Pharmaceutical Technology

MARCH 1, 2023

Nedisertib is under clinical development by Merck and currently in Phase I for Neuroendocrine Tumors. According to GlobalData, Phase I drugs for Neuroendocrine Tumors have a 74% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. The drug candidate targets DNA-dependent protein kinase (DNA-PK).

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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. 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. Buy the report here.

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Gene Editing DNA Cosmetics Life Science 100

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. Food and Drug Administration (FDA) regulation as a medical device. If so, developers must develop and execute on a regulatory strategy.

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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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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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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%

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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). Interestingly, the company’s blockbuster diabetes drug, Mounjaro (tirzepatide), is not available through the new digital service.

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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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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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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. director of the FDA’s Center for Drug Evaluation and Research. Today, the U.S.

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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

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. Any change should be made by enacting new law, and not by Food and Drug Administration (FDA) administrative fiat. By Jeffrey K.

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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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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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Camargo

JANUARY 27, 2021

Comparing Orphan Drug, Rare Pediatric Disease, and Humanitarian Use Device Designations. Orphan Drug Designation. 21 Code of Federal Regulations (CFR) §316 ; Orphan Drug Act. Section 529 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)/ 21 United States Code (USC) §360ff. Drugs and biological products.

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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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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. is the largest dedicated food and drug law firm in the country.

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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. stake in the company.

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The Pharma Data

NOVEMBER 23, 2021

director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. Cytomegalovirus infections that are resistant or do not respond to available drugs are of even greater concern. Approval is for Cytomegalovirus, a Type of Herpes Virus. Today, the U.S. Source link: [link].

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FDA Law Blog

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. For more on FDORA’s other provisions, see HPM’s complete summary here ). FDORA § 3209(a)(2).

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

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FDA Law Blog

APRIL 12, 2022

This document contains a number of legislative proposals, including three proposed amendments to the accelerated approval statutory provisions in section 506(c) of the Federal Food, Drug, and Cosmetic Act. Food and Drug Administration , No. A key to efficient drug development is transparency. 1:22-cv-0938 (D.D.C.

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The Pharma Data

NOVEMBER 21, 2021

Food and Drug Administration approved Voxzogo (vosoritide) injection to improve growth in children five years of age and older with achondroplasia and open epiphyses (growth plates), meaning these children still have the potential to grow. director of the Division of General Endocrinology in the FDA’s Center for Drug Evaluation and Research.

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FDA Law Blog

JANUARY 7, 2024

A review of FDA’s Postmarketing Requirements and Commitments database reveals that one of the most common reasons FDA requires postmarketing studies is to assess the impact of a drug on maternal and fetal outcomes when taken by pregnant women. For many drugs, both a registry and an outcomes study are required.

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FDA Law Blog

JULY 7, 2022

Livornese — Ten years in the making, a proposed rule was issued by FDA last week that has the potential to bring some prescription drugs that have not been able to gain an OTC approval to retail shelves at long last. To date, no OTC drug has been approved under this guidance.

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FDA Law Blog

JUNE 28, 2023

This legislation, named the Innovative Feed Enhancement and Economic Development Act (Innovative FEED Act) , is an effort to create an approval process for ingredients with environmental or food safety claims as food additives rather than as animal drugs. 1844 – Animal Drug and Animal Generic Drug User Fee Amendments of 2023.

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The Pharma Data

NOVEMBER 30, 2020

01, 2020 (GLOBE NEWSWIRE) — TearClear , an emerging ophthalmic pharmaceutical company, today announced successful completion of pre-IND (Investigational New Drug) meeting with the U.S. A 505(b)(2) NDA can be utilized for new chemical entities or for changes to previously approved drugs. BOSTON, Dec. Section 505(b)(2) of the U.S.

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XTalks

JUNE 17, 2022

Eli Lilly’s Olumiant (baricitinib) has won US Food and Drug Administration (FDA) approval as the first systemic treatment for severe alopecia areata (AA), an autoimmune disorder that leads to patchy baldness. The drug was evaluated in 1,200 adult patients with severe AA.

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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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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 ). CADTH makes non-binding recommendations on public drug reimbursement (except in Quebec).

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FDA Law Blog

MAY 6, 2024

The draft guidance provides recommendations on what is required to meet cybersecurity obligations under section 524B of the Food, Drug and Cosmetic Act (FD&C). Manufacturers are required to design, develop, and provide a “reasonable assurance” that both the cyber device and related systems (e.g., are cybersecure.

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The Pharma Data

MAY 17, 2021

Conducting clinical trials to see if a drug is safe and effective can be a very time-consuming process. Today, we’re providing industry guidance for creating master protocols (an overarching protocol designed to answer multiple questions) when evaluating drugs for the treatment or prevention of COVID-19.

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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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The Pharma Data

APRIL 7, 2023

Food and Drug Administration announced the final decision to withdraw approval of Makena—a drug that had been approved under the accelerated approval pathway. This drug was approved to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. Today, the U.S.

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FDA Law Blog

DECEMBER 21, 2023

This dinner—at the Waldorf Astoria in DC—will commemorate FDLI’s role during key eras in food and drug law and will have fun surprises as well!” Mark your calendars now.

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Roots Analysis

FEBRUARY 20, 2022

Over the last decade, one of the major challenges faced by pharmaceutical players across the globe is low drug solubility. As a matter of fact, recently many drug developers have initiated formulating novel therapeutic interventions that utilize nanoparticles as a major component ( nanomedicines ). Our Social Media Platform.

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