Chemical compounds

UroGen Pharma Announces License and Supply Agreement with Neopharm to Pursue Regulatory Approval and Commercialization for Jelmyto® in Israel

Retrieved on: 
Wednesday, July 28, 2021

We are proud to be the first company outside the US to have started the regulatory approval and commercialization process for Jelmyto, demonstrating Israel's importance in geographic expansion.

Key Points: 
  • We are proud to be the first company outside the US to have started the regulatory approval and commercialization process for Jelmyto, demonstrating Israel's importance in geographic expansion.
  • I am confident that our well-established expertise and heritage of collaboration with innovative biopharmaceutical companies will make Jelmyto a success in Israel.
  • UroGen is committed to bringing the promise of Jelmyto to as many patients as possible, as quickly as feasible.
  • JELMYTO and UroGen are registered trademarks of UroGen Pharma, Ltd.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210728005968/en/

ENYO Pharma Announces Positive Vonafexor (EYP001) Results for the LIVIFY Phase 2a Study in F2-F3 NASH Patients over 12 weeks

Retrieved on: 
Wednesday, July 28, 2021

In this Phase 2a trial, 96 patients with NASH were randomized 1:1:1 to receive oral, once-daily Vonafexor at 200 mg or 100 mg, or placebo.

Key Points: 
  • In this Phase 2a trial, 96 patients with NASH were randomized 1:1:1 to receive oral, once-daily Vonafexor at 200 mg or 100 mg, or placebo.
  • There were no significant differences in efficacy endpoints between the 100 mg and the 200 mg Vonafexor treatment groups.
  • 76 % of the patients receiving Vonafexor had improved kidney function as measured by eGFR over 12 weeks while 66 % of patients receiving placebo had deterioration of kidney function over the 12 week study period1).
  • The positive results seen on several key non-invasive tests at 12 weeks of dosing are highly encouraging and support advancement of this compound forward in NASH.

Venatorx Pharmaceuticals Announces Positive Phase 1 Results for VNRX-7145

Retrieved on: 
Wednesday, July 28, 2021

Venatorx Pharmaceuticals today announced positive top line results for its Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial ( ClinicalTrials.gov NCT04243863 ) of VNRX-7145, a novel component of the investigational oral antibiotic combination product.

Key Points: 
  • Venatorx Pharmaceuticals today announced positive top line results for its Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial ( ClinicalTrials.gov NCT04243863 ) of VNRX-7145, a novel component of the investigational oral antibiotic combination product.
  • The Phase 1 study was a 2-part, first-in-human dose-ranging study to evaluate the safety and pharmacokinetics (PK) of escalating oral doses of VNRX-7145.
  • Venatorxs two lead antibacterial clinical-stage programs are intravenous (cefepime-taniborbactam) and oral (ceftibuten/VNRX-7145) broad-spectrum beta-lactam/beta-lactamase inhibitor combinations that are in Phase 3 and Phase 1, respectively.
  • In addition, Venatorx is in Phase 1 with its first antiviral compound (VNRX-9945), a Hepatitis B virus inhibitor.

Study: Common Drugs Associated with Increased Risk for Cardiac Arrhythmia and Sudden Death in Elderly Patients

Retrieved on: 
Wednesday, July 28, 2021

This means outcome studies including the measure of sudden death based on large clinical data sets are especially important to assess the risk of drug-induced arrhythmia.

Key Points: 
  • This means outcome studies including the measure of sudden death based on large clinical data sets are especially important to assess the risk of drug-induced arrhythmia.
  • Of the short-term drugs, researchers found the antibiotics levofloxacin increased the risk of cardiac arrhythmia or sudden death by 51% compared to the amoxicillin control, while erythromycin had an increased risk of 63%.
  • The anti-nausea drug ondansetron increased the risk of a cardiac adverse event by 205%, while the antifungal fluconazole increased the risk by 123%.
  • Current patients prescribed the antipsychotics showed an increased risk of arrhythmia or sudden death of 118% compared to patients who never received the drug.

Myovant Sciences Announces Financial Results for First Quarter of Fiscal Year 2021 and Corporate Updates

Retrieved on: 
Wednesday, July 28, 2021

First fiscal quarter 2021 net product revenues for ORGOVYX in the U.S. were $10.5 million, driven by increased prescriber demand.

Key Points: 
  • First fiscal quarter 2021 net product revenues for ORGOVYX in the U.S. were $10.5 million, driven by increased prescriber demand.
  • The FDA approval of MYFEMBREE triggered a $100.0 million regulatory milestone payment from Pfizer, which Myovant received in July 2021 (Myovants second fiscal quarter 2021).
  • As previously announced, Myovant will hold a webcast and conference call at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) today, July28, 2021, to discuss financial results for its first fiscal quarter ended June 30, 2021 and corporate updates.
  • Sumitovant is the majority shareholder of Myovant, and wholly owns Urovant Sciences, Enzyvant Therapeutics, Spirovant Sciences, and Altavant Sciences.

RLE Technologies Adds Wireless Carbon Dioxide Sensor to WiNG Product Line

Retrieved on: 
Tuesday, July 27, 2021

RLE Technologies , a leading provider of patented raised floors and containment , web-based monitoring solutions , and leak detection systems for mission-critical facilities, is improving the insight and oversight users have into the their buildings with the introduction of the WiNG-CO2 wireless carbon dioxide sensor .

Key Points: 
  • RLE Technologies , a leading provider of patented raised floors and containment , web-based monitoring solutions , and leak detection systems for mission-critical facilities, is improving the insight and oversight users have into the their buildings with the introduction of the WiNG-CO2 wireless carbon dioxide sensor .
  • The WiNG-CO2 sensor monitors three critical facility metrics: carbon dioxide, temperature, and humidity.
  • This sensor is a versatile solution that you can quickly add to any new or existing WiNG system.
  • The CO2 module we use in the WiNG-CO2 sensor is self-calibrating, zero maintenance, has a broad range and excellent accuracy, plus a 15-year CO2 sensor life expectancy.

FDA Grants Meeting to Petros Pharmaceuticals to Discuss Label Expansion of Erectile Dysfunction Drug STENDRA®

Retrieved on: 
Tuesday, July 27, 2021

"While the PDE5 inhibitor class of erectile dysfunction drugs has a respected history, we believe that the data collected on STENDRA may further differentiate it from other drugs in the class.

Key Points: 
  • "While the PDE5 inhibitor class of erectile dysfunction drugs has a respected history, we believe that the data collected on STENDRA may further differentiate it from other drugs in the class.
  • We look forward to sharing our data with the FDA and discussing the additional necessary steps toward modification of the STENDRA label, and thereby the patient populations that may benefit from treating their erectile dysfunction with STENDRA."
  • Stendra(avanafil), originally launched by Auxilium Pharmaceuticals prior to that company's sale to Endo Pharmaceuticals, is an oral phosphodiesterase 5 (PDE5) inhibitor for the treatment of erectile dysfunction.
  • STENDRA may affect the way other medicines work, and other medicines may affect the way STENDRA works, which may cause side effects.

Allarity Therapeutics and Lantern Pharma Enter into Agreement for Future Clinical Development of Irofulven

Retrieved on: 
Monday, July 26, 2021

Hrsholm, Denmark and Dallas, TX, U.S.A. (July 26, 2021) Allarity Therapeutics A/S (Allarity) and Lantern Pharma Inc. (Lantern) today announced that they have entered into an exclusive agreement under which Lantern will reacquire global rights to Irofulven (LP-100) and assume full authority to manage and guide future clinical development and commercialization.

Key Points: 
  • Hrsholm, Denmark and Dallas, TX, U.S.A. (July 26, 2021) Allarity Therapeutics A/S (Allarity) and Lantern Pharma Inc. (Lantern) today announced that they have entered into an exclusive agreement under which Lantern will reacquire global rights to Irofulven (LP-100) and assume full authority to manage and guide future clinical development and commercialization.
  • The drug was originally developed by MGI Pharma (USA) and Eisai (Japan), through Phase 3 clinical trials.
  • Under the agreement, Lantern will purchase assets and reacquire global, exclusive rights to further develop and commercialize Irofulven, and Allarity will discontinue further involvement in the Irofulven program.
  • Lantern will also receive a license to utilize, in its sole discretion, Allaritys Irofulven DRP companion diagnostic in future clinical development and commercialization of the drug.

Global Astaxanthin Producer Atacama Bio Broadens Its Distribution Reach to China with an Exclusive Partnership with Carelife

Retrieved on: 
Monday, July 26, 2021

The agreement with Atacama Bio aligns with the company values and will allow them to distribute NatAxtin exclusively, a NAXA-Verified Astaxanthin sustainably produced in Chile.

Key Points: 
  • The agreement with Atacama Bio aligns with the company values and will allow them to distribute NatAxtin exclusively, a NAXA-Verified Astaxanthin sustainably produced in Chile.
  • And, best of all, commits to spreading the word about NatAxtin, the world's most sustainable Astaxanthin," stated Jos Luis Arenas, Founder, and CEO of Atacama Bio.
  • Atacama Bio has a unique approach to culture Haematococcus pluvialis to extract Astaxanthin.
  • Edmond Yi, General Manager at Carelife, commented, "I expect this cooperation to be greatly successful for Atacama and Carelife in the Chinese market.

Laekna Therapeutics will present two clinical study results in ESMO 2021

Retrieved on: 
Monday, July 26, 2021

This ClinicalTrials NCT03843918 is a phase I monotherapy dose-escalation study of LAE001, in patients with metastatic castration-resistant prostate cancer (mCRPC).

Key Points: 
  • This ClinicalTrials NCT03843918 is a phase I monotherapy dose-escalation study of LAE001, in patients with metastatic castration-resistant prostate cancer (mCRPC).
  • Laekna plan to further develop LAE001 to treat patients with mCSPC, who usually have a much longer treatment duration, and would benefit more from using LAE001.
  • The global randomized, open-label, multi-center Phase 2 PROFECTA-II clinical trial of afuresertib is the world's first registration-directed clinical study of a pan-AKT kinase inhibitor to treat platinum-resistant ovarian cancer.
  • Laekna is committed to a science-based, innovation-driven approach to create an international leading clinical research and development platform for the development of first-in-class and best-in-class innovative drugs.