Pyrrolidines

HUTCHMED and AstraZeneca Initiate Phase II Trial of ORPATHYS® in Patients with MET Amplified Gastric Cancer

Retrieved on: 
Wednesday, July 28, 2021

Patients whose tumors harbor MET amplification were treated with ORPATHYS monotherapy, reporting an ORR of 50% (10/20, 95% CI: 28.0, 71.9).

Key Points: 
  • Patients whose tumors harbor MET amplification were treated with ORPATHYS monotherapy, reporting an ORR of 50% (10/20, 95% CI: 28.0, 71.9).
  • ORPATHYS is an oral, potent, and highly selective MET tyrosine kinase inhibitor (TKI) that has demonstrated clinical activity in advanced solid tumors.
  • In 2011, following its discovery and initial development by HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing agreement to jointly develop and commercialize ORPATHYS.
  • Joint development in China is led by HUTCHMED, while AstraZeneca leads development outside of China.

Sermonix Pharmaceuticals Completes Enrollment of Phase 2 Clinical Trial Collaboration Studying Lasofoxifene in Combination With Eli Lilly and Company’s Abemaciclib

Retrieved on: 
Monday, June 28, 2021

Sermonix expects initial data from the trial to be available in the first half of 2022.

Key Points: 
  • Sermonix expects initial data from the trial to be available in the first half of 2022.
  • We are delighted to have promptly completed enrollment and thank our participants, their families and clinical centers for supporting our efforts.
  • It is Sermonixs second Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) study and is known as ELAINE 2.
  • Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lamberts Pharmaceutical Division.

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.

Innovation Pharma Completes Enrollment in Phase 2 Clinical Trial for COVID-19

Retrieved on: 
Thursday, June 3, 2021

WAKEFIELD, Mass., June 03, 2021 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (the Company), a clinical stage biopharmaceutical company, announced today that it has achieved full patient enrollment in its randomized, double-blind, placebo-controlled Phase 2 clinical trial of Brilacidin for the treatment of moderate-to-severe COVID-19 in hospitalized patients (see NCT04784897 ).

Key Points: 
  • WAKEFIELD, Mass., June 03, 2021 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (the Company), a clinical stage biopharmaceutical company, announced today that it has achieved full patient enrollment in its randomized, double-blind, placebo-controlled Phase 2 clinical trial of Brilacidin for the treatment of moderate-to-severe COVID-19 in hospitalized patients (see NCT04784897 ).
  • Innovation Pharmaceuticals is developing Brilacidin for treatment of COVID-19 under U.S. FDA Fast Track designation.
  • Complete trial enrollment comprised 120 dosed patients recruited across multiple sites.
  • Brilacidin is the only non-peptidic defensin-mimetic drug candidate currently in a clinical trial as a treatment for SARS-CoV-2, the coronavirus responsible for COVID-19.

New Long-Term Efficacy and Safety Analyses Evaluating RINVOQ® (upadacitinib) in Patients with Rheumatoid Arthritis to be Presented at EULAR 2021 Virtual Congress

Retrieved on: 
Wednesday, June 2, 2021

The integrated safety analysis included pooled data from six randomized, controlled RINVOQ rheumatoid arthritis clinical trials.

Key Points: 
  • The integrated safety analysis included pooled data from six randomized, controlled RINVOQ rheumatoid arthritis clinical trials.
  • Long-Term Safety and Efficacy of Upadacitinib or Adalimumab in Patients with Rheumatoid Arthritis: Results at 3 years From the SELECT-COMPARE Study.
  • Integrated Safety Profile of Upadacitinib With up to 4.5 Years of Exposure in Patients With Rheumatoid Arthritis (RA Integrated Safety Update).
  • Long-Term Safety and Effectiveness of Upadacitinib or Adalimumab in Patients with Rheumatoid Arthritis: Results at 72 weeks from the SELECT-COMPARE Study.

Patient Enrollment Reaches 90 Percent in Innovation Pharmaceuticals Phase 2 Clinical Trial of Brilacidin for COVID-19

Retrieved on: 
Thursday, May 27, 2021

WAKEFIELD, Mass., May 27, 2021 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (the Company), a clinical stage biopharmaceutical company, today announces that patient enrollment in the Companys 120-patient, Phase 2 clinical trial of Brilacidin for COVID-19 has reached 90 percent and that the Company anticipates full enrollment to be completed in approximately two weeks.

Key Points: 
  • WAKEFIELD, Mass., May 27, 2021 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (the Company), a clinical stage biopharmaceutical company, today announces that patient enrollment in the Companys 120-patient, Phase 2 clinical trial of Brilacidin for COVID-19 has reached 90 percent and that the Company anticipates full enrollment to be completed in approximately two weeks.
  • Innovation Pharma is developing Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients under U.S. FDA Fast Track designation (see NCT04784897 ).
  • The Company intends to provide an update to shareholders upon the final patients entering the trial.
  • Brilacidin is the only non-peptidic defensin-mimetic drug candidate currently in a clinical trial as a treatment for SARS-CoV-2, the coronavirus responsible for COVID-19.

Annual General Meeting of Active Biotech AB

Retrieved on: 
Wednesday, May 19, 2021

b'The Annual General Meeting of Active Biotech was held on May 19, 2021.

Key Points: 
  • b'The Annual General Meeting of Active Biotech was held on May 19, 2021.
  • Due to the extraordinary situation as a result of the COVID-19 pandemic, the Meeting was carried out through postal voting, without any physical attendance.
  • Following a portfolio refocus, the business model of Active Biotech aims to advance projects to the clinical development phase and then further develop the programs internally or pursue in partnership.
  • Active Biotech currently holds three projects in its portfolio: Naptumomab, a targeted anti-cancer immunotherapy, partnered to NeoTX Therapeutics, is in a Phase I/II clinical program in patients with advanced solid tumors.

Dr. Reddy's Laboratories Announces the Launch of Ertapenem for Injection in the U.S. Market

Retrieved on: 
Wednesday, May 12, 2021

Reddy\xe2\x80\x99s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as \xe2\x80\x9cDr.

Key Points: 
  • Reddy\xe2\x80\x99s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as \xe2\x80\x9cDr.
  • Reddy\xe2\x80\x99s\xe2\x80\x9d) today announced the launch of Ertapenem for Injection, 1 g/vial, a therapeutic equivalent generic version of INVANZ (ertapenem for injection) for injection, 1 g/vial approved by the U.S. Food and Drug Administration (USFDA).\n\xe2\x80\x9cWe are pleased to bring this important product to market at this time,\xe2\x80\x9d says Marc Kikuchi, CEO, North America Generics, Dr. Reddy\xe2\x80\x99s Laboratories.
  • Gland Pharma has an exclusive API supply arrangement for this product and a dedicated manufacturing facility in Hyderabad for Ertapenem Injection.
  • The company assumes no obligation to update any information contained herein.\xe2\x80\x9d\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210511006310/en/\n'

Investigation Report on China's Meropenem Market 2021-2025 - ResearchAndMarkets.com

Retrieved on: 
Thursday, May 6, 2021

b'The "Investigation Report on China\'s Meropenem Market 2021-2025" report has been added to ResearchAndMarkets.com\'s offering.\nSales revenue of Meropenem in the Chinese market has an increasing trend from 2016 to 2019.

Key Points: 
  • b'The "Investigation Report on China\'s Meropenem Market 2021-2025" report has been added to ResearchAndMarkets.com\'s offering.\nSales revenue of Meropenem in the Chinese market has an increasing trend from 2016 to 2019.
  • In 2020, sales revenue of Meropenem in China was CNY1.88 billion, which decreased 12.2% Year on Year.
  • The main reason is that the COVID-19 epidemic has impacted the hospitals\' overall operation.
  • Meropenem is jointly developed by Sumitomo Dainippon Pharma and Imperial Chemical Industries (ICI).

LB Pharmaceuticals To Participate in the B. Riley Securities’ Neuroscience Conference

Retrieved on: 
Monday, April 26, 2021

Following the presentation, Mr. Prensky will participate in a question-and-answer session.

Key Points: 
  • Following the presentation, Mr. Prensky will participate in a question-and-answer session.
  • Our approach is to create a research-focused organization dedicated to generating novel intellectual property around improved versions of these former best-selling drugs.
  • LB-102 has the potential to offer schizophrenia patients the benefits of amisulpride at a lower dose than amisulpride.
  • A first-in-human, double-blind placebo-controlled Phase 1 study designed to test the safety and pharmacokinetics of LB-102 was completed over the summer of 2020.