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Evofem Announces Padagis Will Not Seek FDA Approval to Market a Generic Version of Phexxi® Until Evofem's Phexxi Patents Expire

Retrieved on: 
Wednesday, September 27, 2023
Abbreviated New Drug Application, Lactic acid, Paragraph, OTCQB, Certification, Orange Book, SAN, Citric acid, ANDA, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Approved Drug Products with Therapeutic Equivalence Evaluations, Generic drug, Lactic acid/citric acid/potassium bitartrate

SAN DIEGO, Sept. 27, 2023 /PRNewswire/ -- Evofem Biosciences, Inc., (OTCQB: EVFM) today announced that Padagis Israel Pharmaceuticals Ltd. (Padagis) has withdrawn the Paragraph IV certification in its previously-submitted Abbreviated New Drug Application (ANDA) for a generic version of Phexxi® (lactic acid, citric acid and potassium bitartrate) and has instead converted to a Paragraph III certification. With this pivot to Paragraph III certification, rather than challenging the Phexxi patents and seeking approval of the ANDA prior to expiration of any of those patents, Padagis is instead now asking the U.S. Food and Drug Administration (FDA) to wait until after all the Phexxi patents expire before issuing final approval of the ANDA. The latest-expiring Phexxi patents do not expire until 2033.

Key Points: 
  • With this pivot to Paragraph III certification, rather than challenging the Phexxi patents and seeking approval of the ANDA prior to expiration of any of those patents, Padagis is instead now asking the U.S. Food and Drug Administration (FDA) to wait until after all the Phexxi patents expire before issuing final approval of the ANDA.
  • Padagis previously submitted its ANDA in April 2023 requesting permission to manufacture and market a generic version of Phexxi.
  • That ANDA contained a Paragraph IV certification, in response to which Evofem initiated patent infringement litigation against Padagis.
  • ' All four patents would need to expire or be deemed invalid or not infringed before a generic version of Phexxi could be marketed.

Notice Administrator Angeion Group Announces Proposed Settlement in Aqueous Film-Forming Foams Product Liability Litigation Involving Public Water Systems

Retrieved on: 
Tuesday, September 5, 2023
Broad Street, State, Class representative, DuPont, PFAS, Fairness, Public water system, Class, Hearing, Courtroom, Chemours, Paragraph, Water, PO, Vexatious litigation, Release, Special master, Judgement, Settlement, District court, Collection, Court, LA, Tobacco Master Settlement Agreement, Federation, Claim, Insurance

The Settling Defendants have agreed to pay $1,185,000,000, subject to final approval of the Settlement by the Court and certain other conditions specified in the Settlement Agreement.

Key Points: 
  • The Settling Defendants have agreed to pay $1,185,000,000, subject to final approval of the Settlement by the Court and certain other conditions specified in the Settlement Agreement.
  • In no event shall the Settling Defendants be required to pay any amounts under the Settlement Agreement above the Settlement Amount.
  • Any fees, costs, or expenses payable under the Settlement Agreement shall be paid out of, and shall not be in addition to, the Settlement Amount.
  • The Final Fairness Hearing may be postponed, adjourned, or continued by Order of the Court without further notice to the Class.

Cleveland-Cliffs Receives Exclusive Assignment of Right to Bid from United Steelworkers

Retrieved on: 
Friday, August 18, 2023
Professional Services, Manufacturing, Steel, Finance, Wardwell, Cleveland-Cliffs, MUFG, Section, Cliff, Paragraph, USW, Sale, Truist, UBS, United, Union, Letter, Wells Fargo, BLA, Labour, NYSE, J. P. Morgan, U.S. Steel

Cleveland-Cliffs Inc. (NYSE: CLF) (“Cleveland-Cliffs” or “Cliffs”) today announced receipt of the assignment of the United Steelworkers’ (USW) right to bid under their Basic Labor Agreement with United States Steel Corporation (NYSE:X) (“U.S.

Key Points: 
  • Cleveland-Cliffs Inc. (NYSE: CLF) (“Cleveland-Cliffs” or “Cliffs”) today announced receipt of the assignment of the United Steelworkers’ (USW) right to bid under their Basic Labor Agreement with United States Steel Corporation (NYSE:X) (“U.S.
  • Steel”).
  • With this exclusive assignment, Cliffs is the only realistic buyer able to acquire the totality of U.S. Steel.
  • The assignment transfers to Cliffs the USW’s right to bid on such potential transactions.

Supremex Announces Q2 2023 Results

Retrieved on: 
Thursday, August 10, 2023
Income Tax Act 1967, Envelope, Table, Eastern Time Zone, Conference call, Paragraph, Absorption, Ratio, Wind, Calumet Specialty Products Partners, EBITDA, Acquisition, Social Democrats (Slovenia), Corporation, Income Tax Act, TSX, Depreciation, Adjustment, Conference, Legislation, Leyland Royal Tiger PSU, Audit, Retail, Rare-earth element, Cryptocurrency, Video game, Bookkeeping, Fine chemical, Bank, Risk management, Webcast, Packaging and labeling

“Our second quarter results reflect the temporary effect of inventory adjustments by certain customers and lower demand from sectors more affected by inflation and interest rate levels,” said Stewart Emerson, President & CEO of Supremex.

Key Points: 
  • “Our second quarter results reflect the temporary effect of inventory adjustments by certain customers and lower demand from sectors more affected by inflation and interest rate levels,” said Stewart Emerson, President & CEO of Supremex.
  • On August 9, 2023, the Board of Directors declared a quarterly dividend of $0.035 per common share, payable on September 22, 2023, to the shareholders of record at the close of business on September 7, 2023.
  • August 10, 2023 - Second Quarter Results Conference Call:
    A conference call to discuss the Company’s results for the second quarter ended June 30, 2023 will be held Thursday, August 10, 2023 at 10:00 a.m. (Eastern Time).
  • Management also believes this non-IFRS measure provides users with enhanced understanding of the Company’s results and provides better comparability between periods.

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:

TMC Announces Corporate Update on Expected Timeline, Application Costs and Production Capacity Following Part II of the 28th Session of the International Seabed Authority

Retrieved on: 
Tuesday, August 1, 2023
Agreement, The Hidden Gem, LTC, Project Zero, Clipperton Fracture Zone, AMS, United Nations Convention on the Law of the Sea, United Nations Convention, Paragraph, EIS, Environmental resource management, Section 1, Water, Sanitation and Hygiene Monitoring Program, Part, International Seabed Authority, Mining Code, Radio Technical Commission for Maritime Services, Implementation, Environmental monitoring, ATM, Regeneration, TMC, Party, Data, Council, Motivation, Hand, Rare-earth element, Property management, Natural gas, Life insurance, Bank, Risk management, Security (finance), UNCLOS, Allseas

Assuming a one-year review process, NORI expects to be in production in the fourth quarter of 2025.

Key Points: 
  • Assuming a one-year review process, NORI expects to be in production in the fourth quarter of 2025.
  • The Company estimates that it will require $60 to 70 million of additional cash to submit an application for an exploitation contract following the July 2024 meeting of the ISA.
  • TMC had $20M cash on hand and an undrawn $25M unsecured credit facility as of June 30th 2023.
  • Assuming a one-year review process for an application, NORI expects to be in production in the fourth quarter of 2025.

Reply S.p.A: the Board of Directors Approves the Half-Year Financial Report as of 30 June 2023

Retrieved on: 
Tuesday, August 1, 2023
Other Professional Services, Consulting, Data Management, Professional Services, Technology, IOT (Internet of Things), Mobile, Wireless, Other Technology, Insurance, EXM, Big data, STAR, Reply, Paragraph, Intelligence, EBIT, Vserv Digital Services, Cloud computing, Internet, EBITDA, Investment, ISIN, Artificial intelligence, AI, Retail, Bookkeeping, Cryptocurrency, Video game

Today, the Board of Directors of Reply S.p.A. [EXM, STAR: REY] approved the results as at 30 June 2023.

Key Points: 
  • Today, the Board of Directors of Reply S.p.A. [EXM, STAR: REY] approved the results as at 30 June 2023.
  • Pre-tax profit, from January to June 2023, was €113.5 million (€108.7 million in 2022), corresponding to 10.9% of turnover.
  • EBITDA, from April to June 2023, amounted to €72.9 million, with EBIT of €58.0 million and pre-tax profit of €51.4 million.
  • As at 30 June 2023, the Group's net financial position was positive for €101.6 million, while at 31 March 2023 was positive for €190.7 million.

EQS-News: Reply SpA: : The Board of Directors approves the half-year financial report as of 30 June 2023

Retrieved on: 
Tuesday, August 1, 2023
Insurance, EXM, Big data, STAR, Reply, Paragraph, Intelligence, EBIT, Digital Services Act, Cloud computing, Internet, EBITDA, Investment, ISIN, Artificial intelligence, AI, Renewable energy, Retail, Bookkeeping, Cryptocurrency, Video game

All economic and financial indicators grew:

Key Points: 
  • All economic and financial indicators grew:
    Today, the Board of Directors of Reply S.p.A. [EXM, STAR: REY] approved the results as at 30 June 2023.
  • In the first half of 2023, consolidated EBITDA of €153.9 million compared to the €144.4 million recorded in 2022 and corresponds to 14.8% of turnover.
  • Pre-tax profit, from January to June 2023, was €113.5 million (€108.7 million in 2022), corresponding to 10.9% of turnover.
  • As at 30 June 2023, the Group's net financial position was positive for €101.6 million, while at 31 March 2023 was positive for €190.7 million.

The Metals Company Comments on ISA Council Decision and Intention to Deliver Final Rules, Regulations and Procedures for Exploitation

Retrieved on: 
Monday, July 24, 2023
Agreement, Pressure, Uncertainty, International Seabed Authority, Metal, United Nations Convention on the Law of the Sea, United Nations Convention, Paragraph, Section 1, Part, Mining Code, ESIA, UNCLOS, TMC, Non-governmental organization, Collection, RRP, ISA, Whaling

“It is now a question of when — rather than if — commercial-scale nodule collection will begin,” said TMC Chairman and CEO Gerard Barron.

Key Points: 
  • “It is now a question of when — rather than if — commercial-scale nodule collection will begin,” said TMC Chairman and CEO Gerard Barron.
  • Last Friday’s consensus decision that included Member States who have called for a precautionary pause is a hard-won compromise that reduces this uncertainty.
  • We are obviously disappointed that the ISA failed to adopt RRPs by 9 July 2023 as we hoped two years ago.
  • NORI will continue to work tirelessly to complete a comprehensive, science-driven environmental and social impact assessment (ESIA) of the highest quality.