Drug Target Review

OCTOBER 30, 2024

In light of the natural composition of organs, a formal definition of an ‘organoid’ might be a mini organ in a dish that comprises all or most of the various cell types found in the organ being modelled. He has over 20 years’ experience in biomedical research and pharmaceutical drug discovery.

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Drug Target Review

MARCH 3, 2025

However, promising pilot data from ongoing collaborations with pharmaceutical companies suggest that brain organoids are set to become a valuable tool in preclinical research. “We believe this will definitely make its way into preclinical research and practice.”

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Drug Channels

SEPTEMBER 12, 2023

On October 10, 2023, Drug Channels Institute will release 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. pharmaceutical distribution industry. This report—our fourteenth edition—remains the most comprehensive, fact-based tool for understanding and analyzing the large and growing U.S.

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Drug Target Review

OCTOBER 31, 2023

Ashley Hall, CDO of Reneo Pharmaceuticals Throughout my education I was discouraged by many around me. How did that transfer into the pharmaceutical industry? This sector of the pharmaceutical industry combined both my science and law background. By definition, this is the cutting edge, and we are in it.

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FDA Law Blog: Biosimilars

SEPTEMBER 25, 2024

From Chapter 1 (My First Generic Drug Client), through Chapter 4 (The Hatch-Waxman Act), to Chapter 12 (My Prescription for the Future), the 208-page “Breaking the Medicine Monopolies: Reflections of a Generic Drug Pioneer” is definitely worth a read!

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Drug Target Review

JUNE 19, 2024

Also, many companies never reached the point where they received validation from big pharmaceutical companies. Because this programme is still in early research, we are not at a point we can say we definitely know what it is going to work best in setting X or setting Y. Mr Culley served on the Board of Orphagen Pharmaceuticals, Inc.

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FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

By Riëtte van Laack — The dietary supplement exclusionary clause is, as its name suggests, a clause in the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of dietary supplement. On August 28 of this year, NPA sued FDA challenging FDA’s determination that NMN is excluded from the dietary supplement definition.

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FDA Law Blog: Biosimilars

AUGUST 14, 2024

Gaulkin — Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security Act to impose several discount requirements on pharmaceutical manufacturers. Butler & Faraz Siddiqui & Sophia R.

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The Pharma Data

NOVEMBER 19, 2020

Neurotrope and Metuchen previously announced their intent to merge in an all-stock transaction resulting in the formation of a holding company to be named Petros Pharmaceuticals, Inc. (“Petros”), which expects to trade on the Nasdaq Capital Market under the symbol “PTPI” following the closing of the merger.

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DrugBaron

FEBRUARY 7, 2022

Another common pitfall in medicinal chemistry is optimise one characteristic at once: find super-potent molecules, then try and ‘fix’ the pharmacokinetics and then try and improve the pharmaceutical properties and so on. Definitely not just more compounds per week. Not just more data per week. More answers.

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The Premier Consulting Blog

MAY 4, 2023

At Premier Consulting, our team of pharmaceutical regulatory experts is helping clients understand the changing regulatory landscape related to ophthalmic drugs and devices. Our goal is to help biopharma companies navigate these choppy waters as they strive to comply with evolving federal laws and the new FDA guidance.

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The Pharma Data

AUGUST 17, 2020

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products and the definitive agreement with Dragonfly (the “Definitive Agreement”).

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The Premier Consulting Blog

NOVEMBER 8, 2022

Determining if you have a combination product The high-level definition of combination product seems straightforward: a product with at least two constituent parts, such as: Drug/biologic (e.g., metered-dose inhaler) However, the four-part definition in 21 CFR 3.2(e) therapeutic drug/monoclonal antibody) Drug/device (e.g.,

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The Open Targets Blog

AUGUST 13, 2024

The Open Targets consortium is working at its largest scale to date, bringing together two scientific institutes and five pharmaceutical partners. We can fundamentally do a lot better in our understanding and definition of disease through patient stratification and by considering progression and treatment response.

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Eye on FDA

SEPTEMBER 28, 2022

FDA published notice recently that the Office of Prescription Drug Promotion (OPDP) was proposing some new research related to the promotion of medicines by pharmaceutical companies. As one can see, OPDP meticulously follows a thread, sometimes over years, to add definition and context to promotional communications, often highly nuanced.

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Conversations in Drug Development Trends

MAY 1, 2024

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) has made strides in standardizing technical requirements to streamline pharmaceutical development on a global scale. Each nation has varying definitions of what qualifies as a pivotal study. Japan, and China.

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Drug Target Review

JANUARY 12, 2024

Deep phenotyping and AI could assist in the production of patterns which describe a set of patients – in effect, creating a new disease definition. Today, diseases are only what we created as a way of naming disorders, a historic creation from doctors who studied patients that had common symptoms.

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Drug Target Review

SEPTEMBER 16, 2024

My father’s infectious enthusiasm for science is definitely what sparked my initial curiosity about the world around me. The pharmaceutical industry, for example, is a leader in creating a more inclusive environment. What inspired you to pursue a career in STEM, and how did you overcome any obstacles or biases you may have faced?

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The Pharma Data

DECEMBER 28, 2020

Our new directors are well-recognized for their leadership and accomplishments in the biopharmaceutical, biotechnology and pharmaceutical industries, as well as in public capital markets and corporate governance.” Russell served as a director of Endocyte, a Nasdaq-listed public company acquired by Novartis, and AMAG Pharmaceuticals.

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LifeSciVC

NOVEMBER 28, 2023

One can’t always control the former, but the latter is definitely within our power to shape. In these moments, leaning in with empathy and honesty is important: Nimbus’ success was not overnight nor guaranteed even through the fall of 2022, but was instead a product of both good fortune and good governance. The Nimbus phones lit up.

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The Pharma Data

JANUARY 22, 2021

Food and Drug Administration (FDA) approved the use of Aurinia Pharmaceuticals’ Lupkynis TM (voclosporin) as the first oral treatment developed specifically for adults with active lupus nephritis (LN) in combination with standard of care. Click here for the announcement from Aurinia Pharmaceuticals Inc.

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Practical Cheminformatics

JANUARY 8, 2024

When given the prompt “Please estimate the binding affinity between the drug Afatinib and target EGFR”, GPT-4 suggested a docking study, which is definitely not a wise choice. While large pharmaceutical companies have data on thousands or even millions of compounds, this data is rarely shared due to intellectual property concerns.

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The Pharma Data

APRIL 24, 2023

Lilly to Divest BAQSIMI to Amphastar In an effort to continue expanding the availability of BAQSIMI ® to patients, Eli Lilly and Company (NYSE: LLY) and Amphastar Pharmaceuticals, Inc.

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The Open Targets Blog

JUNE 20, 2023

With a background in pharmaceutical science, Irene is constantly looking for ways in which technology can aid scientists in their everyday work. "At My lack of experience in web development was definitely a challenge. Irene Lopez Santiago is a bioinformatician in the Open Targets core team.

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Advarra

JUNE 9, 2022

Trial activities and places where the trial is conducted must also have IRB review if they meet the definition of “engaged” in research under the DHHS/Office of Human Research Protections (OHRP) framework. In contrast, if a study is sponsored by industry (e.g.,

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The Pharma Data

OCTOBER 19, 2020

ZOLL’s leading resuscitation and critical care technologies are field proven in all roles of operational medical care on the battlefield, in aeromedical evacuation and transport, in field hospitals, and in garrison for definitive care. For more information, visit www.zoll.com/medical-markets/military/. About ZOLL Medical Corporation.

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Alta Sciences

SEPTEMBER 13, 2023

ELECTRICAL STIMULATION MODELS Using controlled electrical currents, or impulses, scientists can investigate the effects of pharmaceutical compounds on neural muscular or physiological systems. The revised definition also included an additional six keynotes and the etymology of the word, to provide further context.

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The Pharma Data

NOVEMBER 25, 2020

Vifor Pharma Group is a global pharmaceuticals company. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. The company develops, manufactures and markets pharmaceutical products for precision patient care. Worldwide prevalence of anaemia 1993-2005. Available at URL: [link].

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FDA Law Blog: Biosimilars

MARCH 5, 2024

Even if the company did obtain approval, such approval would likely be after generic competition for Farxiga enters the market, in which case the definition of a qualifying single source drug would no longer apply to Farxiga. AstraZeneca argued it would very likely have products in future lists of drugs selected for negotiations. “On

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Advarra

JULY 19, 2022

The sponsor is the pharmaceutical company conducting the trial. A: Working in a pharmaceutical company is the best way to learn this. Q: What is the definition of a drug? Q: Please discuss the transfer of investigational new drug (IND) sponsorship from one sponsor to another and that process. A: This does not usually happen.

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DrugBank

DECEMBER 8, 2022

As we pursued a concise definition, we found that our convictions that data quality must be individualized and audience-specific only grew stronger. Over the course of this data quality blog series, we tapped into the deep pool of expertise here at DrugBank and have come to a very simple conclusion, defining quality in data is difficult.

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The Pharma Data

JANUARY 25, 2021

25, 2021– Alexion Pharmaceuticals, Inc. On December 12, 2020 , AstraZeneca and Alexion announced that the companies entered into a definitive agreement for AstraZeneca to acquire Alexion , in which Alexion shareholders will receive $60 in cash and 2.1243 AstraZeneca American Depositary Shares (ADSs) for each Alexion share.

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Advarra

AUGUST 16, 2022

A rare, or orphan, disease by definition affects a small percentage of the population — fewer than 200,000 people in the U.S. But the numbers add up, and taken together, rare diseases impact an estimated 30 million Americans. The Orphan Drug Act of 1983 was instrumental in changing the number of orphan drugs approved in the U.S.

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Practical Cheminformatics

DECEMBER 7, 2023

Goals and definitions of success vary from person to person. On two separate occasions, VP-level medicinal chemists from large pharmaceutical companies told me, “We have a solubility model that is so good, we stopped running the assay.” Subsequently, that can become all you do. As I’ll discuss below, that’s not necessarily a bad thing.

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The Pharma Data

JANUARY 17, 2021

The treatments all use the antisense technology and automation techniques developed at Ionis Pharmaceuticals , which Crooke founded. We are looking forward to more definitive guidance in the coming months.”. “It’s the cause of the mutation, not the name of the disease, that matters.”. Source link.

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The Pharma Data

AUGUST 21, 2020

It’s a coalition of globally renowned academic institutions, pharmaceutical companies and nonprofit research organizations. I guess that’s the true definition of situational leadership. What are the goals of the consortium and what will Novartis contribute? CARE stands for Corona Accelerated R&D in Europe.

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The Pharma Data

MARCH 13, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for lanadelumab subcutaneous injection, a monoclonal antibody therapy for prophylaxis against attacks of hereditary angioedema (HAE).

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