, 2024

The tools it uses to accomplish that mission include those designed to help regulated entities that want to follow best public health practices, like guidances, public notifications, and requests for information. This is another area in which FDA works with industry to try to ensure voluntary compliance from regulated entities.

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Compliance Clinical Trials Clinical Trials Regulation 59

Pharmaceutical Technology

DECEMBER 14, 2022

Antibiotics are the go-to treatment for bacterial infections in developed countries, such as Strep A. Local UK pharmacies are already reporting and forecasting future shortages of antibiotics to treat Strep A infections. However, antibiotic treatment faces two key challenges. Secondly, antibiotics are not a permanent solution.

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Bacteria DNA Clinical Trials Clinical Trials 130

Pharmacy Checkers

JULY 2, 2019

One of the Sustainable Development Goals, 3.8 , created under UN auspices is: “Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.” My comment is below. In support of SDG 3.8,

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Medicine Pharmacy Regulation Development 49

pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. One approach the industry has been exploring is to utilise community retail pharmacies as a central location for people to learn about and participate in clinical trials. About the author.

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Clinical Trials Clinical Trials Trials Clinical Research 111

The Pharma Data

SEPTEMBER 29, 2021

Heerspink, Professor of Clinical Trials and Personalized Medicine and a clinical pharmacologist/trialist at the Department of Clinical Pharmacy and Pharmacology at the University center Groningen, Netherlands, and Co-Chair of the study’s Executive Committee. “If Healthy kidneys act as the body’s filter, removing waste products from the blood.

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Clinical Development Development Clinical Trials Clinical Trials 52

XTalks

JANUARY 29, 2024

Here are some key areas where healthcare consultants make a difference: Healthcare policy and management: Consultants in this area assist in developing effective healthcare policies and management strategies, ensuring compliance with regulatory standards and improving overall healthcare delivery.

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Life Science Regulation Marketing Compliance 94

XTalks

AUGUST 3, 2023

Raphael Pareschi: I started my career in the pharmaceutical industry 16 years ago, transitioning from a background in pharmacy and biochemistry. Due to strict regulations and a general tendency towards conservatism, the industry typically takes time to adopt new technologies.

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Regulation Marketing Life Science Drugs 79

pharmaphorum

JULY 22, 2022

This one-of-a-kind meeting will facilitate networking opportunities with key opinion leaders from all areas of pharmaceuticals, biologicals, and cleanroom industry experts to explore hot topics within cleanroom design and engineering, best practices and regulation, environmental and contamination control, and pharmaceutical microbiology.

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Contamination Production Pharmacy Engineer 52

FDA Law Blog

MARCH 17, 2022

As explained more fully below, CDC concedes that states, insurers, pharmacies and pharmacy benefit managers have implemented laws, regulations and policies that have misapplied the 2016 guideline. and although not an intention, also impacted laws, regulations and policies. 7,838 (Feb. 10, 2022); Dowell, Deborah, MD.,

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Pharmacy Regulation Drugs Nurses 75

XTalks

APRIL 24, 2023

To achieve this, Medpace works in multi-disciplinary teams of experts to jointly develop and execute advanced therapy protocols. For rare disease studies where there is little or no clinical trial experience, outcome assessments would have to be validated within a clinical development program.

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Gene Therapy Gene Trials Clinical Trials 74

ACRP blog

SEPTEMBER 12, 2024

ACRP member Tony Succar, PhD, MScMed, Assistant Professor in the Mann School of Pharmacy and Pharmaceutical Science, Department of Regulatory and Quality Sciences, University of Southern California (USC). ACRP: Can these academic programs really keep up with ever-changing developments in the field these days?

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Clinical Research Research Clinical Trials Clinical Trials 64

XTalks

NOVEMBER 26, 2020

In addition to innovative new antibody drugs and mRNA vaccines, researchers have found that the sleep-regulating hormone melatonin may also offer protection against COVID-19. Melatonin, which regulates the body’s circadian rhythm and sleep-wake cycle, is also available in pill form for use as a sleep aid.

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Research Hormones Protein Regulation 96

Pharmacy Checkers

NOVEMBER 21, 2019

The Food and Drug Administration (FDA) is just one agency out of the many that make up the United States Department of Health and Human Services and, from PharmacyChecker’s relatively small (non-regulatory) role of helping verify online pharmacies to protect public health, I’ve learned just how insanely massive its mandate is.

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Generic Drugs Manufacturing Drugs Regulation 68

Pharma in Brief

NOVEMBER 12, 2023

The Patented Medicine Prices Review Board ( PMPRB ) has released a scoping paper on themes and questions to develop new price review Guidelines. The Board previously indicated that a second phase of consultation in 2024 would focus on the development of new Guidelines.

Drugs 52

Drugs Medicine Compliance Pharmacy 52

pharmaphorum

JUNE 30, 2022

At the 2022 Drug Information Association (DIA) annual meeting last week, it was inspiring to connect with fellow research and development (R&D) stakeholders, regulators, health and digital data partners and more to navigate challenges in drug development that impact patients globally. Patient journey. About the Author.

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Trials Development Drugs Clinical Trials 64

FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). RWD can be collected from a wide range of sources, such as electronic health records, registries, administrative claims, pharmacy data, and feedback from wearables and mobile technology.

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Production Trials Marketing Pharmacy 111

The Pharma Data

JANUARY 18, 2021

BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU ), an emerging biotech company focused on the development and commercialization of cutting-edge treatments in mental disorders and viral infections, is pleased to announce that Health Canada has confirmed that 2-bromo-LSD is not a controlled substance. VANCOUVER, Jan.

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Containment Production Drug Delivery Regulation 40

The Pharma Data

DECEMBER 30, 2020

Britain became the first country to give authorization to the coronavirus vaccine developed by AstraZeneca and the University of Oxford, The New York Times reported Wednesday. Consumers should not use any of this prescription oral rinse, which was distributed to dental offices and pharmacies nationwide, CBS News said. © 2020 HealthDay.

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Contamination Vaccination Vaccine Pharmacy 52

Pharmacy Checkers

JUNE 26, 2020

These drug regulators have engaged in regular consultations since 2003 in order to share insights and best practices. As reported by Regulatory Focus: “The regulators went over challenges each are facing in the race to develop vaccines for COVID-19 and make them available.

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Drugs Regulation Manufacturing Medicine 55

XTalks

NOVEMBER 9, 2023

XTALKS WEBINAR: The Evolution of the Cardiovascular Clinical Development Landscape and Potential Role of GLP-1 RAs Live and On-Demand: Wednesday, December 6, 2023, at 11am EST (4pm GMT/UK) Register for this free webinar to learn about successful study outcomes in developing GLP1s to new therapeutic areas within cardiovascular medicine and more. “In

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FDA Approval Manufacturing Drugs Pharmacy 59

Advarra

MAY 16, 2024

sIRB Reporting Requirements Clinical trial reporting requirements can be tricky in general, and the regulations don’t always provide clear definitions or expectations (for example, noncompliance ). To address such regulatory gray areas, individual IRBs have developed their own policies and requirements.

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Research Compliance Trials Regulation 52

pharmaphorum

JANUARY 27, 2021

Examples like this should be used to reassure people that things are done differently now and to raise awareness of how regulations and standards are evolving. However, the general public is unaware of how such guidelines are developed, why they’re needed, or why they should be adapted. Increase awareness and understanding.

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Research Clinical Trials Clinical Trials Vaccination 52

Advarra

SEPTEMBER 7, 2023

Together, these three principles form the foundation upon which HRPPs were established and provide the basis for laws, regulations, guidelines, and policies governing human subjects research. There are staff dedicated to developing, implementing, and enforcing the organization’s COI policies.

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Research Compliance Clinical Trials Clinical Trials 52

Pharma Marketing Network

NOVEMBER 3, 2021

Native ads have been adopted by all healthcare industries including pharma, device, health systems, retailers, pharmacies, payers, and the gamut of regional service providers. For cautious or highly regulated markets, like pharma, it’s becoming much easier to get approval to run native ads.

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Branding Marketing Sales Production 105

XTalks

NOVEMBER 16, 2020

Moderna’s mRNA vaccine candidate — mRNA-1273 — was developed using its proprietary mRNA technology platform. This is a pivotal moment in the development of our COVID-19 vaccine candidate. The vaccine is given in two doses. Key secondary endpoints include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2.

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Vaccination Vaccine Trials Allergies 105