The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections. SHANGHAI , Jan. ” About SPR206.

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The Pharma Data

NOVEMBER 11, 2020

“These data provide further evidence of efficacy and high potency of SLV213 against SARS-CoV-2 and support the clinical development of SLV213 as a potential oral treatment for COVID-19,” said Ted Daley, President and CEO, Selva Therapeutics. “As Viruses work by infecting host cells and hijacking the cell’s replication machinery.

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The Pharma Data

OCTOBER 27, 2020

The company’s lead program is aimed at Friedrich’s Ataxia, a rare inherited genetic disease that causes cardiac and central nervous system dysfunction. AavantiBio has a unique opportunity to change the lives of those living with FA and other rare diseases,” Cumbo said. and China. said of B cells’ potential. “We

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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.

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The Pharma Data

DECEMBER 14, 2020

The Phase I trial is a randomized, double-blind, placebo-controlled study that is meant to evaluate the safety, pharmacokinetics and pharmacodynamics of single ascending doses of ABBV-47D11. “With the clinical program at AbbVie now underway, we are in a position to contribute a new therapeutic option to address this pandemic.”

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Alta Sciences

OCTOBER 30, 2023

36: Nonclinical Studies in Cell and Gene Therapy – Key Considerations and Regulatory Guidance With an estimated 6,000 monogenic diseases affecting over 350 million people worldwide, the advantages of cell and gene therapy can be a ray of hope—but development of complex, leading-edge therapies requires careful planning. Read it now.

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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.

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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.

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The Pharma Data

MARCH 5, 2021

Key secondary objectives include measures of safety, pharmacokinetics, and anti-tumor activity (i.e. In the Phase 2, patients are enrolled across various cohorts, depending on disease type and prior therapy. Secondary endpoints include duration of response (DOR), overall survival (OS), safety, and pharmacokinetics (PK).

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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.

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Alta Sciences

APRIL 17, 2024

Gene Therapy Gene therapy is currently considered for diseases, often rare, that have no other cures. It is a growing field where new technology, and an increasing understanding of the science, are bringing advancements in drug development. Read The Altascientist , “Nonclinical Studies in Cell and Gene Therapy”. 3.

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The Pharma Data

NOVEMBER 18, 2020

This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels. SEFA’ stands for Structurally Engineered Fatty Acid, i.e. chemically engineered fatty acids, to generate compounds with differentiated physiochemical properties.

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The Pharma Data

JANUARY 3, 2021

Nasdaq: INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced that the U.S. We are initially focused on developing a novel therapy to treat ENPP1 and ABCC6 deficiencies.

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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.

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PPD

MAY 11, 2023

Children and the elderly are among the most vulnerable populations and must be given special consideration in vaccine clinical trials to ensure their protection against vaccine-treatable diseases. The Many Considerations of Pediatric Vaccine Clinical Trials Childhood vaccines are highly effective in the prevention of many diseases.

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The Pharma Data

AUGUST 19, 2021

1 Disease response was evaluated using overall response rate (ORR), per Response Evaluation Criteria in Solid Tumors Version 1.1* (RECIST v1.1) Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “We Interstitial Lung Disease/Pneumonitis 7. as the primary endpoint.

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The Pharma Data

AUGUST 29, 2020

Seven of ten patients discontinued eculizumab and remained on LNP023 as monotherapy, retaining hemoglobin (Hb) levels with no changes in biomarkers of disease activity and with no signs or symptoms of breakthrough hemolysis . Peffault de Latour.

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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. •. .

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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.

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Metabolite Tales Blog

JANUARY 23, 2024

The drug is therefore contraindicated in cases where severe renal impairment or end‐stage renal disease has been confirmed, as well as in combination with CYP1A2 inhibitors [7]. Pharmacokinetics and Disposition of Momelotinib Revealed a Disproportionate Human Metabolite—Resolution for Clinical Development.

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The Pharma Data

APRIL 11, 2023

Bayer will present the first clinical Phase 1 results on aryl hydrocarbon receptor (AhR) inhibitor BAY 2416964, the company’s most advanced Immuno-Oncology program. Bayer will present the first clinical Phase 1 results on aryl hydrocarbon receptor (AhR) inhibitor BAY 2416964, the company’s most advanced Immuno-Oncology program.

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The Pharma Data

DECEMBER 13, 2020

AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and additional chronic and rare metabolic diseases. Summary of New PXL770 Phase 2a Study Results. The Phase 2b trial is expected to begin during the second half of 2021. About NASH.

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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.

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The Pharma Data

APRIL 11, 2021

50 kg, respectively), taken twice daily until disease progression or unacceptable toxicity. i Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. 15 to 89 mL/min, estimated by Modification of Diet in Renal Disease [MDRD] equation). Retevmo is an U.S.

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The Pharma Data

DECEMBER 5, 2020

57% of evaluable patients (4 of 7 patients) were minimal residual disease (MRD) negative. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. 42% (n=8) had a CR or sCR. and the world, respectively, in 2020.

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The Pharma Data

NOVEMBER 4, 2020

Published Findings on Alopecia Areata Burden of Disease in Journal of Investigative Dermatology. Concert Pharmaceuticals is a clinical stage biopharmaceutical company that is developing small molecule drugs that it discovered through the application of its DCE Platform® (deuterated chemical entity platform).

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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.

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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.

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PPD

APRIL 14, 2025

Last year, an American Heart Association presidential advisory for the first time formally identified the strong connections between cardiovascular disease (CVD), kidney disease, Type 2 diabetes and obesity as reason to define cardiovascular-kidney-metabolic (CKM) syndrome.

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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. ,

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The Pharma Data

NOVEMBER 9, 2021

– More than 30 Abstracts Across HDV, HCV, HBV, NASH and PSC Reflect Gilead’s Ongoing Commitment to Addressing Challenges Facing People Living With Liver Diseases –. About Gilead Sciences in Liver Disease. For more than 20 years, Gilead has sought to address some of the biggest challenges in liver disease. Gilead Lores,Inc.

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The Pharma Data

JULY 21, 2021

For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. Forward-Looking Statement of Merck & Co., Kenilworth, N.J.,

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Drug Target Review

OCTOBER 16, 2024

It’s an exciting process—anticipating development risks, predicting outcomes, and aligning these with the greater vision of medical advancement. The true joy comes from navigating these complexities and asking the right questions early on, because these foundational steps are critical to the success of any clinical development process.

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Agency IQ

SEPTEMBER 22, 2023

Since that time, the FDA’s use of single pivotal trials has become more common , especially due to FDA’s expanded reviews of products intended to treat, cure or prevent rare diseases or life-threatening conditions for which there is an unmet clinical need. When should this occur? at the end-of-phase 2 meeting).

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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. Inventiva – The U.S. Follicum – Sweden’s Follicum AB received a patent from the U.S.

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The Pharma Data

JANUARY 3, 2021

Preclinical data from our laboratory have shown that the nasal administration of anti-CD3 stimulates Tregs that can suppress inflammation and ameliorate inflammatory diseases. The pharmacokinetics of nasally administered Foralumab will also be evaluated. . NEW YORK and LONDON, Jan. About Foralumab.

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Sygnature Discovery

NOVEMBER 29, 2023

It was conceived, invented and developed by Professor Stephen Neidle and his team in the School of Pharmacy at University College London with the involvement of Sygnature Discovery scientists. The Phase 1a clinical trial involves a small group of patients who will be given carefully monitored doses of the drug.

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