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.

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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. What is Medical Aesthetics?

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pharmaphorum

OCTOBER 27, 2022

However, there is a general prohibition in the legislation of using celebrities to promote medicines. Jackie Mulryne, Partner, is a member of the Life Sciences practice group, and provides regulatory, policy, and compliance advice to clients in the pharmaceutical, medical technology, cosmetics, and foods sectors.

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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.

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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). Along with the launch of LillyDirect this week, Lilly also issued an open letter recommending that Zepbound and Mounjaro not be used for “cosmetic weight loss.”

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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 reflects the FDA’s continued efforts to increase competition and access to quality, safe, effective and affordable medicines for patients and consumers.”. Today, the U.S.

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Roots Analysis

JANUARY 29, 2024

Medical Aesthetics is an area of modern medicine that specializes in improving the outer appearance of an individual without surgery. 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.

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Olympian Clinical Research

NOVEMBER 30, 2023

Understanding Vitiligo: More Than Skin Deep Vitiligo isn’t just a cosmetic concern; it’s a medical condition that can significantly impact an individual’s life. The Evolution of Vitiligo Treatments From ancient remedies to modern medicine, the treatment of vitiligo has undergone a remarkable transformation.

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Clinical Research Clinical Trials Clinical Trials Immune Response 52

Drug Discovery World

FEBRUARY 2, 2023

This news has been shared widely as a landmark moment, especially in the eyes of animal welfare organisations but also among drug developers. As simplified in a press release by the National Association for Biomedical Research (NABR), the act amends the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

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Drugs Clinical Trials Clinical Trials Cosmetics 52

Cloudbyz

OCTOBER 19, 2023

The pharmaceutical industry plays a critical role in improving healthcare by developing and bringing new medicines to market. Clinical trials are the backbone of drug development, and managing these trials efficiently is paramount.

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Pharma in Brief

JANUARY 10, 2024

As you start the new year, allow us to recap 2023’s important legal and regulatory developments for Canadian pharma. The most significant legal development in 2023 was the introduction of a system of patent term adjustment ( PTA ). We also flag what to watch out for in 2024. PMPRB in flux.

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The Pharma Data

DECEMBER 4, 2021

is a topical prescription medicine used to treat acne vulgaris. Continuing to advance and launch much-needed generic drugs is critical to ensuring access to quality medicines to everyone who needs them.” NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century.

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Pharmacy Checkers

JUNE 26, 2020

Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The new cooperation on Covid-19 is carried out under the auspices of International Coalition of Medicines Regulatory Authorities (ICMRA). We already rely on the EU to assess U.S. drug safety, and current events have only brought that into greater focus.

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The Pharma Data

MARCH 7, 2022

director of the FDA’s Center for Veterinary Medicine. “It We expect that our decision will encourage other developers to bring animal biotechnology products forward for the FDA’s risk determination in this rapidly developing field, paving the way for animals containing low-risk IGAs to more efficiently reach the marketplace.”.

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The Pharma Data

NOVEMBER 23, 2021

Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

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The Pharma Data

DECEMBER 30, 2020

deputy director of the FDA’s Center for Veterinary Medicine (CVM) Division of Compliance: “Although this pet food recall is still unfolding, we are sharing the facts we have so far because the levels of aflatoxin found in the recalled pet food are potentially fatal. SILVER SPRING, Md. , SOURCE U.S. Food and Drug Administration.

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Velocity Clinical Research

JUNE 29, 2023

You have to actually be interested in the science and the advancement of where things are going in medicine,” he says. Dr. Eder is a lead physician for UHS and is board-certified in family medicine. But passion alone isn’t enough. “I I think the other part of it is you need to have a good team around you. and Canada.

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FDA Law Blog

SEPTEMBER 30, 2021

See Federal Food, Drug, and Cosmetic Act (“FDCA”) Section 503A(b)(2). The Plaintiffs’ complaint alleges both substantive and procedural violations in FDA’s development of the MOU. FDA finally settled on a “final” MOU a year ago, and a coalition of compounding pharmacies immediately filed suit.

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Pharmacy Production Drugs Regulation 98

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. PFI has noted that it is not feasible to develop and label products for an individual state.

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The Pharma Data

DECEMBER 13, 2020

As part of its review, the FDA evaluated the safety of the IGA for the animals and people eating meat from them, as well as the product developer’s intention to market the IGA for its ability to eliminate alpha-gal sugar on pigs’ cells. director of the FDA’s Center for Veterinary Medicine. Solomon , D.V.M.,

FDA Approval 52

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The Pharma Data

FEBRUARY 5, 2021

” said Dr. Sabrina Fabi , Board Certified Dermatologist and Associate Research Director at Cosmetic Laser Surgery in San Diego. American Society for Dermatologic Surgery (ASDS) consumer survey on cosmetic dermatologic procedures 2018 available at [link]. N= 3,525 total study population. About Allergan Aesthetics. About AbbVie.

Cosmetics 52

Cosmetics Dermatology Allergies Production 52

The Pharma Data

OCTOBER 22, 2020

discussed how pediatricians and schools can work together during the COVID-19 pandemic to develop a school resumption plan based on currently available data, which will keep children, educators, and supportive communities safe and healthy. In one session, Nathaniel Beers, M.D., of Children’s National Hospital in Washington, D.C.,

Vaccination 52

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The Pharma Data

NOVEMBER 12, 2021

An FDA investigator’s list of examination compliances doesn’t constitute a final FDA determination of whether any condition is in violation of the Federal Food, Drug, and Cosmetic Act or any of its enforcing regulations.

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The Pharma Data

JUNE 2, 2022

To help high school students evaluate the accuracy and credibility of information they may see and hear about dietary supplements, the FDA has developed Science and Our Food Supply: Examining Dietary Supplements (2021 Edition). One reason for this recommendation is because some supplements might interact with medicines or other supplements.

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XTalks

MARCH 25, 2024

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. 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. I think that they’ve gotten overhyped.

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FDA Law Blog

JUNE 17, 2021

Schlanger — In October 2020, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) published a Final Rule (which we summarized here ) that implemented Section 804 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §

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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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Regulation In-Vitro Manufacturing Licensing 81

Fossil Remedies

JUNE 18, 2020

150+ Skin & Cosmetic Products. Cu-Card provides highest quality medicine for all and maintain a leading position in the global markets. It is a growing PCD Pharma company and committed to increase access to high-quality healthcare by developing, producing and marketing affordable pharmaceutical products in India.

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The Pharma Data

DECEMBER 31, 2020

Hacking – While pharmaceutical companies raced to develop vaccines, hackers furiously worked to steal intellectual property. In December, the European Medicines Agency revealed that documents related to the COVID-19 vaccine developed by Pfizer and BioNTech maintained on the agency’s servers were illegally accessed.

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FDA Law Blog

JUNE 23, 2021

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” So, we crafted the Patient-Focused Drug Development, or PFDD, a commitment that was agreed to in PDUFA V. The practice of medicine was viewed as paternalistic. By James E.

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XTalks

NOVEMBER 7, 2023

Their role encompasses navigating the product development cycle, ensuring effective utilization of products, offering support and scholarly exchange within the medical community and providing in-depth scientific knowledge to their company’s internal teams. Innovating and evaluating medical equipment.

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The Pharma Data

NOVEMBER 12, 2021

Treatment for polycythemia vera includes phlebotomies (a procedure that removes excess blood cells though a needle in a vein) as well as medicines to reduce the number of blood cells; Besremi is one of these medicines. Orphan drug designation provides incentives to assist and encourage drug development for rare diseases.

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FDA Approval Gene Production Cosmetics 40

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 power of neurotoxins.

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Pfizer

DECEMBER 13, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Loss of therapeutic effect of PAXLOVID and possible development of viral resistance . IMPORTANT SAFETY INFORMATION .

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The Pharma Data

APRIL 1, 2021

2 When designing the SkinMedica ® Neck Correct Cream, it was imperative for our R&D team to address these concerns with a multi-modal approach and develop a product with cutting edge ingredients, a cosmetically elegant texture and clinically-proven performance.”

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The Pharma Data

JANUARY 31, 2021

BIOLASE is a medical device company that develops, manufactures, markets, and sells laser systems in dentistry and medicine. BIOLASE’s products advance the practice of dentistry and medicine for patients and healthcare professionals. About BIOLASE, Inc.

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Pharmacy Checkers

MARCH 11, 2020

The FDA should be commended for its effort to create rules, pursuant to Section 804 of the Food, Drug and Cosmetic Act, that can lead to a regulated and safe channel of wholesale drug importation from Canada to help reduce cost burdens on states and consumers. counterparts. That the U.S.

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