Drug Target Review

SEPTEMBER 21, 2023

The findings supported the possibility put forward by Cotton et al (2016) concerning the chance of repurposing these drugs for adulticidal treatment. The available treatment for that is minor surgery -to remove the nodules. With accessible and effective treatments, this is feasible. doi: 10.1002/14651858.CD011146.pub2.

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Drug Target Review

JANUARY 8, 2024

Shinya Yamanaka, who was awarded the Nobel prize in 2012, discovered that four transcription factors Oct4, Sox2, Klf4 and c-Myc could reprogram mature, differentiated cells back into stem cells. Our lead program utilises OSK for the treatment of age-related optic neuropathies.

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The Pharma Data

DECEMBER 13, 2020

On December17 ,2018, Toripalimab obtained conditional approval from the NMPA, for the 2 nd line treatment of patients with unresectable or metastatic melanoma. The world’s first-in-human, first-in-class BTLA blocking antibody for solid tumors is currently in phase I clinical trials in the US and China. SHANGHAI, China, Dec.

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The Pharma Data

AUGUST 21, 2020

The FDA has approved Genmab and Janssen’s Darzalex (daratumumab) as a treatment for relapsed and refractory multiple myeloma, when combined with carfilzomib and dexamethasone, in patients who have previously received between one and three lines of therapy. Multiple myeloma affects 26,000 new patients in America every year.

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Eye on FDA

JULY 5, 2022

Over the years, Congress has acted to enhance the ability to bring more new treatments from test tube to medicine chest more quickly. Most notably in 2012 the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law, bring to bear among other things, breakthrough therapy designation. The news is not so hot.

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Drug Target Review

OCTOBER 26, 2023

1 Adeno-associated virus (AAV) vectors are the leading platform for in vivo gene delivery for the treatment of various human diseases. Molecular Therapy 20 , 1831-1832 (2012). Genome engineering and gene therapies that manipulate DNA sequences in cells have driven a biotechnological revolution over the past decade. Russell S, et al.

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Agency IQ

MARCH 29, 2024

FDA’s oncology advisory committee to consider MRD as a multiple myeloma endpoint Yesterday, the FDA announced that its Oncologic Drugs Advisory Committee would weigh in on the potential use of minimal residual disease (MRD) as an endpoint in multiple myeloma clinical trials.

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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. Can you provide a summary of the key findings and implications of the preclinical studies on ISM6331 for the treatment of advanced solid tumours?

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The Pharma Data

JANUARY 10, 2021

The new year began with a fairly low level of clinical trial news. Arcturus Therapeutics got the FDA go-ahead for its Phase II trial of its COVID-19 vaccine candidate ARCT-021. The trial will enroll 600 participants, with 450 receiving ARCT-021 and 150 receiving placebo. Here’s a look. COVID-19-Related. Non-COVID-19-Related.

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Codon

AUGUST 26, 2024

One large-scale clinical trial found that it only reduces the relative risk of death by about ten percent in hospitalized patients. This exponential infection dynamic poses a challenge for existing broad-spectrum antiviral treatments. One solution is to use broad-spectrum antiviral prophylactics rather than treatments.

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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Comenzo, M.D., Director, John C.

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The Pharma Data

JUNE 26, 2021

Together with our research partners, BIG conducts landmark, practice-changing trials that can have a significant impact on the lives of women with breast cancer,” sa id David Cameron , Chair of the BIG Executive Board. Adjuvant therapy helps prevent and delay the progression of disease into the later setting.

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The Pharma Data

NOVEMBER 10, 2020

The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. We believe the scientific rationale for oral treatment with Foralumab is logical to facilitate topical action at the inflamed sites in the gastrointestinal tract. NEW YORK and LONDON, Nov. NEW YORK and LONDON, Nov. and Europe. Dr. Howard L.

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Drug Target Review

AUGUST 24, 2023

We will explore how GDF-15 impacts the tumour microenvironment and hinders the infiltration of T cells into the tumour, as well as the implications of neutralising GDF-15 to reverse its inhibitory effects and sensitise tumours to anti-PD-1 treatment. T-cell infiltration is a prerequisite for responses to checkpoint inhibitors.

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Drug Target Review

OCTOBER 8, 2024

PreTarg-it® is being developed to target tumour markers in challenging cancers, such as pancreatic cancer and our next goal will be to advance our platform toward clinical testing in order to bring an innovative treatment method to patients with limited options. 2012 Mar 2;287(10):7446–55. Journal of Biological Chemistry.

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The Pharma Data

JUNE 18, 2021

1 The full, long-term results from the Phase 3 SELECT-PsA 2 clinical trial will be presented at the EULAR 2021 Virtual Congress. 1 The full, long-term results from the Phase 3 SELECT-PsA 2 clinical trial will be presented at the EULAR 2021 Virtual Congress. Efficacy data reported based on randomized treatment. RINVOQ 15 mg. (n=211).

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New Drug Approvals

AUGUST 21, 2023

5] Medical uses Palovarotene is indicated for the treatment of heterotopic ossification and fibrodysplasia ossificans progressiva. [4] 7] A one-year trial did not demonstrate a significant benefit on lung density in moderate-to-severe emphysema secondary to severe α(1)-antitrypsin deficiency. [8] 22] Ipsen acquired Clementia in 2019.

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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. I work in the Centre for Cancer Drug Discovery (CCDD) at The Institute of Cancer Research in London, which is an academic drug discovery centre.

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The Pharma Data

DECEMBER 21, 2020

An investigational asthma treatment under development by Amgen and AstraZeneca failed to reduce asthma patients’ dependence on corticosteroids in a Phase III study. The 48-week SOURCE study assessed tezepelumab in 150 patients who require the maintenance use of corticosteroids on top of their standard-of-care treatment.

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The Pharma Data

MAY 14, 2021

Product Name: Fast Shingles Cure – The #1 Shingles Treatment Method Available. Fast Shingles Cure – The #1 Shingles Treatment Method Available is backed with a 60 Day No Questions Asked Money Back Guarantee. combination of treatments to cure Shingles as fast as. treatments. sufferers to finally find the right.

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The Pharma Data

OCTOBER 26, 2020

. “Our study highlights how common the early and subtle signs of focal epilepsy are,” said study senior investigator Dr. Jaqueline French, a director of translational research and clinical trials for epilepsy at NYU Langone Health. Delayed diagnosis could affect not only treatment, but car crashes.

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The Pharma Data

JANUARY 24, 2021

Food and Drug Administration (FDA) has granted toripalimab Fast Track designation for the first-line treatment of mucosal melanoma. On December 17, 2018, Toripalimab obtained a conditional approval from the National Medical Products Administration (the “NMPA”) for the second-line treatment of unresectable or metastatic melanoma.

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Agency IQ

DECEMBER 1, 2023

Comment periods for EMA documents (such as concept, reflection, and guidance papers) generally stay open for at least six months, though these timelines can vary drastically. policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected into Q1 2024.

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The Pharma Data

NOVEMBER 18, 2020

Swati Chokalingam, a Boston-area obstetrician/gynecologist and Kaling’s mom, died in 2012 after getting a stage 4 diagnosis eight months earlier. ” PanCAN leads research initiatives working to transform pancreatic cancer outcomes through early detection and new treatment approaches. WEDNESDAY, Nov. © 2020 HealthDay.

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Drug Target Review

MAY 31, 2024

One of the first programs I worked on in my career was drugging a novel, epigenetic target which had potential implications for the treatment of cancers. She completed her PhD in Synthetic Organic Chemistry at Monash University and began her medicinal chemistry career at Cancer Therapeutics (CTx) in Melbourne, Australia in 2012.

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The Pharma Data

DECEMBER 18, 2020

Roxadustat is approved in China, Japan (under the name Evrenzo), and Chile for the treatment of anemia in CKD in non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients. The OLYMPUS, ALPS and ANDES trials evaluated roxadustat compared to placebo in NDD patients. J Am Soc Nephrol (2012); 23:1631-1634.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. That did not happen.

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Agency IQ

AUGUST 2, 2024

While the work on the pharma package will likely take quite some time, another deadline is coming up fast: the full transition of all clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation.

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New Drug Approvals

JANUARY 31, 2024

Due to their different metabolic pathways, obeldesivir can be administered orally, whereas remdesivir must be administered intravenously for COVID-19 treatment. 6] Treatment with obdeldesivir reduced viral load and prevents lung pathology in KI-hACE2 and Ad5-hACE2 mouse models of SARS-CoV-2. Obeldesivir, 2647441-36-7 361.35 Zhang, L.;

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The Pharma Data

OCTOBER 21, 2020

It’s reassuring to know that even in the midst of a global pandemic that has led to restricted access to some clinics and providers, there were few injection visit interruptions and those that occurred were effectively managed by providing participants with oral treatment. Shionogi joined in October 2012. Kimberly Smith, M.D.,

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The Pharma Data

AUGUST 29, 2020

Inclisiran is currently under review by the FDA and the EMA for the treatment of primary hyperlipidemia (including Heterozygous Familial Hypercholesterolemia) in adults who have elevated LDL-C while being on a maximally tolerated dose of statin therapy. 30% reduction of their LDL-C levels with a mean reduction of 54.1%

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PLOS: DNA Science

OCTOBER 12, 2023

In the final chapter of my 2012 book The Forever Fix: Gene Therapy and the Boy Who Saved It , I predicted that the technology would soon expand well beyond the rare disease world. Gene therapy clearly hasn’t had a major impact on health care, offering extremely expensive treatments for a few individuals with rare diseases.

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On Medicine

FEBRUARY 26, 2023

Furthermore, there is the possibility of any organ being affected, and since understanding of its etiology is sparse, treatment remains a significant challenge. After many trials, and misdirection to the sexual health clinic, at the age of twenty-three, Daniella was finally diagnosed with Behçet’s disease.

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Agency IQ

MARCH 29, 2024

Title Type Deadline Guideline on clinical investigation of medicinal products in the treatment of depression [EMA] Scientific guideline 3/31/2024 Concept paper on the establishment of a Guideline on the development and manufacture of human medicinal products specifically designed for phage therapy [EMA] Concept paper 3/31/2024 Pharmeuropa 36.1

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The Pharma Data

DECEMBER 14, 2020

DetermaRx is a treatment stratification test that identifies stage I-IIA non-squamous NSCLC patients at high-risk of recurrence despite ostensibly curative surgery, who may benefit from the addition of chemotherapy. “We March 2012. China’s stage I-IIA non-squamous NSCLC incidence is estimated at over 100,000 per annum.

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NIH Director's Blog: Drug Development

MARCH 18, 2021

Now, Veesler and his lab are turning to another mammal in their search for new leads for the next generation of antiviral treatments, including ones aimed at the coronavirus that causes COVID-19, SARS-CoV-2. And, how can those structural differences serve as blueprints for promising new treatments to combat many potentially deadly viruses?

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NIH Director's Blog: Drug Development

JULY 20, 2017

Helping to fuel this optimism are preliminary results released this week from early-stage clinical trials of three next-generation, triple combination therapies that modulate the function of CFTR. According to preliminary data from one Phase 1 and two Phase 2 clinical trials reported by Vertex Pharmaceuticals Inc.,

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