Symantec Endpoint Protection

PharmaTher Provides Update of its Priority Original Abbreviated New Drug Application for Ketamine

Retrieved on: 
Dienstag, April 16, 2024
Pain, FDA, Hospital, Food, Health Canada, Depression, Quality, Suicidal ideation, Ketamine, Anesthesia, Mental health, Symantec Endpoint Protection, DSM-IV codes, Anxiety, Pharmaceutical industry

TORONTO, April 16, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, provides an update of its Priority Original Abbreviated New Drug Application (“ANDA”) for Ketamine that was accepted by the U.S. Food and Drug Administration (the “FDA”) and assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of April 29, 2024.

Key Points: 
  • TORONTO, April 16, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, provides an update of its Priority Original Abbreviated New Drug Application (“ANDA”) for Ketamine that was accepted by the U.S. Food and Drug Administration (the “FDA”) and assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of April 29, 2024.
  • The Company is prepared to address potential FDA requests and concerns immediately and will update shareholders as they occur.
  • Ketamine has been on the FDA’s drug shortage list since February 2018, which is believed to have encouraged the widespread availability of compounded ketamine products not FDA approved for psychiatric disorders.
  • A recently published new peer-reviewed study on the real-world effectiveness of ketamine intravenous therapy demonstrated significant patient improvement for depression, anxiety and suicidal ideation.

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

Retrieved on: 
Freitag, April 12, 2024
FDA, News, NDA, Food, Myenteric plexus, P.C, Chemistry, CMC, Symantec Endpoint Protection, Migraine, CRL, Therapy, Telephone, 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 .

INVESTOR ALERT: Law Offices of Howard G. Smith Announces Investigation of Abeona Therapeutics Inc. (ABEO) on Behalf of Investors

Retrieved on: 
Donnerstag, Mai 2, 2024
Class Action Lawsuit, Professional Services, Legal, Suite, FDA, CRL, Telephone, CMC, News, Symantec Endpoint Protection

Law Offices of Howard G. Smith announces an investigation on behalf of Abeona Therapeutics Inc. (“Abeona” or the “Company”) (NASDAQ: ABEO ) investors concerning the Company’s possible violations of federal securities laws.

Key Points: 
  • Law Offices of Howard G. Smith announces an investigation on behalf of Abeona Therapeutics Inc. (“Abeona” or the “Company”) (NASDAQ: ABEO ) investors concerning the Company’s possible violations of federal securities laws.
  • If you purchased Abeona securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847 or by email to [email protected] , or visit our website at www.howardsmithlaw.com .
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
  • View source version on businesswire.com: https://www.businesswire.com/news/home/20240501940982/en/

INVESTOR ALERT: Law Offices of Howard G. Smith Announces Investigation of Supernus Pharmaceuticals, Inc. (SUPN) on Behalf of Investors

Retrieved on: 
Donnerstag, Mai 2, 2024
Class Action Lawsuit, Professional Services, Legal, Suite, FDA, CRL, Telephone, News, Symantec Endpoint Protection

Law Offices of Howard G. Smith announces an investigation on behalf of Supernus Pharmaceuticals, Inc. (“Supernus” or the “Company”) (NASDAQ: SUPN ) investors concerning the Company’s possible violations of federal securities laws.

Key Points: 
  • Law Offices of Howard G. Smith announces an investigation on behalf of Supernus Pharmaceuticals, Inc. (“Supernus” or the “Company”) (NASDAQ: SUPN ) investors concerning the Company’s possible violations of federal securities laws.
  • On April 8, 2024, Supernus announced that the FDA had issued a Complete Response Letter (“CRL”) in response to the Company’s New Drug Application for its Parkinson’s disease treatment, SPN-830.
  • On this news, Supernus’s stock price fell $2.12, or 6.3%, to close at $31.43 per share on April 8, 2024, thereby injuring investors.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

The Law Offices of Frank R. Cruz Announces Investigation of Supernus Pharmaceuticals, Inc. (SUPN) on Behalf of Investors

Retrieved on: 
Dienstag, April 30, 2024
Class Action Lawsuit, Professional Services, Legal, Suite, FDA, Law, CRL, News, Symantec Endpoint Protection

The Law Offices of Frank R. Cruz announces an investigation of Supernus Pharmaceuticals, Inc. (“Supernus” or the “Company”) (NASDAQ: SUPN ) on behalf of investors concerning the Company’s possible violations of federal securities laws.

Key Points: 
  • The Law Offices of Frank R. Cruz announces an investigation of Supernus Pharmaceuticals, Inc. (“Supernus” or the “Company”) (NASDAQ: SUPN ) on behalf of investors concerning the Company’s possible violations of federal securities laws.
  • On April 8, 2024, Supernus announced that the FDA had issued a Complete Response Letter (“CRL”) in response to the Company’s New Drug Application for its Parkinson’s disease treatment, SPN-830.
  • On this news, Supernus’s stock price fell $2.12, or 6.3%, to close at $31.43 per share on April 8, 2024, thereby injuring investors.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

The Law Offices of Frank R. Cruz Announces Investigation of Abeona Therapeutics Inc. (ABEO) on Behalf of Investors

Retrieved on: 
Dienstag, April 30, 2024
Professional Services, Class Action Lawsuit, Suite, FDA, Law, CRL, CMC, News, Symantec Endpoint Protection

The Law Offices of Frank R. Cruz announces an investigation of Abeona Therapeutics Inc. (“Abeona” or the “Company”) (NASDAQ: ABEO ) on behalf of investors concerning the Company’s possible violations of federal securities laws.

Key Points: 
  • The Law Offices of Frank R. Cruz announces an investigation of Abeona Therapeutics Inc. (“Abeona” or the “Company”) (NASDAQ: ABEO ) on behalf of investors concerning the Company’s possible violations of federal securities laws.
  • If you are a shareholder who suffered a loss, click here to participate.
  • If you inquire by email please include your mailing address, telephone number, and number of shares purchased.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

MaaT Pharma Presents Positive 18-month Data for MaaT013 Showing a Clear Overall Survival Advantage in aGvHD from the Early Access Program at the 2024 EBMT Event

Retrieved on: 
Montag, April 15, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, FDA, EAP, Cancer, MET, Hospital, Hematology, Food, Sorbonne University, Survival, Orphan, OS, DSMB, Disease, Rated R, Patient, ARES, D28, EMA, Symantec Endpoint Protection, Hematopoietic stem cell transplantation, EBMT, Toxicity, European Medicines Agency, Data monitoring committee, Pharmaceutical industry

Prof. Malard commented: “MaaT013 shows remarkable efficacy at 18 months, yielding more complete responses in aGvHD patients who have shown resistance to current treatments, as compared to other available therapies.

Key Points: 
  • Prof. Malard commented: “MaaT013 shows remarkable efficacy at 18 months, yielding more complete responses in aGvHD patients who have shown resistance to current treatments, as compared to other available therapies.
  • Notably, these results are achieved with just 3 doses in less than 2 weeks of treatment initiation.
  • The data presented highlights the strong safety profile of MaaT013 (full details here ) and translates into increased OS.
  • MaaT Pharma also presented its ongoing Phase 2b trial design for MaaT033 developed as an adjunctive therapy to enhance OS in allogeneic hematopoietic stem cell transplantation.

Supernus Provides Regulatory Update for SPN-830

Retrieved on: 
Montag, April 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.

IntelGenx Updates Status of Buprenorphine Buccal Film ANDA

Retrieved on: 
Freitag, April 5, 2024
Symantec Endpoint Protection, CRL, IGX, Chronic pain, Buprenorphine, TSX, FDA, Food, Pharmaceutical industry

SAINT LAURENT, Quebec, April 05, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the “Company” or “IntelGenx”) today announced that its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC (“Xiromed”), has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its resubmitted abbreviated new drug application (“ANDA”) for Buprenorphine Buccal Film.

Key Points: 
  • SAINT LAURENT, Quebec, April 05, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the “Company” or “IntelGenx”) today announced that its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC (“Xiromed”), has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its resubmitted abbreviated new drug application (“ANDA”) for Buprenorphine Buccal Film.
  • The CRL includes a request for additional Pharmaceutical Quality information.
  • Buprenorphine Buccal Film, which incorporates IntelGenx’s VersaFilm® technology in a novel formulation, is a generic version of Belbuca®, an opioid that is used to manage chronic pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments are inadequate.
  • Approved by the FDA in 2015, Belbuca® is applied to the oral or buccal mucosa every 12 hours and comes in seven strengths ranging from 0.075 mg to 0.9 mg.

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

Retrieved on: 
Donnerstag, April 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 .