Drug Target Review

SEPTEMBER 25, 2024

4 Another related and well described non-oncogene resistance mechanism is the histological transformation of EGFR-mutated non-small cell lung cancer (NSCLC) to small-cell lung cancer upon treatment with an EGFR inhibitor. Notably, TT125-802 stabilised disease and prevented further outgrowth of tumours resistant to standard-of-care treatment.

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Drug Target Review

JULY 1, 2024

As a non-opioid, SRP-001 also eliminates abuse potential, positioning it as a safer and effective drug candidate for the treatment of acute and neuropathic pain and migraine headache. was founded in 2016 to develop safer, non-opioid therapies for acute and chronic pain. South Rampart Pharma, Inc.

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New Drug Approvals

SEPTEMBER 13, 2024

2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7] 14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] nM vs. 24.0

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LifeSciVC

OCTOBER 10, 2024

Anti-TIGIT antibodies have been clinically evaluated since 2016, and an absence of single-agent data has left a void in the scientific community’s understanding of the mechanism. Clear early signals of clinical activity in heavily pre-treated patients who have failed to respond or are no longer responding to any other treatment.

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Drug Target Review

OCTOBER 8, 2024

The OncoOne team is engineering antibodies to optimize pharmacokinetics, biodistribution, tumour retention, and target specificity. This enables more flexible scheduling and simplifies logistics, making treatment more accessible. 2016 Sep 12;7(45):73486–96. 2016 May 26;57(10):1505–11. Oncotarget. 2020 Aug 1;61(8):1205–11.

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Pharmacokinetics Engineering Treatment Science 52

The Pharma Data

JUNE 28, 2021

Earlier this year, Xarelto was approved in Canada, the EU including UK, Japan and Switzerland for the treatment of VTE and prevention of VTE recurrence in children and adolescents aged less than 18 years after at least 5 days of initial parenteral anticoagulation treatment. EINSTEIN-Jr. UNIVERSE was conducted in two parts.

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FDA Clinical Trials Treatment Therapies 52

The Pharma Data

JULY 11, 2021

years with TAKHYZRO is Consistent with Initial Period of Treatment, Building on Growing Body of Evidence on the Long-term Safety and Efficacy Final Patient Subgroup Analysis Suggests Reductions of HAE Attacks Across Range of Patient Demographics and Disease Characteristics with TAKHZYRO. Analysis of Safety and Efficacy for up to 2.5

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Treatment Pharmacokinetics Disease Production 52

The Pharma Data

AUGUST 30, 2021

A pivotal Phase 3 trial evaluating Dupixent ® (dupilumab) for the treatment of children aged 6 months to 5 years with moderate-to-severe atopic dermatitis, a chronic type 2 inflammatory disease, met its primary and all secondary endpoints. In 2016, the U.S. Global Head of Research and Development at Sanofi.

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The Pharma Data

DECEMBER 15, 2020

Treatment induced sustainable clinical responses and reduced systemic inflammation. Daratumumab already is approved for the treatment of multiple myeloma. The company is developing its platform for the treatment of chronic, inflammation-mediated autoimmune diseases, and is initially focused on the treatment of RA.

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Metabolite Tales Blog

JANUARY 23, 2024

Patented active metabolites Gepirone’s metabolites have been patented for “the manufacture of a medicament for the treatment of psychological disorders” [9]. Veozah (Fezolinetant): A Promising Non-Hormonal Treatment for Vasomotor Symptoms in Menopause. Pharmacokinetics and Metabolism of Nirmatrelvir. 131(5): 311- 324.

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The Pharma Data

DECEMBER 13, 2020

In patients with T2DM (41-47% of each group), the results observed showed treatment with PXL770 resulted in a -27% mean relative reduction in liver fat content at 500 mg QD (p=0.004) versus baseline. PXL065 (deuterium-stabilized R-pioglitazone), a MPC inhibitor, is in a streamlined Phase 2 trial for the treatment of NASH.

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Agency IQ

AUGUST 16, 2024

Many commenters took issue with the guidance’s statement that, “The contribution of the psychotherapy component to any efficacy observed with psychedelic treatment has not been characterized. Lykos (formerly MAPS PBC) met with the agency in 2016 for the End of Phase 2 meeting.

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Agency IQ

SEPTEMBER 15, 2023

Background on oral phenylephrine as a nonprescription nasal decongestant Phenylephrine is an alpha-1 adrenergic agonist that is approved as a nonprescription oral treatment for temporary relief of nasal congestion , sinus congestion and pressure. The committee also made recommendations regarding pharmacokinetic and safety assessments.

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Science FDA Clinical Trials Clinical Pharmacology 40

New Drug Approvals

JANUARY 9, 2024

Indeed, flavopiridol, a non-selective pan-CDK inhibitor that targets CTD kinases, has demonstrated efficacy for the treatment of chronic lymphocytic leukemia (CLL), but suffers from a poor toxicity profile (Lin et al.,). Inhibitors of CDK7 are currently being developed for the treatment of cancer. Larochelle, S. 3, S179-S185, 2009).

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Agency IQ

FEBRUARY 23, 2024

As the name implies, the MTD seeks to find the highest dose of a treatment that can both be tolerated and treat the cancer. Additionally, this approach is generally no longer applicable to new treatments that are more targeted in their effects, such as immunotherapies and targeted small molecule therapies.

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Science FDA Trials Clinical Pharmacology 40

New Drug Approvals

SEPTEMBER 29, 2024

Both were reversed by treatment with COR388 ( 2020 AAIC abstract ). The pharmacokinetic profiles of COR388 in AD and controls were reported to be similar. Gingipains also were reported to degrade ApoE, and 28 days of treatment with COR388 was claimed to reduce CSF ApoE fragments ( 2020 AAIC abstract ). and Europe.

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Small Molecule DNA Disease Trials 62

The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. SUZHOU, China and ROCKVILLE, Md. , 22, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK), The milestone payment was made in common stocks from UNITY, totaling 228,310 shares.

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Agency IQ

DECEMBER 11, 2023

The areas within oncology that have seen the most success in terms of new and effective treatment options are now entering a new paradigm where the terms “success” and “harm” are being redefined. In parallel, stakeholders have advocated for recognizing the importance of treatment tolerability when determining doses and regimens.

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FDA Law Blog: Biosimilars

MAY 21, 2024

We wondered how given that HHS and the Drug Enforcement Administration (“DEA”) conducted eight-factor scheduling analyses in 2016, concluding that there was “no substantial evidence that marijuana should be removed from Schedule I.” 12, 2016) ; Denial of Petition to Initiate Proceedings to reschedule Marijuana, 81 Fed. 12, 2016).

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Regulations FDA Drugs Treatment 69

Drug Target Review

OCTOBER 4, 2023

Antibody-drug conjugates (ADCs) have been a groundbreaking approach to cancer treatment with their ability to deliver cytotoxic drugs directly to diseased cells while sparing healthy tissues. Ultimately, flexibility in dual-payload ADC development means better treatments could reach patients sooner.

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OCTOBER 6, 2021

We look forward to participating AZD7442 data for the treatment of COVID-19 thereafter this vintage.” 9) AZD7442 is being studied in a comprehensive clinical trial programme for both forestallment and treatment of COVID-19 in over parties. 2016; 61 (1) e01020-16. Griffin MP, et al. Antimicrob Agents Chemother.

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The Pharma Data

AUGUST 22, 2021

12)AZD7442 is being studied in a comprehensive clinical trial programme for both prevention and treatment of COVID-19 in over 9,000 participants. Ongoing trials include TACKLE COVID-19(13), a Phase III treatment trial in an outpatient setting and collaborator treatment trials in outpatient and hospitalised settings.

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Trials Virus Vaccine Pharmacokinetics 52

New Drug Approvals

MAY 14, 2025

9,13 ]heptacosan-21-yl]oxy]ethyl-trimethylazanium Rezafungin ion Rezafungin cation CD-101 SP-3025 G013B5478J Rezafungin , sold under the brand name Rezzayo (by Melinta Therapeutics), is a medication used for the treatment of invasive candidiasis. [2] 2] [3] CAS No. 2] The applicant for this medicinal product is Mundipharma GmbH. [2]

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New Drug Approvals

APRIL 2, 2025

The compounds of this disclosure may be used as medicaments for the treatment of human brain diseases associated with a cholinergic deficit, including the neurodegenerative diseases Alzheimer’s and Parkinson’s disease and the neurological/psychiatric diseases vascular dementia, schizophrenia and epilepsy. 2016 Jan 20;2(1):13-22.

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Drug Target Review

MAY 8, 2025

However, their complex structures comprising monoclonal antibodies, linkers and cytotoxic payloads require advanced bioanalytical strategies to assess pharmacokinetics (PK), drug-to-antibody ratios (DAR), stability and metabolite profiling. The most effective strategies for ADC characterisation include: Ligand-binding assays (LBA).

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New Drug Approvals

APRIL 27, 2025

SYN Tropium chloride is one of the azoniaspironortropine derivatives and is used for the treatment of urinary bladder dysfunction due to bladder dysfunction, night urination, overactive bladder, and urinary incontinence. 9] [10] [11] Pharmacokinetics After oral administration, less than 10% of the dose is absorbed. Useful compounds.

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FDA Approval FDA Pharmacokinetics Licensing 57

New Drug Approvals

MAY 22, 2025

“Pharmacokinetics and Pharmacodynamics of -Lactamase Inhibitors” Pharmacotherapy. When given in combination with -lactam antibiotics, sulbactam produces a synergistic effect as it blocks the enzyme responsible for drug resistance by hydrolyzing -lactams. hydrogen peroxide (about 45g) to KMn04, during continue to keep pH=1.25

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