Cyclopropanes

Nicox Completes Enrollment of the Adaptive Design Cohort of NCX 470 Mont Blanc Phase 3 Glaucoma Trial

Retrieved on:

Wednesday, September 2, 2020

Ophthalmology, Drugs, RTT, Chemical compounds, Prostaglandins, Triols, Cyclopropanes, Blindness, Latanoprost, Glaucoma, Ocular hypertension, Eye drop

The adaptive design portion of the trial is intended to select the optimal dose of NCX 470 for the subsequent head-to-head 3-month safety and efficacy evaluation of NCX 470 vs. latanoprost, the current U.S. standard of care for patients with open-angle glaucoma and ocular hypertension.

Key Points:

The adaptive design portion of the trial is intended to select the optimal dose of NCX 470 for the subsequent head-to-head 3-month safety and efficacy evaluation of NCX 470 vs. latanoprost, the current U.S. standard of care for patients with open-angle glaucoma and ocular hypertension.
We would like to thank the clinical investigators, research coordinators, all other trial personnel, and patients for their support.
The Mont Blanc trial is a multi-regional, double-masked, 3-month, parallel group, adaptive design trial evaluating the efficacy and safety of NCX 470 ophthalmic solution, 0.065% and 0.1%, compared to latanoprost ophthalmic solution, 0.005% in patients with open-angle glaucoma or ocular hypertension.
Due to potential delays caused by COVID-19, the Company is not currently providing a target date for the Mont Blanc topline results.

SIGA Technologies, Inc. Reports Financial Results for Three and Six Months Ended June 30, 2020

Retrieved on:

Thursday, August 6, 2020

Chemical compounds, Chemistry, Functional groups, Antivirals, Benzamides, Cyclopropanes, Imides, Poxviruses, Tecovirimat, Siga, Immunoglobulin A, SIGA Technologies

On June 1, the Company announced its first international delivery of TPOXX(tecovirimat) with 2,500 courses delivered to theCanadian Department of National Defence(CDND).

Key Points:

On June 1, the Company announced its first international delivery of TPOXX(tecovirimat) with 2,500 courses delivered to theCanadian Department of National Defence(CDND).
Meridian is counterparty to the Canadian Contract and SIGA is responsible for manufacture and delivery of oral TPOXX.
During the second quarter, SIGA repurchased approximately 2.5 million shares of its common stock, for approximately $15.2 million.
SIGA will host a conference call and webcast to provide a business update today, Thursday, August 6, 2020, at 4:30 P.M.

Exelixis Announces Second Quarter 2020 Financial Results and Provides Corporate Update

Retrieved on:

Thursday, August 6, 2020

Biotechnology, Health, Genetics, Pharmaceutical, Oncology, Tyrosine kinase inhibitors, Cyclopropanes, Quinolines, Cabozantinib, Exelixis, Ipsen, Chemical substances, Medicine, Companies

Based upon cabozantinib-related revenues generated by Exelixis partner Ipsen in the second quarter of 2020, Exelixis earned $16.3 million in royalty revenues.

Key Points:

Based upon cabozantinib-related revenues generated by Exelixis partner Ipsen in the second quarter of 2020, Exelixis earned $16.3 million in royalty revenues.
In September 2020, cabozantinib will be the subject of multiple presentations at ESMO 2020 (September 19-21).
Notably, detailed results from CheckMate -9ER will be the subject of an oral presentation during the meetings Presidential Symposium II.
Exelixis management will discuss the companys financial results for the second quarter of 2020 and provide a general business update during a conference call beginning at 5:30 p.m. EDT / 2:30 p.m. PDT today, Thursday, August 6, 2020.

Eisai: Application for Additional Indication of Anti Cancer Agent Lenvima for Unresectable Thymic Carcinoma Submitted in Japan

Retrieved on:

Friday, July 31, 2020

Orphan drugs, Organic compounds, Chemical compounds, Chloroarenes, Ureas, Chemistry, Cyclopropanes, Lenvatinib, Protein kinase inhibitor, Thymic carcinoma

a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A., announced today that Eisai has submitted an application in Japan for the additional indication of treatment of unresectable thymic carcinoma for multiple receptor tyrosine kinase inhibitor LENVIMA (generic name: lenvatinib mesylate).

Key Points:

a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A., announced today that Eisai has submitted an application in Japan for the additional indication of treatment of unresectable thymic carcinoma for multiple receptor tyrosine kinase inhibitor LENVIMA (generic name: lenvatinib mesylate).
In June 2020, LENVIMA received orphan drug designation in Japan for unresectable thymic carcinoma.
This application is based on the results of an open-label, single-arm, multicenter, investigator-initiated clinical phase II study (NCCH1508) conducted in Japan, evaluating LENVIMA as a single agent in 42 patients with thymic carcinoma previously treated with at least one platinum-based regimen.
This study met its endpoint as the lower value of the CI exceeded the pre-specified statistical criteria, a threshold ORR of 10%.

SIGA Announces Marketing Authorization Filing for oral tecovirimat with the European Medicines Agency for Multiple Indications

Retrieved on:

Thursday, July 30, 2020

Medical specialties, Chordopoxvirinae, Microbiology, Clinical medicine, Poxviruses, RTT, Vaccines, Cyclopropanes, Tecovirimat, Vaccinia, Smallpox, Monkeypox

SIGA has filed its application for oral tecovirimat seeking a broader label indication covering the treatment of smallpox, monkeypox, cowpox, and complications from Vaccinia infection.

Key Points:

SIGA has filed its application for oral tecovirimat seeking a broader label indication covering the treatment of smallpox, monkeypox, cowpox, and complications from Vaccinia infection.
This is also an important step in our international strategy for tecovirimat for maximizing access to the European market.
SIGA developed oral tecovirimat in partnership with the U.S. Government, and the combined expertise generated a robust set of data supporting the efficacy and safety of the product, said Dr. Dennis Hruby, CSO of SIGA.
On July 13, 2018, the FDA approved oral TPOXX (tecovirimat) for the treatment of smallpox to mitigate the impact of a potential outbreak or bioterror attack.

Exelixis Announces Initiation of CONTACT-03 Phase 3 Pivotal Trial of Cabozantinib in Combination With Atezolizumab in Previously Treated Metastatic Renal Cell Carcinoma

Retrieved on:

Monday, July 20, 2020

Pharmaceutical, Health, Oncology, Clinical trials, Branches of biology, Clinical medicine, Cancer, Tyrosine kinase inhibitors, Cyclopropanes, Quinolines, Atezolizumab, Cabozantinib, Growth factors, Exelixis, Renal cell carcinoma, C-Met, RCC

Patients will be randomized 1:1 to the experimental arm of cabozantinib in combination with atezolizumab or the control arm of cabozantinib alone.

Key Points:

Patients will be randomized 1:1 to the experimental arm of cabozantinib in combination with atezolizumab or the control arm of cabozantinib alone.
CABOMETYX in combination with atezolizumab is not indicated for metastatic renal cell carcinoma.
On January 30, 2017, Exelixis and Takeda jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib indications in Japan.
Markedly increased amounts of messenger RNAs for vascular endothelial growth factor and placenta growth factor in renal cell carcinoma associated with angiogenesis.

BRILINTA Significantly Reduced the Rate of the Composite of Stroke and Death in Patients Who Had an Acute Ischemic Stroke or Transient Ischemic Attack in the Phase III THALES Trial

Retrieved on:

Thursday, July 16, 2020

BRILINTA is not indicated in patients with minor acute ischemic stroke or high-risk transient ischemic attack.

Key Points:

BRILINTA is not indicated in patients with minor acute ischemic stroke or high-risk transient ischemic attack.
BRILINTA also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS.
BRILINTA is indicated to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events.
Dyspnea from BRILINTA is often self-limiting
Discontinuation of BRILINTA will increase the risk of MI, stroke, and death.

Nicox Reports on Enrollment Progress in Mont Blanc Phase 3 Clinical Trial in Glaucoma

Retrieved on:

Wednesday, July 15, 2020

Organic compounds, Chemical compounds, RTT, Chemistry, Prostaglandins, Triols, Cyclopropanes, NicOx, Latanoprost, Glaucoma

We would like to thank the clinical investigators, research coordinators, all other trial personnel, and trial patients from the participating clinical sites for the rapid trial start-up and a strong first month of enrolment while carefully implementing COVID-19 precautions.

Key Points:

We would like to thank the clinical investigators, research coordinators, all other trial personnel, and trial patients from the participating clinical sites for the rapid trial start-up and a strong first month of enrolment while carefully implementing COVID-19 precautions.
The Mont Blanc trial is a multi-regional, double-masked, 3-month, parallel group, adaptive design trial evaluating the efficacy and safety of NCX 470 ophthalmic solution, 0.065% and 0.1% compared to latanoprost ophthalmic solution, 0.005% in patients with open-angle glaucoma or ocular hypertension.
The trial is expected to randomize approximately 670 patients at approximately 50 clinical sites, primarily in the U.S., and at a small number of clinical sites in China.
The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox.

Eisai to Launch In-House Developed New Anti-insomnia Drug Dayvigo (Lemborexant) with Indication for Insomnia in Japan

Retrieved on:

Monday, July 6, 2020

Branches of biology, Chemical compounds, Biology, Molecular neuroscience, Hypnotics, Cyclopropanes, Lemborexant, Organofluorides, Pyrimidines, Eisai, Insomnia, Sleep onset

2.5 mg, 5 mg, 10 mg tablets (lemborexant) for treatment of insomnia in Japan on July 6, 2020.

Key Points:

2.5 mg, 5 mg, 10 mg tablets (lemborexant) for treatment of insomnia in Japan on July 6, 2020.
DAYVIGO acts on the orexin neurotransmitter system and is believed to facilitate sleep onset, sleep maintenance, and wake by regulating sleep-wake rhythm.
(9)
Through the launch of DAYVIGO, Eisai will continue to prioritize the provision of appropriate usage and safety information.
For more information about Eisai Co., Ltd., please visit https://www.eisai.com
Public Relations Department Eisai Co., Ltd. +81-(0)3-3817-5120
Copyright 2020 JCN Newswire .

Ipsen Joins Clinical Collaboration to Evaluate Cabozantinib (CABOMETYX®) Plus Atezolizumab in Metastatic Non-Small Cell Lung Cancer and Metastatic Castration-Resistant Prostate Cancer

Retrieved on:

Thursday, July 2, 2020

Ipsen has built its strength in oncology through solid long-term partnerships which are evaluating new approaches to target difficult-to-treat cancers.

Key Points:

Ipsen has built its strength in oncology through solid long-term partnerships which are evaluating new approaches to target difficult-to-treat cancers.
Ipsen has an exclusive collaboration agreement with Exelixis for the further development and commercialization of cabozantinib outside of the United States and Japan.
Patients will be randomized 1:1 to the experimental arm of cabozantinib in combination with atezolizumab and the control arm of docetaxel.
Patients should be instructed to not eat anything for at least 2 hours before through 1 hour after taking CABOMETYX.