Alvogen

Alvotech Reports Financial Results for Full Year 2023 and Provides a Business Update

Retrieved on: 
Wednesday, March 20, 2024
Joint venture, Patient, Sale, Business analyst, CCHN, IP, Marketing, Research, Mallinckrodt, Absorption, European Economic Area, Gross metropolitan product, Webcast, Asset, Alvogen, Denosumab, Neovascularization, Biosimilar, Macular degeneration, Safety, Food, U.S. FDA, Teva Pharmaceuticals, Revenue, Q3, CES, AMD, FDA, ISK, Administration, Adalimumab, Research and development, Pharmaceutical industry

Management will conduct a business update conference all and live webcast on March 21, 2024 at 8:00 am ET (12:00 pm GMT).

Key Points: 
  • Management will conduct a business update conference all and live webcast on March 21, 2024 at 8:00 am ET (12:00 pm GMT).
  • Alvotech announced positive top-line results from a pharmacokinetic (PK) study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab).
  • Alvotech announced positive top-line results from a PK study for AVT03, a biosimilar candidate to Prolia® and Xgeva®, which both contain denosumab.
  • Alvotech will conduct a business update conference call and live webcast on Thursday, March 21, 2024, at 8:00 am ET (12:00 pm GMT).

Alvotech Appoints Interim Chief Quality Officer

Retrieved on: 
Thursday, February 29, 2024
Biology, Mallinckrodt, Alvogen, FDA, Temple University, GMP, Regulatory affairs, Bachelor, Norwich Pharma Services, Patient, Heart, Quality assurance, Georgia Tech

REYKJAVIK, Iceland, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that Christina Siniscalchi will join its corporate leadership team as interim Chief Quality Officer.

Key Points: 
  • REYKJAVIK, Iceland, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that Christina Siniscalchi will join its corporate leadership team as interim Chief Quality Officer.
  • Christina Siniscalchi has for over ten years served in senior quality positions for Alvogen and its manufacturing site in Norwich, NY, most recently as Alvogen’s Chief Quality Officer.
  • “We thank Sandra for her valuable contribution to Alvotech, as she successfully steered our quality team through the recent FDA facility inspection, which now has led to the approval of our interchangeable high-concentration biosimilar to Humira in the U.S.,” said Robert Wessman, Chairman and CEO of Alvotech.
  • Continuous improvement, quality, and compliance, is at the heart of everything we do.”
    Christina Siniscalchi has 25 years of experience in the U.S. pharmaceuticals industry.

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Reports Comments by Strategic Partner Lotus Pharmaceutical Co. Ltd. (1975.TW) in Recent Financial Report

Retrieved on: 
Friday, February 9, 2024
World Health Organization, JPMorgan Chase, Alvogen, Dark Enlightenment, Partnership, DSM-IV codes, Clinical trial, Patient, Pharmaceutical industry

Lotus notes that NRx has "achieved a significant milestone by completing enrollment for its phase 2b/3 trial of NRX-101 in suicidal treatment-resistant bipolar depression.

Key Points: 
  • Lotus notes that NRx has "achieved a significant milestone by completing enrollment for its phase 2b/3 trial of NRX-101 in suicidal treatment-resistant bipolar depression.
  • Lotus further reported revenues of NT$1996, a 45% month over month increase.
  • RADNOR, Pa., Feb. 9, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that its Asia Pacific strategic partner Lotus Pharmaceutical Co. Ltd (1975.TW) identified enrollment completion of the NRx clinical trial in bipolar depression as a material event in is February 7 financial filing.
  • "We at NRx are honored that Lotus has focused its resources on helping us advance NRX-101 for the benefit of patients in the Asia Pacific region.

NRx Pharmaceuticals to Participate in LifeSci Corporate Access Event

Retrieved on: 
Monday, December 11, 2023
Therapy, Dark Enlightenment, Urine, Pain, GMP, HOPE, Beacon Grand Hotel, Comment, IND, DCS, Patient, Alvogen, FDA, DSM-IV codes, Cyclothymia, Conference, NIH, Low back pain, HEAL, Powell Street, Chronic pain, Ketamine, Bipolar, Pharmaceutical industry

RADNOR, Pa., Dec. 11, 2023 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced the Company will be participating in-person at the LifeSci Partners Corporate Access Event for three days from January 8th through the 10th in San Francisco.

Key Points: 
  • RADNOR, Pa., Dec. 11, 2023 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced the Company will be participating in-person at the LifeSci Partners Corporate Access Event for three days from January 8th through the 10th in San Francisco.
  • NRx currently has four (4) near-term shots on goal with meaningful commercial and/or monetization opportunities:
    NRX-100 – Intravenous Ketamine.
  • NRx will be hosting 1x1 meetings at the Beacon Grand Hotel (450 Powell Street, a block away from the JP Morgan Conference at Union Square).
  • To schedule a meeting, please register at LifeSci Partners Corporate Access Event 2024 and request a meeting with management.

NRx Pharmaceuticals Announces FDA Permission to Proceed on Investigational New Drug (IND) Application for NRX-101 to Treat Chronic Pain

Retrieved on: 
Monday, October 2, 2023
Alvogen, Priority review, Patent, Partnership, Rockefeller Neuroscience Institute, Schnitzer, Nociception, File, Spinal cord, Clinical trial, Licensure, Coronavirus Scientific Advisory Board, United States patent law, NMDA, Research, CNS, Feinberg School of Medicine, Dark Enlightenment, Data collection, Pain, Thalamus, Investigational New Drug, Patient, Risk, Ketamine, DCS, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Northwestern University, Food, Pharmaceutical industry, Poultry farming, Defense, Anesthesia, Chronic pain, IND, Surgery

RADNOR, Pa., Oct. 2, 2023 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that FDA has given the company clearance to proceed with human trials to treat Chronic Pain under the Investigational New Drug (IND) application filed with the U.S. Food and Drug Administration (FDA) for the use of NRX-101.

Key Points: 
  • RADNOR, Pa., Oct. 2, 2023 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that FDA has given the company clearance to proceed with human trials to treat Chronic Pain under the Investigational New Drug (IND) application filed with the U.S. Food and Drug Administration (FDA) for the use of NRX-101.
  • "More than one in five adults in the United States suffers from chronic pain and patients lack options that do not carry the risk of addiction and opioid side effects.
  • Chronic pain is estimated to be a $72 billion industry today with the potential to grow to a $120 billion industry by 2033.
  • Dr. Apkarian is the inventor of the patent and a global expert in pain research and has important experience studying DCS in chronic pain.

Alvotech Announces Changes to the Leadership Team

Retrieved on: 
Tuesday, September 5, 2023
Alvogen, Synthon, Radboud University Nijmegen, Biologics license application, Head, Adalimumab, MBA, Patient, BLA, Management, INSEAD, Chemistry

Faysal has served as Head of Portfolio and Project Management since earlier this year and as a member of Alvotech’s Board of Directors since 2020.

Key Points: 
  • Faysal has served as Head of Portfolio and Project Management since earlier this year and as a member of Alvotech’s Board of Directors since 2020.
  • He has a master’s degree in Chemistry from Radboud University Nijmegen and an executive MBA from Insead.
  • “It is a great pleasure to welcome Faysal to the role of Chief Operating Officer, as he knows our operations and portfolio intimately,” said Robert Wessman, Chairman and CEO of Alvotech.
  • “I look forward to continue working with the exceptionally talented and dedicated team assembled and contributing to the Company’s further development into a global leader in the biosimilars industry.”

NRx Pharmaceuticals Announces Submission of an Investigational New Drug (IND) Application for NRX-101 in the Treatment of Chronic Pain

Retrieved on: 
Wednesday, August 30, 2023
Alvogen, Priority review, Patent, Partnership, Rockefeller Neuroscience Institute, Nociception, Schnitzer, Spinal cord, Drug discovery, Clinical trial, Licensure, DSM-IV codes, United States patent law, Coronavirus Scientific Advisory Board, Medication, NMDA, Research, Brain, Tylenol, CNS, Feinberg School of Medicine, Dark Enlightenment, Data collection, Pain, Thalamus, Nonsteroidal anti-inflammatory drug, Ketamine, DCS, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Northwestern University, Food, Pharmaceutical industry, Dietary supplement, Vaccine, Poultry farming, Defense, Anesthesia, File, Chronic pain, Surgery

The IND application leverages pioneering research on the use of D-cycloserine (a key ingredient of NRX-101) in the treatment of chronic pain and the recent licensure by NRx of a US Patent for the use of D-cycloserine in the treatment of pain.

Key Points: 
  • The IND application leverages pioneering research on the use of D-cycloserine (a key ingredient of NRX-101) in the treatment of chronic pain and the recent licensure by NRx of a US Patent for the use of D-cycloserine in the treatment of pain.
  • Chronic pain is estimated to be a $72 billion industry today with the potential to grow to a $120 billion industry by 2033.
  • Dr. Apkarian is the inventor of the patent and a global expert in pain research and has important experience studying DCS in chronic pain.
  • In experimental models and clinical studies, NMDA antagonists have demonstrated attenuation of pain and shown potential to reduce opioid craving.

Rothschild & Co hires Alex Mironov and Matthew O’Donnell as Managing Directors in North America

Retrieved on: 
Monday, August 7, 2023
General Health, Professional Services, Health, Finance, Alvogen, University, Executive officer, Dominic Lee, MBA, Pernix Therapeutics Holdings, U.S. Bancorp, Washington University in St. Louis, Rutgers University, Global Advisory Committee on Vaccine Safety, Business administration, DCM, Rothschild & Co, Ranbaxy Laboratories, Knowledge, Growth, COVI-VAC (U.S. COVID-19 vaccine), ECM, Olin Business School, Therapy, Pfizer, Pharmaceutical industry, Interior design, Health care, Biochemistry

Rothschild & Co announced today that Alex Mironov and Matthew O’Donnell have joined the Healthcare team as Managing Directors.

Key Points: 
  • Rothschild & Co announced today that Alex Mironov and Matthew O’Donnell have joined the Healthcare team as Managing Directors.
  • The senior hires represent the continued growth of the healthcare franchise and expansion of the firm’s presence and capabilities in the Northeast region within the Global Advisory business in North America.
  • They will report to Dominic Hollamby, Partner and Global Head of Healthcare, and Lee LeBrun, Partner and Head of Global Advisory, North America.
  • Mr. Mironov brings over 20 years of global experience in the healthcare and pharmaceutical sectors, spanning business development, M&A and corporate strategy, to Rothschild & Co.

NRx Pharmaceuticals, Lotus Pharmaceuticals and Alvogen Inc. Announce Collaboration to Develop and Commercialize NRX-101

Retrieved on: 
Monday, June 5, 2023
Partnership, Depression, Suicide, Trial of the century, Breakthrough therapy, BTD, CNS, Dark Enlightenment, Medication, Patient, Risk, SPA, Ketamine, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, DSM-IV codes, Bipolar, Food, Pharmaceutical industry, Alvogen, Lotus

Lotus will partner with Alvogen, a longstanding partner for Lotus in the U.S., to commercialize NRX-101 for treatment of S-TRBD in the U.S. market through Alvogen’s Almatica label.

Key Points: 
  • Lotus will partner with Alvogen, a longstanding partner for Lotus in the U.S., to commercialize NRX-101 for treatment of S-TRBD in the U.S. market through Alvogen’s Almatica label.
  • Almatica is the CNS-focused division of Alvogen that currently markets six branded products.
  • NRX-101 provides an excellent addition to our growing CNS pipeline.”
    Petar Vazharov, Chief Executive Officer of Lotus, commented, “This is an exciting transaction for Lotus.
  • NRx will be hosting a conference call to discuss in greater detail the impact of the transaction.

Alvotech Reports Financial Results for Full Year 2022 and Provides Business Update

Retrieved on: 
Wednesday, March 1, 2023
European Medicines Agency, Food and Drug Administration, FDA, Patient, Trade-weighted US dollar index, Ustekinumab, United States dollar, BLA, Nasdaq Iceland, Biosimilar, Main–Market Historic District, EMA, Food, Good manufacturing practice, Webcast, R, GMP, Alvogen, External commercial borrowing, Absorption, Generic drug, Pharmaceutical industry, Cryptocurrency, Security (finance), G&A, News, Icelandic króna

In February 2023, Alvotech announced the completion of a private share placement for aggregate gross proceeds of approximately $137.0 million.

Key Points: 
  • In February 2023, Alvotech announced the completion of a private share placement for aggregate gross proceeds of approximately $137.0 million.
  • In December 2022, Alvotech announced completion of a private placement of subordinated convertible bonds for gross proceeds of approximately $70.0 million.
  • Alvotech recognized a loss on extinguishment of financial liabilities of $27.3 million during the year ended December 31, 2022, compared to a gain of $151.8 million during 2021.
  • Alvotech will conduct a business update conference call and live webcast on Thursday, March 2, 2023, at 8:00 am ET (1:00 pm GMT).