FDA

EQS-News: Heidelberg Pharma Announces Royalty Financing Agreement with HealthCare Royalty for up to USD 115 million

Retrieved on: 
Wednesday, March 13, 2024

Ladenburg, Germany, 4 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech Company developing innovative Antibody Drug Conjugates (ADCs), and HealthCare Royalty (HCRx) today announced that they have signed a royalty financing agreement.

Key Points: 
  • Ladenburg, Germany, 4 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech Company developing innovative Antibody Drug Conjugates (ADCs), and HealthCare Royalty (HCRx) today announced that they have signed a royalty financing agreement.
  • Key terms of the agreement between Heidelberg Pharma and HCRx:
    Following the receipt by HCRx of a maximum cumulative amount, royalty payments will revert to Heidelberg Pharma and HCRx will receive a low single digit royalty tail percentage thereafter
    Prof. Dr. Andreas Pahl, Chief Executive Officer at Heidelberg Pharma, commented: “We are delighted to partner with HealthCare Royalty.
  • This agreement will provide us with a non-dilutive financing based on expected royalty payments from the worldwide sales of ZircaixTM.
  • Heidelberg Pharma will hold a conference call on 25 March 2024 with the publication of the Annual Report.

EQS-News: Rentschler Biopharma contributes to nearly 25% of FDA approved biopharmaceuticals in 2023

Retrieved on: 
Wednesday, March 13, 2024

Laupheim, Germany, Milford (MA), USA, and Stevenage, UK, March 6, 2024 – In 2023, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 55 new drugs, 17 of which were biopharmaceuticals.

Key Points: 
  • Laupheim, Germany, Milford (MA), USA, and Stevenage, UK, March 6, 2024 – In 2023, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 55 new drugs, 17 of which were biopharmaceuticals.
  • Rentschler Biopharma SE, a leading contract development and manufacturing organization (CDMO) for biopharmaceuticals, including advanced therapy medicinal products (ATMPs), contributed to four, which equals nearly 25%, of these biopharmaceuticals.
  • For the four newly approved products, Rentschler Biopharma provided support with integrated capabilities, including consulting, regulatory services, process development, technology transfer and manufacturing.
  • Benedikt von Braunmühl, CEO of Rentschler Biopharma, said: “At Rentschler Biopharma, we strive to create value sustainably, together with our client partners, for patients with serious and rare diseases worldwide.

EQS-News: DEFENCE THERAPEUTICS AWARDED BROAD U.S. PATENT COVERING ITS PIONEERING CANCER-KILLING ACCUTOX® TECHNOLOGY

Retrieved on: 
Wednesday, March 13, 2024

DEFENCE THERAPEUTICS AWARDED BROAD U.S. PATENT COVERING ITS PIONEERING CANCER-KILLING ACCUTOX® TECHNOLOGY

Key Points: 
  • DEFENCE THERAPEUTICS AWARDED BROAD U.S. PATENT COVERING ITS PIONEERING CANCER-KILLING ACCUTOX® TECHNOLOGY
    The issuer is solely responsible for the content of this announcement.
  • DEFENCE THERAPEUTICS AWARDED BROAD U.S. PATENT COVERING ITS PIONEERING CANCER-KILLING ACCUTOX® TECHNOLOGY
    Vancouver, BC, Canada, March 4th, 2024 - Defence Therapeutics Inc. (“Defence” or the “Company”), a Canadian biopharmaceutical company developing novel immune-oncology therapeutics and drug delivery technologies, is pleased to announce the granting of US patent no.
  • 11,890,350 (‘350) by the United States Patent and Trademark Office (USPTO), broadly covering its breakthrough AccuTOX® technology.
  • This patent marks the fourth granted US patent in Defence’s ever-growing patent portfolio, which currently incudes seven published patent families.

EQS-News: Mainz Biomed Partners with Trusted Health Advisors to Support U.S. Go-To-Market Strategy for Next Generation Early Colorectal Cancer Diagnostic

Retrieved on: 
Wednesday, March 13, 2024

Mainz Biomed Partners with Trusted Health Advisors to Support U.S. Go-To-Market Strategy for Next Generation Early Colorectal Cancer Diagnostic

Key Points: 
  • Mainz Biomed Partners with Trusted Health Advisors to Support U.S. Go-To-Market Strategy for Next Generation Early Colorectal Cancer Diagnostic
    The issuer is solely responsible for the content of this announcement.
  • Mainz Biomed Partners with Trusted Health Advisors to Support U.S. Go-To-Market Strategy for Next Generation Early Colorectal Cancer Diagnostic
    Dr. Jay Wohlgemuth, former Chief Medical & Scientific Officer of Quest Diagnostics and Dr. Ray Tabibiazar, a seasoned industry executive, to lead collaboration
    BERKELEY, US – MAINZ, Germany – March 5, 2024 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a leader in molecular genetics diagnostic solutions for early cancer detection, announced today a partnership with Trusted Health Advisors (THA), a market leader in supporting the U.S. launches and management of commercial programs for diagnostic products.
  • In the U.S., Mainz Biomed is in final regulatory planning stages of ReconAAsense clinical trial to seek Premarket Approval (PMA) for its next generation diagnostic test.
  • The Company currently commercializes its first-generation test in Europe and in select international territories through its flagship product ColoAlert® via partnerships with third-party laboratories.

ROSEN, GLOBAL INVESTOR COUNSEL, Encourages InMode Ltd. Investors to Secure Counsel Before Important Deadline in Securities Class Action - INMD

Retrieved on: 
Monday, March 11, 2024

WHAT TO DO NEXT: To join the InMode class action, go to https://rosenlegal.com/submit-form/?case_id=22575 or call Phillip Kim, Esq.

Key Points: 
  • WHAT TO DO NEXT: To join the InMode class action, go to https://rosenlegal.com/submit-form/?case_id=22575 or call Phillip Kim, Esq.
  • The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.
  • Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company.
  • 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017.

Biotech/Oncology Stocks Targeting the Pancreatic Cancer Market - A Race Worth Winning

Retrieved on: 
Wednesday, March 6, 2024

Research Nester says , "The global pancreatic cancer market size is slated to expand at ~18% CAGR between 2024 and 2036.

Key Points: 
  • Research Nester says , "The global pancreatic cancer market size is slated to expand at ~18% CAGR between 2024 and 2036.
  • The American Cancer Society's estimates for pancreatic cancer in the United States for 2024 are: "About 66,440 people (34,530 men and 31,910 women) will be diagnosed with pancreatic cancer.
  • Pancreatic cancer accounts for about 3% of all cancers in the US and about 7% of all cancer deaths."
  • Biotech/oncology stocks targeting the growing global pancreatic cancer market have made headlines with recent developments and breakthroughs in treatments.

ASRT SHAREHOLDER ALERT: Kessler Topaz Meltzer & Check, LLP Reminds Investors of Securities Fraud Class Action Lawsuit Filed Against Assertio Holdings, Inc. (ASRT)

Retrieved on: 
Thursday, February 29, 2024

Radnor, Pennsylvania--(Newsfile Corp. - February 29, 2024) - The law firm of Kessler Topaz Meltzer & Check, LLP ( www.ktmc.com ) informs investors that a securities class action lawsuit has been against Assertio Holdings, Inc. ("Assertio") (NASDAQ: ASRT).

Key Points: 
  • Radnor, Pennsylvania--(Newsfile Corp. - February 29, 2024) - The law firm of Kessler Topaz Meltzer & Check, LLP ( www.ktmc.com ) informs investors that a securities class action lawsuit has been against Assertio Holdings, Inc. ("Assertio") (NASDAQ: ASRT).
  • The action charges Assertio with violations of the federal securities laws, including omissions and fraudulent misrepresentations relating to the company's business, operations, and prospects.
  • As a result of Assertio' s materially misleading statements and omissions to the public, Assertio' s investors have suffered significant losses.
  • Kessler Topaz Meltzer & Check, LLP encourages Assertio investors who have suffered significant losses to contact the firm directly to acquire more information.

Phizzle Launches Next Phase of Digital Air at Pittcon; Company adds Beckman Coulter APCs to Industry-Leading Platform

Retrieved on: 
Tuesday, February 27, 2024

San Diego, California--(Newsfile Corp. - February 27, 2024) - In a Pharma industry first from the floor of Pittcon this week, Phizzle will remotely operate both a Beckman Coulter and a Climet air particle counter at the same time via a single user interface.

Key Points: 
  • San Diego, California--(Newsfile Corp. - February 27, 2024) - In a Pharma industry first from the floor of Pittcon this week, Phizzle will remotely operate both a Beckman Coulter and a Climet air particle counter at the same time via a single user interface.
  • To view the full announcement, including downloadable images, bios, and more, click here .
  • Phizzle's EDGMaker is the world's first and only scientific instrument platform to centrally manage drug production data.
  • Our technology is unlocking the manufacturing potential of the pharmaceutical industry by bringing data standardization, instrument automation, and FDA-compliant digital record-keeping to critical drug production.

Cardiol Therapeutics Completes Patient Enrollment in its Phase II MAvERIC-Pilot Study Investigating CardiolRx(TM) for Recurrent Pericarditis

Retrieved on: 
Wednesday, February 21, 2024

Topline Results Expected in Q2 2024

Key Points: 
  • "Having achieved full patient enrollment, we are now positioned to announce high-level MAvERIC-Pilot clinical trial data in the second quarter of this year.
  • MAvERIC-Pilot (NCT05494788) is a Phase II open-label pilot study investigating the tolerance, safety, and effect of CardiolRx™ administered to patients with recurrent pericarditis.
  • The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis.
  • The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention.

OrbusNeich Achieves Record-High Revenue and Net Profit of US$154 Million and US$45.1 Million Respectively, Recommends Final Dividend Payment of HK10 cents per Share

Retrieved on: 
Thursday, March 7, 2024

-- Revenue hit record high at US$153.9 million, up 12.5% year-on-year

Key Points: 
  • -- Revenue hit record high at US$153.9 million, up 12.5% year-on-year
    -- Revenue from PCI balloons and PTA balloons grew by 12.1% and 29.0% year-on-year, respectively.
  • In particular, revenue from PCI balloons and PTA balloons grew by 12.1% and 29.0% year-on-year to US$115.4 million and US$14.7 million, respectively.
  • As at December 31, 2023, the Group was in a strong financial position with cash and bank balances amounting to US$255.8 million (2022: US$229.1 million).
  • Having considered future capital requirements, the Board has proposed a final dividend of HK10 cents per share in cash, as a token of appreciation for the continuous support of shareholders.