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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The Pharma Data

NOVEMBER 15, 2020

R&D collaboration building on Lead Pharma’s expertise in the discovery, design and optimization of small molecule treatments. Lead Pharma is a pharmaceutical company focusing on the discovery and development of innovative medicines for the treatment of immune diseases and cancer. About Lead Pharma.

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Drug Patent Watch

DECEMBER 13, 2023

The small molecule drug covered by this patent is AMITIZA. Takeda Pharmaceutical Company… The post New patent lawsuit: Walgreen CO v. Takeda Pharmaceutical Company Limited – Drug patent: 7,795,312 appeared first on DrugPatentWatch - Make Better Decisions. A new lawsuit citing drug patent 7,795,312 has been filed.

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Drug Patent Watch

DECEMBER 13, 2023

The small molecule drug covered by this patent is AMITIZA. Takeda Pharmaceutical Company… The post New patent lawsuit: Walgreen CO v. Takeda Pharmaceutical Company Limited – Drug patent: 8,779,187 appeared first on DrugPatentWatch - Make Better Decisions. A new lawsuit citing drug patent 8,779,187 has been filed.

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Drug Target Review

OCTOBER 23, 2024

Technologies for the rapid and efficient testing of small molecules and biologics have greatly accelerated drug discovery. However, many pharmaceutically relelvant targets remain ‘undruggable’. 2024 Jun 14;384(6701):1259–65.

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Drug Target Review

JULY 4, 2023

These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. 2 However, when dosed at the MTD, ADCs display improved efficacy over small molecules in oncology trials. 3D rendering of Antibody Drug Conjugate Molecules.

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The Pharma Data

NOVEMBER 19, 2020

The Company is also aiming to leverage the highly conserved structure of the SARS-CoV-2 M pro protease as a basis for the design of novel oral small molecules against predicted future variants of SARS-CoV-2 and other related human viruses.

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The Pharma Data

NOVEMBER 30, 2020

Biohaven acquires exclusive global rights to a portfolio of novel, small-molecule CGRP antagonists. NURTEC is a trademark of Biohaven Pharmaceutical Ireland DAC. Sosei Heptares will receive an upfront payment of US$10 million, plus downstream payments of up to US$370 million, plus tiered royalties.

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Drug Target Review

JULY 6, 2023

1 TPD is expected to challenge undruggable proteins, which are highly difficult to target by conventional small molecules. 1 The concept of TPD was first demonstrated with a heterobifunctional small molecule to degrader a protein of interest in the early 2000s.

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DrugBank

MAY 15, 2024

One approach is to look beyond the traditional drug molecule. Researchers are experimenting with biologics—larger biological molecules that can do things small molecules can't, like targeting larger, more complex structures on cell surfaces or even inside cells.

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Drug Target Review

NOVEMBER 1, 2024

Strategies for the synthesis and development of complex active pharmaceutical ingredients While the prevalence of biologics has grown within the pharmaceutical sector over recent decades, small molecules remain important and can offer significant advantages. References [1] Clemons et al.

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Broad Institute

OCTOBER 4, 2023

By Allessandra DiCorato October 4, 2023 Credit: AbbVie The new small molecule inhibitor (green) sits inside the PTPN2 protein, where acidic sites are marked in red and basic sites are marked in blue. A new small-molecule drug candidate being tested in an early-stage clinical trial aims to improve patient responses to immunotherapy.

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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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Zobio

MARCH 12, 2024

This event serves as a premier gathering for medicinal chemists in the pharmaceutical and biotech industries, focusing on the challenges and advancements in small molecule drug discovery and optimization. This year Johan Veerman presented Site.

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Zobio

MARCH 12, 2024

This event serves as a premier gathering for medicinal chemists in the pharmaceutical and biotech industries, focusing on the challenges and advancements in small molecule drug discovery and optimization. This year Johan Veerman presented Site.

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Zobio

MARCH 12, 2024

This event serves as a premier gathering for medicinal chemists in the pharmaceutical and biotech industries, focusing on the challenges and advancements in small molecule drug discovery and optimization. Johan Veerman’s presentation on Site Directed.

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Conversations in Drug Development Trends

APRIL 4, 2024

Developing pharmaceuticals is a complex process, requiring stringent bioanalytical method validation guidelines to ensure drug safety and efficacy. To help integrate these various regulatory standards, the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use was founded in 2016.

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The Pharma Data

MARCH 13, 2022

NYSE: PFE) announced today the completion of its acquisition of Arena Pharmaceuticals, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases. Pfizer Inc. The root cause of many immunological diseases is immuno-inflammation, which requires specifically designed agents.

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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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Metabolite Tales Blog

FEBRUARY 15, 2024

Senior Purification Chemist Hypha Discovery has an exciting opportunity for an experienced purification chemist to join our team to work on metabolite synthesis and impurity purification projects with our global pharmaceutical and agrochemical partners. The role is predominantly lab-based.

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FDA Law Blog: Biosimilars

SEPTEMBER 11, 2024

One specific kind of nitrosamines called N-nitrosamine drug substance-related impurities, or NDSRIs, are especially vexing to FDA and to industry because they mimic the structure of the specific active pharmaceutical ingredients (API), making them difficult to detect. It’s these varied scenarios that give quality managers nightmares.

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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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Drug Target Review

NOVEMBER 25, 2024

As the CEO of iOnctura, an innovative oncology biopharmaceutical company she co-founded in 2017, Catherine has played a key role in advancing the development of highly targeted small molecules aimed at revolutionising cancer treatment. Gender diversity is a hot topic in pharmaceutical and biotech drug development.

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Sygnature Discovery

APRIL 18, 2023

Sygnature Discovery is pleased to have entered into a research collaboration agreement with the global healthcare group Daewoong Pharmaceutical to accelerate the discovery of a novel small molecule to target autoimmune disease.

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DrugBank

MAY 22, 2024

In the dynamic world of drug discovery, the notion of "undruggable" targets presents both a significant challenge and an intriguing frontier for researchers and pharmaceutical companies. Strategies to Tackle PPIs Despite these challenges, some wins in targeting PPIs with small molecules have emerged.

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DrugBaron

FEBRUARY 7, 2022

Finding small molecule drugs is much harder than finding a needle in a haystack – discovering the right arrangement of atoms to bind precisely to a protein target to elicit a particular response is a problem of vast dimensionality. Yet the situation with small molecules is even worse.

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Drug Target Review

OCTOBER 11, 2023

Autophagy boosters, in contrast, are conventional small molecule drugs. Small molecules have been the mainstay of the pharmaceutical industry for nearly a century, they are easy to deliver – they are often given orally – and our health systems have a lot of experience of working with them.

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Drug Target Review

DECEMBER 6, 2023

We also relay the application of a high-throughput assay to screen for potential small molecule inhibitors of SARS-CoV-2 replication, underscoring the ongoing efforts to combat the global pandemic.

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Broad Institute

NOVEMBER 2, 2023

Our joint goal is to bring innovation to cancer patients by building a robust, sustainable pipeline in oncology,” said Dominik Ruettinger, Global Head of Research and Early Development for Oncology, Pharmaceuticals Division, Bayer AG.

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DrugBank

OCTOBER 17, 2024

By harnessing the vast amounts of data generated throughout the development pipeline, pharmaceutical companies can accelerate the discovery of novel therapies, optimize clinical trial design, enhance drug safety monitoring, and deliver personalized medicine, ultimately improving patient outcomes and transforming the future of healthcare.

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PPD

NOVEMBER 11, 2024

According to Citeline’s Pharmaprojects tracking, some 21,000 molecules are in the drug development pipeline right now – and they are all being developed because they have the potential to change and save lives. Accelerate your drug development and clinical trial goals and benefit from our 360° CDMO and CRO solutions and expertise.

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PPD

OCTOBER 18, 2023

There has been an unprecedented expansion of different types of pharmaceutical therapies, as well as a change in the overall approach to health care. PPD ® Laboratory services are backed by a proven track record with over three decades of experience providing CMC pharmaceutical testing.

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The Pharma Data

JANUARY 5, 2021

Durham, North Carolina-based Ribometrix announced a strategic collaboration deal with Genentech , a Roche company, to identify and advance novel RNA-targeted small molecule therapeutics. This is because many proteins do not have small-molecule binding sites. This is not the first deal for RNA therapeutics for Genentech.

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Drug Hunter

MAY 18, 2023

Dian eventually made her way to Shanghai, where she encountered a much bigger world while earning degrees in pharmaceutical engineering and medicinal chemistry. In her small molecule DMPK research, proteomics also served to identify reactive metabolites (e.g., Dian recalls. But I didn’t want to take that as my fate.” Proteomics!

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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. Transplanting cells could prove to be more beneficial than treating a particular condition with a small molecule or an antibody, and that really speaks to the power of cell therapy. from May 2017 until December 2022.

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Drug Target Review

NOVEMBER 1, 2023

The mission of the CCDD is to discover novel small-molecule therapeutics for the treatment of cancer and progress them to hypothesis testing phase 1 clinical trials. We have several exciting projects in various stages of discovery, but a small-molecule drug that is causing a lot of excitement at the moment is Capivasertib.

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Alta Sciences

NOVEMBER 5, 2024

As the final dosage form is not needed until Phase II, we can take advantage of LFCs in the early phases and then consider an alternate dosage form such as tablets, if the client prefers.” — Ben Reed, Executive Vice President, CDMO Operations, Benefits of Liquid-Filled Capsules for Pharmaceutical Development.

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