Orange Book

CorMedix Inc. Announces Issuance of U.S. Patent Covering Lead Product Defencath

Retrieved on: 
Wednesday, August 30, 2023
Infection, Patent, Intellectual property, The Orange Book, Abbreviated New Drug Application, New Drug Application, NDA, New chemical entity, Orange Book, Approved Drug Products with Therapeutic Equivalence Evaluations, FDA, United States patent law, Pharmaceutical industry

11,738,120 with claims directed to the composition of a catheter lock solution for preventing infection and reduced blood flow in central venous catheters.

Key Points: 
  • 11,738,120 with claims directed to the composition of a catheter lock solution for preventing infection and reduced blood flow in central venous catheters.
  • This newly issued U.S. Patent, for which CorMedix previously announced the allowance of patent claims, reflects the unique and proprietary nature of DefenCath®, and will extend the Company’s current intellectual property protection with an expiration date of April 15, 2042.
  • The newly issued patent claims supplement CorMedix’s existing licensed U.S. Patent No.
  • 7,696,182, and provide an additional layer of patent protection for DefenCath.

Alkermes Announces Settlement With Teva Related to VIVITROL® Patent Litigation

Retrieved on: 
Wednesday, August 30, 2023
1836 U.S. Patent Office fire, Patent, Orange, Teva, Justice, United States Department of Justice, Naltrexone, Federal Trade Commission, ALKS, Food and Drug Administration, Orange Book, Injunction, VIVITROL, District court, Alkermes, Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., Court, Douglas v. U.S. District Court ex rel Talk America, Generic drug

DUBLIN, Aug. 30, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) announced today that the company entered into a settlement agreement with Teva Pharmaceuticals USA, Inc. ("Teva") to resolve the ongoing patent litigation between the parties in the U.S. District Court for the District of New Jersey related to VIVITROL® (naltrexone for extended-release injectable suspension). Pursuant to the terms of the settlement agreement, the company has granted Teva a license under U.S. Patent No. 7,919,499 to market a generic version of VIVITROL in the United States beginning January 15, 2027, or earlier under certain customary circumstances.

Key Points: 
  • DUBLIN, Aug. 30, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) announced today that the company entered into a settlement agreement with Teva Pharmaceuticals USA, Inc. ("Teva") to resolve the ongoing patent litigation between the parties in the U.S. District Court for the District of New Jersey related to VIVITROL® (naltrexone for extended-release injectable suspension).
  • Pursuant to the terms of the settlement agreement, the company has granted Teva a license under U.S. Patent No.
  • 7,919,499 to market a generic version of VIVITROL in the United States beginning January 15, 2027, or earlier under certain customary circumstances.
  • The company and Teva will submit the settlement agreement for review to the United States Federal Trade Commission and the United States Department of Justice.

Alkermes Announces Settlement With Teva Related to VIVITROL® Patent Litigation

Retrieved on: 
Wednesday, August 30, 2023
1836 U.S. Patent Office fire, Patent, Orange, Teva, Justice, United States Department of Justice, Naltrexone, Federal Trade Commission, ALKS, Food and Drug Administration, Orange Book, Injunction, VIVITROL, District court, Alkermes, Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., Court, Douglas v. U.S. District Court ex rel Talk America, Generic drug

DUBLIN, Aug. 30, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) announced today that the company entered into a settlement agreement with Teva Pharmaceuticals USA, Inc. ("Teva") to resolve the ongoing patent litigation between the parties in the U.S. District Court for the District of New Jersey related to VIVITROL® (naltrexone for extended-release injectable suspension). Pursuant to the terms of the settlement agreement, the company has granted Teva a license under U.S. Patent No. 7,919,499 to market a generic version of VIVITROL in the United States beginning January 15, 2027, or earlier under certain customary circumstances.

Key Points: 
  • DUBLIN, Aug. 30, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) announced today that the company entered into a settlement agreement with Teva Pharmaceuticals USA, Inc. ("Teva") to resolve the ongoing patent litigation between the parties in the U.S. District Court for the District of New Jersey related to VIVITROL® (naltrexone for extended-release injectable suspension).
  • Pursuant to the terms of the settlement agreement, the company has granted Teva a license under U.S. Patent No.
  • 7,919,499 to market a generic version of VIVITROL in the United States beginning January 15, 2027, or earlier under certain customary circumstances.
  • The company and Teva will submit the settlement agreement for review to the United States Federal Trade Commission and the United States Department of Justice.

Eagle Pharmaceuticals Announces Positive Type C Meeting with FDA for EA-114, an Estrogen Receptor Antagonist Used in the Treatment of Metastatic Breast Cancer in Post-Menopausal Women

Retrieved on: 
Tuesday, August 29, 2023
CMS, The Orange Book, NDA, Fulvestrant, Woman, Medicine, Research, Oncology, Orange Book, Patent, Patient, MBC, Physician, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Tariff, Food, Breast cancer, Pharmaceutical industry, IQVIA, Eagle

WOODCLIFF LAKE, N.J., Aug. 29, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced a positive Type C meeting with the U.S. Food and Drug Administration (“FDA”). Eagle and the FDA agreed on a path forward to advance the clinical development of EA-114, an estrogen receptor antagonist used in the treatment of breast cancer in post-menopausal women. EA-114 has the potential to provide healthcare providers with a formulation that meaningfully optimizes the dosing regimen for all fulvestrant patients. Eagle currently anticipates filing a new drug application (“NDA”) for EA-114 in 2024. If approved for all uses, EA-114 would allow physicians to provide a personalized treatment regimen to all patients, including specific sub-populations.

Key Points: 
  • Eagle and the FDA agreed on a path forward to advance the clinical development of EA-114, an estrogen receptor antagonist used in the treatment of breast cancer in post-menopausal women.
  • If approved for all uses, EA-114 would allow physicians to provide a personalized treatment regimen to all patients, including specific sub-populations.
  • Currently, fulvestrant is indicated as monotherapy first-line endocrine treatment in post-menopausal women with hormone receptor-positive metastatic breast cancer (MBC) and in combination therapy to treat hormone receptor positive, advanced breast cancer in women whose breast cancer has spread or worsened after being treated with anti-estrogen medications.
  • Eagle intends to provide additional updates on the progress of the EA-114 development program for the sub-populations as discussions with the FDA progress.

Evoke Pharma Reports Second Quarter 2023 Financial Results

Retrieved on: 
Thursday, August 10, 2023
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SOLANA BEACH, Calif., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, announced its financial results for the second quarter ended June 30, 2023, and recent corporate developments.

Key Points: 
  • “The second quarter of 2023 concluded on a highly encouraging note with $1.1 million in net revenue, a 40% increase from our sales last quarter.
  • At the end of the second quarter, we captured a total of 1,388 prescribers, a 17% increase from our reported results in Q1 2023.
  • For the second quarter of 2023, net product sales were $1,131,368 compared to $461,795 during the second quarter of 2022.
  • For the second quarter of 2023, selling, general and administrative expenses were approximately $2.8 million compared to $2.3 million for the second quarter of 2022.

Optinose Reports Second Quarter 2023 Financial Results and Operational Updates

Retrieved on: 
Thursday, August 10, 2023
ENT, Patent, Exhalation delivery system, SG, Ear, Conference call, OPTN, General Administration of Press and Publication, Telephone, Prescription Drug User Fee Act, GAAP, Research, Nose, Orange Book, United States Patent and Trademark Office, Sinusitis, Patient, Approved Drug Products with Therapeutic Equivalence Evaluations, Fluticasone, PDUFA, Webcast, FDA, MPH, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Cryptocurrency, MD, Conference

YARDLEY, Pa., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today reported financial results for the quarter ended June 30, 2023, and provided operational updates.

Key Points: 
  • Conference call and webcast to be held today at 8:00 a.m. Eastern Time
    YARDLEY, Pa., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today reported financial results for the quarter ended June 30, 2023, and provided operational updates.
  • “We are pleased with the progress we made in the second quarter of 2023 towards our strategic objectives,” stated CEO Ramy Mahmoud, MD, MPH.
  • “That means we are outperforming our initial expectations for full year 2023 XHANCE net revenues while operating far more efficiently.
  • Members of the Company’s leadership team will host a conference call and presentation to discuss financial results and corporate updates beginning at 8:00 a.m. Eastern Time today.

Liquidia Corporation Reports Second Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, August 10, 2023
Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., Student Borrower Protection Center, Partnership, United States Court of Appeals for the Federal Circuit, Inter partes review, The Orange Book, PAH, CAFC, Calendar, Treprostinil, NDA, PTAB, Sale, Certification, Security, Orange Book, Patent Trial and Appeal Board, District court, Patent, Patient, United States district court, Research, FDA, Pulmonary hypertension, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, UTHR, Cryptocurrency, Pharmaceutical industry, United Therapeutics

MORRISVILLE, N.C., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) today reported financial results for the second quarter ended June 30, 2023.

Key Points: 
  • MORRISVILLE, N.C., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) today reported financial results for the second quarter ended June 30, 2023.
  • ET to discuss the financial results and provide a corporate update.
  • Dr. Roger Jeffs, Liquidia’s Chief Executive Officer, said: “This quarter saw Liquidia significantly advance our mission to become the leading inhaled treprostinil provider for pulmonary hypertension patients.
  • Briefing in the appeal should be completed in fourth quarter 2023 and oral arguments will be heard on the next available date in the oral argument calendar, expected to be late fourth quarter 2023 to early 2024.

Newron Announces H1 2023 Results and Provides R&D Update

Retrieved on: 
Friday, August 4, 2023
Science, Neurology, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Business development, US Foods, Partnership, Psychosis, Schizophrenia, TRS, Paragraph, XETRA, AGM, Don, Evenamide, The International Journal of Neuropsychopharmacology, CNS, Movement, Clozapine, Medication, Tablet, Sale, Congress, Incidence, European College of Neuropsychopharmacology, Orange Book, Patient, Canadian International Council, NCE, ECNP, Abbreviated New Drug Application, Phase, FDA, Food, Safety, Peripheral nervous system, Pharmaceutical industry, Medical imaging, Management, Newron Cup

We have reported three striking sets of data from our evenamide development program for treatment-resistant schizophrenia (TRS), presented these results at international psychiatry scientific conferences, and published key results in a peer-reviewed journal.

Key Points: 
  • We have reported three striking sets of data from our evenamide development program for treatment-resistant schizophrenia (TRS), presented these results at international psychiatry scientific conferences, and published key results in a peer-reviewed journal.
  • The exciting results triggered substantial interest from potential partners on future collaboration opportunities for the development of evenamide.”
    In Q1 2023, Newron announced three exciting new sets of data evaluating evenamide as an add-on treatment for patients with TRS.
  • Study 008A is continuing to enroll patients in this indication, and results are expected by end of 2023/early in 2024.
  • Financial Summary (IFRS) H1 2023 and H1 2022:

EQS-News: Newron announces H1 2023 results and provides R&D update

Retrieved on: 
Friday, August 4, 2023
Business development, US Foods, Partnership, Psychosis, CET, Schizophrenia, TRS, Paragraph, XETRA, AGM, Don, Evenamide, The International Journal of Neuropsychopharmacology, CNS, Movement, Clozapine, Sale, Tablet, Congress, Incidence, European College of Neuropsychopharmacology, Orange Book, Patient, Canadian International Council, NCE, ECNP, Abbreviated New Drug Application, Phase, FDA, Food, Safety, Peripheral nervous system, Pharmaceutical industry, Medical imaging, Management, Newron Cup

We have reported three striking sets of data from our evenamide development program for treatment-resistant schizophrenia (TRS), presented these results at international psychiatry scientific conferences, and published key results in a peer-reviewed journal.

Key Points: 
  • We have reported three striking sets of data from our evenamide development program for treatment-resistant schizophrenia (TRS), presented these results at international psychiatry scientific conferences, and published key results in a peer-reviewed journal.
  • Study 008A is continuing to enroll patients in this indication, and results are expected by end of 2023/early in 2024.
  • The results seen validate the rule of glutamate release inhibition in repairing disturbed neural connectivity in the TRS population.
  • Financial Summary (IFRS) H1 2023 and H1 2022:

Aurinia Pharmaceuticals Reports Second Quarter and Six Months 2023 Financial and Operational Results

Retrieved on: 
Thursday, August 3, 2023
Biotechnology, Pharmaceutical, Health, Patent, MMF, SG, POT, European Renal Association, Marketing, PSF, Bank statement, Nephrology, AURORA, Conversation, J.P. Morgan & Co., Risk, EDGAR, LN, ERA, Proteinuria, European Alliance of Associations for Rheumatology, Orange Book, Arthritis & Rheumatology, Patient, Investment, Analysis, SEDAR, Rheumatology, Webcast, United Kingdom, Management, Growth, EULAR, R, Research, FDA, NICE, National Institute for Health and Care Excellence, Cryptocurrency, Pharmaceutical industry, Clothing, Aurinia, Swissmedic

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today issued its financial results for the three and six months ended June 30, 2023.

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today issued its financial results for the three and six months ended June 30, 2023.
  • Financial Results for the Three and Six Months Ended June 30, 2023
    Total net revenue was $41.5 million and $28.2 million for the three months ended June 30, 2023 and June 30, 2022, respectively.
  • Interest expense was $0.1 million for the three and six months ended June 30, 2023 due to the commencement of the monoplant finance lease during the second quarter of 2023.
  • Aurinia will host a conference call and webcast to discuss the quarter ended June 30, 2023 financial results today, Thursday, August 3, 2023 at 8:30 a.m.