Drug Target Review

SEPTEMBER 25, 2024

Notably, TT125-802 stabilised disease and prevented further outgrowth of tumours resistant to standard-of-care treatment. Several patients have experienced disease stabilisation, and one NSCLC patient showed a confirmed partial response. 2019 Dec 13 [cited 2024 Sep 4];122(4):465–72. Nature Reviews Drug Discovery [Internet].

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The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. Spero plans to initiate additional Phase 1 studies to assess the penetration of SPR206 into the pulmonary compartment and pharmacokinetics in subjects with renal impairment in 2021. SHANGHAI , Jan.

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Clinical Trials Clinical Development Pharmacokinetics Pharmaceutical Companies 52

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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Clinical Trials Pharmacokinetics Trials Therapies 52

The Pharma Data

AUGUST 22, 2021

We are very encouraged by these efficacy and safety data in high-risk people, showing our long-acting antibody combination has the potential to protect from symptomatic and severe disease, alongside vaccines. We look forward to sharing further data from the AZD7442 Phase III clinical trial programme later this year.” About AstraZeneca.

Trials 52

Trials Vaccine Virus Pharmacokinetics 52

The Pharma Data

FEBRUARY 25, 2022

The study met its primary goal by demonstrating pharmacokinetic equivalence in patients who switched multiple times between treatment with the two medicines. The root cause of many immunological diseases is immuno-inflammation, which requires specifically designed agents.

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

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. A Phase 2b study was initiated in July 2019 (ICONA) to study the efficacy of icosabutate in NASH. SEFA-1024 is one of NST’s three SEFA programs.

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Trials Engineering Pharmacokinetics Therapies 40

The Pharma Data

JULY 2, 2023

In 2019, a team of researchers around Marcus Conrad, Director of the Institute of Metabolism and Cell Death at Helmholtz Munich, had already identified the first FSP1-specific inhibitor, known as iFSP1. Notably, during de-differentiation or metabolic rewiring, certain malignant cancer cells acquire an intrinsic vulnerability to ferroptosis.

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The Pharma Data

NOVEMBER 8, 2020

The resubmission came after a meeting with the FDA in February 2020 and addresses issues raised by the agency’s Complete Response Letter (CRL) in November 2019. “We Progeria, also called Hutchinson-Gilford Progeria Syndrome (HGPS), is an ultra-rare and fatal genetic disease of accelerated aging in children.

FDA 52

FDA Trials Therapies Pharmacokinetics 52

The Pharma Data

MARCH 9, 2022

Sanofi and Swedish Orphan Biovitrum AB (publ) (Sobi ® ) (STO:SOBI) today announced positive topline results from the pivotal XTEND-1 Phase 3 study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa (BIVV001) in previously treated patients ?12 12 years of age with severe hemophilia A.

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Treatment Pharmacokinetics Therapies FDA 52

New Drug Approvals

OCTOBER 24, 2023

1 Therefore, S1P receptor modulators like etrasimod were investigated in treating immune-mediated diseases like ulcerative colitis where a high level of inflammatory T cells is present in the gastrointestinal tract, thus causing diffuse mucosal inflammation. June 2019). twitter +919321316780 call whatsaapp EMAIL. PMID 36871574. ^

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Alta Sciences

APRIL 17, 2024

Ketamine is a dissociative anesthetic approved in 2019 by the U.S. Gene Therapy Gene therapy is currently considered for diseases, often rare, that have no other cures. And since proteins are often linked to disease, there's huge potential to treat a broad range of diseases with this technology.

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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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Treatment Pharmacokinetics Disease Production 52

The Pharma Data

DECEMBER 9, 2020

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days.

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Clinical Trials Trials Pharmaceuticals Pharmacokinetics 40

The Pharma Data

SEPTEMBER 19, 2020

While we have made great progress in the treatment of many forms of breast cancer, TNBC remains an aggressive and difficult-to-treat disease,” said Levi Garraway, M.D., Secondary endpoints include OS, event-free survival, disease-free survival and quality of life measures. In 2019, Roche invested CHF 11.7 from 41.1% (95% CI: 33.6–48.9)

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Treatment Disease Therapies Pharmaceuticals 52

The Pharma Data

SEPTEMBER 26, 2021

With MS, finding the proper treatment option is the maximum amount about managing the clinical aspects of the disease because it is about how treatment fits into a person’s life,” said Simon Faissner, M.D., Food and Drug Administration in October 2019 and is currently the amount one prescribed oral MS therapy within the country.

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Treatment Clinical Trials Virus Pharmacokinetics 40

The Pharma Data

DECEMBER 28, 2020

NASH, which is a severe form of non-alcoholic fatty liver disease affects approximately 17 million people in the U.S. The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. and is a leading cause of liver transplantation.

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The Pharma Data

OCTOBER 27, 2020

2019. 2019. million for the three months ended September 30, 2020 , compared to the same period in 2019. In addition, as previously disclosed, our 2019 revenues were impacted by a mistake by one of our U.S. million in total, during the third quarter of 2019. 2019.

FDA 40

FDA Production Licensing Licensing 40

The Pharma Data

APRIL 27, 2021

In 2019, the U.S. In April 2020, mobocertinib received Breakthrough Therapy Designation from the FDA for patients with EGFR Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC) whose disease has progressed on or after platinum-based chemotherapy. About the Phase 1/2 Trial. Takeda’s Commitment to Oncology.

FDA 52

FDA Treatment Pharmaceutical Companies Therapies 52

New Drug Approvals

SEPTEMBER 13, 2024

14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] 14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] Lazar MA, McIntyre RS (2019). Browne CA, Lucki I (September 2019). 2] [3] [4] A regulatory application for approval of the medication is expected to be submitted by 2025. [2]

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Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

The Pharma Data

SEPTEMBER 15, 2020

Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. Rare Disease. Given the encouraging safety and efficacy profile, the Company initiated a Phase 3 study in 2019 and the prospective lead-in study with 40 patients has now been fully enrolled.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

The Pharma Data

MAY 4, 2021

Lilly will donate both baricitinib (4 mg tablet) as well as bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together – providing options to treat COVID-19 patients at different stages of the disease. ” The allocation of therapies will be based on the disease burden and hospitalization rates in each country.

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The Pharma Data

APRIL 11, 2021

50 kg, respectively), taken twice daily until disease progression or unacceptable toxicity. Retevmo has not been studied in patients with clinically significant active cardiovascular disease or recent myocardial infarction. 15 to 89 mL/min, estimated by Modification of Diet in Renal Disease [MDRD] equation). Retevmo is an U.S.

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Research Therapies Treatment Trials 52

The Pharma Data

FEBRUARY 8, 2021

IBRANCE is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy. 2,3 In the U.S., The full U.S.

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Clinical Trials Treatment Therapies Production 52

Agency IQ

JULY 28, 2023

The Centers for Disease Control and Prevention (CDC) explains that the first wave began with increased prescription of opioids in the 1990s. During the COVID-19 pandemic, the number of opioid-involved deaths climbed sharply, with mortality rates increasing by 38% between 2019 and 2020. Read the full AgencyIQ analysis here.

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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.

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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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Production Trials Treatment Disease 40

The Pharma Data

FEBRUARY 8, 2021

ACIS is a Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical study evaluating the efficacy and safety of ERLEADA ® and ZYTIGA ® plus prednisone compared to placebo and ZYTIGA ® plus prednisone in 982 patients with chemotherapy-naïve mCRPC disease who received ADT. The primary endpoint of the study was rPFS.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

Agency IQ

FEBRUARY 2, 2024

after ischemic heart disease and stroke. In 2019 more than one in four (28%) of deaths in the E.U. EMA floated these updates through a Concept Paper in 2019 and subsequently issued a draft updated guideline for public consultation in late 2020. were from cancer. Even under the shadow of the Covid-19 pandemic, 1.2

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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. Independently optimized receptor bias and potency as well as pharmacokinetics to create a potentially best-in-class IL-2 product. .

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Clinical Trials Clinical Development Small Molecule Trials 40

The Pharma Data

DECEMBER 3, 2020

The disease is classified as a developmental and epileptic encephalopathy due to the developmental delays and cognitive impairment associated with the disease. The primary endpoints are safety, tolerability and pharmacokinetic (PK) profile of STK-001 in Dravet syndrome patients. BEDFORD, Mass.–(

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Clinical Trials Protein Expression Pharmacokinetics Trials 52

The Pharma Data

JULY 6, 2021

“Breaking barriers for people living with rare blood disorders requires that we push ourselves to transform the therapeutic landscape, ” said Karin Knobe, MD, PhD, Head of Development, Rare Disease s and Rare Blood Disorders at Sanofi. “We Three additional Phase 2 studies in immunological diseases are planned to start in 2021.

Therapies 52

Therapies Pharmacokinetics RNA 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 Therapies 52

The Pharma Data

JANUARY 21, 2021

Results from these trials were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI). Hepatotoxicity: Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine with or without known pre-existing hepatic disease or identifiable risk factors. cp-51575v4.

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FDA Approval Treatment RNA FDA 52

The Pharma Data

JUNE 28, 2021

There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure. From November 2016 to June 2019, a total of 112 participants were enrolled across 36 sites in 10 countries. for use in pediatric patients. EINSTEIN-Jr. About the EINSTEIN-Jr.

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FDA Clinical Trials Treatment Therapies 52

The Pharma Data

OCTOBER 14, 2020

VBL has recently demonstrated ex-vivo activity of anti-MOSPD2 antibodies in patients with relapsing-remitting and progressive multiple sclerosis (MS), as well as in animal models of rheumatoid arthritis (RA), nonalcoholic steatohepatitis (NASH) and inflammatory bowel disease (IBD). Inventiva – The U.S. Growth Programme.

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Clinical Trials Trials Pharmaceuticals Therapies 52

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. “We

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Science FDA Clinical Trials Clinical Pharmacology 40

The Pharma Data

NOVEMBER 4, 2020

Published Findings on Alopecia Areata Burden of Disease in Journal of Investigative Dermatology. million as of December 31, 2019. million for the same period in 2019. million for the same period in 2019. per share, for the quarter ended September 30, 2019. 2019.

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