Alta Sciences

JULY 25, 2024

Top 10 Life Science Resources for Summer 2024 pmjackson Thu, 07/25/2024 - 14:44 There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for your convenience. Catch up on what you might have missed below!

Science 52

Science Clinical Trials Clinical Pharmacology FDA 52

The Pharma Data

FEBRUARY 15, 2022

Treatment for MIBC typically combines cisplatin-based chemotherapy with radical cystectomy, or removal of the bladder, as well as pelvic lymph node dissection. Cohort H of the Phase 1b/2 EV-103 trial enrolled patients with MIBC who were eligible for surgical treatment, but ineligible for cisplatin-based chemotherapy. The most common (?20%)

Clinical Pharmacology 52

Clinical Pharmacology Trials Treatment Therapies 52

Agency IQ

MAY 3, 2024

FDA’s Diversity Action Plan guidance: The FDA’s hotly-anticipated revised draft guidance document is currently under review at the White House’s Office of Information and Regulatory Affairs (OIRA), and we anticipate that it will be published over the next two months.

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FDA Science Regulations Clinical Trials 40

Alta Sciences

OCTOBER 30, 2023

Top 10 Life Science Resources pmjackson Mon, 10/30/2023 - 16:16 There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below! Read or listen now. Read the fact sheet.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

The Pharma Data

OCTOBER 1, 2021

Deucravacitinib demonstrated efficacy no matter baseline characteristics, including weight , disease severity and former treatment with biologic or non-biologic therapies. Deucravacitinib also demonstrated durable efficacy in scalp psoriasis through 52 weeks of treatment (Poster Number: P1391).

Disease 52

Disease Laboratories Clinical Pharmacology Treatment 52

The Pharma Data

NOVEMBER 1, 2020

Mission Therapeutics is an early-stage drug development company targeting the ubiquitin pathway for the treatment of kidney disease, neurodegenerative disease, rare mitochondrial diseases and fibrosis. The Company is managed by a team with broad international, commercial and clinical-science experience. Source link.

Clinical Pharmacology 52

Clinical Pharmacology Small Molecule Clinical Research Science 52

Metabolite Tales Blog

JULY 5, 2023

Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. With metabolic stability in mind, we take a look at the metabolism of some FDA approved synthetic macrocyclic drugs, and a few of those that were/are in clinical development where metabolism data was available.

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Metabolic Stability Drugs FDA Approval Treatment 52

Metabolite Tales Blog

JULY 5, 2023

Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. With metabolic stability in mind, we take a look at the metabolism of some FDA approved synthetic macrocyclic drugs, and a few of those that were/are in clinical development where metabolism data was available.

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Metabolic Stability Drugs FDA Approval Treatment 52

Agency IQ

DECEMBER 1, 2023

That guidance, first issued in May 2020 , was released at a time when there were no FDA-approved drugs to treat Covid-19, and the standard-of-care for treatment relied on clinical management of symptoms and supportive care (e.g., supplemental oxygen, mechanical ventilation). drug-drug interactions) and intrinsic factors (e.g.,

FDA 40

FDA Clinical Trials Vaccine Trials 40

Agency IQ

JULY 28, 2023

According to the notice, the contract includes at least three deliverables: (1) an internal report or presentation to FDA, (2) a public workshop with stakeholders using data collected and published in the Federal Register Notice, and (3) a summary of the public workshop and recommendations to inform potential updates to FDA’s guidances.

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FDA Pharmacokinetics Clinical Pharmacology Government 40

The Pharma Data

NOVEMBER 9, 2020

He is a German trained expert in biopharmaceutics with a focus on oral and inhalable nanoparticles for the treatment of cancer and infectious disease and is the former president of the Canadian Society for Pharmaceutical Sciences and vice chair of the United States Pharmacopeia Dietary Supplement Expert Committee. Forward looking statements.

Drug Development 40

Drug Development Drugs Clinical Pharmacology Pharmaceuticals 40

Agency IQ

JULY 8, 2024

FDA Regulations and guidance under OIRA review as of July The White House’s Office of Information and Regulatory Affairs (OIRA) is the regulator of regulators, tasked with ensuring that all federal policies and regulations adhere to laws, existing regulations, federal policies and the wishes of the President.

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FDA Science Regulations Production 40

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 trials assessed change in nasal congestion score over one week of treatment.

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Science FDA Clinical Trials Clinical Pharmacology 40

FDA Law Blog: Drug Discovery

JULY 17, 2024

In December 2023, FDA established the Genetic Metabolic Diseases Advisory Committee (also called “GeMDAC,” which we blogged about here ) to advise FDA regarding treatments for genetic metabolic diseases (i.e., clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g.,

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FDA Disease Clinical Pharmacology Science 105

The Premier Consulting Blog

JUNE 18, 2023

This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. These data inform the construction of disease mechanistic models used to generate a synthetic control arm for use in the trial.

Drug Development 52

Drug Development Disease Clinical Trials Drugs 52

Alta Sciences

SEPTEMBER 20, 2023

Steve Mason, Co-Chief Operating Officer, Altasciences, added: “The creation of AnQlar as a treatment, if successful, could be a huge leap forward in preventing the spread of influenza and similar viruses. For more information, please visit virpaxpharma.com or follow on Twitter, LinkedIn, and YouTube.

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Virus Clinical Pharmacology FDA Approval Drugs 40

New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 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]

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

The Pharma Data

FEBRUARY 8, 2021

No statistically significant difference was demonstrated for secondary endpoints including overall survival (OS), time to initiation of cytotoxic chemotherapy, chronic opioid use, and pain progression between treatment arms. Grade 3/4 treatment emergent adverse events (TEAEs) were reported in 63.3 percent in the control arm.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

Agency IQ

FEBRUARY 12, 2024

to analyze data, generate summaries of certain information, or other tasks of interest to companies in the interest of efficiencies. A new real-world evidence guidance on the list is meant to address the integration of randomized controlled trials for drug and biological products into routine clinical practice.

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

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.

Science 40

Science FDA Trials Clinical Pharmacology 40

Alta Sciences

JULY 31, 2024

Similarly, Health Canada's guidance highlights the need to represent various demographic groups in clinical trials, ensuring that study results are broadly applicable for enhanced safety and efficacy of drug development. Furthermore, there are cases in which certain racial groups biologically react to particular conditions or treatments.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Pharmacokinetics 52

The Anticancer Fund

JUNE 7, 2022

Treatment with DFMO aka eflornithine, already a high-profile repurposing candidate in neuroblastoma, decreased intracellular pH in TAMCs and was associated with improved survival, more so when combined with immunotherapy or radiotherapy. Patients were randomised to treatment or observation groups and followed for six months.

Clinical Trials 40

Clinical Trials Drugs Trials Treatment 40

Agency IQ

SEPTEMBER 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED SEP 25, 2023 10:39 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. the drug and device) of the combination product.

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FDA Science Regulations Production 40

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 Science Clinical Trials Trials 40

Agency IQ

OCTOBER 27, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED OCT 25, 2023 10:59 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

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FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

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FDA Science Regulations Production 40

The Pharma Data

DECEMBER 17, 2020

In addition, TLC is preparing for scale-up production of TLC590, as for complex lipid products, the manufacturing process and batch size used in pivotal clinical trials and New Drug Application submission must be the same as future commercial batches. Actual results may differ materially from these forward-looking statements.

Clinical Trials 40

Clinical Trials Trials Pharmaceutical Companies Clinical Pharmacology 40

Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

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