CRL

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Checkpoint Therapeutics, Inc. - CKPT  

Retrieved on: 
Friday, December 22, 2023
Marketing, Checkpoint, Food, LLP, CKPT, News, Pomerantz, CRL, Prior, Patient, Radiation

NEW YORK, Dec. 22, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of Checkpoint Therapeutics, Inc. (“Checkpoint” or the “Company”) (NASDAQ: CKPT).

Key Points: 
  • NEW YORK, Dec. 22, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of Checkpoint Therapeutics, Inc. (“Checkpoint” or the “Company”) (NASDAQ: CKPT).
  • The investigation concerns whether Checkpoint 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.

U.S. Food and Drug Administration Issues Complete Response Letter for Cosibelimab Solely Due to Inspection Findings at Third-Party Manufacturer

Retrieved on: 
Monday, December 18, 2023
Marketing, Regulation, Food, Risk, Research, Chemistry, FDA, CKPT, Clinical trial, Patent, COVID-19, CRL, Patient, Safety, Radiation, Annual report

The CRL only cites findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization as approvability issues to address in a resubmission.

Key Points: 
  • The CRL only cites findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization as approvability issues to address in a resubmission.
  • The CRL did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab.
  • Any forward-looking statements set forth in this press release speak only as of the date of this press release.
  • The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

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

Retrieved on: 
Tuesday, December 12, 2023
Telephone, Psychiatry, Dementia, Acadia Pharmaceuticals, Shanda, Symantec Endpoint Protection, FDA, Complaint, DSM-IV codes, News, P.C, CRL, Schizophrenia, ACAD, Patient

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

Key Points: 
  • Our investigation concerns whether the board of directors of Acadia have breached their fiduciary duties to the company.
  • Acadia is a biopharmaceutical company that focuses on the development and commercialization of small molecule drugs that address unmet medical needs in central nervous system disorders.
  • The Company is developing pimavanserin as a treatment for dementia-related psychosis and as an adjunctive treatment for schizophrenia, as well as an adjunctive treatment for major depressive disorder.
  • The complaint, filed on April 19, 2021, alleges that throughout the Class Period defendants made materially false and misleading statements regarding the Company’s business, operations, and compliance policies.

ACADIA SHAREHOLDER ALERT: Kaskela Law LLC Announces Investigation of Acadia Pharmaceuticals, Inc. (NASDAQ: ACAD) and Encourages Long-Term ACAD Investors to Contact the Firm

Retrieved on: 
Sunday, December 10, 2023
Psychiatry, Food, Dementia, Shanda, Symantec Endpoint Protection, FDA, Acquisition, Complaint, News, New Drug Application, CRL, ACAD, Patient, Pharmaceutical industry

PHILADELPHIA, Dec. 10, 2023 (GLOBE NEWSWIRE) -- Kaskela Law LLC announces that it is investigating Acadia Pharmaceuticals Inc. (“Acadia”) (NASDAQ: ACAD) on behalf the company’s long-term investors.

Key Points: 
  • PHILADELPHIA, Dec. 10, 2023 (GLOBE NEWSWIRE) -- Kaskela Law LLC announces that it is investigating Acadia Pharmaceuticals Inc. (“Acadia”) (NASDAQ: ACAD) on behalf the company’s long-term investors.
  • According to the complaint, Acadia’s most valuable drug from a commercial perspective is pimavanserin, which Acadia touts as a treatment for dementia-related psychosis (“DRP”).
  • Current Acadia stockholders who purchased or acquired shares of the company’s common stock prior to September 9, 2019 are encouraged to contact Kaskela Law LLC (D. Seamus Kaskela, Esq.
  • Kaskela Law LLC exclusively represents investors in securities fraud, corporate governance, and merger & acquisition litigation on a contingent basis.

Outlook Therapeutics® Announces Strategic Organizational Realignment

Retrieved on: 
Wednesday, December 6, 2023
Senior, SPA, Ranibizumab, Partnership, Food, Senior advisor, Symantec Endpoint Protection, Marketing, FDA, MAA, EMA, Acquisition, Type, Retina, CMC, Therapy, Bevacizumab, Calendar, European Medicines Agency, CRL, Committee, Patient, Food and Drug Administration, CHMP, BLA

Effective immediately, Joel Prieve, formerly the Senior Vice President of Commercial Operations, has been appointed to the role of Senior Vice President of Licensing and M&A.

Key Points: 
  • Effective immediately, Joel Prieve, formerly the Senior Vice President of Commercial Operations, has been appointed to the role of Senior Vice President of Licensing and M&A.
  • Previously, Outlook Therapeutics announced the addition of Jedd Comiskey as Senior Vice President – Head of Europe to focus on potential commercial launch and commercial partnership opportunities for ONS-5010 in the EU, if approved.
  • As previously reported, Outlook Therapeutics is working with the FDA to design an additional adequate and well-controlled clinical trial to support the planned ONS-5010 BLA resubmission.
  • Outlook Therapeutics also submitted a Marketing Authorization Application (MAA) in Europe, which was validated for review in December 2022.

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

Retrieved on: 
Tuesday, December 5, 2023
Dollar, Risk, Primate, Class, LLP, Wildfire, Justice minister, Dollar General, CRL, 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.

Investigation Alert FedEx, Charles River, Acadia Healthcare, and Hawaiian Electric: Johnson Fistel, LLP Encourages Long-Term Investors to Submit Their Information Below

Retrieved on: 
Tuesday, November 28, 2023
FDX, Risk, FedEx, Primate, LLP, Wildfire, Justice minister, CRL, Pharmaceutical industry

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

Key Points: 
  • Johnson Fistel, LLP is investigating potential claims on behalf of FedEx Corporation (NYSE: FDX) 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.
  • In some cases, the issues would be so severe, the vans were useless and businesses went bust.
  • Johnson Fistel, LLP is investigating potential claims on behalf of Charles River Laboratories International, Inc. (NYSE: CRL) against certain of its officers and directors.

Outlook Therapeutics® Announces Receipt of Type A Meeting Minutes and Reiterates Regulatory Path Forward for ONS-5010

Retrieved on: 
Monday, November 27, 2023
SPA, Ranibizumab, Food, Division, Outlook, Symantec Endpoint Protection, FDA, Retina, Type, CMC, AMD, Biologics license application, Therapy, Clinical trial, Bevacizumab, Calendar, CRL, Patient, BLA, Pharmaceutical industry

As previously reported, the FDA requires an additional adequate and well-controlled study to support the ONS-5010 BLA.

Key Points: 
  • As previously reported, the FDA requires an additional adequate and well-controlled study to support the ONS-5010 BLA.
  • As recommended by the FDA at the Type A meeting, Outlook Therapeutics has been working with the Division of Ophthalmology to design an appropriate study to satisfy the FDA’s requirements.
  • The FDA and Outlook Therapeutics have also identified the approaches needed to resolve the CMC comments in the CRL.
  • Based on the October Type A meeting and ongoing informal discussions with the FDA, Outlook Therapeutics has submitted a protocol for review at an upcoming Type A meeting with the FDA in December 2023.

Investigation Alert FedEx, Charles River, Acadia Healthcare, and Hawaiian Electric: Johnson Fistel, LLP Encourages Long-Term Investors to Submit Their Information Below

Retrieved on: 
Wednesday, November 22, 2023
FDX, Risk, FedEx, Primate, LLP, Wildfire, Justice minister, CRL, Pharmaceutical industry

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

Key Points: 
  • Johnson Fistel, LLP is investigating potential claims on behalf of FedEx Corporation (NYSE: FDX) 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.
  • In some cases, the issues would be so severe, the vans were useless and businesses went bust.
  • Johnson Fistel, LLP is investigating potential claims on behalf of Charles River Laboratories International, Inc. (NYSE: CRL) against certain of its officers and directors.

Merck Provides U.S. Regulatory Update on Gefapixant

Retrieved on: 
Wednesday, December 20, 2023
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, MSD, Food, UCC, Symantec Endpoint Protection, Chronic cough, NDA, Clinical trial, Asthma, Knowledge, P2X3, Merck & Co., Gastroesophageal reflux disease, RCC, CRL, Patient, Safety, MRK, Pharmaceutical industry

In the CRL, the FDA concluded that Merck’s application did not meet substantial evidence of effectiveness for treating RCC and UCC.

Key Points: 
  • In the CRL, the FDA concluded that Merck’s application did not meet substantial evidence of effectiveness for treating RCC and UCC.
  • The CRL was not related to the safety of gefapixant.
  • Merck is reviewing the FDA’s feedback to determine next steps.
  • “Acknowledging the absence of any approved treatments for refractory or unexplained chronic cough, we are disappointed in the FDA’s response to our application for gefapixant.”