Drug Discovery World

OCTOBER 24, 2023

MP : I think industry and academia just now are starting to discover the potential that this technology has, as treatments for various diseases that use CRISPR are in clinical trials, but there are so many more applications that could be developed. Treating disease is great, but feeding people could be even greater.

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Advarra

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. These risks face fewer regulations but must meet certain standards to ensure ethical use. High Risk AI-powered Systems: Key Requirements The AI Act will likely consider many AI-based systems used in clinical trials today as “high risk.”

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Drug Discovery World

NOVEMBER 29, 2023

After making its scientific review of Ketamir-2, the DEA concluded that Ketamir-2 is not a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations.

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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. The Phase 1/2a first-in-human clinical trial of the vaccine candidate, Ad26.COV2.S,

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Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?

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Drug Discovery World

NOVEMBER 24, 2022

Despite the importance of the pharmaceutical industry to national economies and population health, the report paints a picture of falling competitiveness, with the global share of R&D investment, clinical trials and manufacturing output all decreasing. . Overall clinical trial activity in the region is also on the decline.

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The Pharma Data

OCTOBER 15, 2020

Moderna is working with international regulators to accelerate approval of the company’s coronavirus disease 2019 (COVID-19) vaccine candidate, mRNA-1273, which is currently leading the global COVID-19 vaccine race alongside vaccine candidates from AstraZeneca, Pfizer and Johnson & Johnson. The Cambridge, Mass.-based In the U.S.,

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Drug Discovery World

MAY 6, 2024

billion on R&D during 2021, with Germany and Switzerland being the biggest contributors, and around one fourth of clinical trials worldwide were performed in Europe 1. The city is host to many innovative biotech companies, including relative newcomers Orexa, a company that recently launched its first Phase II clinical trial.

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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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DrugBank

APRIL 25, 2024

This tech can speed up everything from drug design to clinical trials by processing complex datasets more efficiently. Focus on building robust systems to manage and analyze a vast array of data types, ensuring top-notch data governance and quality. Data Management: AI thrives on data. In the U.S.,

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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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The Pharma Data

SEPTEMBER 12, 2020

Trials of a Covid-19 vaccine being developed by AstraZeneca and Oxford University will resume after being paused due to a reported side effect in a patient in the UK. Health Secretary Matt Hancock welcomed the news that the trials would resume. Image copyright. But on Saturday, the university said it had been deemed safe to continue.

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FDA Law Blog: Biosimilars

JULY 8, 2024

The court ruled that the Securities and Exchange Commission (SEC) may not impose fines to penalize securities in its administrative proceedings because that practice violates the Seventh Amendment “right of trial by jury” in all “suits at common law.” Here are some brief facts of the case. This did not end the analysis, however.

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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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Drug Discovery World

OCTOBER 31, 2023

It has been used experimentally in international trials 1 , but researchers are hopeful that further use and evaluation in the UK will accelerate drug development for hard-to-treat neurodegenerative diseases. Currently, 15 trials of the new potential therapies for ALS have included NfL as an endpoint 8.

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Drug Discovery World

FEBRUARY 6, 2024

As AI-designed drugs start to enter large-scale clinical trials, DDW’s Diana Spencer investigates how new digital tools are reinventing and reshaping drug discovery for the future. The use of AI is rapidly developing in society and as regulators we see more and more applications in the field of medicines.

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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. What is the regulatory landscape of medical cannabis? There is, however, one cannabis-derived drug product that the FDA has approved, which is Epidiolex (cannabidiol).

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Drug Discovery World

OCTOBER 9, 2023

Akin to a computer’s central processing unit, mitochondria orchestrate broad ranging processes pertaining to cellular health, including metabolism, energy, and immune regulation. This is a new dynamic and efforts on research, clinical trials regulatory, and financial support are required. In their paper, Guarnieri et al.

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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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Advarra

DECEMBER 15, 2022

As the research community continues to seek clinical trial efficiencies designed to bring therapies to patients faster, more governing bodies are pushing for single institutional review board (single IRB) review as one way to streamline efforts. Policies and Regulations Affecting Single IRB Review. Common Rule Single IRB Policy.

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Vial

FEBRUARY 15, 2024

Clinical trials play a crucial role in advancing medical breakthroughs, but effective management is essential to unlock their full potential. Pharmaceutical companies often face challenges in conducting clinical trials due to the need for substantial knowledge, time, and resources. over the forecast period (2022-2030).

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Vial

DECEMBER 4, 2023

This change in perception may be largely attributable to the evolution of regulations and guidelines that govern clinical research. The Current Role and Impact of Patient Payments In the current landscape of clinical research, patient payments and incentives play a critical role in encouraging participation in clinical trials.

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The Pharma Data

APRIL 3, 2021

The CoVIg-19 Plasma Alliance today announced that the Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints. About the ITAC Trial.

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Agency IQ

AUGUST 30, 2024

FDA AdComm to discuss patient-centric informed consent The FDA’s Center for Devices and Radiological Health (CDRH) will soon convene its Patient Engagement Advisory Committee to discuss “patient-centered informed consent” policies – notably, not just for medical devices but for “FDA regulated medical products” writ large.

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Agency IQ

JANUARY 4, 2024

Swissmedic reorg adds new focus on medical device market surveillance The Swiss regulator, Swissmedic, just announced a reorganization, with a new head of the medicinal product authorization and vigilance sector, but also a new and discrete medical devices surveillance sector. Read more about what the regulator plans for its database here.]

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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). Moderna has previously announced that the 30,000 participant Phase 3 clinical trial of mRNA-1273 at the 100 µg dose level in the U.S. is fully enrolled.

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SugarCone Biotech

APRIL 2, 2024

Finally, both WuXi Apptec and WuXi Bio are accused of having deep ties with the Chinese military, which are kept hidden from Western companies and governments. In practice the Chevron Doctrine can support regulation, or deregulation, as seen fit by the specific agency of each specific administration. What is the best strategy here?

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The Pharma Data

OCTOBER 19, 2020

The refusal to share data or even basic information about the study and the pause comes on the heels of a recent and widely-touted joint pledge of prudence and caution on vaccine trial safety by nine drug companies, including J&J, working on COVID 19 vaccines.

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Drug Discovery World

FEBRUARY 7, 2023

The website Pharmavibes 3 suggests that it could be a useful source of information about regulations in different countries and in helping companies to understand those regulations in relation to their own product. It also suggests companies could use ChatGPT when putting together applications to regulatory agencies.

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The Pharma Data

MAY 27, 2022

federal government spent an estimated $1.8 The FDA approves around 50 new drugs each year after clinical trials and data analyses demonstrate a drug’s safety and effectiveness. Under the program, drug companies are then required to demonstrate the drug’s clinical benefit through a confirmatory trial.

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Agency IQ

MAY 10, 2024

The proposal for a regulation on the sustainable use of pesticides (SUR), however, died in European Parliament in November 2023. In June 2023, the French Socialist party used its allotted yearly right of inquiry to question the government on its failure to implement Ecophyto ambitions. [ See AgencyIQ’s analysis of this event here. ]

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Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 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. Read AgencyIQ’s analysis of a lower court’s ruling.

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The Pharma Data

DECEMBER 9, 2020

We are delighted with our progress and anticipate that data from this trial will yield important insights that will be applied to our planned Phase 2b clinical trial, which is scheduled to begin in 2021.” In parallel with the completion of this dosing cohort, we have now dosed the first NASH patient in the 225 mg cohort.

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The Pharma Data

AUGUST 20, 2020

Poor regulation of antibodies tests – that could indicate if someone has had coronavirus – could be putting the public at risk, doctors have warned. “These regulations aren’t fit for purpose and don’t protect the public from bad tests,” he said. Image copyright. Getty Images.

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The Pharma Data

DECEMBER 28, 2020

The AMBITION trial is the first placebo-controlled study of CRV431 in NASH patients with evidence of moderate-to-severe fibrosis. The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. To date, there are no approved drugs to treat NASH.

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The Pharma Data

DECEMBER 30, 2020

The British government also decided to start giving as many people as possible a first dose of vaccines, rather than keeping supplies for second shots, expanding the number of people who will be vaccinated. Some people in clinical trials of the Oxford-AstraZeneca vaccine were given the two doses several months apart. WEDNESDAY, Dec.

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The Premier Consulting Blog

DECEMBER 28, 2023

This article reviews the regulations governing charging or obtaining insurance coverage for an investigational device. The complete FDA Category A or Category B approval letter IDE study protocol Institutional Review Board (IRB) approval letter National Clinical Trial (NCT) number Supporting materials, as appropriate Table 1.

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