The Premier Consulting Blog

NOVEMBER 20, 2024

Process validation is a critical regulatory requirement in pharmaceutical manufacturing. 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.

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Dark Matter Blog

JANUARY 16, 2023

Our terra firma is small-molecule medicines. As we know, small molecules have been the mainstay of our pharmacopeia for several centuries and have, almost without exception, targeted proteins. This is why Arrakis set out in 2015 on an expedition to figure out how to develop small molecules that can target RNA.

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The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Eloxx Pharmaceuticals, Inc. International Dial-in Number: (210) 874-7715. About Eloxx Pharmaceuticals. Eloxx Pharmaceuticals, Inc. Eloxx’s lead investigational product candidate, ELX-02, is a small molecule drug candidate designed to restore production of full-length functional proteins.

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Drug Target Review

APRIL 19, 2024

Sibylla’s scientific founders come from very different scientific fields that do not usually speak to each other, such as theoretical physics, molecular biology and pharmaceutical chemistry. We also have collaborations with pharmaceutical companies where we leverage the best of our unique platform and pharma expertise on the target.

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The Pharma Data

JANUARY 13, 2021

14, 2021 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals, Inc. The patent application is titled “Anti-CD154 Antibodies and Uses Thereof” and published under International Publication No. International Immunol. (11):1583 Tonix Pharmaceuticals Holding Corp. CHATHAM, N.J., Holding Corp. WO 2021/001458 A1. Structure.

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Agency IQ

NOVEMBER 10, 2023

BY ALEXANDER GAFFNEY, MS, RAC | NOV 9, 2023 6:35 PM CST Background on CDER’s Office of Pharmaceutical Quality (OPQ) CDER’s Office of Pharmaceutical Quality became operational in January 2015, making it a still relatively recent addition to the agency. Read our analysis of a recent meeting focused on KASA here. ]

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The Pharma Data

APRIL 28, 2021

OSAKA, Japan, April 28, 2021 – Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that it was awarded by the International Society for Pharmaceutical Engineering (ISPE) for the 2021 Facility Of the Year Awards (FOYA) in two categories.

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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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The Pharma Data

DECEMBER 21, 2020

Program focused on identifying small molecules that target a GPCR for degradation as potential therapeutic agents for gastrointestinal disorders. The principle of TPD is to use small molecules to commit the target protein into the E3 ligase-mediated degradation pathway thereby eliminating or reducing its activity.

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Practical Cheminformatics

JANUARY 8, 2024

While large pharmaceutical companies have data on thousands or even millions of compounds, this data is rarely shared due to intellectual property concerns. Data from 21 million molecules and more than 40,000 assays was securely combined into a multitask model. increase in AUC-PR over internal models.

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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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Drug Target Review

JULY 31, 2023

When it came time to graduate, I thought I wanted to go to graduate school in chemistry, but first I took a year abroad and worked as a teacher at the international school in Israel. That’s how I got into chemistry. When I started in academics 16 years ago, I heard the question, “how can I evaluate your work if you are not the last author?

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The Pharma Data

NOVEMBER 23, 2020

At Ultimovacs, he will lead all business and corporate development efforts and continue to maintain and foster connections with leading biotechnology and pharmaceutical companies. “In Berkien will join Ultimovacs from his current position at Amgen as Director Global Business Development.

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The Pharma Data

JULY 15, 2021

JJIPO@Monash was originally launched in 2018 to provide crucial support to researchers and companies in the Victorian life-science sector as part of the Government’s commitment to the medical technologies and pharmaceuticals sector – one of eight priority growth sectors.

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Drug Target Review

JULY 7, 2023

It normally binds to and recycles internalised immunoglobin G (IgG) antibodies, which are important for fighting infections, as well as albumin, which helps move many small molecules through the blood. Current Pharmaceutical Design. International Journal of Molecular Sciences. 2021 [cited 2023Feb28]. Deane KD, Holers VM.

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The Pharma Data

OCTOBER 18, 2020

Previously he served as President, Chief Medical Officer and Board Director of Sideris Pharmaceuticals and was also Chief Medical Officer at Vedantra Pharmaceuticals, BIND Therapeutics, Inc., Inflection Biosciences Ltd is developing small molecule therapeutics for the treatment of cancer. About Inflection Biosciences.

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The Pharma Data

JANUARY 17, 2021

Aurinia Pharmaceutical’s Voclosporin for Lupus Nephritis. Aurinia Pharmaceuticals , based in Victoria, British Columbia and Rockville, Maryland, has a target action date of January 22 for its voclosporin. On December 17, 2020, Aurinia inked a collaboration and license deal with Japan’s Otsuka Pharmaceutical Co.

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The Pharma Data

DECEMBER 17, 2020

Hartfield previously served as CEO of Vitae Pharmaceuticals prior to its acquisition by Allergan. X4 Pharmaceuticals – Diego Cadavid was named chief medical officer of Boston-based X4 Pharmaceuticals. Karydas is chief financial officer at Syndax Pharmaceuticals. Sucampo Pharmaceuticals and Histogenics Corporation.

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The Pharma Data

JANUARY 19, 2021

TC-210 is currently in a Phase I/II trial for mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. Syros Pharmaceuticals – Syros announced its IPO on January 20, offering 5.4 million shares of common stock at $14 per share, to raise $75.6

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Sygnature Discovery

JUNE 17, 2024

Biophysics in Drug Discovery: A Sygnature Approach Our key biophysics leaders alone possess over 50 years of combined experience in drug discovery, spanning CRO, pharmaceutical, and biotech sectors, and applied across various target classes and therapeutic modalities. Nucleic Acid Targets: Focusing on specific interactions and functions.

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Drug Target Review

DECEMBER 13, 2024

Typically, these combinations include an immune checkpoint inhibitor (CPI; eg, anti-programmed cell death protein 1 [PD-1] / programmed cell death ligand 1 [PD-L1]) combined with other components such as chemotherapy, a targeted small molecule drug, novel CPIs, or ADCs. Pharmaceuticals (Basel). Discov Oncol. 2024;15(1):327.

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The Pharma Data

DECEMBER 15, 2020

(hereinafter referred to as: CHIPSCREEN BIOSCIENCES) and ZHEJIANG HISUN PHARMACEUTICAL CO., hereinafter referred to as: HISUN PHARMACEUTICAL) announced that they have reached a strategic cooperation. SH) was founded in Shenzhen on 2001, specializing in the research and development of novel small molecule drugs.

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The Pharma Data

JANUARY 19, 2021

–( BUSINESS WIRE )– Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, announced today that it has priced an underwritten public offering of 5,400,000 shares of common stock at a public offering price of $14.00 About Syros Pharmaceuticals. 20, 2021 03:41 UTC.

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New Drug Approvals

JANUARY 31, 2024

PATENT The free base and salts of the compound of formula (I) may be prepared for example, according to the procedures given in International Patent Application No. It works as a colony-stimulating factor 1 ( CSF1 ) receptor inhibitor. [1] PCT/US2007/066898 filed on Apr. 18, 2007 and published as WO2007/121484 on Oct.

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The Pharma Data

DECEMBER 15, 2020

Small Molecule Inhibitors. NMD670 is a first-in-class small molecule inhibitor of the muscle specific chloride ion channel, the ClC-1 ion channel. Oral, Small Molecules. KAN-101 is in a randomized, double-blind, placebo-controlled Phase I study, Assessment of KAN-101 in Celiac Disease.

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The Pharma Data

MAY 16, 2022

LINZESS is part of a collaboration between AbbVie and Ironwood Pharmaceuticals to share development and commercialization of LINZESS in the United States. Use of risankizumab in Crohn’s disease is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

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New Drug Approvals

JANUARY 31, 2024

INAXAPLIN, 2446816-88-0 2446816-88-0 S2SJ2RVZ6Y UNII-S2SJ2RVZ6Y C 21 H 18 F 3 N 3 O 3 3-[5,7-difluoro-2-(4-fluorophenyl)-1 H -indol-3-yl]- N -[(3 S ,4 R )-4-hydroxy-2-oxopyrrolidin-3-yl]propanamide Inaxaplin ( VX-147 ) is a small-molecule apolipoprotein L1 inhibitor developed by Vertex Pharmaceuticals for APOL1-mediated kidney disease.

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Drug Target Review

SEPTEMBER 26, 2024

Cresset delivers software solutions and contract research expertise enabling companies around the world to accelerate their small molecule discovery processes efficiently and effectively. Customers include the pharmaceutical, biotechnology and agrochemical industries.

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The Premier Consulting Blog

OCTOBER 5, 2022

Generate a process description document First, we recommend that a “ process description ” document be generated and internally reviewed prior to the start of the process technology transfer. Supply chain constraints are endemic for many goods in the post-COVID era, and this has impacted the pharmaceutical manufacturing industry as well.

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The Pharma Data

FEBRUARY 18, 2022

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Source link: [link].

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Vial

FEBRUARY 19, 2024

Explore the groundbreaking VersAptx bioconjugation platform, designed to elevate cancer therapies and uncover the delicate balance between clinical excellence and commercial viability in the dynamic landscape of pharmaceuticals. We can link small molecule drugs to a payload that would enter in the cell and kill it.

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The Pharma Data

NOVEMBER 11, 2020

Adding a new building, which will house up to 100 biologists by the end of the year, will bring together all the key functions for cutting-edge and high-performance small molecule discovery and up to commercial development.

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The Pharma Data

MARCH 4, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) and Ovid Therapeutics Inc. The live event will be available on the investor page of the Ovid Therapeutics website at investors.ovidrx.com or by dialing (866) 830-1640 (domestic) or (210) 874-7820 (international) and referencing conference ID number 6343028.

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LifeSciVC

APRIL 27, 2023

Fourteen years on, this corporate experiment has gone far beyond the initial idea, and has established an R&D engine more effective than most big pharma R&D groups at producing best-in-class small molecules against targets that matter in human disease biology. Our long-time clinical development lead, Bhaskar Srivastava, an M.D.

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New Drug Approvals

SEPTEMBER 13, 2024

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 21] In August 2017, it was announced that Cerecor had sold its rights to aticaprant to Janssen Pharmaceuticals. [22] 2] Aticaprant is taken by mouth. [1] nM vs. 24.0

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Codon

DECEMBER 12, 2024

A drug called thalidomide, initially made by a West German pharmaceutical company called Chemie Grünenthal, was manufactured and given to patients as a mixture containing both enantiomers. The most obvious defense would not be vaccines, but rather antibiotics; small molecules that treat or prevent bacterial infections.

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The Pharma Data

SEPTEMBER 15, 2020

Pfizer announced several key advances in its efforts to protect humankind from the COVID-19 pandemic and prepare the pharmaceutical industry to better respond to future global health crises. Internal Medicine. These results were presented in August at the Digital International Liver Congress 2020. approval in 2021. and -50.4%

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