Camargo

NOVEMBER 15, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. While not fatal to the application, this development is certainly a setback for the sponsor, primarily in terms of a delay in approval.

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Development Manufacturing Production Packaging 187

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. Regulatory Considerations for Biologics. BLA process (CBER). 510(k) process (CBER). Premarket Approval (PMA) process (CBER).

Development 161

Development Production Immune Response Licensing 161

pharmaphorum

SEPTEMBER 29, 2022

Although mHealth has been gaining in popularity for at least the past decade, before commercializing their mHealth products, developers must determine whether the product is subject to U.S. If so, developers must develop and execute on a regulatory strategy. Food and Drug Administration (FDA) regulation as a medical device.

Development 101

Development Regulation Production Life Science 101

Pharma Mirror

DECEMBER 1, 2021

CPhI awards the first ever CPhI Verified certificate to Medinfar – an international pharmaceutical manufacturer of Rx, cosmetics, food supplements and veterinary products. The service forms part of the platinum membership on CPhI Online and is designed to further supply.

Cosmetics 130

Cosmetics Compliance Branding Manufacturing 130

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.

Cosmetics 59

Cosmetics Compliance Generic Drugs Regulation 59

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.

Cosmetics 130

Cosmetics Allergies Manufacturing Production 130

Pharmaceutical Technology

JUNE 10, 2023

Pimitespib is under clinical development by Otsuka Pharmaceutical and currently in Phase I for Metastatic Lung Cancer. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Buy the report here.

Cosmetics 100

Cosmetics Clinical Trials Clinical Trials Drugs 100

Pharmaceutical Technology

JUNE 10, 2023

Pimitespib is under clinical development by Otsuka Pharmaceutical and currently in Phase I for Metastatic Lung Cancer. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Buy the report here.

Cosmetics 100

Cosmetics Clinical Trials Clinical Trials Drugs 100

Scienmag

SEPTEMBER 16, 2020

Goddard III A research team from Caltech and the UCLA Samueli School of Engineering has demonstrated a promising way to efficiently convert carbon dioxide into ethylene — an important chemical used to produce plastics, solvents, cosmetics and other important products globally.

Cosmetics 88

Cosmetics Research Engineer Scientist 88

Pharmaceutical Technology

APRIL 4, 2023

On April 4, Scorpion Therapeutics announced a collaboration and license agreement with the French dermo-cosmetic and pharmaceutical group Pierre Fabre to codevelop two next-generation epidermal growth factor receptor (EGFR) inhibitors. of NSCLC patients with exon 19 and 21 mutations develop resistance mutations at C797S. Up to 12.5%

Cosmetics 130

Cosmetics Development Licensing Licensing 130

Pharmaceutical Technology

MARCH 1, 2023

Nedisertib is under clinical development by Merck and currently in Phase I for Neuroendocrine Tumors. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Merck overview Merck, a subsidiary of E.

Gene Editing 100

Gene Editing DNA Cosmetics Life Science 100

Pharmaceutical Technology

MARCH 1, 2023

Nedisertib is under clinical development by Merck and currently in Phase I for Head And Neck Cancer Squamous Cell Carcinoma. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Gene Editing 100

Gene Editing DNA Cosmetics Life Science 100

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.

Containment 52

Containment Production Cosmetics Contamination 52

FDA Law Blog

JUNE 14, 2021

Shapiro — In our last post on Laboratory Developed Tests (LDTs) , we suggested that Congress, not FDA, should lead in directing modernization of LDT regulation. FDA argues that technological advances in LDTs necessitate FDA’s regulatory oversight pursuant to the Food, Drug, and Cosmetic Act (FDCA). By Jeffrey K.

Regulation 92

Regulation Development Cosmetics In-Vitro 92

Scienmag

DECEMBER 10, 2020

Environmental risk assessment through the development of an artificial organ-based toxicity assessment.

Cosmetics 52

Cosmetics Development Engineer 52

The Pharma Data

FEBRUARY 13, 2022

Food and Drug Administration took new steps aimed at fostering the development of non-addictive alternatives to opioids to manage acute pain and decreasing exposure to opioids and preventing new addiction. Opioid misuse and abuse remain a serious public health crisis facing the country. Source link: [link].

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Development Cosmetics Production Drugs 40

BioTech 365

AUGUST 10, 2020

Nasdaq: SLP), a premier developer of drug discovery and development software for modeling and simulation software products and services for the pharmaceutical, biotechnology, agrochemical, cosmetics and food industries, today announced the closing of its previously … Continue reading → LANCASTER, Calif.–(BUSINESS

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Cosmetics Production Development Drugs 52

BioTech 365

AUGUST 5, 2020

Nasdaq: SLP), a premier developer of drug discovery and development software for modeling and simulation software products and services for the pharmaceutical, biotechnology, agrochemical, cosmetics and food industries, today announced the entry into an underwriting … Continue reading → LANCASTER, Calif.–(BUSINESS

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Cosmetics Production Development Drugs 52

Drug Discovery World

NOVEMBER 30, 2023

As with all gene therapy products with integrating vectors (lentiviral or retroviral vectors), the potential risk of developing secondary malignancies is labelled as a class warning in the US prescribing information (USPIs) for approved BCMA-directed and CD19-directed genetically modified autologous T cell immunotherapies.

Cosmetics 64

Cosmetics Clinical Trials Clinical Trials Gene Therapy 64

Clinical Trial Podcast

JULY 31, 2022

He has led rare disease pharmaceutical companies in developing global programs to foster clinical trial transparency and enhance public health. Previously, Darshan was on the editorial board of cosmetics and personal products for FDAnews where guided the publication with his clinical trial and pharmaceutical expertise.

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Clinical Research Clinical Trials Clinical Trials Research 80

Cloudbyz

APRIL 12, 2022

” About Cloudbyz Through innovative digital clinical research solutions and services, Cloudbyz, a fast-growing integrated clinical research and development solution provider with integrated capabilities helps life sciences organizations to bring new therapies and medical devices faster to market reliably.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

pharmaphorum

MAY 27, 2022

First launched in 2006, Roblox is an online space where users can play games – more than 20 million of them at a recent count – created by developers and individuals. EndeavorRx will connect to Roblox, and playing it will unlock cosmetics that draw on the design of the game.

Cosmetics 93

Cosmetics Marketing Medicine Development 93

Roots Analysis

JANUARY 3, 2024

Medical aesthetics is a growing area of modern medicine that focuses on improving the cosmetic appearance of an individual through various medical treatments. However, Botulinum toxin was the real game-changer when it was approved for cosmetic use by the FDA in 2002.

Filler 40

Filler Cosmetics Production Dermatology 40

Roots Analysis

JANUARY 17, 2024

However, the spotlight now shifts to tirzepatide, a drug developed by Lilly and approved in 2022 under the brand name Mounjaro for treating type 2 diabetes. As the drug gains momentum, the demarcation between medical and cosmetic applications becomes increasingly nuanced.

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Drugs Cosmetics Marketing FDA Approval 40

XTalks

DECEMBER 10, 2020

Cosmetics and pharmaceutical companies can also participate in the circular economy by reducing waste and allowing other firms to create by-products. The company recently developed a plant-based, nutrition-packed protein called CanolaPROTM that was made from a by-product of crushed and oil-extracted rapeseed.

Cosmetics 98

Cosmetics Production Protein Scientist 98

The Pharma Data

NOVEMBER 8, 2020

We are very pleased to announce the achievement of two key milestones in our strategy to pursue specific clinical indications that will enable us to market and sell Renuvion ® for target procedures in the cosmetic surgery market,” said Charlie Goodwin, President and Chief Executive Officer.

Cosmetics 52

Cosmetics Marketing Containment Manufacturing 52

pharmaphorum

JULY 27, 2021

Drug delivery specialist Aptar Group has agreed a deal to take a near two-thirds share in Voluntis, a French developer of digital therapeutics (DTx), with a view to taking full control of the company later this year. per share in the initial deal, which will give it a 64.6% stake in the company.

Drug Delivery 110

Drug Delivery Insulin Cosmetics Development 110

Roots Analysis

JANUARY 29, 2024

Moreover, the medical aesthetics companies are also now focusing on the development of more customized solutions to expand their reach and build reputation within the industry. Body Contouring: Body contouring is a cosmetic procedure that aims to redefine, recreate and reshape the body. A laser is used to remove black color tattoos.

Filler 40

Filler Cosmetics Botox Marketing 40

FDA Law Blog

AUGUST 13, 2023

As reported previously , MOCRA includes a requirement for facility registration and listing of cosmetic products. Specifically, with some exceptions, parties that own or operate a facility engaged in the manufacturing or processing of a cosmetic product for distribution in the United States must list their facilities.

Cosmetics 52

Cosmetics Contract Manufacturing Manufacturing Production 52

Delveinsight

JANUARY 6, 2021

As a result of the high healthcare cost, people from developed countries move from their home country to another to receive treatment. In the past, most people from developing countries used to travel to developed countries for healthcare services due to the availability of advanced technology and healthcare specialists.

Cosmetics 79

Cosmetics In-Vitro Development Vaccination 79

Pharmaceutical Technology

APRIL 18, 2023

They are used as biocatalysts in pharmaceutical production, such as polymer synthesis, cosmetics, flavouring agents, and similar. According to GlobalData, there are 60+ companies, spanning technology vendors, established pharmaceutical companies, and up-and-coming start-ups engaged in the development and application of lipase compositions.

Cosmetics 130

Cosmetics Antibody DNA Development 130

XTalks

JUNE 17, 2022

Treatments for AA have been limited and largely cosmetic, such as the use of wigs and false eyelashes, or corticosteroid injections in the scalp. Individuals can develop alopecia at any age, but most develop it during childhood or teenage years.

FDA Approval 97

FDA Approval Gene Expression Cosmetics Trials 97

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. Servier has since stepped in as the partner for that project, which remains in preclinical development.

Licensing 76

Licensing Licensing Cosmetics Drugs 76

FDA Law Blog

NOVEMBER 6, 2023

The LMG awards are reflective of HPM’s excellence across several of our core life sciences practices, from controlled substances work to drug development, to Hatch-Waxman, to drug pricing, to medical device regulation. “While our attorneys don’t do this work for the recognition, it is gratifying to see their excellent work recognized.

Life Science 40

Life Science Cosmetics Regulation Drugs 40

FDA Law Blog

JULY 13, 2021

With the approach of the January 1, 2022 mandatory compliance deadline for the BE standard, manufacturers and importers of food and dietary supplements should work to develop strategies for compliance and evaluating each product’s bioengineered (BE) status if they have not already done so.

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Compliance Cosmetics Regulation Manufacturing 52

Roots Analysis

AUGUST 15, 2023

It is worth mentioning that the first reconstituted system, Protein Synthesis Using Recombinant Elements (PURE) , was developed in 2001. In addition to the healthcare industry, other industries, such as food industry, cosmetics industry and enzyme synthesis industry, are also benefiting from the cell free manufacturing process.

Protein 52

Protein In-Vitro Production Reagent 52

XTalks

DECEMBER 10, 2020

Cosmetics and pharmaceutical companies can also participate in the circular economy by reducing waste and allowing other firms to create by-products. The company recently developed a plant-based, nutrition-packed protein called CanolaPROTM that was made from a by-product of crushed and oil-extracted rapeseed.

Cosmetics 52

Cosmetics Production Protein Scientist 52