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What Do Patients Have to Say about Gene Therapy Trials? An Upcoming FDA Public Meeting to Hear from Patients and Caregivers
…has the goal of trying to treat serious genetically based illnesses, which often are rare diseases caused by defective genes. The treatment consists of inserting healthy genes into an affected…
Novel Clinical Trial Designs for Gene Therapies: An Exploration of Challenges by the National Academiesâ Forum on Regenerative Medicine
…our additional coverage of gene therapy regulation: Gene Therapy and Orphan Drug “Sameness” here FDA’s Comprehensive Policy Framework for Regenerative Medicines here FDA “State of Cell and Gene Therapy Statement”…
Commissioner Gottlieb and CBER Director Marks Deliver âState of Cell and Gene Therapyâ Joint Statement
…cell and gene therapies, Commissioner Gottlieb and CBER Director Marks underscored the importance of FDA developing a comprehensive framework for these technologies. This is consistent with the work FDA has…
Fitting New Scientific Advances Into an Old Regulatory Paradigm (Part 2): Gene Therapy and Orphan Drug âSamenessâ
…recombinant virus gene therapy product has two components: (1) the genetic component (DNA or RNA); and (2) the viral vector. Determining the “sameness” of two genetic components would certainly seem…
NAD Says Fast Relief Claims for Crest Sensitivity Toothpaste Should Be Discontinued
…significant and immediate reduction or elimination of tooth sensitivity. Procter & Gamble had studies to support that the toothpaste could reduce tooth sensitivity, and the NAD determined that many aspects…
COVID At-Home Antigen Tests: If at First You Don’t Succeed Try, Try and Try Again
…performance data on this population. While companies were required to commit to conducting such studies post-authorization, none have been completed to date based on our knowledge. (This nebulous post-authorization study…
A Final LDT Rule in April!? Will FDA be Prepared?
…how many comments were actually logged in; on December 7, FDA showed 19,655 comments, and the next day 6,732.) While some comments were boilerplate, others were comprehensive, detailed critiques of…
A Historic Day in Drug Development: AveXis Gene Therapy for SMA Approved
On May 24, 2019, FDA approved Avexis’s BLA for its gene therapy, Zolgensma (onasemnogene abeparvovec-xioi), for treatment of spinal muscular atrophy (SMA). This represents the first approval of a systemically-administered…
Shhh! Itâs a Secret! FDA is Not Providing Key Details in the EUA Templates
We have previously posted about the heartache and anxiety that is the EUA process (here). Companies are waiting months for feedback from FDA and are frequently given comically short timelines…
What FDAâs Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?
…FDA following, in order, Luxturna (voretigene neparvovec), Zolgensma (onasemnogene abeparvovec) (see previous coverage here), Zynteglo (betibeglogene autotemcel), and Skysona (elivaldogene autotemcel). As demonstrated by the few gene therapies approved by…
Supreme Court Rules in Bartlett Generic Drug Preemption Case; Says State-Law Design-Defect Claims That Turn on a Drug Warningâs Adequacy are Preempted
…ruled that federal law does not preempt state-law design defect claims concerning generic drug products because any conflict between federal and state law can be avoided if the the generic…
FDA Issues âCliffs Notesâ-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)
…(3) comparability of the physiology and anatomy, and (4) the sensitivity of the selected species to potential toxicities. Additional specific considerations for cell therapies include the ability of the species/strain…
Preemption, Preemption, and More Preemption â A Cert Petition, a Circuit Court Decision, and the Upcoming Battle in Mutual v. Bartlett
…to mirror the label of the brand-name manufacturer preempt state-law failure-to-warn claims against generic drug manufacturers, because it is impossible for generic drug manufacturers to comply with both federal and…
With Briefing Over, Post-Mensing Generic Drug Preemption Appeal Awaits Word From the Supreme Court
…preventing generic drug manufacturers from changing their labeling except to mirror the label of the brand-name manufacturer preempt state-law failure-to-warn claims against generic drug manufacturers, because generic drug manufacturers are…
HP&M Attorney Mark Tobolowsky Co-Authors Article in Human Gene Therapy Advocating for the Acceptance of Microdystrophin Expression in DMD Patients as a Surrogate Endpoint for Accelerated Approval
…Gene Therapy. The article arose out of work conducted by the Pathway Development Consortium, a partnership between stakeholders in the AAV gene therapy space. The article describes the challenges facing…