Lesbian flag

Assertio Holdings, Inc. Announces FDA Orange Book Listing for New Sympazan® Oral Film Patent

Retrieved on: 
Monday, January 9, 2023
Seizure, United States patent law, Lesbian flag, Orange Book, Therapy, Patent, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Approved Drug Products with Therapeutic Equivalence Evaluations, Food, Growth, Patient, Business development, Epilepsy, ASRT, Pharmaceutical industry, Clobazam, Assertio Therapeutics

11541002 for Sympazan® oral film is now listed in the U.S. Food and Drug Administration (“FDA”) publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.

Key Points: 
  • 11541002 for Sympazan® oral film is now listed in the U.S. Food and Drug Administration (“FDA”) publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.
  • The patent, which is valid until 2039, is assigned to Aquestive Therapeutics, Inc. and exclusively licensed to Assertio.
  • It covers an oral film for delivering clobazam and methods for using the film to treat epilepsy and/or seizures.
  • “We are pleased to see this patent listed in the Orange Book, as originally anticipated in our Sympazan licensing agreement with Aquestive.

Catalyst Pharmaceuticals Reports Record Third Quarter 2022 Financial Results and Provides a Corporate Update

Retrieved on: 
Wednesday, November 9, 2022
GLOBE, Squamous cell carcinoma, U.S. Securities and Exchange Commission, Forward-looking statement, Intellectual property, Congress, Investment, Amifampridine, ESG, Adult, Patent, Accounting, Tablet, New Drug Application, Depreciation, Health Canada, Index, COVID-19, Companies listed on the Toronto Stock Exchange (A), Kayleigh McEnany, Mission statement, SEC, Annual report, Share repurchase, Goal, LEMS, Achievement, Lambert–Eaton myasthenic syndrome, Catalyst Pharmaceuticals, Orange Book, Lesbian flag, Company, Conference call, United, Research, Conference, GAAP, Degenerative disease, Patient, Growth, CEO, Industry, Acquisition, FDA, Income, Beauty salon, Pharmaceutical industry, Renewable energy, Fine chemical, Video game, Online shopping, Catalysis, Webcast, Social

"Catalyst delivered another solid quarter driven by record net revenues that exceeded expectations, marking this as another strong quarter of sequential growth of our FIRDAPSE brand.

Key Points: 
  • "Catalyst delivered another solid quarter driven by record net revenues that exceeded expectations, marking this as another strong quarter of sequential growth of our FIRDAPSE brand.
  • With robust year-to-date performance and continued momentum going into the fourth quarter, we are raising our 2022 full year total revenue guidance to $205-210 million."
  • In the third quarter of 2022 we were ranked #39 in the 2022 Fortune 100 Fastest Growing Companies List.
  • Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.

FTC Amicus Brief Challenges Abuse of FDA “Orange Book” Listing Procedures to Block Drug Competition

Retrieved on: 
Friday, November 11, 2022
Risk Evaluation and Mitigation Strategies, Patent, Approved Drug Products with Therapeutic Equivalence Evaluations, Food, FTC, Commission, Jazz, News, District, Federal Trade Commission, REMS, Douglas v. U.S. District Court ex rel Talk America, Lesbian flag, Program, Blog, District court, Social media, History, Orange Book, FDA, Pharmaceutical industry, Avadel Pharmaceuticals

The FDAs Orange Book is a list of drugs that are approved by the agency as safe and effective.

Key Points: 
  • The FDAs Orange Book is a list of drugs that are approved by the agency as safe and effective.
  • The FTCs amicus brief explains how the Orange Book listing process can be abused and emphasizes the harm to competition and consumers that can result from that abuse, including depriving consumers of potential competition from lower-cost alternatives and the ability to choose between products.
  • After listing it in the Orange Book, Jazz filed a patent infringement lawsuit against Avadel, triggering a 30-month stay and blocking final FDA approval of Avadels competing narcolepsy drug.
  • The FTC amicus brief takes no position on the scope or claim construction of the 963 patent but argues generally that REMS distribution patents are not properly listed in the Orange Book.

FTC Amicus Brief Challenges Abuse of FDA “Orange Book” Listing Procedures to Block Drug Competition

Retrieved on: 
Friday, November 11, 2022
Risk Evaluation and Mitigation Strategies, Patent, Approved Drug Products with Therapeutic Equivalence Evaluations, Food, FTC, Commission, Jazz, News, District, Federal Trade Commission, REMS, Douglas v. U.S. District Court ex rel Talk America, Lesbian flag, Program, Blog, District court, Social media, History, Orange Book, FDA, Pharmaceutical industry, Avadel Pharmaceuticals

The FDAs Orange Book is a list of drugs that are approved by the agency as safe and effective.

Key Points: 
  • The FDAs Orange Book is a list of drugs that are approved by the agency as safe and effective.
  • The FTCs amicus brief explains how the Orange Book listing process can be abused and emphasizes the harm to competition and consumers that can result from that abuse, including depriving consumers of potential competition from lower-cost alternatives and the ability to choose between products.
  • After listing it in the Orange Book, Jazz filed a patent infringement lawsuit against Avadel, triggering a 30-month stay and blocking final FDA approval of Avadels competing narcolepsy drug.
  • The FTC amicus brief takes no position on the scope or claim construction of the 963 patent but argues generally that REMS distribution patents are not properly listed in the Orange Book.

Baudax Bio Reports Third Quarter 2022 Financial Results and Business Highlights

Retrieved on: 
Tuesday, November 8, 2022
BX, IND, Asset, Travel, Meloxicam, Lesbian flag, Company, Program, Security (finance), Director, Hospital, IV, Marketing, United States Patent and Trademark Office, Patent, Board, News, U.S. Securities and Exchange Commission, Pharmacokinetics, Intubation, Research, GAAP, Patient, CEO, COVID-19, Vomiting, Analgesic, Omicron, Constipation, Depreciation, NSAID, Phase, Nausea, Volunteering, FDA, GLOBE, Nasdaq, Intellectual property, National Railway Company of Belgium, ASC, Technology, Reversal, NASDAQ, Safety, Hypoventilation, Pain, NMB, Therapy, Orange Book, Pharmaceutical industry, Video game, Birth control, Risk management, Reinsurance

MALVERN, Pa., Nov. 08, 2022 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX) (the “Company”), a pharmaceutical company focused on innovative products for hospital and related settings, today reported financial results for the three and nine months ended September 30, 2022, updated the status of the neuromuscular blocking (NMB) agent development program, provided key metrics around the ongoing commercialization of ANJESO (meloxicam) injection, and provided an overview of other corporate and financial developments.

Key Points: 
  • Baudax Bio expects to complete nonclinical studies and manufacturing data required to support the IND for BX3000 in the first half of 2023.
  • In August 2022, Baudax Bio announced that the United States Patent and Trademark Office (USPTO) had provided a Notice of Allowance for patent application No.
  • As of September 30, 2022, Baudax Bio had cash and cash equivalents of $5.6 million.
  • These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

Baudax Bio receives notice of allowance for U.S. Patent Application covering use of ANJESO® for the treatment of moderate to severe pain

Retrieved on: 
Monday, August 22, 2022
Orange Book, Security (finance), COVID-19, Technology, Pain, Approved Drug Products with Therapeutic Equivalence Evaluations, Nasdaq, United States Patent and Trademark Office, Patent, NASDAQ, USPTO, National Railway Company of Belgium, U.S. Securities and Exchange Commission, Analgesic, GLOBE, Constipation, Company, FDA, Therapy, Vomiting, NSAID, Lesbian flag, Hypoventilation, Intellectual property, Nausea, Pharmaceutical industry

A Notice of Allowance is issued after the USPTO makes the determination that a patent should be granted from an application.

Key Points: 
  • A Notice of Allowance is issued after the USPTO makes the determination that a patent should be granted from an application.
  • The 095 Application emphasizes ANJESOs potential to treat moderate to severe pain while potentially reducing the use of rescue analgesics.
  • ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.
  • Baudax Bio markets ANJESO, the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain.

Catalyst Pharmaceuticals Delivers Strong Second Quarter 2022 Financial Results with Record FIRDAPSE® Revenues and Provides Corporate Update

Retrieved on: 
Tuesday, August 9, 2022
FDA, U.S. Securities and Exchange Commission, United, Income, CEO, Forward-looking statement, Accounting, Lambert–Eaton myasthenic syndrome, GLOBE, Kayleigh McEnany, Growth, SEC, Lesbian flag, Investment, Jacobus, Congress, Orange Book, Annual report, Catalyst Pharmaceuticals, Patient, Review, LEMS, COVID-19, Company, Degenerative disease, Mission statement, EBITDA, Acquisition, Depreciation, Tablet, GAAP, Research, Conference call, Share repurchase, Drug discovery, Conference, Biophysical environment, New Drug Application, Appellate court, Adult, Pharmaceutical industry, Renewable energy, Generic drug, Fine chemical, Video game, Online gambling, Catalysis, Webcast, Amifampridine

These results marked a quarter of record revenues from FIRDAPSE net sales and reflect the 5th period of consecutive quarter-over-quarter growth for Catalyst.

Key Points: 
  • These results marked a quarter of record revenues from FIRDAPSE net sales and reflect the 5th period of consecutive quarter-over-quarter growth for Catalyst.
  • Revenue: Product revenue, net in the second quarter of 2022 was $53.0 million, compared to $33.6 million for the second quarter of 2021, representing an increase of 57.7% year-over-year.
  • Total revenue for the second quarter of 2022 was $53.1 million, compared to $36.4 million for the second quarter of 2021, representing an increase of 46.1% year-over-year.
  • Research and development expenses: R&D expenses in the second quarter of 2022 were $4.0 million, compared to R&D expenses of $4.5 million in the second quarter of 2021.

Avadel Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2022 Financial Results

Retrieved on: 
Tuesday, August 9, 2022
FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, U.S. Securities and Exchange Commission, Drug Quality and Security Act, Cataplexy, NDA, Forward-looking statement, GLOBE, Securities Exchange Act of 1934, SEC, Lesbian flag, Sodium oxybate, District, Patent, Security (finance), Orange Book, Knowledge, Workforce, REMS, Income, Douglas v. U.S. District Court ex rel Talk America, Court, Narcolepsy, Patient, Review, EDS, Company, Avadel Pharmaceuticals, International, Excessive daytime sleepiness, Safety, District court, 1836 U.S. Patent Office fire, Securities Act of 1933, Webcast, Food and Drug Administration, Nasdaq, Certification, Food, Fine chemical, Pharmaceutical industry, Online gambling, Risk management, Generic drug

ET

Key Points: 
  • ET
    DUBLIN, Ireland, Aug. 09, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today provided a corporate update and announced its financial results for the second quarter ended June 30, 2022.
  • R&D expenses were $4.5 million in the quarter ended June 30, 2022, compared to $6.8 million for the same period in 2021.
  • SG&A expenses were $21.8 million in the quarter ended June 30, 2022, compared to $15.2 million for the same period in 2021.
  • These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events.

Liquidia Receives Favorable Ruling in Inter Partes Review against United Therapeutics Patent

Retrieved on: 
Tuesday, July 19, 2022
Regulation of tobacco by the U.S. Food and Drug Administration, Goal, INSPIRE, Environment, GLOBE, PAH, Inter partes review, Court, Industry, Food, Trial of the century, New York Heart Association Functional Classification, SEC, Orange Book, Hypertensive emergency, Functional, Lesbian flag, Private Securities Litigation Reform Act, United Therapeutics, Judgement, NDA, UTC, Patent, Adult, COVID-19, Safety, NASDAQ, PTAB, IPR, Treprostinil, Lung, Exercise, Pharmacology, FDA, Patient, Pulmonary hypertension, Degenerative disease, District court, Douglas v. U.S. District Court ex rel Talk America, LLC, District, NYHA, USPTO, Coronavirus, Pharmaceutical industry, Risk management, Generic drug

10,716,793 (793 patent) owned by United Therapeutics Corporation (UTC) and listed in the Orange Book for Tyvaso (treprostinil inhalation solution).

Key Points: 
  • 10,716,793 (793 patent) owned by United Therapeutics Corporation (UTC) and listed in the Orange Book for Tyvaso (treprostinil inhalation solution).
  • In its ruling, the PTAB found that, based on the preponderance of the evidence, all the claims of the 793 patent have been shown to be unpatentable.
  • Roger Jeffs, Chief Executive Officer of Liquidia said: We are very pleased with this decision by the PTAB.
  • The PTABs decision with respect to the 793 patent does not resolve the on-going district court litigation brought by UTC related to YUTREPIA.

Avadel Pharmaceuticals Announces Tentative Approval of LUMRYZ™ (sodium oxybate) extended-release oral suspension

Retrieved on: 
Tuesday, July 19, 2022
Research, SEC, Patent, District court, Lesbian flag, Patient, Security (finance), Regulation of food and dietary supplements by the U.S. Food and Drug Administration, REMS, Nasdaq, Securities and Exchange Commission (Philippines), EDS, Safety, Knowledge, Orange Book, GLOBE, Securities Exchange Act of 1934, Food, Forward-looking statement, Narcolepsy, Avadel Pharmaceuticals, Sodium oxybate, Cataplexy, District, Securities Act of 1933, Motion, Company, NDA, Drug Quality and Security Act, Excessive daytime sleepiness, Annual report, Court, FDA, 1836 U.S. Patent Office fire, Somnolence, Douglas v. U.S. District Court ex rel Talk America, Population, Pharmaceutical industry, Online gambling, Risk management

DUBLIN, Ireland, July 19, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to LUMRYZ, also known as FT218. Tentative approval indicates that LUMRYZ has met all required quality, safety, and efficacy standards necessary for approval in the U.S. Final approval is pending disposition of U.S. Patent No. 8,731,963 (the “REMS patent”) which is listed in FDA’s Orange Book. LUMRYZ is a once-at-bedtime investigational formulation of sodium oxybate for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.

Key Points: 
  • Tentative approval indicates that LUMRYZ has met all required quality, safety, and efficacy standards necessary for approval in the U.S.
  • We have reached a critical milestone, as tentative approval confirms the safety profile and clinical efficacy of LUMRYZ for adults with narcolepsy, said Greg Divis, Chief Executive Officer at Avadel Pharmaceuticals.
  • Tentative approval is an important regulatory step forward and indicates LUMRYZ could potentially be granted final approval in 11 months or less.
  • We believe once-at-bedtime LUMRYZ offers the opportunity to positively transform the lives of oxybate eligible patients living with narcolepsy.