STAT News

MARCH 29, 2023

British Columbia plans to limit sales of the popular diabetes drug Ozempic to Canadian residents in response to a wave of Americans flocking to local pharmacies in search of the drug, potentially straining supplies in the province.

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Pharmacy Sales Regulation Drugs 116

Pharma in Brief

OCTOBER 29, 2020

Regulatory amendments to the Food and Drug Regulations ( FDR ) and the Natural Health Products Regulations ( NHPR ) were published in Canada Gazette (Part II) on October 14, 2020. any drug identification number or natural product number previously issued for the drug has not been cancelled for safety reasons.

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Regulation Sales Drugs Manufacturing 40

The Pharma Data

AUGUST 17, 2020

The UK government is imposing stricter regulations on the sale of laxatives, to help prevent their misuse. People will need to be 18 or older to buy them from pharmacies and supermarkets. Getty Images. Rebecca Wojturska, who has overused the drugs in the past, welcomed the safeguards.

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Sales Pharmacy Medicine Production 52

XTalks

MARCH 1, 2021

Anti-inflammatory drugs like Restasis and Xiidra are popular treatment options for the condition, but will the emergence of mask-associated dry eye bolster their sales? But if you thought the growing number of patients presenting with mask-associated dry eye would mean higher sales for Restasis, think again.

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Sales Drugs Life Science Containment 119

Pharmacy Checkers

JUNE 4, 2020

Using very similar talking points to Big Pharma-funded experts , in its quest to “educate” the public about the dangers of internet pharmacies and personal medicine imports, the National Association of Boards of Pharmacy (NABP) appears to have ignored the greatest pharmacy-related public health travesty happening right under its nose.

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Pharmacy Sales Drugs Medicine 56

Pharmaceutical Technology

JANUARY 2, 2023

The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next. Its primary focus is on cancer, cardiovascular, immunology and fibrotic therapeutic projects.

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Drugs Pharmacy Production Development 100

Pharmaceutical Technology

SEPTEMBER 15, 2022

Increasing medicine sales through e-pharmacies and the growing adoption of advanced packaging solutions are projected to drive the demand for contract commercial packaging in the pharmaceutical sector. Finding the best commercial packaging suppliers in contract marketing. Trends in pharmaceutical contract packaging.

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Packaging Packaging Marketing Containment 130

pharmaphorum

NOVEMBER 16, 2022

Walmart has become the latest big pharmacy chain in the US to put forward a settlement to resolve claims it contributed to the national opioid crisis by failing to regulate prescriptions at its outlets. The retail giant has confirmed it has offered $3.1 The retail giant has confirmed it has offered $3.1

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Pharmacy Regulation Manufacturing Drugs 52

XTalks

AUGUST 3, 2023

While most post-marketing activities are typically oriented towards marketing, sales, and commercialization of the drug, pharmacovigilance is fundamentally patient-centric, focusing on the safety and efficacy of pharmaceutical products once they reach the market.

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Regulation Marketing Life Science Drugs 97

pharmaphorum

JANUARY 8, 2021

Gone are the days of long lunches with reps – what’s needed is accurate information that is fully compliant with marketing regulations, presented in most cases in a digital format, according to Hale. Digital tools have therefore become essential for the company to continue to interact with doctors.

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Marketing Doctors Doctor Pharma Companies 96

pharmaphorum

NOVEMBER 13, 2020

Each country has different regulations in regard to the online advertising of prescription drugs and over-the-counter medicines. In the UK, Google allows the promotion of online pharmacies providing they follow Google’s procedures and are registered with the relevant pharmaceutical authorities in the countries their ad campaign targets.

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Branding Pharmacy Marketing Compliance 123

FDA Law Blog

FEBRUARY 4, 2022

The preamble to the Proposed Rule cites heavily to a 2013 report prepared by the National Association of Board of Pharmacy (“NABP”) titled Wholesale Drug Distribution: Protecting the Integrity of the Nation’s Prescription Drug Supply as well as NABP’s Model State Pharmacy Act and Model Rules. For example, at least 4 states (i.e.,

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Licensing Licensing Drugs Pharmacy 40

FDA Law Blog

MAY 3, 2021

The CSA establishes a closed system of controlled substance distribution that requires every entity in the chain, from importers to manufacturers, distributors, exporters, pharmacies, hospitals, narcotic treatment programs and practitioners, to obtain a DEA registration and account for the controlled substances they handle. 21 U.S.C. §

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Compliance Pharmacy Regulation Manufacturing 52

Druggist

FEBRUARY 28, 2021

In other words, melatonin acts as a biological clock that regulates sleep. Melatonin, therefore, can be used to promote and regulate sleep (Wagner et al., Buying melatonin from UK online pharmacies (private service). Melatonin is a hormone that is released at night by the pineal gland located in the brain. 1,640 Reviews.

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Pharmacy Licensing Licensing Medicine 98

Pharmacy Checkers

JULY 2, 2019

Determinants of Health: Providing regulatory space to promote safe international Internet pharmacy practice in furtherance of SDG 3.8 the Internet, via international online pharmacies, has helped tens of millions of Americans obtain medicines from pharmacies in other countries. [v]. My comment is below. Author: Gabriel Levitt.

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Medicine Pharmacy Regulation Insulin 49

pharmaphorum

JANUARY 13, 2022

The data plays into the ongoing debate about the factors behind high medicine prices in the US, with pharma manufacturers and the middlemen – pharmacy benefit managers (PBMs) and the like – each pointing fingers at each other. “We must address what is really driving up costs for patients.”

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Branding Medicine Manufacturing Pharmacy 109

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

XTalks

NOVEMBER 9, 2023

Since its approval in May 2022, Mounjaro sales have hit $1.4 In the first half of 2023, sales of Ozempic and Wegovy rose by 58 percent and 363 percent, respectively. “In Zepbound contains mimetics of the GLP-1 and GIP hormones that regulate appetite and blood sugar. billion in just one year and a quarter. billion for Novo.

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FDA Approval Manufacturing Drugs Pharmacy 59

FDA Law Blog

MAY 3, 2021

The CSA establishes a closed system of controlled substance distribution that requires every entity in the chain, from importers to manufacturers, distributors, exporters, pharmacies, hospitals, narcotic treatment programs and practitioners, to obtain a DEA registration and account for the controlled substances they handle. 21 U.S.C. §

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Compliance Pharmacy Regulation Manufacturing 40

pharmaphorum

APRIL 29, 2022

Bristol-Myers Squibb’s has become the first company to bring a cardiac myosin inhibitor through to FDA approval, claiming a green light from the US regulator for mavacamten as a therapy for obstructive hypertrophic cardiomyopathy (HCM). The FDA approval was delayed b three months while the RENS was drawn up.

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Drugs FDA Approval Pharmacy Trials 52

pharmaphorum

JULY 22, 2022

The pair have been found to have exploited a loophole by de-branding phenytoin sodium capsules – formerly known as Epanutin – so they were no longer subject to price regulations.

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Drugs Marketing Pharmacy Branding 109

The Pharma Data

MAY 7, 2021

Massachusetts sues Publicis for designing ‘marketing schemes’ to boost OxyContin sales ( STAT ). International regulators and WHO call for wider public access to clinical data ( EMA ). International regulators and WHO call for wider public access to clinical data ( EMA ). What happens now?

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Vaccination Vaccine Drugs Regulation 52

pharmaphorum

JANUARY 24, 2023

Heating, ventilation, and air conditioning (HVAC) systems for validated cleanroom areas of a plant, for example, are essential and subject to stringent regulation, and consume many times more energy than non-validated areas. Medicines distribution and supply is also an energy intensive and regulated business.

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Medicine Manufacturing Regulation Marketing 98

pharmaphorum

JANUARY 27, 2021

Its sale was never approved in the US because the FDA did not think sufficient testing had taken place. 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.

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Research Clinical Trials Clinical Trials Vaccination 52

XTalks

MARCH 7, 2023

Pegcetacoplan Trial Results Syfovre is a C3 therapy designed to regulate the over activation of the complement cascade. In a company presentation, Apellis revealed the list price of Syfovre to be $2,190 per vial before discounts and said it would be made available through specialty distributors and pharmacies across the US.

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FDA Approval Drugs Sales Trials 98

pharmaphorum

JANUARY 26, 2021

Pharma should update the role of the rep from simply delivering a sales message to more of a concierge service model, providing access to – and facilitating the delivery of – meaningful content that physicians want and need. As such, reps will need to be reskilled. Integration of telehealth strategy into commercial models.

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Clinical Trials Clinical Trials Sales Life Science 141

The Pharma Data

MAY 27, 2022

It is our goal to ensure that hospitals, specialty pharmacies, and retail store shelves will begin seeing adequate supplies again in the coming weeks.”. The agency also monitors online marketplaces for fraudulent products and works with major online retailers to remove violative and harmful products offered for sale on their sites.

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Production Manufacturing Pharmacy Cosmetics 52

pharmaphorum

AUGUST 5, 2021

The authority says the two companies were the two dominant suppliers of the drug at the time, and “exploited a loophole” by de-branding the drug so it was no longer subject to price regulation.

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Drugs Pharmacy Marketing Branding 52

pharmaphorum

FEBRUARY 25, 2022

Accenture’s Healthcare Provider Survey found that two-thirds (64%) of UK healthcare providers (HCPs) communicate with pharma sales representatives now more than before the pandemic, and 71% agree that pharmaceutical companies are being more helpful in offering virtual solutions.

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Life Science Vaccination Vaccine Pharmacy 98

pharmaphorum

OCTOBER 3, 2022

The way pharma is regulated based on compliance is a considerable barrier to allowing such a change, though. Over the last 20 years, Kapoor has led Indegene’s sales and business development efforts in the APAC region, including China and the European and North American regions. He holds a bachelor’s degree in Pharmacy from St.

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Branding Doctors Doctor Compliance 113

The Pharma Data

AUGUST 8, 2020

Besides benefiting cHL patients, the listing provides a boost to [Tyvyt’s] general accessibility in hospital pharmacies over rivals,” GBI wrote in a recent report. In the first half of 2020, Innovent reported Tyvyt sales of CNY 331.6 BeiGene’s application for that indication was accepted by Chinese regulators in June.

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Trials Antibody Pharmacy Drugs 52

Drug Discovery World

FEBRUARY 22, 2023

Regulators, payers and other stakeholders (not to mention you and your team) will want to see that you have an infrastructure in place and are ready to go. Hopefully you’ll have started this prior to launch, and data pushing from the clinical trial post-launch is more important than ever to support your sales reps.

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Drugs Marketing Production Development 52

XTalks

FEBRUARY 8, 2021

While there are currently six biosimilars for AbbVie’s Humira (adalimumab) that have been approved by the regulator, the company’s patents prevent biosimilars from being launched until 2023. The regulator allows biosimilars to show slight differences in clinically inactive components of a product.

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Production Insulin Branding Generic Drugs 78

FDA Law Blog

JUNE 16, 2023

Prohibition on Excessive Price Increases The law prohibits manufacturers from imposing or causing to be imposed an “excessive price increase,” whether directly or through a wholesale distributor, pharmacy, or similar intermediary, on the sale of any generic or off-patent drug sold or dispensed to any consumer in the state.

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Drugs Manufacturing Generic Drugs Production 45

Pharmacy Checkers

OCTOBER 2, 2020

Unlike wholesale importation, Section 804 does not legalize personal importation from Canada or other countries, but it does permit it through enforcement discretion, regulation or waiver. They do so by buying directly from pharmacies in other countries. Personal importation is directly importing from a pharmacy in Canada.

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Pharmacy Drugs FDA Approval Cosmetics 54

The Pharma Data

JANUARY 17, 2021

And the company supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care. As a recognized leader in transfusion medicine, Grifols also offers a comprehensive portfolio of solutions designed to enhance safety from donation through transfusion.

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Clinical Trials Clinical Trials Trials Containment 52

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 In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4

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Clinical Development Development Clinical Trials Clinical Trials 52