Cyclopropanes

SIGA Announces Collaboration with Oxford University to Support Expanded Access Protocol for Use of TPOXX® (Tecovirimat) To Treat Monkeypox in Central African Republic

Retrieved on: 
Thursday, July 29, 2021

Under the agreement, Oxford University will sponsor the protocol and study in CAR, and SIGA will provide up to 500 courses of TPOXX (tecovirimat) at no cost.

Key Points: 
  • Under the agreement, Oxford University will sponsor the protocol and study in CAR, and SIGA will provide up to 500 courses of TPOXX (tecovirimat) at no cost.
  • SIGA is proud to provide TPOXX (tecovirimat) as a treatment for this public health challenge under an expanded access protocol, as we believe it may be an important approach to addressing the growing challenge of monkeypox in Central Africa.
  • Monkeypox is a contagious disease caused by infection with monkeypox virus, a virus closely related to variola virus, which causes smallpox.
  • SIGA urges investors and security holders to read those documents free of charge at the SEC's web site at http://www.sec.gov.

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.

Exelixis to Release Second Quarter 2021 Financial Results on Thursday, August 5, 2021

Retrieved on: 
Thursday, July 22, 2021

Exelixis, Inc. (Nasdaq: EXEL) announced today that its second quarter 2021 financial results will be released on Thursday, August 5, 2021 after the markets close.

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) announced today that its second quarter 2021 financial results will be released on Thursday, August 5, 2021 after the markets close.
  • At 5:00 p.m. EDT / 2:00 p.m. PDT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update.
  • For more information about Exelixis, please visit www.exelixis.com , follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.
  • Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered trademarks of Exelixis, Inc. MINNEBRO is a registered trademark of Daiichi Sankyo Company, Limited.

Exelixis to Present at the Virtual William Blair Biotech Focus Conference on July 15, 2021

Retrieved on: 
Thursday, July 8, 2021

Exelixis, Inc. (Nasdaq: EXEL) today announced that Peter Lamb, Ph.D., the companys Executive Vice President, Scientific Strategy and Chief Scientific Officer, will present at the virtual William Blair Biotech Focus Conference 2021 on Thursday, July 15th at 2:00 p.m. EDT / 1:00 p.m. CDT / 11:00 a.m. PDT.

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) today announced that Peter Lamb, Ph.D., the companys Executive Vice President, Scientific Strategy and Chief Scientific Officer, will present at the virtual William Blair Biotech Focus Conference 2021 on Thursday, July 15th at 2:00 p.m. EDT / 1:00 p.m. CDT / 11:00 a.m. PDT.
  • Exelixis is a member of the Standard & Poors (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies.
  • For more information about Exelixis, please visit www.exelixis.com , follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.
  • Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered trademarks of Exelixis, Inc. MINNEBRO is a registered trademark of Daiichi Sankyo Company, Limited.

New Cancer Treatment For Australian Dogs With APVMA Approval Of Qbiotics' Stelfonta®

Retrieved on: 
Tuesday, July 6, 2021

This approval represents Australia's first pharmaceutical treatment available for all grades of canine non-metastatic MCT.

Key Points: 
  • This approval represents Australia's first pharmaceutical treatment available for all grades of canine non-metastatic MCT.
  • QBiotics' CEO and Managing Director, Dr Victoria Gordon said "APVMA approval of STELFONTAmarks an important milestone for QBiotics.
  • As an Australian company with a strong heritage in discovery, research and development, we are proud that our lead molecule will now be available to treat cancer in Australian dogs."
  • In this study,a single injection of STELFONTA induced a 75% Complete Response (where the tumour is completely destroyed), compared to untreated control dogs (p=0.001).

CytoSorbents Receives Full FDA Approval of Investigational Device Exemption (IDE) for U.S. STAR-T Trial on Ticagrelor Removal During Cardiothoracic Surgery

Retrieved on: 
Tuesday, July 6, 2021

This study is being performed under the previously announced FDA Breakthrough Designation granted for the removal of ticagrelor in a cardiopulmonary bypass circuit during urgent and emergent cardiothoracic surgery with CytoSorbents' proprietary polymer adsorption technology.

Key Points: 
  • This study is being performed under the previously announced FDA Breakthrough Designation granted for the removal of ticagrelor in a cardiopulmonary bypass circuit during urgent and emergent cardiothoracic surgery with CytoSorbents' proprietary polymer adsorption technology.
  • Finally, we will continue to collaborate closely with the FDA to leverage the priority review associated with our ticagrelor removal application in the spirit of the granted Breakthrough Designation."
  • In April 2020, the FDA granted CytoSorbents Breakthrough Device Designation to remove ticagrelor during cardiothoracic surgery, recognizing this major unmet medical need.
  • If cleared by the FDA, DrugSorb-ATR would be marketed in the United States for ticagrelor removal in a cardiopulmonary bypass circuit during cardiothoracic surgery.

China Moxifloxacin Markets, 2016-2020 & 2021-2025 - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 1, 2021

Moxifloxacin can be used to treat several infections, including respiratory infections, cellulitis, anthracnose, endocarditis, intra-abdominal infections, meningitis and tuberculosis.

Key Points: 
  • Moxifloxacin can be used to treat several infections, including respiratory infections, cellulitis, anthracnose, endocarditis, intra-abdominal infections, meningitis and tuberculosis.
  • The survey data shows that the sales value of Moxifloxacin has grown steadily from 2016 to 2019 in China.
  • Moxifloxacin of Bayer Vital GmbH dropped by 77.70%, and Moxifloxacin of Nanjing Youke Pharmaceutical Co., Ltd. dropped by 53.07%.
  • 2 Sales of Moxifloxacin in China, 2016-2020
    2.3 Sales of Moxifloxacin by Dosage Form in China, 2016-2020

Valent BioSciences Announces U.S. EPA Registration of AccedeTM Plant Growth Regulator for Effective Thinning of Stone Fruit and Apples

Retrieved on: 
Wednesday, June 30, 2021

Valent BioSciences LLC announces U.S. EPA (Environmental Protection Agency) registration of a new plant growth regulator (PGR), which will be marketed under the brand name AccedeTM, utilizing the active ingredient 1-aminocyclopropane-1-carboxylic acid (ACC).

Key Points: 
  • Valent BioSciences LLC announces U.S. EPA (Environmental Protection Agency) registration of a new plant growth regulator (PGR), which will be marketed under the brand name AccedeTM, utilizing the active ingredient 1-aminocyclopropane-1-carboxylic acid (ACC).
  • Accede is the first PGR based on a naturally occurring compound developed specifically for thinning of stone fruit, including peaches and nectarines.
  • It also gives apple growers an effective tool to thin apples in the late thinning window when fruit are 15-20 mm in diameter.
  • The ethylene generated after application of Accede stimulates and accelerates flower and fruit drop in apples and stone fruit.

Gilead Submits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting Capsid Inhibitor for the Treatment of HIV-1 in People With Limited Therapy Options

Retrieved on: 
Monday, June 28, 2021

Gilead plans to submit marketing authorization applications for lenacapavir to the European Medicines Agency and other global agencies in the coming months.

Key Points: 
  • Gilead plans to submit marketing authorization applications for lenacapavir to the European Medicines Agency and other global agencies in the coming months.
  • Lenacapavir is a potential first-in-class, long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 infection.
  • GILEAD and the GILEAD logo are trademarks of Gilead Sciences, Inc. All other trademarks are the property of their respective owners.
  • For more information about Gilead, please visit the companys website at www.gilead.com , follow Gilead on Twitter ( @Gilead Sciences ) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Antares Pharma Announces Partner Idorsia Initiates the Phase 3 Study With Selatogrel for Acute Myocardial Infarction

Retrieved on: 
Monday, June 28, 2021

Idorsia is initiating an international, multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to assess the clinical efficacy and safety of 16 mg selatogrel when self-administered (on top of standard-of-care) upon occurrence of symptoms suggestive of an acute myocardial infarction.

Key Points: 
  • Idorsia is initiating an international, multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to assess the clinical efficacy and safety of 16 mg selatogrel when self-administered (on top of standard-of-care) upon occurrence of symptoms suggestive of an acute myocardial infarction.
  • The primary efficacy endpoint is the occurrence of death from any cause, or non-fatal AMI after any study treatment self-administration.
  • A Special Protocol Assessment has been agreed with the U.S. Food and Drug Administration (FDA) for Idorsias selatogrel.
  • Idorsia selected Antares Quickshot autoinjector for the development of selatogrel due to the robustness, reliability, ease-of-use and emergency-ready capabilities of our technology.