Drug Target Review

MAY 27, 2024

Antibody-drug conjugates have seen explosive growth in the last few years which has materialised with numerous clinical trials demonstrating meaningful improvements in survival. What role do ADCs play in Caris’ strategy for targeted cancer therapy, particularly in terms of patient-specific treatment plans?

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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. FBX-101 is a first-in-human AAV gene therapy.

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Eye on FDA

JULY 5, 2022

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 most obvious impact is that of COVID-19 to recruiting and maintaining clinical trials.

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The Pharma Data

OCTOBER 21, 2020

In the midst of the global pandemic, the analysis found no antiretroviral therapy interruptions across the entirety of the ongoing clinical development programme for long-acting cabotegravir and rilpivirine. Of those participants who transitioned back to injectables, the median duration of oral therapy was 51 days.

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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. 2021 – and a robust pipeline that includes 3 AI-designed drugs (for IPF, COVID-19 and cancer) currently in clinical trials.

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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.

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The Pharma Data

JANUARY 21, 2021

Precigen is focused on next-generation gene and cell therapy using precision technology. The rest are in Phase I trials for ovarian cancer, AML, MDS, heart failure, HPV+ solid tumors and recurrent respiratory papillomatosis (RRP). Its first drug is PHVS416 for HAE, with plans to initiate a Phase II trial this year.

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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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The Pharma Data

JUNE 26, 2021

The Phase 3 AMEERA-6 study will evaluate the efficacy and safety of Sanofi’s amcenestrant vs tamoxifen for women with estrogen receptor-positive (ER+) breast cancer who were unable to continue their adjuvant aromatase inhibitor (AI) therapy. Adjuvant therapy helps prevent and delay the progression of disease into the later setting.

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Drug Target Review

AUGUST 24, 2023

Neutralising GDF-15 with CatalYm’s anti-GDF-15 antibody visugromab was shown to reverse its inhibitory effects and to re-sensitise tumours to anti-PD-1 treatment, achieving commensurate survival benefit of anti-GDF-15-anti-PD-1 combination therapy in vivo. 2012 Feb 1;24(1):107-15. in North America) in late 2017. Biophysical Journal.

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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’re excited to be collaborating with Tiziana to support the development of a novel, oral therapy that could provide Crohn’s patients with another option in their repertoire of treatments to combat this devastating disease.”. and Europe. Weiner, H.

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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.

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Drug Target Review

OCTOBER 8, 2024

DOTA’s strong binding affinity to metal ions such as ¹⁷⁷Lu and other medical radioisotopes used for therapeutic or diagnostic purposes, along with its demonstrated safety profile in approved radioligand therapies, has made it the most widely used chelator in pretargeting strategies to date. 2012 Mar 2;287(10):7446–55.

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The Pharma Data

DECEMBER 21, 2020

On Monday, the two companies said the investigational asset tezepelumab did not meet its primary endpoint in the Phase III SOURCE trial assessing the drug’s ability to generate a statistically significant reduction of corticosteroid use on top of standard of care treatment in some asthma patients. In 2018, the U.S.

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The Pharma Data

DECEMBER 13, 2020

In addition, toripalimab for the treatment of recurrent/metastatic nasopharyngeal carcinoma was granted the Breakthrough Therapy designation by the US Food and Drug Administration in September 2020. 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.

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The Pharma Data

JANUARY 24, 2021

25, 2021 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that U.S. The trial intends to enroll 220 patients who will be randomized at 1:1 ratio into two study arms.

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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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Drug Target Review

MAY 31, 2024

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. As a woman in STEM, what unique perspectives or strengths do you believe you bring to your work? She is an active voice for diversity and inclusion in the Sciences.

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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 18, 2020

The OLYMPUS, ALPS and ANDES trials evaluated roxadustat compared to placebo in NDD patients. AstraZeneca in CVRM Cardiovascular, Renal and Metabolism (CVRM) together forms one of AstraZeneca’s three therapy areas and is a key growth driver for the Company. J Am Soc Nephrol (2012); 23:1631-1634. Available from: URL: [link] 2.

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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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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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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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Agency IQ

JULY 8, 2024

Device regulators have dropped important guidance recently , publishing guidance on alternative trial designs for orphan devices and updating how to carry out benefit-risk assessments on the use of toxic phthalates in medical devices. elections over, AgencyIQ is also anticipating the new European Parliament to start work again soon.

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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. Patients should be screened for TB before starting upadacitinib therapy.

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The Pharma Data

APRIL 28, 2021

1 The submissions were supported by two pivotal Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated SKYRIZI in adults with active psoriatic arthritis including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 2012 Feb;26(1):147-56.

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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

JANUARY 15, 2021

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Today’s approval underscores our commitment to deliver innovative therapies for patients with plasma cell diseases.”. About Darzalex Faspro® In August 2012, Janssen Biotech, Inc.

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The Pharma Data

DECEMBER 14, 2020

We believe aligning with one of the largest and fastest growing companies in China’s NGS-based cancer therapy selection market speaks to the strength of DetermaRx as a valuable treatment stratification tool to help clarify this critical treatment decision point in early stage tumors. March 2012. 1 Kratz et al.,

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Agency IQ

MARCH 1, 2024

There are also some product-specific bioequivalence guidelines open for comment, along with concept papers proposing the development of materials on the topics of biosimilar development and non-inferiority comparisons in clinical trials.

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The Pharma Data

DECEMBER 9, 2020

(Tokyo, Japan) announced that Biogen has submitted a Japanese New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) for aducanumab, an investigational therapy for Alzheimer’s disease. million people live with dementia and about 4 million people live with Mild Cognitive Impairment (MCI) in Japan (2012).

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On Medicine

FEBRUARY 26, 2023

After many trials, and misdirection to the sexual health clinic, at the age of twenty-three, Daniella was finally diagnosed with Behçet’s disease. In addition to meaningful specialized treatment, Daniella uses her creative pursuits as a form of therapy, inspiring others living with chronic health issues through the use of her podcast.

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NIH Director's Blog: Drug Development

APRIL 7, 2015

The compound, called saracatinib, is particularly exciting because it acts through a different mechanism than other experimental therapies now being tested for Alzheimer’s disease. Although the oral drug proved safe in human clinical trials, its performance was not impressive against cancer. 2012 Sep;15(9):1227-35. Nat Neurosci.

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The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,

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The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

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The Pharma Data

APRIL 7, 2023

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today provided updates on two Phase 3 trials, LEAP-003 and LEAP-017 investigating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai.

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The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. LUMAKRAS received accelerated approval based on overall response rate and duration of response.

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