Pharmacist Digest

STAT+: U.K. becomes the first country to release detailed data on sponsors that fail to register clinical trials

STAT

MARCH 28, 2024

The United Kingdom has released comprehensive data showing which institutions have failed to register their clinical trials, a move that was hailed by transparency advocates who say this marks the first time that a country has taken such a step. In 2022, 92% of the trials had been registered. The findings were notable.

STAT+: Survey: Confusion over key requirements means clinical trials aren’t registered and results aren’t reported

STAT

JANUARY 16, 2024

More than half of those responsible for registering clinical trials and reporting results fail to do so over confusion about key requirements, according to a new survey that highlighted ongoing difficulties in achieving transparency surrounding study data. government database. government database.

GPhC temporary register to close in March 2024

The Pharmacist

SEPTEMBER 25, 2023

The General Pharmaceutical Council (GPhC) has received instruction by the UK Government to close its temporary Covid-19 register in March 2024. The temporary register was set up in 2020 when the GPhC used its emergency powers to register pharmacy professionals rapidly in response to the Covid-19 pandemic.

STAT+: FDA is petitioned to boost enforcement of trial sponsors that fail to register studies or report results

STAT

FEBRUARY 27, 2023

An organization that promotes and studies clinical trial disclosure has petitioned the Food and Drug Administration to take several steps to boost its enforcement of wayward trial sponsors and investigators that fail to register studies and report results.

Register Now: JULY 26 Webinar on IRA Medicare Price Negotiations

Safe Biologics

JULY 13, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). REGISTER HERE.

Drug Pricing

Drug Pricing Biosimilars

Register Now: JULY 26 Webinar on IRA Medicare Price Negotiations

Safe Biologics

JULY 13, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). REGISTER HERE.

Drug Pricing

Drug Pricing Biosimilars

Half a million people register organ donation status via NHS App

The Pharmacist

SEPTEMBER 29, 2023

More than half a million people have registered their organ donation decision for the first time via the NHS App, new data has shown. According to NHS England, 546,825 organ donation decisions have been registered for the first time through the NHS App, up 22% from 448,562 last August.

Provisional Registered Pharmacist Training: Hospital or Community

RX Note

MARCH 27, 2023

Introduction The Registration of Pharmacists Act 1951 requires provisionally registered pharmacists (PRPs) to complete their training at training premises recognized by Pharmacy Board Malaysia , which may be either public or private institutions. A complete list of training premises for PRPs can be found here.

Hospitals

Hospitals Community Pharmacies Inventory Control Inpatient

Register Today: The PMN HCP Engagement Summit

Pharma Marketing Network

FEBRUARY 18, 2022

Register Today. The post Register Today: The PMN HCP Engagement Summit appeared first on Pharma Marketing Network. You won’t want to miss the round robin style discussion on the what, when and where of HCP engagement, what it should be, what it is now and where it’s going.

Register for the Oligonucleotide Therapeutics and Delivery Conference

pharmaphorum

JUNE 28, 2022

Interested parties can register for the conference and workshop at: [link]. The post Register for the Oligonucleotide Therapeutics and Delivery Conference appeared first on. Chairs for the conference are industry expert Ekkehard Leberer, Senior Consultant, Elbiocon, and Jim Weterings, Principal Scientist, AstraZeneca.

STAT+: FDA gives a mixed response to a petition seeking greater clinical trial transparency

STAT

FEBRUARY 22, 2024

Food and Drug Administration told an advocacy group that it is not planning to take a tougher stance against wayward clinical trial sponsors and investigators that fail to register studies or report results, a central issue in the ongoing debate over greater transparency into clinical research.

Early Bird Gets the (Pharmacy) Worm: Register for Catalyst Connect 2024

PioneerRx

FEBRUARY 6, 2024

The new year is not so new anymore, the ice is thawing, and the almighty groundhog declares that an early spring is around the corner. Though spring is slowly.

Proposed amendments to the PM(NOC) Regulations: Patents claiming different salt forms of medicinal ingredients eligible for inclusion on the Patent Register

Pharma in Brief

APRIL 25, 2021

salt forms) to be listed on the patent register and are intended to balance Proposed FDR Amendments [2] published on March 30, 2019 which allow generic manufacturers to file an ANDS for an alternative form of a medicinal ingredient in comparison to the CRP. Transition Provisions to Permit Listing of Previously Ineligible Patents.

STAT+: Most clinical trials run in Canada failed to take basic steps toward transparency, analysis finds

STAT

NOVEMBER 27, 2023

Just 3% of more than 3,700 studies run exclusively in Canada over a recent 10-year period were registered prospectively, reported results, and published the findings, underscoring ongoing concerns about clinical trial transparency, according to a new analysis. In all, 42% took all three of those steps concurrently.

Generic not required to address Patent Register when reference innovator drug is no longer marketed in Canada

Pharma in Brief

SEPTEMBER 8, 2022

On August 17, 2022, the Federal Court dismissed applications for judicial review regarding the product-specificity requirements for addressing patents listed on the Patent Register under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). Background. mL strength pre-filled syringe). mL pre-filled syringe.

Biosimilars

Biosimilars Dosage Documentation

Juul’s internal playbook opens a rare window into influence in Washington

STAT

FEBRUARY 15, 2024

WASHINGTON — A new trove of internal emails and other documents from the e-cigarette maker Juul reveals the company’s extensive behind-the-scenes efforts to promote its interests in Washington — a rare insight into the otherwise opaque methods corporations use to influence the government.

Documentation

STAT+: UnitedHealth is on a buying spree of outpatient surgery centers

STAT

MARCH 11, 2024

That overlap reinforces how UnitedHealth, which is expected to register $400 billion in revenue this year, is looking to funnel more of its insurance members toward providers that it owns.

STAT+: Vertex offers limited access to a cystic fibrosis drug in South Africa — and may undercut a court case

STAT

APRIL 25, 2024

Under the arrangement, the company is making its Trikafta medication available through a government mechanism that allows a medicine that is not registered for sale in the country to be made available to individual patients.

Drug Pricing

Supplement Patient Care with a Registered Dietetic Technician Nutritionist

PioneerRx

DECEMBER 14, 2022

More independent pharmacies are realizing that healthcare is undergoing a huge shift. According to Amina Abubakar in her most recent update, “As of 2019…

Independent Pharmacies

Nurses and health care support workers at higher risk of suicide, study finds

STAT

SEPTEMBER 26, 2023

Jobs in health care are known to be challenging for workers’ mental health. million employed people (both within the health care field and outside) observed from 2008 to 2019.

STAT+: In response to criticism, FDA publishes new database of wayward clinical trial sponsors

STAT

DECEMBER 14, 2023

Food and Drug Administration earlier this month launched a dashboard containing preliminary notices sent to companies, universities, and researchers that failed to register clinical trials or report study results. In a bid toward greater transparency, the U.S.

STAT+: Little transparency, lots of waste: NIH funds pediatric research, but many trials results go unpublished

STAT

FEBRUARY 24, 2023

Specifically, just under two-thirds of the 354 trials studied were registered in advance with ClinicalTrials.gov , the federal database, and just 13% of finished trials were registered within 12 months of completion, according to the analysis , which was published in JAMA.

STAT+: What disclosure? Clinical trials run in Canada fail to take basic steps toward transparency

STAT

SEPTEMBER 8, 2022

Amid ongoing controversy over clinical trial transparency, a new analysis found that just 3% of the more than 3,700 studies run exclusively in Canada over a recent 10-year period were registered prospectively, reported results, and published the findings. The analysis examined trials that were completed between 2009 and 2019.

STAT+: New NIH head says government has fallen behind pharma on clinical trials

STAT

NOVEMBER 14, 2023

Industry-sponsored trials increased 43% from 2006 to 2014, while newly registered NIH-funded trials decreased 24% over the same period. ” A Johns Hopkins University study published in 2015 showed that the pharmaceutical industry funds six times more clinical trials than the government. Continue to STAT+ to read the full story…

STAT+: Backed by Mayo Clinic and Microsoft, a nonprofit forms to test AI tools used in health care

STAT

JANUARY 8, 2024

Its goal is to create a system to certify and register AI models, and publish details about their performance before they are widely adopted. The nonprofit will establish the laboratories at Mayo Clinic, Duke, Stanford, and other major universities and institutions around the country.

Mayo Clinic

Mayo Clinic Hospitals

Opinion: Every smartphone should have an app to connect to 988, the mental health crisis line

STAT

SEPTEMBER 22, 2023

can be used to dial 911, regardless of whether it is currently registered with a cellular carrier. The good news was that I could still have used this bricked phone to call 911 in the event of an emergency. Any phone in the U.S. Read the rest…

STAT+: Patent thickets and terminal disclaimers: How pharma blocks biosimilars from the marketplace

STAT

DECEMBER 21, 2023

To ring the register, a pharmaceutical company may create a patent thicket , which involves filing dozens of patents that, in some cases, add little value to their medicines but extend precious monopolies. And one crucial, but little-known tool for making this happen is something called a terminal disclaimer.

STAT+: Private equity-owned physician groups plan lobbying push on mergers

STAT

AUGUST 1, 2023

Radiology Specialists each registered with Forbes Tate Partners, a lobbying shop founded by political insiders who used to work in President Bill Clinton’s administration. Over the past two weeks, United Musculoskeletal Partners, U.S. Anesthesia Partners, and U.S.

Hospitals

Should I Sit for My Critical Care Registered Nurse Certification?

Board Vitals - Pharmacist

NOVEMBER 11, 2018

The post Should I Sit for My Critical Care Registered Nurse Certification? He now focuses on the education of new and experienced ICU nurses, working to expand their knowledge and improve the level of care delivered to their patients. appeared first on BoardVitals Blog.

Hospitals

STAT+: Pharmalittle: U.K. regulator to streamline clinical trial approvals; NIH won’t seize patents to cut price of cancer drug

STAT

MARCH 22, 2023

The plan also includes a legally binding requirement to register new trials in a World Health Organization public register and provide results within 12 months of completing a study. Continue to STAT+ to read the full story…

Consultation launched on pharmacy technician PGDs

The Pharmacist

AUGUST 18, 2023

The government has launched a consultation on whether registered pharmacy technicians should be allowed to supply medicines under a patient group direction (PGD). It also asks respondents whether the current training undertaken by registered pharmacy technicians would be considered sufficient for this.

Pharmacy Technician

Pharmacy Technician Vaccines

STAT+: FDA cites cancer links in seeking to withdraw approval of antibiotic used in pigs

STAT

NOVEMBER 7, 2023

In addition to once again attempting to withdraw approval, the agency is also saying there is no reliable method for determining how much drug residue may be found in the tissue of pigs and hogs, according to a pair of Federal Register notices (see this and this ). Continue to STAT+ to read the full story…

STAT+: UnitedHealth’s profit jumps as medical costs come in lower than expected

STAT

OCTOBER 13, 2023

UnitedHealthcare, the health insurance division of the conglomerate, registered a medical loss ratio of 82.3% In the third quarter of this year, UnitedHealth’s net profit increased by more than 11%, to more than $5.8 billion, the company reported Friday. in the quarter.

Hospitals

STAT+: ‘Learning each other’s language’: FDA, patent office seek to work together to lower drug prices

STAT

DECEMBER 7, 2023

And critics say this helped ring the register at the expense of the American public. Patent & Trademark Office granted two more patents, but did not do so until 2008. One expires next year and the other in 2027, well beyond the original patent expiration date. Continue to STAT+ to read the full story…

Drug Pricing

Drug Pricing Compounding Pharmaceutical Companies Pharmaceutical Companies

Changes That Bring an Additional Restriction on the Product Compared to Registered Conditions

PharmaTech

AUGUST 15, 2022

A case study discussing why post-approval changes present a very low risk, and therefore can be downgraded from a prior-approval to a notification after implementation and managed in the PQS with immediate implementation effect.

Ashoka University wins Innovation Award for AMR Data Challenge

Express Pharma

OCTOBER 5, 2023

In response to this pressing issue, Vivli and Wellcome launched the AMR Register in 2022, a platform featuring industry datasets, consolidating surveillance data for the benefit of researchers. A total of 56 teams from 28 different countries participated in the challenge this year.

JOIN US AT GEP INNOVATE 2024

Pharma and Life Sciences Blog

MAY 3, 2024

JOIN US AT GEP INNOVATE 2024 Vijendra Fri, 05/03/2024 - 17:08 Discover how applied AI is driving the value revolution September 16 – 18, 2024 | New York Hilton Midtown REGISTER NOW Asset type Event CLP Banner Slide Title JOIN VENUS WILLIAMS AND ETHAN MOLLICK AT GEP INNOVATE 2024 Mobile Banner Image Top Banner

Dangerous Drugs Act 1952 and Regulations

RX Note

MARCH 28, 2024

Possession Under Regulation 6 , a person shall not be in possession of a drug or preparation unless it is lawfully supplied by a registered medical practitioner/veterinary surgeon or on a prescription.

Documentation

Documentation Drug Storage Compounding

Include pharmacists as health professionals, creators tell YouTube

The Pharmacist

SEPTEMBER 13, 2023

This month the online video platform launched new content features which aim to help highlight health videos from trusted channels, including using a badge on videos from registered health creators. But the […] The post Include pharmacists as health professionals, creators tell YouTube appeared first on The Pharmacist.

ABPI responds to rebooted MHRA clinical trials framework

Pharma Times

MARCH 22, 2023

Measures include a requirement to publicly register studies and share results among research participants

Key Predictions in the Accumulator/Maximizer Battle

Drug Channels

AUGUST 25, 2023

To learn more, register for ConnectiveRx’s free October online panel discussion with Chris: The Battle Over Accumulators and Maximizers: What You Need to Know for 2024. Drug Channels® is a registered trademark of Pembroke Consulting, Inc. He also discusses current legal cases that cover prescription medication access.

Poisons (Psychotropic Substances) Regulations 1989

RX Note

MARCH 28, 2024

Psychotropic Substance Posession Control of Import and Export Prescription Register Storage Disposal Psychotropic Substance Psychotropic Substance is anything found in Third Schedule of the Poisons Act 1952.

Dosage

Dosage Hospitals Packaging Documentation

Pharmacy First will launch as planned on 31 January, NHSE confirms

The Pharmacist

JANUARY 25, 2024

More than 10,000 pharmacies have registered to deliver Pharmacy First to date, NHSE said in a letter to community […] The post Pharmacy First will launch as planned on 31 January, NHSE confirms appeared first on The Pharmacist.

Industry growth weakens sharply in Mar’24

Express Pharma

APRIL 15, 2024

Prevennar-13 (Rs 370 m) registered the highest growth of 42 per cent YoY in Mar’24 in top 40 brands. Macleods Pharma registered the highest price hike of 7.4 After strong growth in Feb’24, both Indian and MNC pharma registered a sharp decline in growth in Mar’24. For the 12 months through Mar’24, IPM grew 7.6 per cent/0.7

Diabetes

STAT+: U.K. becomes the first country to release detailed data on sponsors that fail to register clinical trials

STAT+: Survey: Confusion over key requirements means clinical trials aren’t registered and results aren’t reported

Trending Sources

GPhC temporary register to close in March 2024

STAT+: FDA is petitioned to boost enforcement of trial sponsors that fail to register studies or report results

Register Now: JULY 26 Webinar on IRA Medicare Price Negotiations

Register Now: JULY 26 Webinar on IRA Medicare Price Negotiations

Half a million people register organ donation status via NHS App

Provisional Registered Pharmacist Training: Hospital or Community

Register Today: The PMN HCP Engagement Summit

Register for the Oligonucleotide Therapeutics and Delivery Conference

STAT+: FDA gives a mixed response to a petition seeking greater clinical trial transparency

Early Bird Gets the (Pharmacy) Worm: Register for Catalyst Connect 2024

Proposed amendments to the PM(NOC) Regulations: Patents claiming different salt forms of medicinal ingredients eligible for inclusion on the Patent Register

STAT+: Most clinical trials run in Canada failed to take basic steps toward transparency, analysis finds

Generic not required to address Patent Register when reference innovator drug is no longer marketed in Canada

Juul’s internal playbook opens a rare window into influence in Washington

STAT+: UnitedHealth is on a buying spree of outpatient surgery centers

STAT+: Vertex offers limited access to a cystic fibrosis drug in South Africa — and may undercut a court case

Supplement Patient Care with a Registered Dietetic Technician Nutritionist

Nurses and health care support workers at higher risk of suicide, study finds

STAT+: In response to criticism, FDA publishes new database of wayward clinical trial sponsors

STAT+: Little transparency, lots of waste: NIH funds pediatric research, but many trials results go unpublished

STAT+: What disclosure? Clinical trials run in Canada fail to take basic steps toward transparency

STAT+: New NIH head says government has fallen behind pharma on clinical trials

STAT+: Backed by Mayo Clinic and Microsoft, a nonprofit forms to test AI tools used in health care

Opinion: Every smartphone should have an app to connect to 988, the mental health crisis line

STAT+: Patent thickets and terminal disclaimers: How pharma blocks biosimilars from the marketplace

STAT+: Private equity-owned physician groups plan lobbying push on mergers

Should I Sit for My Critical Care Registered Nurse Certification?

STAT+: Pharmalittle: U.K. regulator to streamline clinical trial approvals; NIH won’t seize patents to cut price of cancer drug

Consultation launched on pharmacy technician PGDs

STAT+: FDA cites cancer links in seeking to withdraw approval of antibiotic used in pigs

STAT+: UnitedHealth’s profit jumps as medical costs come in lower than expected

STAT+: ‘Learning each other’s language’: FDA, patent office seek to work together to lower drug prices

Changes That Bring an Additional Restriction on the Product Compared to Registered Conditions

Ashoka University wins Innovation Award for AMR Data Challenge

JOIN US AT GEP INNOVATE 2024

Dangerous Drugs Act 1952 and Regulations

Include pharmacists as health professionals, creators tell YouTube

ABPI responds to rebooted MHRA clinical trials framework

Key Predictions in the Accumulator/Maximizer Battle

Poisons (Psychotropic Substances) Regulations 1989

Pharmacy First will launch as planned on 31 January, NHSE confirms

Industry growth weakens sharply in Mar’24

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