NDA

CorMedix Inc. Announces Commercial Agreement With ARC Dialysis, LLC

Retrieved on: 
월요일, 4월 8, 2024
Dialysis, Antibiotic, CVC, Infection, Patient, NDA, Taurolidine, Heparin, ARC, FDA, Health, Medical device

CorMedix received NDA approval of DefenCath® under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) on November 15, 2023, and expects to begin commercialization of the product in the inpatient setting on April 15th.

Key Points: 
  • CorMedix received NDA approval of DefenCath® under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) on November 15, 2023, and expects to begin commercialization of the product in the inpatient setting on April 15th.
  • CorMedix is committed to building meaningful long-term relationships with dialysis providers that are dedicated to innovation and infection reduction.
  • ARC Dialysis, a Miami-based medium-sized dialysis organization, provides inpatient dialysis services to approximately 100 inpatient facilities, and is the operator of 18 outpatient dialysis units throughout Florida.
  • “This agreement with CorMedix for the adoption of DefenCath reinforces our commitment to innovation and patient care, and we are proud of the reputation we’ve established for ourselves as a leading dialysis provider in the southeast United States,” says Fred Dumenigo, CEO of ARC Dialysis.

Supernus Provides Regulatory Update for SPN-830

Retrieved on: 
월요일, 4월 8, 2024
Symantec Endpoint Protection, PD, Central nervous system, Patient, CNS, Food and Drug Administration, CRL, NDA, FDA, Food

ROCKVILLE, Md., April 08, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced a regulatory update for SPN-830.

Key Points: 
  • ROCKVILLE, Md., April 08, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced a regulatory update for SPN-830.
  • The FDA has issued a Complete Response Letter (CRL) in response to the Company’s New Drug Application (NDA) for SPN-830.
  • The CRL mentions two areas that require additional review by the FDA or additional information to be provided to the FDA.
  • We will work with the FDA to address the CRL and to successfully resubmit our SPN-830 NDA,” said Jack Khattar, President & CEO of Supernus.

Eyenovia Announces Updated Strategy and Corporate Priorities to Focus on Shareholder Value Generation and Immediate Commercial Opportunities

Retrieved on: 
월요일, 4월 8, 2024
Organization, Clobetasol, Disease, Inflammation, Near-sightedness, Sale, NDA, Mydriasis, Pain, FDA, Pharmaceutical industry

In conjunction with the strategic process and focus on its late stage MicroPine asset, Eyenovia reiterated its immediate commercialization opportunities and corporate savings intended to reduce operating expenses while continuing to support meaningful value generation from the company's two FDA-approved products.

Key Points: 
  • In conjunction with the strategic process and focus on its late stage MicroPine asset, Eyenovia reiterated its immediate commercialization opportunities and corporate savings intended to reduce operating expenses while continuing to support meaningful value generation from the company's two FDA-approved products.
  • “The pediatric progressive myopia market represents a significant opportunity for Eyenovia both in the United States and China.
  • This disease, for which there are no FDA-approved pharmaceutical treatments, has been called an epidemic by several medical and optometric organizations.
  • Eyenovia does not intend to make any further disclosures regarding the strategic review process unless and until a specific course of action is approved.

AXSOME ALERT: Bragar Eagel & Squire, P.C. is Investigating Axsome Therapeutics, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm

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목요일, 4월 4, 2024
Symantec Endpoint Protection, Telephone, CRL, News, NDA, CMC, Migraine, Myenteric plexus, Chemistry, P.C, Therapy, FDA, Food, Pharmaceutical industry

Our investigation concerns whether the board of directors of Axsome have breached their fiduciary duties to the company.

Key Points: 
  • Our investigation concerns whether the board of directors of Axsome have breached their fiduciary duties to the company.
  • Axsome is a biopharmaceutical company that engages in the development of novel therapies for central nervous system disorders in the United States.
  • However, unbeknownst to investors, the Company’s preparation and eventual submission of the AXS-07 NDA was plagued with chemistry, manufacturing, and control (“CMC”) issues.
  • Then, on April 25, 2022, Axsome disclosed in a filing with the U.S. Securities and Exchange Commission that, “[o]n April 22, 2022, Axsome .

Basilea announces US FDA approval of antibiotic ZEVTERA® (ceftobiprole medocaril) for three indications

Retrieved on: 
목요일, 4월 4, 2024
Disease, MSSA, MRSA, Development, TARGET, Associate, Partnership, CABP, New Drug Application, Patient, HHS, Mortality, NDA, Fungal infection, Staphylococcus aureus, Bronchopneumonia, Infection, Safety, SAB, ASPR, Staphylococcus, Ceftobiprole, Administration, FDA, ABSSSI, Pharmaceutical industry

David Veitch, Chief Executive Officer of Basilea, said: “We are excited with the US approval of ZEVTERA.

Key Points: 
  • David Veitch, Chief Executive Officer of Basilea, said: “We are excited with the US approval of ZEVTERA.
  • The positive decision by the FDA is a key milestone towards bringing ZEVTERA to patients in the US.
  • This approval is a landmark for ceftobiprole and reflects its broad clinical utility.
  • Through this partnership, Basilea has been awarded approximately USD 112 million, or approximately 75 percent of the costs related to the SAB and ABSSSI phase 3 studies, regulatory activities and non-clinical work.

ARS Pharmaceuticals Submits Response to FDA Complete Response Letter for neffy® (Epinephrine Nasal Spray)

Retrieved on: 
수요일, 4월 3, 2024
Nitrosamine, Anaphylaxis, Symantec Endpoint Protection, Entrepreneurship, ARS, Caregiver, NAC, PD, New Drug Application, Patient, Adrenaline, CRL, Allergy, NDA, Food, FDA, PDUFA, Pharmaceutical industry

In February 2024, ARS Pharma announced the successful completion of the repeat dosing study of neffy in seasonal allergic rhinitis under NAC conditions.

Key Points: 
  • In February 2024, ARS Pharma announced the successful completion of the repeat dosing study of neffy in seasonal allergic rhinitis under NAC conditions.
  • ARS Pharma also completed the nitrosamine testing requested with no measurable levels of nitrosamines detected.
  • In May 2023, the FDA Advisory Committee (PADAC) determined a favorable benefit-risk profile for neffy (16:6 for adults and 17:5 for children).
  • ARS Pharma anticipates an FDA review period of up to six months, and the PDUFA date is anticipated to be October 2, 2024, based on the submission receipt date of April 2, 2024.

HUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fruquintinib Combination with Sintilimab for the Treatment of Advanced Endometrial Cancer with Priority Review Status

Retrieved on: 
화요일, 4월 2, 2024
Toxicity, Radiation, Sintilimab, NMPA, Endometrial cancer, Disease, DCR, New Drug Application, Patient, NDA, Breakthrough therapy, Senior, Priority review, HKEX, Dor, IRC, Prognosis, PFS, Pharmaceutical industry

HONG KONG, SHANGHAI, China & FLORHAM PARK, N.J., April 02, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) and Innovent Biologics, Inc. (“Innovent”) (HKEX:1801) today jointly announce that the New Drug Application (“NDA”) for the combination of fruquintinib and sintilimab for the treatment of patients with advanced endometrial cancer with pMMR1 or non-MSI-H2 tumors that have failed prior systemic therapy but are not candidates for curative surgery or radiation has been accepted and granted priority review by the China National Medical Products Administration (“NMPA”).

Key Points: 
  • The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase II study investigating fruquintinib in combination with sintilimab in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity with treatment on platinum-based doublet chemotherapy.
  • Data from FRUSICA-1 will be submitted for presentation at an upcoming medical conference.
  • “This is the first regulatory filing for the combination of fruquintinib and the immune checkpoint inhibitor sintilimab.
  • “Endometrial cancer remains one of the most common gynecological malignancies.

Cingulate Inc. Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Clinical and Business Update

Retrieved on: 
월요일, 4월 1, 2024
Research, ADHD, Psych, NDA, Sale, Cingulata, Attention deficit hyperactivity disorder, Insurance, IND, Market, Adolescence, Safety, Clutch (eggs), Poster, WFIA, FDA, Security (finance)

KANSAS CITY, Kan., April 01, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced its financial results for the twelve months ended December 31, 2023, and provided a clinical and business update. Highlights include capital raised from multiple sources and the addition of three independent board members.

Key Points: 
  • “Our lead asset CTx-1301 continues to impress clinical investigators and key opinion leaders as we share our Phase 3 results.
  • These tailwinds put Cingulate in a position to obtain non-dilutive capital and expand our pipeline of assets.
  • Looking ahead, Cingulate has several financial instruments in place to raise additional capital while fighting to preserve shareholder’s equity.
  • “Overall, I am very pleased with the progress made by our team in 2023 and into 2024.

Update on Favorable Legal and Regulatory Outcomes Clearing Path for Potential FDA approval of YUTREPIA™ (treprostinil) inhalation powder

Retrieved on: 
월요일, 4월 1, 2024
UTHR, District court, Pulmonary hypertension, United Therapeutics, NDA, Motion, Originality, Orthostatic hypertension, Therapy, Patent, PAH, FDA, Court, Hearing, Food

As a result, the U.S. Food and Drug Administration (FDA) is no longer enjoined from issuing final approval of Liquidia’s New Drug Application (NDA) for YUTREPIA™ (treprostinil) inhalation powder.

Key Points: 
  • As a result, the U.S. Food and Drug Administration (FDA) is no longer enjoined from issuing final approval of Liquidia’s New Drug Application (NDA) for YUTREPIA™ (treprostinil) inhalation powder.
  • We have submitted the judge’s order to the FDA and look forward to a decision from the FDA in the near future.
  • Our commercial team is fully prepared to launch YUTREPIA in both PAH and PH-ILD should the FDA grant final approval.
  • The FDA is now able to take final action on YUTREPIA’s amended NDA that seeks approval for both indications.

Zevra Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Updates

Retrieved on: 
목요일, 3월 28, 2024
Narcolepsy, Exercise, Somnolence, New Drug Application, Patient, Visual analogue scale, Sale, NDA, G&A, Arimoclomol, Nature, IND, Bank statement, Microsoft Access, Investment, Therapy, Priority review, Corporation, Audit committee, Research, Niemann–Pick disease, Medical science liaison, Sleep disorder, Brain, Trial of the century, Safety, Interim, Food, Sleep, QuickStart, Disease, FY, Acquisition, Emetine, UCD, COL3A1, Celiprolol, Syndrome, FDA, Marketing, Conference call, Conference, EAP, SDX, NPC, Epworth Sleepiness Scale, Idiopathic hypersomnia, Physician, PDUFA, Pharmaceutical industry

CELEBRATION, Fla., March 28, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the fourth quarter and year ended December 31, 2023. 

Key Points: 
  • ET
    CELEBRATION, Fla., March 28, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the fourth quarter and year ended December 31, 2023.
  • “We made solid progress on our key priorities in 2023,” said Neil F. McFarlane, President and Chief Executive Officer of Zevra.
  • Overview of Q4 2023 and FY 2023 Financial Results:
    Net revenue for Q4 2023 was $13.2 million, compared to prior year Q4 net revenue of $2.2 million.
  • ET, to discuss its corporate and financial results for Q4 and FY 2023.