Agency IQ

SEPTEMBER 15, 2023

The committee also made recommendations regarding pharmacokinetic and safety assessments. When looking at several pharmacokinetic studies, the FDA found that the 10 mg oral dose of phenylephrine has a very low bioavailability of less than 1% and, subsequently, low systemic alpha-1 adrenergic activity.

Science 40

Science FDA Clinical Trials Pharmacy 40

The Pharma Data

DECEMBER 5, 2020

” In the trial, the 49 patients evaluated had a median of five prior lines of therapy (range: 2-17) with 100% being triple-refractory and 57% being penta-refractory; all patients were refractory to anti-CD38 therapy. With a median follow up of 2.6 Multiple myeloma is not curable despite treatment advances.

Production 40

Production Trials Treatment Pharmaceuticals 40

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. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

Clinical Development 40

Clinical Development Disease Treatment Licensing 40

Alta Sciences

APRIL 17, 2024

Psychedelics Psychedelic therapy (or psychedelic-assisted therapy) refers to the use of psychedelic drugs, such as psilocybin, MDMA, LSD, ketamine, and ayahuasca, to treat mental disorders, especially those that have no effective treatments available or are treatment resistant.

Drug Development 52

Drug Development Treatment FDA Approval Drugs 52

The Pharma Data

MARCH 5, 2021

Currently available BTK inhibitors irreversibly inhibit BTK and the long-term efficacy of these therapies can be limited by acquired resistance, most commonly through BTK C481 mutations. In rapidly growing tumors with inherently high rates of BTK turnover, resistance to covalent BTK therapies may be the result of incomplete target inhibition.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Trials Therapies 52

Drug Discovery World

DECEMBER 13, 2023

Custom antibodies can be developed for pharmacokinetic assays and biodistribution assays, supporting therapeutic development by giving researchers data about the behaviour of their novel therapeutic in vivo. Caplacizumab, for the treatment of a rare blood clotting disease, achieved FDA approval in 2019 2.

Science 147

Science Small Molecule Laboratories Engineering 147

The Pharma Data

APRIL 8, 2021

FDA and global approvals for our groundbreaking therapies in SMA and NMOSD, Roche’s data at AAN reflect our continued commitment to meaningful therapeutic progress for people living with neurological disorders,” said Levi Garraway, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We Following U.S.

Clinical Trials 52

Clinical Trials Trials Disease Nurses 52

Drug Discovery World

FEBRUARY 15, 2023

The number of new cases recorded between 2016 and 2018 was 375,400, with 167,142 deaths caused by cancer between 2017 and 2019. Existing therapies have been focused on eliminating the cancer cells and/or on preventing its progression by using a combination of chemotherapy, radiotherapy, and surgical approaches.

Research 130

Research Therapies Immune Response Clinical Trials 130

The Pharma Data

JANUARY 10, 2021

In 2019, we introduced Vision 3×3, the company’s strategic roadmap through 2025, to build a leading biopharma company by achieving sustainable growth through multiple approaches. We expect 2021 will mark a number of key clinical and commercial milestones. Ascendis reported pre-clinical data for TransCon IL-2 ?/?

Clinical Trials 40

Clinical Trials Clinical Development Small Molecule Trials 40

The Pharma Data

SEPTEMBER 15, 2020

The company announced the initiation of its Phase 1b clinical trial to evaluate the safety of a novel investigational therapeutic for COVID-19, PF-07304814. In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. In 2019 more than one in four (28%) of deaths in the E.U. after ischemic heart disease and stroke.

Clinical Trials 40

Clinical Trials Trials Treatment Production 40

Agency IQ

SEPTEMBER 22, 2023

An AgencyIQ analysis from May 2020 found that a quarter of all New Molecular Entities (NMEs) approved since 2011 had relied upon a single pivotal trial, and that this reliance had remained relatively stable between 2011-2019 despite some year-to-year variability. When should this occur? at the end-of-phase 2 meeting).

FDA 40

FDA Science Trials Clinical Trials 40

The Pharma Data

OCTOBER 14, 2020

Priothera will use the funds to progress the clinical development of mocravimod, a modulator of sphingosine 1 phosphate (S1P) receptors, to enhance the curative potential of allogeneic hematopoietic stem cell transplantation (HSCT) for treating AML. CARB-X will provide Polyphor with initial funding of up to $2.62 Growth Programme.

Clinical Trials 52

Clinical Trials Trials Pharmaceuticals Pharmaceutical Companies 52

The Pharma Data

MARCH 16, 2021

Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively. and 10%, respectively), nasopharyngitis (21.7%

Pharmacokinetics 52

Pharmacokinetics Treatment Clinical Trials Disease 52

The Pharma Data

MARCH 30, 2021

Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation in 2019. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. Evrysdi has been approved in 38 countries and submitted in a further 33 countries.

Treatment 52

Treatment Clinical Trials Pharmacokinetics Trials 52

The Pharma Data

SEPTEMBER 27, 2020

Evrysdi is being studied in more than 450 people as part of a broad and robust clinical trial programme in SMA, with patients ranging from birth to 60 years old, and includes pre-symptomatic patients and those previously treated with other SMA-targeting therapies. In 2019, Roche invested CHF 11.7

Pharmacokinetics 52

Pharmacokinetics FDA Approval Treatment Clinical Trials 52