Parexel’s Post

I’m excited to join the panel discussion during next week’s FDA-AACR public workshop on Optimizing Dosages for Oncology Drug Products! It will be a great discussion with a lot of practical examples on how to integrate dose optimization into drug development programs. The workshop is on Thursday and Friday next week and registration is free, please join us! https://lnkd.in/eciVhExX #AACRSciencePolicy

#News: The FDA will convene its Oncologic Drugs Advisory Committee (ODAC) for a full-day meeting March 15 to review the applications for Bristol Myers Squibb and 2seventy bio #Abecma and Johnson & Johnson and Legend Biotech ’s #Carvykti in earlier treatment of #multiplemyeloma, a government filing shows. External experts invited by the #FDA will review clinical data from Carvykti’s CARTITUDE-4 trial and Abecma’s KarMMa-3 study. In both cases, overall survival data will be the focus of the discussions. The meeting is expected to carry a lot of weight in the oncology community. For one, industry watchers are trying to take the #FDA’s pulse around the benefit-risk profile of #CART #celltherapies amid an investigation into a new safety signal of secondary #Tcell #cancers. In an even broader implication, the gathering offers cancer drug developers a chance to understand the FDA’s view around the impact of control arm crossovers on final patient survival. Read more from Fierce Pharma 👇🏽 https://lnkd.in/eYBJD33n

"Conclusion: About 32% of all oncology drug approvals have evidence for an improvement in Overall Survival. Higher standards are needed in drug regulation to ensure that approved drugs are delivering better patient outcomes, specifically in regards to survival." Not good: we have to invest more in the diagnostic tests that help oncologist identify those drugs that will address the patient-specific genomic variants in play. Something is wrong when we spend only 2 - 3% of our healthcare budget on the diagnostics that drive 2/3rds or more healthcare decisions. #Oncology #Healthcare #DrugRegulation #PatientOutcomes #DiagnosticTests #HealthcareDecisions #PrecisionMedicine #NGS

Did you catch our exciting recent news? We celebrated BVX001's FDA Orphan Drug Designation (ODD) for treating acute myeloid leukaemia.   This isn't just about the paperwork - it signifies a major step forward for BVX001's journey to becoming a revolutionary cancer treatment.   The ODD designation not only validates the critical need for novel therapies in AML, but strengthens BVX001's potential for market exclusivity – a key element for continued development. We also had a productive INTERACT meeting with the FDA, paving the way for a smoother Investigational New Drug (IND) application process as we move towards clinical trials.   This early success reflects BiVictriX’s commitment to developing groundbreaking treatments through our innovative Bi-Cygni® approach. As our CEO, Tiffany Thorn, said, “With strong alignment between our future development plans and the comments from the FDA reviewers, it is an exciting time for the company.”   This is an important milestone in BVX001's promising journey, taking us closer to bringing this therapy to patients. For more details, check out the full press release on our website: https://lnkd.in/eV_Jimxv   #DrugDevelopment #Oncology #Biotherapeutics #Biotech #ADC #Antibodies #AML

This study provides valuable insights into the most common topics and recurring queries discussed in oncology business pipeline meetings (BPMs) at the European Medicines Agency (EMA) . Hashtags: #oncology #BPMs #EMA #clinicaltrials #regulatory #pharma #drugdevelopment

In January, Keytruda picked up its 39th indication! 😲 It is an impactful medication in the oncology space. That impact goes past clinical as it can hit a medical benefit for $200K plus a year and that is if it is price reasonably, which we don't often see unfortunately! 💲 💲 💲 While we will most likely see loss of exclusivity by the end of the decade, with so many indications, and with multiple orphan drug approvals, it may not be clean cut so cost control measures are needed! At current, many providers are hesitant for this to go outside the hospital licensed space as it is related to cancer, but it is becoming more of a chronic treatment and doing so would help control costs. So, it is interesting news that Merck is going after a subcutaneous version. While too soon to know details, could this lead to home use and better cost control on pharmacy benefits. Can we get there sooner? #pharmacists #pharmacybenefits #oncology #medicaldrugs #savings https://lnkd.in/gf_kVeBy.

Only 2.2% of #Medicare beneficiaries with cancer are estimated to see lower drug costs under the Inflation Reduction Act's (IRA) pricing reforms. That’s according to a new #USCSchaeffer Center study co-authored by expert Mireille Jacobson. Published in JCO Oncology Practice, Jacobson and colleagues found that few cancer drugs covered by Medicare would meet the #IRA eligibility thresholds for price negotiations. Although novel #cancer drug treatments are priced high, they generally treat relatively few beneficiaries and do not meet negotiation eligibility criteria, which are primarily based on a ranking of total spending. Learn more here: https://lnkd.in/gB59eSZA USC Sol Price School of Public Policy USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences

Malignant Pleural Effusion Pipeline and Clinical Trials Assessment 2023: FDA Approvals, Therapies and Key Companies involved by DelveInsight | LIPAC Oncology, Clover Biopharmaceuticals, Wuhan YZY #Business #HealthMedicine #MarketingSales #PharmaceuticalsBiotech

The FDA's oncology chief, Dr. Richard Pazdur, adopting a familiar "regulatory flexibility" language when it comes to confirmatory trial requirement at the time of an accelerated approval, said: “If we really believe that there are no other therapeutic alternatives, then there will be obviously some degree of flexibility. When we do see, however, that there may be accelerated approval with the same class of drugs with the same diseases and with sponsors previously having most of the confirmatory study accrual already completed at the time of accelerated approval, we have to have a level playing field for all of the pharmaceutical companies.” #acceleratedapproval #FDA #cancerdrugs #oncology #oncologydrugs

(Benefit-Risk Management / Real-Time Oncology Review / Final Guidance) On the edge of regulatory science, oncology BLA and NDA applicants have been given an opportunity to submit topline data to regulatory reviewers at an earlier timeframe (under certain conditions). With the intent of identifying data quality and potential review issues and providing earlier feedback to the applicant upon data lock of registrational studies (pivotal, key studies) and before the full submission package is assembled, it's how cancer drug review is being accelerated! Benefits/risks to patients w/cancer. Enjoy. #fda #drugs #biologics #clinicaltrials #oncology #oncologytrials #clinicalstudies #nda #bla