The Pharma Data

APRIL 11, 2021

In this cohort, the most common treatment-emergent adverse events of any grade (?20%) No patients in this cohort discontinued treatment due to treatment-related adverse events. 50 kg, respectively), taken twice daily until disease progression or unacceptable toxicity. 3 hemorrhagic events occurred in 2.3%

Research 52

Research Treatment Therapies Trials 52

The Pharma Data

SEPTEMBER 19, 2020

Basel, 19 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it presented the latest results from three Phase III studies from the Tecentriq® (atezolizumab) clinical development programme in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

Treatment 52

Treatment Disease Pharmaceuticals Therapies 52

The Pharma Data

DECEMBER 5, 2020

57% of evaluable patients (4 of 7 patients) were minimal residual disease (MRD) negative. The most common adverse events (AEs) were cytokine release syndrome (CRS; 39%; n=19), anemia (37%; n=18), fatigue (35%; n=17), nausea (31%; n=15), pyrexia (31%; n=15) and back pain (27%; n=13). 42% (n=8) had a CR or sCR.

Production 40

Production Trials Treatment Pharmaceuticals 40

Drug Discovery World

JANUARY 4, 2024

In the study, ANX1502 achieved target serum levels and demonstrated pharmacokinetic (PK) measures that support advancement into a proof-of-concept clinical study to assess pharmacodynamics (PD) and efficacy in patients with cold agglutinin disease (CAD) in 2024.

Small Molecule 130

Small Molecule Pharmacokinetics Clinical Development Disease 130

The Pharma Data

OCTOBER 25, 2020

In addition, this indication offers synergy with the commercial infrastructure being developed to support our first New Drug Application.”. This condition may be caused by numerous underlying pathologic processes and disease states. Agitation associated with delirium occurs in the majority of patients with this condition.

Treatment 52

Treatment Trials FDA Hospitals 52

The Pharma Data

SEPTEMBER 1, 2020

study investigator and Professor of Clinical Neurology, University of California San Francisco (UCSF) Weill Institute for Neurosciences and clinical research director, UCSF MS Center. Pregnancy outcomes in the ozanimod multiple sclerosis clinical development program. Presentation Topic: Clinical Outcome Measures.

Clinical Trials 52

Clinical Trials Treatment Trials Disease 52

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

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

JULY 21, 2021

Most adverse events (AEs) were mild and there were no serious drug-related AEs in people who received islatravir. After 24 weeks, once-monthly oral islatravir was generally well tolerated versus placebo. For more information, visit www.merck.com and connect with us on Twitter , Facebook , Instagram , YouTube and LinkedIn.

Clinical Trials 52

Clinical Trials Pharmacokinetics Trials International 52

LifeSciVC

APRIL 24, 2024

Target validation : Do we believe the target(s) plays a central role in disease biology and that modulation will modify disease? I will note that “de-risked” is never fully risk-free in therapeutics investing, as even precedented mechanisms hit stumbling blocks in preclinical or clinical development.

Production 115

Production Small Molecule Regulations Trials 115

The Pharma Data

NOVEMBER 4, 2020

The 8 mg and 12 mg twice-daily doses continued to be generally well tolerated and adverse events were consistent with those reported in the Phase 2 trials. Published Findings on Alopecia Areata Burden of Disease in Journal of Investigative Dermatology.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Small Molecule 52

The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. No Pharmacokinetic Interaction Between Novel NNRTI MK-8507 and Islatravir.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Trials Treatment 52

The Pharma Data

APRIL 8, 2021

OCREVUS data show its consistent benefit on slowing disease progression in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). Data for ENSPRYNG in neuromyelitis optica spectrum disorder (NMOSD) reinforce safety and efficacy, including in patients with concomitant autoimmune diseases (CAIDs). Following U.S.

Clinical Trials 52

Clinical Trials Trials Disease Nurses 52

Drug Target Review

JULY 1, 2024

As a non-NSAID, it reduces adverse effects associated with these pain relief drugs, including kidney injury, GI gastritis/ulceration and blood pressure elevation, which can affect patients with cardiovascular disease and the elderly. We set out to improve health by developing a novel non-opioid that avoids potential abuse.

Treatment 59

Treatment Clinical Trials Molecular Biology Therapies 59

The Pharma Data

DECEMBER 21, 2020

Phase I safety, tolerability, and pharmacokinetic study in healthy volunteers expected to start in coming weeks following acceptance of a request for a Clinical Trial Authorization (CTA) granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA). ALLSCHWIL, Switzerland, Dec. Source link.

Clinical Trials 40

Clinical Trials Trials Pharmacokinetics Clinical Development 40

The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset. STOCKHOLM , Jan.

Trials 40

Trials Clinical Trials Pharmacokinetics Small Molecule 40

The Pharma Data

MARCH 17, 2021

percent compared to ET alone – a statistically significant improvement in invasive disease-free survival for HR+, HER2- high risk early breast cancer (HR: 0.713; 95% CI: 0.583, 0.871; p = 0.0009). After the treatment period, all patients will continue on endocrine therapy for five to 10 years, as clinically indicated.

Trials 52

Trials Therapies Treatment Pharmacokinetics 52

The Pharma Data

MARCH 23, 2023

Patients are generally diagnosed around 60 years of age, often at later stages of the disease. This approval of Calquence in China can provide a new treatment option which can better benefit patients with this disease.” Calquence reduced the risk of disease progression or death by 51.5% (95% CI 33.3-67.0) months (95% CI 36.5-NE).

Clinical Trials 40

Clinical Trials Trials Treatment Disease 40

The Pharma Data

MARCH 8, 2021

We are delighted to share our early data at CROI 2021 supporting the potential for a once-yearly dosing regimen for islatravir using a subdermal implant,” said Dr. Joan Butterton, vice president, global clinical development, infectious diseases, Merck Research Laboratories. “We Our Commitment to Infectious Diseases.

Trials 52

Trials Clinical Trials Pharmacokinetics Research Laboratories 52

The Pharma Data

JANUARY 10, 2021

“We expect 2021 will mark a number of key clinical and commercial milestones. By the end of the year, we expect to have five independent TransCon product candidates in clinical development leveraging TransCon technologies through our algorithm for product innovation. Pipeline Updates. •. .

Clinical Trials 40

Clinical Trials Clinical Development Small Molecule Trials 40

Agency IQ

AUGUST 9, 2024

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time.

Science 40

Science FDA Production Trials 40

Agency IQ

AUGUST 16, 2024

intermediate or surrogate) endpoints and clinical outcome endpoints (e.g., Further, some newer therapies are associated with immune-mediated adverse events such as cytokine release syndrome that are not always dose-related. Other issues also arise: Unlike conventional cytotoxic drugs where the relationship between early (e.g.,

Production 40

Production FDA Science Clinical Trials 40

The Pharma Data

MAY 7, 2021

The EMA will evaluate all data on sotrovimab, including evidence from clinical trials, as they become available. The multi-center, double-blind, placebo-controlled, Phase 3 COMET-ICE trial investigated sotrovimab in adults with mild or moderate COVID-19 at high risk of progression to severe disease. Vir’s Commitment to COVID-19.

Treatment 52

Treatment Virus Vaccine Trials 52

FDA Law Blog: Drug Discovery

JULY 9, 2024

DAP Content In developing DAPs, the Draft Guidance recommends that sponsors consider whether certain demographic groups may have a different response to a medical product regarding either effectiveness or safety. The enrollment goals should be informed by the estimated prevalence or incidence of the disease or condition in the U.S.

FDA 59

FDA Clinical Trials Disease Trials 59

The Pharma Data

SEPTEMBER 15, 2020

Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. 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. Rare Disease. BNT162 mRNA-based Vaccine Program.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

Agency IQ

JUNE 9, 2023

For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinical development. However, even the most innovative in vitro assays still present major limitations when it comes to fully understanding and assessing the risks of a product.

FDA 40

FDA Science Small Molecule Immune Response 40

The Pharma Data

DECEMBER 29, 2020

(NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx ® plant cell-based protein expression system, and Chiesi Global Rare Diseases , a business unit of Chiesi Farmaceutici S.p.A.,

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

The Pharma Data

MARCH 20, 2023

Data confirm increases in motor function were sustained at four years and the overall rate of adverse events continued to decrease over the 48 month period, reinforcing the long-term efficacy and safety of Evrysdi. Professor of Paediatric Neuromuscular Diseases at the MDUK Oxford Neuromuscular Centre.

Pharmacokinetics 40

Pharmacokinetics Treatment Clinical Trials Trials 40

The Pharma Data

MARCH 16, 2021

SUNFISH Part 2 study population includes broad range of ages and disease severities, representing a real-world spectrum of people living with Type 2 or 3 SMA. More than 2,500 patients now treated with Evrysdi in clinical trial, compassionate use and real-world settings. The most common serious adverse events were pneumonia (6.7%

Pharmacokinetics 52

Pharmacokinetics Treatment Clinical Trials Disease 52

The Pharma Data

MARCH 30, 2021

Basel, 30 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has approved Evrysdi (risdiplam) for the treatment of 5q spinal muscular atrophy (SMA) in patients two months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies.

Treatment 52

Treatment Clinical Trials Pharmacokinetics Trials 52

The Pharma Data

SEPTEMBER 27, 2020

The most common adverse events (n=21) included fever (pyrexia; 71%), upper respiratory tract infection (52%), cough (33%), vomiting (33%), diarrhea (29%) and respiratory tract infection (29%). The most serious adverse event that occurred in 24% of infants was pneumonia. “We At the time of the analysis, the youngest infant was 28.4

Pharmacokinetics 52

Pharmacokinetics FDA Approval Treatment Clinical Trials 52

Agency IQ

JUNE 28, 2024

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time. What about rare diseases?

FDA 40

FDA Science Clinical Trials Production 40