CRL

Vanda Pharmaceuticals Announces FDA Update for supplemental NDA for HETLIOZ® in the Treatment of Insomnia

Retrieved on: 
Wednesday, March 6, 2024
Symantec Endpoint Protection, FDA, Food, Shanda, CRL, New Drug Application, Insomnia, Vanda, Pharmaceutical industry

In July 2023, the FDA had assigned a Prescription Drug User Fee Act target date of March 4, 2024 for the completion of its review of the sNDA.

Key Points: 
  • In July 2023, the FDA had assigned a Prescription Drug User Fee Act target date of March 4, 2024 for the completion of its review of the sNDA.
  • As previously reported, on February 4, 2024, the FDA provided a notification stating that it identified deficiencies that precluded discussion of labeling and postmarketing requirements/commitments.
  • Consistent with that notification, the FDA has issued a CRL, indicating that the FDA cannot approve the sNDA in its present form.
  • Vanda is reviewing the CRL and evaluating its next steps.

Wheeler Bio Seals Agreement with Charles River to Offer Portable CMC® to Discovery Clients to Accelerate Their Journey to First-in-Human Use

Retrieved on: 
Thursday, February 29, 2024
Investigational New Drug, CRL, Charles River Laboratories, LEAP, Entrepreneurship, OK, ATUM, Chemistry, CDMO, Safety, CHO, CGMP, Organization, Portable, Control, IND, CMC, Partnership, Pharmaceutical industry

The collaboration is designed to enable a swift transition from pre-clinical stages directly to human clinical trials.

Key Points: 
  • The collaboration is designed to enable a swift transition from pre-clinical stages directly to human clinical trials.
  • Combining Charles River's industry-leading experience in antibody discovery services, safety, and analytics with Wheeler's Portable CMC® platform will accelerate therapeutic discovery to Investigational New Drug (IND) submission timelines.
  • Wheeler Bio's mission is to solve translational challenges inherent in advancing from discovery to CMC development and early-clinical trial material supply.
  • Jesse McCool, CEO and Co-Founder of Wheeler Bio, stated, "Wheeler is excited to expand our relationship with Charles River and to link with their discovery organization.

Citius Pharmaceuticals Resubmits the Biologics License Application of LYMPHIR™ (Denileukin Diftitox) for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma

Retrieved on: 
Wednesday, February 14, 2024
Symantec Endpoint Protection, FDA, Food, Safety, BLA, CRL, PDUFA, CTCL, Letter, Patient

CRANFORD, N.J., Feb. 13, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today announced the resubmission of the Company's Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for LYMPHIR™ (denileukin diftitox), an IL-2-based immunotherapy for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

Key Points: 
  • The resubmission follows ongoing engagement with the FDA resulting from a Complete Response Letter (CRL) received on July 28, 2023.
  • Citius believes it has addressed enhanced product testing and additional manufacturing controls noted in the letter.
  • There were no safety or efficacy issues cited and no additional trials required.
  • Based on Center for Drug Evaluation and Research timelines, FDA acceptance of the completed resubmission package and issuance of a Prescription Drug User Fee Act (PDUFA) date is expected within 30 days of resubmission.

Outlook Therapeutics® Reports Financial Results for First Quarter Fiscal Year 2024 and Provides Corporate Update

Retrieved on: 
Wednesday, February 14, 2024
AmerisourceBergen, EMA, Injection, Committee, Fiscal, CRL, Outlook, MAA, Ranibizumab, FDA, Calendar, Completion, Bevacizumab, Symantec Endpoint Protection, Chemistry, Therapy, CHMP, European Medicines Agency, AMD, Patient, SPA, Retina, CMC

ISELIN, N.J., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve regulatory approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced financial results for first quarter fiscal year 2024 and provided a corporate update.

Key Points: 
  • ISELIN, N.J., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve regulatory approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced financial results for first quarter fiscal year 2024 and provided a corporate update.
  • Importantly, the first subject was enrolled in NORSE EIGHT in January 2024,” commented Russell Trenary, President and Chief Executive Officer.
  • In January 2024, Outlook Therapeutics announced that it received written agreement on the NORSE EIGHT trial protocol from the FDA under a SPA for NORSE EIGHT.
  • Outlook Therapeutics expects NORSE EIGHT topline results and resubmission of the ONS-5010 BLA by the end of calendar year 2024.

Charles River Laboratories Announces Fourth Quarter and Full-Year 2023 Results and Provides 2024 Guidance

Retrieved on: 
Wednesday, February 14, 2024
Biotechnology, General Health, Medical Devices, Health, Pharmaceutical, Acquisition, CRL, Drug development, Charles River Laboratories, Sale, Calendar, Discovery, CDMO, GAAP, DSA, RMS, Environment, Beauty salon

Charles River Laboratories International, Inc. (NYSE: CRL) today reported its results for the fourth-quarter and full-year 2023 and provided guidance for 2024.

Key Points: 
  • Charles River Laboratories International, Inc. (NYSE: CRL) today reported its results for the fourth-quarter and full-year 2023 and provided guidance for 2024.
  • For the quarter, revenue was $1.01 billion, a decrease of 7.9% from $1.10 billion in the fourth quarter of 2022.
  • Revenue for the RMS segment was $195.8 million in the fourth quarter of 2023, a decrease of 0.2% from $196.1 million in the fourth quarter of 2022.
  • In the fourth quarter of 2023, the DSA segment’s GAAP operating margin decreased to 20.2% from 22.7% in the fourth quarter of 2022.

FDA Accepts Xspray Pharma’s NDA-resubmission for Dasynoc® – PDUFA Date set to 31 July 2024

Retrieved on: 
Monday, February 12, 2024
Oncology, Health, FDA, Other Science, Science, Pharmaceutical, Biotechnology, Dasatinib, CRL, Food, Acute leukemia, PDUFA, Bristol Myers Squibb, BMS, Symantec Endpoint Protection, Patent, Patient, PKI, NDA, CML, Cancer, Pharmaceutical industry

The FDA has now assigned a Prescription Drug User Fee Act (PDUFA) date to 31st of July, 2024.

Key Points: 
  • The FDA has now assigned a Prescription Drug User Fee Act (PDUFA) date to 31st of July, 2024.
  • This is the FDA’s deadline for completing the approval process, marking a significant milestone for Dasynoc®, Xspray’s innovative protein kinase inhibitor (PKI) product candidate for CML treatment.
  • With an established PDUFA date set to 31st of July, Xspray Pharma continues to strategically plan for the commercial launch of Dasynoc® on September 1, 2024.
  • As the PDUFA date approaches, the company remains focused on its goal to improve the lives of those affected by CML with this novel therapy.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Theratechnologies Inc. - THTX

Retrieved on: 
Sunday, February 11, 2024
Pomerantz, CRL, Chemistry, FDA, Prior, News, Food, Microbiology, Symantec Endpoint Protection, LLP, CMC

NEW YORK, Feb. 11, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Theratechnologies Inc. (“Theratechnologies” or the “Company”) (NASDAQ: THTX).

Key Points: 
  • NEW YORK, Feb. 11, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Theratechnologies Inc. (“Theratechnologies” or the “Company”) (NASDAQ: THTX).
  • The investigation concerns whether Theratechnologies and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.
  • The Firm has recovered billions of dollars in damages awards on behalf of class members.

Amneal Announces Complete Response Resubmission for IPX203 New Drug Application

Retrieved on: 
Thursday, February 8, 2024
Food, NDA, PD, CRL, Symantec Endpoint Protection, FDA, Pharmaceutical industry

BRIDGEWATER, N.J., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced that it has provided a Complete Response resubmission to the U.S. Food and Drug Administration (FDA) for IPX203, a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules for the treatment of Parkinson’s disease (PD).

Key Points: 
  • BRIDGEWATER, N.J., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced that it has provided a Complete Response resubmission to the U.S. Food and Drug Administration (FDA) for IPX203, a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules for the treatment of Parkinson’s disease (PD).
  • The original NDA for IPX203 resulted in a Complete Response Letter (CRL) from FDA.
  • The resubmission package included data from a healthy volunteer study which was conducted in the fourth quarter of 2023.
  • “We are pleased to provide our complete response resubmission for IPX203 as we look to expand our Parkinson’s franchise,” said Chirag and Chintu Patel, Co-Chief Executive Officers at Amneal.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Theratechnologies Inc. - THTX

Retrieved on: 
Saturday, February 3, 2024
Pomerantz, Microbiology, CMC, News, CRL, FDA, Chemistry, Prior, Food, Symantec Endpoint Protection, LLP

NEW YORK, Feb. 03, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Theratechnologies Inc. (“Theratechnologies” or the “Company”) (NASDAQ: THTX).

Key Points: 
  • NEW YORK, Feb. 03, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Theratechnologies Inc. (“Theratechnologies” or the “Company”) (NASDAQ: THTX).
  • The investigation concerns whether Theratechnologies and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.
  • The Firm has recovered billions of dollars in damages awards on behalf of class members.

Investigation Alert Dollar General, Charles River, Acadia Healthcare, and Hawaiian Electric: Johnson Fistel, LLP Encourages Investors to Submit Their Information Below

Retrieved on: 
Friday, February 2, 2024
Justice minister, Class, Dollar, Wildfire, CRL, Risk, Dollar General, Primate, LLP, Pharmaceutical industry

Johnson Fistel, LLP is investigating potential claims on behalf of Dollar General Corporation (NYSE: DG) against certain of its officers and directors.

Key Points: 
  • Johnson Fistel, LLP is investigating potential claims on behalf of Dollar General Corporation (NYSE: DG) against certain of its officers and directors.
  • You may also be able to assist in reforming the Company's corporate governance to prevent future wrongdoing.
  • You can click or copy and paste the link below in a browser to join this action:
    Recently a class action lawsuit was filed against Dollar General.
  • Johnson Fistel, LLP is investigating potential claims on behalf of Charles River Laboratories International, Inc. (NYSE: CRL) against certain of its officers and directors.