Lactams | Jotup

Idorsia announces financial results for the first half 2021 – Building momentum towards becoming a fully-fledged biopharmaceutical company

Retrieved on:

Tuesday, July 27, 2021

Food and Drug Administration, Drugs, Pharmaceutical industry, Health sciences, Health care, Drug Safety, GABAA receptor positive allosteric modulators, Lactams, PMDA, New Drug Application, Flunitrazepam

In April and July of 2020, Idorsia reported positive results in each of the two pivotal Phase 3 studies of daridorexant in patients with insomnia.

Key Points:

In April and July of 2020, Idorsia reported positive results in each of the two pivotal Phase 3 studies of daridorexant in patients with insomnia.
Should approval be received, the company anticipates launch in the US in the second quarter of 2022, followed by other regions thereafter.
A New Drug Application (NDA) to the Japanese PMDA for clazosentan was submitted on March 1, 2021.
Based on initial clinical pharmacology investigation with ACT-541478, the company has decided not to pursue the development of this CNS compound further.

Aprea Therapeutics Announces Positive Results from Phase 2 Trial of Eprenetapopt + Azacitidine for Post-Transplant Maintenance Therapy in TP53 Mutant MDS and AML

Retrieved on:

Wednesday, July 21, 2021

Chemical compounds, Organic compounds, Heterocyclic compounds, Orphan drugs, Lactams, Nucleosides, Triazines, Antineoplastic drugs, Azacitidine, Venetoclax, H. Lee Moffitt Cancer Center & Research Institute, 7+3

In addition, the post- transplant regimen of eprenetapopt and azacitidine was well tolerated among patients in the clinical trial.

Key Points:

In addition, the post- transplant regimen of eprenetapopt and azacitidine was well tolerated among patients in the clinical trial.
The post-transplant RFS and OS data with eprenetapopt and azacitidine maintenance therapy in these very difficult-to-treat TP53 mutant MDS and AML patients are incredibly exciting, said trial principal investigator Asmita Mishra, M.D., of the H. Lee Moffitt Cancer Center and Research Institute.
Post-transplant maintenance therapy with eprenetapopt and azacitidine could, if approved, represent a new treatment paradigm that meaningfully improves outcomes for these patients with limited treatment options.
A Phase 1/2 clinical trial of eprenetapopt with venetoclax and azacitidine for the frontline treatment of TP53 mutant AML met the primary efficacy endpoint of complete remission.

FDA Grants Breakthrough Therapy Designation for Venclexta in Combination With Azacitidine for the Treatment of Patients With Myelodysplastic Syndromes

Retrieved on:

Wednesday, July 21, 2021

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that Venclexta® (venetoclax) in combination with azacitidine has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS) based on the revised International Prognostic Scoring System (IPSS-R). MDS are a rare group of blood cancers that gradually affect the ability of the bone marrow to produce normal blood cells. This can lead to weakness, frequent infections, anemia and debilitating fatigue that can profoundly affect a person’s quality of life. In some cases, MDS can also progress into acute myeloid leukemia (AML). Every year in the United States, approximately 10,000 people are diagnosed with MDS, and the median survival for those with higher-risk MDS is approximately 18 months.

Key Points:

We are pleased that the FDA has granted Venclexta its sixth Breakthrough Therapy Designation in recognition of its potential to improve outcomes for people with MDS in combination with azacitidine.
The patients doctor will do blood tests to check for TLS when the patient first starts treatment and during treatment with Venclexta.
Patients should not receive a live vaccine before, during, or after treatment with Venclexta, until the patients doctor tells them it is okay.
The patients doctor will do blood tests to check their blood counts during treatment with Venclexta and may pause dosing.

Outlook on the Irritable Bowel Syndrome Treatment Global Market to 2028 - by Type, Product, Distribution Channel and Geography - ResearchAndMarkets.com

Retrieved on:

Monday, July 12, 2021

Health, General Health, Medical specialties, Clinical medicine, Gastroenterology, Abdominal pain, Irritable bowel syndrome, Lactams, Imidazoles, Lubiprostone, Rifaximin, Eluxadoline, Immuron, Small intestinal bacterial overgrowth

The factors such as increasing prevalence of irritable bowel syndrome (IBS) diseases and rising research & development activities drive the market growth.

Key Points:

The factors such as increasing prevalence of irritable bowel syndrome (IBS) diseases and rising research & development activities drive the market growth.
However, the limited number of product availability and treatment inefficiency hinder the growth of the irritable bowel syndrome (IBS) treatment market.
The global irritable bowel syndrome (IBS) treatment market is segmented on the basis of type, product, and distribution channel.
The irritable bowel syndrome (IBS) treatment market, based on product, is segmented into rifaximin, eluxadoline, lubiprostone, linaclotide, and others.

TRIO Completes Enrolment for Phase 2 Giredestrant Early Breast Cancer Trial Ahead of Schedule

Retrieved on:

Tuesday, July 6, 2021

Chemical compounds, Organic compounds, Drugs, Protein kinase inhibitors, Breakthrough therapy, Piperazines, Cyclopentanes, Lactams, Palbociclib, Breast cancer, Conjugated estrogens, Cancer research

The trial is investigating the ability to expand the safety and efficacy of giredestrant as monotherapy and in combination with palbociclib into the early breast cancer setting.

Key Points:

The trial is investigating the ability to expand the safety and efficacy of giredestrant as monotherapy and in combination with palbociclib into the early breast cancer setting.
The trial design evaluates the efficacy, safety, and pharmacokinetics of presurgical treatment with giredestrant plus palbociclib compared with anastrozole plus palbociclib for postmenopausal women with ER+ and HER2-negative untreated early breast cancer.
The scale of interest from patients further underlines the urgency to bring forward new treatment options to treat early stage breast cancer.
TRIO advances translational cancer research by introducing innovative and novel targeted therapeutic concepts into the clinical trial setting.

Global Kinase Inhibitors Market Report 2021: Data from 2019, 2020 Estimates for 2021 and Projections of CAGRs Through 2026 - ResearchAndMarkets.com

Retrieved on:

Thursday, July 1, 2021

Biotechnology, Pharmaceutical, Health, Protein kinase inhibitors, Lactams, Tyrosine kinase inhibitors, Drugs, Morpholines, Enzyme inhibitors

The global market for kinase inhibitors should grow from $57.6 billion in 2021 to $79.2 billion by 2026 with a compound annual growth rate (CAGR) of 6.6% for the period of 2021-2026.

Key Points:

The global market for kinase inhibitors should grow from $57.6 billion in 2021 to $79.2 billion by 2026 with a compound annual growth rate (CAGR) of 6.6% for the period of 2021-2026.
This report is designed to be a business tool that will provide a thorough evaluation of the markets for kinase inhibitors.
Various types of kinase inhibitors have been analyzed in the report, and along with their different application scenarios, the scope of this study includes regulatory aspects, pipeline analysis and demand for kinase inhibitors.
The market for kinase inhibitor market is experiencing an increasing demand for a number of novel kinase inhibitors being utilized in human trials.

Angion Announces Results from the Phase 2 ALI-201 Study in Patients with COVID-19 Associated Pneumonia

Retrieved on:

Tuesday, June 29, 2021

Branches of biology, Biology, MTOR, Signal transduction, Tyrosine kinase receptors, Lactams, Protein kinase inhibitors

The adverse events and overall safety of the trial were consistent with previously published reports in patients hospitalized with severe COVID-19 pneumonia.

Key Points:

The adverse events and overall safety of the trial were consistent with previously published reports in patients hospitalized with severe COVID-19 pneumonia.
In contrast, patients in our ongoing trials receive ANG-3777 within 1-3 days after the targeted organ injury.
Angion is also currently evaluating ANG-3070, a tyrosine kinase receptor inhibitor for the treatment of fibrotic disease, in Phase 1.
Angion undertakes no obligation to update any forward-looking statement in this press release, except as required by law.

Kura Oncology Doses First Patient in Phase 1b Expansion Cohorts with Menin Inhibitor KO-539

Retrieved on:

Thursday, June 24, 2021

Lactams, Lestaurtinib

Kura expects to enroll at least 12 patients in each of the Phase 1b expansion cohorts and assess those patients for safety and tolerability, pharmacokinetics, pharmacodynamics and efficacy in order to determine the recommended Phase 2 dose.

Key Points:

Kura expects to enroll at least 12 patients in each of the Phase 1b expansion cohorts and assess those patients for safety and tolerability, pharmacokinetics, pharmacodynamics and efficacy in order to determine the recommended Phase 2 dose.
In addition, the Phase 1b gives the Company flexibility to enroll up to 18 additional patients per cohort, as appropriate.
We believe KO-539 has the potential to be both a first-in-class and a best-in-class menin inhibitor, said Stephen Dale, M.D., Chief Medical Officer of Kura Oncology.
KOMET-001 (Kura Oncology Menin Inhibitor Trial) is a Phase 1/2, first-in-human, open-label trial to determine the safety, tolerability and anti-tumor activity of KO-539 in patients with refractory or relapsed AML.

Lyndra Therapeutics Completes $60.5 Million Series C Financing

Retrieved on:

Thursday, June 24, 2021

Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Other Health, Chemical compounds, Organic compounds, Drugs, Prolactin releasers, Atypical antipsychotics, Lactams, Mood stabilizers, Piperidines, Risperidone, Schizophrenia

Lyndra Therapeutics , a clinical-stage biotechnology company pioneering a novel technology platform that transforms daily pills into once-weekly to monthly oral treatment options, today announced the closing of its $60.5 million Series C financing.

Key Points:

Lyndra Therapeutics , a clinical-stage biotechnology company pioneering a novel technology platform that transforms daily pills into once-weekly to monthly oral treatment options, today announced the closing of its $60.5 million Series C financing.
View the full release here: https://www.businesswire.com/news/home/20210624005094/en/
Lyndras ultra-long-acting, extended-release oral capsule dosage form technology is the first of its kind.
Our trailblazing lead product candidate is a once-weekly oral risperidone treatment which has the potential to provide a meaningful benefit to the over two million people with schizophrenia, their caregivers and healthcare providers, said Dr. Patricia Hurter, Chief Executive Officer of Lyndra Therapeutics.
Lyndra has raised almost $250 million in funding, inclusive of this round.

LYNPARZA® (olaparib) Approved in China for the Treatment of Certain Patients with BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

Retrieved on:

Thursday, June 24, 2021

Dose interruptions due to an AR occurred in 45% of patients receiving LYNPARZA and dose reductions due to an AR occurred in 22% of LYNPARZA patients.

Key Points:

Dose interruptions due to an AR occurred in 45% of patients receiving LYNPARZA and dose reductions due to an AR occurred in 22% of LYNPARZA patients.
AstraZeneca and Merck are exploring additional trials in metastatic prostate cancer, including the ongoing Phase 3 PROpel trial evaluating LYNPARZA in combination with abiraterone as a first-line treatment for patients with mCRPC versus abiraterone alone.
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in approximately 1.5% of patients exposed to LYNPARZA monotherapy, and the majority of events had a fatal outcome.
Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (Grade 1).