NDS

Scilex Holding Company Provides Responses to Product Composition Questions Related to its ELYXYB® Patent in Canada for a New Drug Submission Under Review by Health Canada for the Approval of ELYXYB® for Acute Treatment of Migraine With or Without Aura in

Retrieved on: 
Monday, March 18, 2024
Neurology, Headache, NDS, Patient, Contraindication, Nonsteroidal anti-inflammatory drug, Chronic pain, Migraine, Health Canada, Chemical patent, PALO, OPML, Patent, Therapy, FDA

ELYXYB® (celecoxib oral solution) is in the same class of agents, is fast acting, and has the potential to have the lowest gastrointestinal (GI) side effects of all NSAIDs.3

Key Points: 
  • ELYXYB® (celecoxib oral solution) is in the same class of agents, is fast acting, and has the potential to have the lowest gastrointestinal (GI) side effects of all NSAIDs.3
    The anticipated timeline for approval in Canada is approximately 12 months depending on review cycles and information requests by Health Canada.
  • ELYXYB®’s product profile mapped with a high degree of certainty to these stated unmet needs.
  • For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com .
  • For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com .

Air Force Research Laboratory Leverages SparkCognition Government Systems' AI Solutions to Optimize Supply Chain

Retrieved on: 
Thursday, March 21, 2024
Innovation, NDS, Digital, Partnership, DLA, Artificial intelligence, SGS, LLM, The, Air force, Defense Logistics Agency, Government

The contract expands SGS' partnership with the United States Air Force to deploy AI-powered solutions, in collaboration with Boeing.

Key Points: 
  • The contract expands SGS' partnership with the United States Air Force to deploy AI-powered solutions, in collaboration with Boeing.
  • This aims to strengthen the Air Force's supply chain health and create mitigation strategies for operational risks related to our National Defense Strategy (NDS).
  • As a result of using SGS technology, the Air Force will look to increase warfighting readiness, reduce expense, and enhance industrial-base resilience.
  • "With SGS' AI-enabled solutions, actionable insights are generated to help the Air Force quickly identify and fix supply chain vulnerabilities and strengthen our national security posture."

Iovance Biotherapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Updates 

Retrieved on: 
Wednesday, February 28, 2024
IOV, NSCLC, Acquisition, Cohort, Units of paper quantity, Research, MAA, TIL, Information, FDA, Melanoma, Food, Cancer, Growth, U.S. FDA, PD-1, European, Interim, Safety, NDS, Endometrial cancer, Food and Drug Administration, Second generation, Patent, Patient, MMR, Clinical trial, Investment, Intellectual property, Travel, Pharmaceutical industry

SAN CARLOS, Calif., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today reported fourth quarter and full year 2023 financial results and corporate updates.

Key Points: 
  • The Iovance Cell Therapy Center ( iCTC ) began commercial manufacturing for Amtagvi patients within a week of approval.
  • More than 700 patients have been treated with Iovance TIL therapy manufactured using proprietary Iovance processes as of December 31, 2023.
  • Revenue for the fourth quarter and year ended December 31, 2023, was $0.5 million and $1.2 million, respectively, and comprised of product sales following the Proleukin® acquisition in May 2023.
  • Research and development expenses were $87.5 million for the fourth quarter ended December 31, 2023, an increase of $6.9 million compared to $80.6 million for the same period ended December 31, 2022.

Nabors Announces Fourth Quarter 2023 Results

Retrieved on: 
Tuesday, February 6, 2024
Growth, ExxonMobil, NBR, SLB, International, Lithium, NDS, Capital, Capital expenditure, Erosion, Automation, Acquisition, Arms industry

HAMILTON, Bermuda, Feb. 6, 2024 /PRNewswire/ -- Nabors Industries Ltd. ("Nabors" or the "Company") (NYSE: NBR) today reported fourth quarter 2023 operating revenues of $726 million, compared to operating revenues of $734 million in the third quarter.

Key Points: 
  • HAMILTON, Bermuda, Feb. 6, 2024 /PRNewswire/ -- Nabors Industries Ltd. ("Nabors" or the "Company") (NYSE: NBR) today reported fourth quarter 2023 operating revenues of $726 million, compared to operating revenues of $734 million in the third quarter.
  • The fourth quarter results included a gain, related to mark-to-market treatment of Nabors warrants, of $10 million, or $1.14 per diluted share, compared to a charge of $8 million, or $0.86 per diluted share, in the third quarter.
  • Fourth quarter adjusted EBITDA was $230 million, compared to $210 million in the previous quarter.
  • Anthony G. Petrello, Nabors Chairman, CEO and President, commented, "Our fourth quarter operating results exceeded our expectations across all of our segments.

Scilex Holding Company Chief Executive Officer and President Issues Letter to Stockholders Highlighting 2023 Accomplishments and Outlook for 2024

Retrieved on: 
Monday, January 8, 2024
Sciatica, Kidney, Orange Book, Pain management, Food, Migraine, LRP, Pain, FDA, Gout, CMC, Chronic pain, Injection, Patent, NDA, Health, GMP, Neurology, PALO, Medicare, Letter, PDL, Observation, Paracetamol, Growth, Pharmacy, Medicaid, Safety, Patient, MENA, Therapy, Rheumatology, NDS, Creativity, Acute liver failure, Communication, Pharmaceutical industry

PALO ALTO, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today issued a letter from Jaisim Shah, its Chief Executive Officer and President, to its stockholders highlighting the Company’s accomplishments in 2023 and its forward outlook for 2024.

Key Points: 
  • PALO ALTO, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today issued a letter from Jaisim Shah, its Chief Executive Officer and President, to its stockholders highlighting the Company’s accomplishments in 2023 and its forward outlook for 2024.
  • Dear Scilex Holding Company Stockholders,
    I would like to express my deepest gratitude for your unwavering support, patience, and invaluable feedback throughout the transformative year in 2023.
  • As we continue to navigate the complexities of the pharmaceutical landscape, your role as stockholders in this journey is invaluable.
  • Despite the challenges that remain ahead, we are setting ambitious goals for the Company in 2024, including:
    Expected launch of Gloperba®.

Scilex Holding Company Announces Filing of a New Drug Submission (NDS) to Health Canada’s Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences for the Approval of ELYXYB® for Acute Treatment of Migraine With or Without

Retrieved on: 
Tuesday, December 26, 2023
Pain management, Contraindication, Migraine, Physician, FDA, Chronic pain, Headache, Nonsteroidal anti-inflammatory drug, Neurology, PALO, Health Canada, Patient, Therapy, NDS, Pharmaceutical industry

Clinicians in a recent market research study expressed their desire for fast and safe alternatives for two large pools of acute migraine patients – those who have an insufficient response to triptan therapy, and those who have contraindications to triptan use.

Key Points: 
  • Clinicians in a recent market research study expressed their desire for fast and safe alternatives for two large pools of acute migraine patients – those who have an insufficient response to triptan therapy, and those who have contraindications to triptan use.
  • ELYXYB®’s product profile mapped with a high degree of certainty to these stated unmet needs.
  • This is a highly complementary commercial asset that allows us to provide physicians with another tool in their pain management armamentarium to treat migraines earlier in the patient journey.
  • For more information on ELYXYB®, including Full Prescribing Information, please visit ELYXYB.com

Duchesnay Inc. is seeking Health Canada approval for a segesterone acetate/ethinyl estradiol contraceptive vaginal system, a new option for women

Retrieved on: 
Thursday, November 30, 2023
Marketing, Regulation, Partnership, Government, Commercial, Woman, Research, FDA, Hormone, Health, DPG, Health Canada, Population Council, Birth, Strategy, NDS, Food and Drug Administration, Pharmaceutical industry

With its long-acting properties, this product is another step toward bringing contraceptive choice, convenience and control to women around the world.

Key Points: 
  • With its long-acting properties, this product is another step toward bringing contraceptive choice, convenience and control to women around the world.
  • RingzaTM * is a soft reusable silicone vaginal ring which combines two hormones, a novel progestin (segesterone acetate) and a widely used estrogen (ethinyl estradiol), which are diffused at a slow, steady rate in the bloodstream.
  • “Our partnership with Population Council and the submission of this novel contraceptive method is in line with our research interests and global expansion efforts.
  • The product’s safety and efficacy are still under investigation of Health Canada and marketing authorization has not yet been granted.

NDS Announces the Hiring of Gary Shoemake as Director of Client Engagement

Retrieved on: 
Monday, October 23, 2023
Insurance, Professional, Attention, Negotiation, RPA, The Big Picture, Marketing, CIA, NDS, Sales

HOLLYWOOD, Fla., Oct. 23, 2023 /PRNewswire-PRWeb/ -- We are thrilled to announce the hiring of Gary Shoemake as the new Director of Client Engagement at NDS Property Restoration.

Key Points: 
  • We are thrilled to announce the hiring of Gary Shoemake as the new Director of Client Engagement at NDS Property Restoration.
  • HOLLYWOOD, Fla., Oct. 23, 2023 /PRNewswire-PRWeb/ -- We are thrilled to announce the hiring of Gary Shoemake as the new Director of Client Engagement at NDS Property Restoration.
  • As the Director of Client Engagement, Gary will be responsible for generating new commercial business opportunities, driving sales, promoting and marketing the company, and leading participation in industry functions.
  • As the liaison between our clients and the NDS organization, Gary will oversee the client service teams, develop client engagement strategies, and communicate with clients to understand their expectations and provide solutions.

Certara Announces 300th Regulatory Submission Milestone Using its Technology-enabled Services and Software

Retrieved on: 
Tuesday, September 19, 2023
Medical Affairs Bureau, Central nervous system, Drug development, NDS, Therapy, Marketing, Type 2, Pediatrics, New Drug Application, European Medicines Agency, Health care, CMC, Clinical trial, NDA, Therapeutic Goods Administration, Cancer, CTA, Regulatory science, CNS, Common Technical Document, EMA, Chemistry, Shanda, Investigational New Drug, Patient, Pinnacle, Certara, Medicines and Healthcare products Regulatory Agency, MAA, Rare, TGA, FDA, Health Canada, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, BLA, Food, MHRA, Pharmaceutical industry, Risk management, Medical device, EU, Swiss Medical Students' Association

Certara has supported clients' global regulatory submissions across a wide range of therapeutic areas including cancer, rare diseases, central nervous system (CNS) diseases, and pediatrics.

Key Points: 
  • Certara has supported clients' global regulatory submissions across a wide range of therapeutic areas including cancer, rare diseases, central nervous system (CNS) diseases, and pediatrics.
  • “As the global regulatory drug development environment changes at an ever-increasing pace, Certara has combined regulatory writing expertise with technology platforms that streamline a complex process,” said Demetrius Carter, Sr. Vice President, Regulatory Sciences & Medical Affairs at Certara.
  • In addition to regulatory submission services, Certara offers a software portfolio that saves time and resources in submission development.
  • The software portfolio includes:
    Pinnacle 21™ software used to facilitate all aspects of preparing clinical trial data for regulatory submissions.

Health Canada Accepts Valneva’s Chikungunya Vaccine License Application for Review

Retrieved on: 
Tuesday, August 29, 2023
Epidemic, Priority review, NDS, Biologics license application, Pan American Health Organization, Saint-Herblain, Priority, Marketing, Coalition, European Medicines Agency, Valneva SE, CEPI, PAHO, Coalition for Epidemic Preparedness Innovations, Licensure, Chikungunya, Person, Trial of the century, Fast track (FDA), EMA, Euronext Paris, VLA, MD, Instituto Butantan, Ageing, FDA, Health Canada, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, Pharmaceutical industry, Vaccine, Lancet

Based on Health Canada’s performance standard to process an NDS application, the Company believes the regulatory review could be completed by mid-2024.

Key Points: 
  • Based on Health Canada’s performance standard to process an NDS application, the Company believes the regulatory review could be completed by mid-2024.
  • This is the second regulatory application for VLA1553 filed by Valneva, and the Company intends to make additional regulatory submissions in 2023.
  • A Biologic License Application (BLA) is currently under priority review1 by the U.S. Food and Drug Administration (FDA)2.
  • VLA1553 is currently the only chikungunya vaccine candidate worldwide for which regulatory review processes are underway and, if approved, it could become the first licensed chikungunya vaccine available to address this unmet medical need.