Oncology Drug Advisory Committee

Bragar Eagel & Squire, P.C. Is Investigating Clariant, TG Therapeutics, Coinbase, and GoodRx and Encourages Investors to Contact the Firm

Retrieved on: 
Tuesday, May 17, 2022
Follicular lymphoma, Company, Shanda, Oncology Drug Advisory Committee, Regulation of tobacco by the U.S. Food and Drug Administration, Fraud, Food, Chronic lymphocytic leukemia, News, Patient, NASDAQ, Umbralisib, Therapy, Review, Lymphocytosis, Adult, BLA, FDA, GoodRx, The Nuts & Bolts of PBM, ODAC, CLL, SLL, Letter, TG, GLOBE, Pharmaceutical industry, Medical device, Audit, Renewable energy, U2, P.C, Clariant, Coinbase

Our investigations concern whether these companies have violated the federal securities laws and/or engaged in other unlawful business practices.

Key Points: 
  • Our investigations concern whether these companies have violated the federal securities laws and/or engaged in other unlawful business practices.
  • On this news, shares of Clariant AG ADR shares fell more than 14% in intraday trading on February 14, 2022.
  • On this news, TG Therapeutics' stock price fell $8.16 per share, or 34.93%, to close at $15.20 per share on November 30, 2021.
  • For more information on the TG Therapeutics investigation go to: https://bespc.com/cases/TGTX
    On May 10, 2022, Coinbase reported its first quarter 2022 results.

CRISPR Therapeutics Announces the Appointment of Phuong Khanh Morrow, M.D., FACP, as Chief Medical Officer

Retrieved on: 
Monday, May 16, 2022
Knowledge, Food, U.S. Securities and Exchange Commission, FLT3, Oncology Drug Advisory Committee, Form 10-K, Hemoglobinopathy, University, Private Securities Litigation Reform Act, SEC, Assistant professor, Regenerative medicine, Cas9, KRAS, ARS, Therapy, Degenerative disease, Clinical trial, Amgen, Growth, GLOBE, Department, DNA, Vertex Pharmaceuticals, Uncertainty, Coronavirus, Gene editing, MD Anderson Cancer Center, FDA, ODAC, Internal medicine, CRISPR, Monroe Dunaway Anderson, CRSP, Employment, Risk, Regulation of tobacco by the U.S. Food and Drug Administration, Annual report, Leadership, Patient, FACP, Baylor University, Industry, Global, Technology, CRISPR Therapeutics, Bayer, Medical device, Pharmaceutical industry, Hematology, Pharmacy

Morrow, M.D., FACP, as Chief Medical Officer, effective May 23, 2022.

Key Points: 
  • Morrow, M.D., FACP, as Chief Medical Officer, effective May 23, 2022.
  • I am excited to join CRISPR Therapeutics leadership team at this important time in its growth and evolution, said Dr. Phuong Khanh (P.K.)
  • CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform.
  • CRISPR THERAPEUTICS word mark and design logo are registered trademarks of CRISPR Therapeutics AG.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of TG Therapeutics, Inc. - TGTX

Retrieved on: 
Thursday, April 28, 2022
Adult, Patient, FDA, GLOBE, Pomerantz, Therapy, Follicular lymphoma, Umbralisib, Food, Lymphocytosis, LLP, Oncology Drug Advisory Committee, Company, ODAC, BLA, News, CLL, TG, Chronic lymphocytic leukemia, Shanda, SLL, NASDAQ, Review, Regulation of tobacco by the U.S. Food and Drug Administration, U2

NEW YORK, April 28, 2022 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of TG Therapeutics, Inc. (TG Therapeutics or the Company) (NASDAQ: TGTX).

Key Points: 
  • NEW YORK, April 28, 2022 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of TG Therapeutics, Inc. (TG Therapeutics or the Company) (NASDAQ: TGTX).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether TG Therapeutics 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.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of TG Therapeutics, Inc. - TGTX

Retrieved on: 
Wednesday, April 20, 2022
SLL, News, LLP, CLL, Chronic lymphocytic leukemia, Adult, Lymphocytosis, Oncology Drug Advisory Committee, NASDAQ, Regulation of tobacco by the U.S. Food and Drug Administration, Food, TG, GLOBE, Company, Patient, Shanda, Review, ODAC, Pomerantz, Umbralisib, FDA, BLA, Therapy, Follicular lymphoma, U2

NEW YORK, April 19, 2022 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of TG Therapeutics, Inc. (TG Therapeutics or the Company) (NASDAQ: TGTX).

Key Points: 
  • NEW YORK, April 19, 2022 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of TG Therapeutics, Inc. (TG Therapeutics or the Company) (NASDAQ: TGTX).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether TG Therapeutics 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.

TG Therapeutics Announces Voluntary Withdrawal of the BLA/sNDA for U2 to Treat Patients with CLL and SLL

Retrieved on: 
Friday, April 15, 2022
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The Companys decision to withdraw UKONIQ from sale was primarily based on the withdrawal of the BLA and sNDA for U2 in CLL.

Key Points: 
  • The Companys decision to withdraw UKONIQ from sale was primarily based on the withdrawal of the BLA and sNDA for U2 in CLL.
  • The trial met its primary endpoint, with U2 significantly prolonging independent review committee (IRC) assessed progression-free survival (PFS) vs. the control arm.
  • Based on the results of the UNITY-CLL trial, a BLA and sNDA were submitted to the FDA for U2 to treat patients with CLL/SLL.
  • To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Update Call.

TG Therapeutics Announces Scheduling of Planned Oncologic Drug Advisory Committee Meeting

Retrieved on: 
Thursday, March 10, 2022
ODAC, Commissioner, NASDAQ, Safety, SPA, IRC, BLA, Adult, CLL, Company, Shanda, Survival, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Umbralisib, Cancer, TG, Biologics license application, Food and Drug Administration Amendments Act of 2007, Death, Oncology Drug Advisory Committee, PDUFA, SLL, Chronic lymphocytic leukemia, GLOBE, Prescription Drug User Fee Act, PFS, Patient, Progression-free survival, COVID-19, Lymphocytosis, Follicular lymphoma, Therapy, Trial of the century, OS, Review, Pharmaceutical industry, Dietary supplement, U2, Food

Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm .

Key Points: 
  • Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm .
  • The FDAs concern giving rise to the ODAC meeting appears to stem from an early analysis of overall survival from the UNITY-CLL trial.
  • FDA considered the updated OS data a substantial amendment and extended the PDUFA date for the BLA/sNDA to June 25, 2022.
  • The UNITY-CLL Phase 3 trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).

TG Therapeutics Announces Extension of U.S. FDA BLA/sNDA PDUFA Date for Ublituximab Plus UKONIQ® (U2) to Treat Patients with CLL and SLL

Retrieved on: 
Thursday, March 3, 2022
Progression-free survival, PFS, Shanda, Regulation of tobacco by the U.S. Food and Drug Administration, BLA, Patient, TG, IRC, Death, Oncology Drug Advisory Committee, Food and Drug Administration Amendments Act of 2007, Biologics license application, Safety, ODAC, Lymphocytosis, PDUFA, Chronic lymphocytic leukemia, FDA, New Drug Application, Therapy, Survival, SLL, Company, Prescription Drug User Fee Act, COVID-19, Time, Cancer, SPA, Commissioner, Follicular lymphoma, Review, Umbralisib, CLL, Trial of the century, GLOBE, NASDAQ, Pharmaceutical industry, Medical device, Dietary supplement, Food, U2

Mr. Weiss continued, We continue to believe in the potential of U2 to provide a meaningful treatment option to patients with CLL and SLL.

Key Points: 
  • Mr. Weiss continued, We continue to believe in the potential of U2 to provide a meaningful treatment option to patients with CLL and SLL.
  • As part of the ongoing review of the BLA/sNDA, the FDA requested an early analysis of overall survival from the UNITY-CLL trial.
  • In February 2022, the Company submitted updated overall survival data with the same September 2021 cut-off date.
  • Withhold UKONIQ in patients with suspected PJP of any grade and permanently discontinue in patients with confirmed PJP.

Triple-Negative Breast Cancer Disease Market Analysis Report 2021-2027 - Keytruda will Overtake Tecentriq in the TNBC Market - ResearchAndMarkets.com

Retrieved on: 
Friday, January 28, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Growth, Patient, Triple-negative breast cancer, Breast cancer, PTEN, HER2, Roche, Probability, PARP, Oncology Drug Advisory Committee, Immunotherapy, CXCR4, Patent, Pembrolizumab, Talazoparib, Cancer Drugs Fund, TNBC, Biomarker, Hypersensitivity, Chugai Pharmaceutical Co., PIK3CA, Fast Track, Paclitaxel, Phase, Protein kinase B, FDA, Bevacizumab, Pharmaceutical industry, Atezolizumab, Sacituzumab govitecan, EU

The publisher estimates that in 2018, there were 2.1 million incident cases and 8.6 million five-year prevalent cases of breast cancer worldwide.

Key Points: 
  • The publisher estimates that in 2018, there were 2.1 million incident cases and 8.6 million five-year prevalent cases of breast cancer worldwide.
  • By 2027, incident and five-year prevalent cases of breast cancer are expected to increase to 2.3 million and 9.3 million cases, respectively.
  • The market for TNBC is also becoming increasingly segmented by biomarker status, creating fierce competition among both approved and pipeline therapies for small patient populations.
  • Breast cancer drugs, on average, take 9.7 years from Phase I to approval, compared to 9.6 years in the overall oncology space.

TG THERAPEUTICS ALERT: Bragar Eagel & Squire, P.C. is Investigating TG Therapeutics, Inc. on Behalf of TG Therapeutics Stockholders and Encourages Investors to Contact the Firm

Retrieved on: 
Tuesday, December 28, 2021
BLA, P.C, Company, ODAC, Chronic lymphocytic leukemia, Shanda, Umbralisib, Oncology Drug Advisory Committee, Telephone, FDA, Therapy, Follicular lymphoma, Food, Regulation of tobacco by the U.S. Food and Drug Administration, Review, Adult, TG, NASDAQ, CLL, News, SLL, Patient, GLOBE, U2

NEW YORK, Dec. 27, 2021 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, is investigating potential claims against TG Therapeutics, Inc. (TG Therapeutics or the Company) (NASDAQ: TGTX) on behalf of TG Therapeutics stockholders.

Key Points: 
  • NEW YORK, Dec. 27, 2021 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, is investigating potential claims against TG Therapeutics, Inc. (TG Therapeutics or the Company) (NASDAQ: TGTX) on behalf of TG Therapeutics stockholders.
  • Our investigation concerns whether TG Therapeutics has violated the federal securities laws and/or engaged in other unlawful business practices.
  • Click here to participate in the action.
  • On this news, TG Therapeutics stock price fell $8.16 per share, or 34.93%, to close at $15.20 per share on November 30, 2021.

TG THERAPEUTICS ALERT: Bragar Eagel & Squire, P.C. is Investigating TG Therapeutics, Inc. on Behalf of TG Therapeutics Stockholders and Encourages Investors to Contact the Firm

Retrieved on: 
Thursday, December 23, 2021
SLL, Oncology Drug Advisory Committee, ODAC, Umbralisib, Patient, News, Regulation of tobacco by the U.S. Food and Drug Administration, CLL, Telephone, NASDAQ, TG, Review, Follicular lymphoma, Adult, Shanda, BLA, Company, Chronic lymphocytic leukemia, Therapy, P.C, Food, GLOBE, FDA, U2

NEW YORK, Dec. 22, 2021 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, is investigating potential claims against TG Therapeutics, Inc. (TG Therapeutics or the Company) (NASDAQ: TGTX) on behalf of TG Therapeutics stockholders.

Key Points: 
  • NEW YORK, Dec. 22, 2021 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, is investigating potential claims against TG Therapeutics, Inc. (TG Therapeutics or the Company) (NASDAQ: TGTX) on behalf of TG Therapeutics stockholders.
  • Our investigation concerns whether TG Therapeutics has violated the federal securities laws and/or engaged in other unlawful business practices.
  • Click here to participate in the action.
  • On this news, TG Therapeutics stock price fell $8.16 per share, or 34.93%, to close at $15.20 per share on November 30, 2021.