PPD

NOVEMBER 11, 2024

By accelerating timelines, anticipating challenges and alleviating bottlenecks, pharmaceutical companies and combined CDMO and CRO partners together can help ensure those potential treatments reach the patients who need them as efficiently as possible.

Drug Development 97

Drug Development Clinical Trials Drugs Small Molecule 97

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.

Therapies 105

Therapies Research Small Molecule Clinical Trials 105

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.

Small Molecule 80

Small Molecule Clinical Trials Pharmaceuticals Pharmaceutical Companies 80

The Pharma Data

NOVEMBER 30, 2020

Biohaven acquires exclusive global rights to a portfolio of novel, small-molecule CGRP antagonists. The lead candidate, HTL0022562, has advanced through preclinical development demonstrating promising and differentiated properties for further investigation in human trials.

Small Molecule 40

Small Molecule Licensing Licensing Treatment 40

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.

Small Molecule 40

Small Molecule Structure Based Drug Design (SBDD) Molecular Biology International 40

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.

Fragment Screening 96

Fragment Screening Biochemical Assays Small Molecule Biophysical Assays 96

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.

Drug Development 71

Drug Development Metabolic Stability Clinical Trials Drugs 71

Drug Target Review

AUGUST 25, 2023

However, in tissues where the 3 Hs are not present, the small molecule has anti-toxicity activity through 1) direct inhibition of the NLRP3 inflammasome, an inflammation starter and perpetuator, and 2) upregulation of the master antioxidant transcription factor, Nrf2. References Oronsky B, Scribner C, Aggarwal R, Cabrales P.

Small Molecule 98

Small Molecule Virus International Clinical Trials 98

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.

Pharmaceuticals 52

Pharmaceuticals Small Molecule Biosimilars Disease 52

Drug Target Review

MARCH 28, 2024

Between 2000 and 2020, approximately 30 percent of the newly introduced small molecule drugs were derived from natural products. In short, this hypothesis underscores the potential benefits of aligning pharmaceutical development more closely with nature.

Production 128

Production Drugs Small Molecule Bioinformatics 128

The Pharma Data

OCTOBER 15, 2020

Vertex Pharmaceuticals has decided to give up on its experimental VX-814, a small molecule drug for the rare genetic disease Alpha-1 antitrypsin deficiency (AATD), canning the drug’s development after seeing lackluster results from an early phase 2 trial.

Disease 52

Disease Small Molecule Pharmacokinetics Licensing 52

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.

Small Molecule 52

Small Molecule Drugs FDA Production 52

The Pharma Data

DECEMBER 5, 2020

–(BUSINESS WIRE) December 5, 2020 — Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, today announced new clinical data from its Phase 2 trial evaluating SY-1425, its first-in-class selective retinoic acid receptor alpha (RAR?) CAMBRIDGE, Mass.–(BUSINESS

Clinical Trials 52

Clinical Trials Trials Small Molecule Treatment 52

Drug Target Review

JUNE 19, 2024

Also, many companies never reached the point where they received validation from big pharmaceutical companies. That would provide wonderful information as we think about then going into a first-in-human clinical trial. Just like small molecules and antibodies, cell therapies are changing how we treat patients.

Therapies 84

Therapies Small Molecule Pharmaceutical Companies Molecular Biology 84

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. Additionally, we are preparing to launch several other trials over the coming months.

Treatment 52

Treatment Small Molecule Clinical Trials Trials 52

DrugBank

AUGUST 15, 2024

To effectively navigate this ecosystem and expedite the development of new therapies, collaboration between the pharmaceutical industry and academia is proving increasingly vital. This includes funding large-scale clinical trials and establishing robust manufacturing/distribution networks.

Drug Development 81

Drug Development Clinical Trials Drugs Therapies 81

The Pharma Data

OCTOBER 25, 2020

NASDAQ: PTCT), today announced the initiation of a registration-directed Phase 2/3 clinical trial to evaluate vatiquinone (PTC743) in patients with mitochondrial epilepsy, the highly morbid condition of refractory seizures in children with inherited mitochondrial disease. . SOUTH PLAINFIELD, N.J. , Peltz , Ph.D.,

Clinical Trials 52

Clinical Trials Trials Small Molecule Regulations 52

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. s Kurt R.

Small Molecule 52

Small Molecule Clinical Trials FDA Pharmaceuticals 52

The Pharma Data

JUNE 26, 2021

BioNTech SE (NASDAQ: BNTX, “BioNTech” or “the Company”), announced that the first patient has been treated in its BNT111 Phase 2 cancer vaccine trial (2020-002195-12; NCT04526899). The trial is enrolling a total of 120 patients and will evaluate the effects of the combination as well as single agents alone.

Clinical Trials 52

Clinical Trials Trials Immune Response Vaccine 52

The Pharma Data

SEPTEMBER 12, 2020

Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.

Vaccine 52

Vaccine Trials Clinical Trials Small Molecule 52

The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Eloxx Pharmaceuticals, Inc. 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. SOURCE: Eloxx Pharmaceuticals, Inc.

Pharmaceuticals 52

Pharmaceuticals RNA Small Molecule Protein Production 52

The Pharma Data

DECEMBER 10, 2020

11, 2020 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. Lexicon is currently enrolling patients with diabetic peripheral neuropathic pain in a Phase 2 proof-of-concept study of LX9211 and is preparing to initiate a second Phase 2 clinical trial of LX9211 in post-herpetic neuralgia. About Lexicon Pharmaceuticals.

FDA 52

FDA Pharmaceuticals Small Molecule Clinical Development 52

The Pharma Data

OCTOBER 21, 2020

22, 2020 (GLOBE NEWSWIRE) — Atea Pharmaceuticals, Inc. , Chief Executive Officer and Founder of Atea Pharmaceuticals. Importantly, the manufacturing process for our small molecule direct-acting antiviral allows us to produce AT-527 quickly and at scale.”. About Atea Pharmaceuticals. BOSTON, Oct.

RNA 52

RNA Pharmaceuticals Virus Small Molecule 52

The Pharma Data

SEPTEMBER 8, 2020

Phase III clinical trial programme initiated for investigational medicine fenebrutinib, designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS).

Clinical Trials 52

Clinical Trials Trials Disease FDA Approval 52

The Pharma Data

JANUARY 17, 2021

The year is starting to pick up in terms of clinical trial announcements. NeuroRx , Relief Therapeutics and Quantum Leap Healthcare Collaborative (QLHC) announced that NeuroRx and QLHC have signed a Clinical Trial Participation Agreement for the inclusion of Zyesami (RLF-100 aviptadil) in the I-SPY COVID-19 trial.

Immune Response 52

Immune Response Small Molecule Clinical Trials Trials 52

The Pharma Data

MARCH 23, 2022

Statistically significant improvements were achieved in all key secondary endpoints in the trial as well. Etrasimod was developed by Arena Pharmaceuticals, which was recently acquired by Pfizer. The safety profile was consistent with previous Phase 2 studies. Results from the ELEVATE 52 study will be available by the end of Q1.

Trials 52

Trials Small Molecule Biosimilars Therapies 52

Drug Target Review

JULY 18, 2023

If we look at the pharmaceutical industry’s discovery and development success rate over the last 20 to 30 years, it has not improved, staying stubbornly at around 10 percent. With support from pharmaceutical companies, ultimately, the answer to this question should be yes. Will systems like the NHS be able to deliver it?

Drug Development 98

Drug Development Drugs Clinical Development Pharmaceutical Companies 98

PPD

JUNE 27, 2024

In recent years, AA has followed in the footsteps of other dermatology indications — including psoriasis and atopic dermatitis — with growing research and clinical studies focusing on small molecules with broad cellular effects (JAK and PDE4 inhibitors) and cytokine-specific molecules antagonists (IL-23, Th2 and IL17) to treat the condition.

Treatment 52

Treatment Clinical Trials Clinical Research Small Molecule 52

The Pharma Data

OCTOBER 27, 2020

The objective of the Phase 3 clinical trial is to evaluate safety and effectiveness of 18 F-APN-1607 to differentiate patients with Mild Cognitive Impairment (MCI) and different stages of Alzheimer’s disease (AD) from healthy subjects. The proposed trial will enroll approximately 230 subjects with all receiving 18 F-APN-1607.

Clinical Trials 40

Clinical Trials Trials Small Molecule Pharmaceutical Companies 40

The Pharma Data

MARCH 29, 2022

The positive 12- and 52-week results from ELEVATE UC 52 follow the recent announcement of positive 12-week findings from the ELEVATE UC 12 trial on March 23. Etrasimod demonstrated a safety profile consistent with previous studies, including the Phase 2 OASIS trial. About Etrasimod.

Trials 52

Trials Small Molecule Disease Biosimilars 52

The Pharma Data

OCTOBER 26, 2020

27, 2020 /PRNewswire/ — Aridis Pharmaceuticals, Inc. Dr. Hasan Jafri , Chief Medical Officer of Aridis Pharmaceuticals, will be a speaker on a panel entitled “Direct Antivirals and Other Agents Against SARS-CoV2 Virus.” About Aridis Pharmaceuticals, Inc. Aridis Pharmaceuticals, Inc. SAN JOSE, Calif. ,

Pharmaceuticals 52

Pharmaceuticals Virus Hospitals Clinical Trials 52

Practical Cheminformatics

JANUARY 8, 2024

In November and December, several large pharmas held “AI Day” presentations featuring LLM applications for clinical trial data analysis. These information retrieval capabilities have many applications, from writing computer code and collating clinical trial results to summarizing papers on a specific topic.

Drugs 141

Drugs Small Molecule Bioinformatics Packaging 141

The Pharma Data

JANUARY 13, 2021

14, 2021 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals, Inc. we determined the crystal structure of CD40-ligand 2 , developed a humanized version of our antibody (hu5c8, ruplizumab, or Antova®) and tested it in human trials for preventing organ transplant rejection and autoimmunity. Tonix Pharmaceuticals Holding Corp.

Pharmaceuticals 52

Pharmaceuticals Small Molecule Vaccine Protein Expression 52

New Drug Approvals

SEPTEMBER 29, 2024

link] 01 Aug 2022 Cortexyme is now called Quince Therapeutics You need to be a logged in or subscribed to view this content This small molecule is an orally available protease inhibitor targeting the lysine proteases of the periodontal pathogen Porphyromonas gingivalis. This trial involves 93 sites in the U.S. and Europe.

Small Molecule 62

Small Molecule DNA Disease Trials 62

Drug Target Review

JUNE 12, 2023

With 13 preclinical candidates and three AI-designed drugs currently undergoing clinical trials, Insilico is spearheading a revolution in cancer treatment and beyond. 2021 – and a robust pipeline that includes 3 AI-designed drugs (for IPF, COVID-19 and cancer) currently in clinical trials.

Metabolic Stability 92

Metabolic Stability Clinical Trials Small Molecule Pharmacokinetics 92

Dark Matter Blog

JULY 16, 2021

My last stop at Arrakis Therapeutics is with a company targeting RNA with small molecules. I was enticed by Arrakis’ founder Jen Petter to serve in one more operational role, leading the research group at Arrakis as the company launched as one of the first biotechs to target RNA with drug-like small molecules.

Small Molecule 52

Small Molecule RNA Clinical Trials DNA 52

The Pharma Data

JANUARY 17, 2021

The results provide an opportunity for the company to pursue a pivotal Phase 2/3 clinical trial in patients with primary biliary cholangitis (PBC), based on interactions with the FDA. The trial consisted of a single ascending dose (SAD) part and a multiple ascending dose (MAD) part with dosing up to 1600mg/day. About Calliditas.

Trials 40

Trials Clinical Trials Pharmacokinetics Small Molecule 40