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. In its August 16, 2023 decision in Le-Vel Brands, LLC v. Natural health product vs. regulated drug In Winning Combination Inc.

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FDA Law Blog

MARCH 6, 2024

The American Conference Institute (“ACI”) will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes. Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY.

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XTalks

FEBRUARY 16, 2023

In 2022, Indorsia’s insomnia drug Quviviq (daridorexant) brought in a total of ₣6.5 Though the drug — which was launched in the US in May 2022 and in parts of Europe in November — wasn’t the focus of the disease-awareness campaign, Indorsia was using the campaign to establish its reputation in the sleep aid space.

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XTalks

JANUARY 19, 2021

The US Food and Drug Administration (FDA) has announced that in an operation with the US Customs and Border Protection (CBP) officers at the Dallas Fort Worth International Airport, 33,681 units of e-cigarettes were seized with a manufacturer’s suggested retail price of $719,453.

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Roots Analysis

JANUARY 17, 2024

Renowned for psychiatric drugs such as Prozac, the company faced several challenges in revenue generation during the 2010s due to patent expiration of its innovative drugs. However, a strategic shift and a focus on innovative treatments have catapulted Eli Lilly to unprecedented heights, especially in the field of anti-obesity drugs.

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Fossil Remedies

APRIL 7, 2020

150+ Skin & Cosmetic Products. It has a significant presence in brands across all therapeutic segment like from cough & cold to life threatening serious diseases. They offer pharma franchise to interested parties. Some of their product ranges are: 400+ Antibiotics and general products. 150+ Cardiac & Diabetes Product.

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XTalks

OCTOBER 10, 2024

The US Food and Drug Administration (FDA) recently removed Eli Lilly’s GLP-1 tirzepatide drugs Mounjaro and Zepbound from its drug shortages list, prompting a lawsuit from compounders. Lilly’s tirzepatide products were on the FDA’s drug shortages list for just under two years (22 months).

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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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FDA Law Blog

SEPTEMBER 15, 2022

Draft Guidance Regarding the Statement of Identity and Strength for Human Nonprescription Drug Products. FDA indicates that this guidance is intended to help manufacturers ensure consistent content and format of the statement of identity and strength for all nonprescription drug products, which then will allow consumers to compare products.

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XTalks

APRIL 14, 2021

The US Food and Drug Administration (FDA) defines color additives as “any substance that imparts color to a food, drug, cosmetic, or the human body. In Europe, brands like Nestlé use radish, lemon and red cabbage extracts as a food coloring in their chocolates. 40 and yellow food dyes no.

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XTalks

MARCH 13, 2024

As the stars lined up on Hollywood Boulevard for the Oscars on Sunday evening, Eli Lilly took the stage with a TV ad that took shots at Hollywood’s latest weight loss frenzy — GLP-1 drugs. Novo’s weight loss version of Ozempic is branded Wegovy (semaglutide). This isn’t the first time the GLP-1 drugs made it to the Oscars.

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XTalks

NOVEMBER 24, 2022

Earlier this week, the US Food and Drug Administration (FDA) sent out warning letters to five companies illegally selling CBD-infused food and beverage products. According to the warning letters, these products are considered adulterated under “section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C.

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Roots Analysis

JULY 28, 2024

While cosmetic procedures can effectively target specific aging concerns like deep wrinkles, sagging skin, and volume loss, they may not comprehensively improve the overall skin quality. One example of a successful clean beauty brand is Tata Harper, which offers a range of skincare products made with 100% natural and non-toxic ingredients.

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XTalks

JUNE 17, 2024

Hugel, a Korean medical aesthetics company, recently announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its botulinum toxin, Letybo (letibotulinumtoxinA-wlbg), for the treatment of glabellar lines. We are thrilled with the FDA’s approval of Letybo.

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FDA Law Blog

AUGUST 11, 2024

By Sarah Wicks & Dara Katcher Levy — FDA’s Office of Prescription Drug Promotion (OPDP) has issued two new Untitled Letters this summer after 5 months without any letter activity. Haven’t we all learned that celebrity endorsements for prescription drugs still need to meet traditional promotional requirements?

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pharmaphorum

FEBRUARY 12, 2021

Though most people will know of these toxins through Allergan’s ‘Botox’ brand name and its association with cosmetic surgery, they can be used for a wide variety of medical indications and are often used to relieve spasticity in patients following stroke, traumatic brain injury or other neurological conditions. “The

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XTalks

MAY 22, 2023

Allergan Aesthetics, an AbbVie company renowned for its development of leading aesthetics brands and products, recently announced the US Food and Drug Administration (FDA) approved their ground-breaking hyaluronic acid product, SkinVive by Juvéderm, for achieving remarkable skin smoothness.

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FDA Law Blog

APRIL 30, 2021

Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “ Addressing Anticompetitive Conduct and Consolidation in Health Care Markets ,” while others found their way into the Bill Hopper because of a renewed interest in Congress to address drug prices (see a recent U.S.

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FDA Law Blog

APRIL 30, 2021

Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “ Addressing Anticompetitive Conduct and Consolidation in Health Care Markets ,” while others found their way into the Bill Hopper because of a renewed interest in Congress to address drug prices (see a recent U.S.

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The Pharma Data

NOVEMBER 4, 2020

Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”). million and US$1.8 million. . Juyou Bio-Technology Co.,

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XTalks

SEPTEMBER 28, 2023

One of the reasons behind this gap is the US Food and Drug Administration’s (FDA) “ generally recognized as safe ” — or GRAS — designation. Up until recently, popular fruit drinks from leading brands like Coca-Cola and PepsiCo, including Mountain Dew and Gatorade, contained BVO.

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XTalks

NOVEMBER 7, 2023

Some may even extend their expertise to consumer goods sectors, including cosmetic brands. Calibrating drug strength, methodologies and dosages to facilitate large-scale manufacturing and distribution of pharmaceuticals and medicinal compounds. Innovating and evaluating medical equipment.

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XTalks

FEBRUARY 8, 2021

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world. What is a Biosimilar?

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The Pharma Data

NOVEMBER 30, 2020

30, 2020 – Nearly 15% of talc-based cosmetic products analyzed in a recent study contained asbestos. Environmental Working Group (EWG) — an American advocacy nonprofit that commissioned the tests and did the analysis — said methods used by the cosmetics industry to screen talc supplies are inadequate. MONDAY, Nov.

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FDA Law Blog

DECEMBER 21, 2023

Those who attended their annual Enforcement, Litigation, and Compliance Conference holiday reception earlier this month got a sneak peek at this new branding effort with the unveiling of the association’s new logo ( here ). The new logo — and a host of other new association branding—will be rolling out throughout 2024.

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The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.

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The Pharma Data

NOVEMBER 10, 2020

coli O157:H7 strain found by Michigan Department of Agriculture and Rural Development (MDARD) in Tanimura & Antle brand packaged single head romaine lettuce. brand packaged single head romaine lettuce with a pack date of Oct. Food and Drug Administration. SILVER SPRING, Md. , coli O157:H7 illnesses that matches the E.

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FDA Law Blog

AUGUST 21, 2023

FDA approves (or sometimes dictates depending on the product and regulatory pathway to market) the content of drug product labeling to set forth the conditions of use for which the benefits of the product outweigh the risks.

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The Pharma Data

MAY 27, 2022

Food and Drug Administration is providing an update on steps it has taken that will lead to millions of bottles of specialized medical infant formula to help address immediate needs for infants with certain allergies or critical health conditions. Today, the U.S. store shelves beginning in June.

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pharmaphorum

DECEMBER 15, 2022

We’re seeing everything from over-the-counter cold medication to cosmetic injection brands leverage different tiers of influencers. Back in 2015, the influencer-of-influencers, Kim Kardashian, was slammed for failing to mention the potential side effects of an anti-nausea drug, leading to the US FDA getting involved.

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FDA Law Blog

JANUARY 8, 2025

Koblitz Whether a patent can be listed in the Orange Book is a critical issue for both brand and generic manufacturers, and, of particular interest in the last few years is whether patents claiming just the device constituent of a combination product is eligible for listing.

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FDA Law Blog

JANUARY 9, 2025

As part of the Food and Drug Administration Safety and Innovation Act (known as FDASIA) and later under the FDA Reauthorization Act of 2017 (known as FDARA), a drug or medical device can be deemed adulterated if a regulated company delays, denies, or limits an inspection, or refuses to permit an entry or inspection.

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Pharmacy Checkers

JANUARY 4, 2020

The FDA has drafted a proposed rule to facilitate wholesale importation of lower-cost drugs from Canada, pursuant to Section 804 of the Food, Drug and Cosmetic Act. What about personal drug importation ? drug products to which patents apply) cost on average three times more in the United States than Canada (Refs.

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XTalks

MARCH 27, 2023

Earlier this month, the US Food and Drug Administration (FDA) requested $7.2 The extent of the FDA’s problems is reflective of all the different responsibilities the vast agency has, ranging from control and supervision of food safety and cosmetics to pharmaceutical drugs and medical devices. million of the $7.2

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Pharmacy Checkers

JANUARY 30, 2020

No, not for raising a drug price – otherwise the jails would overflow with pharma execs – but for financial fraud related to his work as hedge fund manager. Pasted from the AG’s press release : Attorney General James Sues ‘Pharma Bro’ Martin Shkreli And Vyera Pharmaceuticals For Illegally Monopolizing Life-Saving Drug.

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Pharmacy Checkers

DECEMBER 20, 2019

The FDA has done something that prescription drug importation advocates had possibly given up on. The agency drafted a new proposed rule to allow importation from Canada of lower-cost drugs and industry guidance for drug manufacturers to import their FDA-approved foreign drug versions, for which they can charge lower prices.

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Pharmacy Checkers

MARCH 11, 2020

Below is a copy of Gabriel Levitt’s comments on the FDA Notice of Proposed Rulemaking titled “Importation of Prescription Drugs” that were submitted Monday, March 9th, 2020. Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. 70796 “ Docket No.

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