Orange Book

Amicus Therapeutics Announces First Quarter 2023 Financial Results and Corporate Updates

Retrieved on: 
Wednesday, May 10, 2023
Fabry, Loss, Table, Civil service commission, CER, CER1, European Directive on Traditional Herbal Medicinal Products, Amicus, Glycogen storage disease type II, GAAP, Committee, PIN, EAMS, Acquisition, Patient, Physician, Cipaglucosidase alfa, European, Growth, WuXi Biologics, Depreciation, Diagnosis, Committee for Medicinal Products for Human Use, Orange Book, Amicus Therapeutics, FDA, Therapy, EC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, European Commission, Wuxi, CHMP, Pharmaceutical industry, Bank, Video game, Cryptocurrency, EU, Migalastat

In the U.K., the regulatory submission process was initiated in December 2022, with final approval expected in the third quarter of 2023.

Key Points: 
  • In the U.K., the regulatory submission process was initiated in December 2022, with final approval expected in the third quarter of 2023.
  • Total GAAP operating expenses of $117.0 million for the first quarter 2023 decreased as compared to $146.5 million for the first quarter 2022.
  • ET to discuss the first quarter 2023 financial results and corporate updates.
  • A live audio webcast and related presentation materials can also be accessed via the Investors section of the Amicus Therapeutics corporate website at ir.amicusrx.com .

Exelixis Announces First Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, May 9, 2023
Biotechnology, Pharmaceutical, Health, Oncology, Orange, Share repurchase, District court, Investigational New Drug, Royalty payment, Patent, Checkmate, Ipilimumab, News, Software, Calendar, MSN, DC, Pharmacokinetics, Orange Book, IMDC, FDA, IND, Conference, Safety, 1836 U.S. Patent Office fire, Allele, Cabozantinib, Antibody, PIN, Webcast, Acceleration, RCC, Exelixis, OS, Trial of the century, ASCO, American Society of Clinical Oncology, ANDA, United States District Court for the Eastern District of Texas, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Douglas v. U.S. District Court ex rel Talk America, Tumor microenvironment, Society, Food, Nivolumab, Online shopping, Pharmaceutical industry, Patient

Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners during the quarter ended March 31, 2023, Exelixis earned $32.7 million in royalty revenues.

Key Points: 
  • Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners during the quarter ended March 31, 2023, Exelixis earned $32.7 million in royalty revenues.
  • Cabozantinib Data at the 2023 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium (ASCO GU 2023).
  • This IND clearance triggered a $35.0 million milestone payment to Sairopa, paid in the first quarter of 2023.
  • Exelixis management will discuss the company’s financial results for the first quarter of 2023 and provide a general business update during a conference call beginning at 5:00 p.m.

Lantern Pharma Reports First Quarter 2023 Financial Results and Operational Highlights

Retrieved on: 
Tuesday, May 9, 2023
Other Health, Research, Pharmaceutical, Oncology, Technology, Artificial Intelligence, Clinical Trials, Science, Biotechnology, Other Technology, Other Science, Health, Sherpa, Pancreatic cancer, Computational biology, Patent, US Foods, DNA, Human, Brain, AACR, Central nervous system, GBM, DDR, United States Patent and Trademark Office, DHL, NHL, Traffic barrier, NSCLC, Prostate, Lung cancer, CNS, Glioblastoma, Actuate, Orange Book, Phase 10, BBB, Metadata, Permeability, Patient, Machine learning, Mantle cell lymphoma, Algorithm, Starlight, Cancer, MCL, Poster, AI, FDA, Therapy, PARP, IND, Food, D, Pharmaceutical industry, Medical imaging, Cryptocurrency, Olaparib, Lantern

Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company using its proprietary RADR® artificial intelligence ("AI") and machine learning (“ML”) platform to transform the cost, pace, and timeline of oncology drug discovery and development, today announced operational highlights and financial results for the first quarter ended March 31, 2023.

Key Points: 
  • Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company using its proprietary RADR® artificial intelligence ("AI") and machine learning (“ML”) platform to transform the cost, pace, and timeline of oncology drug discovery and development, today announced operational highlights and financial results for the first quarter ended March 31, 2023.
  • First Quarter 2023 Financial Overview:
    Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $51.5 million as of March 31, 2023, compared to approximately $55.2 million as of December 31, 2022.
  • G&A Expenses: General and administrative expenses were approximately $1.7 million for the quarter ended March 31, 2023, compared to approximately $1.4 million for the quarter ended March 31, 2022.
  • Earnings Call and Webinar Details:
    Lantern will host its first quarter 2023 earnings call and webinar today, Tuesday, May 9, 2023 at 4:30 p.m.

Eagle Pharmaceuticals Reports First Quarter 2023 Results

Retrieved on: 
Tuesday, May 9, 2023
Laboratory, Centers for Medicare & Medicaid Services, Eagle, Medicare, Orange Book, Acquisition, Investment, Healthcare Common Procedure Coding System, HCPCS, FDA, Pemetrexed, Tariff, Hand, Hospira, Beauty salon, Pharmaceutical industry, Bookkeeping, Real estate, Video game, Reinsurance, Bank

WOODCLIFF LAKE, N.J., May 09, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced financial results for the three months ended March 31, 2023.

Key Points: 
  • WOODCLIFF LAKE, N.J., May 09, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced financial results for the three months ended March 31, 2023.
  • Net product sales of PEMFEXY totaled $22.9 million in the first quarter 2023.
  • Inventory on hand is expected to be depleted by the end of the second quarter of 2023.
  • Q1 2023 royalty revenue was $20.1 million, compared to $25.8 million in the prior year quarter.

SpringWorks Therapeutics Reports First Quarter 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Wednesday, May 3, 2023
NRAS, 1836 U.S. Patent Office fire, KRAS, Priority review, Patent, The New England Journal of Medicine, AACR, Plantar fibromatosis, Marketing, Neoplasm, United States Patent and Trademark Office, European Medicines Agency, New Drug Application, Clinical trial, NDA, Cancer, MAPK, American Association for Cancer Research, BRAF, G&A, Research, NSCLC, MEK, Lung cancer, Common, TEAD, Orange Book, Endometrial cancer, Patient, RAS, Administration, PDUFA, Mouse, Growth, Research and development, R, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, BCMA, RAF, Pharmaceutical industry

STAMFORD, Conn., May 03, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today reported first quarter financial results for the period ended March 31, 2023 and provided an update on recent company developments.

Key Points: 
  • "In the first quarter of 2023 we continued to deliver strong results across our diversified oncology pipeline.
  • The application has been granted Priority Review and given a Prescription Drug User Fee Act (PDUFA) action date of August 27, 2023.
  • SpringWorks also expects to file a Marketing Authorization Application for nirogacestat with the European Medicines Agency in 2024.
  • Net Loss Attributable to Common Stockholders: SpringWorks reported a net loss of $73.4 million, or $1.18 per share, for the first quarter of 2023.

New GIMOTI Patent Listed in FDA Orange Book

Retrieved on: 
Monday, May 1, 2023
The Orange Book, Approved Drug Products with Therapeutic Equivalence Evaluations, Orange Book, Patent, Collection, Patient, Metoclopramide, FDA, Food, Pharmaceutical industry

11,628,150 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: 
  • 11,628,150 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”.
  • This new patent is now listed in the FDA’s Orange Book and carries a patent term to 2029.
  • The listing of the patent in the Orange Book adds additional patent protection for GIMOTI beyond the prior two listed patents.
  • Patents listed in the Orange Book cover drugs that the FDA has approved and deemed both safe and effective for the general public's use.

CorMedix Inc. Announces Notice of Allowance for U.S. Patent Application Covering Lead Product DefenCath

Retrieved on: 
Monday, May 1, 2023
1836 U.S. Patent Office fire, Infection, Patent, The Orange Book, New Drug Application, NDA, New chemical entity, Orange Book, Food and Drug Administration, Patient, Approved Drug Products with Therapeutic Equivalence Evaluations, FDA, Food, Pharmaceutical industry

CorMedix’s newly allowed U.S. Patent Application (No.

Key Points: 
  • CorMedix’s newly allowed U.S. Patent Application (No.
  • 17/721,699) reflects the unique and proprietary formulation of its product, DefenCath™, for which the Company expects to resubmit its New Drug Application (NDA) to the Food and Drug Administration (FDA) by mid-May.
  • As we updated last week, CorMedix intends to resubmit the DefenCath NDA by mid-May and is focused on building out plans for commercialization following an anticipated FDA approval later this year.”
    The newly allowed application provides patent coverage that supplements CorMedix’s existing licensed U.S. Patent No.
  • 7,696,182, and has the potential to provide an additional layer of patent protection for DefenCath through 2042.

United States Patent and Trademark Office (USPTO) Grants Evoke Pharma a Formulation Patent Covering GIMOTI

Retrieved on: 
Thursday, April 20, 2023
Patent, Orange Book, Patient, Orange, Metoclopramide, FDA, GI, Food, Pharmaceutical industry, EU

SOLANA BEACH, Calif., April 20, 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 that the United States Patent and Trademark Office (USPTO) issued US patent No.

Key Points: 
  • SOLANA BEACH, Calif., April 20, 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 that the United States Patent and Trademark Office (USPTO) issued US patent No.
  • 11,628,150 under the title “Nasal Formulations of Metoclopramide.”
    This patent expires in 2029 and covers the nasal solution of metoclopramide and its characteristics when formulated.
  • The patent augments Evoke’s existing patent portfolio, which includes U.S. Food and Drug Administration (FDA) Orange Book-listed patents and other patents in the EU, Japan, Canada, and Mexico.
  • “This patent will continue to protect GIMOTI’s proprietary route of administration which is incredibly important to our commercial efforts,” Mr. D’Onofrio concluded.

Evoke Pharma Receives Notice of Allowance from USPTO for GIMOTI-Related Patent

Retrieved on: 
Thursday, April 6, 2023
Patent, Metoclopramide, United States Patent and Trademark Office, Food and Drug Administration, Vomiting, Orange Book, Patient, Gastroparesis, FDA, GI, Food, Disease, Pharmaceutical industry

SOLANA BEACH, Calif., April 06, 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 the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for U.S.

Key Points: 
  • SOLANA BEACH, Calif., April 06, 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 the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for U.S.
  • Once issued on April 18, 2023, the patent entitled “Nasal Formulation of Metoclopramide,” will expire in 2030 and will be assigned patent number 11628150.
  • This new patent will add to Evoke’s existing U.S. Food and Drug Administration (FDA) Orange Book-listed patent portfolio.
  • We continue to develop and grow the product in the market and are pleased to fortify our patent estate once again,” commented Matt D’Onofrio, President & COO of Evoke Pharma.

Eagle Pharmaceuticals Reaches Settlement Agreement with Dr. Reddy’s Laboratories Inc. and Dr. Reddy’s Laboratories Ltd. Related to BENDEKA® (bendamustine hydrochloride)

Retrieved on: 
Wednesday, April 5, 2023
Laboratory, Justice, U.S. Department of Agriculture Cotton Annex, U.S. Department of Justice Office of Legislative Affairs, Eagle, Orange Book, Hospira, Pharmaceutical industry

WOODCLIFF LAKE, N.J., April 05, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that it has reached a settlement agreement with Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, “Dr.

Key Points: 
  • WOODCLIFF LAKE, N.J., April 05, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that it has reached a settlement agreement with Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, “Dr.
  • Reddy’s”).
  • Eagle had asserted its Orange Book-listed patents against Dr. Reddy’s related to its new drug application referencing BENDEKA®.
  • Under the settlement agreement, Dr. Reddy’s has the right to market its product beginning November 17, 2027, or earlier based on certain circumstances.