Pyridines

AVEO Oncology Announces Presentation of Long-Term Efficacy Follow Up, Additional Tolerability Data from the Phase 3 TIVO-3 Study of FOTIVDA® (tivozanib) in Relapsed or Refractory Renal Cell Carcinoma

Retrieved on: 
Wednesday, May 19, 2021

\xe2\x80\x9cWe were also pleased to see efficacy advantages relative to sorafenib were maintained or improved with longer follow-up.

Key Points: 
  • \xe2\x80\x9cWe were also pleased to see efficacy advantages relative to sorafenib were maintained or improved with longer follow-up.
  • Additional analyses and long-term follow up results from the TIVO-3 study to be presented at the 2021 ASCO Annual Meeting include:\nDurability of Response and Updated Overall Survival.
  • It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability.
  • While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.

Propella Therapeutics Receives FDA Clearance to Begin Phase 1 Clinical Study of Novel Prostate Cancer Treatment

Retrieved on: 
Wednesday, May 19, 2021

Under the IND, Propella plans to initiate an open-label, phase 1/2a clinical study in June 2021.

Key Points: 
  • Under the IND, Propella plans to initiate an open-label, phase 1/2a clinical study in June 2021.
  • "We have strong preclinical data, and we\'re excited to be initiating a first-in-human trial.
  • The acetate prodrug of abiraterone is the current standard of care for advanced prostate cancer.
  • "\nToday, Propella also announced the appointment of Brendan Griffin to its leadership team asthe company\'s Chief Financial Officer(CFO).

Tenax Therapeutics Reports First Quarter 2021 Results and Provides Business Update

Retrieved on: 
Monday, May 17, 2021

The purpose of this study is to determine the dose we will take into Phase 3 trials in 2022.

Key Points: 
  • The purpose of this study is to determine the dose we will take into Phase 3 trials in 2022.
  • As a reminder, this new formulation is expected to address the previous GI-related side effects associated with its oral administration.
  • The FDA has granted Orphan Drug Designation for imatinib for the treatment of PAH, an indication with a high unmet medical need.
  • The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release.

Trevena to Release First Quarter 2021 Financial Results on May 6, 2021

Retrieved on: 
Wednesday, May 5, 2021

b'The webcast should be accessed 15 minutes prior to the conference call start time.

Key Points: 
  • b'The webcast should be accessed 15 minutes prior to the conference call start time.
  • A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the company\xe2\x80\x99s website.\nTrevena, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative medicines for patients with CNS disorders.
  • The Company has one approved product in the United States, OLINVYK\xe2\x84\xa2 (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.
  • The Company\xe2\x80\x99s novel pipeline is based on Nobel Prize winning research and includes four differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, TRV045 for epilepsy and chronic neuropathic pain, and TRV027 for acute respiratory distress syndrome and abnormal blood clotting in COVID-19 patients.\n'

Phathom Pharmaceuticals Announces Positive Topline Results from Pivotal Phase 3 Trial of Vonoprazan in Helicobacter pylori (H. pylori) Infection; Study Met All Primary and Secondary Endpoints

Retrieved on: 
Thursday, April 29, 2021

PHALCON-HP is the largest Phase 3 registration trial ever conducted in H. pylori infection, randomizing 992 patients with confirmed H. pylori infection.\nThe primary endpoints in the PHALCON-HP study were non-inferiority of the H. pylori eradication rate for each of vonoprazan triple and dual therapy compared to lansoprazole triple therapy.

Key Points: 
  • PHALCON-HP is the largest Phase 3 registration trial ever conducted in H. pylori infection, randomizing 992 patients with confirmed H. pylori infection.\nThe primary endpoints in the PHALCON-HP study were non-inferiority of the H. pylori eradication rate for each of vonoprazan triple and dual therapy compared to lansoprazole triple therapy.
  • Based on U.S. Food and Drug Administration (FDA) feedback, the primary endpoint excluded patients with amoxicillin or clarithromycin resistant strains of H. pylori.\nBoth vonoprazan-based regimens successfully met their primary endpoints.
  • pylori is a bacterial pathogen that is estimated to infect over 200 million individuals in the United States and Europe.
  • The inclusion of forward-looking statements should not be regarded as a representation by Phathom that any of its plans will be achieved.

Trevena, Inc. to Participate at the Sachs Associates 4th Annual Neuroscience Innovation Forum

Retrieved on: 
Thursday, April 29, 2021

b'Trevena\xe2\x80\x99s panel discussion will be available on demand during the conference to registered participants.\nTrevena, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative medicines for patients with CNS disorders.

Key Points: 
  • b'Trevena\xe2\x80\x99s panel discussion will be available on demand during the conference to registered participants.\nTrevena, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative medicines for patients with CNS disorders.
  • The Company has one approved product in the United States, OLINVYK\xe2\x84\xa2 (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.
  • The Company\xe2\x80\x99s novel pipeline is based on Nobel Prize winning research and includes four differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, TRV045 for epilepsy and chronic neuropathic pain, and TRV027 for acute respiratory distress syndrome and abnormal blood clotting in COVID-19 patients.\n'

Melinta Therapeutics and Hikma Sign Exclusive Licensing Agreement for Two Novel Anti-Infectives for the Middle East and North Africa Region

Retrieved on: 
Thursday, April 29, 2021

This extends Hikma\xe2\x80\x99s existing partnership with Melinta for their intravenous and oral formulations of Baxdela\xc2\xae (delafloxacin), a novel antibiotic product.

Key Points: 
  • This extends Hikma\xe2\x80\x99s existing partnership with Melinta for their intravenous and oral formulations of Baxdela\xc2\xae (delafloxacin), a novel antibiotic product.
  • \xe2\x80\x9cAs one of the leading suppliers in the region, it is our responsibility to equip doctors with the latest and most innovative developments to treat their patients.
  • Visit www.melinta.com for more information.\nHikma helps put better health within reach every day for millions of people around the world.
  • For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them.

Arcus Biosciences Presents Updated Data for Etrumadenant in Third-Line Metastatic Colorectal Cancer and New Data on its HIF-2α Program at the AACR 2021 Annual Meeting

Retrieved on: 
Saturday, April 10, 2021

Efficacy Results (n=22 efficacy-evaluable 3L+ patients as of the DCO of Feb. 26, 2021)

Key Points: 
  • Efficacy Results (n=22 efficacy-evaluable 3L+ patients as of the DCO of Feb. 26, 2021)
    Median progression-free survival (PFS) of 4.2 months.
  • Reported data for current standard-of-care (SOC) therapies have shown a median PFS of 2.0 and 1.9 months for trifluridine-tipiracil and regorafenib, respectively3,4.
  • Reported data for trifluridine-tipiracil and regorafenib have shown a median OS of 7.1 and 6.4 months, respectively3,4.
  • Few options exist today to treat third-line colorectal cancer, and these therapies are associated with significant toxicity and limited efficacy.

DGAP-News: PAION ANNOUNCES PRODUCT LAUNCH OF BYFAVO (REMIMAZOLAM) IN SOUTH KOREA BY HANA PHARM

Retrieved on: 
Wednesday, April 7, 2021

Aachen (Germany), 07 April 2021 - The Specialty Pharma Company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard) today announces that Hana Pharm, remimazolam licensee for South Korea, informed PAION about the launch of ByfavoTM (remimazolam) for the use in general anesthesia in South Korea.

Key Points: 
  • Aachen (Germany), 07 April 2021 - The Specialty Pharma Company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard) today announces that Hana Pharm, remimazolam licensee for South Korea, informed PAION about the launch of ByfavoTM (remimazolam) for the use in general anesthesia in South Korea.
  • Remimazolam was approved in South Korea for general anesthesia in January 2021 and will be marketed under the brand name ByfavoTM.
  • Dr. Jim Phillips, Chief Executive Officer of PAION AG, stated: "The launch in South Korea is great news and a testament to the strong commitment of our partner Hana Pharm.
  • PAION is eligible to royalties of 10% of net sales in South Korea.

China NMPA Approves QINLOCK® (Ripretinib) for Treatment of Advanced Gastrointestinal Stromal Tumors (GIST)

Retrieved on: 
Wednesday, March 31, 2021

NMPAs approval of QINLOCK establishes a new standard of care for treating patients with fourth-line GIST in China.

Key Points: 
  • NMPAs approval of QINLOCK establishes a new standard of care for treating patients with fourth-line GIST in China.
  • QINLOCK may potentially alter the treatment landscape for patients in China with GIST.
  • In March 2021, the NMPA approved QINLOCK for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib.
  • QINLOCK and the QINLOCK logo are registered trademarks, and Deciphera and the Deciphera logo are trademarks, of Deciphera Pharmaceuticals, LLC.