The Pharma Data

NOVEMBER 17, 2020

The study demonstrated favorable proof-of-concept for LYT-100’s tolerability and pharmacokinetic (PK) profile, which will also enable twice-a-day (BID) dosing of LYT-100 in future studies. The therapeutic dose of pirfenidone approved by the US Food and Drug Administration (FDA) for the treatment of IPF is 801 mg three times a day.

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The Pharma Data

FEBRUARY 12, 2022

(Nasdaq GILD) moment blazoned new data from an interim analysis of its ongoing, Phase2/3 single arm, open- marker study to estimate the safety, tolerability and pharmacokinetics of Veklury ® (remdesivir) in pediatric cases rehabilitated with COVID-19 with periods ranging from 28 days to lower than 18 times.

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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. 5 Here, the original oncogene is still present but the transdifferentiated cancer cells are less dependent on it.

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The Pharma Data

AUGUST 19, 2021

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. 1 Treatment-related Grade ?3

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The Pharma Data

FEBRUARY 8, 2021

Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA ® (abiraterone acetate) CombinationS. Grade 3/4 treatment emergent adverse events (TEAEs) were reported in 63.3 percent of patients in the combination arm versus 56.2

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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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Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

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The Pharma Data

APRIL 11, 2023

Bayer is progressing novel research around its prostate cancer treatment darolutamide. The presentation highlights the synergistic anti-cancer effects of a PSMA (prostate-specific membrane antigen)-actinium-225 conjugate in combination with darolutamide in preclinical prostate cancer models.

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The Pharma Data

NOVEMBER 11, 2020

Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for SLV213 for the treatment of COVID-19 and has dosed the first subjects in a Phase 1 clinical study. SAN DIEGO–( BUSINESS WIRE )– Selva Therapeutics, Inc. announced today that the company has received U.S.

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PPD

JULY 29, 2024

This blog presents examples that demonstrate how AI can be used throughout the drug development process, with a specific focus on patient enrollment. Predicting clinical outcomes helps identify participants who would likely respond better to treatment and who might be at a higher risk.

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The Pharma Data

MARCH 13, 2021

“Lanadelumab is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein activity, with a proven efficacy and safety profile as a preventive treatment for HAE attacks. Subject to approval, we are looking forward to providing lanadelumab as a new treatment option for patients in Japan living with HAE.”.

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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. Can you discuss the single-cell transcriptomic analysis presented in the paper and its implications for understanding the pain-relief mechanisms of SRP-001?

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DrugBank

MARCH 7, 2024

Inspired by its success, pharmaceutical companies are pursuing the development of drugs with similar therapeutic profiles, aiming to expand treatment options. Key Players and Challenges For pharmaceutical giants like Novo Nordisk and Eli Lilly, 2024 presents both opportunities and challenges.

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The Pharma Data

SEPTEMBER 19, 2020

Results from the Phase III IMpassion131 study, evaluating Tecentriq in combination with paclitaxel for the treatment of people with metastatic TNBC and whose tumours expressed PD-L1, did not meet its primary endpoint of progression-free survival . There was no significant difference in OS between the treatment groups in the ITT population.

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The Pharma Data

APRIL 16, 2021

for the treatment of COVID-19 – as planned with the FDA – follows the modification of contracts with the U.S. Lilly developed bamlanivimab and etesevimab for administration together to meet the potential challenge of treatment-resistant variants likely to resist treatment with either monoclonal antibody used alone.

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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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Conversations in Drug Development Trends

AUGUST 9, 2024

It broadens recruitment strategies, diversifies the patient population, and expands the study population, thus increasing access to potentially life-saving treatments. These trials increase the chances of success by enabling the early detection of effective treatments in defined populations and focusing efforts on the most promising options.

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LifeSciVC

OCTOBER 10, 2024

This presentation marked the most significant clinical disclosure of any CBL-B inhibitor to date, an important moment not only for industry, but for us at HotSpot. That said, two presentations at ESMO in non-small cell lung cancer (NSCLC) were perhaps “green shoots” for the field.

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Drug Target Review

JUNE 6, 2023

In this IO arena, we continue to search for additional treatments that can further benefit patients. Immune checkpoint inhibitors, a well-established class of IO treatments, are designed to improve the ability of T-cells to fight cancer by removing inhibitory or suppressive mechanisms that may dampen the anti-cancer functions of T cells.

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The Pharma Data

APRIL 27, 2021

Patients with EGFR Exon20 insertion+ mNSCLC face considerable challenges, as current treatment options provide limited benefit, resulting in poor survival outcomes,” said Christopher Arendt, head, Oncology Therapeutic Area Unit, Takeda. “We and around the globe.”. In 2019, the U.S. About the Phase 1/2 Trial. Takeda’s Commitment to Oncology.

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The Pharma Data

NOVEMBER 5, 2021

The data were presented at the American Society of Nephrology (ASN) 2021 Annual Meeting. With presently no approved treatments, there’s a major unmet need for curatives that can delay progression to order failure, “ said John Tsai, Head of Global Drug Development and Chief Medical Officer at Novartis.

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The Pharma Data

OCTOBER 14, 2021

The results, which demonstrate that patients treated with Biogen’s portfolio of MS therapies mount an effective antibody response to COVID-19 vaccination, are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021.

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The Pharma Data

JULY 29, 2021

P-tau217 in blood showed promise as additional biomarker of efficacy- Donanemab treatment led to 24% lowering of P-tau217 from baseline. Today at the Alzheimer’s Association International Conference © (AAIC © 2021), Eli Lilly and Company (NYSE: LLY) presented two new exploratory analyses of data from the Phase 2 TRAILBLAZER-ALZ study.

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The Pharma Data

MARCH 5, 2021

The data in the publication include key findings previously presented at the 2020 American Society of Hematology (ASH) Annual Meeting. Key secondary objectives include measures of safety, pharmacokinetics, and anti-tumor activity (i.e. chief medical officer of Loxo Oncology at Lilly. chief medical officer of Loxo Oncology at Lilly.

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The Pharma Data

APRIL 4, 2023

Biosimilars help patients to gain broader access to effective and high-quality treatments that improve their disease therapies,” said Rebecca Guntern, Head of Region Europe, Sandoz. The HCF formulation is presented in the same auto-injector as currently available to patients, aiming for an enhanced yet familiar patient experience.

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The Pharma Data

AUGUST 9, 2021

Since 40% of people with DLBCL relapse after initial therapy, achieving meaningful treatment effects in the front-line setting has the potential to be transformative,” said Levi Garraway, M.D., Safety outcomes were consistent with those seen in previous trials. Roche’s Chief Medical Officer and Head of Global Product Development.

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The Pharma Data

FEBRUARY 25, 2022

“Today’s announcement builds on our commitment to broaden access to essential, high-quality and cost-effective treatment options for patients living with certain chronic inflammatory conditions.”. The company anticipates submitting study results for presentation at an upcoming medical congress.

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The Pharma Data

APRIL 13, 2022

Takeda ( TSE:4502/NYSE:TAK ) today announced that the Phase 3 SHP643-301 study ( NCT04070326 ) evaluating the safety profile and pharmacokinetics (PK) of TAKHZYRO ® (lanadelumab) in patients 2 to <12 years of age is complete and has met its objectives. We look forward to discussing these data with global health authorities.

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Agency IQ

OCTOBER 20, 2023

FDA’s newest draft guidance lays out considerations for developing treatments for diabetic foot infections In a new draft guidance document released within weeks of a related clinical practice guideline, the FDA provides considerations for developing therapies to treat diabetic foot infections, focusing on Phase 3 efficacy trials.

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The Pharma Data

APRIL 22, 2023

Nasdaq: GILD) today announced positive results from several COVID-19 clinical and real-world evidence studies being presented at the 33rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). Veklury® (Remdesivir) Efficacy and Safety Profile Further Demonstrated in Vulnerable Patient Populations Gilead Sciences, Inc.

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The Pharma Data

JULY 22, 2021

Takeda Pharmaceutical Company Limited ( TSE: 4502 /NYSE:TAK) (“Takeda”) today announced the results of a phase 3 trial investigating the efficacy and safety of recombinant von Willebrand factor (rVWF) prophylaxis, 1 one of the 12 abstracts being presented at the International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress 2021.

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The Pharma Data

AUGUST 22, 2021

Full results from PROVENT will be submitted for publication in a peer-reviewed medical journal and presented at a forthcoming medical meeting. 12)AZD7442 is being studied in a comprehensive clinical trial programme for both prevention and treatment of COVID-19 in over 9,000 participants. About PROVENT. Griffin MP, et al. Yu XQ, et al.

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The Premier Consulting Blog

AUGUST 8, 2024

For example, pharmacokinetic (PK) data from a comparative BA study and PK modeling approaches (e.g., patients with renal, hepatic, or cardiovascular concerns).

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New Drug Approvals

SEPTEMBER 29, 2024

Both were reversed by treatment with COR388 ( 2020 AAIC abstract ). According to a company press release and a poster presentation at the 2018 CTAD conference, healthy adults received 25, 50, or 100 mg COR388 or placebo every 12 hours for 10 days; AD patients took 50 mg or placebo every 12 hours for 28 days. and Europe.

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The Pharma Data

AUGUST 29, 2020

Phase II results are promising for treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disorder; 1,2 second Phase II study with LNP023 monotherapy in anti-C5 naïve PNH patients ongoing . All patients required RBC transfusions prior to starting LNP023 treatment. “In Peffault de Latour.

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FDA Law Blog: Drug Discovery

JANUARY 7, 2024

Additionally, this review excluded pharmacokinetic and animal studies. The only example of a pregnancy PMC is for Paxlovid, for treatment of COVID-19, which is a distinguishable example because the sponsor committed to this study while the drug was still under an Emergency Use Authorization (EUA), not an NDA.

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Metabolite Tales Blog

DECEMBER 13, 2023

The pyrazole in a drug compound developed by LEO as an oral IL-17A protein-protein interaction modulator for the treatment of psoriasis and other inflammatory disorders is susceptible to N -glucuronidation. Mark Andrews, presentation at the 3rd RSC Anglo-Nordic Medicinal Chemistry Symposium, 13th-16th June 2023. [5] Oncotarget.

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