Drug Target Review

SEPTEMBER 26, 2023

Early detection of neurotoxicity induced by potential new therapies is a major challenge, and hiPSC-neuronal cells may provide a solution. 2008 Mar;153 Suppl 2(Suppl 2):S1-209. Human derived induced pluripotent stem cells (hiPSCs) have revolutionised research and are increasingly used for toxicology screening and disease modelling.

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The Pharma Data

DECEMBER 17, 2020

A total of 5,083 such patients were randomly assigned to receive either hormone therapy alone or intravenous taxane and/or anthracycline-based chemotherapy followed by hormone therapy. The patients were monitored for a median of five years to assess invasive disease-free survival (IDFS) and overall survival (OS). Reshma Jagsi, M.D.,

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The Pharma Data

DECEMBER 10, 2020

He became Head of Development for Rare Diseases and Gene Therapy in Sanofi-Genzyme’s office in Cambridge, Massachusetts. Dr Pirozzi subsequently was inspired to pursue a career in rare diseases after his daughter Valentina was diagnosed with a rare chromosomal syndrome, called Smith-Magenis Syndrome. positions he assumed in 2020.

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Conversations in Drug Development Trends

APRIL 5, 2024

Observed annually on the last day of February since 2008, Rare Disease Day has grown into a global movement for raising awareness, promoting research, and advocating for improved access to rare disease treatments and support services. For others, this rare day is aptly the day we honor rare disease communities.

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NIH Director's Blog: Drug Discovery

MAY 9, 2019

Such information will not only expand fundamental biological understanding, but will accelerate efforts to discover new therapies for diseases, such as cancer, in which disruption of allosteric proteins plays a crucial role. 2008 Sep;33(9):420-425. [2] ’ Fenton AW. Trends Biochem Sci.

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The Pharma Data

DECEMBER 17, 2020

Goater is CEO at Surface Oncology, an immuno-oncology company developing next-generation antibody therapies. Thérin is the president of Advanced Therapies at Siemens Healthineers. Prior to SpringWorks, Smith was the executive vice president of Gene Therapy at Bamboo Therapeutics. Previously he was CFO of Voyager Therapeutics.

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NIH Director's Blog: Drug Development

JUNE 14, 2016

The study, which analyzed vast troves of genomic and clinical data collected over many years from more than 50,000 people with and without diabetes, indicates that anti-diabetes therapies that lower glucose by targeting the product of a specific gene, called GLP1R , are unlikely to boost the risk of cardiovascular disease. December 2008. [2]

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The Pharma Data

NOVEMBER 20, 2020

And an AHA advisory in 2008 recommended screening for depression in people with coronary heart disease. Medications, talk therapy and exercise can help, Moser and Celano said. Preventive Services Task Force in 2016 recommended depression screening for the general population, with an emphasis on people with cardiovascular disease.

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NIH Director's Blog: Drug Development

OCTOBER 11, 2022

The approach also is being used to improve delivery of antibody-based therapies and to create new biomaterials. Science 2008, 320 (5876), 664–667. [6] For clinical researchers, click chemistry has emerged as a workhorse in drug discovery and the improved targeting of cancer chemotherapies and other small-molecule drugs.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

The first multiple PTE case up-to-bat concerns Gilead Sciences Inc.’s In September 2014—nearly ten years ago!

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The Pharma Data

AUGUST 9, 2020

Etrolizumab failed to meet its primary endpoint versus placebo as maintenance therapy in people with ulcerative colitis. 2008; 14(supp 2):S4–S5. [6] Etrolizumab met its primary endpoint of inducing remission versus placebo for people with ulcerative colitis in only two of three studies. Gastroenterol Hepatol. 2016; 12:438–41. [5]

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The Pharma Data

NOVEMBER 25, 2020

It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. For more information, including an easy-to-use symptom checker, visit takeironseriously.com/raise-awareness and follow on Instagram and on Twitter, using the hashtags #IDDay2020 #TakeIronSeriously #IronDeficiency #IronDeficiencyDay. Am J Clin Nutr.

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Codon

JUNE 11, 2024

But in 2008 , physicists at the University of Washington made a nanopore sequencer using a protein, called MspA, from Mycobacterium smegmatis, a bacterium first described in the 1880s. Stephen Malina is Head of Engineering at Dyno Therapeutics, a company using machine learning to design better viral vectors for gene therapy.

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The Pharma Data

NOVEMBER 5, 2020

Velders is presently chairman of HollandBIO, the association of Dutch biotech companies, and provides years of experience, specifically in the cell and gene therapy areas. Taveras will lead all research and non-clinical development functions supporting the company’s pipeline of investigational therapies.

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New Drug Approvals

APRIL 19, 2025

New Drug Therapy Approvals 2024 (PDF). “Metoprolol Therapy and CYP2D6 Genotype” In Pratt VM, McLeod HL, Rubinstein WS, et al. . ^ Jump up to: a b c d [link] ^ “List of nationally authorised medicinal products Active substance: landiolol” (PDF). Procedure no.: PSUSA/00010570/201802. Retrieved 12 October 2024.

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DrugBank

JUNE 27, 2023

Their use, as well as their integration into other types of data, has enabled the development of more precise therapies. 9 , 477–485 (2008). Out of the millions of genetic variants present in human populations, GWAS are designed to uncover those associated with specific traits or diseases. 12 , 713230 (2021).  Slatkin, M.

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Metabolite Tales Blog

JULY 5, 2023

However, more de novo designed molecules in this “beyond the Rule of 5 chemical space” have emerged, with the first in this class, plerixafor , approved in oncology in 2008. A combination therapy of glecaprevir and pibrentasvir has recently been implicated in a case of liver injury.

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Metabolite Tales Blog

JULY 5, 2023

2] However, more de novo designed molecules in this “beyond the Rule of 5 chemical space” have emerged, with the first in this class, plerixafor , approved in oncology in 2008. A combination therapy of glecaprevir and pibrentasvir has recently been implicated in a case of liver injury.

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Agency IQ

JUNE 7, 2024

Active medical devices fall into these categories: MD 1100 general active medical devices, MD 1200 devices for imaging, MD 1300 monitoring devices, MD 1400 devices for radiation and thermo therapy. Series AIMD 0100 describes all active implantable device types.

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Agency IQ

APRIL 19, 2024

beyond small molecule drugs) have the potential to transform the development of promising new therapies for patients with rare and common chronic diseases. KEVIN BUGIN will serve as C3TI Director.

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PLOS: DNA Science

MARCH 21, 2024

The Food and Drug Administration just announced approval of Lenmeldy (atidarsagene autotemcel), a gene therapy to treat the neurological condition metachromatic leukodystrophy (MLD). The history of gene therapy for MLD is compelling – DNA Science covered it for Rare Disease Day in 2021, here. She passed away in 2013.

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Drug Target Review

MARCH 21, 2024

There are a few approved therapies for DMD including four exon-skipping drugs and one AAV-microdystrophin drug, which uses a shortened version of dystrophin. AAV-based therapies often can’t be dosed more than once due to concerns about an immune response. 2008 Sep 1;17(17):2622-32. Molecular Therapy-Nucleic Acids.

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Drug Target Review

OCTOBER 26, 2023

Genome engineering and gene therapies that manipulate DNA sequences in cells have driven a biotechnological revolution over the past decade. Endgame: glybera finally recommended for approval as the first gene therapy drug in the European union. Molecular Therapy 20 , 1831-1832 (2012). Nature 578 , 229-236 (2020). e419 (2023).

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Drug Target Review

JANUARY 15, 2024

2008 October 27 [2024 January 5]; 4:435-459. Pluripotent Stem Cell-Based Cell Therapy – Promise and Challenges. References 1 Hogg JC, Timens W. The Pathology of Chronic Obstructive Pulmonary Disease. Annual Review of Pathology: Mechanisms of Disease. Available from: [link] 2 Yamanaka S. Cell Stem Cell.

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Codon

APRIL 9, 2024

With help from the Global Fund to Fight AIDS, Tuberculosis, and Malaria (GFATM), artemisinin-based combination therapy became much more economically accessible worldwide. When Louis Miller, now Chief of Malaria Cell Biology at the NIH, attended a malaria conference in Shanghai in 2008, he asked: Who discovered artemisinin?

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The Pharma Data

AUGUST 16, 2020

First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology. Having an approved therapy that can be administered subcutaneously in the home, and has demonstrated an impact on the frequency of relapses, is an important advancement for patients.”. “We

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New Drug Approvals

DECEMBER 3, 2022

“Bcl-2 inhibitors: small molecules with a big impact on cancer therapy.” 2008): 360–367. Hann CL, Daniel VC, Sugar EA, Dobromilskaya I, Murphy SC, Cope L, Lin X, Hierman JS, Wilburn DL, Watkins DN, Rudin CM (April 2008). Bibcode : 2016NatCo…711190Y. doi : 10.1038/ncomms11190. PMC 4823827. PMID 27048913.

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Agency IQ

OCTOBER 6, 2023

In a first, FDA tackles treatments for stimulant use disorder A new draft guidance from the FDA gives developers a roadmap to advance the development of novel therapies to address stimulant use disorders. Regulatory context FDA held a workshop in December 2019 to discuss development of substance use disorder therapies.

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National Institute on Drug Abuse: Nora's Blog

FEBRUARY 1, 2024

In 2008, the Mental Health Parity and Addiction Equity Act required insurers to provide benefits for substance use treatment to the same extent they cover other forms of mental health care.

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The Pharma Data

AUGUST 17, 2021

In the Guidelines, vericiguat is the only treatment recommended following a worsening heart failure event, on top of foundational, recommended heart failure therapies. Predictors of adverse clinical outcomes in atrial fibrillation patients with concomitant renal impairment under rivaroxaban therapy o Atrial fibrillation e-posters; on demand.

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The Pharma Data

DECEMBER 1, 2020

The authors performed an observational analysis of the Boston Birth Cohort between 2008 and 2016 and found that the prevalence of cardiovascular risk factors was higher in U.S.-born Garima Sharma, M.D., born Black women. born Black women compared with foreign-born Black women. ” Press Release. WEDNESDAY, Nov. TUESDAY, Nov. 13 to 17.

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New Drug Approvals

APRIL 27, 2025

2008 ; Nagel 2014 ) Briefly, to a mixture of mucochloric acid ( 1 ) (1.18 New Drug Therapy Approvals 2024 (PDF). Flurpiridaz F 18 WeightAverage: 367.84 3] Flurpiridaz ( 18 F) It is given by intravenous injection. [3] 3] Flurpiridaz ( 18 F) was approved for medical use in the United States in September 2024. [3] 25 October 2024.

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Elrig

MARCH 10, 2025

The free-to-attend event will bring together scientists, researchers and entrepreneurs from across the drug discovery community working on proteins, RNA, cell and gene therapies, PROTACs, as well as the application of big data to support target identification, biomarkers and the development of big molecules.

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Drug Target Review

NOVEMBER 27, 2024

As precision medicines, including RNA interference (RNAi) and oligonucleotide therapies, become more prominent, the importance of advanced techniques in streamlining biomarker validation and expediting the regulatory review process becomes even clearer. 2008 Aug 1;63(8):879–84. Biomarker Qualification: Evidentiary Framework [Internet].

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LifeSciVC

OCTOBER 28, 2024

During this time, novel science-heavy platforms were “hot” and well-funded: CRISPR, gene therapy, CAR-T, Targeted Protein Degradation, oligo/mRNAs, next gen chemistry, ADCs, Radiopharm, bispecifics… Truly an amazing period, and Atlas started and backed a number of great stories during this period (e.g.,

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The Pharma Data

FEBRUARY 25, 2021

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Tick-borne encephalitis virus in wild rodents in winter, Finland, 2008-2009. Although TBE is not endemic in the U.S., 5 Currently there is no cure or treatment for TBE, only management of symptoms.

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Codon

AUGUST 10, 2023

Nature Reviews Molecular Cell Biology (2008). Drug Discovery Today: Disease Models (2008). Molecular Systems Biology (2008). Link Modelling and analysis of gene regulatory networks , by Karlebach G. & & Shamir R. Link Artificial Gene Regulatory Networks—A Review , by Cussat-Blanc S. Artificial Life (2018).

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