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.”

Disease 52

Disease Treatment Therapies Cell Biology 52

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.

Pharmaceuticals 40

Pharmaceuticals Pharmacy Biosimilars Licensing 40

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.

Cell Biology 108

Cell Biology Pharmaceuticals Science Disease 108

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.

Therapies 84

Therapies Small Molecule Pharmaceutical Companies Molecular Biology 84

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!

Drugs 59

Drugs Pharmaceuticals 59

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.

Production 59

Production FDA Licensing Licensing 59

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.

Regulations 59

Regulations Drugs Pharmaceuticals 59

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.

Pharmaceuticals 52

Pharmaceuticals Marketing Disease Clinical Trials 52

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.

Small Molecule 100

Small Molecule Synthetic Chemistry Pharma Companies Pharmacokinetics 100

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.

FDA 52

FDA Packaging Regulations Compliance 52

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”).

Licensing 52

Licensing Licensing Production Clinical Trials 52

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.,

Production 52

Production Efficacy & Potency Packaging Drugs 52

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.

Bioinformatics 70

Bioinformatics Disease Treatment Drugs 70

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.

Research 69

Research Pharmaceutical Companies FDA Production 69

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.

Clinical Research 69

Clinical Research Trials Clinical Trials Research 69

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.

Doctors 111

Doctors Clinical Trials Treatment Therapies 111

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?

Science 59

Science Pharmaceutical Companies Treatment Pharmaceuticals 59

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.

Pharmaceuticals 52

Pharmaceuticals Pharmaceutical Companies Government Therapies 52

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.

Research 52

Research Treatment FDA Approval Disease 52

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.

Clinical Trials 40

Clinical Trials Pharmaceutical Companies Treatment Pharmaceuticals 40

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.

Drugs 136

Drugs Small Molecule Bioinformatics Packaging 136

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.

Marketing 95

Marketing FDA Pharma Companies Government 95

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.

Production 52

Production Science Pharmaceuticals Research 52

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.,

Clinical Trials 52

Clinical Trials Trials FDA Pharmaceutical Companies 52

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.

Therapies 52

Therapies Hospitals Marketing Production 52

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.

Clinical Trials 52

Clinical Trials Treatment Trials Drug Development 52

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].

International 52

International Pharmaceuticals Disease Pharmaceutical Companies 52

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

Government 64

Government Marketing Production Drugs 64

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.

Packaging 52

Packaging FDA Trials Regulations 52

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.

Pharmaceuticals 52

Pharmaceuticals Drugs Research 52

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.

Production 52

Production Science Pharmaceuticals Marketing 52

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.

Disease 52

Disease Clinical Trials FDA Approval FDA 52

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.

Computational Chemistry 86

Computational Chemistry Pharmacokinetics Drugs Pharmaceutical Companies 86

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.

Disease 52

Disease Clinical Trials Small Molecule Treatment 52

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.

Virus 52

Virus Small Molecule Licensing Licensing 52

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).

Treatment 52

Treatment Pharmacokinetics Drugs Production 52

The Pharma Data

JANUARY 11, 2021

“Some of those associations have never been documented before,” Cohen said, though the study did not definitively prove that brown fat causes disease risk to drop. ” Researchers and pharmaceutical companies also are looking into drugs that might activate brown fat and promote these benefits, Cohen said.

Disease 52

Disease Pharmaceutical Companies Research Hospitals 52