XTalks

JANUARY 9, 2024

Swoop , a leader in healthcare marketing, recently introduced a groundbreaking portfolio of predictive AI targeting for pharmaceutical and life sciences advertisers. This capability will usher in a new era in healthcare marketing, moving beyond traditional methods that rely on past data to a future-focused approach.

Marketing 104

Marketing Life Science Compliance Doctors 104

Intouch Solutions

SEPTEMBER 13, 2023

As the world evolves at an increasing pace – technology, medical science, and more – life-sciences brands need to evolve their concept of promotional peer-to-peer medical education and what it’s capable of. It’s a mainstay of all robust life-sciences brands… Or, at least, it should be.

Branding 64

Branding Life Science Marketing Regulation 64

Pharma in Brief

MAY 4, 2023

The Ontario Superior Court ( ONSC ) has dismissed a claim for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the Regulations ) brought by Apotex Inc. The Court conducted a purposive interpretation of the Regulations and found that Apotex did not meet the statutory requirements for damages.

Regulation 52

Regulation Sales Production Compliance 52

World of DTC Marketing

JUNE 22, 2022

Between 2019 and 2021, Alphabet’s venture-capital arms, Google Ventures, and Gradient Ventures, and its private-equity unit, CapitalG, made about 100 deals, a quarter of Alphabet’s combined total, in life sciences and health care. Generic drugs versus branded is also a considerable expense.

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Pharmacy Generic Drugs Life Science Branding 227

Drug Discovery World

JULY 18, 2023

Chris Hughes, Managing Director North Europe, Revvity, said: “We are thrilled to be part of the UK’s life sciences industry through our Scientific Centre of Excellence and top expertise in Cambridge.

Genome 52

Genome Genomics Life Science Gene Editing 52

Pharma in Brief

NOVEMBER 20, 2023

The Courts’ decisions provide insight into how natural health products are distinguished, under federal law, from cosmetics and from drugs subject to the Food and Drug Regulations. These distinctions are important as they determine the regulatory burden required to market a product in Canada.

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Production Cosmetics Regulation Branding 52

pharmaphorum

DECEMBER 15, 2022

The Association of the British Pharmaceutical Industry (ABPI) said today that in 2023 manufacturers of branded medicines will have to return almost £3.3 of total sales – under the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS) introduced in 2019. billion (around $4 billion) in revenue to the government – 26.5%

Branding 72

Branding Life Science Manufacturing Medicine 72

Pharma in Brief

NOVEMBER 5, 2023

For a generic or biosimilar product, the manufacturer may also apply to have the drug product designated on the Formulary as interchangeable with the original brand product. 201/96 under the Ontario Drug Benefit Act ( ODBA Regulations ). 935 under the Drug Interchangeability and Dispensing Fee Act ( DIDFA Regulations ).

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Drugs Regulation Production Generic Drugs 52

FDA Law Blog

MARCH 6, 2024

John counsels FDA-regulated entities on litigation, enforcement, and compliance matters including FDA inspections, Form 483s, Warning and Untitled Letters and Consent Decrees, internal investigations, and data privacy concerns. His presentation will focus on “MoCRA is Here – Now What?

Cosmetics 59

Cosmetics Compliance Generic Drugs Regulation 59

FDA Law Blog

AUGUST 4, 2022

Gain insight and training in core regulatory concepts for life sciences attorneys, business executives, and policy analysts. It is important for attorneys who do not have regulatory practices and life sciences executives who deal with FDA-regulated products to have a familiarity with these concepts.

Life Science 40

Life Science Clinical Trials Clinical Trials Regulation 40

pharmaphorum

OCTOBER 12, 2022

Remaining compliant is imperative to the life sciences industry, so adhering to regulatory requirements is mandatory. This need for data integrity facilitates and maintains trust between the regulators and the manufacturing organisations and, in turn, patients. Both of these can ultimately deteriorate brand reputation.

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Compliance Manufacturing Life Science Production 98

XTalks

MAY 17, 2024

The settlement requires Totality to take several specific corrective actions, which include refraining from making any statements that suggest the spa’s products are genuine, FDA-approved Lilly products, and stopping the use of Eli Lilly branding in promoting any of the products.

Sales 52

Sales FDA Approval Pharmacy Production 52

Drug Channels

MARCH 6, 2023

Experts from across the industry will discuss how current and future drug pricing transparency regulations will impact commercialization, reimbursement, pricing and compliance practices. Plus, assess how companies are internally planning for these changes.

Drugs 82

Drugs Life Science Compliance Branding 82

XTalks

MAY 21, 2021

They can give your company brand awareness when used for training sessions, educational courses or corporate events. Drive marketing and branding efforts . As employees across an organization would need to be informed of health and safety regulations. . Panel-based webinars are excellent forums for brand awareness.

Marketing 116

Marketing Branding Production Sales 116

Delveinsight

FEBRUARY 5, 2021

According to the CDC, in 2018, tobacco companies spent over USD 9 Billion in just promoting and marketing their cigars and cigarettes in the US. Smoking Cessation: What are the drugs available in the market? The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products.

Marketing 52

Marketing FDA Approval Branding Production 52

pharmaphorum

APRIL 7, 2021

Originally developed with GlaxoSmithKline, ofatumumab was first approved by regulators to treat chronic lymphocytic leukaemia under the brand name Arzerra. It was approved by in Europe in late March , after the FDA okayed it for the US market last year. We will build more value by ourselves building an iconic biotech.”.

Branding 70

Branding Life Science Regulation Drugs 70

XTalks

MARCH 25, 2021

Sydney writes about various food industry topics, including safety and regulation, grocery and foodservice, innovation and sustainability. She focuses on news relating to the food industry and writes blogs on recruitment and HR in the life sciences. 3. A Podcast to Help Food Industry Professionals Stay Informed.

Life Science 95

Life Science HR Branding Production 95

XTalks

SEPTEMBER 28, 2023

In most cases, commercials are regulated to ensure they provide accurate information, include the benefits and risks of the drugs and encourage viewers to talk to their healthcare providers about the medication. Most of the ad’s impressions came from NBC, particularly during a marketing push at the beginning of allergy season.

Drugs 105

Drugs Allergies Branding FDA Approval 105

pharmaphorum

OCTOBER 27, 2022

Companies are responsible for all content disseminated via a digital channel when the content is initiated, branded, and/or sponsored by the company or a third party acting on its behalf. Therefore, companies are encouraged to establish a methodology for calculating fair market value rates. Why is guidance needed? About the authors.

Life Science 93

Life Science Compliance Regulation Cosmetics 93

pharmaphorum

OCTOBER 19, 2022

Emma Hyland, VP strategy, commercial content at Veeva Systems, tells us modular content is the most significant wave of innovation hitting the content world in life sciences, and rightly so because HCPs’ needs and expectations have changed. “There isn’t a one-size-fits-all for how the life sciences industry creates content.

Life Science 89

Life Science Compliance Production Pharma Companies 89

XTalks

MARCH 22, 2023

In October 2022, Xtalks celebrated two decades of bringing diverse stakeholders in the life science industry together through first holding physical events, then soon after, hosting exclusively online events. In that time, we’ve gone from running 25 webinars each year to over 400, working with more than 800 expert speakers each year.

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Life Science Drugs FDA Approval Vaccination 97

pharmaphorum

JANUARY 20, 2022

Companies seek efficiency and speed to market during the content creation process, review and approval cycles, and thus the collective time for content to be approved for distribution, says Ian Hale, vice president of commercial content at Veeva Systems. Every country has its regulations. Compliant pharma content.

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Compliance Branding Sales Marketing 98

pharmaphorum

OCTOBER 3, 2022

. “TV used to be very brand-centric. The entertainment industry has also moved from brand-centric content to experiential content, designed to immerse its audience in its message by attempting to create deep emotional connections between the customer and the brand.

Branding 114

Branding Doctors Doctor Compliance 114

Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Production 52

pharmaphorum

JULY 13, 2021

The regulated content and labeling software firm has made three new customer-facing appointments and created a brand-new Customer Experience Team to provide enhanced, end-to-end customer support for medical device and clinical trial organizations.

Clinical Trials 52

Clinical Trials Clinical Trials Compliance Trials 52

XTalks

OCTOBER 14, 2022

GLP-1 is involved in the regulation of appetite and caloric intake. Musk is not connected to Novo Nordisk and a spokesperson from the company told Fierce Pharma Marketing that “we were not aware of Elon Musk’s use of Wegovy before he shared this information publicly.”. Last year alone, Wegovy sales totaled $1.2

Drugs 59

Drugs Marketing Branding Sales 59

Intouch Solutions

DECEMBER 9, 2021

But as a metaphor for your brand content, these unvisited idylls are everything you DON’T want to be. Content strategy ensures that brand claims and messages are packaged such that users actually want to see them. Life-sciences companies ought to have the most high-ranking content about health online.

Branding 52

Branding Engineer Life Science Marketing 52

XTalks

MAY 16, 2024

For pharmaceutical companies, this is crucial in ensuring compliance with stringent regulations while maximizing campaign efficacy. A spokesperson from Innovid said the company believes the findings are related to “brand stories traditionally fitting into 30-second slots and, as viewers, we’ve become accustomed to that duration.”

Compliance 52

Compliance Branding Regulation Life Science 52

pharmaphorum

APRIL 7, 2021

Under the leadership of CEO Jan van de Winkel it has gone from financially precarious position following the stock market crash in the late noughties, to the darling of the Nasdaq with a US IPO of more than $500 million in 2019. He also had to renegotiate a contract with GSK relating to ofatumumab – branded at that time as Arzerra.

Antibody 71

Antibody Life Science Development Regulation 71

XTalks

JANUARY 19, 2021

In the 2020 fiscal year, CBP seized 93,590 units of e-cigarettes that did not meet US federal regulations. According to the FDA, the shipments included individual disposable flavored e-cigarette cartridges resembling the Puff Bar brand, including Puff XXL and Puff Flow.

Production 98

Production Cosmetics Marketing Branding 98

Pharmaceutical Technology

NOVEMBER 29, 2022

In March 2019, the American regulator approved esketamine , an enantiomer of ketamine, for use in treatment-resistant depression as a nasal spray. The Canadian company Awakn Life Sciences is focused on the drug’s use as an treatment of conditions like alcohol use disorder and and behavioral conditions such as addiction.

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Research Trials Drugs Generic Drugs 275

Drug Discovery World

AUGUST 3, 2023

Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance. For example, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition to date 1.

Medicine 52

Medicine Scientist Production Regulation 52

XTalks

JANUARY 9, 2024

The thyroid plays a critical role in the body by producing hormones that regulate metabolism, heart rate and body temperature among others. In the US, some of the brand names that levothyroxine is sold under include Synthroid (from AbbVie), Levoxyl (Pfizer) and Tirosint (by Swiss manufacturer IBSA Institut Biochimique).

Hormones 105

Hormones Antibody Trials Production 105

XTalks

JANUARY 29, 2021

This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. As more trials show equivalency in outcomes between the branded and biosimilar product, more purchasers will choose the cheaper option.

Clinical Trials 104

Clinical Trials Clinical Trials Production Trials 104

ACRP blog

SEPTEMBER 20, 2023

Pell: Before I got into life sciences translation, I worked on the client side. I used to work in brand management and led an account for a major female sanitary product. Q: Can you tell us a little bit about how you got into the translations/language services business? On a personal level, I was born and raised in the U.S.

Clinical Research 59

Clinical Research Research Life Science Clinical Trials 59

Pharma in Brief

AUGUST 3, 2023

Promotional messages and activities are subject to the advertising provisions of the Food and Drugs Act ( FDA ) and the Food and Drug Regulations ( FDR ). The Distinction Guidance outlines the factors that contribute to rendering a message or activity promotional in nature. New examples. Definition of “general public”.

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Production Drugs Manufacturing Clinical Trials 52

XTalks

FEBRUARY 8, 2021

Like generic forms of synthetic pharmaceuticals, biosimilars have the advantage of being less costly compared to their branded counterparts. To date, the FDA has approved 29 biosimilars, 19 of which are currently being marketed. 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