New Drug Approvals

JULY 7, 2025

Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of NMPA granted pimicotinib breakthrough therapy designation (BTD) for the treatment of tenosynovial giant cell tumor patients that are not amenable to surgery in January 2023 and July 2022, respectively. [7] amcrasto@gmail.com NEW DRUG APPROVALS ONE TIME $10.00

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New Drug Approvals

JULY 6, 2025

It is a small molecule delivered orally. [1] “Prospect of acromegaly therapy: molecular mechanism of clinical drugs octreotide and paltusotine” Nature Communications. amcrasto@gmail.com NEW DRUG APPROVALS ONE TIME $10.00 amcrasto@gmail.com NEW DRUG APPROVALS ONE TIME $10.00 mmol) and DIPEA (1.19

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Small Molecule Pharmaceuticals Production Drugs 62

FDA Law Blog: Biosimilars

JULY 2, 2025

Our team assists clients with a wide variety of quality and manufacturing regulatory topics for drugs and biologics. Reviewing test protocols and reports for small molecule or biologic drug programs. Specifically, manufacturing/testing procedures and compliance with cGMPs.

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addgene Blog

JULY 25, 2024

originally developed the ELISA assay to measure antibody levels, scientists have since adapted it for a host of different proteins and small molecules from a variety of sample types (Engvall 1971). and use them in numerous fields including research and development, diagnostics, drug discovery, and food safety.

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Practical Cheminformatics

JANUARY 8, 2024

Picking up where we left off in Part I , this post covers several other ML in drug discovery topics that interested me in 2023. Most of the LLM activity in the drug discovery space in 2023 was reported as preprints from academic groups. Most of the drug discovery examples were underwhelming. Here’s the structure of Part II.

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The Premier Consulting Blog

NOVEMBER 20, 2024

In the case of urgent or immediate public interest, process validation may be conducted concurrently with manufacturing the commercial small molecule or biologic product to expedite product availability for patients. It ensures that a production process consistently yields products of predetermined quality and safety.

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Small Molecule Drugs FDA Production 52

FDA Law Blog: Biosimilars

SEPTEMBER 11, 2024

Claud — Last week, FDA revised one of its two guidances relating to nitrosamines, Control of Nitrosamine Impurities in Human Drugs. Nitrosamines are impurities that can form during drug manufacturing and are considered potentially potent carcinogens. It’s these varied scenarios that give quality managers nightmares.

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Small Molecule FDA Production Drugs 105

Molecular Design

DECEMBER 31, 2024

My pulse will be quickenin' With each drop of strychnine We feed to a pigeon It just takes a smidgin To poison a pigeon in the park Tom Lehrer, Poisoning Pigeons in the Park | video ** Ill be reviewing the H2024 study (Occurrence of Natural Selection in Successful Small Molecule Drug Discovery) in this post.

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Small Molecule Drugs Production Science 85

LifeSciVC

APRIL 24, 2024

Is a novel target at the inflection point where enough evidence is available to suggest it may prove to be a compelling drug? and whether a molecule’s pharmacology can help to mitigate safety risk. based on “tool” molecule precedent. Finally, as part of a broader pathway analysis, consider potential implications for selectivity.

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FDA Law Blog: Biosimilars

AUGUST 27, 2024

The series, held virtually on Tuesday and Thursday afternoons on ACI’s interactive platform, will provide an in-depth review of Hatch-Waxman and the BPCIA, as well as other intellectual property basics related to small molecules and biologics. FDA Law Blog readers receive a 10% discount (use FDA Law Blog promo code: D10-999-FDA25).

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Small Molecule FDA Regulations Science 59

Dark Matter Blog

JANUARY 16, 2023

We want to mark this progress with some updates and perspectives in the Dark Matter blog. Our terra firma is small-molecule medicines. We want a drug that we understand, whose behavior is predictable, that is inexpensive and reliable to make, and that can be packed into trucks and shipped to your local drugstore.

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NIH Director's Blog: Drug Development

OCTOBER 30, 2018

Now comes word of another absolutely incredible use of cryo-EM: determining with great ease and exquisite precision the structure of the smaller organic chemical compounds, or “small molecules,” that play such key roles in biological exploration and drug development. Also analyzed were eight less-familiar small molecules.

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PerkinElmer

JANUARY 7, 2020

Drug discovery is always evolving. From new processes to advanced technologies, excellence in drug discovery is the result of combining different approaches. Emerging and Resurrecting Technologies We’ve made huge strides in the drug discovery process, and it’s only getting better as we move forward.

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Molecular Design

DECEMBER 31, 2023

BW2014 has been heavily cited in the drug discovery literature (it was cited as the first reference in the ACS assay interference editorial which I reviewed in K2017 ) despite providing nothing in the way of practical advice for dealing with nuisance behavior. Most PAINS function as reactive chemicals rather than discriminating drugs. [It

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FDA Law Blog: Biosimilars

JULY 24, 2024

Each fall, leading pharmaceutical patent litigators for brand-name and generic drug companies gather at the Paragraph IV Disputes Master Symposium in Chicago to receive up-to-the-minute information on the latest developments affecting Hatch-Waxman litigation and participate in significant peer-to-peer networking opportunities.

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Atomwise Blog

JULY 11, 2022

Our scientists developed AtomNet® PoseRanker to improve our technology’s ability to rank poses for protein-ligand interactions with potential drug compounds Identifying the highest-quality protein-ligand poses generated from structure-based virtual high-throughput screening (vHTS) approaches is a major challenge for drug discovery.

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Small Molecule Drugs 52

PerkinElmer

SEPTEMBER 8, 2019

Over the last 20 years, Cisbio has become a leading Life Sciences company which develops, manufactures, and markets high quality kits and reagents for the drug discovery and life science markets used by pharmaceutical, biotechnology, academia and contract research organizations across the globe. Learn more about Cisbio here.

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FDA Law Blog: Biosimilars

JULY 21, 2023

This series will provide an in-depth review of Hatch-Waxman and the BPCIA along with other IP basics relative to small molecules and biologics. Save 10% with the FDA Law Blog promo code: D10-999-FDA24. To learn more visit here , or email at customerservice@americanconference.com.

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Small Molecule Regulations FDA Science 52

The Strateos Blog: Drug Discovery

MARCH 18, 2022

strategies to increase the speed, efficiency and reduce the cost of the drug discovery process. Early-stage drug discovery is highly complex and iterative, which bottlenecks the overall workflow. John Harman, Sr. Director of Product Management, Strateos. “Strateos is pioneering new ways to help the industry do better.”

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Dark Matter Blog

JUNE 21, 2023

As a small biotech company with new technology at the frontier of the known drug discovery universe, it may feel like you’re charting a course alone in a dark, cold, and empty void with hailing frequencies open, but with no incoming transmissions. But you would be wrong. This latter course is Arrakis’ strategy.

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BMG Labtech

APRIL 16, 2024

In this blog, we take stock of progress, look at what’s in store for drug development, and give examples of ways microplate readers can help advance research into molecular glues. Conventional drug development has often focused on finding small molecules that fit the active site of a protein.

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Targeted Protein Degradation Small Molecule Drug Development Disease 40

New Drug Approvals

JULY 10, 2025

1] The US Food and Drug Administration granted the application for sebetralstat orphan drug designation. [4] “Sebetralstat (KVD900): A Potent and Selective Small Molecule Plasma Kallikrein Inhibitor Featuring a Novel P1 Group as a Potential Oral On-Demand Treatment for Hereditary Angioedema” Journal of Medicinal Chemistry.

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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. the nanotube—is irrelevant, as it is the “active ingredient” that matters for purposes of classifying the product as a drug or biologic.

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The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.

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Dark Matter Blog

JULY 16, 2021

I wanted to use molecular biology to create drugs. Both companies were founded to explore new space for drug discovery related to RNA, representing the revolution in RNA-focused drug discovery that has happened in the past decade or so. My last stop at Arrakis Therapeutics is with a company targeting RNA with small molecules.

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Small Molecule RNA Clinical Trials DNA 52

The Premier Consulting Blog

JULY 9, 2023

During the development of new small molecule drug products, developers must conduct impurity and degradant evaluation at several points in the program and to varying degrees. These evaluations include the active pharmaceutical ingredient (API), also known as the drug substance, and the drug product (formulated product).

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Small Molecule DNA Drugs Clinical Development 52

Metabolite Tales Blog

DECEMBER 13, 2023

N -glucuronidation: the human element By Julia Shanu-Wilson In our last blog of the year, we look at why N -glucuronidation of drugs is important in human drug metabolism. Glucuronidation is the most common phase II reaction observed in the metabolism of drugs in humans.

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FDA Law Blog: Biosimilars

MARCH 3, 2024

Effect on FDA approvals— In cases where a biological product or drug needs to change aspects of its manufacturing processes to avoid using a covered equipment or service, will it need to file supplements with FDA for the CMC update?

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Government Small Molecule FDA Approval Regulations 102

Dark Matter Blog

AUGUST 31, 2020

The majority of small molecule drugs induce their therapeutic effects by seeking out and binding to their intended target while avoiding most other molecules in the dense milieu of the cell interior. Our overall mission at Arrakis is to expand the set of “druggable” targets for small-molecule medicines to include RNA.

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The Premier Consulting Blog

SEPTEMBER 11, 2024

The 505(b)(2) new drug application (NDA) pathway offers a unique opportunity for small molecule developers to bring innovative products to market more efficiently by leveraging existing data they do not own or have right of reference to. Since there was no change in drug substance, the sponsor was able to reference the DMF.

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Zobio

NOVEMBER 23, 2023

Recent years have seen a surge of interest in the use of covalent compounds in small molecule drug discovery. Het bericht Smoothening the Bumpy Road of Covalent Drug Discovery with Protein NMR verscheen eerst op ZoBio - Drug Discovery Technology.

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Small Molecule Drugs 40

Metabolite Tales Blog

FEBRUARY 15, 2024

As part of a team, the successful applicant will undertake a variety of interesting projects to deliver purified small molecules to collaborators and for our own proprietary projects in the field of biotransformation and natural products drug discovery. The role is predominantly lab-based.

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Nvidia Developer: Drug Discovery

APRIL 20, 2020

Molecular dynamics simulations offer accurate approximations of real molecular behavior, which is useful in different stages of drug development. They are used to simulate proteins and lipids and they shed light on how drugs might bind to a protein. Simulations in these applications can run for several hundred nanoseconds.

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The Strateos Blog: Drug Discovery

JULY 26, 2022

Strateos had the pleasure of participating with Evariste Technologies in a webinar hosted by 20/15 Visioneers, about cloud lab automation-as-a-service being leveraged to accelerate cycle times for faster drug discovery. This in silico approach can reduce time and increase the probability of successfully identifying clinical drug candidates.

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The Premier Consulting Blog

MAY 31, 2023

As a cornerstone of the drug development process, nonclinical investigational new drug (IND)-enabling studies are essential for supporting first-in-human (FIH) dosing for novel therapeutics. Pharmacology A typical IND-enabling package includes information on the primary, secondary, and safety pharmacology of the drug.

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The Strateos Blog: Drug Discovery

FEBRUARY 22, 2022

Strateos’ SVP of Strategy & Operations, Daniel Sipes, echoed this sentiment during his presentation on how automated labs are accelerating medicinal chemistry (MedChem) cycles for drug discovery. The model quality data generated is well-suited to support AI and machine learning tools.”

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The Premier Consulting Blog

JANUARY 31, 2023

Food and Drug Administration (FDA) adopted an addendum to the guidance titled “ S1B(R1) Testing for Carcinogenicity of Pharmaceuticals ,” which had previously been finalized by the International Council for Harmonization (ICH). On November 1, 2022, the U.S. However, the quality and relevance of that data can vary.

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