Pharmaceutical industry

HUTCHMED Initiates a Phase I Trial of HMPL-653 in Patients with Advanced Malignant Solid Tumors and TGCT in China

Retrieved on: 
Thursday, January 20, 2022 - 12:00am

The Phase I trial is a multicenter, open-label, single-arm study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HMPL-653 in the treatment of patients with advanced or metastatic solid tumors and tenosynovial giant cell tumors (TGCT).

Key Points: 
  • The Phase I trial is a multicenter, open-label, single-arm study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HMPL-653 in the treatment of patients with advanced or metastatic solid tumors and tenosynovial giant cell tumors (TGCT).
  • Approximately 110 patients are expected to be enrolled in the dose escalation and expansion phase of this study.
  • The primary endpoints are dose limiting toxicity, safety, tolerability, recommended phase II dose and maximum tolerated dose.
  • The incidence of TGCT is approximately between 1.8 and 50 per 1 million people.1 Surgery is the standard treatment for TGCT patients.

INVESTOR ALERT: Kirby McInerney LLP Reminds Investors That Securities Class Action Lawsuits Have Been Filed on Behalf of Investors in Desktop Metal, Inc. (DM), Marathon Digital Holdings, Inc. (MARA), and Redwire Corporation (RDW) and Encourages Investors

Retrieved on: 
Wednesday, January 19, 2022 - 11:11pm

NEW YORK, Jan. 19, 2022 (GLOBE NEWSWIRE) -- The law firm of Kirby McInerney LLP reminds investors that securities class action lawsuits have been filed on behalf of investors in securities of Desktop Metal, Inc., Marathon Digital Holdings, Inc., and Redwire Corporation.

Key Points: 
  • NEW YORK, Jan. 19, 2022 (GLOBE NEWSWIRE) -- The law firm of Kirby McInerney LLP reminds investors that securities class action lawsuits have been filed on behalf of investors in securities of Desktop Metal, Inc., Marathon Digital Holdings, Inc., and Redwire Corporation.
  • Investors have until the deadlines below to apply to the Court to be appointed as lead plaintiff in the lawsuits.
  • Kirby McInerney is a New York-based plaintiffs law firm concentrating in securities, antitrust, whistleblower, and consumer litigation.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Fourth Street Clinic Receives Contribution from Intermountain Healthcare for Emergency COVID-19 Quarantine Services for Those Experiencing Homelessness

Retrieved on: 
Wednesday, January 19, 2022 - 10:29pm

Since July 2021, Fourth Streets quarantine and isolation program has served 561 individuals and families experiencing homelessness.

Key Points: 
  • Since July 2021, Fourth Streets quarantine and isolation program has served 561 individuals and families experiencing homelessness.
  • In the summer of 2021, the Fourth Street Clinic began managing Salt Lake Countys quarantine and isolation operations.
  • While Fourth Street Clinic will be pursuing state funding for operation in February and March, the COVID-19 Emergency Response Fund would support Fourth Street Clinic until that time.
  • I appreciate the Fourth Street Clinic for providing vital services to Utahns experiencing homelessness, especially during the Covid-19 Pandemic, said Wayne Niederhauser, chief administrative officer of the Office of Homeless Services.

Omeros Confirms Submission of Response to FDA Regarding the BLA for Narsoplimab in the Treatment of HSCT-TMA

Retrieved on: 
Wednesday, January 19, 2022 - 10:52pm

The response comprises a comprehensive briefing package drafted in close collaboration with external clinical, regulatory and legal experts that addresses in detail the points raised by FDA in its CRL for narsoplimab.

Key Points: 
  • The response comprises a comprehensive briefing package drafted in close collaboration with external clinical, regulatory and legal experts that addresses in detail the points raised by FDA in its CRL for narsoplimab.
  • Omeros concurrently requested a Type A meeting with FDA to resolve any outstanding items.
  • Narsoplimab is the first drug candidate submitted to FDA for approval in HSCT-TMA.
  • OMS906, Omeros inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial.

Marker Therapeutics Receives FDA Orphan Drug Designation for its Multi-Antigen Targeted T Cell Therapy for Pancreatic Cancer

Retrieved on: 
Wednesday, January 19, 2022 - 9:49pm

The FDAs orphan drug designation underscores MT-601s potential as a treatment for pancreatic cancer, a cancer typically diagnosed at an incurable advanced stage with a total overall 5-year survival rate of 10%, said Peter L. Hoang, President & CEO of Marker Therapeutics.

Key Points: 
  • The FDAs orphan drug designation underscores MT-601s potential as a treatment for pancreatic cancer, a cancer typically diagnosed at an incurable advanced stage with a total overall 5-year survival rate of 10%, said Peter L. Hoang, President & CEO of Marker Therapeutics.
  • Marker developed MT-601, a new product targeting six tumor-associated antigens (PRAME, NY-ESO-1, Survivin, MAGE-A4, SSX2, WT1) highly expressed in pancreatic cancer.
  • The Company plans to file an Investigational New Drug Application (IND) for MT-601 for the treatment of pancreatic cancer in 2022.
  • The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval.

Treace Announces Grant of U.S. Patent on Instrumented Bunion Correction

Retrieved on: 
Wednesday, January 19, 2022 - 9:15pm

The patent, granted earlier this month, augments Treaces extensive and growing patent portfolio covering instrumented bunion correction.

Key Points: 
  • The patent, granted earlier this month, augments Treaces extensive and growing patent portfolio covering instrumented bunion correction.
  • We are pleased that the Patent Office continues to recognize the novel advances made by Treace.
  • The addition of this recent patent grant further strengthens our intellectual property position and highlights our commitment to innovation in advancing the surgical treatment of bunion patients, said John T. Treace, CEO, Founder and Board Member of Treace.
  • Treace recently expanded its offering with the Adductoplasty Midfoot Correction System, designed for reproducible correction of the midfoot which could provide further support to hallux valgus patients.

INVESTOR ALERT: Law Offices of Howard G. Smith Announces Investigation of NRx Pharmaceuticals, Inc. (NRXP) on Behalf of Investors

Retrieved on: 
Wednesday, January 19, 2022 - 9:59pm

Law Offices of Howard G. Smith announces an investigation on behalf of NRx Pharmaceuticals, Inc. (NRx or the Company) (NASDAQ: NRXP ) investors concerning the Companys possible violations of the federal securities laws.

Key Points: 
  • Law Offices of Howard G. Smith announces an investigation on behalf of NRx Pharmaceuticals, Inc. (NRx or the Company) (NASDAQ: NRXP ) investors concerning the Companys possible violations of the federal securities laws.
  • In June 2021, NRx announced that it filed an application with U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for ZYESAMI (Aviptadil-acetate) to treat critically ill COVID-19 patients suffering with respiratory failure.
  • On this news, NRxs stock fell $2.27, or 25.5%, to close at $6.65 per share on November 5, 2021, thereby injuring investors.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

AHF Echoes Lawmakers’ Call to Boost Global Vaccine Supply

Retrieved on: 
Wednesday, January 19, 2022 - 9:11pm

The only entity currently in charge of this pandemic response is the virus itself the only way that changes is by having sufficient vaccine quantities to vaccinate our world.

Key Points: 
  • The only entity currently in charge of this pandemic response is the virus itself the only way that changes is by having sufficient vaccine quantities to vaccinate our world.
  • We fully support Senator Warrens and Representative Schakowskys call to utilize the Defense Production Act to increase worldwide manufacturing of vaccines, said AHF President Michael Weinstein.
  • And even though over 60% of the global population has gotten at least one dose of a vaccine, most of the world is still struggling to gain access.
  • To learn more about AHF, please visit our website: www.aidshealth.org , find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare and Instagram: @aidshealthcare
    View source version on businesswire.com: https://www.businesswire.com/news/home/20220119006051/en/

Zymeworks Provides Corporate Update on Key Strategic Priorities and Outlook for 2022

Retrieved on: 
Wednesday, January 19, 2022 - 9:15pm

Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today provided a corporate update on its key strategic priorities for 2022 and 2023 in addition to confirming its upcoming clinical development milestones for zanidatamab and ZW49.

Key Points: 
  • Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today provided a corporate update on its key strategic priorities for 2022 and 2023 in addition to confirming its upcoming clinical development milestones for zanidatamab and ZW49.
  • These measures, including the reduction in our workforce announced today, provide opportunities to reduce our future planned expenditures while continuing to fund our key priorities for 2022 and 2023.
  • The Company intends to report full Q4 and FY 2021 results and provide any further corporate updates on February 24, 2022.
  • Zymeworks suite of therapeutic platforms and its fully integrated drug development engine enable precise engineering of highly differentiated product candidates.

New England Journal of Medicine Publishes Data from ECOSPOR lll Phase 3 Study Evaluating Investigational Microbiome Therapeutic SER-109 in Recurrent C. Difficile Infection

Retrieved on: 
Wednesday, January 19, 2022 - 10:01pm

Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced the publication in the New England Journal of Medicine (NEJM) of data from its Phase 3 ECOSPOR III study evaluating SER-109, an investigational oral microbiome therapeutic for the treatment of recurrent C. difficile infection (rCDI).

Key Points: 
  • Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced the publication in the New England Journal of Medicine (NEJM) of data from its Phase 3 ECOSPOR III study evaluating SER-109, an investigational oral microbiome therapeutic for the treatment of recurrent C. difficile infection (rCDI).
  • The SER-109 ECOSPOR III Phase 3 study ( ClinicalTrials.gov identifier: NCT03183128) was a multicenter, randomized, placebo-controlled study.
  • In May 2021, Seres presented 24-week clinical data from the study that demonstrated significantly reduced recurrence rates compared to placebo.
  • The SER-109 program is being advanced to reduce the recurrence of C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic.