World of DTC Marketing

JUNE 6, 2021

SUMMARY: The media headlines promise weight loss for diabetes patients, but Norvo’s new drug is in the same class as other drugs and carries many warnings. Can diabetes patients really stay adherent to a drug for 63 weeks in which 85% of patients report GI side effects and will insurance cover the cost?

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Drugs Cosmetics Production FDA Approval 318

XTalks

SEPTEMBER 14, 2022

Daxxify was FDA-approved for similar cosmetic purposes as Botox and other neuromodulators like Dysport and Xeomin. Many people choose to undergo non-invasive cosmetic procedures to prevent or reduce the appearance of signs of aging. By reducing the movement of these muscles, wrinkles become less pronounced over time.

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Botox FDA Approval Cosmetics Clinical Trials 98

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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Containment Production Cosmetics Contamination 52

XTalks

SEPTEMBER 17, 2020

The US Food and Drug Administration (FDA) has issued its first injunction under the Produce Safety Rule against Fortune Food Product Inc., an Illinois-based processor of sprouts and soy products. Fortune Food Product did not respond to Xtalks’ request for comment.

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Production Contamination Cosmetics Bacteria 98

Pharmaceutical Technology

MAY 16, 2023

It will benefit from Omega’s newly opened injectable manufacturing facility, which has received clearances from Health Canada and the US Food and Drug Administration, as well as from Juno’s commercial network and product development pipeline.

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Cosmetics Allergies Manufacturing Production 130

Pharmaceutical Technology

SEPTEMBER 29, 2022

Holding a presence in the cosmetic dermatology sector, Curatio’s portfolio comprises more than over 50 brands that are commercialised in India. Curatio has built a commendable set of high market share brands in cosmetic and pediatric dermatology that we look forward to adding to our product offerings.”.

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Dermatology Cosmetics Branding Scientist 147

The Pharma Data

FEBRUARY 19, 2022

Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. The FDA is working with the company to initiate a voluntary recall External Link Disclaimer of the affected products. Families rely on stores like Family Dollar for products such as food and medicine.

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Contamination Production Cosmetics Packaging 52

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 8, 2021

While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. Biosimilars are the “generic” drugs of the biopharma world. What is a Biosimilar?

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Production Insulin Branding Generic Drugs 78

FDA Law Blog

JANUARY 22, 2023

On December 29, 2022, the President signed into law the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act, 2023 , Pub. FDORA primarily amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. 117-328 (2022).

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Cosmetics Regulation Drugs Production 59

Cloudbyz

MAY 24, 2023

Consumer products companies constantly strive to develop superior products that meet the ever-evolving needs of their consumer base. The pursuit for the most effective and safe products requires rigorous clinical research, which involves meticulous trial design, recruitment, data collection, and subsequent analysis.

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XTalks

JANUARY 11, 2024

The US Food and Drug Administration (FDA) has given authorization to Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug and Cosmetic Act (FD&C Act). This means Florida could soon import select prescription drugs from Canada.

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Drugs Cosmetics Medicine FDA Approval 69

FDA Law Blog

AUGUST 10, 2023

Cato — On August 3rd, FDA issued 11 warning letters to foreign facilities registered as OTC drug manufacturers. Instead, FDA issued a request for records pursuant to Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FDCA).

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Manufacturing Cosmetics Drugs Production 52

Pharma in Brief

JANUARY 7, 2024

On January 5, 2024, the US Food and Drug Administration ( FDA ) approved Florida’s proposal to import prescription drugs from Canada. Whether Florida is able to import drugs from Canada, including in light of Canadian regulations controlling drug exports, remains to be seen.

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Drugs Regulation FDA Approval Manufacturing 52

FDA Law Blog

JULY 11, 2023

Koblitz — One of the most important questions FDA has to answer is whether a given product is appropriately characterized as a drug, biologic, device, food, cosmetic, or something entirely different. FDA, on the other hand, argued that the finished product form—i.e.,

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Protein Production Regulation Cosmetics 95

XTalks

MARCH 25, 2024

The latest phase of Oprah’s weight loss journey brought her to GLP-1 receptor agonist drugs, which have taken Hollywood and social media by storm. GLP-1 receptor agonists, a class of drugs initially developed to treat type 2 diabetes, have been found to have significant effects on weight loss.

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Drugs Medicine Life Science Production 105

Pharmaceutical Technology

MARCH 30, 2023

The FDA’s proposed FY2024 Budget tops $7bn, to be shared between drug, food, and cosmetics tasks and overheads such as buildings; this is $372m higher than in FY 2023, a 10% increase. Recall powers for all drugs: The budget reveals legislative as well as spending plans; the agency wants to expand its authority to recall any drug.

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Contract Manufacturing Manufacturing Pharma Companies Cosmetics 147

Drug Discovery World

NOVEMBER 30, 2023

The Food and Drug Administration (FDA) said it will investigate the safety of BCMA- or CD19-directed autologous CAR-T cell immunotherapies, following reports of T cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in these patients.

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Pharmaceutical Technology

JUNE 10, 2023

According to GlobalData, Phase I drugs for Metastatic Lung Cancer does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Pimitespib LoA Report. Buy the report here.

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Cosmetics Clinical Trials Clinical Trials Drugs 100

Pharmaceutical Technology

JUNE 10, 2023

According to GlobalData, Phase I drugs for Metastatic Lung Cancer does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Pimitespib LoA Report. Buy the report here.

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Cosmetics Clinical Trials Clinical Trials Drugs 100

FDA Law Blog

SEPTEMBER 30, 2021

See Federal Food, Drug, and Cosmetic Act (“FDCA”) Section 503A(b)(2). The matter involves a “decades old skirmish” dating back to the late 1990s, (and previously blogged about here and here ) when Congress passed the Food and Drug Administration Modernization Act (“FDAMA”), which created Section 503A.

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Pharmacy Production Drugs Regulation 98

Camargo

SEPTEMBER 8, 2021

Some Drugs May Require Reclassification to Devices. On August 9, the FDA published a Federal Register notice requesting information and comments regarding products currently classified as drugs which may require reclassification as devices. This is in response to the decision from the U.S.

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Development Regulation Production Drugs 186

Pharmaceutical Technology

MARCH 1, 2023

According to GlobalData, Phase I drugs for Neuroendocrine Tumors have a 74% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Nedisertib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Gene Editing DNA Cosmetics Life Science 100

Pharmaceutical Technology

MARCH 1, 2023

According to GlobalData, Phase I drugs for Head And Neck Cancer Squamous Cell Carcinoma have an 80% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Nedisertib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Gene Editing DNA Cosmetics Life Science 100

XTalks

JANUARY 5, 2024

Eli Lilly launched LillyDirect this week, an online service that provides access to the company’s medicines, including its newly approved weight loss drug Zepbound (tirzepatide). Interestingly, the company’s blockbuster diabetes drug, Mounjaro (tirzepatide), is not available through the new digital service.

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Drugs Pharmacy Cosmetics Insulin 59

The Pharma Data

MARCH 7, 2022

Food and Drug Administration announced it has made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring after determining that the intentional genomic alteration (IGA) does not raise any safety concerns (low-risk determination). Today, the U.S. Solomon, D.V.M.,

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Genome Genomics Production Marketing 52

XTalks

JUNE 5, 2023

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). GLP-1 stimulates insulin production, thus reducing blood glucose levels, and it interacts with the brain to suppress appetite and create a feeling of fullness. mg and 2.4 mg doses of Wegovy.

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FDA Approval Containment Drugs Pharmacy 98

Camargo

NOVEMBER 15, 2021

The 21 st Century Cures Act generated a good deal of excitement and interest when it added a section called “ Utilizing Real World Evidence ” to the Food, Drug, and Cosmetic Act (Section 505F). The FDA recently published the ICH’s Harmonised Guideline Q13, titled “ Continuous Manufacturing of Drug Substances and Drug Products.”

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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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Drugs Production Generic Drugs Cosmetics 52

FDA Law Blog

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution. Deb along with fellow panelists Kyle Y.

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Compliance Drugs Regulation FDA Approval 52

XTalks

MARCH 21, 2024

The US Food and Drug Administration (FDA) has unveiled its ambitious proposal for a $7.2 This significant financial request is aimed at bolstering food safety and nutrition, alongside advancing medical product safety and strengthening public health initiatives. billion budget for fiscal year 2025.

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Cosmetics Production Regulation Manufacturing 52

Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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Development Production Immune Response Licensing 161

Fossil Remedies

OCTOBER 16, 2022

Every pharma company needs a drug license number to begin distribution, marketing, and manufacturing activities. Wholesale Drug License. A Wholesale Drug License is required when you want to sell medicines in bulk quantities. Retail Drug License. Manufacturing Drug License. Loan Drug License in India.

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Licensing Licensing Pharma Companies Cosmetics 52

FDA Law Blog

JANUARY 5, 2022

Sara’s practice covers the intersection of FDA regulatory issues and Intellectual Property, including the Hatch-Waxman Amendments, the Biologics Price Competition and Innovation Act, and the Orphan Drug Act, biosimilars, and the Orange Book. Sara joined the firm from a well-recognized intellectual property firm in 2017.

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Cosmetics FDA Approval Drugs Production 52

XTalks

NOVEMBER 14, 2022

In the US, it’s against the law to use the carcinogenic color additive Red 3 in cosmetics, such as lipsticks or blush or topicals. As a result, in 1990, the agency eliminated certain “provisionally listed” uses of the chemical — meaning cosmetics and externally applied drugs. But those steps were never taken.

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Advarra

JULY 26, 2022

However, it’s not legal federally and is considered a Schedule I drug by the U.S. Drug Enforcement Administration (DEA), meaning it has no accepted medical use and a high potential for abuse. In order to understand the current status on cannabis and CBD research studies, it’s important to understand where each product stands.

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XTalks

MAY 25, 2023

In this episode, Vera talked about the US Food and Drug Administration’s (FDA) approval of Veozah (fezolinetant), the new type of drug for menopausal hot flashes and night sweats. The team discussed Veozah and the benefits of this drug for women’s health. during or after the menopausal transition.

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