WEBINAR:: The FDA Approval of Sarepta Therapeutics's ELEVIDYS to Duchenne Patients Ages 4 and up. https://lnkd.in/g773j3kG #DMD #FDA #CureDuchenne #Duchenne
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BioPharma & HealthTech Competitive Strategy & Insights | Digital & AI Solutions | Gene & Cell Therapy | Vaccines
Thoughts on this? >> FDA adcomm backs Carvykti's benefit in earlier patients; Abecma vote to come >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #biotech #pharmaceutical #healthcare #productmarketing
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Thoughts on this? >> FDA adcomm backs Carvykti's benefit in earlier patients; Abecma vote to come >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #biotech #healthcare #productmarketing #pharmaceutical #pharma
FDA adcomm backs Carvykti's benefit in earlier patients; Abecma vote to come
https://endpts.com
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Excellent hot take from Professor David Nutt about the shortcomings in the FDA’s recent policy position on MDMA-assisted psychotherapy for PTSD in light of the evidence base and in light of the Australian approval by the FDA. “This clinical data, presented by the MAPS for profit company Lykos, at face value fulfils the FDA requirement of two placebo-controlled trials demonstrating efficacy to permit marketing authorisation. The Lykos data showed this requirement was met with a between-subjects effect size of approximately 1 [a large effect size p<0.001]. This is about 3 time greater than that of the only class of licensed medicine used for PTSD, the SSRIs (fluoxetine sertraline venlafaxine and paroxetine) [Note the between subjects effect size subtracts the effect of the therapy from the effect of the therapy plus MDMA, leaving the effect only of the MDMA. A more clinically relevant effect size is the within-subjects effect size, 2.1 in MAPP1 and 1.95 in MAPP2]. The MDMA effect size is even more remarkable given that many of the patients in the MAPs trials were treatment-resistant i.e. had failed to adequately respond to both SSRIs and psychotherapy, an all-to-common situation for people with PTSD. As one member of the panel reportedly said “It is strange to vote no when the p-value involved three zeroes,” acknowledging the clear mathematical significance of the clinical results. An added benefit to the clinical efficacy data is that MDMA-assisted therapy differs from other medical treatments in psychiatry in that the drug administration is transient. In the Lykos trials just 3 doses of MDMA were given, unlike with other psychiatric medicines e.g. the SSRIs that are generally given chronically and hence carry a side-effect burden. What was especially surprising about the FDA panel’s vote was that other national expert groups had previously come to the opposite conclusion, i.e. that MDMA is a medicine (for some patients). In 2023 the Australian equivalent of the FDA [the TGA] decided to down-schedule MDMA to allow its use for treatment-resistant PTSD by authorised psychiatrists. Very recently the Dutch State Commission on MDMA, established by the government and comprised of experts from psychiatry, medicine, criminology, prevention and law, issued its recommendations two days before the AdCom decision. In a lengthy report the Commission concluded that “with what is currently known, there appears to be sufficient scientific evidence for the effectiveness and safety of this form of therapy” and “the government must act expeditiously to enable the therapeutic use of MDMA”. It concluded that until MDMA-assisted therapy is registered in the Netherlands, the best way to provide state-of-the-art treatment is through a large naturalistic study”. https://buff.ly/45G853b
You'll be interested to read a short article analysing the recent FDA Advisory Committee’s views against MDMA therapy. This article is a joint publication by @Drug_Science, @PareaScience and @MindMedicineAU. Read more: https://buff.ly/45G853b #psychedelics #fda #mdma #mentalhealth
Doubt it not, MDMA is a medicine
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For serious diseases lacking sufficient treatments, the FDA's Accelerated Approval regulatory pathway provides a means to expedite market access for promising new therapies. Our NDA Insight examines the qualification criteria for this expedited review route, such as validated surrogate endpoints that can reasonably predict clinical benefit earlier than traditional measures. It also explores uncertainties around confirmation of anticipated effects and lack of diligence in post-approval studies. Click the link below to understand better how to leverage Accelerated Approval in navigating development and regulatory review timelines. ⤵️ https://lnkd.in/dKuNvWKE #FDA #DrugDevelopment #RegulatoryScience #AcceleratedApproval #ExpeditedPathways #DrugApproval #RegulatoryAffairs #UnmetNeed
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The latest episode of Pharmacy Friends “Get the Skinny on GLP-1s” is available to listen to NOW!🎙️ In this episode, industry experts discuss clinical evidence, drug information and appropriate patient selection for GLP1 use. Listen here ➡️ https://lnkd.in/gJ7dwjxb
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New in our QTdrugs Blog Series: "Two medications are contraindicated for use together. Who says?" A recent study highlights the complexities and risks of prescribing fluconazole and itraconazole, with significant discrepancies between commercial medical databases. Discover the importance of reliable sources, such as FDA-approved drug labels and AZCERT's MedSafetyScan®, in ensuring safe prescribing practices. Read the full article for a deeper understanding of medication safety and informed decision-making: https://bit.ly/41NvNZJ #QTdrugs #MedicationSafety #CredibleMeds
Two medications are contraindicated for use together. Who says? :: Crediblemeds
crediblemeds.org
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Find out what FDA's 2024 draft guidance has to say about program-level DMCs in our blog:
The Value of Continuity: Program-level DSMBs
https://www.advarra.com
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In a move aimed to help those living with #psoriaticarthritis and #plaquepsoriasis, the U.S. FDA approved a #biosimilar, the second approval stemming from our strategic partnership with Alvotech. Biosimilars create opportunities for cost savings across healthcare systems and provide patients with additional treatment options. This milestone supports our commitment to expanding the availability, access, and uptake of #biosimilars in the U.S. for patients. Learn more about the impact: https://ow.ly/fAjA50RhGs2 #TevaPharm
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BioPharma & HealthTech Competitive Strategy & Insights | Digital & AI Solutions | Gene & Cell Therapy | Vaccines
Thoughts on this? >> Merck touts updated 21-valent pneumococcal data weeks ahead of FDA decision >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #productmarketing #pharmaceutical #biotech #healthcare
Merck touts updated 21-valent pneumococcal data weeks ahead of FDA decision
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Watch the recording from the FSHP Med Safety Clinical Forum webinar held on Jan 16: 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗲𝘀 𝘁𝗼 𝗱𝗿𝗶𝘃𝗲 𝗰𝗵𝗮𝗻𝗴𝗲 𝗯𝗮𝘀𝗲𝗱 𝗼𝗻 𝗜𝗦𝗠𝗣 𝗤𝘂𝗮𝗿𝘁𝗲𝗿𝗹𝘆 𝗥𝗲𝗽𝗼𝗿𝘁𝘀 Access this and other FSHP webinar recordings at: https://lnkd.in/es3BiPCp #pharmacy #MedSafety #webinar
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