Mesothelioma

Cyclacel Pharmaceuticals Reports Fadraciclib Phase 1 Data Suggesting Efficacy Against Tumors With CDKN2A, CDKN2B and MTAP Deletions

Retrieved on: 
Monday, December 18, 2023
Patient, Immunotherapy, NGS, Neoplasm, PR, CDKN2B, CDK2, Histology, Glioma, DLT, CYCC, Lung, CDK9, PLK1, Metformin, Half-life, Melanoma, Hyperglycemia, Blood, Cyclacel, Cancer, Endometrial cancer, T-cell lymphoma, Mesothelioma, Head, Laboratory, Pancreatic cancer, MTAP, Biomarker, Tablet, Lymphoma, NSCLC, Deletion, PRMT5, Neck

BERKELEY HEIGHTS, N.J., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, announced today interim results from its Phase 1, dose escalation 065-101 study of fadraciclib (“fadra”) in patients with advanced solid tumors and lymphoma.

Key Points: 
  • “The data suggest tumor sensitivity in patients with one or more of three abnormalities, CDKN2A, CDKN2B and/or MTAP deletion subject to confirmation in further studies.
  • The Phase 2 part of 065-101 is designed to evaluate fadra safety and efficacy in cohorts defined by histology and/or next generation sequencing (NGS).
  • “After retrospectively analyzing a subset of previously treated Phase 1 patients who experienced clinical benefit with fadra, we found four patients with CDKN2A, CDKN2B and/or MTAP deletions.
  • CDKN2B deletions occur in over 30% of several solid tumors, including bladder, glioma, pancreatic, esophageal, lung (incl.

Polaris Group Initiates Rolling Submission of Biologic License Application (BLA) for ADI-PEG 20 with U.S. FDA to Treat Malignant Pleural Mesothelioma

Retrieved on: 
Friday, November 17, 2023
SAN, Chemistry, Food, BLA, Pemetrexed, Patient, FDA, Medical Affairs Bureau, MPM, Mesothelioma, Biologics license application, Pharmaceutical industry

The rolling submission process allows for the submission of individual modules of the BLA as they are completed, which can streamline the regulatory review process and may expedite the potential approval timeline.

Key Points: 
  • The rolling submission process allows for the submission of individual modules of the BLA as they are completed, which can streamline the regulatory review process and may expedite the potential approval timeline.
  • Dr. John Bomalaski, Executive Vice President of Medical Affairs at Polaris Group, commented, "Our clinical trials have demonstrated promising results, with ADI-PEG 20 showing statistically significant potential to address the medical needs of patients with malignant pleural mesothelioma.
  • Howard Chen, CEO and Chairman of Polaris Group, added, "We are fully committed to addressing the urgent medical needs of patients facing malignant pleural mesothelioma.
  • Today’s submission brings us one step closer to expanding treatment options for patients impacted by MPM in the U.S.

Oncotelic Reports Q3 2023 Compared to Q3 2022 Financial Results

Retrieved on: 
Wednesday, November 15, 2023
Parkinson's disease, Pancreatic cancer, Glioma, Mesothelioma, OTCQB, Security (finance), Therapy, CFO, Disease, Patient, Artificial intelligence, PDAC, G&A, COVID-19, JV, Growth, DIPG, WalletHub, Pharmaceutical industry, Hong Kong

AGOURA HILLS, Calif., Nov. 15, 2023 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (OTCQB:OTLC) ("Oncotelic", the "Company" or "We"), a developer of treatments for rare and orphan indications, including Parkinson's Disease, PDAC, DIPG, and COVID-19, today announced financial results for the three months ended September 30, 2023 (“Q3 2023”) as compared to the three months ended September 30, 2022 (“Q3 2022”).

Key Points: 
  • AGOURA HILLS, Calif., Nov. 15, 2023 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (OTCQB:OTLC) ("Oncotelic", the "Company" or "We"), a developer of treatments for rare and orphan indications, including Parkinson's Disease, PDAC, DIPG, and COVID-19, today announced financial results for the three months ended September 30, 2023 (“Q3 2023”) as compared to the three months ended September 30, 2022 (“Q3 2022”).
  • The financial results are based on the Quarterly Report on Form 10-Q as filed with the Securities and Exchange Commission on November 14, 2023.
  • Highlights for Q3 2023 and thereafter:
    We have been enjoying the effects of the benefits of the JV transaction, between Dragon Overseas Limited (“Dragon”) and us, through the formation of GMP Biotechnology Limited (“GMP Bio” or “JV”) being reflected in our financial results.
  • “Commencing April 2022, with the culmination of the JV with Dragon, and continuing into 2023 till date, have been a good eighteen months for us.

Key Talc Lawyers: Planned “Prepack” J&J Bankruptcy is “Farce” and Improper Litigation Tactic

Retrieved on: 
Wednesday, December 13, 2023
Women, Legal, Oncology, General Health, Health, Professional Services, Consumer, Other Health, Asbestos, JNJ, NYSE, Johnson & Johnson, History, Patient, Mesothelioma, Science, Ovarian cancer, Lawyer, Talc, Deception, AND, Bankruptcy, Bloomberg News, J&J, Pharmaceutical industry, Security (finance)

Recent media reports indicate that J&J has abandoned litigation to settle cases with law firms representing approximately 100 victims of mesothelioma who were exposed to talc.

Key Points: 
  • Recent media reports indicate that J&J has abandoned litigation to settle cases with law firms representing approximately 100 victims of mesothelioma who were exposed to talc.
  • The science is clear.”
    Scientific consensus is unequivocal that asbestos exposure from J&J's products causes both mesothelioma and ovarian cancer.
  • J&J's prior failed bankruptcy strategy, attorneys say, not only harmed cancer victims and their families but also adversely impacted shareholders.
  • Concludes Mr. Birchfield, “The law says that bankruptcy can’t be used as a tactic in litigation to wear down plaintiffs and drive down the value of claims.

Publication in Bloomberg Law: ‘A Third J&J Bankruptcy Attempt Won’t Resolve Victims’ Talc Claims’ by Andy Birchfield

Retrieved on: 
Tuesday, December 5, 2023
Communications, Legal, Professional Services, Publishing, Asbestos, JNJ, NYSE, Johnson & Johnson, History, Mesothelioma, Weapon, Ovarian cancer, Talc, Bankruptcy, Face, J&J, Pharmaceutical industry, Bloomberg Law

Dozens of peer-reviewed scientific studies have reinforced the connection between talc usage and these debilitating diseases, with the presence in talc of asbestos, a known carcinogen, raising alarming concerns.

Key Points: 
  • Dozens of peer-reviewed scientific studies have reinforced the connection between talc usage and these debilitating diseases, with the presence in talc of asbestos, a known carcinogen, raising alarming concerns.
  • Rather than acknowledging the scientific evidence and providing equitable compensation to victims, Birchfield argues that Johnson & Johnson has resorted to evasive tactics and legal maneuvering.
  • Birchfield also sheds light on J&J's unwillingness to negotiate in good faith if it retains the threat of bankruptcy, which previously halted jury trials.
  • In light of J&J signaling a third bankruptcy filing, Birchfield calls for a united front to refuse further negotiations within the bankruptcy arena.

U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Opdivo (nivolumab) in Combination with Cisplatin-Based Chemotherapy for the First-Line Treatment of Adult Patients with Unresectable or Metastatic...

Retrieved on: 
Tuesday, December 5, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Cisplatin, Priority review, Bristol Myers Squibb, Safety, NYSE, Food, Hope, Progression-free survival, ESMO, Patient, PFS, BMY, FDA, Lung cancer, Checkmate, File, Survival, Cancer, Congress, PDUFA, OS, Mesothelioma, Pharmaceutical industry, Nivolumab

The FDA granted the application Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 5, 2024.

Key Points: 
  • The FDA granted the application Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 5, 2024.
  • “The FDA’s acceptance of our application for Opdivo in combination with cisplatin-based chemotherapy represents important progress toward addressing the unmet need for options that may offer durable responses and improved survival for patients with metastatic urothelial carcinoma.
  • The OS and PFS data from CheckMate -901 were presented at the European Society of Medical Oncology (ESMO) Congress 2023 .
  • The safety profile was tolerable and consistent with the known safety profiles of the individual components of the regimen.

Baron & Budd Represents Henrico County, Virginia in Lawsuit Against Pharmaceutical Manufacturers and Pharmacy Benefit Managers for Alleged Insulin Pricing Scheme

Retrieved on: 
Monday, November 20, 2023
Class Action Lawsuit, Professional Services, Legal, P.C, Government, Asbestos, Baron & Budd, P.C., Wildfire, Pharmacy, Insulin, Mesothelioma, Insulin lispro, PBM, Pharmaceutical industry

Today, the nationally recognized law firm Baron & Budd announced it is representing Henrico County, Virginia in a newly filed case against pharmaceutical manufacturers and pharmacy benefit managers (PBMs) alleging the defendants inflated the price of insulin and other diabetes medications.

Key Points: 
  • Today, the nationally recognized law firm Baron & Budd announced it is representing Henrico County, Virginia in a newly filed case against pharmaceutical manufacturers and pharmacy benefit managers (PBMs) alleging the defendants inflated the price of insulin and other diabetes medications.
  • Henrico County’s lawsuit alleges that the defendant pharmaceutical manufacturers colluded with pharmacy benefit managers to suppress competition and increase the prices of their insulins up to 1000%.
  • “Inflating the costs of life-saving medications, like insulin, puts an unnecessary financial burden on privately funded health plans,” said Baron & Budd Shareholder, Mark Pifko .
  • With more than 40 years of experience, Baron & Budd has the expertise and resources to handle complex litigation throughout the United States.

Baron & Budd Represents Arlington County, Virginia in Lawsuit Against Pharmaceutical Manufacturers and Pharmacy Benefit Managers for Alleged Insulin Pricing Scheme

Retrieved on: 
Friday, November 17, 2023
Class Action Lawsuit, Professional Services, Legal, P.C, Government, Asbestos, Baron & Budd, P.C., Wildfire, Pharmacy, Insulin, Mesothelioma, Insulin lispro, PBM, Pharmaceutical industry

The nationally recognized law firm Baron & Budd represents Arlington County, Virginia in a newly filed case against pharmaceutical manufacturers and pharmacy benefit managers (PBMs).

Key Points: 
  • The nationally recognized law firm Baron & Budd represents Arlington County, Virginia in a newly filed case against pharmaceutical manufacturers and pharmacy benefit managers (PBMs).
  • In the lawsuit, Arlington County alleges that the defendants inflated the price of insulin and other diabetes medications.
  • Arlington County’s lawsuit alleges that the defendant pharmaceutical manufacturers worked in tandem with pharmacy benefit managers to increase the prices of their insulins up to 1,000%, while also suppressing competition.
  • “Millions of individuals across the country need affordable access to life-saving medications like insulin,” said Baron & Budd Shareholder, Mark Pifko.

Talc Lawyer: Johnson & Johnson Settlements Undermine Bankruptcy Strategy, Serve as Acknowledgment That Baby Powder Contained Asbestos

Retrieved on: 
Friday, November 17, 2023
Legal, Professional Services, Woman, Asbestos, Baby powder, JNJ, NYSE, Johnson & Johnson, Alameda County Superior Court, Patient, Mesothelioma, FDA, Ovarian cancer, Talc, Action Replay, Bankruptcy, Superior court, J&J, Pharmaceutical industry

Andy Birchfield , head of the Mass Torts Section at the Beasley Allen Law Firm, says the settlements have profound implications.

Key Points: 
  • Andy Birchfield , head of the Mass Torts Section at the Beasley Allen Law Firm, says the settlements have profound implications.
  • “Perhaps this is an indication that J&J is abandoning its ‘bankruptcy or bust’ strategy in favor of good faith settlement discussions.
  • In October 2019, an FDA lab analysis of a Johnson’s Baby Powder sample revealed asbestos in the talc, leading to a voluntary recall of 33,000 bottles of Baby Powder.
  • We remain steadfast in our commitment to representing the interests of ovarian cancer patients and pursuing fair resolutions in the ongoing litigation against Johnson & Johnson.”

Ikena Oncology Shares Initial Positive and Differentiated Dose Escalation Data from IK-930 Phase I Trial and Reports Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 9, 2023
EGFR, Research, NSCLC, Fatigue, Epithelioid hemangioendothelioma, TEAD, Diarrhea, Physician, Hippopotamus, Weight gain, Meningioma, Liver, Quarter, Wind, Additive effect, Nausea, NF2, Quality of life, Growth, Disease, Caregiver, Clinical trial, Neoplasm, TEAD1, Biology, DLT, Cancer, Partnership, Collaboration, Mesothelioma, Liver failure, Nephrotoxicity, Blood, Pain, Patient, VGLL4, TAZ, EHE, Therapeutic index, Proteinuria, Pharmaceutical industry, Vaccine, Cryptocurrency, Pionýr

BOSTON, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Ikena Oncology, Inc. (Nasdaq: IKNA, “Ikena,” “Company”), a targeted oncology company forging new territory in patient-directed cancer treatment, today announced financial results for the quarter ended September 30, 2023, and provided a corporate update. The Company also shared initial data from twenty-six (26) patients treated in the ongoing dose escalation portion of the Phase I clinical trial of IK-930, a novel, oral, potent, and highly selective Hippo pathway inhibitor.

Key Points: 
  • The Company also shared initial data from twenty-six (26) patients treated in the ongoing dose escalation portion of the Phase I clinical trial of IK-930, a novel, oral, potent, and highly selective Hippo pathway inhibitor.
  • “This early look at the IK-930 dose escalation data strongly supports our differentiated approach to targeting the Hippo pathway.
  • Importantly, following the target biology and initially focusing on EHE has allowed us to observe clinical activity of IK-930 early in our dose escalation.
  • Twenty-six patients with a range of solid tumors were treated in the dose escalation portion of the study as of October 31, 2023.