NDA

As Drafted, Insurance Commissioner's Proposed Rules for Insurance Catastrophe Models Preserve Secrecy of Black Box Models

Retrieved on: 
Thursday, March 14, 2024
Consumer Watchdog, Organization, Commissioner, Science, Bias, NDA, Confidentiality, Multimedia, Proposition 103

LOS ANGELES, March 14, 2024 /PRNewswire/ -- Consumer Watchdog issued the following statement about the proposed catastrophe modeling rules released by Insurance Commissioner Ricardo Lara today.

Key Points: 
  • LOS ANGELES, March 14, 2024 /PRNewswire/ -- Consumer Watchdog issued the following statement about the proposed catastrophe modeling rules released by Insurance Commissioner Ricardo Lara today.
  • "Black box catastrophe models are notoriously contradictory and unreliable, which is why public review and transparency are key before insurance companies are allowed to use them to raise rates.
  • Commissioner Lara's proposed rule appears drafted to limit the information available to the public about the impact of models on rates in violation of Proposition 103.
  • Read Consumer Watchdog's testimony before the July and September 2023 catastrophe modeling workshops at the Department of Insurance.

Everest Medicines' Partner Calliditas Therapeutics Announces U.S. FDA Grants an Additional Seven-Year Orphan Drug Exclusivity Period for Nefecon®

Retrieved on: 
Tuesday, March 12, 2024
Mount Everest, Risk, Patient, NDA, CALT, HKEX, Ministry, FDA, Pharmaceutical industry

SHANGHAI, March 11, 2024 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company")'s licensing partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") announced that the U.S. FDA has granted an orphan drug exclusivity period of seven years for Nefecon®, expiring in December 2030 based on Calliditas obtaining full approval with a new indication for this drug product in December 2023.

Key Points: 
  • SHANGHAI, March 11, 2024 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company")'s licensing partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") announced that the U.S. FDA has granted an orphan drug exclusivity period of seven years for Nefecon®, expiring in December 2030 based on Calliditas obtaining full approval with a new indication for this drug product in December 2023.
  • Following full approval in December 2023, Nefecon® is indicated "to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression".
  • "Nefecon® represents a revolutionary first-in-disease therapeutic option for Chinese patients who have more rapid disease progression in IgAN with no effective treatment options.
  • South Korea's Ministry of Food and Drug Safety granted Orphan Drug Designation status for Nefecon® in November 2022.

NRx Pharmaceuticals (NASDAQ:NRXP) Completes Memorandum of Understanding and Collaborations with Distribution Partners for HTX-100 (IV Ketamine)

Retrieved on: 
Monday, March 11, 2024
Organization, HOPE, Partnership, Patient, Sale, NDA, Detail, Therapy, Pharmacy, FDA, PTSD, Pharmaceutical industry

These are important steps to providing a full suite of ketamine options for customers across the country, and preparation for potential approval of HTX-100 by regulatory authorities worldwide.

Key Points: 
  • These are important steps to providing a full suite of ketamine options for customers across the country, and preparation for potential approval of HTX-100 by regulatory authorities worldwide.
  • The Company has further entered into a business relationship with an organization that currently serves the business needs of more than 100 ketamine clinics nationwide.
  • The Company has been given a target delivery date prior to the end of this month (March 2024) for initial stock of ketamine for sale to licensed end users.
  • Details for ordering will be available on our website as soon as they are available.

Congressional "Minibus" Includes Historic Funding for MDMA-Assisted Therapy Trials

Retrieved on: 
Monday, March 11, 2024
Diagnosis, Congress, Veteran, Federation, Executive, Research, Public policy, NDA, Breakthrough therapy, Safety, Suicide, FDA, PTSD, PDUFA, Pharmaceutical industry

WASHINGTON, March 11, 2024 /PRNewswire/ -- Healing Breakthrough, the leading federal advocacy group for veteran access to MDMA-assisted therapy (MDMA-AT), celebrates the achievement of its FY24 advocacy goal: securing the first-ever Congressional appropriation for large-scale, nationwide trials of MDMA-AT. This effort was led by a courageous coalition of bipartisan legislators who are committed to combating PTSD and bringing the veteran suicide epidemic to an end.

Key Points: 
  • To combat PTSD and Veteran suicide, Congress directs the VA to fund nationwide trials of FDA-designated "Breakthrough Therapies," including MDMA-Assisted Therapy.
  • WASHINGTON, March 11, 2024 /PRNewswire/ -- Healing Breakthrough , the leading federal advocacy group for veteran access to MDMA-assisted therapy (MDMA-AT), celebrates the achievement of its FY24 advocacy goal: securing the first-ever Congressional appropriation for large-scale, nationwide trials of MDMA-AT.
  • This effort was led by a courageous coalition of bipartisan legislators who are committed to combating PTSD and bringing the veteran suicide epidemic to an end.
  • This historic Congressional appropriation marks a shift from decades of philanthropically funded private research to public funding of the VA's continued research and deployment of this FDA-designated "Breakthrough Therapy."

Kudelski IoT Partners with Infineon to Enhance Smart Home Device Security with New Matter-Certified Solution

Retrieved on: 
Wednesday, March 13, 2024
Matter, DAC, Cheseaux-sur-Lausanne, PAA, Connectivity Standards Alliance, Internet of things, Device, Ecosystem, ABI, NDA, Internet, Partnership

Cheseaux-sur-Lausanne, Switzerland, and Phoenix, AZ, USA, March 12 2024 – Kudelski IoT, a leader in digital security and IoT solutions, and Infineon Technologies AG, a global semiconductor leader in power systems and IoT, today announced a security solution with a Matter provisioning service for the smart home and smart building device ecosystems.

Key Points: 
  • Cheseaux-sur-Lausanne, Switzerland, and Phoenix, AZ, USA, March 12 2024 – Kudelski IoT, a leader in digital security and IoT solutions, and Infineon Technologies AG, a global semiconductor leader in power systems and IoT, today announced a security solution with a Matter provisioning service for the smart home and smart building device ecosystems.
  • The Matter standard, developed by the Connectivity Standards Alliance with contributions from over 600 companies, including Kudelski IoT and Infineon, aims to revolutionize the smart home industry by ensuring devices work seamlessly together while maintaining the highest security levels.
  • Frédéric Thomas, CTO of Kudelski IoT, emphasizes the importance of this collaboration: "In the era of IoT, security and interoperability are not just features but necessities.
  • To learn more about this innovative solution and how it can benefit your smart home device development, visit Infineonand Kudelski IoT websites.

EQS-News: fox e-mobility AG announces preliminary figures for the 2022 financial year and provides information on current activities

Retrieved on: 
Wednesday, March 13, 2024
MIA, Supervisory board, VDL, Marketing, FSS, News, NDA, Partnership, Security (finance)

So far, fox e-mobility has not generated any revenue from vehicle sales as the company is still in the development phase.

Key Points: 
  • So far, fox e-mobility has not generated any revenue from vehicle sales as the company is still in the development phase.
  • The publication of the complete and audited annual financial statements for the 2022 financial year is expected by April 30, 2024 latest.
  • The company will announce preliminary figures for the key financial data for the 2023 financial year in the upcoming week.
  • Since the resignation of Supervisory Board member Russell Pfeiffer on February 8, 2022, the Supervisory Board has only had three members.

Lexicon Preparing to Resubmit Sotagliflozin NDA for Type 1 Diabetes Following Feedback From FDA

Retrieved on: 
Monday, March 11, 2024
Chronic kidney disease, Lexicon, CRL, New Drug Application, FDA, CKD, Diabetes, Patient, Hearing, NDA, Pharmaceutical industry

THE WOODLANDS, Texas, March 11, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that, following the receipt of recent feedback from FDA, it is preparing to resubmit its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in patients with type 1 diabetes and chronic kidney disease (CKD). The resubmission is planned for mid-year, with an anticipated six-month regulatory review period.

Key Points: 
  • THE WOODLANDS, Texas, March 11, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that, following the receipt of recent feedback from FDA, it is preparing to resubmit its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in patients with type 1 diabetes and chronic kidney disease (CKD).
  • The resubmission is planned for mid-year, with an anticipated six-month regulatory review period.
  • “We have remained steadfast in our support of sotagliflozin in type 1 diabetes and have worked diligently to identify a regulatory path forward for what we believe will be an important new therapy,” said Lonnel Coats, Director and Chief Executive Officer.
  • Lexicon and FDA subsequently agreed in late 2023 to hold the NOOH proceedings in abeyance in order to engage in discussions regarding a path forward for resubmission and potential approval of the NDA.

Tonix Pharmaceuticals Reports Improvement in “Brain Fog,” in Fibromyalgia Patients Treated with Tonmya™ in RESILIENT, an NDA-Enabling Phase 3 Clinical Trial, at the 6th International Congress on Controversies in Fibromyalgia

Retrieved on: 
Monday, March 11, 2024
Blood pressure, Tonix Pharmaceuticals, Woman, New Drug Application, FDA, Pain, Food, Sleep, Hope, Hydrogen chloride, FIQ, Human, Fatigue, Weight gain, Patient, Tablet, Insomnia, NDA, Brain, DSM-IV codes, Pharmaceutical industry

CHATHAM, N.J., March 11, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the presentation of additional efficacy data from RESILIENT, the second positive Phase 3 study evaluating Tonmya (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia, at the 6th International Congress on Controversies in Fibromyalgia in Brussels, Belgium, March 7-8, 2024.

Key Points: 
  • We now report that the effect sizes of the five continuous key secondary outcomes measures ranged from 0.3 to 0.5.
  • The FIQ-R cognitive item showed nominal improvement in Tonmya-treated patients vs placebo-treated patients with a p=0.001 and effect size of 0.31.
  • RELIEF, the first Phase 3 trial of Tonmya 5.6 mg in fibromyalgia, was completed in December 2020.
  • We also believe the favorable tolerability and side effect profiles will be important to patients and doctors managing this debilitating condition on a long-term basis.”

Lexicon Pharmaceuticals Reports Fourth Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, March 11, 2024
Research, New Drug Application, American Heart Association, Investment, Obesity, Growth, EASD, Arrowhead Conference, Patient, Chronic kidney disease, Post hoc, Neuropathic pain, Marketing, Heart failure, Hypertension, Hypertrophic cardiomyopathy, Left ventricular hypertrophy, NDA, Express, PROGRESS, AAK1, Risk, Conference, HCM, Clinical trial, Neuroscience, Lexicon, FDA, Research and development, Cardiology, U.S. FDA, Medicare, Administration, Travel, Pharmaceutical industry

ET

Key Points: 
  • ET
    THE WOODLANDS, Texas, March 11, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months ended December 31, 2023 and provided an update on key corporate milestones.
  • “2023 was a pivotal year for Lexicon,” said Lonnel Coats, Lexicon’s chief executive officer.
  • Unless otherwise stated, all comparisons are for the fourth quarter and full year of 2023 compared to the fourth quarter and full year of 2022.
  • Revenues: Revenues for the fourth quarter and full year of 2023 were $0.7 million and $1.2 million, respectively, primarily from the commercialization of INPEFA.

XOMA Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent and Upcoming Events Expected to Drive Shareholder Value

Retrieved on: 
Friday, March 8, 2024
Acquisition, Roche, Blue Owl Capital, License, G&A, CVR, NDA, Video game

EMERYVILLE, Calif., March 08, 2024 (GLOBE NEWSWIRE) --  XOMA Corporation (Nasdaq: XOMA), the biotech royalty aggregator, reported its fourth quarter and full year 2023 financial results and highlighted portfolio activities expected to drive long-term shareholder value.

Key Points: 
  • XOMA recorded total revenues of $1.8 million and $4.8 million for the fourth quarter and full year of 2023, respectively.
  • General and administrative (“G&A”) expenses were $7.3 million for the fourth quarter and $25.6 million for the full year of 2023.
  • In the fourth quarter of 2023, G&A expenses included $2.6 million in non-cash stock-based compensation expense, compared with $1.0 million in the fourth quarter of 2022.
  • In 2023, net loss for the fourth quarter and year ended December 31, 2023, was $20.1 million and $40.8 million, respectively.