pharmaphorum

JULY 16, 2021

The deal gives Ipsen worldwide rights to the mid-stage drug – called mesdopetam – and puts the company on the hook for another $335 million in development, regulatory and sales milestones. Ipsen’s other main research areas are oncology and rare diseases.

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XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. billion in pharmaceutical sales from 2021. In contrast, several drugs experienced sale declines, such as Remicade (infliximab), an old immunology medication that continues to decline due to the rise of biosimilars since 2016.

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FDA Law Blog

MARCH 7, 2024

Gibbs — Our last post on small business certification requests described how small medical device manufacturers, defined as those with gross receipts of less than $100 million in gross receipts and sales for the most recent tax year, are eligible for a reduced fee on those medical device submissions that require a user fee.

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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 recent months, the Federal Courts have twice upheld Health Canada’s findings as to what is, and is not, a natural health product.

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XTalks

APRIL 12, 2023

Last year, it announced plans to end global sales as well. The baby powder had multiple uses, including application to prevent diaper rash and for cosmetic uses, including dry shampoo. Johnson & Johnson had been selling the iconic baby powder for almost 130 years. The company now sells a cornstarch-based version of it.

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XTalks

APRIL 26, 2021

The marker may soon be found on food and beverage products, pet food, dietary supplements, cosmetics and more. To become a UFA member, upcycled food companies must pay yearly membership fees based on their gross annual sales and are eligible for discounted fees if they are woman-owned or led by a Person of Color.

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XTalks

NOVEMBER 28, 2023

Consequently, its sale is banned in 21 states, with strict limitations in others. Under the provisions of the 1938 Food, Drug, and Cosmetic Act, Kinder Surprise eggs are classified as “adulterated food,” rendering their importation and sale illegal. The FDA also challenged the sale of caffeinated alcoholic beverages.

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FDA Law Blog

JULY 26, 2022

Like all Guidance documents, it starts out with background, explaining that the Orange Book is FDA’s list of drug products approved under the Federal Food, Drug, and Cosmetic Act and contains patent and exclusivity information related to such products.

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FDA Law Blog

AUGUST 19, 2021

Regulations to establish requirements for the sale of food online, including access to label or labeling information prior to purchase. A provision setting forth requirements for infant and toddler beverages. A study on text size and color contrast that make food labeling information visually accessible to most consumers.

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FDA Law Blog

OCTOBER 7, 2024

27, 2024), the plaintiff H&P challenged an FDA administrative complaint assessing a civil money penalty of $20,678 for H&P sale of an electronic cigarette without FDA authorization. Food and Drug Administration, No. 8:24-cfv-02110 (C.D. filed Sept. 21 U.S.C. § 333(f)(9)(A); 21 C.F.R.

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pharmaphorum

DECEMBER 9, 2021

She has experience in R&D management of new product development, external innovation and OTC, cosmetic and commodity regulatory affairs. Heather is passionate about identifying innovations and crafting collaborations that help J&J bring the best health solutions to our consumers.

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FDA Law Blog

JUNE 12, 2023

The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled. By Riëtte van Laack — FDA regulates pet food similar to other animal foods.

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XTalks

NOVEMBER 7, 2023

Some may even extend their expertise to consumer goods sectors, including cosmetic brands. Transitioning into a medical science liaison role from a position such as a pharmaceutical sales representative or from a non-related field is less common but also possible. What Is the Job Outlook Like?

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Doctors Doctor Life Science Production 59

FDA Law Blog

JUNE 2, 2022

Since 1984, generic drugs have been approved under ANDAs pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (FDCA); before 1984, no formal mechanism for an ANDA existed so FDA used sections 505(b) and 505(c) to approve follow-on drugs based on the Agency’s previous findings of safety and efficacy.

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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 About Juyou Bio – Technology Co. Juyou Bio-Technology Co.,

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XTalks

OCTOBER 10, 2024

Related: Eli Lilly Reaches Settlement with Totality MediSpa Over Sale of Compounded Mounjaro and Zepbound The complaint was filed jointly by the Outsourcing Facilities Association and North American Custom Laboratories, which operates under the name FarmaKeio Superior Custom Compounding.

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XTalks

JANUARY 25, 2023

XTALKS WEBINAR: Review of Key Trends for Life Science Commercial Teams in 2023 Register for this free on-demand webinar to learn about the latest trends in sales and marketing campaigns that could help bolster commercial success for life science companies this year.

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Druggist

OCTOBER 25, 2020

Sale Care 100 g Aqueous Calamine Cream Care aqueous calamine cream - relieves and soothes Symptomatic relief of mild sunburn Relief from other skin conditions £2.99 −£0.99 £2.00 Glycerin is a commonly used ingredient in the cosmetic industry, which helps to ‘hydrate’ the skin by attracting and binding of the water.

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The Pharma Data

DECEMBER 4, 2021

Epiduo® Forte Gel had annual sales of $253 million in the U.S., Avoid skin products that may dry or irritate your skin such as medicated or harsh soaps, astringents, cosmetics that make your skin dry, and products containing high levels of alcohol, spices, or limes. Currently, 1 in 11 generic prescriptions dispensed in the U.S.

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The Pharma Data

FEBRUARY 4, 2021

– Full-Year Global Net Revenues from the Aesthetics Portfolio Were $2.590 Billion; Global Botox Cosmetic Net Revenues Were $1.112 Billion. on a GAAP Basis, Inclusive of a Non-cash Charge for Skyrizi Contingent Consideration Revaluation Based on Higher Estimated Future Sales; Adjusted Diluted EPS of $2.92. to $12.52. .

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The Pharma Data

MAY 27, 2022

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. HHS has also released a fact sheet with information to help families find infant formula. Source link: [link].

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The Pharma Data

MAY 27, 2022

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. Additionally, since many of these fraudulent products originate overseas, the agency targets and examines these products at ports of entry. Source link: [link].

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Creogenic Pharma

MARCH 8, 2021

Our Pharma Franchise version relies on Monopoly rights, Real rates & no massive sale goal. With over 2800 pharma products in 8 specific divisions that have antibiotics, cardiac, diabetes, gynec, ophthalmology, dental and cosmetic and skin products, their range of products is quite varied and impressive.

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The Pharma Data

NOVEMBER 26, 2020

in Daily E-Commerce Sales and recorded 103 individual E-Commerce Order Transactions (average order size: $92.37). We have also launched several new product offerings, most notably a dark chocolate coin (each infused with 20mg CBD) and some skin care/cosmetics selections. On Wednesday, November 25, 2020, the Company generated $9,514.49

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FDA Law Blog

MARCH 20, 2022

The Guidance applies to voluntary recalls of any food, drug intended for human and animal use, any cosmetic, biological, and tobacco product intended for human use, and any item subject to a quarantine regulation under 21 CFR part 1240. What is a recall?

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XTalks

MARCH 25, 2024

Access is complex, just like the disease itself is complex,” said Negelle Morris, Novo’s senior VP of cardiometabolic sales. Recently, Eli Lilly took shots at the growing cosmetic use of GLP-1 drugs, particularly in Hollywood, in a TV commercial aired during the Oscars. Oprah asked why coverage of weight loss drugs is still limited.

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FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Lenz, Principal Medical Device Regulation Expert & Sophia R. Gaulkin & Jeffrey N.

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FDA Law Blog

JULY 5, 2023

Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance). An area of clarification that we believe will be appreciated by industry concerns sales to a group purchasing organization (GPO).

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FDA Law Blog

FEBRUARY 16, 2023

sales of naloxone from a wholesale distributor to a harm reduction program) from certain requirements under the Drug Supply Chain Security Act. In August 2022, FDA announced the creation of the Overdose Prevention Framework with the vision to “undertake impactful, creative actions to prevent drug overdoses and reduce deaths.”

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XTalks

FEBRUARY 8, 2021

This replaces the previous approval pathway for insulin drugs and their analogs which have historically been reviewed as new drug applications under section 505(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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Roots Analysis

SEPTEMBER 9, 2024

Further, $400 billion is the anticipated sales of protein-based therapeutics in 2023. In addition, other industries, such as agriculture, cosmetics, food, environmental sciences, biomedical research and enzyme synthesis industry, are also benefiting from the protein expression process.

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FDA Law Blog

OCTOBER 4, 2021

In yet another decision based on statutory interpretation, an appellate court has decided that FDA’s interpretation of the Federal Food, Drug, and Cosmetic Act (FDCA) is contrary to the plain text of the statute. Karst — In the appellate courts lately, it’s been FDA “ Against the Music.” Earlier this year, the D.C.

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The Pharma Data

AUGUST 1, 2021

AbbVie delivered another strong quarter and our business continues to perform extremely well across the portfolio, with AbbVie’s new immunology assets contributing more than $1 billion of combined sales in the quarter,” said Richard A. Global Botox Cosmetic net revenues were $584 million, an increase of over 100.0

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FDA Law Blog

FEBRUARY 29, 2024

As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.

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The Pharma Data

NOVEMBER 4, 2020

Key findings of the research showed that patients with alopecia areata suffer significantly increased burden of illness, including a negative impact on many aspects of daily life, extending considerably beyond the cosmetic concerns of hair loss. Investments, available for sale. .

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FDA Law Blog

AUGUST 17, 2022

While some comments, including those from 41 State Attorneys’ General , raised concerns about the implications of the ambiguity of that preemption proposal and the application to state law, FDA decided against any further clarification.

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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. In addition to paid ads targeting the general public or specific disease communities, non-traditional DTC marketing, including influencer marketing, is becoming more common.

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