The Pharma Data

JULY 2, 2025

Timeline of the Transaction The acquisition process began on May 16, 2025, when BioMarin and Inozyme jointly announced the signing of a definitive merger agreement. By incorporating Inozyme’s scientific platform and lead asset into its portfolio, BioMarin aims to accelerate the path to regulatory approval and eventual commercialization.

Therapies

The Pharma Data

JUNE 16, 2025

This further strengthens the biologicial rationale for proceeding into a larger and more definitive Phase III trial. An array of biomarker signals related to neurodegenerative processes — typically influenced by the toxic accumulation of alpha-synuclein — revealed desirable trends following prasinezumab administration.

Disease

LifeSciVC

APRIL 17, 2025

In building the target product profile (TPP) for these, consider what makes the mechanism uniquely suited to address unmet needs in a given disease, and objectively map out what would be base, low, and high cases for the program in the context of the competitive landscape (see Fig. 1 for an exemplary framework).

International

Advarra

DECEMBER 17, 2024

These companies are laying the groundwork for more sophisticated AI applications designed to transform clinical operations, improving both efficiency and productivity. As AI continues to evolve, its ability to transform the efficiency, quality, and scalability of clinical research will grow exponentially.

Clinical Research

Perficient: Drug Development

JANUARY 30, 2025

What to Do Now This is a definite leap forward and progress in the direction of what we have long said is the destinationmore and smaller models targeted at specific use cases. For now, when looking at our clients, we advise a healthy dose of wait and see.

Research

Conversations in Drug Development Trends

NOVEMBER 5, 2024

Both Durveqtix and Adzynma were major advancements this year, as well as the EMA granting PRIME designation for Ultragenyx’s Angelman syndrome, Sangamo’s Fabry disease, and Spur’s Gaucher disease products. Both approaches need experts in the drug process, and CROs can definitely make an impact. DA: Several things!

Disease

New Drug Approvals

JULY 8, 2025

The suspension is stirred and filtered; the product cake is washed with purified water and dried at room temperature in a nitrogen stream and then under vacuum. The product is isolated by filtration and washed with purified water. The product is isolated by filtration and washed with purified water. Crute, J.J.; Tsurumi, T.;

Virus

Molecular Design

DECEMBER 31, 2024

Derek has already posted on the H2024 study which been included in the BL2024 Virtual Special Issue on natural products (NPs) in medicinal chemistry. A more permissive definition of activity would generally be expected to make SAR appear to be less tight (or looser if you prefer).

Small Molecule

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. The draft guidance states that only one 90-minute pre-BLA meeting will typically be granted for a specific product or indication planned for an original marketing application.

Therapies

BMG Labtech

DECEMBER 20, 2024

We look at some widely used practical applications, consider some definitions, and shed some light on recommended usage. Lets start by looking at some definitions. In this blog, we examine the utility of absorbance and optical density measurements, including examples where microplate readers can help.

DNA

FDA Law Blog: Biosimilars

NOVEMBER 18, 2024

The second part of Kennedy’s statement expresses concern that because companies are essentially paying the salaries of the review teams, that the teams somehow feel obligated to approve the products. CDRH’s long-standing definition of “valid scientific evidence” does not include opinions or beliefs.

FDA

Perficient: Drug Development

NOVEMBER 25, 2024

Now more than ever, we’re witnessing a significant shift from simple AI capabilities to action-driven AI Agents that promise to revolutionize how we approach knowledge work, product development, and business processes. Role Definition : A clear, contextual understanding of its purpose and role often within a team.

Production

Perficient: Drug Development

DECEMBER 4, 2024

Ethical Responsibility: The Foundation of Responsible AI Ethical responsibility is often our go-to definition for Responsible AI. Let’s dive into what “Responsible AI” could mean with a broader scope. While AI should offer flexibility, there’s a balance to be struck.

International

FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

FDA provides definitions for the three datasets. PMS requires manufacturers to gather information from various sources, evaluate the data for trends, and integrate the data into product development, risk management and design updates. In fact, the final guidance includes an example of a combination product in Appendix B.

FDA

Perficient: Drug Development

FEBRUARY 13, 2025

SAP Business Data Cloud I don’t know much about SAP, so you can definitely learn more here. I don’t want to get ahead of myself, but I would definitely consider putting that other instance of Databricks on another hyperscaler. In both directions. With governance. This is big.

Government

DrugBank

SEPTEMBER 12, 2024

Your Definitive Source of Truth The Data Dictionary is tailored to transform your data experience, offering the official DrugBank perspective on every piece of information in our database. Enhanced User Experience By offering immediate access to detailed data definitions, the Data Dictionary saves you time and reduces errors.

Production

DrugBaron

OCTOBER 17, 2022

Before long, the story rather than the product candidates themselves have become the principal “asset” of the company. Global pharma companies, at least until recently, didn’t have “stories” linking assets but an uncorrelated pipeline of product candidates chosen for their individual value. New oncology products.

Pharma Companies

FDA Law Blog: Biosimilars

APRIL 3, 2023

Kirschenbaum — On March 31, the Federal District Court for the District of Maryland upheld CMS’s definition of a “new formulation” under the Medicaid Drug Rebate Program (MDRP). All of these products are line extensions under CMS’s definition. Vanda Pharmaceuticals, Inc. MJM-22-977 (Dist.

Drugs

FDA Law Blog: Biosimilars

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

Biosimilars

FDA Law Blog: Biosimilars

JULY 11, 2023

Koblitz — One of the most important questions FDA has to answer is whether a given product is appropriately characterized as a drug, biologic, device, food, cosmetic, or something entirely different. As we have explained before , that distinction is critical to assigning a particular product to the appropriate regulatory scheme.

FDA

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

FDA Law Blog: Biosimilars

JULY 16, 2025

Kennedy told a House congressional committee that he would like to see all Americans make use of wearable products, such as Apple Watch, Oura Rings, Fitbits, and WHOOP, to “take control of their health.” The WHOOP Warning Letter turns this well-established precedent on its head. Two clear examples of this are SpO2 and heart rate monitoring.

Production

Advarra

JULY 27, 2022

As a pharmaceutical product makes its way through the lifecycle, there are often Food and Drug Administration (FDA) guidelines organizations should pay particular attention to. Managing regulatory submissions through increased product and process knowledge. The definition of the levels of reporting categories for such changes.

Production

The Premier Consulting Blog

NOVEMBER 8, 2022

With the promise of simplified and improved treatments, the $118 billion combination-product market is projected to increase at a compound annual growth rate (CAGR) of 8.8%. metered-dose inhaler) However, the four-part definition in 21 CFR 3.2(e) metered-dose inhaler) However, the four-part definition in 21 CFR 3.2(e)

Production

FDA Law Blog: Biosimilars

JUNE 13, 2024

As we explained back in March , Teva had initiated Hatch-Waxman pre-launch patent litigation against Amneal for infringement of 5 Orange Book-listed patents reading on the device constituent (a metered dose inhaler) of Teva’s combination product ProAir HFA. b)(1) that drug product patents may be listed if they claim the “drug product.

FDA

LifeSciVC

NOVEMBER 17, 2023

This year we start with a deep dive into the biomedical innovation across our industry – “putting the Big back into Big Pharma” with obesity and Alzheimer’s, and the state of play across other disease areas, industry R&D productivity, and the risks facing the sector.

Science

FDA Law Blog: Biosimilars

APRIL 25, 2023

510(k), premarket approval application (PMA), Product Development Protocol (PDP), De Novo, or Humanitarian Device Exemption (HDE)] for a device that meets the definition of a cyber device under this section shall include such information as [FDA] may require to ensure that such cyber device meets the cybersecurity requirements. . . .

FDA

FDA Law Blog: Biosimilars

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.

FDA

Agency IQ

OCTOBER 6, 2023

The EPA has a new, enforceable definition for PFAS. As part of its new PFAS reporting rule, the Environmental Protection Agency has published a newly enforceable definition of PFAS that significantly increases the number of chemicals covered by the definition, and therefore, the rule. What does it actually cover?

Regulations

Agency IQ

MAY 10, 2024

FDA holds the line on remanufacturing definitions in newly finalized guidance Almost three years after the initial draft, the FDA has now finalized guidance describing the differences between medical device “servicing” and “remanufacturing” and each activity’s quality system implications. That draft guidance came out in 2021.

FDA

Perficient: Drug Development

NOVEMBER 6, 2023

Moving from the traditional monolithic CMS model to composable does allow you to pick and choose “best in breed” products, but it can lead to confusion and uncertainty. If there are tools that definitely aren’t going anywhere, make a note of those. These are key metrics in determining which products will yield the largest ROI.

Production

PLOS: DNA Science

DECEMBER 14, 2023

I don’t use scented products other than Pine-Sol, so this was all new to me. Before I dig into the science, I’ll relate taking a quiz on the Future Society website that would help me choose a product. ” Definitely Zen retreat, because Wendy meditates. Next, the screen asked me to describe Wendy.

DNA

Agency IQ

JUNE 28, 2024

New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time.

Trials

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Amongst other things, FDA co-opted many of the same definitions for key terms for implementation of the BPCIA. FDA borrowed this definition from 21 C.F.R. FDA replied that its definition of strength including concentration was clear even in 2009. mg/mL) for liquid parenteral drug products.

FDA

Cytel

APRIL 22, 2024

Adler, Director, Global Product Engagement, and J. Each definition of probability of success has benefits and limitations both in the way it is measured, and the way it is accounted for in study design and execution. Written by Boaz N.

Clinical Trials

Perficient: Drug Development

NOVEMBER 14, 2023

Effective consent solutions stem from upfront strategy definition and a clear understanding of each client’s unique regulatory, technology, and policy landscape. Production operation strategy, business workflow design and implementation: Developing strategies and workflows for efficient consent management in production.

Compliance

FDA Law Blog: Biosimilars

JULY 15, 2025

CMS proposes to add a definition of “bundled arrangement” to the existing ASP regulations at 42 C.F.R. This definition is familiar to drug manufacturers because it is substantially identical to the definition that has existed under the MDRP since 2007. See 42 CFR 447.502. Now, CMS proposes much more oversight.

Regulations