FDA Law Blog: Biosimilars

MARCH 15, 2023

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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Drug Target Review

NOVEMBER 3, 2023

They identified ZNF800 as a key regulator of the differentiation of a specific gut cell type, the enteroendocrine cells. These hormones regulate digestive processes, like nutrient absorption, appetite, and glucose metabolism. This is like switching the ‘traffic lights’ on or off.”

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Agency IQ

MARCH 1, 2024

Explainer: What a government shutdown would mean for the FDA (Updated) With Congress again debating the passage of appropriations legislation, the FDA is facing a potential shutdown of operations as of Midnight on March 1. What is a government shut down? If none of the 12 bills are completed, then all government operations shut down.

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Drug Discovery World

NOVEMBER 29, 2023

MIRA Pharmaceuticals and MIRALOGX have formed a new partnership to develop and commercialise oral ketamine analog Ketamir-2, hoping to change the landscape of depressive disorder treatments. Ketamir-2 is a patent-pending compound under investigation to potentially deliver ultra-rapid antidepressant effects as early as four hours after dosing.

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The Pharma Data

NOVEMBER 18, 2020

The topic of sanitation regulation is also covered in ‘ Catalysing Citywide Sanitation For All Through Regulating Service Providers ‘ by IWA’s Regulation for Citywide Inclusive Sanitation initiative’s advisory and taskforce members – Yvonne Magawa (ESAWAS), Diego Polania (CRA), and Gustavo Saltiel (World Bank).

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The Pharma Data

NOVEMBER 23, 2020

Zhang’s arrest was for “the suspected offense of smuggling goods prohibited by the import and export regulations under the laws of the PRC,” according to a GenScript statement. Human genetic goods are tightly regulated by the Chinese government. Zhang had served as the chairman of board of directors of Legend Biotech since 2015.

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The Pharma Data

AUGUST 31, 2020

Johnson & Johnson Announces Agreement in Principle with Government of Canada to Supply its COVID-19 Vaccine Candidate. Johnson & Johnson Announces Agreement in Principle with Government of Canada to Supply its COVID-19 Vaccine Candidate. MONTRÉAL, QC – August 31, 2020 – Janssen Inc.,

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Drug Discovery World

JULY 25, 2024

Why: The US has been a leader in biotech since the 1970s, thanks to significant government support for biomedical research, a strong venture capital industry and a lack of regulation over pricing. Why: Government backing has played an important role in the development of India’s biotech industry.

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The Pharma Data

AUGUST 5, 2020

Government for 100 Million Doses of Investigational COVID-19 Vaccine. Government for 100 Million Doses of Investigational COVID-19 Vaccine. Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators. government may also purchase an additional 200 million doses of Ad26.COV2.S

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Drug Discovery World

FEBRUARY 6, 2024

However, many have cautioned against too great a reliance on these tools and emphasised the importance of checks and balances to ensure the systems are properly regulated and results are verified. Pharos iBio, which utilises AI technology to develop treatments for refractory and rare diseases such as cancers and repurpose existing therapies.

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Drug Discovery World

JULY 12, 2023

Following this investigation and a complaint from doctors and other healthcare professionals to the Care Quality Commission (CQC), the regulator says it has launched a review into the concerns. Issues raised include late and missed deliveries of medicines, leading to potentially serious consequences for patients’ health.

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The Pharma Data

MAY 27, 2022

The FDA’s decision is informed by the results of Pfizer’s nonclinical studies and a Phase 2a clinical study of ervogastat/clesacostat, which showed that treatment with ervogastat/clesacostat reduced liver fat with a favorable safety and tolerability profile. Pfizer Inc. NYSE: PFE) today announced the U.S.

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The Pharma Data

AUGUST 5, 2020

Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators. government for the large scale domestic manufacturing and delivery in the U.S. government may also purchase an additional 200 million doses of Ad26.COV2.S NEW BRUNSWICK, N.J., S under a subsequent agreement.

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Drug Discovery World

AUGUST 3, 2023

Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance. For example, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition to date 1.

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Drug Discovery World

OCTOBER 9, 2023

Despite the size of the market and the global impact, there are currently no effective treatments. Akin to a computer’s central processing unit, mitochondria orchestrate broad ranging processes pertaining to cellular health, including metabolism, energy, and immune regulation. In their paper, Guarnieri et al.

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Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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H1 Blog

SEPTEMBER 26, 2023

When it comes to developing new treatments and vaccines, the development timeline is often long and arduous, especially outside of the U.S. Another challenge faced by international clinical trials is the lack of reliable data about local health systems and regulations. It comes just a day after the U.S.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. NEW YORK, Nov.

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The Pharma Data

OCTOBER 28, 2020

This effort is part of a three-way agreement among Takeda, Moderna and the Government of Japan’s Ministry of Health Labour and Welfare (MHLW). Takeda is collaborating with the Japanese Government and vaccine developers to provide rapid and sustained access to COVID-19 vaccines in Japan,” said Rajeev Venkayya, M.D., is fully enrolled.

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Drug Discovery World

JULY 30, 2024

This multifaceted role offers a tremendous opportunity to regulate human biology, such as regulating splicing or translation of proteins, or RNA-protein, or RNA-DNA interactions, providing multiple avenues to intervene in human biology and have a therapeutic effect for currently untreatable diseases. We generated 2.4

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The Pharma Data

JULY 23, 2021

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Ronapreve (casirivimab and imdevimab), for the treatment of patients with mild to moderate COVID-19 via intravenous infusion. Roche’s Chief Medical Officer and Head of Global Product Development.

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The Pharma Data

MARCH 27, 2021

Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has recommended that the use of Saxenda ® is expanded for the treatment of obesity in adolescents aged 12–17 years. If approved, Saxenda ® will be the first EU-approved treatment for obesity in adolescents.

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The Pharma Data

JUNE 12, 2021

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The Pharma Data

JANUARY 26, 2021

Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B , a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. (OTCQB: QBIO), announced today that the U.S. . Source link.

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Drug Discovery World

OCTOBER 31, 2023

However, progress in the field has been painfully slow for decades – particularly in terms of disease modifying treatments – because of the complexity of these diseases, the expense involved in lengthy clinical trials and the uncertainty around efficacy.

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Agency IQ

APRIL 26, 2024

Background: CERCLA In 1980, Congress passed the Comprehensive Environmental Response, Compensation and Liability Act ( CERCLA or Superfund) , establishing a liability scheme which authorizes the federal government to clean up contaminated sites and force potentially responsible parties (PRPs) to pay for those cleanup costs.

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Vial

DECEMBER 4, 2023

It is pivotal in the development of cutting-edge treatments, therapies, and interventions for a wide array of diseases. This change in perception may be largely attributable to the evolution of regulations and guidelines that govern clinical research. United States regulations In the U.S.,

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The Pharma Data

OCTOBER 25, 2020

for the treatment of severe vernal keratoconjunctivitis (VKC) in patients ages 4-18. “We look forward to working with the FDA during the review process and are optimistic this treatment could provide much needed symptom relief for those affected so they may better engage in their daily activities.”

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Agency IQ

JULY 12, 2024

EPA grants petition on PFAS in fluorinated containers Following a loss at the Fifth Circuit, the EPA has a new plan to regulate PFAS in fluorinated plastic containers: traditional Toxic Substances Control Act Section 6 rulemaking.

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Agency IQ

MAY 3, 2024

What we expect the EPA to do in May 2024 In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. TSCA new chemicals procedural regulations. TSCA risk management rules.

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Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

MARCH 25, 2024

PFAS can repel oil and water and are produced for use as surface treatments for soil, stain, and water resistance; for textiles, paper, and metals; and most notably for fire suppression foams (aqueous film-forming foams, or AFFFs). They are used in cleaning products, cookware, leather, paint, and wire insulation. DEBBIE STABENOW (D-Mich.),

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H1 Blog

DECEMBER 12, 2023

For life sciences, this means that tools used for diagnostics, treatment protocols, and patient monitoring must clear higher bars of reliability and safety. This adoption could also ensure compliance with strict regulations, such as HIPAA, and potentially offer a new standard for data privacy that could serve as a model globally.

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

MARCH 25, 2022

The World Health Organization (WHO) and the Government of India today signed an agreement to establish the WHO Global Centre for Traditional Medicine. I’m grateful to the Government of India for its support, and we look forward to making it a success.”. Around 80% of the world’s population is estimated to use traditional medicine.

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Agency IQ

APRIL 19, 2024

Focus: Three “widely-used, commercially available” destruction and disposal methods : Thermal treatment, landfills and underground injection. The subsection is relatively short but does note that the most applicable destruction and disposal technologies for these applications would be landfill disposal or thermal treatment.

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Agency IQ

FEBRUARY 15, 2024

MHRA selects eight technologies to help it test its new innovative devices pathway The British regulator and its partners just released the list of products and companies chosen to participate in the pilot of its Innovative Device Access Pathway (IDAP). device regulations and the pilot for innovative products. Life Sciences Vision.

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